How an ER Storyline Helped Pass the Patient Navigator Act

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SCRIPTDOCTOR: MEDICINE IN THE MEDIA How an ER Storyline Helped Pass the Patient Navigator Act

By Andrew Holtz, MPH picked up on the importance of patient Andrew Holtz, MPH, is a former CNN Medical Correspondent navigation and if even they have, then t’s a happy picture: President and the author of “The Medical Science of House, M.D.” This you’ve got to know that there’s rele- Bush beaming, flanked by smil- column examines mass media programs, particularly vance for this. So it was another way of ing members of Congress, as he entertainment TV, for insight into popular perceptions, so that stimulating the people who were work- signs the Patient Navigator Out- ing on it.” I rather than merely wincing at distortions or reach and Chronic Disease Prevention DoCanto notes that members of oversimplifications in the portrayals of medicine on these Act of 2005. It was one of the few Congress are besieged by pleas for shows, health care professionals can learn something from pieces of health care-related pieces of action…so anything that can cut legislation to reach his desk during media professionals about the way that medical and health through the clutter is useful. “They are the last session. topics are presented. Send questions to him about how the real people, too. They watch these pro- “For a bill that, in the scheme of media treat medical topics or suggestions for future columns grams. I think they do have an impact.” things, was small, for it to rise to the to [email protected] DoCanto got the video from Dr. level where the President invites the Freeman, who had worked with ER members of Congress who were in- writers to create the storyline. volved in this effort to the White House Dr. Freeman, now a Senior Adviser and they have a signing ceremony in move a bill funding more patient navi- and-true technique of bringing a to the Director of the NCI on cancer dis- the Oval Office, with photographs and gator programs. Hollywood celebrity to Washington to parities and Medical Director of the such; that’s pretty amazing,” says Licy But they also got an assist from open doors and perhaps win some Ralph Lauren Center for Cancer Care DoCanto, who was with the American some unusual “testimony:” votes. and Prevention in New York City, says Cancer Society’s Government Relations In the ER hallway, Dr. Ray Barnett the collaboration began with a briefing Office at the time. and Dr. Gregory Pratt look back ‘Refusal of Care’ Episode set up by the Hollywood, Health & For reasons I’ll explain shortly, I at a cancer patient and another Society program at USC Annenberg’s took a personal interest in the recollec- woman talking inside Trauma In the episode titled “Refusal of Care,” Norman Lear Center. He told the ER tions of DoCanto and other supporters Room One. doctors were trying to persuade a reluc- writers about patients who resisted of patient navigator programs, such as Barnett: “Where’d you find her?” tant patient to accept treatment for the surgery because they had the mistaken former Harlem Hospital Cancer Chief Pratt: “There’s a cancer support advanced cancer they had stumbled on belief that if air touches a tumor, the Harold Freeman, MD. They have group upstairs. They have patient while treating her for a bone fracture. cancer will spread. pushed for many years to expand the navigators to help people get The woman blocked out the pleas of use of these trained lay people, who through the system.” white-coated physicians, but opened up help guide patients through treatment Clips of an episode of ER featuring to a cancer survivor. and bridge the gulf between the worlds a patient navigator were played for leg- “I brought it to them,” says Do- “Members of Congress of patients and physicians. They used islators and key staffers in what could Canto. “Here we took a very popular all the standard lobbying techniques to be thought of as a twist on the tried- program and we said, ‘Even ER has are besieged by pleas for action, so anything that can cut through the clutter M. D. Anderson using thalidomide, an therapy, as is the Src oncogene inhibitor Osseous-Epithelial agent that is active in disrupting the dasatinib. And researchers will soon be is useful. They are real continued from page 22 interaction between a primary prostate using insulin-like growth factor-1 people, too. They watch cancer tumor and the bone stroma. blocking pathways in combination with prostate cancer progression and may Thalidomide is not an ideal drug for chemotherapy, he said. these programs. They do account for how prostate cancer pre- this purpose because of its adverse have an impact.” sents in the clinic, he said. The clinical effects, he noted, but there are new ‘Cutting Edge’ implication is that those pathways agents in development that do possess become further targets to consider in many of the properties of thalidomide Another speaker at the meeting, inhibiting the disease. without the toxicity. Gregory R. Mundy, MD, the John A. Dr. Freeman, a member of OT’s Dr. Logothetis said researchers saw Oates Chair in Translational Medicine Editorial Board, said he suspects the Combination Key a disruption of the stromal-epithelial and Director of the Vanderbilt Univer- myth may spring from stories of people interaction with thalidomide adminis- sity Center for Bone Biology, spoke who did not appear to be seriously ill As with many other newly developed tration, but importantly this was seen about this osseous-epithelial interaction until after they were treated. targeted therapies, treatments targeting prior to any evidence of an effect on the in an interview at the meeting. “The community translates the case the stromal-epithelial connection would epithelial compartments. “That’s just been characterized in into, I believe: ‘John walked into the have to be used as part of a combina- This validated the principle of tar- the last several years, and it’s clearly emergency room. He was strong tion regimen, Dr. Logothetis said. geting the host component in metastatic going to be very important for metasta- enough to walk in. They operated on Blocking the bone stroma alone would disease as a therapeutic approach. sis and maybe for the dormant state of him. He seemed to tolerate the surgery not be curative, although it could be a He mentioned some of the new some tumor cells,” Dr. Mundy said. okay; he was discharged in 10 days. strategy to prolong survival. agents in ongoing experiments that “That’s cutting-edge stuff.” And then he died.’ So the translation is: “Therapies blocking the stroma might interfere with this interaction: He said other speakers had de- ‘The air touched the cancer and caused plus cytotoxic therapies is how we Atrasentan, a selective endothelin-A scribed how cells now being identified the cancer to spread,’” Dr. Freeman envision it,” he said. receptor antagonist, was the first to in the bone marrow actually prepare said. enter major trials and is now being test- the metastatic site of the tumor cells to The pervasiveness of this belief Early Clinical Research ed in combination with chemotherapy. later settle down and grow. These are was documented in a 2003 survey by with Thalidomide Sunitinib, an inhibitor targeting several also in the bone marrow, he said, but Mitchell L. Margolis, MD, and col- receptor tyrosine kinases, is also being presumably the whole process is direct- leagues at the Philadelphia VA Medical O He described early clinical research at studied in combination with chemo- ed by the primary tumor cells. T (continued on page 25) ® and was severe in 1%. In patients with advanced colorectal cancer, acneform rash was reported in 89% ERBITUX (Cetuximab) (686/774) of all treated patients, and was severe in 11% (84/774). Subsequent to the development of severe dermatologic toxicities, complications including S. aureus sepsis and abscesses requiring incision and For intravenous use only. drainage were reported. Brief Summary of Prescribing Information. For complete prescribing information please consult official Patients developing dermatologic toxicities while receiving ERBITUX (Cetuximab) should be monitored package circular. for the development of inflammatory or infectious sequelae, and appropriate treatment of these symptoms initiated. Dose modifications of any future ERBITUX infusions should be instituted in case of severe WARNING acneform rash (see DOSAGE AND ADMINISTRATION, Table 3). Treatment with topical and/or oral antibi- Infusion Reactions: Severe infusion reactions occurred with the administration of ERBITUX in approx- otics should be considered; topical corticosteroids are not recommended. imately 3% of patients, rarely with fatal outcome (<1 in 1000). Approximately 90% of severe infusion Use of ERBITUX in Combination With Radiation and Cisplatin reactions were associated with the first infusion of ERBITUX. Severe infusion reactions are character- The safety of ERBITUX in combination with radiation therapy and cisplatin has not been established. ized by rapid onset of airway obstruction (bronchospasm, stridor, hoarseness), urticaria, hypotension Death and serious cardiotoxicity were observed in a single-arm trial with ERBITUX, delayed, accelerated and/or cardiac arrest (see WARNINGS and ADVERSE REACTIONS). Severe infusion reactions require (concomitant boost) fractionation radiation therapy, and cisplatin (100 mg/m2) conducted in patients with immediate interruption of the ERBITUX infusion and permanent discontinuation from further treatment. locally advanced squamous cell carcinoma of the head and neck. Two of 21 patients died, one as a (See WARNINGS: Infusion Reactions and DOSAGE AND ADMINISTRATION: Dose Modifications.) result of pneumonia and one of an unknown cause. Four patients discontinued treatment due to adverse Cardiopulmonary Arrest: Cardiopulmonary arrest and/or sudden death occurred in 2% (4/208) of events. Two of these discontinuations were due to cardiac events (myocardial infarction in one patient patients with squamous cell carcinoma of the head and neck treated with radiation therapy and ERBITUX and arrhythmia, diminished cardiac output, and hypotension in the other patient). as compared to none of 212 patients treated with radiation therapy alone. Fatal events occurred within 1 to 43 days after the last ERBITUX treatment. ERBITUX in combination with radiation therapy should PRECAUTIONS be used with caution in head and neck cancer patients with known coronary artery disease, congestive General heart failure, and arrhythmias. Although the etiology of these events is unknown, close monitoring of ERBITUX therapy should be used with caution in patients with known hypersensitivity to Cetuximab, serum electrolytes, including serum magnesium, potassium, and calcium, during and after ERBITUX ther- murine proteins, or any component of this product. apy is recommended. (See WARNINGS: Cardiopulmonary Arrest, PRECAUTIONS: Laboratory Tests: It is recommended that patients wear sunscreen and hats and limit sun exposure while receiving Electrolyte Monitoring, and ADVERSE REACTIONS: Electrolyte Depletion.) ERBITUX as sunlight can exacerbate any skin reactions that may occur. INDICATIONS AND USAGE Use of ERBITUX in Combination with Radiation Therapy Head and Neck Cancer ERBITUX plus radiation therapy should be used with caution in patients with a known history of coronary ERBITUX (Cetuximab), in combination with radiation therapy, is indicated for the treatment of locally or artery disease, arrhythmias and congestive heart failure. Close monitoring of serum electrolytes, includ- regionally advanced squamous cell carcinoma of the head and neck. ing serum magnesium, potassium, and calcium, during and after ERBITUX therapy is recommended. ERBITUX as a single agent is indicated for the treatment of patients with recurrent or metastatic squa- (See BOXED WARNING, WARNINGS: Cardiopulmonary Arrest, and PRECAUTIONS: Laboratory Tests: mous cell carcinoma of the head and neck for whom prior platinum-based therapy has failed. Electrolyte Monitoring.) Colorectal Cancer EGF Receptor Testing ERBITUX, used in combination with irinotecan, is indicated for the treatment of EGFR-expressing, metastatic Head and Neck Cancer colorectal carcinoma in patients who are refractory to irinotecan-based chemotherapy. Pretreatment assessment for evidence of EGFR expression is not required for patients with squamous cell ERBITUX administered as a single agent is indicated for the treatment of EGFR-expressing, metastatic carcinoma of the head and neck (SCCHN). colorectal carcinoma in patients who are intolerant to irinotecan-based chemotherapy. Colorectal Cancer The effectiveness of ERBITUX for the treatment of EGFR-expressing, metastatic colorectal carcinoma Patients enrolled in the colorectal cancer clinical studies were required to have immunohistochemical is based on objective response rates (see CLINICAL STUDIES in Full Prescribing Information). Currently, evidence of EGFR expression using the DakoCytomation EGFR pharmDx™ test kit. Assessment for EGFR no data are available that demonstrate an improvement in disease-related symptoms or increased expression should be performed by laboratories with demonstrated proficiency in the specific technol- survival with ERBITUX for the treatment of EGFR-expressing, metastatic colorectal carcinoma. ogy being utilized. Improper assay performance, including use of suboptimally fixed tissue, failure to utilize specified reagents, deviation from specific assay instructions, and failure to include appropriate CONTRAINDICATIONS controls for assay validation, can lead to unreliable results. Refer to the DakoCytomation test kit pack- None. age insert for full instructions on assay performance. (See CLINICAL STUDIES: EGFR Expression and Response in Full Prescribing Information.) WARNINGS Laboratory Tests: Electrolyte Monitoring Infusion Reactions (See BOXED WARNING: Infusion Reactions, ADVERSE REACTIONS: Infusion Patients should be periodically monitored for hypomagnesemia, and accompanying hypocalcemia and Reactions, and DOSAGE AND ADMINISTRATION: Dose Modifications.) hypokalemia, during and following the completion of ERBITUX therapy. Monitoring should continue for a Severe infusion reactions occurred with the administration of ERBITUX in approximately 3% (46/1485) of period of time commensurate with the half-life and persistence of the product; ie, 8 weeks. (See ADVERSE patients, rarely with fatal outcome (<1 in 1000). Approximately 90% of severe infusion reactions were REACTIONS: Electrolyte Depletion.) associated with the first infusion of ERBITUX despite the use of prophylactic antihistamines. These reactions were characterized by the rapid onset of airway obstruction (bronchospasm, stridor, hoarseness), Drug Interactions urticaria, hypotension, and/or cardiac arrest. Caution must be exercised with every ERBITUX infusion, as A drug interaction study was performed in which ERBITUX was administered in combination with irinotecan. there were patients who experienced their first severe infusion reaction during later infusions. A 1-hour There was no evidence of any pharmacokinetic interactions between ERBITUX and irinotecan. observation period is recommended following the ERBITUX infusion. Longer observation periods may be Carcinogenesis, Mutagenesis, Impairment of Fertility required in patients who experience infusion reactions. Long-term animal studies have not been performed to test Cetuximab for carcinogenic potential. No Severe infusion reactions require the immediate interruption of ERBITUX therapy and permanent dis- mutagenic or clastogenic potential of Cetuximab was observed in the Salmonella-Escherichia coli (Ames) continuation from further treatment. Appropriate medical therapy including epinephrine, corticosteroids, assay or in the in vivo rat micronucleus test. A 39-week toxicity study in cynomolgus monkeys receiv- intravenous antihistamines, bronchodilators, and oxygen should be available for use in the treatment of ing 0.4 to 4 times the human dose of Cetuximab (based on total body surface area) revealed a tendency such reactions. Patients should be carefully observed until the complete resolution of all signs and symp- for impairment of menstrual cycling in treated female monkeys, including increased incidences of irreg- toms. ularity or absence of cycles, when compared to control animals, and beginning from week 25 of treat- In clinical trials, mild to moderate infusion reactions were managed by slowing the infusion rate of ERBITUX ment and continuing through the 6-week recovery period. Serum testosterone levels and analysis of and by continued use of antihistamine medications (eg, diphenhydramine) in subsequent doses (see sperm counts, viability, and motility were not remarkably different between Cetuximab-treated and con- DOSAGE AND ADMINISTRATION: Dose Modifications). trol male monkeys. It is not known if Cetuximab can impair fertility in humans. Cardiopulmonary Arrest (See BOXED WARNING: Cardiopulmonary Arrest, PRECAUTIONS: Labora- Pregnancy Category C tory Tests: Electrolyte Monitoring, and ADVERSE REACTIONS: Electrolyte Depletion.) Animal reproduction studies have not been conducted with Cetuximab. However, the EGFR has been In a randomized, controlled trial in patients with squamous cell carcinoma of the head and neck (SCCHN), implicated in the control of prenatal development and may be essential for normal organogenesis, prolif- cardiopulmonary arrest and/or sudden death occurred in 4/208 patients (2%) treated with radiation eration, and differentiation in the developing embryo. In addition, human IgG1 is known to cross the therapy and ERBITUX as compared to none of 212 patients treated with radiation therapy alone. Three placental barrier; therefore Cetuximab has the potential to be transmitted from the mother to the devel- patients with prior history of coronary artery disease died at home, with myocardial infarction as the pre- oping fetus. It is not known whether ERBITUX can cause fetal harm when administered to a pregnant sumed cause of death. One of these patients had arrhythmia and one had congestive heart failure. Death woman or whether ERBITUX can affect reproductive capacity. There are no adequate and well-controlled occurred 27, 32, and 43 days after the last dose of ERBITUX. One patient with no prior history of coro- studies of ERBITUX in pregnant women. ERBITUX should only be given to a pregnant woman, or any nary artery disease died one day after the last dose of ERBITUX. ERBITUX in combination with radiation woman not employing adequate contraception if the potential benefit justifies the potential risk to the therapy should be used with caution in head and neck cancer patients with a history of coronary artery fetus. All patients should be counseled regarding the potential risk of ERBITUX treatment to the develop- disease, congestive heart failure, and arrhythmias. Although the etiology of these events is unknown, close ing fetus prior to initiation of therapy. If the patient becomes pregnant while receiving this drug, she monitoring of serum electrolytes, including serum magnesium, potassium, and calcium, during and after should be apprised of the potential hazard to the fetus and/or the potential risk for loss of the pregnancy. ERBITUX therapy is recommended. Nursing Mothers Pulmonary Toxicity It is not known whether ERBITUX is secreted in human milk. Because human IgG is secreted in human Interstitial lung disease (ILD) was reported in 3 of 774 (<0.5%) patients with advanced colorectal can- milk, the potential for absorption and harm to the infant after ingestion exists. Based on the mean half- cer and in 1 of 796 patients with head and neck cancer receiving ERBITUX in clinical studies. Among these life of Cetuximab after multiple dosing of 114 hours [range 75-188 hours] (see CLINICAL PHARMA- four cases, interstitial pneumonitis with non-cardiogenic pulmonary edema resulting in death was COLOGY: Human Pharmacokinetics in Full Prescribing Information), women should be advised to reported in one patient with colon cancer. In two of the remaining cases, the patients had pre-existing discontinue nursing during treatment with ERBITUX and for 60 days following the last dose of ERBITUX. fibrotic lung disease and experienced an acute exacerbation of their disease while receiving ERBITUX in combination with irinotecan. The onset of symptoms occurred between the fourth and eleventh doses of Pediatric Use treatment in all reported cases. The safety and effectiveness of ERBITUX in pediatric patients have not been established. In the event of acute onset or worsening pulmonary symptoms, ERBITUX therapy should be inter- Geriatric Use rupted and a prompt investigation of these symptoms should occur. If ILD is confirmed, ERBITUX should Of the 424 patients with head and neck cancer who received ERBITUX with radiation therapy or radia- be discontinued and the patient should be treated appropriately. tion therapy alone, 110 patients were 65 years of age or older [65 (30%) in the radiation therapy alone Dermatologic Toxicity (See ADVERSE REACTIONS: Dermatologic Toxicity and DOSAGE AND ADMIN- arm, 45 (21%) in the radiation and ERBITUX arm]. In a subgroup analysis of patients less than 65 years ISTRATION: Dose Modifications.) of age, the hazard ratio of the radiation and ERBITUX arm versus radiation therapy alone arm for dura- In cynomolgus monkeys, Cetuximab, when administered at doses of approximately 0.4 to 4 times the weekly tion of locoregional control was 0.68 (95% confidence interval 0.50-0.93), and in patients age 65 years human exposure (based on total body surface area), resulted in dermatologic findings, including inflam- and older the hazard ratio was 0.87 (95% confidence interval 0.56-1.37). For overall survival, the mation at the injection site and desquamation of the external integument. At the highest dose level, the hazard ratio in patients less than 65 years of age was 0.68 (95% confidence interval 0.49-0.94), and in epithelial mucosa of the nasal passage, esophagus, and tongue were similarly affected, and degenera- patients age 65 years and older the hazard ratio was 1.15 (95% confidence interval 0.72-1.84). tive changes in the renal tubular epithelium occurred. Deaths due to sepsis were observed in 50% (5/10) Of the 774 patients who received ERBITUX with irinotecan or ERBITUX monotherapy in four advanced of the animals at the highest dose level beginning after approximately 13 weeks of treatment. colorectal cancer studies, 253 patients (33%) were 65 years of age or older. No overall differences in safety In clinical studies of ERBITUX, dermatologic toxicities, including acneform rash, skin drying and fissuring, or efficacy were observed between these patients and younger patients. and inflammatory and infectious sequelae (eg, blepharitis, cheilitis, cellulitis, cyst) were reported. In ADVERSE REACTIONS patients with head and neck cancer treated with ERBITUX plus radiation, acneform rash was reported in Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed 87% as compared with 10% in patients treated with radiation therapy alone. The incidence of severe acne- in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and form rash was markedly increased in the ERBITUX plus radiation arm (17% versus 1%). In patients with may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, head and neck cancer treated with ERBITUX monotherapy, acneform rash was reported in 76% of patients

that. And then I said, ‘Hopefully, you Graham: “You want to cut me? I Dr. Pratt: “Relax.” ScriptDoctor could utilize something I developed, don’t think so. Graham: “No, no…” continued from page 24 and that is a patient navigator, who is a Dr. Pratt: “An operation may be Dr. Barnett: “It’s okay…” lay person who can talk to people, and part of the treatment plan.” Graham: “You don’t cut into Center and University of Pennsylvania, those people will tend more to listen to Agitated, Graham sits up, tries to get cancer…” the Los Angeles VA Medical Center, somebody who looks and talks like out of bed. Dr. Barnett: “We’re not going to.” and the Medical University of South them.’ They then created an episode Graham: “Where are my clothes?” Graham: “I know what happens.” Carolina. Of 626 consecutive patients in that involves both of those things.” Dr. Barnett: “Take it easy, you’re all Dr. Pratt: “Settle down.” pulmonary and lung cancer clinics, 38% ER writer Joe Sachs, MD, picks up hooked up.” Graham: “You cut into cancer, it stated that they believe air exposure at what happened next: “So we did a Alarms sound as some of the monitor spreads…” surgery causes tumor spread. The belief story where [the character of Dr.] Pratt cables disconnect. Dr. Pratt: “Mrs. Graham…” was more common among African- confronted, but couldn’t get through to, Graham: “I never should have come Graham: “It spreads and you die.” American patients, with almost one in this woman who absolutely refused here.” Dr. Sachs says he was drawn to the five saying it was a reason for opposing surgery.” Dr. Pratt: “You need to stay.” topic because it allowed them to surgery. Graham: “I don’t want you cutting explore Dr. Pratt’s struggle with the “So I said,” Dr. Freeman recalled, Scene in Trauma One as Dr. Pratt and Dr. into me.” gap that had developed between him “‘Maybe you should create a scene in Barnett examine cancer patient Debra Pratt and Barnett have to hold her and the world he had grown up in. He which you have a patient who believes Graham: down for her own safety. (continued on page 26) however, provide a basis for identifying the adverse events that appear to be related to drug use and for Table 1: Incidence of Selected Adverse Events (*10%) in Patients with Locoregionally Advanced approximating rates. SCCHN (continued) Immunogenicity ERBITUX plus Radiation Radiation Therapy Alone As with all therapeutic proteins, there is potential for immunogenicity. Potential immunogenic responses (n=208) (n=212) to Cetuximab were assessed using either a double antigen radiometric assay or an enzyme-linked Grades Grades Grades Grades immunosorbant assay. Due to limitations in assay performance and sampling timing, the incidence of Body System 1-4 3 and 4 1-4 3 and 4 antibody development in patients receiving ERBITUX (Cetuximab) has not been adequately determined. Preferred Term % of Patients The incidence of antibodies to Cetuximab was measured by collecting and analyzing serum pre-study, prior Metabolic/Nutritional to selected infusions and during treatment follow-up. Patients were considered evaluable if they had a neg- Weight Loss 84 11 72 7 ative pre-treatment sample and a post-treatment sample. Non-neutralizing anti-Cetuximab antibodies were Dehydration 25 6 19 8 detected in 5% (49 of 1001) of evaluable patients. In patients positive for anti-Cetuximab antibody, the Respiratory median time to onset was 44 days (range 8-281 days). Although the number of sero-positive patients is Pharyngitis 26 3 19 4 limited, there does not appear to be any relationship between the appearance of antibodies to Cetuximab Cough Increased 20 <1 19 0 and the safety or antitumor activity of ERBITUX. The observed incidence of anti-Cetuximab antibody responses may be influenced by the low sensitivity Skin/Appendages 3 of available assays, inadequate to reliably detect lower antibody titers. Other factors which might influ- Acneform Rash 87 17 10 1 ence the incidence of anti-Cetuximab antibody response include sample handling, timing of sample col- Radiation Dermatitis 86 23 90 18 lection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence Application Site Reaction 18 0 12 1 of antibodies to Cetuximab with the incidence of antibodies to other products may be misleading. Pruritus 16 0 4 0 1 Includes cases also reported as infusion reaction. Electrolyte Depletion 2 In 244 patients evaluated in ongoing, controlled clinical trials, the incidence of hypomagnesemia, both Infusion reaction is defined as any event described at any time during the clinical study as “allergic reac- overall and severe (NCI-CTC Grades 3 and 4), was increased in patients receiving ERBITUX alone or in com- tion” or “anaphylactoid reaction”, or any event occurring on the first day of dosing described as “allergic reaction”, “anaphylactoid reaction”, “fever”, “chills”, “chills and fever”, or “dyspnea”. bination with chemotherapy as compared to those receiving best supportive care or chemotherapy alone. 3 Approximately one-half of these patients receiving ERBITUX experienced hypomagnesemia and 10-15% Acneform rash is defined as any event described as “acne”, “rash”, “maculopapular rash”, “pustular experienced severe hypomagnesemia. The onset of electrolyte abnormalities has been reported to occur rash”, “dry skin”, or “exfoliative dermatitis”. from days to months after initiation of ERBITUX. Electrolyte repletion was necessary in some patients and Late Radiation Toxicity in severe cases, intravenous replacement was required. The time to resolution of electrolyte abnormal- The overall incidence of late radiation toxicities (any grade) was higher in ERBITUX (Cetuximab) in com- ities is not well known, hence monitoring during and after ERBITUX treatment is recommended. (See bination with radiation therapy compared with radiation therapy alone. The following sites were affected: PRECAUTIONS: Laboratory Tests: Electrolyte Monitoring.) salivary glands (65% versus 56%), larynx (52% versus 36%), subcutaneous tissue (49% versus 45%), Infusion Reactions (see BOXED WARNING: Infusion Reactions) mucous membrane (48% versus 39%), esophagus (44% versus 35%), skin (42% versus 33%), brain (11% In clinical trials, severe, potentially fatal infusion reactions were reported. These events include the rapid versus 9%), lung (11% versus 8%), spinal cord (4% versus 3%), and bone (4% versus 5%). The incidence onset of airway obstruction (bronchospasm, stridor, hoarseness), urticaria, and/or hypotension. In major of Grade 3 or 4 late radiation toxicities were generally similar between the radiation therapy alone and clinical studies in advanced SCCHN, severe infusion reactions (Grade 3 or 4) were observed in 3% of patients the ERBITUX plus radiation treatment groups. receiving ERBITUX plus radiation and 4% of patients receiving ERBITUX monotherapy. In studies in Colorectal Cancer advanced colorectal cancer, severe infusion reactions were observed in 3% of patients receiving ERBITUX Except where indicated, the data described below reflect exposure to ERBITUX in 774 patients with plus irinotecan and 2% of patients receiving ERBITUX monotherapy. Grade 1 and 2 infusion reactions, includ- advanced metastatic colorectal cancer. ERBITUX was studied in combination with irinotecan (n=354) or ing chills, fever, and dyspnea usually occurring on the first day of initial dosing, were observed in 16% as monotherapy (n=420). Patients receiving ERBITUX plus irinotecan received a median of 12 doses [with of patients receiving ERBITUX plus irinotecan and 19% of patients receiving ERBITUX monotherapy. (See 88/354 (25%) treated for over 6 months], and patients receiving ERBITUX monotherapy received a median WARNINGS: Infusion Reactions and DOSAGE AND ADMINISTRATION: Dose Modifications.) of 7 doses [with 36/420 (9%) treated for over 6 months]. The population had a median age of 59 and was In the clinical studies described above, a 20-mg test dose was administered intravenously over 10 min- 59% male and 91% Caucasian. The range of dosing for patients receiving ERBITUX plus irinotecan was utes prior to the loading dose to all patients. The test dose did not reliably identify patients at risk for severe 1-84 infusions, and the range of dosing for patients receiving ERBITUX monotherapy was 1-63 infusions. allergic reactions. The most serious adverse reactions associated with ERBITUX were: Head and Neck Cancer • Infusion reaction (3%) (see BOXED WARNING, WARNINGS, and DOSAGE AND ADMINISTRATION: Except where indicated, the data described below reflect exposure to ERBITUX in 208 patients with Dose Modifications); locally or regionally advanced SCCHN who received ERBITUX in combination with radiation and as • Dermatologic toxicity (1%) (see WARNINGS and DOSAGE AND ADMINISTRATION: Dose Modifications); monotherapy in 103 patients with recurrent or metastatic SCCHN. Of the 103 patients receiving ERBITUX • Interstitial lung disease (0.4%) (see WARNINGS); monotherapy, 53 continued to a second phase with the combination of ERBITUX plus chemotherapy. • Fever (5%); Patients receiving ERBITUX plus radiation therapy received a median of 8 doses (range 1-11 infu- • Sepsis (3%); sions). The population had a median age of 56; 81% were male and 84% Caucasian. • Kidney failure (2%); Patients receiving ERBITUX monotherapy, received a median of 11 doses (range 1-45 infusions). The • Pulmonary embolus (1%); population had a median age of 57; 82% were male and 100% Caucasian. • Dehydration (5%) in patients receiving ERBITUX plus irinotecan, 2% in patients receiving ERBITUX The most serious adverse reactions associated with ERBITUX in combination with radiation therapy monotherapy; in patients with head and neck cancer were: • Diarrhea (6%) in patients receiving ERBITUX plus irinotecan, 0.2% in patients receiving ERBITUX • Infusion reaction (3%) (see BOXED WARNINGS, WARNINGS, and DOSAGE AND ADMINISTRA- monotherapy. TION: Dose Modifications); Thirty-seven (10%) patients receiving ERBITUX plus irinotecan and 17 (4%) patients receiving ERBITUX • Cardiopulmonary arrest (2%) (see BOXED WARNINGS, WARNINGS); monotherapy discontinued treatment primarily because of adverse events. • Dermatologic toxicity (2.5%) (see WARNINGS and DOSAGE AND ADMINISTRATION: Dose Modifi- The most common adverse events seen in 354 patients receiving ERBITUX plus irinotecan were acne- cations); form rash (88%), asthenia/malaise (73%), diarrhea (72%), nausea (55%), abdominal pain (45%), and vom- • Mucositis (6%); iting (41%). • Radiation dermatitis (3%); The most common adverse events seen in 420 patients receiving ERBITUX monotherapy were acne- • Confusion (2%); form rash (90%), asthenia/malaise (48%), nausea (29%), fever (27%), constipation (26%), abdominal pain • Diarrhea (2%). (26%), headache (26%), and diarrhea (25%). Fourteen (7%) patients receiving ERBITUX plus radiation therapy and 5 (5%) patients receiving ERBITUX Data in patients with advanced colorectal carcinoma in Table 2 are based on the experience of 354 patients monotherapy, discontinued treatment primarily because of adverse events. treated with ERBITUX plus irinotecan and 420 patients treated with ERBITUX monotherapy. The most common adverse events seen in 208 patients receiving ERBITUX in combination with radi- Table 2: Incidence of Adverse Events (*10%) in Patients with Advanced Colorectal Carcinoma ation therapy were acneform rash (87%), mucositis (86%), radiation dermatitis (86%), weight loss (84%), ERBITUX plus Irinotecan ERBITUX Monotherapy xerostomia (72%), dysphagia (65%), asthenia (56%), nausea (49%), constipation (35%), and vomiting (29%). (n=354) (n=420) The most common adverse events seen in 103 patients receiving ERBITUX monotherapy were acneform rash (76%), asthenia (45%), pain (28%), fever (27%), and weight loss (27%). Grades Grades Grades Grades Body System 1-4 3 and 4 1-4 3 and 4 The data in Table 1 are based on the experience of 208 patients with locoregionally advanced SCCHN 1 treated with ERBITUX plus radiation therapy compared to 212 patients treated with radiation therapy Preferred Term % of Patients alone. Body as a Whole Asthenia/Malaise2 73 16 48 10 * Table 1: Incidence of Selected Adverse Events ( 10%) in Patients with Locoregionally Advanced Abdominal Pain 45 8 26 9 SCCHN Fever3 34 4 27 <1 ERBITUX plus Radiation Radiation Therapy Alone Pain 23 6 17 5 (n=208) (n=212) Infusion Reaction4 19 3 21 2 Grades Grades Grades Grades Infection 16 1 14 1 Body System 1-4 3 and 4 1-4 3 and 4 Back Pain 16 3 10 2 Preferred Term % of Patients Headache 14 2 26 2 Digestive Body as a Whole Diarrhea 72 22 25 2 Asthenia 56 4 49 5 Nausea 55 6 29 2 Fever1 29 1 13 1 Vomiting 41 7 25 3 Headache 19 <1 8 <1 Anorexia 36 4 23 2 Infusion Reaction2 15 3 2 0 Constipation 30 2 26 2 Infection 13 1 9 1 Stomatitis 26 2 10 <1 Chills1 16 0 5 0 Dyspepsia 14 0 6 0 Digestive Hematic/Lymphatic Mucositis/Stomatitis 93 56 94 52 Leukopenia 25 17 <1 0 Xerostomia 72 5 71 3 Anemia 16 5 9 3 Dysphagia 65 26 63 30 Metabolic/Nutritional Nausea 49 2 37 2 Weight Loss 21 0 7 1 Constipation 35 5 30 5 Peripheral Edema 16 1 10 1 Vomiting 29 2 23 4 Dehydration 15 6 10 3 Anorexia 27 2 23 2 Nervous Diarrhea 19 2 13 1 Insomnia 12 0 10 <1 Dyspepsia 14 0 9 1 Depression 10 0 7 0 (continued) (continued)

beliefs.” matic story for Pratt and then, as a side done by Elmer E. Huerta, MD, MPH, of ScriptDoctor Dr. Sachs had latched onto the can- effect, having it result in the passage of Washington Cancer Institute. continued from page 25 cer myths and patient navigator con- congressional legislation that’s going to “The media, without a doubt, was cepts brought to him by a New York affect millions of people. That’s a cool critical as an influence,” DoCanto says. had left his poor Chicago neighbor- City oncologist because of their dramat- story,” Dr. Sachs says. hood, gained an education and a med- ic potential. It was a bonus that the ER Licy DoCanto says that of course Staffers Who Worked on ical degree; but he had lost the ability to episode then echoed from Los Angeles many people worked on many efforts the Legislation Credit the connect with people who were once his back to Washington, DC. over several years to win federal fund- Show with Helping to neighbors. ing for patient navigator programs, Raise Awareness “And then a patient navigator was ‘Remarkable Circle’ such as Gilbert H. Friedell, MD, at the brought in who started to get through University of Kentucky Cancer Center, Representative (now Senator) Bob to her. It was somebody like her from “So that’s a remarkable circle of that who could show that the problems Menendez (D-NJ) sponsored the House the community, who had cancer that story, starting with the kernel of an idea weren’t restricted to big cities. But the bill to fund patient navigator programs. had spread to the bone and was in from a briefing about the fact that there ER episode came along at the right His spokesman, Allyn Brooks-LaSure, remission three years out,” Dr. Sachs are differences in cancer statistics in the time, and it dovetailed with other says that staffers who worked on the says. “And that clip worked dramati- inner city and in more suburban areas, media outreach, such as Dr. Freeman’s legislation credit the ER clips with help- cally for Pratt, who is educated and talking to the expert, Dr. Harold Free- work with the Ralph Lauren Center ing to raise awareness. smart, to have to confront some of these man, coming up with a compelling dra- and Spanish-language radio programs “They didn’t see any sort of direct Table 2: Incidence of Adverse Events (*10%) in Patients with Advanced Colorectal Carcinoma Dose Modifications (continued) Infusion Reactions PAGE 27 ERBITUX plus Irinotecan ERBITUX Monotherapy If the patient experiences a mild or moderate (Grade 1 or 2) infusion reaction, the infusion rate should be (n=354) (n=420) permanently reduced by 50%. ERBITUX (Cetuximab) should be immediately and permanently discontinued in patients who experience Grades Grades Grades Grades severe (Grade 3 or 4) infusion reactions. (See WARNINGS and ADVERSE REACTIONS.) Body System 1-4 3 and 4 1-4 3 and 4 Preferred Term1 % of Patients Dermatologic Toxicity and Related Disorders Respiratory Dosage modifications for dermatologic toxicity are recommended for severe acneform rash (NCI CTC Grades Dyspnea3 23 2 17 7 3 or 4), as specified in Table 3. ERBITUX dosage modification is not recommended for severe radiation der- Cough Increased 20 0 11 1 matitis. (See WARNINGS and ADVERSE REACTIONS.) AstraZeneca Giving Skin/Appendages Table 3: ERBITUX Dose Modification Guidelines Acneform Rash5 88 14 90 8 Severe Acneform ERBITUX Outcome ERBITUX Dose Alopecia 21 0 4 0 Rash Modification $10 Million to Skin Disorder 15 1 4 0 1st occurrence Delay infusion Improvement Continue at 250 mg/m2 Nail Disorder 12 <1 16 <1 1 to 2 weeks No Improvement Discontinue ERBITUX ACS Patient Pruritus 10 1 11 <1 Conjunctivitis 14 1 7 <1 2nd occurrence Delay infusion Improvement Reduce dose to 200 mg/m2 1 to 2 weeks No Improvement Discontinue ERBITUX 1 Adverse events that occurred (toxicity Grades 1 through 4) in *10% of patients with refractory colorectal Navigator Program carcinoma treated with ERBITUX (Cetuximab) plus irinotecan or in *10% of patients with refractory 3rd occurrence Delay infusion Improvement Reduce dose to 150 mg/m2 colorectal carcinoma treated with ERBITUX monotherapy. 1 to 2 weeks No Improvement Discontinue ERBITUX 2 Asthenia/malaise is defined as any event described as “asthenia”, “malaise”, or “somnolence”. 4th occurrence Discontinue ERBITUX s OT went to press, Astra- 3 Includes cases also reported as infusion reaction. 4 Infusion reaction is defined as any event described at any time during the clinical study as “allergic A Zeneca and the American ® reaction” or “anaphylactoid reaction”, or any event occurring on the first day of dosing described as ERBITUX is a registered trademark of ImClone Systems Incorporated. Cancer Society announced a col- “allergic reaction”, “anaphylactoid reaction”, “fever”, “chills”, “chills and fever”, or “dyspnea”. Manufactured by ImClone Systems Incorporated, Branchburg, NJ 08876 5 Acneform rash is defined as any event described as “acne”, “rash”, “maculopapular rash”, “pustular Distributed and Marketed by Bristol-Myers Squibb Company, Princeton, NJ 08543 laboration to significantly extend rash”, “dry skin”, or “exfoliative dermatitis”. Dermatologic Toxicity and Related Disorders the reach of the Society’s Patient Non-suppurative acneform rash described as “acne”, “rash”, “maculopapular rash”, “pustular rash”, “dry Navigator Program. skin”, or “exfoliative dermatitis” was observed in patients receiving ERBITUX plus radiation, ERBITUX plus irinotecan, or ERBITUX monotherapy. One or more of the dermatological adverse events were reported The company has pledged in 87% (17% Grade 3 or 4) of patients receiving ERBITUX plus radiation and in 76% (1% Grade 3 or 4) receiving ERBITUX monotherapy during treatment for advanced SCCHN. In studies of advanced colorec- funding of $10 million to help the tal cancer, dermatological adverse events were reported in 88% (14% Grade 3) of patients receiving ERBITUX ©2006 by ImClone Systems Incorporated and Bristol-Myers Squibb Company. plus irinotecan and in 90% (8% Grade 3) of patients receiving ERBITUX monotherapy. Acneform rash most All rights reserved. ACS develop at least 50 new commonly occurred on the face, upper chest, and back, but could extend to the extremities and was char- ER-B0001A-03-06 Revised March 2006 Patient Navigator Program sites acterized by multiple follicular- or pustular-appearing lesions. Skin drying and fissuring were common Based on 51-022606-04, 1169848A4 in some instances, and were associated with inflammatory and infectious sequelae (eg, blepharitis, over the next five years. There are cellulitis, cyst). Two cases of S. aureus sepsis were reported. The onset of acneform rash was generally within the first two weeks of therapy. Although in a majority of the patients the event resolved following currently 60 such sites across the cessation of treatment, in nearly half of the cases, the event continued beyond 28 days. US. (See WARNINGS: Dermatologic Toxicity and DOSAGE AND ADMINISTRATION: Dose Modifications.) A related nail disorder, occurring in 12% of patients (0.4% Grade 3), was characterized as a The first new three sites are paronychial inflammation with associated swelling of the lateral nail folds of the toes and fingers, with the great toes and thumbs as the most commonly affected digits. Seattle Cancer Care Alliance; OVERDOSAGE Helen F. Graham Cancer Center Single doses of ERBITUX higher than 500 mg/m2 have not been tested. There is no experience with at Christiana Care in Wilmington, overdosage in human clinical trials. DE; and, John H. Stroger Jr. Hos- DOSAGE AND ADMINISTRATION General pital of Cook County in Chicago. Premedication with an H1 antagonist (eg, 50 mg of diphenhydramine IV) is recommended. Appropriate medical resources for the treatment of severe infusion reactions should be available during ERBITUX Harold P. Freeman, MD, infusions. (See WARNINGS: Infusion Reactions.) Medical Director of the Ralph Squamous Cell Carcinoma of the Head and Neck The recommended dose of ERBITUX, in combination with radiation therapy is 400 mg/m2 as an initial load- Lauren Cancer Center in Harlem, ing dose (first infusion) administered as a 120-minute IV infusion (maximum infusion rate 5 mL/min) NY, who pioneered the concept, one week prior to initiation of a course of radiation therapy. The recommended weekly maintenance dose (all other infusions) is 250 mg/m2 infused over 60 minutes (maximum infusion rate 5 mL/min) said in a statement, “Patient navi- weekly for the duration of radiation therapy (6-7 weeks). In clinical studies, Cetuximab was administered 1 hour prior to radiation therapy. gators directly assist patients by The recommended dosing regimen for single-agent ERBITUX in the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck is a 400-mg/m2 initial dose followed by 250 mg/m2 eliminating financial, communi- weekly until disease progression or unacceptable toxicity. cation and emotional barriers to Colorectal Cancer The recommended dose of ERBITUX, in combination with irinotecan, or as monotherapy, is 400 mg/m2 timely diagnosis and treatment. as an initial loading dose (first infusion) administered as a 120-minute IV infusion (maximum infusion rate This kind of support may be life 5 mL/min). The recommended weekly maintenance dose (all other infusions) is 250 mg/m2 infused over 60 minutes (maximum infusion rate 5 mL/min). saving.”

movement as a result of it being included in the episode on television; no specific action or follow-up,” Brooks- LaSure says. “But they believe that it was helpful from a practical perspec- tive, because it provided a tangible example of exactly how the patient navigator program would work—sort of a tool to be able to point people to.”

Personal Interest from CNN Work 15 Years Ago

Does a dramatic story have a different sort of persuasive power than standard hearing testimony or a straight factual report, such as a news story? That’s where my personal interest in this episode of health care legislative lobbying comes in. You see, I did a series of reports on cancer in poor communities that included Dr. Freeman and showed a patient navigator at President Bush signing into law HR 1812, work. That series aired on CNN the “Patient Navigator Outreach and 15 years ago. I’m not aware that Chronic Disease Prevention Act of 2005,” the stories produced any move- which authorized appropriations through ment on related health care pol- FY 2010 for the Department of Health and icy. Human Services to establish a competitive Maybe it was a confluence grant program designed to help patients of factors that led to federal access health care services. Shown here funding for patient navigator with President Bush in the Oval Office on programs just months after they June 29, 2005, are (left to right) were mentioned on ER. But I Congressman Bob Menendez (D-NJ), think that at the very least, the Congresswoman Deborah Pryce (R-OH), show was a bellwether of popu- Senator Mike Enzi (R-WY), Senator Jeff lar attitudes. The way that the Bingaman (D-NM), and Congressman patient navigator was portrayed Joe Barton (R-TX). indicated that the mood had (continued on page 28) PAGE 28 / FEBRUARY 25, 2007

Good News & Bad News from 20-Year Follow-Up of AML Survivors

By Naomi Pfeiffer of second cancers and heart disease in population at 59%, but lower compared particular—as well as other troubling with the sibling comparison group at RLANDO—If youngsters with conditions due to the original cancer 69%; divorce rates also were lower. acute myeloid leukemia (AML) treatment—seemed to increase with Educational attainment was “terrif- survive the first five years after time. ic,” particularly considering the sur- O diagnosis, they are very likely He urged oncologists with AML vivors’ history, Dr. Mulrooney said. to survive for a long life. But the quality survivors as patients to start monitor- “Some early studies had suggested they of that life may be problematic. ing them early and continue monitor- tended to do poorly in school, setting That was the conclusion of study of ing as a routine part of health care them up for low expectations. We a cohort of young AML survivors fol- because these patients always would be looked at AML survivors who had lowed for 20 years, reported here at the at high risk. received only chemotherapy as well as American Society of Hematology “It is crucial that they be evaluated those receiving both chemo and radia- Annual Meeting for life in a long-term follow-up clinic, tion. They all did about the same in where a physician familiar with the grade school and college. The sur- unique issues of cancer survivors can vivors’ rate of college graduation was ASH Abstract 560 review their prior treatment and screen 44% compared with the siblings’ 52%, for late effects of cancer therapy,” he but was higher than the 34% reported American Society of Hematology said. for the general population.” AML now accounts for approxi- Daniel A. Mulrooney, MD: “The survival All survivors and siblings mately 25% of childhood leukemias, Multiple Quality-of-Life rates are wonderful—A colleague called were employed, and most had with an increased incidence in Factors these overall survival data one of the great health insurance (93% vs 90%). teenagers and young adults, noted the success stories of clinical oncology. At the lead researcher, Daniel A. Mulrooney The study is a first-ever look same time, however, we found that ‘Our Job is Educational’ MD, Assistant Professor at the Uni- into quality-of-life factors such serious—even life-threatening—illnesses versity of Minnesota Medical School. as education, employment, and appeared many years later in these Asked for his opinion, Rajaram “The survival rates are wonderful,” marriage among AML survivors aggressively treated patients….It is crucial Nagarajan, MD, Assistant Pro- he said in presenting the results. compared with a sibling control that they be evaluated for life in a long-term fessor in the Division of Hematol- Among the five-year survivors, 97% group and the general popula- follow-up clinic, where a physician familiar ogy/Oncology/BMT at Cincin- were still alive 10 years later and 94% tion. The investigators—all pedi- with the unique issues of cancer survivors nati Children’s Hospital Medical were alive after 20 years (25 years after atric cancer specialists—evaluat- can review their prior treatment and screen Center, who was not involved in diagnosis). “A colleague called these ed 272 AML survivors (55% for late effects of cancer therapy.” the study, called the information overall survival data one of the great female) enrolled in the Child- encouraging and said, “As a pedi- success stories of clinical oncology,” Dr. hood Cancer Survivor Study, a atric oncologist, I sometimes find Mulroney said. retrospective cohort study that tracks AML survivors who were treated with it difficult to experience ‘the fruits of the health status of adults diagnosed certain families of drugs such as anthra- our labor’ since many survivors are lost with various childhood cancers cyclines will virtually always be at risk. to follow-up as adults. In this case, I between 1970 and 1986. “Signs of cardiac disease and/or was gratified to encounter such positive “We call the emergence To take part in the AML investiga- second cancers may show up 20 or 30 outcomes in the survivors despite the tion, survivors had to have lived at years after diagnosis. Many clinicians intensive therapy they received. of these illnesses ‘late least five years after diagnosis, have are still unaware that these wonderful medical effects,’ but in been younger than 21 at diagnosis, and drugs—so successful in promoting have never received treatment with a longer life—can also cause high mor- a normal population blood or marrow transplant (due to bidity later on.” “This study should remind they would be seen as reports about the unfavorable conse- quences of total body irradiation). The Endocrine System Dysfunction us that while childhood alarmingly early effects.” average age at follow-up was about 22. cancer survivors can do “We call the emergence of these ill- Additionally, the research team looked nesses ‘late medical effects,’ but in a at chronic health conditions in the well after therapy, we normal population they would be seen young survivors and found that—as “At the same time, however, we as alarmingly early effects.” previously shown—the most worri- must be vigilant about found that serious—even life-threaten- Among the five-year survivors some involved endocrine system dys- them over the long term.” ing—illnesses appeared many years studied, six reported disease recur- function as well as progressive car- later in these aggressively treated rences, two died from relapse, one from diomyopathies and repeat malignan- patients.” congestive heart failure, and one from a cies. In fact, he emphasized in his oral myocardial infarction. The incidence of About 16% had a severe or chron- “However, it is sobering to realize presentation, the incidence and severity recurring AML was 1.8% at 10 years ic—but treatable—condition such as that problems such as heart disease and and 3.7% at 20 years. renal dysfunction or osteoporosis com- secondary neoplasms can appear Like several other recent reports on pared with 6% in the siblings. decades after treatment. Additionally, childhood cancer survivors, the AML Additionally, new studies— although many late effects are caused study suggests that early therapy with notably a poster study on ALL sur- by radiation therapy, it’s important to ScriptDoctor high-dose anthracyclines—as well as vivors presented at the ASH meeting note that many others may occur in sur- continued from page 27 radiation—is largely responsible for the (Abstract 1833)—report that chronic vivors not treated with radiation. This gradual deterioration of cardiac func- painful musculoskeletal conditions also study should remind us that while shifted from “What are they? Why do tion and the reappearance of cancer in are showing up later in life, limiting childhood cancer survivors can do well we need them?” to “Oh, of course, let’s these young people. physical functioning and daily activi- after therapy, we must be vigilant get more of them now.” Approximately 56% of the AML ties, he said. about them over the long term. Our job And so, now more patient naviga- study subjects received chemotherapy In contrast, on social outcomes, the is educational: to educate not only the tors are on the way. only, and 34% had both chemotherapy data show that AML survivors did survivors, but also their families and and radiation. remarkably well as adults, he said. primary care physicians about the Next time: “It’s Only TV”—evidence “Adriamycin in particular has been Among those 25 years or older, mar- threat, perhaps even the inevitability, of that entertainment messages have an shown to involve many cardiac struc- riage rates were similar between the the late effects of cancer treatment and O O effect. T tures,” Dr. Mulrooney said, adding that survivors and the general American the need for appropriate follow-up.” T