] ] [ News ] Analysis ] Commentary ] Controversy ] June 25, 2012 Vol. 34 No. 12 oncology-times.com

Publishing for O34 Years ncology The Independent Times Hem/Onc News Source

ASCO Annual Meeting!

• Controlling Breakthrough Chemo-Induced Nausea & Vomiting • Needed: More MD Knowledge about Long-Term Effects of Cancer Drugs • Myeloma: Novel Agents + Standard Therapy for Bortezomib-Refractory Patients • CLL: Ibrutinib for Older Patients • GIST: New Third-Line Agent • Pediatric Cancer: Crizotinib Effective for ALK-Driven Tumors Coverage starts on page 8 Photos from the Annual Meeting: Todd Buchanan/ASCO2012 Todd Meeting: the Annual from Photos

Hodgkin Lymphoma: ANNE TSAO: How I Treat Novel Agents as Bridge Changing Perceptions about Patients with Limited-Stage to Transplant for Selected Unnecessary Tests p.9 OT iPad App! Small Cell Lung Cancer p.20 Patients p.26

[ALSO] SHOP TALK ������������������������������������������������������������������������������������������5 LETTERS ��������������������������������������������������������������������������������������������������������������������������������������6 Crossover Trial Validates Accelerated Approval of Sunitinib for GIST ������������������������������������������19 Early Breast Cancer: HER2 Peptide Vaccine Helps Delay Recurrence ������������������������������������������24 GEORGE SLEDGE: ‘Perchance to Dream’ ����������������������������������������������������������������������������������28 POETRY BY CANCER CAREGIVERS: Amir Steinberg, MD ����������������������������������������������������30 Treating Hepatitis Infection and Liver Cancer Together ����������������������������������������������������������������30

Facebook.com/ @OncologyTimes Periodicals OncologyTimesNews B:10.75” T:10.5” S:9.5”

5 TARCEVA® (erlotinib) TABLETS BRIEF SUMMARY Please see including abnormal eyelash growth, keratoconjunctivitis sicca or keratitis elevations were mainly transient or associated with liver metastases. pustules, but is histopathologically different. This skin reaction commonly the Tarceva package insert for full prescribing information. have been observed with TARCEVA treatment and are known risk factors Grade 2 (> 2.5 – 5.0 x ULN) ALT elevations occurred in 4% and <1% of occurs on the face, upper chest and back, but may be more generalized or Appointments, Promotions, Honors, oncology times INDICATIONS AND USAGE Non-Small Cell Lung Cancer for corneal ulceration/perforation [see Adverse Reactions (6.1)]. Interrupt TARCEVA and placebo treated patients, respectively. Grade 3 (> 5.0 – 20.0 severe (NCI-CTC Grade 3 or 4) with desquamation. Skin reactions may Grants, & ‘People News’ (NSCLC) TARCEVA monotherapy is indicated for the maintenance or discontinue TARCEVA therapy if patients present with acute/worsening x ULN) elevations were not observed in TARCEVA-treated patients. occur or worsen in sun exposed areas; therefore, the use of sunscreen or Shop Talk treatment of patients with locally advanced or metastatic non-small cell ocular disorders such as eye pain. Elevated International TARCEVA dosing should be interrupted or discontinued if changes in liver avoidance of sun exposure is recommended. Associated symptoms may lung cancer whose disease has not progressed after four cycles of Normalized Ratio and Potential Bleeding International Normalized function are severe [see Dosage and Administration (2.3)]. Pancreatic include itching, tenderness and/or burning. Also, hyperpigmentation or platinum-based first-line chemotherapy [see Clinical Studies (14.1)]. Ratio (INR) elevations and bleeding events, including gastrointestinal and Cancer Adverse reactions, regardless of causality, that occurred in at dry skin with or without digital skin fissures may occur. Hair and nail TARCEVA monotherapy is indicated for the treatment of patients with non-gastrointestinal bleeding (including fatalities), have been associated least 10% of patients treated with TARCEVA 100 mg plus gemcitabine in disorders including alopecia, hirsutism, eyelash/eyebrow (see above) locally advanced or metastatic non-small cell lung cancer after failure of with concomitant warfarin administration. Patients taking warfarin or other the randomized trial of patients with pancreatic cancer are summarized by changes, paronychia and brittle and loose nails have been reported. at least one prior chemotherapy regimen [see Clinical Studies (14.2)]. coumarin-derivative anticoagulants should be monitored regularly for NCI-CTC (version 2.0) Grade in Table 3. The most common adverse Other Disorders Epistaxis was also reported in both the single-agent Results from two, multicenter, placebo-controlled, randomized, Phase 3 changes in prothrombin time or INR [see Adverse Reactions (6.1) and reactions in pancreatic cancer patients receiving TARCEVA 100 mg plus NSCLC and the pancreatic cancer clinical trials. In general, no notable At Moffitt Cancer The Academy of Medical Sciences of Maureen T. Kavanah, Research Program at Yale Cancer Center trials conducted in first-line patients with locally advanced or metastatic Drug Interactions (7)]. Use in Pregnancy TARCEVA can cause fetal gemcitabine were fatigue, rash, nausea, anorexia and diarrhea. In the differences in the safety of TARCEVA monotherapy or in combination with Center, G. Douglas the UK has elected 46 medical research- MD, Associate Pro­ and Smilow Cancer Hospital at Yale- NSCLC showed no clinical benefit with the concurrent administration of harm when administered to a pregnant woman. Erlotinib administered to TARCEVA plus gemcitabine arm, Grade 3/4 rash and diarrhea were each gemcitabine could be discerned between females or males and between TARCEVA with platinum-based chemotherapy [carboplatin and paclitaxel rabbits during organogenesis at doses that result in plasma drug reported in 5% of TARCEVA plus gemcitabine-treated patients. The patients younger or older than the age of 65 years [see Use in Specific Letson, MD, has been ers to the Fellowship of the Academy fessor of Surgery at New Haven Hospital, a change that will • or gemcitabine and cisplatin] and its use is not recommended in that concentrations of approximately 3 times those in humans at the Populations (8.5 and 8.6)]. The safety of TARCEVA appears similar in median time to onset of rash and diarrhea was 10 days and 15 days, appointed Executive of Medical Sciences. “These new Boston University take effect in August. june 25, 2012 setting [see Clinical Studies (14.3)]. Pancreatic Cancer TARCEVA in recommended dose of 150 mg daily, was associated with embryofetal respectively. Rash and diarrhea each resulted in dose reductions in 2% of Caucasian and Asian patients. Post-marketing Experience The combination with gemcitabine is indicated for the first-line treatment of lethality and abortion. When erlotinib was administered to female rats patients, and resulted in study discontinuation in up to 1% of patients following adverse reactions have been identified during post approval use Vice President for Fellows represent the wealth of talent School of Medicine and patients with locally advanced, unresectable or metastatic pancreatic prior to mating and through the first week of pregnancy, at doses 0.3 or receiving TARCEVA plus gemcitabine. The 150 mg cohort was associated of TARCEVA. Because these reactions are reported voluntarily from a Clinical Affairs and within the UK biomedical commu- Surgical Oncologist at Eward C. Halperin, 2 cancer [see Clinical Studies (14.4)]. CONTRAINDICATIONS None. 0.7 times the clinical dose of 150 mg, on a mg/m basis, there was an with a higher rate of certain class-specific adverse reactions including population of uncertain size, it is not always possible to reliably estimate Physician-in-Chief, and nity,” said Professor Sir John Tooke, Boston Medical Center MD, MA, has become WARNINGS AND PRECAUTIONS Pulmonary Toxicity There have increase in early resorptions that resulted in a decrease in the number of rash and required more frequent dose reduction or interruption. Table 3: their frequency or establish a causal relationship to drug exposure. Skin G. DOUGLAS KATHY been reports of serious Interstitial Lung Disease (ILD)-like events, live fetuses [see Use in Specific Populations (8.1)]. There are no adequate Adverse Reactions Occurring in ≥ 10% of TARCEVA-treated and subcutaneous tissue disorders Hair and nail changes, mostly Johnathan Lancaster, PMedSci, President of the Academy of (BMC), has received Chancellor for Health including fatalities, in patients receiving TARCEVA for treatment of NSCLC, and well-controlled studies in pregnant women using TARCEVA. Women Pancreatic Cancer Patients: 100 mg cohort non-serious e.g. hirsutism, eyelash/eyebrow changes, paronychia and MD, PhD, has been ap- LETSON, MD Medical Sciences, in a news release. The the 2012 National PRITCHARD- Affairs and Chief pancreatic cancer or other advanced solid tumors. In the randomized of childbearing potential should be advised to avoid pregnancy while on TARCEVA + Placebo + brittle and loose nails. Bullous, blistering and exfoliative skin conditions JONES, single-agent NSCLC studies [see Clinical Studies (14.1, 14.2)], the TARCEVA. Adequate contraceptive methods should be used during Gemcitabine Gemcitabine have been reported including cases suggestive of Stevens-Johnson pointed President of the new fellows include Surgical Adjuvant Executive Officer at New 1000 mg/m2 IV 1000 mg/m2 IV FMEDSCI incidence of serious ILD-like events in the TARCEVA treated patients versus therapy, and for at least 2 weeks after completing therapy. If TARCEVA is syndrome/Toxic epidermal necrolysis [see Warnings and Precautions N = 259 N = 256 Moffitt Medical Group the following mem- Breast and Bowel York Medical College; he

placebo treated patients was 0.7% versus 0% in the maintenance study used during pregnancy, or if the patient becomes pregnant while taking (5.6)]. Gastrointestinal Disorders Gastrointestinal perforations [see • Any Grade Grade Any Grade Grade

nd rd and 0.8% for both groups in the 2 and 3 line study. In the pancreatic this drug, the patient should be apprised of the potential hazard to a fetus. NCI-CTC Grade Grade 3 4 Grade 3 4 Warnings and Precautions (5.5)]. Hepatic Disorders Hepatic failure (charged with oversee- bers of the oncology Project Distinguished was also named Provost EWARD C. cancer study – in combination with gemcitabine – [see Clinical Studies Pregnancy Category D. ADVERSE REACTIONS Clinical Trial MedDRA has been reported in patients treated with single-agent TARCEVA or oncology-times.com % % % % % % ing the medical practice community: Investigator Lifetime for Biomedical Affairs (14.4)], the incidence of ILD-like events was 2.5% in the TARCEVA plus Experience Non-Small Cell Lung Cancer Maintenance Study Preferred Term TARCEVA combined with chemotherapy [see Warnings and Precautions HALPERIN, gemcitabine group vs. 0.4% in the placebo plus gemcitabine group. The Adverse reactions, regardless of causality, that occurred in at least 3% of Fatigue 73 14 2 70 13 2 (5.3)]. DRUG INTERACTIONS Erlotinib is metabolized predominantly by of physicians and health • Johann de Bono, Achievement Award for the Touro College MD, MA overall incidence of ILD-like events in approximately 32,000 patients treated with single-agent TARCEVA at 150 mg and at least 3% Rash 69 5 0 30 1 0 CYP3A4, and inhibitors of CYP3A4 would be expected to increase Nausea 60 7 0 58 7 0 care professionals). FMedSci, Professor of for her research contri- and University System, TARCEVA-treated patients from all studies (including uncontrolled studies more often than in the placebo group in the randomized maintenance trial exposure. Co-treatment with the potent CYP3A4 inhibitor ketoconazole Anorexia 52 6 <1 52 5 <1 As Sarcoma Program Experimental Cancer butions in breast and which acquired New York Medical College and studies with concurrent chemotherapy) was approximately 1.1%. are summarized by NCI-CTC (version 3.0) Grade in Table 1. The most Diarrhea 48 5 <1 36 2 0 increased erlotinib AUC by 2/3. When TARCEVA was co-administered with Reported diagnoses in patients suspected of having ILD-like events common adverse reactions in patients receiving single-agent TARCEVA Abdominal pain 46 9 <1 45 12 <1 ciprofloxacin, an inhibitor of both CYP3A4 and CYP1A2, the erlotinib leader, Letson, an or- JOHNATHAN Medicine, Institute of Research of Cancer Institute colorectal cancers. in 2011. He was most recently Dean at the exposure [AUC] and maximum concentration [Cmax included pneumonitis, radiation pneumonitis, hypersensitivity 150 mg were rash and diarrhea. Grade 3/4 rash and diarrhea occurred in Vomiting 42 7 <1 41 4 <1 ] increased by 39% JOHANN pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative 6.0% and 1.8%, respectively, in TARCEVA-treated patients. Rash and Weight decreased 39 2 0 29 <1 0 and 17% respectively. Caution should be used when administering or thopedic surgeon and LANCASTER, Cancer Research and She has been a re- University of Louisville School of Medicine. bronchiolitis, pulmonary fibrosis, Acute Respiratory Distress Syndrome diarrhea resulted in study discontinuation in 1.2% and 0.5% of Infection* 39 13 3 30 9 2 taking TARCEVA with ketoconazole and other strong CYP3A4 inhibitors musculoskeletal tumor Honorary Consultant DE BONO, search investigator with MAUREEN T. He assumed his new positions in May. Edema 37 3 <1 36 2 <1 MD, PHD and lung infiltration. Symptoms started from 5 days to more than 9 months TARCEVA-treated patients, respectively. Dose reduction or interruption for such as, but not limited to, atazanavir, clarithromycin, indinavir, FMEDSCI (median 39 days) after initiating TARCEVA therapy. In the lung cancer rash and diarrhea was needed in 5.1% and 2.8% of patients, respectively. Pyrexia 36 3 0 30 4 0 itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, specialist, has developed Medical Oncologist, the NSABP since 1981, KAVANAH, MD trials most of the cases were associated with confounding or contributing In TARCEVA-treated patients who developed rash, the onset was within two Constipation 31 3 1 34 5 1 troleandomycin (TAO), voriconazole and grapefruit or grapefruit juice Bone pain 25 4 <1 23 2 0 the largest program of its kind in Florida Royal Marsden NHS during which time The University of Texas MD Anderson factors such as concomitant/prior chemotherapy, prior radiotherapy, weeks in 66% and within one month in 81%. Table 1: NSCLC [see Dosage and Administration (2.3)]. Pre-treatment with the CYP3A4 Dyspnea 24 5 <1 23 5 0 and the Southeast. Lancaster, a gyneco- Foundation Trust she has been principal investigator of the Cancer Center has renewed its agreement pre-existing parenchymal lung disease, metastatic lung disease, or Maintenance Study: Adverse Reactions Occurring More Stomatitis 22 <1 0 12 0 0 inducer rifampicin for 7 days prior to TARCEVA decreased erlotinib AUC pulmonary infections. In the event of an acute onset of new or progressive Frequently (≥ 3%) in the Single-Agent TARCEVA Group than in the Myalgia 21 1 0 20 <1 0 by about 2/3 to 4/5, which is equivalent to a dose of about 30 to 50 mg in logic oncologist and Deputy Physician- • Rosalind Eeles, project’s Clinical Research at BMC; led with the Norwegian Cancer Consortium unexplained pulmonary symptoms such as dyspnea, cough, and fever, Placebo Group and in ≥ 3% of Patients in the TARCEVA Group. Depression 19 2 0 14 <1 0 NSCLC patients. In a separate study, treatment with rifampicin for TARCEVA therapy should be interrupted pending diagnostic evaluation. If Dyspepsia 17 <1 0 13 <1 0 11 days, with co-administration of a single 450 mg dose of TARCEVA on in-Chief and Chair of the Department FMedSci, Professor of NSABP-sponsored clinical studies in breast (NCC), keeping it part of the MDACC TARCEVA PLACEBO Cough 16 0 0 11 0 0 ILD is diagnosed, TARCEVA should be discontinued and appropriate N = 433 N = 445 day 8 resulted in a mean erlotinib exposure (AUC) that was 57.6% of that of Women’s Oncology, currently leads a Oncogenetics, Institute and bowel cancers, served on the Board of Sister Institution Network, founded in treatment instituted as needed [see Dosage and Administration (2.3)]. Dizziness 15 <1 0 13 0 <1 observed following a single 150 mg TARCEVA dose in the absence of Renal Failure Cases of hepatorenal syndrome, acute renal failure Any Grade Grade Any Grade Grade Headache 15 <1 0 10 0 0 rifampicin treatment [see Dosage and Administration (2.3)]. Use of multidisciplinary women’s cancer research of Cancer Research & Directors (since 1988); and serves as the 2007 as a global, academic network of NCI-CTC Grade Grade 3 4 Grade 3 4 (including fatalities), and renal insufficiency have been reported. Some Insomnia 15 <1 0 16 <1 0 alternative treatments lacking CYP3A4 inducing activity is strongly team and oversees a translational research Honorary Consultant Chairman of the Ethics Committee. She cancer centers, hospitals, and universi- Alopecia 14 0 0 11 0 0 Research of Cancer Institute were secondary to baseline hepatic impairment while others were MedDRA Preferred recommended. If an alternative treatment is unavailable, adjusting the Term % % % % % % Anxiety 13 1 0 11 <1 0 lab focused on ovarian and gynecological in Clinical Oncology, ROSALIND also established BMC as a full-member ties collaborating to lessen the world’s associated with severe dehydration due to diarrhea, vomiting, and/or Neuropathy 13 1 <1 10 <1 0 starting dose should be considered. If the TARCEVA dose is adjusted anorexia or concurrent chemotherapy use. In the event of dehydration, Rash 49.2 6.0 0 5.8 0 0 Flatulence 13 0 0 9 <1 0 upward, the dose will need to be reduced immediately to the indicated malignancies. Royal Marsden NHS EELES, institution of the Southwest Oncology cancer burden. The NCC is comprised particularly in patients with contributing risk factors for renal failure (eg, starting dose upon discontinuation of rifampicin or other inducers. Other Diarrhea 20.3 1.8 0 4.5 0 0 Rigors 12 0 0 9 0 0 Earlier this year, Moffitt had an- Foundation Trust FMEDSCI Group in 1990 and was principal investi- of Oslo University Hospital, Stavanger pre-existing renal disease, medical conditions or medications that may *Includes all MedDRA preferred terms in the Infections and Infestations CYP3A4 inducers include, but are not limited to, rifabutin, rifapentine, Fatigue 9.0 1.8 0 5.8 1.1 0 lead to renal disease, or other predisposing conditions including System Organ Class. In the pancreatic carcinoma trial, 10 patients in the phenytoin, carbamazepine, phenobarbital and St. John’s Wort [see Dosage nounced these additional organizational • Patrick Johnston, gator until 1994. University Hospital and The Cancer advanced age), TARCEVA therapy should be interrupted and appropriate Anorexia 9.2 <1 0 4.9 <1 0 TARCEVA/gemcitabine group developed deep venous thrombosis and Administration (2.3)]. Cigarette smoking has been shown to reduce B:14.25” S:13” T:14” changes (OT, 3/25/12): William S. FMedSci, Dean of Registry of Norway with programs spe- measures should be taken to intensively rehydrate the patient. Periodic Pruritus 7.4 <1 0 2.7 0 0 (incidence: 3.9%). In comparison, 3 patients in the placebo/gemcitabine erlotinib AUC. Patients should be advised to stop smoking; however, if monitoring of renal function and serum electrolytes is recommended in they continue to smoke, a cautious increase in the dose of TARCEVA may Dalton, PhD, MD, current President Medicine, Queen’s Lajos Pusztai, MD, cializing in biochemistry, cell and tumor Acne 6.2 <1 0 0 0 0 group developed deep venous thrombosis (incidence 1.2%). The overall patients at risk of dehydration [see Adverse Reactions (6.1) and Dosage incidence of grade 3 or 4 thrombotic events, including deep venous be considered, while monitoring the patient’s safety. If the TARCEVA dose and CEO, will become the new CEO of University Belfast DPhil, Professor in the biology, genetics, radiation biology, im- and Administration (2.3)]. Hepatotoxicity Cases of hepatic failure and Dermatitis is adjusted upward, the dose should be reduced immediately to the Acneiform 4.6 <1 0 1.1 0 0 thrombosis, was similar in the two treatment arms: 11% for TARCEVA hepatorenal syndrome (including fatalities) have been reported during use plus gemcitabine and 9% for placebo plus gemcitabine. No differences in indicated starting dose upon cessation of smoking [see Dosage and M2Gen Personalized Medicine Institute, • Kathy Pritchard- Department of Breast munology, cancer prevention, personal- Dry Skin 4.4 0 0 <1 0 0 of TARCEVA, particularly in patients with baseline hepatic impairment. Grade 3 or Grade 4 hematologic laboratory toxicities were detected Administration (2.3) and Clinical Pharmacology (12.3)]. Pretreatment and a Moffitt subsidiary focused on per- Jones, FMedSci, Medical Oncology at ized breast cancer therapy, GI surgery, Therefore, periodic liver function testing (transaminases, bilirubin, and co-administration of TARCEVA decreased the AUC of CYP3A4 substrate, Weight Decreased 3.9 <1 0 <1 0 0 between the TARCEVA plus gemcitabine group compared to the placebo sonalizing cancer care; Alan List, MD, Professor of Pediatric the University of Texas and hematology. alkaline phosphatase) is recommended. In the setting of worsening liver plus gemcitabine group. Severe adverse reactions (≥ grade 3 NCI-CTC) midazolam, by 24%. The mechanism is not clear. In a study, there were no function tests, dose interruption and/or dose reduction with frequent liver Paronychia 3.9 <1 0 0 0 0 in the TARCEVA plus gemcitabine group with incidences < 5% included significant effects of gemcitabine on the pharmacokinetics of erlotinib nor Executive Vice President and Physician- Oncology, University MD Anderson Cancer “Our partners in Norway provide function test monitoring should be considered. TARCEVA dosing should syncope, arrhythmias, ileus, pancreatitis, hemolytic anemia including were there significant effects of erlotinib on the pharmacokinetics of PATRICK Liver function test abnormalities (including elevated alanine in-Chief, will become Moffitt CEO; and College London Institute Center, has been ap- great strategic opportunities to engage in be interrupted or discontinued if total bilirubin is >3 x ULN and/or microangiopathic hemolytic anemia with thrombocytopenia, myocardial gemcitabine. Drugs that alter the pH of the upper GI tract may alter the aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin) JOHNSTON, transaminases are >5 x ULN in the setting of normal pretreatment values infarction/ischemia, cerebrovascular accidents including cerebral solubility of erlotinib and reduce its bioavailability. Increasing the dose of Thomas A. Sellers, PhD, will become of Child Health, and pointed Director of the LAJOS research,” said Oliver Bogler, PhD, Vice were observed in patients receiving single-agent TARCEVA 150 mg in the [see Adverse Reactions (6.1, 6.2) and Dosage and Administration (2.3)]. hemorrhage, and renal insufficiency [see Warnings and Precautions (5)]. TARCEVA when co-administered with such agents is not likely to FMEDSCI Maintenance study. Grade 2 (>2.5 – 5.0 x ULN) ALT elevations occurred the Center Director. Honorary Consultant Breast Cancer Research PUSZTAI, MD, President of Global Academic Programs Patients with Hepatic Impairment In a pharmacokinetic study in Liver function test abnormalities (including elevated alanine compensate for the loss of exposure. Co-administration of TARCEVA with in 2% and 1%, and Grade 3 (>5.0 – 20.0 x ULN) ALT elevations were patients with moderate hepatic impairment (Child-Pugh B) associated with aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin) omeprazole, a proton pump inhibitor, decreased the erlotinib AUC by 46%. All the changes will take effect next Oncologist, Great Ormond Street Hospital Group and Co-director DPHIL at MD Anderson. “The ability of the observed in 1% and 0% of TARCEVA and placebo treated patients, significant liver tumor burden, 10 out of 15 patients died on treatment or have been observed following the administration of TARCEVA plus Since proton pump inhibitors affect pH of the upper GI tract for an respectively. The TARCEVA treatment group had Grade 2 (>1.5-3.0 x ULN) month. NHS Foundation Trust and UCL. of the Cancer Genetics continued on page 6 within 30 days of the last TARCEVA dose. One patient died from gemcitabine in patients with pancreatic cancer. Table 4 displays the most extended period, separation of doses may not eliminate the interaction. bilirubin elevations in 4% and Grade 3 (>3.0-10.0 x ULN) in <1% hepatorenal syndrome, 1 patient died from rapidly progressing liver severe NCI-CTC grade of liver function abnormalities that developed. The concomitant use of proton pump inhibitors with TARCEVA should be compared with <1% for both Grades 2 and 3 in the placebo group. failure and the remaining 8 patients died from progressive disease. Six TARCEVA dosing should be interrupted or discontinued if changes in liver avoided if possible. Co-administration of TARCEVA with 300 mg ranitidine, out of the 10 patients who died had baseline total bilirubin > 3 x ULN TARCEVA dosing should be interrupted or discontinued if changes in liver an H receptor antagonist, decreased erlotinib AUC by 33%. When Richard T. Hoppe, MD function are severe [see Dosage and Administration (2.3)]. Table 4: 2 Professor/Chairman of Radiation Oncology, Editor: Serena Stockwell suggesting severe hepatic impairment. Treatment with TARCEVA should function are severe [see Dosage and Administration (2.3)]. Second/ TARCEVA was administered with ranitidine 150 mg twice daily (at least Liver Function Test Abnormalities (most severe NCI-CTC grade) Stanford University be used with extra caution in patients with total bilirubin > 3 x ULN. Third Line Study Adverse reactions, regardless of causality, that 10 h after the previous ranitidine evening dose and 2 h before the ranitidine Oncology ASSISTANT EDITOR: Sarah DiGiulio in Pancreatic Cancer Patients: 100 mg Cohort Patients with hepatic impairment (total bilirubin > ULN or Child-Pugh A, B occurred in at least 10% of patients treated with single-agent TARCEVA at morning dose), the erlotinib AUC decreased by 15%. If patients need to be Robert J. Mayer, MD, Faculty Vice President for Academic Associate Director of Production: 150 mg and at least 3% more often than in the placebo group in the TARCEVA + Placebo + Affairs, Dana-Farber Cancer Institute; Faculty Associate Dean for Barbara Nakahara and C) should be closely monitored during therapy with TARCEVA. Gemcitabine Gemcitabine treated with an H2-receptor antagonist such as ranitidine, it should be randomized trial of patients with NSCLC are summarized by NCI-CTC 2 2 Times Admissions and Stephen B. Kay Family Professor of Medicine, 1000 mg/m IV 1000 mg/m IV TARCEVA dosing should be interrupted or discontinued if changes in liver used in a staggered manner. TARCEVA must be taken once a day, 10 hours Vol. 34, No. 12 PRODUCTION ASSOCIATE: Nick Strickland N = 259 N = 256 Harvard Medical School function are severe such as doubling of total bilirubin and/or tripling of (version 2.0) Grade in Table 2. The most common adverse reactions in after the H -receptor antagonist dosing and at least 2 hours before the this patient population were rash and diarrhea. Grade 3/4 rash and Grade Grade Grade Grade Grade Grade 2 Desktop Manager: Peter Castro transaminases in the setting of pretreatment values outside normal range NCI-CTC Grade next dose of H -receptor antagonist. Although the effect of antacids on Frank L. Meyskens, Jr., MD, Daniel C. Aldrich, Jr. Endowed 2 3 4 2 3 4 2 Editorial Board [see Clinical Pharmacology (12.3) and Dosage and Administration (2.3)]. diarrhea occurred in 9% and 6%, respectively, in TARCEVA-treated erlotinib pharmacokinetics has not been evaluated, the antacid dose and Chair and Professor of Medicine and Biological Chemistry Desktop associate: Monica Dyba Gastrointestinal Perforation Gastrointestinal perforation (including patients. Rash and diarrhea each resulted in study discontinuation in 1% Bilirubin 17% 10% <1% 11% 10% 3% the TARCEVA dose should be separated by several hours, if an antacid is Chairman: Robert C. Young, MD Director, Chao Family Comprehensive Cancer Center, Associate NATIONAL ACCOUNT MANAGER: Ben Harkinson ALT 31% 13% <1% 22% 9% 0% Manager of Circulation: Deborah Benward Wolters Kluwer Health, Lippincott Williams & Wilkins fatalities) has been reported in patients receiving TARCEVA. Patients of TARCEVA-treated patients. Six percent and 1% of patients needed dose necessary [see Clinical Pharmacology (12.3)]. The combination of Emeritus Chancellor, Fox Chase Cancer Center Vice Chancellor of Health Sciences College of Medicine, AST 24% 10% <1% 19% 9% 0% COLUMNISTS: Lola Butcher; Wendy Harpham, MD; Ovid Technologies, 333 Seventh Avenue, 20th Floor receiving concomitant anti-angiogenic agents, corticosteroids, NSAIDs, reduction for rash and diarrhea, respectively. The median time to onset of TARCEVA and a statin may increase the potential for statin-induced UC Irvine rash was 8 days, and the median time to onset of diarrhea was 12 days. NSCLC and Pancreatic Indications: Low Frequency Adverse Joseph V. Simone, MD; George W. Sledge, Jr., MD; New York, NY 10001 and/or taxane-based chemotherapy, or who have prior history of peptic myopathy, including rhabdomyolysis, which was observed rarely. The Clinical Advisory Editor for Hematology/Oncology: Joseph V. Simone, MD, President, Simone Consulting Table 2: NSCLC 2nd/3rd Line Study: Adverse Reactions Reactions Gastrointestinal Disorders Gastrointestinal perforations Mikkael Sekeres, MD, MS Andrew Turrisi, MD 646-674-6498, fax: 646-607-4253 ulceration or diverticular disease are at increased risk [see Adverse mechanism of this interaction is not clear. Pediatric Use The safety and [email protected] Reactions (6.1, 6.2)]. Permanently discontinue TARCEVA in patients who Occurring More Frequently (≥ 3%) in the Single-agent have been reported [see Warnings and Precautions (5.5)]. During the effectiveness of TARCEVA in pediatric patients have not been established. Director, Leukemia Program, Cleveland Clinic Taussig Cancer Ellen Stovall, Senior Health Policy Advisor, SPECIAL CORRESPONDENT: Eric T. Rosenthal TARCEVA 150 mg Group than in the Placebo Group and in Institute; Chair, Hematology/Oncology Pharmacy & Therapeutics National Coalition for Cancer Survivorship Editorial/Publishing Offices: develop gastrointestinal perforation. Bullous and Exfoliative Skin NSCLC and the combination pancreatic cancer trials, infrequent cases of OVERDOSAGE Single oral doses of TARCEVA up to 1,000 mg in healthy Contributing Writers: Robert H. Carlson, Peggy Committee 333 Seventh Ave., 19th Fl., New York, NY 10001; Disorders Bullous, blistering and exfoliative skin conditions have been ≥10% of Patients in the TARCEVA Group. gastrointestinal bleeding have been reported, some associated with subjects and weekly doses up to 1,600 mg in cancer patients have been Paul A. Volberding, MD Eastman, Charlene Laino, Heather Lindsey, [email protected], oncology-times.com reported including cases suggestive of Stevens-Johnson syndrome/Toxic TARCEVA 150 mg Placebo concomitant warfarin or NSAID administration [see Warnings and tolerated. Repeated twice-daily doses of 200 mg single-agent TARCEVA in Clinical Advisory Editor for Oncology: Ramaswamy Professor of Medicine, UCSF; Chief, Medical Service, San Francisco Kurt Samson, Rabiya S. Tuma, Cynthia Washam epidermal necrolysis, which in some cases were fatal [see Adverse N = 485 N = 242 Precautions (5.11)]. These adverse reactions were reported as peptic ulcer healthy subjects were poorly tolerated after only a few days of dosing. Govindan, MD VA Medical Center; Vice Chair, Dept. of Medicine, UCSF Classified ADVERTISING: Mike Rusch, Any Grade Grade Any Grade Grade bleeding (gastritis, gastroduodenal ulcers), hematemesis, hematochezia, Co-Director, Section of Medical Oncology, Professor of Medicine, 215-521-8404, fax 215-689-2453; Reactions (6.1, 6.2)]. Interrupt or discontinue TARCEVA treatment if the NCI-CTC Grade Grade 3 4 Grade 3 4 Based on the data from these studies, an unacceptable incidence of severe Carolyn Weaver RN, MSN, AOCN melena and hemorrhage from possible colitis. Renal Disorders Cases Washington University School of Medicine, Alvin J Siteman Theresa Steltzer [email protected] patient develops severe bullous, blistering or exfoliating conditions. MedDRA Preferred adverse reactions, such as diarrhea, rash, and liver transaminase EXECUTIVE PUBLISHER: % % % % % % Clinical Nurse Specialist, Patient Education Coordinator, Term of acute renal failure or renal insufficiency, including fatalities, with or Cancer Center Myocardial Infarction/Ischemia In the pancreatic carcinoma trial, six elevation, may occur above the recommended dose [see Dosage and Fox Chase Cancer Center VICE PRESIDENT, NURSING, HEALTH & WELLNESS Oncology Times (ISSN 0276-2234) is published twice a month by Lippincott Rash 75 8 <1 17 0 0 without hypokalemia have been reported [see Warnings and Precautions patients (incidence of 2.3%) in the TARCEVA/gemcitabine group Administration (2)]. In case of suspected overdose, TARCEVA should be Joseph S. Bailes, MD, Partner, Texas Oncology PUBLISHING: Jennifer E. Brogan Williams & Wilkins, at 116522 Hunters Green Parkway, Hagerstown, MD (5.2)]. Hepatic Disorders Hepatic failure has been reported in patients Jane C. Weeks, MD, MSc developed myocardial infarction/ischemia. One of these patients died due Diarrhea 54 6 <1 18 <1 0 withheld and symptomatic treatment instituted. Manufactured for: OSI 21740. Business, editorial, and production offices are at 333 Seventh Ave., Director, Center for Outcomes & Policy Research VICE PRESIDENT, PUBLISHING: Jayne Marks Anorexia 52 8 1 38 5 <1 treated with single-agent TARCEVA or TARCEVA combined with Paul A. Bunn Jr., MD, Executive Director, International 19th Fl., New York, NY 10001, [email protected], oncology-times.com. to myocardial infarction. In comparison, 3 patients in the placebo/ Pharmaceuticals, LLC, Farmingdale, NY 11735 an affiliate of Astellas Dana-Farber Cancer Institute, Fatigue 52 14 4 45 16 4 chemotherapy [see Warnings and Precautions (5.3)]. Ocular Disorders Association for the Study of Lung Cancer; and PRESIDENT & CEO, MEDICAL RESEARCH, Printed in USA Copyright­ 2012 by Lippincott Williams & Wilkins. Indexed gemcitabine group developed myocardial infarction (incidence 1.2%) and Pharma US, Inc. Manufactured by: Kremers Urban Pharmaceuticals, Harvard Medical School Dyspnea 41 17 11 35 15 11 Corneal ulcerations or perforations have been reported in patients James Dudley Endowed Professor of Lung Cancer Research, WOLTERS KLUWER HEALTH: Karen Abramson in the CINAHL® database of nursing and allied health one died due to myocardial infarction. Cerebrovascular Accident In the Inc., Seymour, IN 47274 Distributed by: Genentech USA, Inc. 1 DNA Cough 33 4 0 29 2 0 receiving TARCEVA treatment. Abnormal eyelash growth including University of Colorado Norman Wolmark, MD literature. Periodical postage rates paid at Hagerstown, pancreatic carcinoma trial, six patients in the TARCEVA/gemcitabine Way, South San Francisco, CA 94080-4990. For further information VICE PRESIDENT, GLOBAL SALES: Diane Corrado Nausea 33 3 0 24 2 0 in-growing eyelashes, excessive growth and thickening of the eyelashes Chairman and Principal Investigator for Operations MD, and at additional mailing offices. Physicians, nurses, group developed cerebrovascular accidents (incidence: 2.3%). One of Infection 24 4 0 15 2 0 please call 1-877-TARCEVA (1-877-827-2382). Michael A. Caligiuri, MD Vice President, ADVERTISING sales: Fabien Savenay and pharmacists specializing in oncology and related specialties have been reported [see Warnings and Precautions (5.10)] and are risk National Surgical Adjuvant Breast and Bowel Project these was hemorrhagic and was the only fatal event. In comparison, in the Vomiting 23 2 <1 19 2 0 Director, Ohio State University Comprehensive Cancer Center; (within the US) are eligible for a free subscription. To place a new order, or to renew Allegheny General Hospital Cancer Center, Pittsburgh SALES DIRECTOR, LWW JOURNALS: Ray Lender placebo/gemcitabine group there were no cerebrovascular accidents. Stomatitis 17 <1 0 3 0 0 factors for corneal ulceration/perforation. NCI-CTC Grade 3 conjunctivitis CEO, The James Cancer Hospital and Solove Institute or cancel an existing subscription, go to www.myOTsub.com. To change your Pruritus 13 <1 0 5 0 0 and keratitis have been reported infrequently in patients receiving ­address, call 800-430-5450 or email [email protected] (for quickest Microangiopathic Hemolytic Anemia with Thrombocytopenia In Harold P. Freeman, MD, Founder, President and CEO, the pancreatic carcinoma trial, two patients in the TARCEVA/gemcitabine Dry skin 12 0 0 4 0 0 TARCEVA therapy in the NSCLC and pancreatic cancer clinical trials service, please include your account number, located­ above your name on your Harold P. Freeman Patient Navigation Institute mailing label). POSTMASTER: Send address changes to: Oncology Times, 2340 group developed microangiopathic hemolytic anemia with Conjunctivitis 12 <1 0 2 <1 0 [see Patient Counseling Information (17)]. Skin, Hair, and Nail Astellas and the Flying Star logo are trademarks of Astellas Pharma Inc. River Rd., Ste 408, Des Plaines, IL 60019-9883. No part of this publication may be Keratoconjunctivitis sicca 12 0 0 3 0 0 Disorders Bullous, blistering and exfoliative skin conditions have been Tarceva is a trademark of OSI Pharmaceuticals, LLC, Farmingdale, NY 11735, Joyce Hendershott, MSW, ACSW, LISW-S thrombocytopenia (incidence: 0.8%). Both patients received TARCEVA reproduced without the prior written permission­ of the publisher. The appearance Abdominal pain 11 2 <1 7 1 <1 reported including cases suggestive of Stevens-Johnson syndrome/Toxic Associate Director, Patient Education Department, and gemcitabine concurrently. In comparison, in the placebo/gemcitabine USA, an affiliate of Astellas Pharma US, Inc. of advertising in Oncology Times does not constitute on the part of Lippincott­ The Ohio State University James Cancer Hospital & group there were no cases of microangiopathic hemolytic anemia with Liver function test abnormalities (including elevated alanine epidermal necrolysis [see Warnings and Precautions (5.6)]. In patients ©2012 OSI Pharmaceuticals, LLC, an affiliate of Astellas Pharma US, Inc., and Williams & Wilkins a guarantee or endorsement of the quality or value of the Solove Research Institute thrombocytopenia. Ocular Disorders Corneal perforation and ulceration aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin) who develop skin rash, the appearance of the rash is typically Genentech, Inc. All rights reserved. advertised product or services or of the claims made for them by their advertisers. have been reported during use of TARCEVA. Other ocular disorders were observed in patients receiving single-agent TARCEVA 150 mg. These erythematous and maculopapular and it may resemble acne with follicular 012E-071-5538 12D031-TAR-MKT TAR0000485002 5/12

OTUS_JUNE25-12.indd 5 22/06/12 9:32 AM 6392355_Tarceva_Ad_King_ONC_TIMES_JUNE_M02.indd 3 5/21/12 1:57 PM 6 Letters

Re: Wendy Harpham’s handout on the very first visit empha- with the PCP, but have such difficulty Yours is a common, complex prob- ‘Stewards of sizing that I work with not instead of having patients embrace the idea? lem involving heightened emotions on their PCP for their general health. both sides of the stethoscope. Patients Survivorship’ ‘View from Many of the PCPs, as Dr. Harpham Frankie Ann Holmes, MD may be struggling with uncertainty and the Other Side of the notes in her column, may not be up Texas Oncology, PA their sense of vulnerability, as well as the oncology-times.com to speed on survivorship and many are CoDirector, Breast Cancer emotional, ­financial and time burdens of

• Stethoscope’ Column, simply deer in the headlights, thinking Research Program medical visits. Oncologists may be feel-

4/25/12 issue that any aches or pains are due to the US Oncology Research ing annoyed or disappointed with PCPs cancer. There is no attempt to get a film Houston, TX who encourage survivors to see their on- hank you for addressing a most perplex- or to do an exam—just “Call your can- www.breastcancerdoc.md cologists for primary-care issues. PCPs Ting issue in our clinic in Dr. Wendy cer doctor.” They are a conduit only. may be struggling with loss of confidence Harpham’s “Stewards of Survivorship” col- Then, when we suggest this to patients, in their ability to properly evaluate and umn. Our patients won’t go to their PCP. they are angry, and feel we are not Reply from Wendy Harpham, MD treat medical problems that arise during They trust only . It is everything I can do caring. Your dilemma highlights the difference or after cancer treatment.

june 25, 2012 us

to get them to go to their PCP—for UTIs, My staff knows this is our practice— between theory and practice. Since your Realistic answers are available. In forth- •

hypertension, immunizations, lipid man- suggest this to the patient and then come patients’ initial consultation, you’ve de- coming “View” columns, I’ll explore the agement. I tell them, “Together we saved to me with angry patient phone calls. fined roles and boundaries by explaining emotional and logistical challenges of keep- you from the cancer but not to die of a Sometimes we are forced to see them and clearly that their PCP will continue to ing PCPs involved in their patients’ care preventable illness….And, we cannot, just end up doing exams, x-rays, labs that are manage their non-oncology medical care. throughout treatment and recovery, as well because you are here, refill your thyroid or generally normal and sending them back Yet some patients still pressure you to as when transitioning patients’ post-treat- blood pressure medications because ‘you’re to their “virtual” PCP. tend to medical issues that have nothing ment “survivorship” care back to their PCPs. my doctor, aren’t you?’” Dr. Harpham, what do you suggest to do with their history of cancer. Worse I give my patients a “How Will You for those of us who embrace your con- yet, in some cases the pressure originated With hope, oncology times Check Me and What Tests Will You Do?” cept that we need to work in partnership with the PCP. Wendy

➞SHOPTALK recently served as Director of the two years for his research on the genetic re- Sandra Rome, RN, continued from page 5 Oncology service line at MedStar Good arrangement of the RET gene to eventually MN, AOCN, Clinical Samaritan and MedStar Union Memorial develop new lung cancer therapies. Nurse Specialist in Norwegian Cancer hospitals. Hematology and Registry to capture the The Eastern Cooperative Oncology Oncology at Cedars- entire medical history of Elisa Oricchio, PhD, Group Research and Education Sinai Samuel Oschin the Norwegian popula- Research Fellow at Foundation has announced the following Comprehensive Cancer tion is research that we Memorial Sloan Ketter­ recipients of its annual research awards for Institute, has received SANDRA can’t do in the U.S.” ing Cancer Center, has young investigators researching the causes the Distinguished ROME, RN, been named a win- and treatments of neoplastic diseases: Alumni Award from the MN, AOCN Seattle’s Swedish Medi­ OLIVER ner in the New York Bryan P. Schneider, MD, received UCLA School of Nursing for raising aware- ELISA • cal Center has opened BOGLER, PHD Academy of Sciences’ the Young Investigator Award for his re- ness of the critical role nurses play in the ORICCHIO, the True Family Women’s Cancer Center, 2012 Blavatnik Awards search on breast can- nation’s health care system. She has been at PHD to consolidate and coordinate care ser- for Young Scientists cer biomarkers that Cedars-Sinai since 1991 and currently over- vices for women with cancer. The center Competition. She received a $15,000 prize identified two single sees 100 nurses in the Medical Oncology is funded by a $2 million gift from Jane for identifying a new molecular target for nucleotide polymor- and Bone Marrow Transplant Unit there True and her family, and an additional lymphoma therapy in her clinical medicine phisms with VEGF and is also Assistant Clinical Professor on $10 million in other work at the Wendel Lab at MSKCC. that predicted increased the UCLA School of Nursing Faculty. donations. “There are a few awards for young sci- breast cancer risk and Patricia L. Dawson, entists, but almost all of them are based on angiogenesis-specific The Intel International Science and BRYAN P. MD, PhD, is the center’s proposals that you submit, and not on the SNPs related to beva- Engineering Fair awarded its top prize to SCHNEIDER, first Medical Director. actual work that you do as a young scien- cizumab therapy. He is 15-year-old Jack Andraka, of Crownsville, MD Before this role, she was tist,” 2010 Blavatnik Awards faculty win- Associate Professor of Maryland, who won a breast surgeon with the ner Michal Lipson, MacArthur Fellow and Medicine in the Department of Medicine’s $75,000, for develop- Swedish Cancer Institute. PATRICIA L. Associate Professor in the Nanophotonics Division of Hematology/Oncology and ing a blood or urine DAWSON, MD, Research Group at Cornell University, Clinical Pharmacology and the Department test to find pancreatic The newly created PHD noted in a statement. “[The Blavatnik of Medical and Molecular Genetics at cancer with 90 percent Oncology service line Awards are] a true recognition of the Indiana University School of Medicine. accuracy. The test is for the MedStar Health work of young scientists; it is unique in An ECOG member since 2007, he is a 28 times cheaper and Baltimore region has ap- that sense. There is no equivalent.” member of ECOG’s Breast Committee, faster than less-sensitive JACK pointed Stephen Noga, The competition is open to research- as well as the Developmental Therapeutics tests. The competition ANDRAKA MD, PhD, as Medical ers under age 42, pursing research in the Committee, where he serves as Vice-Chair run by the non-profit Director and Phyllis life sciences, physical sciences, math- of the Pharmacogenetics Sub-Committee. Society for Science & the Public in- Gray, MS, as Regional ematics, or engineering. Nine winners • David L. Bajor, cluded more than 1,500 students from Vice President. The STEPHEN and two finalists were chosen out of MD, received the 70 nations. new service line will in- NOGA, MD, 170 nominations. Paul Carbone, MD tegrate cancer services PHD Fellowship Award for The Oncology Nursing among MedStar’s four Alexander Drilon, MD, his investigation into Society has announced Baltimore hospitals. a fellow at Memorial the clinical and im- the following awards Noga will continue Sloan-Kettering Cancer munological impact of given by the Oncology as Chief of Hematology Center, has received CD40 monoclonal an- Nursing Certification DAVID L. at the MedStar Franklin the International tibody in patients with Corporation: BAJOR, MD Square Medical Center, Association for the resectable pancreatic • Sylvia Danko, SYLVIA where he developed Study of Lung Cancer adenocarcinoma. He is a Hematology/ RN, OCN, CBCN, has DANKO, RN, a Blood Disorders PHYLLIS GRAY, Fellowship Award, an ALEXANDER Oncology Fellow at Perelman School of been named Oncology OCN, CBCN Division. Gray most MS $80,000 grant given over DRILON, MD Medicine at the University of Pennsylvania. continued on page 8 8 Breakthrough Chemotherapy-Induced Nausea & Vomiting: Control Increased with Olanzapine in Phase III Study BY CHARLENE LAINO oncology-times.com

•

he anti-psychotic drug olanzapine In addition, 28 patients (67%) in the improves the control of break- olanzapine group reported no nausea versus through nausea and vomiting in nine (24%) in the metoclopramide arm. patients receiving highly emeto- Both differences were statistically significant. genic chemotherapy, according to results Used as an anti-psychotic, olanzapine june 25, 2012 T

of a Phase III trial reported at the ASCO is associated with side effects, including •

Annual Meeting. weight gain, although this occurs in pa- “This is the first study to demon- tients after several months of treatment— strate an effective treatment for break- “three, six, nine months”—Navari said. through chemotherapy-induced nausea Used for a short period of three days as an and vomiting [CINV],” said lead author anti-emetic in the current study, the drug Rudolph M. Navari, MD, PhD, Professor was well tolerated, with no Grade 3 or of Medicine, Associate Dean, and Clinical Grade 4 toxicities and no central nervous Director of Harper Cancer Institute at system adverse effects. oncology times Indiana University School of Medicine- South Bend, who presented the findings ‘Truly Remarkable’ at a webcast briefing held in advance of Commenting on the study, ASCO 2012- the meeting. He noted that this is the first RUDOLPH M. NAVARI, MD, PHD: “This 2013 President Sandra M. Swain, MD, time that breakthrough CINV has been is the first study to demonstrate an Medical Director of the Washington studied in a systematic way. effective treatment for breakthrough Cancer Institute at Medstar Washington “About 30% of patients chemotherapy-induced nausea and Hospital Center, Professor of Medicine at Serendipitous Discovery vomiting.” Georgetown University, and a member of treated with highly In the study (Abstract 9064), 205 patients Lombardi Comprehensive Cancer Center, emetic chemotherapy with a range of tumor types who had not that they appeared to have less nausea and called the results truly remarkable— previously received chemotherapy were vomiting from other drugs they were on,” “a huge benefit for a really important will have breakthrough given standard guideline-recommended Navari said. quality-of-life issue.” vomiting despite drugs to prevent CINV prior to start- He added that the mechanism of ac- ing highly emetogenic chemotherapy tion is unclear, but olanzapine appears to “The findings are recommended with cisplatin or cyclophosphamide and block receptors in the central nervous sys- doxorubicin. tem that stimulate nausea and vomiting. a huge benefit for prophylactic therapy, Eighty of the patients developed break- Metoclopramide, which is approved to a really important and the proportion through CINV and were randomized in treat heartburn caused by gastroesophageal a double-blind manner to receive either reflux, was chosen as the control drug since quality-of-life issue.” goes up another 20% olanzapine (10 mg daily for three days) it has been shown to be an effective anti- or metoclopramide (10 milligrams three emetic in some circumstances, he explained, if you add in nausea.” times a day for three days). noting, though, that it is not recommended About 30% of patients treated with Baseline characteristics, including age for prophylaxis in any national guidelines. highly emetic chemotherapy will have range (39 to 79 years), percentage of females breakthrough vomiting despite preven- (about one-fifth), ECOG performance Olanzapine Outperforms tive treatment recommended by ASCO scores (about 31% had scores of 0), and Metoclopramide or other guidelines, “and [the proportion] distribution of tumor types (breast, lung, Patients were monitored for 72 hours af- goes up another 20 percent if you add in lymphoma, and bladder), were similar ter initiation of randomization. Among nausea,” she said. between the two groups. the 42 patients given olanzapine, 30 “As we get better at treating and curing The researchers chose to test olanzapine (71%) had no emesis episodes, compared cancer, [these figures] remind us that we still because physicians treating patients with with 12 (32%) of the 38 patients given have to find ways to improve the patient’s O psychosis made the “empirical observation metoclopramide. experience.” T

➞SHOPTALK tioner and genetic edu- $1 million en- nurses have aided them,” Mr. Miller said continued from page 5 cator at West Michigan dowment from in a statement. He and his wife have sup- Cancer Center in Samuel and ported advances in several specialties at Certified Nurse of the Year for her service Kalamazoo, she helped Maria Miller, the clinic since 1983, and he also serves to and support for certification in oncology develop multidisci- which will for- as a Trustee and member of the Board of O nursing, and being a leader throughout the plinary breast cancer, mally establish Directors. T Central Texas community she serves. She neuro-oncology, and the Sam and SAMUEL AND MARIA is a network oncology nurse educator at cancer risk assessment KELLY SMITH, Maria Miller MILLER Seton Healthcare Family in Austin. programs at her facil- MSN, RN, NP, Nurs­ing Excellence Awards to annually Share Your Good • Kelly Smith, MSN, RN, NP, ity, and provides edu- AOCN recognize 95 nurses at the institution. News! AOCN, has been selected Advanced cational programs to her institution and “Nurses have unfailing vigor, kindness Oncology Certified Nurse of the Year for area hospitals. and generosity and will forever be re- end information and her support and promotion of oncology membered by their patients. Cleveland S­photos for this column to nursing certification in her institution, Cleveland Clinic’s Stanley Shalom Zielony Clinic patients will always know how the [email protected] chapter, and community. A nurse practi- Institute for Nursing Excellence received a Cleveland Clinic organization and its