] ] [ News ] Analysis ] Commentary ] Controversy ] June 25, 2012 Vol. 34 No. 12 oncology-times.com Publishing for O34 Years NCOLOGY The Independent IMES Hem/Onc News Source T 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