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Elective Neck Dissection Improves Survival in Early Oral Cancers E lective neck dissection (END) improved overall survival (OS) by 12.5% and reduced risk of death by 36% compared with a watch- and-wait policy with therapeu- tic neck dissection (TND) in pa- tients with early node-negative squamous cell carcinoma of the oral cavity. END also improved disease-free survival (DFS) by 23.6% and reduced the risk of recurrence by 55% in the trial, said Anil D'Cruz, MBBS, MS, FRCS, of Tata Memorial Hospi- tal, India, at the Plenary Press Briefi ng held on Sunday, May 31 (Abstract LBA3). "This has been a matter of considerable debate in the head a nd neck community spanning 5 decades," Dr. D'Cruz said. "There has been no conclusive evidence of a survival disadvan- tage with the watch-and-wait approach with neck dissection at the time of nodal relapse." The prospective, randomized phase III trial enrolled patients with T1 or T2 squamous car- cinoma of the oral cavity who were amenable to per-oral exci- sion. The primary endpoint was OS and the secondary endpoint was DFS. The trial was powered to demonstrate a 10% improve- ment in OS for END compared with TND, assuming 5-year sur- vival of 60% in the TND arm and with a calculated sample size of 710. An interim intention-to-treat analysis was performed on the fi rst 500 out of 596 patients enrolled with a minimum of 9 months of follow-up. The study MEETING COVERAGE PI3K, mTOR Inhibitors in HNSCC 3A IFCT-GFPC-0701 MAPS Phase III Trial Results 4A Bankruptcy, Mortality Risk in Patients with Cancer 4A Cost of Cancer Drugs Should Be Part of Treatment Decisions 6A No Benefi t Adding Erlotinib to Gemcitabine in R0-Resected Pancreatic Cancer 8A Clinical Trial Designs for Targeted Therapies 18A PD-1 Agents Show Promise in Small Cell Lung Cancer 19A Increased Effi cacy but Added Toxicity with Bevacizumab plus Everolimus in pNETs 19A PROCLAIM Trial Results 20A Docetaxel with Traditional Treatments Improves Outcomes of Advanced, Localized Prostate Cancer 20A Incorporating Technology into Practice 22A Immediate ADT Confers Modest Survival Benefi t in Prostate Cancer 23A Dr. Ernest Hawk Named ASCO–ACS Award Recipient 1B Addressing Burnout in Oncology 1C Integrating Antibody-Drug Conjugates into Clinical Practice 1C Key Sessions from Monday and Tuesday's Program 1D PHYSICIAN AUTHORED Expert Editorials Oncology Workforce Needs: An Alternative Scenario 14A How Oncologists Can Better Support F amily Caregivers 4B COME HOME Project: The Center for Cancer and Blood Disorders 19B The ASCO Leadership Development Program 22B Professional Burnout: Physician Assistants and Nurse Practitioners 31B Communicating Genetic Test Results to Patients and Their Families 1C Alternatives to BCG Immunotherapy During Drug Shortages 26C A Global Look at Drug Approval In South Africa 1B In Ghana, Nigeria, Kenya 35C Exploring the Pathway MEK Inhibition Fact Sheet 38B RAS/RAF/MEK/ERK P athway Fact Sheet 14C TRAINEE AND EARLY-CAREER ONCOLOGIST SPOTLIGHT Meet Dr. Reshma Jagsi 44B ASCO NEWS New Edition of ASCO-SEP ® 21C JOP Quality Issue 23C HIGHLIGHTS Nivolumab, Ipilimumab Combination Effective in Advanced Melanoma; Cost Questions Raised T he combination of nivolumab and ipilim- umab signifi cantly in- creased progression-free survival (PFS) for patients with advanced melanoma compared with ipilimumab alone, accord- ing to a randomized, double- blind, phase III trial (Abstract LBA1). Nivolumab monothera- py also performed better than ipilimumab alone. Though this was a positive trial, a Discussant also noted the extreme high costs of these drugs, and others like them. Jedd D. Wolchok, MD, PhD, of Memorial Sloan Kettering Cancer Center and Weill Cornell Medi- cal College, presented results of the CheckMate 067 trial dur- ing the Plenary Session on Sun- day, May 31. The trial involved two immunotherapy approach- es: Nivolumab, a PD-1 check- point inhibitor, and ipilimumab, a CTLA-4 checkpoint inhibitor. "The immune system is regu- lated by a dynamic interplay of positive and negative signaling pathways," Dr. Wolchok said. Both the individual drugs have yielded improvements in sur- vival in melanoma, and pre- clinical and earlier stage studies have indicated a synergistic ef- fect with the combination. The study included 945 pa- tients with treatment-naive, advanced melanoma who were randomly assigned to one of three treatm ent groups: 1 mg/ kg of nivolumab plus 3 mg/kg of ipilimumab every 3 weeks for four doses followed by 3 mg/kg of nivolumab every 2 weeks (314 patients); 3 mg/kg of nivolumab every 2 weeks plus ipilimumab-matched pla- cebo (316 patients); or 3 mg/ kg of ipilimumab every 3 weeks for four doses plus nivolumab- matched placebo (315 patients). The coprimary endpoints were PFS and overall survival (OS), on an intent-to-treat ba- sis. The OS data is not yet avail- able. The median PFS in the group treated with combination therapy was 11.5 months com- pared with 6.9 months in the nivolumab monotherapy group and 2.9 months in the ipilim- umab monotherapy group. The hazard ratio (HR) for Jedd D. Wolchok, MD, PhD DAILY NEWS MONDAY · J U N E 1 , 20 1 5 A See Early Oral Cancers, Page 8A The Meeting Slides for the 2015 Annual Meeting are available for purchase: • Includes unlimited access to slides from all captured presentations • Fully searchable Attendee Tip of the Day ➤ Stop by the ASCO University Bookstore (Oncology Professionals Hall, ASCO Central, Booth 7004) for more information or to purchase. In Brain Metastases, Adding WBRT to SRS Improves Local Control but Not Survival I n patients with one to three brain metastases, whole-brain radiation ther- apy (WBRT) improved brain control but did not improve overall survival (OS) when added to stereotactic radiosur- gery (SRS), a randomized trial found. Decline in cognitive function was more frequent with the addition of WBRT to SRS, said Jan C. Buckner, MD, of Mayo Clinic. "For patients with newly diagnosed brain metastases that are amenable to SRS, we recommend initial treatment with SRS alone and close monitoring to better preserve cognitive function and qual- ity of life," Dr. Buckner said, presenting the results of the trial during the Sunday, May 31, Plenary Press Briefi ng (Ab- stract LBA4) on behalf of Paul D. Brown, MD, of the Univer- sity of Texas MD Anderson Cancer Center. SRS is an effective treatment for brain metastases, but with SRS alone there is a high rate of development of new metas- tases and progression of treat- ed lesions. Adjuvant WBRT added to SRS improves local control and decreases devel- opment of new brain metasta- ses. Despite the improvement Changes in Pediatric Cancer Treatments Yield Reduced Late Mortality E fforts to reduce late effects of pediatric cancer treatments have resulted in reductions in late mortality for chil- dren diagnosed more recently, according to new data from the Childhood Cancer Survivor Study (Abstract LBA2) presented during the Plenary Press Brief- ing on Sunday, May 31. Deaths as a result of second malignant neoplasms, cardiac toxicity, and other issues have decreased. "The improvement in cure rate for childhood cancer really is one of the success stories of modern medicine," said Greg- ory T. Armstrong, MD, MSCE, of St. Jude Children's Research Hospital. By 2020, there will be an estimated 500,000 survivors of childhood cancers. "These 5-year survivors, as they move forward, are still at risk for late effects and late mortality." Specifi c changes in the treat- ment of certain childhood can- cers have been made with the aim of reducing late effects. For example, there have been changes to the use of cranial radiotherapy (RT) for acute lym- phoblastic leukemia (ALL), and dosage and usage of RT have also dropped for Hodgkin lym- phoma. There also recently have been improvements in screen- ing and early detection of late effects, treatment of those ef- fects, and supportive care. The Childhood Cancer See Advanced Melanoma, Page 6A See Brain Metastases, Page 18A See Pediatric Cancer Treatments, Page 8A

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