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NEWS & VIEWS FEBRUARY 10, 2019

POEMS/SWOG Intergroup S0230 Study on Preventing Net Health Benefit Score version 2 and ESMO’s Magnitude of Clinical Early Menopause Benefit Scale version 1.1 and evaluating the concordance between the fi In the long-term follow-up of the Prevention of Early Menopause Study frameworks when used to assess clinical bene t attributable to new 8 (POEMS)/SWOG Intergroup S0230 trial reported in the Journal of the therapies. The joint analysis was published by Cherny et al in the Journal National Cancer Institute, Moore et al1 found that the addition of goserelin of Clinical Oncology. to -containing was associated with vs Standard of Care in Recurrent or fi a higher incidence of pregnancy and nonsigni cant improvements in Metastatic Head and Neck Squamous Cell Carcinoma disease-free and overall survival in premenopausal women with stage I to In the phase III KEYNOTE-040 trial reported in The Lancet, Cohen et al9 – IIIA hormone receptor negative . found that pembrolizumab was associated with a “clinically meaningful Primary Resistance to Immune Checkpoint Inhibitors in prolongation of overall survival” vs investigator’s choice of standard Metastatic Colorectal Cancer and Misdiagnosis of MSI or therapies in patients with previously treated recurrent or metastatic head dMMR Status and neck squamous cell carcinoma. In a study reported in JAMA Oncology, Cohen et al2 found evidence that Radiotherapy Plus or in HPV-Positive primary resistance to immune checkpoint inhibitor treatment in metastatic Oropharyngeal Carcinoma colorectal cancer can be explained in some cases by misdiagnosis of In a noninferiority phase III trial reported in The Lancet, Gillison et al10 microsatellite instability (MSI) or defective mismatch repair status (dMMR). found that radiotherapy plus cetuximab was associated with poorer Vitamin D Supplementation and Cancer Risk overall and progression-free survival vs radiotherapy plus cisplatin in In a trial reported in The New England Journal of Medicine by Manson patients with human papillomavirus (HPV)-positive oropharyngeal et al,3 vitamin D supplementation was found to have no benefitin carcinoma. reducing the risk of invasive cancer vs placebo over 5 years of follow-up. MURANO Trial Follow-up: MRD and Prognosis With Fixed SELECT Trial: Adjuvant in Resected Duration of / in Relapsed or EGFR-Mutant NSCLC Refractory CLL In a phase II trial reported in the Journal of Clinical Oncology, Pennell As reported in the Journal of Clinical Oncology by Kater et al,11 high et al4 found that adjuvant erlotinib improved disease-free survival over undetectable minimal residual disease (MRD) rates persisted after the historical controls in patients with resected EGFR-mutant non–small cell end of venetoclax/rituximab treatment in the phase III MURANO trial in lung cancer (NSCLC). relapsed or refractory chronic lymphocytic (CLL) and were associated with improved progression-free survival. ECHELON-2: Plus Chemotherapy in CD30-Positive Peripheral T-Cell REFERENCES 5 As reported by Horwitz et al in The Lancet, the phase III ECHELON-2 trial 1. Moore HCF, Unger JM, Phillips K-A, et al: Final analysis of the prevention of early menopause showed that brentuximab vedotin plus cyclophosphamide, , study (POEMS)/SWOG Intergroup S0230. J Natl Canc Inst doi: https://doi.org/10.1093/jnci/ djy185 and prednisone improved progression-free and overall survival vs 2. Cohen R, Hain E, Buhard O, et al: Association of primary resistance to immune checkpoint cyclophosphamide, doxorubicin, , and prednisone in inhibitors in metastatic colorectal cancer with misdiagnosis of microsatellite instability or previously untreated CD30-positive peripheral T-cell . mismatch repair deficiency status. JAMA Oncol doi: 10.1001/jamaoncol.2018.4942 3. Manson JE, Cook NK, Lee I-M, et al: Vitamin D supplements and prevention of cancer and Palbociclib Plus in Advanced Breast Cancer: cardiovascular disease. N Engl J Med 380:33-44, 2019 4. Pennell NA, Neal JW, Chaft JE, et al: SELECT: A phase II trial of adjuvant erlotinib in patients Overall Survival Analysis of PALOMA-3 with resected epidermal growth factor receptor–mutant non–small-cell lung cancer. J Clin An overall survival analysis of the PALOMA-3 trial reported by Turner Oncol 37:97-104, 2019 et al6 in The New England Journal of Medicine found that the addition of 5. Horowitz S, O’Connor OA, Pro B, et al: Brentuximab vedotin with chemotherapy for CD30- positive peripheral T-cell lymphoma (ECHELON-2): A global, double-blind, randomised, palbociclib to fulvestrant improved survival among patients with hormone phase 3 trial. Lancet doi: https://doi.org/10.1016/S0140-6736(18)32984-2 – receptor positive, HER2-negative advanced breast cancer who had 6. Turner NC, Slamon DJ, Ro J, et al: Overall survival with palbociclib and fulvestrant in ad- sensitivity to previous endocrine therapy, with the improvement not being vanced breast cancer. N Engl J Med 379:1926-1936, 2018 significant in the entire study population. 7. Owonikoko TK, Dahlberg SE, Sica GL, et al: Randomized phase II trial of cisplatin and in combination with veliparib or placebo for extensive-stage small-cell lung cancer: Addition of Veliparib to Cisplatin/Etoposide in ECOG-ACRIN 2511 Study. J Clin Oncol doi: 10.1200/JCO.18.00264 8. Cherny NI, de Vries EGE, Dafni U, et al: Comparative assessment of clinical benefit using the Extensive-Stage SCLC ESMO-Magnitude of Clinical Benefit Scale Version 1.1 and the ASCO Value Framework Net In a phase II trial reported in the Journal of Clinical Oncology, Owonikoko Health Benefit Score. J Clin Oncol doi: 10.1200/JCO.18.00729 et al7 found that the addition of veliparib to cisplatin/etoposide was 9. Cohen EEW, Soulieres` D, Le Tourneau C, et al: Pembrolizumab versus , , or cetuximab for recurrent or metastatic head-and-neck squamous cell carci- associated with a modest but statistically significant improvement in noma (KEYNOTE-040): A randomised, open-label, phase 3 study. Lancet doi: https://doi.org/ progression-free survival in previously untreated patients with extensive- 10.1016/S0140-6736(18)31999-8 stage small cell lung cancer. 10. Gillison ML, Trotti AM, Harris J, et al: Radiotherapy plus cetuximab or cisplatin in human papillomavirus-positive oropharyngeal cancer (NRG Oncology RTOG 1016): A randomised, multicentre, non-inferiority trial. Lancet doi: https://doi.org/10.1016/S0140- ASCO and ESMO Publish Joint Assessment of Their 6736(18)32779-X Value Frameworks 11. Kater AP, Seymour JF, Hillmen P, et al: Fixed duration of venetoclax-rituximab in relapsed/ ASCO and the European Society for Medical Oncology (ESMO) today refractory chronic lymphocytic leukemia eradicates minimal residual disease and prolongs survival: Post-treatment follow-up of the MURANO phase III study. J Clin Oncol doi: 10.1200/ issued a joint analysis comparing the results of ASCO’s Value Framework JCO.18.01580