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DEVELOPMENTAL THERAPEUTICS AND TRANSLATIONAL RESEARCH Enrolling Patients in Early-Phase Clinical Trials: An Ethical Dilemma CHAIR Steven Joffe, MD, MPH University of Pennsylvania Philadelphia, PA SPEAKERS Stuart M. Lichtman, MD Memorial Sloan Kettering Cancer Center New York, NY Carlos H. Barrios, MD Latin American Cooperative Oncology Group Porto Alegre, Brazil
GERIATRIC ONCOLOGY AND CLINICAL TRIALS Geriatric Oncology and Clinical Trials Stuart M. Lichtman, MD OVERVIEW The overall aging of the population has resulted in a marked increase in the number of older patients with cancer. These patients have specific needs that are different from those of the younger population. Cancer clinical trials have included an inadequate number of older patients, resulting in lack of meaningful data to make evidence-based decisions for this population. As a result, clinicians have to extrapolate data from younger and healthier patients. There are a number of reasons for this under-representation, including a design and implementation structure for clinical trials that does not meet the needs of this vulnerable population. Issues that need to be addressed include alterations in eligibility criteria to make them less restrictive by accounting for multiple comorbidities and prior malignancy and endpoints specific for older patients, such as quality of life, changes in function, and maintenance of independence. Other issues specific to the older population include alterations in dose-limiting toxicity, measures of treatment-related toxicity, and polypharmacy. Phase I trials can be appropriate for older patients but need to be tailored to their needs. Some form of geriatric assessment needs to be included to help with eligibility, assessment, and stratification. For future clinical trials to be truly meaningful they need to appropriately assess and incorporate the needs of the majority of the cancer population. The demographic shift and the resultant increase in the number of older patients with cancer, which was predicted by the founders of geriatric oncology (Dr. B.J. Kennedy, Dr. Rosemary Yancik, and others), has now arrived. It has long been recognized that the most signifıcant risk factor for the development of cancer is aging. Cancer and its treatment can affect the overall life expectancy, as well as the active life expectancy and function, of older individuals. The traditional study approach to cancer, with its focus on younger, healthier patients, has resulted in a lack of highquality data to adequately guide care for older patients. In 1983, Dr. Yancik organized a symposium sponsored by the National Cancer Institute and the National Institute on Aging and published a monograph, “Perspectives on Prevention and Treatment of Cancer in the Elderly,” highlighting the importance of research in cancer and aging. 1 In the 1988 American Society of Clinical Oncology (ASCO) Presidential Address, Dr. Kennedy encouraged the study of aging and cancer. 2 He stated, “Our society need not ration how we will treat our disadvantaged members, but should continue to seek those preventive and positive measures that can shorten our later period of morbidity. A very major cancer load will persist well into the 21st century, even if the attempts at prevention are eventually a total success. There is a developing knowledge on aging. Care of the older person needs to be part of medical education and oncology education. Research will help attain a desirable quality of life with aging and a reduced morbidity.” The goals set forth by Drs. Yancik and Kennedy are yet to be fully achieved; however, many strides have been made toward that end. There has been increased recognition of the importance of the relationship between aging and cancer, as well as an increase in evidence-based research to guide the care of older adults with cancer. In addition, this research is being performed by a growing number of investigators at institutions across the nation, as well as internationally. The International Society of Geriatric Oncology, founded in the year 2000, fosters the mission of developing health professionals in the fıeld of geriatric oncology to optimize treatment of older adults with cancer, through education, clinical practice, and research. The Society’s publication, the Journal of Geriatric Oncology, is the fırst journal devoted solely to the fıeld. The Cancer in the Elderly Committee of the Cancer and Leukemia Group B (now the Alliance for Clinical Trials in Oncology) has supported furthering research in geriatric oncology through clinical trials and secondary data analyses. The Cancer and Aging Research Group has developed an instrument to predict chemotherapy toxicity, initiated and supported trials to validate this methodology in different clinical settings, and, most importantly, mentored junior investigators in geriatric oncology. The Gynecologic Oncology Group Elderly Taskforce is supporting the fırst prospective trial in older women with ovarian cancer and planning further studies in other diseases and modalities. The American Society of Clinical Oncology has also fostered a number of initiatives in geriatric oncology. These From the Memorial Sloan Kettering Cancer Center, Commack, NY. Disclosures of potential conflicts of interest are found at the end of this article. Corresponding author: Stuart M. Lichtman, MD, Memorial Sloan Kettering Cancer Center, 650 Commack Road, Commack, NY 11725; email: lichtmas@mskcc.org. © 2015 by American Society of Clinical Oncology. asco.org/edbook | 2015 ASCO EDUCATIONAL BOOK e127
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AMERICAN SOCIETY OF CLINICAL ONCOLO
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American Society of Clinical Oncolo
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Controversies in Neoadjuvant Therap
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Clinical Trials of Precision Medici
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Managing Ovarian Cancer in the Olde
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Updates in the Multimodality Manage
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PEDIATRIC ONCOLOGY Real-Time Molecu
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2015 ASCO Annual Meeting Disclosure
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2015 Educational Book Expert Panel
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James Marshall, PhD Roswell Park Ca
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2015 Annual Meeting Supporters* MIS
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David Yurman Corporate Allies Conqu
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INVITED ARTICLES This year’s invi
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CAN DIET AND LIFESTYLE PREVENT BREA
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REFORMING THE BUY-AND-BILL CHEMOTHE
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MICHAEL A. POSTOW Managing Immune C
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MICHAEL A. POSTOW diarrhea symptoms
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MICHAEL A. POSTOW nitis during ipil
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PRECISION THERAPY FOR RECTAL CANCER
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PRECISION THERAPY FOR RECTAL CANCER
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ABOU-ALFA ET AL sess liver function
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AHN ET AL Making Sense of Current a
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AHN ET AL Pancreatic cancer has bee
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EGIDIO DEL FABBRO tion of precachex
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CHALLENGING THE TREATMENT PARADIGM
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SALVAGE CHEMOTHERAPY Salvage Therap
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GYNECOLOGIC CANCER Cervical Cancer
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GYNECOLOGIC CANCER Managing Ovarian
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DUSKA, TEW, AND MOORE KEY POINTS A
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GYNECOLOGIC CANCER Treatment of the
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CHEMOTHERAPY FOR PATIENTS WITH BMOC
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HEALTH SERVICES RESEARCH AND QUALIT
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INDUSTRY AND ONCOLOGY KEY POINTS F
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INDUSTRY AND ONCOLOGY has been “l
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INDUSTRY AND ONCOLOGY by (covered)
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CANCER CARE QUALITY: CURRENT STATE
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MANAGING OLDER PATIENTS WITH ALL Th
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MANAGING OLDER PATIENTS WITH ALL FI
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TREATMENT OF PHILADELPHIA CHROMOSOM
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CD19 CAR THERAPY FOR ALL FIGURE 1.
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CD19 CAR THERAPY FOR ALL 5. Zhou G,
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NEW TARGETED THERAPIES FOR iNHL New
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MICHAEL W. DEININGER TABLE 1. Defin
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PEMMARAJU AND MOLITERNO TABLE 1. Ac
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GERBER, PAIK, AND DOWLATI a tumor t
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GERBER, PAIK, AND DOWLATI squamous
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GERBER, PAIK, AND DOWLATI gression
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GERBER, PAIK, AND DOWLATI Disclosur
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GERBER, PAIK, AND DOWLATI receptor
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BERNARDO H.L. GOULART The Value of
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BERNARDO H.L. GOULART every 6 month
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BERNARDO H.L. GOULART lung-cancer/l
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LUNG CANCER Updates in the Multimod
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WOODARD AND JABLONS section, becaus
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NASSER HANNA Current Standards and
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NASSER HANNA At the 2014 ASCO Annua
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NASSER HANNA culty of this task. Va
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LYMPHOMA AND PLASMA CELL DISORDERS
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NOWAKOWSKI AND CZUCZMAN sociated wi
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DAVID W. SCOTT Cell-of-Origin in Di
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CHEAH, OKI, AND FANALE Novel Treatm
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CHEAH, OKI, AND FANALE TABLE 3. Sel
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CHEAH, OKI, AND FANALE 77. Cairns R
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STEPHEN ANSELL associated with pati
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STEPHEN ANSELL Disclosures of Poten
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MATEOS AND SAN MIGUEL Smoldering Mu
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MATEOS AND SAN MIGUEL TABLE 2. Risk
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MOREAU AND TOUZEAU Multiple Myeloma
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LYMPHOMA AND PLASMA CELL DISORDERS
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MANAGEMENT OF CLL Up-Front Manageme
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MANAGEMENT OF CLL than 17p-/TP53mut
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MANAGEMENT OF CLL could be associat
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MANAGEMENT OF CLL tion by nonmalign
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MANAGEMENT OF CLL lymphocytic leuke
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PROGNOSTIC FACTORS AND ADJUVANT RAD
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MERKEL CELL CARCINOMA Merkel Cell C
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MERKEL CELL CARCINOMA tions in PIK3
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MERKEL CELL CARCINOMA treating MCC
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MERKEL CELL CARCINOMA 32. Leonard J
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MELANOMA/SKIN CANCERS Locoregional
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PERFUSION AND INFUSION IN THE ERA O
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NEOADJUVANT THERAPY OF MELANOMA Neo
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NEOADJUVANT THERAPY OF MELANOMA TAB
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NEOADJUVANT THERAPY OF MELANOMA ity
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MELANOMA/SKIN CANCERS Targeted Mole
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SULLIVAN ET AL FIGURE 1. Relevant S
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SULLIVAN ET AL Resistance to BRAF i
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SULLIVAN ET AL TABLE 1. Clinical Tr
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SULLIVAN ET AL 17. Halait H, Demart
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SULLIVAN ET AL NRAS-mutant melanoma
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KLEPIN, RODIN, AND HURRIA Treating
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KLEPIN, RODIN, AND HURRIA plication
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KLEPIN, RODIN, AND HURRIA plan was
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KLEPIN, RODIN, AND HURRIA patient-s
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KLEPIN, RODIN, AND HURRIA 62. Blanc
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PERIPHERAL NEUROTOXICITY IN CANCER
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Page 768 and 769:
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PARTRIDGE, JACOBSEN, AND ANDERSEN C
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PARTRIDGE, JACOBSEN, AND ANDERSEN c
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PARTRIDGE, JACOBSEN, AND ANDERSEN w
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PARTRIDGE, JACOBSEN, AND ANDERSEN v
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LESLIE R. SCHOVER Sexual Healing in
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LESLIE R. SCHOVER tinuous ADT in pr
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LESLIE R. SCHOVER 12. Potosky AL, H
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CATHERINE H. VAN POZNAK TABLE 1. Wo
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CATHERINE H. VAN POZNAK (tamoxifen,
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CATHERINE H. VAN POZNAK TABLE 3. FD
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CATHERINE H. VAN POZNAK premenopaus
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SHARI GOLDFARB KEY POINTS Brea
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SHARI GOLDFARB and friction with va
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SHARI GOLDFARB importance both duri
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PATIENT AND SURVIVOR CARE Moving Su
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MAYER ET AL TABLE 1. Quality Metric
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MAYER ET AL to enhance the quality
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MAYER ET AL FIGURE 2. (A) Infertili
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MAYER ET AL efıcial suggests that
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PATIENT AND SURVIVOR CARE The Chall
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BRUERA AND PAICE Choice of Opioid a
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BRUERA AND PAICE toxicity and proce
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BRUERA AND PAICE effective. Basic s
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PEDIATRIC ONCOLOGY Real-Time Molecu
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CARROLL, RAETZ, AND MEYER KEY POINT
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CARROLL, RAETZ, AND MEYER most are
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CARROLL, RAETZ, AND MEYER markers a
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PEDIATRIC ONCOLOGY Translating Surv
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REDUCING THE BURDEN OF LATE EFFECTS
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PROFESSIONAL DEVELOPMENT The Challe
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ADVANCES IN WEBSITE INFORMATION RES
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COMMUNICATION AND TECHNOLOGY: IT’
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Page 850 and 851:
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PATIENT-REPORTED OUTCOMES IN ONCOLO
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PATIENT-REPORTED OUTCOMES IN ONCOLO
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PROFESSIONAL DEVELOPMENT Trends, An
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CLINICAL ONCOLOGY PRACTICE 2015 FIG
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CLINICAL ONCOLOGY PRACTICE 2015 (6.
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CLINICAL ONCOLOGY PRACTICE 2015 Pro
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ADJUVANT/NEOADJUVANT MEDICAL THERAP
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Page 868 and 869:
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INDICATIONS FOR ADJUVANT RADIATION
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Page 874 and 875:
Page 876 and 877:
Page 878 and 879:
SARCOMA Latest Advances in Systemic
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SYSTEMIC THERAPY FOR OSTEOSARCOMA A
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SYSTEMIC THERAPY FOR OSTEOSARCOMA A
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RETHINKING TREATMENT FOR CHONDROSAR
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Page 888 and 889:
Page 890 and 891:
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BONE SARCOMAS IN ADULTS local disea
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BONE SARCOMAS IN ADULTS structure a
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SARCOMA Well-Differentiated and Ded
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ABBAS MANJI ET AL ticular region. 7
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ABBAS MANJI ET AL MYXOID (ROUND CEL
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ABBAS MANJI ET AL versus doxorubici
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SHLUSH AND HERSHKOVITZ Clonal Evolu
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SHLUSH AND HERSHKOVITZ FIGURE 1. Ti
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TUMOR BIOLOGY New Strategies to Und
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KNAPP, DHAWAN, AND OSTRANDER in dog
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KNAPP, DHAWAN, AND OSTRANDER TABLE
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KNAPP, DHAWAN, AND OSTRANDER 14. Fe
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SOURBIER, SRINIVASAN, AND LINEHAN M
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SOURBIER, SRINIVASAN, AND LINEHAN F
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SOURBIER, SRINIVASAN, AND LINEHAN T
Page 922:
Author Index Abbas Manji, Gulam ...
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