Pilleron S, Soto-Perez-de-Celis E, Vignat J, Ferlay J, Soerjomataram I, Bray F, et al. Estimated global cancer incidence in the oldest adults in 2018 and projections to 2050. Int J Cancer. 2021;148(3):601–8.
Article CAS PubMed Google Scholar
Global Cancer Observatory. Cancer Tomorrow, Globocan 2022 (version 1.1) [Internet]. Lyon (France): International Agency for Research on Cancer; 2024. Available from: https://gco.iarc.who.int. Cited 27 Apr 2025
Health AIo. Welfare. Older Australians. Canberra: AIHW; 2024.
Bumanlag IM, Jaoude JA, Rooney MK, Taniguchi CM, Ludmir EB. Exclusion of older adults from cancer clinical trials: review of the literature and future recommendations. Semin Radiat Oncol. 2022;32(2):125–34.
Article PubMed PubMed Central Google Scholar
An L, Ju W, Zheng R, Zeng H, Zhang S, Chen R, et al. Trends in survival for cancer patients aged 65 years or over from 1995 to 2014 in the United States: a population-based study. Cancer Med. 2023;12(5):6283–93.
Article CAS PubMed Google Scholar
Bizuayehu HM, Ahmed KY, Kibret GD, Dadi AF, Belachew SA, Bagade T, et al. Global disparities of cancer and its projected burden in 2050. JAMA Netw Open. 2024;7(11):e2443198.
Article PubMed PubMed Central Google Scholar
Singh H, Kanapuru B, Smith C, Fashoyin-Aje LA, Myers A, Kim G, et al. FDA analysis of enrollment of older adults in clinical trials for cancer drug registration: a 10-year experience by the US food and drug administration. J Clin Oncol. 2017;35(15_suppl):10009.
Kanapuru B, Singh H, Kwitkowski V, Blumenthal G, Farrell AT, Pazdur R. Older adults in hematologic malignancy trials: representation, barriers to participation and strategies for addressing underrepresentation. Blood Rev. 2020;43:100670.
Sedrak MS, Freedman RA, Cohen HJ, Muss HB, Jatoi A, Klepin HD, et al. Older adult participation in cancer clinical trials: a systematic review of barriers and interventions. CA Cancer J Clin. 2021;71(1):78–92.
Murthy VH, Krumholz HM, Gross CP. Participation in cancer clinical trials: race-, sex-, and age-based disparities. JAMA. 2004;291(22):2720–6.
Article CAS PubMed Google Scholar
Outlaw D, Williams GR. Is the lack of evidence in older adults with cancer compromising safety? Expert Opin Drug Saf. 2020;19(9):1059–61.
Article PubMed PubMed Central Google Scholar
Boyle HJ, Alibhai S, Decoster L, Efstathiou E, Fizazi K, Mottet N, et al. Updated recommendations of the International Society of Geriatric Oncology on prostate cancer management in older patients. Eur J Cancer. 2019;116:116–36.
Article CAS PubMed Google Scholar
Kunkler IH, Audisio R, Belkacemi Y, Betz M, Gore E, Hoffe S, et al. Review of current best practice and priorities for research in radiation oncology for elderly patients with cancer: the International Society of Geriatric Oncology (SIOG) task force. Ann Oncol. 2014;25(11):2134–46.
Article CAS PubMed Google Scholar
Diaz FC, Hamparsumian A, Loh KP, Verduzco-Aguirre H, Abdallah M, Williams GR, et al. Geriatric oncology: a 5-year strategic plan. Am Soc Clin Oncol Educ Book. 2024;44(3):e100044.
Article PubMed PubMed Central Google Scholar
Hamaker M, Lund C, Te Molder M, Soubeyran P, Wildiers H, van Huis L, et al. Geriatric assessment in the management of older patients with cancer—a systematic review (update). J Geriatr Oncol. 2022;13(6):761–77.
Article CAS PubMed Google Scholar
Parks RM, Holmes HM, Cheung K-L. Current challenges faced by cancer clinical trials in addressing the problem of under-representation of older adults: a narrative review. Oncology and Therapy. 2021;9(1):55–67.
Article PubMed PubMed Central Google Scholar
Jiang Z, Sun W, Du R, Yang R. A review of dose escalation for FDA-approved products treating solid tumors and hematological malignancies in first-in-human trials. Clin Transl Oncol. 2024;26(9):2116–25.
Lee SM, Wages NA, Goodman KA, Lockhart AC. Designing dose-finding phase I clinical trials: top 10 questions that should be discussed with your statistician. JCO Precis Oncol. 2021;5:317–24.
Conaway MR, Petroni GR. The impact of early-phase trial design in the drug development process. Clin Cancer Res. 2019;25(2):819–27.
Unger JM, Xiao H, Vaidya R, Threlkel SA, Chansky M, Hayes A, et al. The cost of doing business: drug costs in federally sponsored cancer clinical trials. JCO Oncol Pract. 2024;20(10_suppl):10.
Zhang SX, Fergusson D, Kimmelman J. Proportion of patients in phase I oncology trials receiving treatments that are ultimately approved. J Natl Cancer Inst. 2020;112(9):886–92.
Article PubMed PubMed Central Google Scholar
Horstmann E, McCabe MS, Grochow L, Yamamoto S, Rubinstein L, Budd T, et al. Risks and benefits of phase 1 oncology trials, 1991 through 2002. N Engl J Med. 2005;352(9):895–904.
Article CAS PubMed Google Scholar
Decoster G, Stein G, Holdener EE. Responses and toxic deaths in phase I clinical trials. Ann Oncol. 1990;1(3):175–81.
Article CAS PubMed Google Scholar
Chakiba C, Grellety T, Bellera C, Italiano A. Encouraging trends in modern phase 1 oncology trials. N Engl J Med. 2018;378(23):2242–3.
Abbasi J. Older patients (still) left out of cancer clinical trials. JAMA. 2019;322(18):1751–3.
Tamura K, Tsurutani J, Takahashi S, Iwata H, Krop IE, Redfern C, et al. Trastuzumab deruxtecan (DS-8201a) in patients with advanced HER2-positive breast cancer previously treated with trastuzumab emtansine: a dose-expansion, phase 1 study. Lancet Oncol. 2019;20(6):816–26.
Article CAS PubMed Google Scholar
Chen EY, Raghunathan V, Prasad V. An overview of cancer drugs approved by the US food and drug administration based on the surrogate end point of response rate. JAMA Intern Med. 2019;179(7):915–21.
Article PubMed PubMed Central Google Scholar
Corr BR, Moroney M, Sheeder J, Eckhardt SG, Sawyer B, Behbakht K, et al. Survival and clinical outcomes of patients with ovarian cancer who were treated on phase 1 clinical trials. Cancer. 2020;126(19):4289–93.
Tan T, Rheaume M, Wang L, Chow H, Spreafico A, Hansen AR, et al. Referrals to a phase I clinic and trial enrollment in the molecular screening era. Oncologist. 2019;24(7):e518–25.
Article PubMed PubMed Central Google Scholar
Thomas D. Omico-MoST-PrOSPeCT [Internet]. 2024. Available from: https://gccti.org.au/wp-content/uploads/2024/04/Omico-MoST-and-PrOSPeCT-Thomas.pdf. Cited 6 May 2025.
Garon EB, Rizvi NA, Hui R, Leighl N, Balmanoukian AS, Eder JP, et al. Pembrolizumab for the treatment of non-small-cell lung cancer. N Engl J Med. 2015;372(21):2018–28.
Moore KN, Martin LP, O’Malley DM, Matulonis UA, Konner JA, Perez RP, et al. Safety and activity of Mirvetuximab Soravtansine (IMGN853), a folate receptor alpha-targeting antibody–drug conjugate, in platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer: a phase I expansion study. J Clin Oncol. 2017;35(10):1112–8.
Article CAS PubMed Google Scholar
Moore KN, Angelergues A, Konecny GE, García Y, Banerjee S, Lorusso D, et al. Mirvetuximab soravtansine in FRα-positive, platinum-resistant ovarian cancer. N Engl J Med. 2023;389(23):2162–74.
Article CAS PubMed Google Scholar
BrintzenhofeSzoc K, Krok-Schoen JL, Canin B, Parker I, MacKenzie AR, Koll T, et al. The underreporting of phase III chemo-therapeutic clinical trial data of older patients with cancer: a systematic review. J Geriatr Oncol. 2020;11(3):369–79.
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