Research Papers:

Older adults in phase I clinical trials: a comparative analysis of participation and clinical benefit rate among older adults versus middle age and AYA patients on phase I clinical trials with VEGF/VEGFR inhibitors

Ishwaria M. Subbiah _, Chad Tang, Arvind Rao, Gerald S. Falchook, Vivek Subbiah, Apostolia M. Tsimberidou, Daniel Karp, Razelle Kurzrock and David S. Hong

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Oncotarget. 2018; 9:28842-28848. https://doi.org/10.18632/oncotarget.25571

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Ishwaria M. Subbiah1, Chad Tang2, Arvind Rao3, Gerald S. Falchook4, Vivek Subbiah5, Apostolia M. Tsimberidou5, Daniel Karp5, Razelle Kurzrock6 and David S. Hong5

1Department of Palliative, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA

2Division of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA

3Department of Bioinformatics and Computational Biology, University of Texas MD Anderson Cancer Center, Houston, TX, USA

4Sarah Cannon Research Institute at HealthONE, Denver, CO, USA

5Department of Investigational Cancer Therapeutics (Phase I Program), University of Texas MD Anderson Cancer Center, Houston, TX, USA

6Center for Personalized Cancer Therapy and Clinical Trials Office, Moores Cancer Center, University of California, San Diego, CA, USA

Correspondence to:

Ishwaria M. Subbiah, email: [email protected]

Keywords: geriatric oncology; elderly; VEGF inhibitors; older adults; phase I trials

Received: May 19, 2018     Accepted: May 24, 2018     Published: June 22, 2018


Background: Older adults aged 65 years and above remain underrepresented in cancer clinical trials. We hypothesized that older participation in early phase trials with VEGF/VEGFR (VEGF/R) inhibitors was lower than cancer prevalence in this group and lower than other age groups (middle age, adolescent/young adults [AYA]).

Results: Of 1489 patients, 278 were older adults (18%, median age 68.9y), 220 AYA (15%, median age 32.6 y), 991 middle age (67%, median age 53.8 y). Common malignancies included gastrointestinal (n = 438, 29%), gynecologic (n = 234, 16%), and thoracic/head/neck (n = 216, 15%). Median time to treatment failure did not vary significantly between the 3 age-based cohorts (3m in older adults, 3.5 m middle age, 3.3 m AYA). OR of achieving clinical benefit in older adults vs middle age (OR 1.10, p 0.19 [two-tailed], p 0.09 [one-tailed]) and AYA vs middle age (OR 0.85, p 0.31 [proportions z-test, two tailed], p 0.15 [one-tailed]) showed no significant differences.

Conclusions: Older adults accounted for <20% of participants on phase I clinical trials with VEGF/R inhibitors but those who participated were just as likely to achieve a clinical benefit as AYA and middle age patients. These findings merit further exploration into patient selection for early phase trials.

Methods: We identified and separated patients treated on VEGF/R-inhibitor-based phase I trials from 12/1/2004–07/31/2013 into 3 age-based cohorts, AYA (15–39y), middle age (40–64 y), older adults (65 y+). We analyzed clinical/treatment characteristics and response outcomes, calculating the odds ratios (OR) of clinical benefit (defined as SD ≥ 6months, PR, CR) for older adults and AYAs versus middle age participants.

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