Work

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

Year: 2018

Type: article

Abstract: // Ishwaria M. Subbiah 1 , Chad Tang 2 , Arvind Rao 3 , Gerald S. Falchook 4 , Vivek Subbiah 5 , Apostolia M. Tsimberidou 5 , Daniel Karp 5 , Razelle Kurzrock 6 and David S. Hong 5 1 Department of Palliative, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA 2 Division of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA 3 Department of Bioinformatics and Computational Biology, University of Texas MD Anderson Cancer Center, Houston, TX, USA 4 Sarah Cannon Research Institute at HealthONE, Denver, CO, USA 5 Department of Investigational Cancer Therapeutics (Phase I Program), University of Texas MD Anderson Cancer Center, Houston, TX, USA 6 Center 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 ABSTRACT 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.

Source: Oncotarget

DOI: 10.18632/oncotarget.25571