Call to integrate supportive care and patient reported outcomes in early phase clinical trials: An exploration of adolescent and young adult (AYA) participation on phase I trials of novel anticancer agents.

Abstract

149 Background: Adolescent and young adults (AYA) aged 15-39 years with cancer represent a patient population with very unique needs extending into the psychosocial realm. Consequently AYA participation on cancer clinical trials has been dismally low in recent decades, particularly on early phase trials with investigational agents. In an effort to better understand AYAs with advanced cancer, we analyzed their characteristics and participation on phase I clinical trials. Methods: We queried a department database to identify 1489 consecutive pts treated on phase I trials bw Dec 2004-July 2013 and then divided into 2 age-based groups (AYA 15-39y, mid age 40-64y) for analysis of their baseline characteristics, participation, time to treatment failure (TTF), and imaging response. We then calculated the odds ratios of achieving a favorable clinical benefit (defined as a RECIST response of prolonged SD≥6m+PR+CR) for AYAs vs mid-age pts. Results: AYAs represented 15% (n = 220) of participants treated on phase I trials while 67% (n = 991) were middle age. Most AYAs were women (63% female, 33% male) w median age being 32.6 years and a median of 3 prior therapies. AYAs most commonly had GYN (n = 41, 19%), sarcoma (n = 39, 18%), GI (n = 35, 16%), thoracic/head/neck (n = 31, 14%), melanoma (n = 27, 12%), and breast (n = 20, 9%) cancers. AYA had a comparable median TTF of 3.3m to mid age pts (3.5m). Overall, 369 (37%) mid age and 96 (44%) AYAs received a non-FDA approved agent. Imaging responses among AYAs showed 93 (42%) SD including 42 (19%) prolonged SD (median duration 9.7m), 34 (15%) PR (median duration 9.5m), and 2 AYAs with a CR lasting 36.2m and 50.1m. Conclusions: AYA patients represented just 15% of phase I clinical trials participants; none of these trials measured patient reported outcomes or quality of life indices, highlighting an urgent need for comprehensive supportive care integration into AYA care to tend to the unique psychosocial, economic, and family needs of this population to ultimately identify and overcome barriers to clinical trial participation.