Abstract
In the era of precision medicine the treatment options for cancer patients and subsequent outcomes are expected to improve. We present a review of patients enrolled in first-in-human Phase1 trials at University of Alabama at Birmingham. Between 1/2015–6/2017, 162 cancer patients (whole cohort, WC) were enrolled on phase1 studies receiving either targeted therapy (TT) or immuno-therapy (IOT). We assessed 90 day mortality (90DM) and time to treatment failure (TTF) to determine the predictors. Of the WC (122 (TT), 40 (IOT)), 90 (56%) received ≥ 2 prior therapies and 38 (24%) ⩾ 5 prior therapies. Overall, Grade 3 or 4 events were observed in 33% (WC) vs 31% (TT) vs 38% (IOT). The 90DM was 9.3% (WC) vs 7.4% (TT) vs 15% (IOT). The median TTF was 4.2 months vs 4.5 m vs 3.6 m. The number of lines of prior therapy and performance status were identified as outcome predictors. Our data reflects the new trend in precision oncology where majority received non-cytotoxic therapeutic interventions. The observation that number of lines of prior therapy and performance status predictive of PFS and 90DM emphasizes the need to consider phase1 trials earlier, preferably upon progression following definitive therapy.
Highlights
While chemotherapeutic agents still have an important role in oncology, the era of precision medicine is beginning to revolutionize treatment options and outcomes for cancer patients
The primary objective is assessment of 90 day mortality (90DM) All patients included in our analysis met the respective protocol specific eligibility and all protocols were approved by Institutional Review Boards and conducted in accordance with Good Clinical Practice Guidelines
All patients enrolled on our first-in-human Phase 1 clinical trials were required to have an ECOG performance status of 0 or 1; one third had an excellent performance status (ECOG 0) at the time of enrollment
Summary
While chemotherapeutic agents still have an important role in oncology, the era of precision medicine is beginning to revolutionize treatment options and outcomes for cancer patients. The UABOCCC, Phase 1 Clinical Trials Program was formally established in 2015, in an effort to offer novel first-in- human therapeutic clinical trials to cancer patients in a one-stop-shop setting. We enrolled 60 patients in our first year and close to 100 by 2017 This single-center, retrospective analysis was performed to assess clinical outcomes and the predictors of survival and efficacy in patients during the first two and a half years of our program. Our program was unique in that all patients received targeted or immuno-oncology agents as the backbone of their treatment[1,2]. There remains an unmet need to identify predictors of outcome and survival in patients treated exclusively on targeted or immuno-oncology Phase 1 studies
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