We found a match
Your institution may have rights to this item. Sign in to continue.
- Title
Characterization and outcomes of patients enrolled to multiple phase I cancer trials.
- Authors
Kuehne, Nathan; Chen, Lina; McDonald, Kate; Wang, Lisa; Spreafico, Anna; Hansen, Aaron; Razak, Albiruni Ryan Abdul; Bedard, Philippe Lucien; Siu, Lillian L.; Shepshelovich, Daniel
- Abstract
<bold>Purpose: </bold>Some patients who participate in early phase cancer trials enroll to more than one trial. Whether these patients have different characteristics or outcomes than patients who enroll to a single phase I trial is unknown.<bold>Methods: </bold>The study included all patients who participated in the solid tumor drug development program of the Princess Margaret Cancer Centre, a specialized academic cancer center, from July 2014 to January 2017. Patients sequentially enrolled to multiple phase I trials were compared to those enrolled in a single trial according to demographics, clinical characteristics, reported toxicities and prognosis.<bold>Results: </bold>The study cohort included 328 patients, including 61 (19%) enrolled to multiple phase I trials and 267 (81%) enrolled to a single phase I trial. Demographics, comorbidities, performance status, cancer site and time between initial diagnosis and initial enrollment to the phase I program were comparable between both groups. Patients enrolled to multiple phase I trials received more previous non-trial treatment lines (median 3 versus 2, p < 0.001) and had a higher average response rate on phase I trials (18% versus 10%, p = 0.03). Toxicity data, including number of any adverse events (AEs), grade 3/4 AEs, serious AEs and dose-limiting toxicities were comparable between both groups. Time to disease progression and time to last documented follow-up were also comparable between both groups.<bold>Conclusions: </bold>Patients enrolled to multiple phase I trials and those enrolled to a single trial had similar toxicity and prognostic profiles. These patients do not introduce bias into early-phase cancer trials results.
- Subjects
DRUG development; CANCER; DISEASE progression; CANCER treatment; THERAPEUTIC use of antineoplastic agents; RESEARCH; CLINICAL trials; RESEARCH methodology; PROGNOSIS; EVALUATION research; MEDICAL cooperation; COMPARATIVE studies; TUMORS
- Publication
Cancer Chemotherapy & Pharmacology, 2020, Vol 85, Issue 2, p469
- ISSN
0344-5704
- Publication type
journal article
- DOI
10.1007/s00280-019-03989-x