TY  - BOOK
AU  - Blackburn, Matthew J
AU  - Lynce, Filipa
TI  - Characteristics and outcomes of breast cancer patients enrolled in the National Cancer Institute Cancer Therapy Evaluation Program sponsored phase I clinical trials
SN  - 0167-6806
PY  - 2018///
KW  - *Antineoplastic Agents/ae [Adverse Effects]
KW  - *Breast Neoplasms/dt [Drug Therapy]
KW  - *Clinical Trials, Phase I as Topic/sn [Statistics & Numerical Data]
KW  - *Patient Selection
KW  - *Response Evaluation Criteria in Solid Tumors
KW  - Adult
KW  - Aged
KW  - Aged, 80 and over
KW  - Clinical Trials, Phase I as Topic/ec [Economics]
KW  - Drug-Related Side Effects and Adverse Reactions/ep [Epidemiology]
KW  - Drug-Related Side Effects and Adverse Reactions/et [Etiology]
KW  - Female
KW  - Humans
KW  - Male
KW  - Middle Aged
KW  - National Cancer Institute (U.S.)/ec [Economics]
KW  - Retrospective Studies
KW  - Time Factors
KW  - United States
KW  - Young Adult
KW  - MedStar Washington Hospital Center
KW  - Washington Cancer Institute
KW  - Hematology and Oncology
KW  - Journal Article
N1  - Available online from MWHC library: 1997 - present
N2  - CONCLUSIONS: Our data confirm our hypothesis that when compared to a general population of patients with cancer enrolled on phase I clinical trials, BC patients tend to derive clinical benefit from these therapies with similar toxicity profile. This evidence further supports enrollment of BC patients on phase I trials; METHODS: We performed a retrospective analysis of all Cancer Therapy Evaluation Program (CTEP) sponsored phase I trials from 1993 to 2012. We report an analysis of demographic variables, rates of response to treatment, grade 4 toxicities, and treatment-related deaths; PURPOSE: Breast cancer (BC) is the most commonly diagnosed cancer and the second leading cause of cancer-related death among women. Given the availability of approved therapies and abundance of phase II and III clinical trials, historically few BC patients have been referred for consideration of participation on a phase I trial. We were interested in determining whether clinical benefit rates differed in patients with BC from other patients enrolled in phase I trials; RESULTS: De-identified data from 8087 patients were analyzed, with 1,376 having a diagnosis of BC. The median time from initial cancer diagnosis to enrollment in a CTEP-sponsored phase I clinical trial was 614 days for all patients. Breast cancer patients were enrolled on average 790 days after initial diagnosis, while non-BC patients had a median enrollment time of 582 days (p < 0.001). Breast cancer patients had more clinical responses than non-BC patients (18.3% vs. 4.3%, respectively). Along with the higher rate of response, BC patients remained on phase I trials longer than non-BC patients with a median of 70 days while the latter were on trial for a median of 57 days. The overall rate of death related to the treatment drugs was 0.47%
UR  - https://dx.doi.org/10.1007/s10549-017-4563-3
ER  -