Evaluating Treatment Tolerability in Cancer Clinical Trials Using the Toxicity Index.

ABSTRACT:

Background

The National Cancer Institute Moonshot research initiative calls for improvements in the analysis and reporting of treatment toxicity to advise key stakeholders on treatment tolerability and inform regulatory and clinical decision making. This study illustrates alternative approaches to toxicity evaluation using the National Surgical Adjuvant Breast and Bowel Project R-04 clinical trial as an example.

Methods

National Surgical Adjuvant Breast and Bowel Project R-04 was a neoadjuvant chemoradiation trial in stage II-III rectal cancer patients. A 2 x 2 factorial design was used to evaluate whether the addition of oxaliplatin (Oxa) to 5-fluorouracil (5FU) or capecitabine (Cape) with radiation therapy improved local-regional tumor control. The toxicity index (TI), whi

SUBMITTER: Gresham G 

PROVIDER: S-EPMC7735773 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature