Immune checkpoint inhibitors have transformed cancer care to the point where the popular Cox proportional-hazards model provides misleading estimates of the treatment effect, according to a new study published April 15 in JAMA Oncology.
The study, “Development and Evaluation of a Method to Correct Misinterpretation of Clinical Trial Results With Long-term Survival,” suggests that some of the published survival data for these immunotherapies should be re-analyzed for potential misinterpretation.
The study’s senior author, Yu Shyr, Ph.D., the Harold L. Moses Chair in Cancer Research and chair of the Department of Biostatistics at Vanderbilt University Medical Center, and colleagues, Chih-Yuan Hsu, Ph.D., and Emily Lin, MD, Ph.D., have proposed an adjustment to convert the inappropriate Cox proportional-hazards model to the appropriate cure model. The adjustment utilizes the Cox-TEL (Cox PH-Taylor expansion for long-term survival data) method.
“The Cox proportional-hazards model has become ingrained as the preferred choice for survival analysis in clinical trials for many reasons, including its robustness; however, researchers should not blindly use this in immunotherapy trials,” Shyr said.
“Because the model’s proportional hazards assumption is clearly violated in some immunotherapy trials, the results and conclusions based on this model are inaccurate and misleading. We wanted to create an approach that would not only correct the hazard ratio of the Cox proportional-hazards model, but also be interpretable and practical for both clinicians and statisticians. We believe Cox-TEL will be used widely to avoid misinterpretation of clinical trials with long-term survival.”
The team of researchers initiated their work because of the common observance of long tails and crossovers in survival curves with immune checkpoint inhibitors. These observances violate the proportional hazards assumption in the widely-used Cox proportional-hazards model. The researchers looked at simulated data and real-world data from published immune checkpoint inhibitor trials. In comparing the Cox proportional-hazards model to the Cox-TEL adjustment method, they determined that the Cox-TEL adjustment method was more accurate in assessing long-term survival. The Cox-TEL adjustment is user friendly and freely available as a package in the statistical software R.
Study shows young early-onset colorectal cancer patients have increased survival
JAMA Oncology (2021). DOI: 10.1001/jamaoncol.2021.0289
Long-term survival rates for immunotherapies could be misinterpreted (2021, April 15)
retrieved 15 April 2021
This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no
part may be reproduced without the written permission. The content is provided for information purposes only.
- Life expectancy in India dropped by two years due to COVID-19: Study - October 23, 2021
- US’ work with India on vaccine manufacturing saving people’s lives, says DFC chief - October 23, 2021
- Bengal reports steady Covid surge for third consecutive day - October 23, 2021
- Sri Lanka gives booster shots to front-line workers - October 23, 2021
- 3 children die of dengue in Uttar Pradesh - October 23, 2021
- India is close to turning the pandemic tide: Poonawalla - October 21, 2021
- Covishield may offer over 90% protection against death from Delta variant: Study - October 21, 2021
- PM Modi congratulated health workers on vaccinating 100 crore India’s population - October 21, 2021
- South African regulator rejects Russia’s COVID-19 vaccine - October 20, 2021
- Second wave of pandemic not receded yet, third wave feared post-Diwali: Maha health minister - October 20, 2021