By Reuters Staff
NEW YORK (Reuters Health) - 15/1/2019
Late-life expectancy (LLE) is a better measure of survival benefit with immune-checkpoint inhibitors than is the American Society of Clinical Oncology Value Framework (ASCO-VF), according to a new report.
"We showed that the use of LLEs ratios may provide a fine-grained assessment of long-term benefit," Dr. Alexandre Vivot of Hotel-Dieu de Paris and colleagues note in the Journal of the National Cancer Institute, online January 4. "However, we only proposed a scoring to be further discussed and improved by the oncology community."
The ASCO-VF awards tail-of-the-curve bonus points using milestone survival at twice the control median survival, Dr. Vivot and his team write. But this approach may have several limitations, they add, including that the milestone is not always reached.
Following up on an earlier proposal that the area under the Kaplan-Meier curve between two milestones would be a better reflection of survival, Dr. Vivot and his team suggest using late-life expectancy (LLE), or the area under the Kaplan Meier curve from median survival time in controls to the end of follow-up.
From 2011 to 2018, the U.S. Food and Drug Administration approved six immune-checkpoint inhibitors (ICIs) in 27 indications, and data on progression-free survival (PFS) or overall survival (OS) was available for 13 indications. Nine (69.2%) qualified for ASCO-VF bonus points for OS or PFS.
LLEs ratios for the six ICIs ranged from 1.18 to 1.89 for OS and from 1.28 to 3.35 for PFS. While the Checkmate-66 trial of nivolumab in melanoma did not receive bonus points from ASCO for OS because twice the median survival was not reached, Dr. Vivot and colleagues note, LLEs ratio was 1.65.
"We found that nivolumab was associated with an increase of 65.3% . . . in overall survival late-life expectancy, which highlights its important long term benefit," they write. "In conclusion, the ASCO-VF could be improved with the use of late-life expectancy."
Dr. Vivot was not available for an interview by press time.
SOURCE: https://bit.ly/2srST83 J Natl Cancer Inst 2019.