Title |
Quality-adjusted survival of nivolumab plus ipilimumab or nivolumab alone versus ipilimumab alone among treatment-naive patients with advanced melanoma: a quality-adjusted time without symptoms or toxicity (Q-TWiST) analysis
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Published in |
Quality of Life Research, September 2018
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DOI | 10.1007/s11136-018-1984-3 |
Pubmed ID | |
Authors |
David F. McDermott, Ruchit Shah, Komal Gupte-Singh, Javier Sabater, Linlin Luo, Marc Botteman, Sumati Rao, Meredith M. Regan, Michael Atkins |
Abstract |
To compare the quality-adjusted survival of nivolumab plus ipilimumab combination and nivolumab alone versus ipilimumab alone among treatment-naive patients with advanced melanoma based on a minimum 36-month follow-up from the CheckMate 067 trial. Overall survival was partitioned into time without symptoms of progression or toxicity (TWiST), time with treatment-related grade ≥ 3 adverse events after randomization but before progression (TOX), and time from progression until end of follow-up or death (REL). Mean quality-adjusted TWiST (Q-TWiST) was calculated by multiplying the mean time spent in each health state by a utility of 1.0 for TWiST and 0.5 for TOX and REL. Sensitivity analyses included varying utilities of TOX and REL; Q-TWiST gains at different follow-up times were calculated using EQ-5D-3L utilities from the trial. Relative Q-TWiST gain of ≥ 10% was considered clinically important. Compared with ipilimumab-treated patients, those who received nivolumab + ipilimumab combination had significantly longer TWiST and TOX but shorter REL; nivolumab-treated patients had significantly longer TWiST, shorter REL, and shorter but statistically nonsignificant TOX. Mean Q-TWiST was highest for nivolumab + ipilimumab (23.5 months; 95% CI 21.9-25.2), followed by nivolumab (21.8 months; 95% CI 20.2-23.4) and ipilimumab (15.3 months; 95% CI 13.9-16.6). Relative Q-TWiST gains were favorable and clinically important for nivolumab + ipilimumab combination (+ 36.81%) and nivolumab alone (+ 29.18%) versus ipilimumab alone. Relative gains increased with follow-up from 3 to 40 months for all comparisons. These gains remained consistent in magnitude and direction in the different sensitivity analyses. Nivolumab + ipilimumab combination and nivolumab alone resulted in a statistically significant and clinically important improvement in quality-adjusted survival compared with ipilimumab alone. |
X Demographics
Geographical breakdown
Country | Count | As % |
---|---|---|
United States | 1 | 50% |
Unknown | 1 | 50% |
Demographic breakdown
Type | Count | As % |
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Members of the public | 2 | 100% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 42 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Other | 8 | 19% |
Researcher | 6 | 14% |
Student > Bachelor | 6 | 14% |
Student > Doctoral Student | 2 | 5% |
Student > Master | 2 | 5% |
Other | 1 | 2% |
Unknown | 17 | 40% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 12 | 29% |
Biochemistry, Genetics and Molecular Biology | 3 | 7% |
Agricultural and Biological Sciences | 3 | 7% |
Pharmacology, Toxicology and Pharmaceutical Science | 2 | 5% |
Nursing and Health Professions | 1 | 2% |
Other | 2 | 5% |
Unknown | 19 | 45% |