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Clinical Trial
. 2013 Jul 9;109(1):8-13.
doi: 10.1038/bjc.2013.298. Epub 2013 Jun 20.

Q-TWiST analysis comparing ipilimumab/dacarbazine vs placebo/dacarbazine for patients with stage III/IV melanoma

B Sherrill  1 , J Wang, S Kotapati, K Chin
Affiliations
Clinical Trial

Q-TWiST analysis comparing ipilimumab/dacarbazine vs placebo/dacarbazine for patients with stage III/IV melanoma

B Sherrill et al. Br J Cancer. .

Abstract

Background: Study CA184024 was a multinational, randomised, double-blind, phase 3 study comparing ipilimumab/dacarbazine (DTIC) vs placebo/DTIC in patients with untreated stage III/IV melanoma, which showed that ipilimumab significantly improves survival in patients with metastatic melanoma. The objective of this analysis was to compare the quality-adjusted survival experience among patients in this trial.

Methods: Survival time was partitioned into health states: toxicity, time before progression without toxicity, and relapse until death or end of follow-up. Q-TWiST (quality-adjusted time without symptoms of disease or toxicity of treatment) was calculated as the utility-weighted sum of the mean health state durations. Analyses were repeated over extended follow-up periods.

Results: Based on a combination of trial-based and external utility scores, the Q-TWiST difference in this trial was 0.50 months (P=0.0326) favoring ipilimumab after 1 year. The Q-TWiST difference was 1.5 months with 2 years of follow-up (P=0.0091), 2.36 months at 3 years (P=0.005) and 3.28 months at 4 years (P=0.0074).

Conclusion: During the first year of study, there was little difference between groups in quality-adjusted survival. However, after 2, 3 and 4 years follow-up for patients with extended survival, the benefits of IPI+DTIC vs PLA+DTIC for advanced melanoma continue to accrue.

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Figures

Figure 1
Figure 1
Study Phases.
Figure 2
Figure 2
Partitioned survival plots with 4-year follow-up (two plots). Ipilimumab+dacarbazine. Placebo+dacarbazine.
Figure 3
Figure 3
Threshold utility analyses (four plots). Note: Numbered lines within the plots represent Q-TWiST difference (in months); positive numbers favour ipilimumab+dacarbazine over placebo+dacarbazine. Grey shading depicts P-values for testing the difference between treatments under utility score combinations; the lighter the grey, the smaller the P-value.
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