Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
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.

PubMed Disclaimer

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.
See this image and copyright information in PMC

References

    1. Agarwala SS. Current systemic therapy for metastatic melanoma. Expert Rev Anticancer Ther. 2009;9:587–595. - PubMed
    1. Attia P, Phan GQ, Maker AV, Robinson MR, Quezado MM, Yang JC, Sherry RM, Topalian SL, Kammula US, Royal RE, Restifo NP, Haworth LR, Levy C, Mavroukakis SA, Nichol G, Yellin MJ, Rosenberg SA. Autoimmunity correlates with tumor regression in patients with metastatic melanoma treated with anti–cytotoxic T-lymphocyte antigen-4. J Clin Oncol. 2005;23 (25:6043–6053. - PMC - PubMed
    1. Batty AJ, Fisher D, Winn B, Wang Q, Tolley K, Rowen D. Estimating quality of life in advanced melanoma; a comparison of standard gamble, SF-36 mapped, and EORTC QLQ-C30 mapped utilities. Value Health. 2011;14:A461–A462.
    1. Beusterien KM, Szabo SM, Kotapati S, Mukherjee J, Hoos A, Hersey P, Middleton MR, Levy AR. Societal preference values for advanced melanoma health states in the United Kingdom and Australia. Br J Cancer. 2009;101:387–389. - PMC - PubMed
    1. Cole BF, Gelber RD, Anderson KM, International Breast Cancer Study Group Parametric approaches to quality-adjusted survival analysis. Biometrics. 1994;50:621–631. - PubMed

Publication types

MeSH terms