Originally published as JCO Early Release 10.1200/JCO.2008.20.5815 on August 10 2009

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Quality-Adjusted Time Without Symptoms or Toxicity Analysis of Adjuvant Chemotherapy in Non–Small-Cell Lung Cancer: An Analysis of the National Cancer Institute of Canada Clinical Trials Group JBR.10 Trial

From the Department of Medical Oncology, Princess Margaret Hospital/University Health Network; Department of Medicine, University of Toronto; Department of Radiation Oncology, Princess Margaret Hospital/University Health Network, Toronto; National Cancer Institute of Canada, Clinical Trials Group; Queen's University, Kingston, Ontario; and the Department of Thoracic Surgery, University of Alberta, Edmonton, Alberta, Canada.

Corresponding author: Natasha Leighl, MD, FRCPC, 5-105 610 University Ave, Toronto Ontario Canada M5G 2M9; e-mail: Natasha.Leighl{at}uhn.on.ca.

Purpose National Cancer Institute of Canada Clinical Trials Group JBR.10 demonstrated that adjuvant vinorelbine and cisplatin after resection of stage IB-II non–small-cell lung cancer (NSCLC) improved relapse-free and overall survival. However, many patients either are not referred for chemotherapy or decline treatment. To aid in treatment decision making, quality-adjusted survival estimates of the JBR.10 trial were derived using a quality-adjusted time without symptoms or toxicity (Q-TWiST) analysis.

Methods Survival curves for treatment (N = 242) and observation groups (N = 240) were partitioned into three health states: time with grade 2 (early or late) chemotherapy-related toxicity (TOX), time in relapse (REL), and time without toxicity or relapse (TWiST). Q-TWiST = u_TOX x TOX + u_TWiST x TWIST + u_REL x REL, where weights u_TOX, u_TWIST, and u_REL range from 0 to 1. Threshold utility analysis was performed to test the sensitivity of the results to changes in the weights. Weights were derived in an exploratory fashion using different methods. Methods included use of arbitrary values, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) quality-of-life data prospectively collected in JBR.10 (global assessment questions and symptom-based questions), and lastly weights European Quality of Life–Five Dimensions questionnaire collected from early-stage NSCLC (nontrial) patients after resection with discounting for toxicity and relapse. The level was .05.

Results Threshold utility analysis revealed that adjuvant chemotherapy was preferred for all possible weight values for relapse and toxicity (u_REL, u_TOX), although the result was not always statistically significant. The adjuvant chemotherapy group had better Q-TWiST in the range of 5 to 6 additional months, which was statistically significant using all methods.

Conclusion Adjuvant chemotherapy in early-stage NSCLC improves quality-adjusted survival despite chemotherapy toxicity.

The JBR.10 trial was supported by the Canadian Cancer Society, the National Cancer Institute of Canada, the National Cancer Institute, the US Intergroup members (Southwest Oncology Group, Eastern Cooperative Oncology Group, and Cancer and Leukemia Group B), and GlaxoSmithKline. R.W.J. was supported by the Princess Margaret Hospital/University Health Network Medical Oncology and the University of Toronto and received an American Society of Clinical Oncology Merit Award and Novartis Oncology Young Canadian Investigator Award.

Presented in part at the 44th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 30-June 3, 2008; and the Annual Meeting of the Canadian Association of Medical Oncology, Toronto, Canada, May 1, 2008.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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