PURPOSE: In a randomized trial conducted by the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG), interferon alpha-2b (IFN) maintenance therapy (2 mU/m2 subcutaneously three times per week) after successful induction with melphalan and prednisone was found to prolong time to progression in patients with multiple myeloma. A favorable effect on survival was also present, but this difference was of borderline significance. However, IFN toxicity was a concern. To evaluate the trade-off between the clinical benefits of IFN and the associated toxicity, we applied the method of quality-adjusted time without symptoms or toxicity (Q-TWiST). MATERIALS AND METHODS: Three clinical health states were defined in this analysis: time with toxicity (TOX), time without disease relapse or toxicity (TWiST), and time following disease relapse (REL). Toxicity information for IFN had been collected using patient-completed diaries so the actual duration of each adverse event could be determined. The health states TOX and REL were weighted using utility scores to account for a possible decrement in quality of life, a weighted sum of the health state durations is used as a measure of quality-adjusted time. RESULTS: The health state durations were calculated at 72 months median follow-up. Patients in the IFN group gained an average of 9.8 months without disease relapse (P = .001) and 5.8 months of overall survival (P = .074) versus the control group. However, the IFN group suffered an average of 4.1 months of moderate or worse toxicity (P < .001). CONCLUSION: The clinical benefits of IFN outweigh the negative effects associated with treatment toxicity for a wide range of plausible utilities.
RCT Entities:
PURPOSE: In a randomized trial conducted by the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG), interferon alpha-2b (IFN) maintenance therapy (2 mU/m2 subcutaneously three times per week) after successful induction with melphalan and prednisone was found to prolong time to progression in patients with multiple myeloma. A favorable effect on survival was also present, but this difference was of borderline significance. However, IFN toxicity was a concern. To evaluate the trade-off between the clinical benefits of IFN and the associated toxicity, we applied the method of quality-adjusted time without symptoms or toxicity (Q-TWiST). MATERIALS AND METHODS: Three clinical health states were defined in this analysis: time with toxicity (TOX), time without disease relapse or toxicity (TWiST), and time following disease relapse (REL). Toxicity information for IFN had been collected using patient-completed diaries so the actual duration of each adverse event could be determined. The health states TOX and REL were weighted using utility scores to account for a possible decrement in quality of life, a weighted sum of the health state durations is used as a measure of quality-adjusted time. RESULTS: The health state durations were calculated at 72 months median follow-up. Patients in the IFN group gained an average of 9.8 months without disease relapse (P = .001) and 5.8 months of overall survival (P = .074) versus the control group. However, the IFN group suffered an average of 4.1 months of moderate or worse toxicity (P < .001). CONCLUSION: The clinical benefits of IFN outweigh the negative effects associated with treatment toxicity for a wide range of plausible utilities.
Authors: David F McDermott; Ruchit Shah; Komal Gupte-Singh; Javier Sabater; Linlin Luo; Marc Botteman; Sumati Rao; Meredith M Regan; Michael Atkins Journal: Qual Life Res Date: 2018-09-06 Impact factor: 4.147
Authors: Paul G Richardson; Vânia T M Hungria; Sung-Soo Yoon; Meral Beksac; Meletios Athanasios Dimopoulos; Ashraf Elghandour; Wieslaw W Jedrzejczak; Andreas Guenther; Thanyaphong Na Nakorn; Noppadol Siritanaratkul; Robert L Schlossman; Jian Hou; Philippe Moreau; Sagar Lonial; Jae Hoon Lee; Hermann Einsele; Monika Sopala; Bourras-Rezki Bengoudifa; Claudia Corrado; Florence Binlich; Jesús F San-Miguel Journal: Blood Date: 2015-12-02 Impact factor: 22.113
Authors: Caitlyn T Solem; Timothy J Bell; Youngmin Kwon; Joseph C Cappelleri; Courtney Johnson; Helen Bhattacharyya; Caroline J Hoang; Jorge E Cortes Journal: Cancer Date: 2020-07-22 Impact factor: 6.860