OBJECTIVES: The phase 3 VISTA study (ClinicalTrials.gov NCT00111319) in transplant-ineligible myeloma patients demonstrated superior efficacy with bortezomib-melphalan-prednisone (VMP; nine 6-wk cycles) vs. melphalan-prednisone (MP) but also increased toxicity. Health-related quality of life (HRQoL; exploratory endpoint) was evaluated using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30). The phase 3 VISTA study (ClinicalTrials.gov NCT00111319) in transplant-ineligible myeloma patients demonstrated superior efficacy with bortezomib-melphalan-prednisone (VMP; nine 6-wk cycles) vs. melphalan-prednisone (MP) but also increased toxicity. Health-related quality of life (HRQoL; exploratory endpoint) was evaluated using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30). METHODS: EORTC QLQ-C30 was administered at screening, on day 1 of each cycle, at the end-of-treatment visit, and every 8 wk until progression. EORTC QLQ-C30 scores were evaluated among patients with a valid baseline and at least one post-baseline HRQoL assessment. RESULTS: At baseline, domain scores were similar between arms. By cycle 4, mean differences were clinically meaningful for most domains, indicating poorer health status with VMP. From cycle 5 onwards, improvements relative to baseline/MP were observed for all domains with VMP. Mean scores were generally improved by the end-of-treatment assessment vs. baseline in both arms. Among responding patients, mean scores generally improved from time of response to end-of-treatment assessment, substantially driven by patients achieving complete response (CR). Multivariate analysis showed a significant impact of duration of response/CR on improving global health status, pain, and appetite loss scores. Analyses by bortezomib dose intensity indicated better HRQoL in patients receiving lower dose intensity. CONCLUSIONS: These findings demonstrate clinically meaningful, transitory HRQoL decrements with VMP and relatively lower HRQoL vs. MP during early treatment cycles, associated with the expected additional toxicities. However, HRQoL is not compromised in the long term, recovering by the end-of-treatment visit to be comparable vs. MP.
RCT Entities:
OBJECTIVES: The phase 3 VISTA study (ClinicalTrials.gov NCT00111319) in transplant-ineligible myelomapatients demonstrated superior efficacy with bortezomib-melphalan-prednisone (VMP; nine 6-wk cycles) vs. melphalan-prednisone (MP) but also increased toxicity. Health-related quality of life (HRQoL; exploratory endpoint) was evaluated using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30). The phase 3 VISTA study (ClinicalTrials.gov NCT00111319) in transplant-ineligible myelomapatients demonstrated superior efficacy with bortezomib-melphalan-prednisone (VMP; nine 6-wk cycles) vs. melphalan-prednisone (MP) but also increased toxicity. Health-related quality of life (HRQoL; exploratory endpoint) was evaluated using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30). METHODS:EORTC QLQ-C30 was administered at screening, on day 1 of each cycle, at the end-of-treatment visit, and every 8 wk until progression. EORTC QLQ-C30 scores were evaluated among patients with a valid baseline and at least one post-baseline HRQoL assessment. RESULTS: At baseline, domain scores were similar between arms. By cycle 4, mean differences were clinically meaningful for most domains, indicating poorer health status with VMP. From cycle 5 onwards, improvements relative to baseline/MP were observed for all domains with VMP. Mean scores were generally improved by the end-of-treatment assessment vs. baseline in both arms. Among responding patients, mean scores generally improved from time of response to end-of-treatment assessment, substantially driven by patients achieving complete response (CR). Multivariate analysis showed a significant impact of duration of response/CR on improving global health status, pain, and appetite loss scores. Analyses by bortezomib dose intensity indicated better HRQoL in patients receiving lower dose intensity. CONCLUSIONS: These findings demonstrate clinically meaningful, transitory HRQoL decrements with VMP and relatively lower HRQoL vs. MP during early treatment cycles, associated with the expected additional toxicities. However, HRQoL is not compromised in the long term, recovering by the end-of-treatment visit to be comparable vs. MP.
Authors: Claudio Cerchione; Davide Nappi; Anna Emanuele Pareto; Maria Di Perna; Irene Zacheo; Marco Picardi; Fabrizio Pane; Lucio Catalano Journal: Support Care Cancer Date: 2018-03-24 Impact factor: 3.603
Authors: Michel Delforge; Leonard Minuk; Jean-Claude Eisenmann; Bertrand Arnulf; Letizia Canepa; Alberto Fragasso; Serge Leyvraz; Christian Langer; Yousef Ezaydi; Dan T Vogl; Pilar Giraldo-Castellano; Sung-Soo Yoon; Charles Zarnitsky; Martine Escoffre-Barbe; Bernard Lemieux; Kevin Song; Nizar Jacques Bahlis; Shien Guo; Mara Silva Monzini; Annette Ervin-Haynes; Vanessa Houck; Thierry Facon Journal: Haematologica Date: 2015-03-13 Impact factor: 9.941
Authors: Meletios A Dimopoulos; Michel Delforge; Roman Hájek; Martin Kropff; Maria T Petrucci; Philip Lewis; Annabel Nixon; Jingshan Zhang; Jay Mei; Antonio Palumbo Journal: Haematologica Date: 2012-12-14 Impact factor: 9.941
Authors: A Keith Stewart; Meletios A Dimopoulos; Tamás Masszi; Ivan Špička; Albert Oriol; Roman Hájek; Laura Rosiñol; David S Siegel; Ruben Niesvizky; Andrzej J Jakubowiak; Jesus F San-Miguel; Heinz Ludwig; Jacqui Buchanan; Kim Cocks; Xinqun Yang; Biao Xing; Naseem Zojwalla; Margaret Tonda; Philippe Moreau; Antonio Palumbo Journal: J Clin Oncol Date: 2016-11-10 Impact factor: 44.544