Emily Kinsey1, Elizabeth Ajazi2, Xiaofei Wang3, Mary Ann Mayzie Johnston4, Jeffrey Crawford5. 1. Department of Medicine, Duke University, Durham, North Carolina. Electronic address: crawf006@mc.duke.edu. 2. Department of Biostatistics, University of North Carolina, Chapel Hill, North Carolina. 3. Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina. 4. GTx, Memphis, Tennessee. 5. Division of Medical Oncology, Duke Cancer Institute, Durham, North Carolina.
Abstract
INTRODUCTION: Muscle wasting has detrimental effects, including increased mortality. Identifying patients at risk can guide treatment efforts. METHODS: POWER 1 and 2 were randomized, double-blind, placebo-controlled, multinational phase III trials that studied 600 patients with lung cancer at the start ofchemotherapy; the studies' aim was to assess the efficacy of enobosarm on prevention and treatment of muscle loss. We performed a secondary analysis restricted to the control group, using a cumulative logit model for ordinal outcome to determine which baseline characteristics predicted physical and functional loss during chemotherapy. RESULTS: In all, 53% of patients had loss of lean body mass and 49% had loss of stair climb power (SCP) at day 84 of treatment. Of the 322 patients who receivedplacebo, 232 with observable outcome and baseline covariates were included for lean body mass analysis and 236 for SCP analysis. More advanced disease predicted a higher probability of greater physical loss (OR = 1.96; 95% confidence interval [CI]: 1.14-3.36). Three factors predicted higher probability of SCP loss: taxane chemotherapy (OR = 1.73; 95% CI: 1.06-2.83), tobacco use before chemotherapy (OR = 2.15, 95% CI: 1.10-4.18), and SCP at baseline (OR = 1.01, 95% CI: 1.004-1.015). Higher body mass index was a protective factor for functional loss (OR = 0.85; 95% CI: 0.73-0.98). A higher Eastern Cooperative Oncology Group Performance Status trended toward being predictive of greater probability of both physical loss (0.767) and functional loss (0.070), but the results were not statistically significant. CONCLUSIONS: Approximately 50% of patients with advanced lung cancer who were undergoingchemotherapy had ongoing loss of muscle mass and muscle function. Advanced stage predicted physical loss. Tobacco use and taxane chemotherapy predicted functional loss. Body mass index was a protective factor for functional loss. We identified predictors of physical and functional loss that could be used as therapeutic targets or to guide treatment efforts.
RCT Entities:
INTRODUCTION: Muscle wasting has detrimental effects, including increased mortality. Identifying patients at risk can guide treatment efforts. METHODS: POWER 1 and 2 were randomized, double-blind, placebo-controlled, multinational phase III trials that studied 600 patients with lung cancer at the start of chemotherapy; the studies' aim was to assess the efficacy of enobosarm on prevention and treatment of muscle loss. We performed a secondary analysis restricted to the control group, using a cumulative logit model for ordinal outcome to determine which baseline characteristics predicted physical and functional loss during chemotherapy. RESULTS: In all, 53% of patients had loss of lean body mass and 49% had loss of stair climb power (SCP) at day 84 of treatment. Of the 322 patients who received placebo, 232 with observable outcome and baseline covariates were included for lean body mass analysis and 236 for SCP analysis. More advanced disease predicted a higher probability of greater physical loss (OR = 1.96; 95% confidence interval [CI]: 1.14-3.36). Three factors predicted higher probability of SCP loss: taxane chemotherapy (OR = 1.73; 95% CI: 1.06-2.83), tobacco use before chemotherapy (OR = 2.15, 95% CI: 1.10-4.18), and SCP at baseline (OR = 1.01, 95% CI: 1.004-1.015). Higher body mass index was a protective factor for functional loss (OR = 0.85; 95% CI: 0.73-0.98). A higher Eastern Cooperative Oncology Group Performance Status trended toward being predictive of greater probability of both physical loss (0.767) and functional loss (0.070), but the results were not statistically significant. CONCLUSIONS: Approximately 50% of patients with advanced lung cancer who were undergoing chemotherapy had ongoing loss of muscle mass and muscle function. Advanced stage predicted physical loss. Tobacco use and taxane chemotherapy predicted functional loss. Body mass index was a protective factor for functional loss. We identified predictors of physical and functional loss that could be used as therapeutic targets or to guide treatment efforts.
Authors: Daniel Shepshelovich; Wei Xu; Lin Lu; Aline Fares; Ping Yang; David Christiani; Jie Zhang; Kouya Shiraishi; Brid M Ryan; Chu Chen; Ann G Schwartz; Adonina Tardon; Xifeng Wu; Matthew B Schabath; M Dawn Teare; Loic Le Marchand; Zuo-Feng Zhang; John K Field; Hermann Brenner; Nancy Diao; Juntao Xie; Takashi Kohno; Curtis C Harris; Angela S Wenzlaff; Guillermo Fernandez-Tardon; Yuanqing Ye; Fiona Taylor; Lynne R Wilkens; Michael Davies; Yi Liu; Matt J Barnett; Gary E Goodman; Hal Morgenstern; Bernd Holleczek; M Catherine Brown; Geoffrey Liu; Rayjean J Hung Journal: J Thorac Oncol Date: 2019-06-01 Impact factor: 15.609
Authors: Kah Poh Loh; Vivian Lam; Katey Webber; Simran Padam; Mina S Sedrak; Vivek Musinipally; Madison Grogan; Carolyn J Presley; Janice Grandi; Chandrika Sanapala; Daniel A Castillo; Grace DiGiovanni; Supriya G Mohile; Louise C Walter; Melisa L Wong Journal: J Natl Compr Canc Netw Date: 2021-04-15 Impact factor: 12.693