title: Relationship between efficacy outcomes and weight gain during treatment of advanced, non-squamous, non-small-cell lung cancer patients.
abstract: Unintentional weight loss occurs among advanced non-small-cell lung cancer (NSCLC) patients and is associated with worse survival. Small studies have suggested that weight gain during treatment is associated with superior survival.
  
  
  
  A retrospective analysis analyzed data from three international phase III studies comprising 2301 advanced, non-squamous NSCLC patients who received a platinum-based, first-line doublet, with or without bevacizumab and maintenance therapy. Body weight was recorded before and after treatment by each study's schedule. The relationship between weight gain and overall survival (OS) and progression-free survival (PFS) was assessed using log-rank test and adjusted Cox modeling. Logistic regression assessed the association between baseline covariates and post-baseline weight gain.
  
  
  
  Four hundred and twenty-one (18.3%) patients had >5% weight gain after baseline. More than half of the weight gain cohort exhibited initial weight gain by 3 weeks. The median OS was 16.7 months versus 10.7 months for the >5% versus ≤5% weight gain subgroup (n = 1880) (P < 0.001). PFS was 6.9 versus 4.8 months, respectively (P < 0.001). Differences in overall tumor response rate (50.8% versus 25.4%, respectively) and disease control rate (tumor response or stable disease) (91.5% versus 63.6%, respectively) were also significant (P < 0.001). The Cox modeling revealed the >5% subgroup had longer survival [hazard ratio (HR) = 0.54, 95% confidence interval (CI) 0.47-0.62; P < 0.001] than the ≤5% subgroup after adjusting for baseline factors. Similar significant results were found for PFS (HR = 0.59, 95% CI 0.52-0.67; P < 0.001). Unadjusted logistic regression indicated a significant association between weight gain (>5% versus ≤5%) and age, and BMI.
  
  
  
  Weight gain during treatment may be an early indicator of clinical benefit. If confirmed in prospective studies, monitoring weight change may provide important information regarding survival outcomes in NSCLC and may provide ideas for new therapeutic strategies.
authors.affiliation: Feinberg School of Medicine, Northwestern University, Chicago, USA.
authors.forename: J D
authors.initials: JD
authors.lastname: Patel
authors.affiliation: Instituto Brasileiro de Cancerologia Toracica, Sao Paulo, Brazil.
authors.forename: J R
authors.initials: JR
authors.lastname: Pereira
authors.affiliation: Eli Lilly and Company, Indianapolis, USA.
authors.forename: J
authors.initials: J
authors.lastname: Chen
authors.affiliation: Eli Lilly and Company, Indianapolis, USA.
authors.forename: J
authors.initials: J
authors.lastname: Liu
authors.affiliation: Eli Lilly and Company, Indianapolis, USA.
authors.forename: S C
authors.initials: SC
authors.lastname: Guba
authors.affiliation: Eli Lilly and Company, Indianapolis, USA.
authors.forename: W J
authors.initials: WJ
authors.lastname: John
authors.affiliation: Eli Lilly and Company, Buenos Aires, Argentina.
authors.forename: M
authors.initials: M
authors.lastname: Orlando
authors.affiliation: University of Turin, San Luigi Hospital, Orbassano, Turin, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Scagliotti
authors.affiliation: Rush University Medical Center, Chicago, USA philip_bonomi@rush.edu.
authors.forename: P D
authors.initials: PD
authors.lastname: Bonomi
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects; D000068258:Bevacizumab / Q000008:administration & dosage* / Q000009:adverse effects; D015992:Body Mass Index; D002100:Cachexia / Q000150:complications / Q000188:drug therapy / Q000503:physiopathology; D002289:Carcinoma, Non-Small-Cell Lung / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D017326:Clinical Trials, Phase III as Topic; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000068437:Pemetrexed / Q000008:administration & dosage* / Q000009:adverse effects; D012189:Retrospective Studies; D016896:Treatment Outcome; D015430:Weight Gain / Q000187:drug effects*
chemical_list: D000068437:Pemetrexed; D000068258:Bevacizumab
keywords: NSCLC; cachexia; phase III clinical trial; retrospective analysis; weight gain