Abstract 1263O
Background
Cancer cachexia is a multifactorial syndrome characterized by anorexia and unintentional weight loss associated with poor clinical outcomes. Conversely, weight gain during cancer treatment may improve survival. The objective of this post-hoc analysis was to examine the relationship between sex, weight gain, and overall survival (OS) in patients with advanced lung cancer receiving standard-of-care (SOC) chemotherapy.
Methods
Data were pooled from three phase III clinical trials (NCT00254891, NCT00254904, NCT00596830) conducted between Nov 2005 and Mar 2011 in patients with advanced (stage IIIB/IV) NSCLC treated with first-line SOC chemotherapy (control arm). Weight was recorded at baseline, day 1 of each 3-week treatment cycle (up to 6 cycles), and after treatment per each study’s schedule. Weight gain was categorized as >0%, >2.5%, and >5% increase from baseline up to 4.5 months after chemotherapy initiation. The Kaplan-Meier method was used to estimate each subgroup's survival and median survival.
Results
The total 1,030 patients were predominantly male (70.5%) with stage IV NSCLC (88.4% male and 88.8% female). The median age (range) of male and female patients was 62 (34-87) and 60 (34-83) years, while the mean BMI (SD) was 24.5 (4.2) and 24.8 (4.8) kg/m2, respectively. Most patients were current/previous smokers (94.2% male and 67.4% female). Overall, 486 (46.1% male vs. 49.7% female), 299 (29.6% vs. 27.6%), and 164 (17.2% vs. 12.8%) patients experienced weight gain from baseline of >0%, >2.5%, and >5%, respectively. Weight gain was associated with a significant decrease in the risk of death in both sexes (Table). The interaction test showed no significant difference in the association between weight gain and increased survival in males vs. females. Table: 1263O
OS hazard ratios (95% CI) associated with weight gain in male and female patients
| Weight Categories | Male (n = 726) | Female (n = 304) | ||
| n | HR (95% CI) | n | HR (95% CI) | |
| >0% | 335 | 0.60 (0.50, 0.71) | 151 | 0.65 (0.49, 0.86) |
| >2.5% | 215 | 0.57 (0.47, 0.70) | 84 | 0.61 (0.44, 0.86) |
| >5.0% | 125 | 0.62 (0.49, 0.79) | 39 | 0.69 (0.43, 1.09) |
Conclusions
The beneficial effect of weight gain on OS was observed regardless of sex in advanced NSCLC patients.
Clinical trial identification
NCT00254891, NCT00254904, NCT00596830.
Editorial acknowledgement
Medical writing support was provided by Diane Hoffman, PhD, of Engage Scientific Solutions and was funded by Pfizer.
Legal entity responsible for the study
Pfizer Inc.
Funding
Pfizer Inc.
Disclosure
E.J. Roeland: Financial Interests, Personal, Advisory Board: Care4ward, Actimed Therapeutics, Meter Health, Napo Pharmaceuticals, Alerion, Takeda; Financial Interests, Personal, Advisory Role: Veloxis Therapeutics, BOYMass; Financial Interests, Personal, Data Monitoring Committee: Enzychem Lifesciences Pharmaceutical Company. R. Yang: Financial Interests, Personal, Full or part-time Employment: Pfizer; Financial Interests, Personal, Stocks/Shares: Pfizer. L.C. Tarasenko: Financial Interests, Personal, Full or part-time Employment: Pfizer; Financial Interests, Personal, Stocks/Shares: Pfizer. T.D. McRae: Financial Interests, Personal, Full or part-time Employment: Pfizer; Financial Interests, Personal, Stocks/Shares: Pfizer. J.H. Revkin: Financial Interests, Personal, Full or part-time Employment: Pfizer; Financial Interests, Personal, Stocks/Shares: Pfizer. P.D. Bonomi: Financial Interests, Personal, Advisory Role: Merck, Pfizer, Roche Genentech. All other authors have declared no conflicts of interest.