Gastrointestinal Cancers Symposium
Gastrointestinal Cancers Symposium
Perspective from Ugo Iroku, MD
Source:

Ghidini M, et al. Abstract 476. Presented at: Gastrointestinal Cancers Symposium (virtual meeting); Jan. 15-17, 2021.

Disclosures: Taiho Oncology Inc. funded this study. Ghidini reports no relevant financial disclosures. Please see the abstract for all other researchers’ relevant financial disclosures.
January 20, 2021
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Early body weight loss linked to shorter OS in gastric, gastroesophageal junction cancer

Perspective from Ugo Iroku, MD
Source:

Ghidini M, et al. Abstract 476. Presented at: Gastrointestinal Cancers Symposium (virtual meeting); Jan. 15-17, 2021.

Disclosures: Taiho Oncology Inc. funded this study. Ghidini reports no relevant financial disclosures. Please see the abstract for all other researchers’ relevant financial disclosures.
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Body weight loss may predict poor outcomes among patients with metastatic gastric or gastroesophageal junction cancer receiving third-line or later treatment, according to study results presented at Gastrointestinal Cancers Symposium.

“Nutritional status is closely linked to cancer mortality, and body weight loss has been shown to be prognostic for survival in curative, first- and second-line settings in metastatic gastric or gastroesophageal junction cancer,” Michele Ghidini, MD, PhD, researcher in the department of oncology at Azienda Ospedaliera di Cremona in Italy, and colleagues wrote. “In the phase 3 TAGS trial, trifluridine-tipiracil [Lonsurf, Taiho Oncology] showed clinical benefit vs. placebo and manageable safety in patients with metastatic gastric or gastroesophageal junction cancer who had received two prior chemotherapy regimens. The association of early body weight loss with survival outcomes in TAGS was examined in retrospective analyses.”

Body weight loss may predict poor outcomes among patients with metastatic gastric or gastroesophageal junction cancer receiving third-line or later treatment.
Body weight loss may predict poor outcomes among patients with metastatic gastric or gastroesophageal junction cancer receiving third-line or later treatment.

Ghidini and colleagues obtained body weight data of 89% of participants in the TAGS trial, including 304 patients who received trifluridine-tipiracil and 147 patients who received placebo.

The researchers categorized patients into two groups: those who experienced less than 3% body weight loss and those who experienced 3% body weight loss from the start of treatment to day 1 of a second, 28-day cycle. They compared OS and PFS between subgroups within each treatment group and assessed the effect of early body weight loss on OS using a Cox proportional hazards model and multivariate Cox proportional hazards model that adjusted for baseline prognostic factors found in the original intention-to-treat analysis.

Results showed that at the end of the first treatment cycle, a greater proportion of patients in the trifluridine-tipiracil group experienced less than 3% body weight loss (74% vs. 65%), whereas a greater proportion of patients in the placebo group experienced 3% or more body weight loss (35% vs. 26%).

Patients in the body weight loss subgroups had similar baseline characteristics, including median age (< 3%, 64 years for both the trifluridine-tipiracil and placebo groups; 3%, 61 years and 58.5 years); however, a higher percentage of patients with 3% or more body weight loss had an ECOG performance status of 1 and three or more metastatic sites.

The survival analysis showed longer OS among those with less than 3% body weight loss in both the trifluridine-tipiracil group (median, 6.5 months vs. 4.9 months; HR = 0.75; 95% CI, 0.55-1.02) and the placebo group (median OS, 6 months vs. 2.5 months; HR = 0.32; 95% CI, 0.21-0.49).

Among patients in the trifluridine-tipiracil group, median PFS was 2.1 months for those with less than 3% body weight loss vs. 1.9 months for those who experienced 3% or more body weight loss (HR for PFS = 0.95; 95% CI, 0.71-1.25). Among patients in the placebo group, median PFS was 1.9 months for those with less than 3% body weight loss vs. 1.7 months for those with 3% or more body weight loss (HR for PFS = 0.49; 95% CI, 0.34-0.72).

Researchers additionally observed a strong prognostic effect of early body weight loss on OS among the pooled intention-to-treat population, with an unadjusted HR of 0.58 (95% CI, 0.46-0.73) for less than 3% vs. 3% or more body weight loss.

Results of multivariate analyses showed that early body weight loss was both a prognostic factor (P < .0001) and predictive factor (interaction P = .0003) for OS.

Grade 3 adverse events of any cause occurred among 77% of patients in the trifluridine-tipiracil group with less than 3% body weight loss and 82% of those in that group with 3% body weight loss, compared with corresponding rates of 45% and 67% in the placebo group. Those in the higher body weight loss subgroup had higher rates of nausea and decreased appetite than those in the lower body weight loss subgroup.

“In TAGS, early body weight loss was a strong negative prognostic factor for OS regardless of trifluridine-tipiracil or placebo treatment,” Ghidini and colleagues wrote. “The relationship of body weight loss to other prognostic factors will be explored further.”

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