Prognostic factor analysis of overall survival (OS) in gastric cancer from two phase III studies of second-line ramucirumab (RAM) (REGARD and RAINBOW) using pooled individual patient (pt) data.

Konference: 2015 51th ASCO Annual Meeting - účast ČR

Kategorie: Gastrointestinální nádory

Téma: Poster

Číslo abstraktu: 4028

Autoři: M.D. Charles S. Fuchs, MPH; Kei Muro; MUDr. Jiří Tomášek, Ph.D.; Eric Van Cutsem; Jae-Yong Cho, M.D., Ph.D.; Prof. M.D. Sang Cheul Oh; Prof. Dr. Howard Safran; M.D. György Bodoky, Ph.D.; M.D. Ian Chau; Yasuhiro Shimada; Dr. Filip Dumitru; MD Salah-Eddin Al-Batran; MD Rodolfo Passalacqua; Dr. Atsushi Ohtsu; MD Michael Emig; Prof. M.D. David R. Ferry, Ph.D.; Kumari Chandrawansa; Yanzhi Hsu, Ph.D.; Andreas Sashegyi, Ph.D.; Prof. MUDr. Hansjochen Wilke

Background: From 2009-2012, 1020 pts were enrolled in two phase III, randomized, double-blind studies of RAM in metastatic gastroesophageal junction and gastric adenocarcinoma following progressive disease (PD) on first-line platinum- and/or fluoropyrimidine-containing therapy: REGARD (N = 355, RAM + best supportive care [BSC] vs placebo [PL] + BSC) and RAINBOW (N = 665, RAM + paclitaxel [PTX] vs PL + PTX). Methods: Individual pt data were pooled, and 41 key baseline covariates, common in both studies, were examined (19 clinical characteristics; 22 lab parameters). Lab tests were parameterized in two ways based on local lab abnormality assessments (high/normal/low): high vs normal or low; low vs normal or high. To identify prognostic factors for OS, univariate Cox models were first used to select covariates with p ≤ 0.05. For these covariates, a multivariate Cox model was used to make stepwise selection with both entry and exit p=0.01. All models were stratified by treatment and geographic region. Results: Of 1,020 pts, 953 (93%) were included in the stepwise Cox regression, after excluding pts with missing covariate values. We identified 12 independent prognostic factors (5 clinical; 7 lab). Conclusions: We identified 12 independent prognostic factors for pts with second-line gastric cancer from the largest randomized, controlled, global trial dataset. A simple prognostic index using these factors to divide pts into risk groups will be constructed and presented. This information may help clinical decision-making, pt risk stratification, and planning future clinical studies. Clinical trial information: NCT01170663 and NCT00917384

Poor Prognostic Factors HR (99% CI) for Mortality
Peritoneal metastasis 1.49 (1.22, 1.83)
Time-to-PD on prior therapy < 6 months 1.35 (1.10, 1.66)
ECOG PS ≥ 1 1.39 (1.12, 1.73)
Tumor differentiation (poor/unknown) 1.33 (1.08, 1.64)
Primary tumor present 1.31 (1.05, 1.62)
Alkaline phosphatase (high) 1.28 (1.03, 1.60)
Sodium (low) 2.04 (1.54, 2.71)
Lactate dehydrogenase (high) 1.31 (1.05, 1.63)
Aspartate Aminotransferase (high) 1.37 (1.06, 1.76)
Albumin (low) 1.33 (1.07, 1.65)
Lymphocytes (low) 1.31 (1.05, 1.63)
Neutrophils (high) 1.52 (1.17, 1.99)


J Clin Oncol 33, 2015 (suppl; abstr 4028)


Datum přednesení příspěvku: 1. 6. 2015