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) |
Citation:
J Clin Oncol 33, 2015 (suppl; abstr 4028)
Datum přednesení příspěvku: 1. 6. 2015
