Abstract
BackgroundIn the ABSOLUTE trial, weekly nanoparticle albumin-bound paclitaxel (w-nab-PTX) showed non-inferiority to weekly solvent-based paclitaxel (w-sb-PTX) for overall survival (OS). Thus, w-nab-PTX might be an option for second-line chemotherapy in advanced gastric cancer (AGC). However, predictive factors for efficacies of these agents have not been evaluated.MethodsPatients previously enrolled in the ABSOLUTE trial were divided into apparent peritoneal metastasis group (PM group) and no apparent peritoneal metastasis group (no PM group) based on baseline imaging evaluated by RECIST ver. 1.1 criteria and amount of ascites. OS, progression-free survival, and overall response rate were compared between two arms in each group.ResultsThis study included 240 and 243 patients in the w-nab-PTX and w-sb-PTX arms, respectively. In the PM group, the w-nab-PTX arm (n = 88) had longer OS than the w-sb-PTX arm (n = 103), and median survival time (MST) of 9.9 and 8.7 months [hazard ratio (HR) 0.63; 95% CI 0.45–0.88; P = 0.0060], respectively. In the no PM group, the w-nab-PTX arm (n = 140) had shorter OS than the w-sb-PTX arm (n = 152), and MST of 11.6 and 15.7 months (HR 1.40; 95% CI 1.06–1.86; P = 0.0180), respectively. After adjusting for prognostic factors, the HR for OS in the w-nab-PTX arm versus the w-sb-PTX arm was 0.59 (95% CI 0.42–0.83; P = 0.0023; PM group) and 1.34 (95% CI 1.01–1.78; P = 0.0414; no PM group), with significant interaction between treatment efficacy and presence of peritoneal metastasis (P = 0.0003).ConclusionsThe presence of apparent peritoneal metastasis might be a predictive factor for selecting w-nab-PTX for pretreated AGC patients.Trial registration numberJapicCTI-132059.
Highlights
Solvent-based paclitaxel is one of the standard second-line chemotherapies for advanced gastric cancer (AGC)
The hazard ratio (HR) for the overall survival (OS) of the w-nabPTX arm compared with the w-Solvent-based paclitaxel (sb-PTX) arm in groups A, B, C, and D were 1.40, 0.64, 0.66, and 0.47, respectively
The HRs for the progressionfree survival (PFS) of the w-nanoparticle albumin-bound paclitaxel (nab-PTX) arm compared with the w-sb-PTX arm in groups A, B, C, and D were 1.02, 0.62, 0.77, and 0.43, respectively
Summary
Solvent-based paclitaxel (sb-PTX) is one of the standard second-line chemotherapies for advanced gastric cancer (AGC). Based on the ABSOLUTE trial results, w-nab-PTX might be an option for second-line chemotherapy for AGC. Several phase II trials showed the promising efficacy of w-sb-PTX for patients with AGC with peritoneal metastasis [2, 3]. A subgroup analysis of the ABSOLUTE trial suggested that w-nab-PTX showed more favorable efficacy than w-sb-PTX in patients with peritoneal metastasis. In the ABSOLUTE trial, weekly nanoparticle albumin-bound paclitaxel (w-nab-PTX) showed non-inferiority to weekly solvent-based paclitaxel (w-sb-PTX) for overall survival (OS). After adjusting for prognostic factors, the HR for OS in the w-nab-PTX arm versus the w-sb-PTX arm was 0.59 (95% CI 0.42–0.83; P = 0.0023; PM group) and 1.34 (95% CI 1.01–1.78; P = 0.0414; no PM group), with significant interaction between treatment efficacy and presence of peritoneal metastasis (P = 0.0003). Conclusions The presence of apparent peritoneal metastasis might be a predictive factor for selecting w-nab-PTX for pretreated AGC patients.
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