Nab-paclitaxel as second line treatment in advanced gastric cancer: A HORG multicenter phase II study

Abstract

Background: There are few therapeutic options for the treatment of metastatic gastric and gastroesophageal junction adenocarcinomas which fail front-line chemotherapy. A phase II multicenter study of second line nab-paclitaxel was conducted aiming to evaluate its efficacy and tolerance in patients with advanced gastric and gastroesophageal junction (GEJ) adenocarcinoma. Methods: Thirty-nine patients (median age 62 years) with locally advanced inoperable and metastatic gastric and GEJ adenocarcinoma were enrolled. All patients had a PS of 0-1, 17 pts (43.6%) had prior surgery, 4 had received prior adjuvant chemotherapy, and 33 (84.6%) had receiver DCF in the first line setting. The median time from the prior treatment was 2.6 months (range, 1.0-13.8). Nab-paclitaxel was given weekly (125mg/ m2, d1,d8, and d15 every 28 days). Results: Partial response (PR) was achieved in nine pts (23.1%), disease stabilization (SD) in 11 (28.2%) and disease progression in 18 (46.2%) for an ORR of 23.1% (95% CI; 9.85-36.3) and a DCR of 51.3%. Responses were observed irrespectively of the prior administration docetxel-based chemotherapy. The median progression free survival was 3.0 months (95% CI 2.1-3.8) and the median overall survival 6.8 months (95% CI 0.7-8.8). Six (15.3%) pts developed grade 3/4 neutropenia, 7 pts (18%) grade 2/3 asthenia and 8 (20.5%) grade 2/3 neurotoxicity. Other AE were mild (grade <2). There was no treatment-related death but treatment discontinuation was required in 3 (7.7%) pts for probable treatment-related reasons. Conclusions: Second line nab-paclitaxed is an active and well tolerated treatment for patients with locally advanced inoperable/metastatic gastric and GEJ carcinomas even in pre-treated pts with a docetaxel-based regimen and merits further evaluation in the first-line setting. (Table Presented).