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Poster display session

2348 - Phase II clinical trial of second-line weekly paclitaxel plus trastuzumab for patients with HER2-positive metastatic gastric cancer.


09 Sep 2017


Poster display session


Cytotoxic Therapy;  Targeted Therapy;  Gastric Cancer


Yosuke Horita


Annals of Oncology (2017) 28 (suppl_5): v209-v268. 10.1093/annonc/mdx369


Y. Horita, M. Nishino, S. Sugimoto, A. Kida, A. Mizukami, M. Yano, F. Arihara, K. Matsuda, M. Matsuda, A. Sakai

Author affiliations

  • Internal Medicine, Toyama Prefectural Central Hospital, 930-8550 - Toyama/JP


Abstract 2348


Combination therapy with fluorouracil, platinum, and trastuzumab (Tmab) has been established as the first-line chemotherapy for HER2-positive gastric cancer, but there is no established therapy in the second-line setting. This study aimed to evaluate the efficacy and safety of weekly paclitaxel plus Tmab as second-line chemotherapy for HER2-positive gastric cancer patients.


Eligible patients were ≥ 20 years old, histologically confirmed gastric adenocarcinoma with HER2-positive (IHC3+ or IHC2+ and FISH (or DISH)-positive), previously treated chemotherapy (not except pretreated-Tmab), ECOG PS of 0, 1 or 2, and adequate organ function. Eligible patients received weekly paclitaxel plus Tmab (paclitaxel: 80 mg/m2 IV on day1, 8, 15, repeated every 4weeks, Tmab: 8mg/kg (1st time) IV on day1, after 2nd time, 6mg/kg IV, repeated every 3weeks). All therapy was administered until disease progression. The primary endpoint was response rate, the secondary endpoint were Progression-free survival (PFS), Overall survival (OS) and Toxicity.


Twenty-eight patients were enrolled between 08/2011 and 03/2017. Patients characteristics were; median age, 69.5 years; male, 22(79%); ECOG-PS0/1/2, 5(18%)/17(61%)/6(21%); Tmab pretreated/untreated, 20(71%)/8(29%). The overall response rate was 22% with 6 partial responses, 8 stable diseases, 13 progression and 1 not evaluable yet. Median PFS was 4.6 months (95% CI: 2.2-7.0). Median OS was 9.6 months (95% CI: 2.3-16.9). Grade 3/4 toxicities included neutropenia in 36%, leukopenia in 21%, anemia in 11%, anorexia in 7%, febrile neutropenia in 7%, respectively. Tmab beyond progression (TBP) group (n = 20) did not differ from non-TBP group (n = 8) in PFS and OS (PFS; 5.0:2.8 (months), p = 0.369, OS; 12.4:6.1 (months), p = 0.363, log-rank test). And, in TBP group, therapeutic effect was associated with duration of PFS of 1st line Tmab combined chemotherapy (≥ 6 months (n = 10): < 6 months (n = 10), PFS; 6.4:2.8 (months), p = 0.016, OS; Not reached:6.5 (months), p = 0.002, log-rank test).


Weekly paclitaxel plus trastuzumab appeared favorable and well tolerated as second-line chemotherapy for HER2-positive gastric cancer patients in this single arm study.

Clinical trial identification

Legal entity responsible for the study

Toyama Prefectural Central Hospital




All authors have declared no conflicts of interest.

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