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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.

Date

09 Sep 2017

Session

Poster display session

Presenters

Yosuke Horita

Citation

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

Authors

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
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Resources

Abstract 2348

Background

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.

Methods

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.

Results

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).

Conclusions

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

Funding

None

Disclosure

All authors have declared no conflicts of interest.

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