Erschienen in:
01.08.2015 | Original Article
Trastuzumab in combination with docetaxel/cisplatin/S-1 (DCS) for patients with HER2-positive metastatic gastric cancer: feasibility and preliminary efficacy
verfasst von:
Yasuhiro Mitsui, Yasushi Sato, Hiroshi Miyamoto, Yasuteru Fujino, Toshi Takaoka, Jinsei Miyoshi, Miwako Kagawa, Hiroyuki Ohnuma, Masahiro Hirakawa, Tomohiro Kubo, Takahiro Osuga, Tamotsu Sagawa, Yasuhiro Sato, Yasuo Takahashi, Shinich Katsuki, Toshinori Okuda, Rishu Takimoto, Masayoshi Kobune, Takayuki Nobuoka, Koichi Hirata, Junji Kato, Tetsuji Takayama
Erschienen in:
Cancer Chemotherapy and Pharmacology
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Ausgabe 2/2015
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Abstract
Purpose
We previously reported that a triplet combination of docetaxel, cisplatin, and S-1 (DCS) is active against metastatic gastric cancer with a very high response rate of 87.1 % in a phase II study. Recently, the efficacy of trastuzumab (T-mab) for the treatment of HER2-positive gastric cancer has been reported. Therefore, we investigated the feasibility and preliminary efficacy of DCS + T-mab (DCS-T) for unresectable HER2-positive metastatic gastric cancer.
Methods
Patients received oral S-1 (40 mg/m2 b.i.d.) on days 1–14, intravenous cisplatin (60 mg/m2), docetaxel (50 mg/m2), and T-mab (8 mg/kg in the first cycle and 6 mg/kg in the second cycle and thereafter) on day 8 every 3 weeks.
Results
The study included 16 patients: median age, 60 (34–76) years; males/females, 11:5; intestinal-type/diffuse-type histology, 11:5; and HER2 3+/2+(FISH+), 13:3. The completion rate until the third cycle was 87.5 % (14/16) (95 %CI 71.3–103.7 %). Adverse events of grade 3/4 severity during the first 3 cycles were: leukopenia/neutropenia, 50.0:75.0 %; febrile neutropenia, 12.5 %; diarrhea, 12.5 %; and stomatitis, 12.5 %. All of these side effects were manageable and well controlled. There were no treatment-related deaths. The overall response rate was 93.8 % (15/16), and the response rate in patients with measurable lesions was 100 % (15/15). The median cycle to response was only 1 (1–3 cycles). Non-curative factors disappeared in 56.3 % (9/16) of patients, and conversion surgery (R0 resection) was performed in all these cases. Pathological response rates in primary and metastatic lesions were 88.9 % (8/9) and 100 % (9/9), respectively. The median PFS and OS were not reached during the median follow-up time of 18.3 months ranged from 11.0 to 34.3 months.
Conclusions
DCS-T was feasible in patients with unresectable HER2-positive metastatic gastric cancer. The observed response was very promising and warrants further investigation.
Clinical trial registration number
UMIN000005603.