A multicenter phase II study of biweekly paclitaxel and S-1 combination chemotherapy for unresectable or recurrent gastric cancer

被引:33
作者
Nakajo, Akihiro [1 ]
Hokita, Shuichi [1 ]
Ishigami, Sumiya [1 ]
Miyazono, Futoshi [1 ]
Etoh, Tadaaki [2 ]
Hamanoue, Masahiro [3 ]
Maenohara, Shigeho [3 ]
Iwashita, Toshimitsu [4 ]
Komatsu, Hideaki [5 ]
Satoh, Kiyoharu [6 ]
Aridome, Kuniaki [7 ]
Morita, Satoshi [8 ]
Natsugoe, Shoji [1 ]
Takiuchi, Hiroya [9 ]
Nakano, Shyuji [10 ,11 ]
Maehara, Yoshihiko [12 ]
Sakamoto, Junichi [8 ]
Aikou, Takashi [1 ]
Taxol, Kyushu
机构
[1] Kagoshima Univ, Grad Sch Med, Dept Surg Oncol & Digest Surg, Kagoshima 8908520, Japan
[2] Miyazaki Univ, Dept Surg 1, Miyazaki, Japan
[3] Kagoshima Kouseiren Hosp, Kagoshima, Japan
[4] Kitakyushu Med Ctr, Fukuoka, Japan
[5] Sasebo City Gen Hosp, Nagasaki, Japan
[6] Saga Univ, Dept Digest Surg, Saga 840, Japan
[7] Saiseikai Sendai Hosp, Kagoshima, Japan
[8] Nagoya Univ, Grad Sch Med, Hlth & Commun Med Program, Nagoya, Aichi 4648601, Japan
[9] Osaka Med Coll, Dept Internal Med 2, Osaka, Japan
[10] Kyushu Univ, Grad Sch Med, Dept Internal Med 1, Fukuoka 812, Japan
[11] Kyushu Univ, Grad Sch Med, Dept Biosyst Sci Med, Fukuoka 812, Japan
[12] Kyushu Univ, Grad Sch Med, Dept Surg & Sci, Fukuoka 812, Japan
关键词
advanced gastric cancer; Phase II; paclitaxel; S-1; chemotherapy;
D O I
10.1007/s00280-008-0693-y
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose This Phase II study assessed the activity and safety of biweekly paclitaxel and oral S-1 as treatment for unresectable and recurrent gastric cancer. The maximum tolerated dose for this regimen had been established previously in a Phase I study performed in Japanese patients. Patients and methods Chemotherapy was performed using two anticancer agents, S-1 and paclitaxel. Oral S-1 (80 mg/m(2)) was administered twice a day after meals for two consecutive weeks from Day 1 to 14, followed by a 2 week recovery period; paclitaxel (120 mg/m(2)) was administered intravenously, biweekly, on Days 1 and 15. The patient received cycles of this regimen every 4 weeks (q 28-day cycles). The primary end point was the response rate according to the Response Evaluation Criteria in Solid Tumors. Results A total of 39 patients (median age, 65 years) were enrolled; 13 other patients were screened, but found to be ineligible. All patients had unresectable and recurrent gastric cancer. The most common treatment-related Grade 3/4 adverse events were neutropenia (37.5%), appetite loss, diarrhea, decreased sodium (each 5%), and anemia, increased alanine aminotransferase, general fatigue, and dizziness (each 2.5%). Almost all the patients experienced alopecia. Intent-to-treat analysis showed a response rate of 43.6%. With a median follow-up of 14 months (range 8-21 months), median survival was 256 days and the median time to progression was 4 months. Conclusion A combination regimen of biweekly paclitaxel and oral S-1 was well tolerated and showed promising activity against unresectable and recurrent gastric cancer.
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收藏
页码:1103 / 1109
页数:7
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