Phase I/II study of S-1 combined with weekly docetaxel in patients with metastatic gastric carcinoma

S. R. Park, H. K. Kim, C. G. Kim, I. J. Choi, J. S. Lee, J. H. Lee, K. W. Ryu, Y. W. Kim, J. M. Bae, Namkyu Kim

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Abstract

We designed a phase I/II trial of S-1 combined with weekly docetaxel to determine the maximum tolerated dose (MTD) and recommended dose (RD) and to evaluate the efficacy and toxicity in metastatic gastric carcinoma (MGC). Patients with measurable disease received S-1 orally b.i.d. on days 1-14 and docetaxel intravenously on days 1 and 8 every 3 weeks. In phase I (n=30), each cohort received escalating doses of S-1 (30-45 mg m-2 b.i.d.) and docetaxel (25-40 mg m-2); MTD was 45 mg m-2 b.i.d. S-1/35 mg m-2 docetaxel and RD was 40 mg m-2 b.i.d. S-1/35 mg m-2 docetaxel. Dose-limiting toxicities included grade 3 elevated liver enzymes, gastric perforation, grade 3 diarrhoea/fatigue, febrile neutropenia with grade 3 anorexia/fatigue, and neutropenic infection with grade 3 stomatitis/anorexia. In phase II (n=52), the overall response rate was 66.7% (95% confidence interval (CI): 53.8-79.6%) and the median time to progression and overall survival were 6.5 months (95% CI: 4.9-8.1) and 13.7 months (95% CI: 9.9-17.5), respectively. The most common grade 3/4 toxicity was neutropenia (29.4%), and febrile neutropenia/neutropenic infection occurred in 19.6% of patients. Non-haematological toxicities were generally mild. There was one treatment-related death due to pneumonitis. S-1 combined with weekly docetaxel is active in MGC with moderate toxicities.

Original languageEnglish
Pages (from-to)1305-1311
Number of pages7
JournalBritish journal of cancer
Volume98
Issue number8
DOIs
Publication statusPublished - 2008 Apr 22

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docetaxel
Stomach
Carcinoma
Febrile Neutropenia
Maximum Tolerated Dose
Anorexia
Confidence Intervals
Fatigue
Stomatitis
Infection
Neutropenia
Diarrhea
Pneumonia

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Park, S. R. ; Kim, H. K. ; Kim, C. G. ; Choi, I. J. ; Lee, J. S. ; Lee, J. H. ; Ryu, K. W. ; Kim, Y. W. ; Bae, J. M. ; Kim, Namkyu. / Phase I/II study of S-1 combined with weekly docetaxel in patients with metastatic gastric carcinoma. In: British journal of cancer. 2008 ; Vol. 98, No. 8. pp. 1305-1311.
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title = "Phase I/II study of S-1 combined with weekly docetaxel in patients with metastatic gastric carcinoma",
abstract = "We designed a phase I/II trial of S-1 combined with weekly docetaxel to determine the maximum tolerated dose (MTD) and recommended dose (RD) and to evaluate the efficacy and toxicity in metastatic gastric carcinoma (MGC). Patients with measurable disease received S-1 orally b.i.d. on days 1-14 and docetaxel intravenously on days 1 and 8 every 3 weeks. In phase I (n=30), each cohort received escalating doses of S-1 (30-45 mg m-2 b.i.d.) and docetaxel (25-40 mg m-2); MTD was 45 mg m-2 b.i.d. S-1/35 mg m-2 docetaxel and RD was 40 mg m-2 b.i.d. S-1/35 mg m-2 docetaxel. Dose-limiting toxicities included grade 3 elevated liver enzymes, gastric perforation, grade 3 diarrhoea/fatigue, febrile neutropenia with grade 3 anorexia/fatigue, and neutropenic infection with grade 3 stomatitis/anorexia. In phase II (n=52), the overall response rate was 66.7{\%} (95{\%} confidence interval (CI): 53.8-79.6{\%}) and the median time to progression and overall survival were 6.5 months (95{\%} CI: 4.9-8.1) and 13.7 months (95{\%} CI: 9.9-17.5), respectively. The most common grade 3/4 toxicity was neutropenia (29.4{\%}), and febrile neutropenia/neutropenic infection occurred in 19.6{\%} of patients. Non-haematological toxicities were generally mild. There was one treatment-related death due to pneumonitis. S-1 combined with weekly docetaxel is active in MGC with moderate toxicities.",
author = "Park, {S. R.} and Kim, {H. K.} and Kim, {C. G.} and Choi, {I. J.} and Lee, {J. S.} and Lee, {J. H.} and Ryu, {K. W.} and Kim, {Y. W.} and Bae, {J. M.} and Namkyu Kim",
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Park, SR, Kim, HK, Kim, CG, Choi, IJ, Lee, JS, Lee, JH, Ryu, KW, Kim, YW, Bae, JM & Kim, N 2008, 'Phase I/II study of S-1 combined with weekly docetaxel in patients with metastatic gastric carcinoma', British journal of cancer, vol. 98, no. 8, pp. 1305-1311. https://doi.org/10.1038/sj.bjc.6604312

Phase I/II study of S-1 combined with weekly docetaxel in patients with metastatic gastric carcinoma. / Park, S. R.; Kim, H. K.; Kim, C. G.; Choi, I. J.; Lee, J. S.; Lee, J. H.; Ryu, K. W.; Kim, Y. W.; Bae, J. M.; Kim, Namkyu.

In: British journal of cancer, Vol. 98, No. 8, 22.04.2008, p. 1305-1311.

Research output: Contribution to journalArticle

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T1 - Phase I/II study of S-1 combined with weekly docetaxel in patients with metastatic gastric carcinoma

AU - Park, S. R.

AU - Kim, H. K.

AU - Kim, C. G.

AU - Choi, I. J.

AU - Lee, J. S.

AU - Lee, J. H.

AU - Ryu, K. W.

AU - Kim, Y. W.

AU - Bae, J. M.

AU - Kim, Namkyu

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N2 - We designed a phase I/II trial of S-1 combined with weekly docetaxel to determine the maximum tolerated dose (MTD) and recommended dose (RD) and to evaluate the efficacy and toxicity in metastatic gastric carcinoma (MGC). Patients with measurable disease received S-1 orally b.i.d. on days 1-14 and docetaxel intravenously on days 1 and 8 every 3 weeks. In phase I (n=30), each cohort received escalating doses of S-1 (30-45 mg m-2 b.i.d.) and docetaxel (25-40 mg m-2); MTD was 45 mg m-2 b.i.d. S-1/35 mg m-2 docetaxel and RD was 40 mg m-2 b.i.d. S-1/35 mg m-2 docetaxel. Dose-limiting toxicities included grade 3 elevated liver enzymes, gastric perforation, grade 3 diarrhoea/fatigue, febrile neutropenia with grade 3 anorexia/fatigue, and neutropenic infection with grade 3 stomatitis/anorexia. In phase II (n=52), the overall response rate was 66.7% (95% confidence interval (CI): 53.8-79.6%) and the median time to progression and overall survival were 6.5 months (95% CI: 4.9-8.1) and 13.7 months (95% CI: 9.9-17.5), respectively. The most common grade 3/4 toxicity was neutropenia (29.4%), and febrile neutropenia/neutropenic infection occurred in 19.6% of patients. Non-haematological toxicities were generally mild. There was one treatment-related death due to pneumonitis. S-1 combined with weekly docetaxel is active in MGC with moderate toxicities.

AB - We designed a phase I/II trial of S-1 combined with weekly docetaxel to determine the maximum tolerated dose (MTD) and recommended dose (RD) and to evaluate the efficacy and toxicity in metastatic gastric carcinoma (MGC). Patients with measurable disease received S-1 orally b.i.d. on days 1-14 and docetaxel intravenously on days 1 and 8 every 3 weeks. In phase I (n=30), each cohort received escalating doses of S-1 (30-45 mg m-2 b.i.d.) and docetaxel (25-40 mg m-2); MTD was 45 mg m-2 b.i.d. S-1/35 mg m-2 docetaxel and RD was 40 mg m-2 b.i.d. S-1/35 mg m-2 docetaxel. Dose-limiting toxicities included grade 3 elevated liver enzymes, gastric perforation, grade 3 diarrhoea/fatigue, febrile neutropenia with grade 3 anorexia/fatigue, and neutropenic infection with grade 3 stomatitis/anorexia. In phase II (n=52), the overall response rate was 66.7% (95% confidence interval (CI): 53.8-79.6%) and the median time to progression and overall survival were 6.5 months (95% CI: 4.9-8.1) and 13.7 months (95% CI: 9.9-17.5), respectively. The most common grade 3/4 toxicity was neutropenia (29.4%), and febrile neutropenia/neutropenic infection occurred in 19.6% of patients. Non-haematological toxicities were generally mild. There was one treatment-related death due to pneumonitis. S-1 combined with weekly docetaxel is active in MGC with moderate toxicities.

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