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

Akihiro Nakajo, Shuichi Hokita, Sumiya Ishigami, Futoshi Miyazono, Tadaaki Etoh, Masahiro Hamanoue, Shigeho Maenohara, Toshimitsu Iwashita, Hideaki Komatsu, Kiyoharu Satoh, Kuniaki Aridome, Satoshi Morita, Shoji Natsugoe, Hiroya Takiuchi, Shyuji Nakano, Yoshihiko Maehara, Junichi Sakamoto, Takashi Aikou

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Abstract

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/m2) 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/m2) 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.

Original languageEnglish
Pages (from-to)1103-1109
Number of pages7
JournalCancer chemotherapy and pharmacology
Volume62
Issue number6
DOIs
Publication statusPublished - Nov 1 2008

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Chemotherapy
Paclitaxel
Combination Drug Therapy
Stomach Neoplasms
Alanine Transaminase
Antineoplastic Agents
Tumors
Sodium
Fatigue of materials
Maximum Tolerated Dose
Recovery
Alopecia
Dizziness
Appetite
S 1 (combination)
Neutropenia
Fatigue
Meals
Anemia
Diarrhea

All Science Journal Classification (ASJC) codes

  • Oncology
  • Toxicology
  • Pharmacology
  • Cancer Research
  • Pharmacology (medical)

Cite this

A multicenter phase II study of biweekly paclitaxel and S-1 combination chemotherapy for unresectable or recurrent gastric cancer. / Nakajo, Akihiro; Hokita, Shuichi; Ishigami, Sumiya; Miyazono, Futoshi; Etoh, Tadaaki; Hamanoue, Masahiro; Maenohara, Shigeho; Iwashita, Toshimitsu; Komatsu, Hideaki; Satoh, Kiyoharu; Aridome, Kuniaki; Morita, Satoshi; Natsugoe, Shoji; Takiuchi, Hiroya; Nakano, Shyuji; Maehara, Yoshihiko; Sakamoto, Junichi; Aikou, Takashi.

In: Cancer chemotherapy and pharmacology, Vol. 62, No. 6, 01.11.2008, p. 1103-1109.

Research output: Contribution to journalArticle

Nakajo, A, Hokita, S, Ishigami, S, Miyazono, F, Etoh, T, Hamanoue, M, Maenohara, S, Iwashita, T, Komatsu, H, Satoh, K, Aridome, K, Morita, S, Natsugoe, S, Takiuchi, H, Nakano, S, Maehara, Y, Sakamoto, J & Aikou, T 2008, 'A multicenter phase II study of biweekly paclitaxel and S-1 combination chemotherapy for unresectable or recurrent gastric cancer', Cancer chemotherapy and pharmacology, vol. 62, no. 6, pp. 1103-1109. https://doi.org/10.1007/s00280-008-0693-y
Nakajo, Akihiro ; Hokita, Shuichi ; Ishigami, Sumiya ; Miyazono, Futoshi ; Etoh, Tadaaki ; Hamanoue, Masahiro ; Maenohara, Shigeho ; Iwashita, Toshimitsu ; Komatsu, Hideaki ; Satoh, Kiyoharu ; Aridome, Kuniaki ; Morita, Satoshi ; Natsugoe, Shoji ; Takiuchi, Hiroya ; Nakano, Shyuji ; Maehara, Yoshihiko ; Sakamoto, Junichi ; Aikou, Takashi. / A multicenter phase II study of biweekly paclitaxel and S-1 combination chemotherapy for unresectable or recurrent gastric cancer. In: Cancer chemotherapy and pharmacology. 2008 ; Vol. 62, No. 6. pp. 1103-1109.
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T1 - A multicenter phase II study of biweekly paclitaxel and S-1 combination chemotherapy for unresectable or recurrent gastric cancer

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AU - Hokita, Shuichi

AU - Ishigami, Sumiya

AU - Miyazono, Futoshi

AU - Etoh, Tadaaki

AU - Hamanoue, Masahiro

AU - Maenohara, Shigeho

AU - Iwashita, Toshimitsu

AU - Komatsu, Hideaki

AU - Satoh, Kiyoharu

AU - Aridome, Kuniaki

AU - Morita, Satoshi

AU - Natsugoe, Shoji

AU - Takiuchi, Hiroya

AU - Nakano, Shyuji

AU - Maehara, Yoshihiko

AU - Sakamoto, Junichi

AU - Aikou, Takashi

PY - 2008/11/1

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N2 - 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/m2) 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/m2) 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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