| Autor: |
Yamaguchi, Kensei, Shimamura, Tomotaka, Komatsu, Yoshito, Takagane, Akinori, Yoshioka, Takashi, Saitoh, Soh, Munakata, Masaki, Sakata, Yu, Sato, Tsukasa, Arai, Tatsuhiro, Saitoh, Hiroshi |
| Předmět: |
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| Zdroj: |
Gastric Cancer; Mar2006, Vol. 9 Issue 1, p36-43, 8p, 4 Charts, 1 Graph |
| Abstrakt: |
Background. Both paclitaxel (TXL) and cisplatin (CDDP) show efficacy against gastric cancer. The aim of this phase I–II study was to determine the maximum tolerated dose (MTD) and to evaluate the toxicity and efficacy of combination chemotherapy with these two agents. Methods. Nineteen patients entered the phase I part of the study, and 21 patients entered the phase II part. TXL infusions were administered on days 1 and 15, with a fixed 30mg/m² dose of CDDP. Results. In the phase I part of the study, we determined dose level 5, which represented a TXL dose of 180mg/m², with CDDP 30mg/m², to be the MTD. The recommended dose (RD) was level 4, with a TXL dose of 160mg/m² with CDDP, 30mg/m². In the phase II part of the study, the response rate was 25.0%; five patients had a partial response, seven had stable disease, 6 had progressive disease, and 2 were not evaluable. Grade 3 or 4 neutropenia was the most common adverse event and occurred in 65% of the patients. During treatment, 25% of the patients received granulocyte colonystimulating factor, but febrile neutropenia was not shown in any of the patients. Major nonhematological toxicities were nausea/vomiting, anorexia, fatigue, alopecia, and sensory neuropathy. Adverse reactions of grade 3 or 4 were shown by two patients, one with anorexia (5%) and the other with sensory neuropathy (5%). Conclusion. The RD was determined to be TXL 140mg/m², with CDDP 30mg/m². [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
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