每周一次紫杉醇与多西氟啶联合化疗用于晚期/复发性胃癌的II期研究。

A phase II study of weekly paclitaxel and doxifluridine combination chemotherapy for advanced/recurrent gastric cancer.

作者信息

Takeyoshi Izumi, Makita Fujio, Tanahashi Yoshifumi, Iwazaki Shigeru, Ogawa Tetsushi, Tomizawa Naoki, Nakamura Seiji, Ishikawa Hitoshi, Ohya Toshihiro, Kakinuma Shinichi, Nakagami Katsunao, Sato Yoshihiro, Koyano Tetsuya, Roppongi Takashi, Izumi Masaru, Kobayashi Junya, Kawate Susumu, Sunose Yutaka, Kobayashi Mitsunobu, Yamada Tatsuya, Sakamoto Ichiro

机构信息

Second Department of Surgery, Gunma University, Faculty of Medicine, Maebashi, Gunma 371-8511, Japan.

出版信息

Anticancer Res. 2011 Jan;31(1):287-91.

PMID:21273612

Abstract

BACKGROUND

Paclitaxel and doxifluridine (5'-DFUR) have distinct mechanisms of action and toxicity profiles. This study evaluated the antitumor activity and toxicities of combination chemotherapy with these drugs in patients with advanced/recurrent gastric cancer (AGC).

PATIENTS AND METHODS

Patients with histologically confirmed AGC, which was either unresectable or metastatic, were included in this study. The treatment consisted of 80 mg/m² paclitaxel given i.v. on days 1, 8, and 15 every 4 weeks, and 533 mg/m² doxifluridine given orally on days 1-5 every week.

RESULTS

One hundred and four patients were evaluated for toxicity and 93 patients were evaluated for a therapeutic response. The overall response rate was 33.3% (1st line: 41.7%, 2nd line: 25.0%), including a complete remission in two patients, a partial remission in 29, stable disease in 39, progressive disease in 17; the response was not evaluable in six patients. The median overall survival was 287 days. Commonly observed grade 3/4 adverse events were leukopenia (13.5%), anorexia (3.8%), fatigue (3.8%) and diarrhea (2.9%).

CONCLUSION

Paclitaxel and doxifluridine combination chemotherapy is a well-tolerated and convenient treatment regimen that can be given on an outpatient basis with promising efficacy for AGC.

摘要

背景

紫杉醇和多西氟尿苷（5'-DFUR）具有不同的作用机制和毒性特征。本研究评估了这两种药物联合化疗对晚期/复发性胃癌（AGC）患者的抗肿瘤活性和毒性。

患者与方法

组织学确诊为不可切除或转移性AGC的患者纳入本研究。治疗方案为每4周的第1、8和15天静脉注射80mg/m²紫杉醇，每周第1 - 5天口服533mg/m²多西氟尿苷。

结果

104例患者接受了毒性评估，93例患者接受了治疗反应评估。总缓解率为33.3%（一线治疗：41.7%，二线治疗：25.0%），包括2例完全缓解，29例部分缓解，39例病情稳定，17例病情进展；6例患者的反应无法评估。中位总生存期为287天。常见的3/4级不良事件为白细胞减少（13.5%）、厌食（3.8%）、疲劳（3.8%）和腹泻（2.9%）。