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(2“R)-4'-O-四氢吡喃阿霉素(THP)治疗晚期或复发性胃癌的II期研究。日本THP治疗胃癌临床研究组

[Phase II study of (2" R)-4'-O-tetrahydropyranyladriamycin (THP) in patients with advanced or recurrent gastric cancer. Clinical study group of THP for gastric cancer in Japan].

作者信息

Nakao I, Wakui A, Hattori T, Sugimachi K, Saito T

机构信息

Dept. of Internal Medicine, Cancer Institute Hospital.

出版信息

Gan To Kagaku Ryoho. 1991 Jul;18(8):1325-32.

PMID:2069402
Abstract

A multi-institutional collaborative phase II study of (2"R)-4-O-tetrahydropyranyladriamycin (THP) was performed by intravenous administration to patients with advanced or recurrent gastric cancer. The administration schedules were (1) 40-60 mg/body every 3 or 4 weeks and (2) 20-40 mg/body once a week. Of 58 registered patients, 49 cases were eligible and 37 cases were evaluable for response. The therapeutic results were 1 CR, 4 PR, 14 NC and 18 PD. The response rate of the evaluable cases was 13.5%. The side effects were mainly bone marrow suppression and digestive symptoms. In particular, the frequency of leukopenia was a high 75.5%, while there was a decrease in hemoglobin in 38.8% and anorexia in 30.6%. The frequency and severity of alopecia, which is a known problem with anthracyclines, were slight, and no abnormal electrocardiograms were observed.

摘要

对晚期或复发性胃癌患者进行了一项多机构合作的II期研究,通过静脉注射给予(2“R)-4-O-四氢吡喃阿霉素(THP)。给药方案为:(1)每3或4周40-60mg/体;(2)每周一次20-40mg/体。58例登记患者中,49例符合条件,37例可评估疗效。治疗结果为1例完全缓解(CR),4例部分缓解(PR),14例疾病稳定(NC),18例疾病进展(PD)。可评估病例的缓解率为13.5%。副作用主要是骨髓抑制和消化系统症状。特别是,白细胞减少的发生率高达75.5%,而血红蛋白降低的发生率为38.8%,食欲不振的发生率为30.6%。作为蒽环类药物已知问题的脱发的发生率和严重程度较轻,未观察到异常心电图。

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