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背景和目的:羟基喜树碱(HCPT)属拓扑异构酶I(TOPOI)抑制剂,对多种实体肿瘤有一定抗瘤活性,拓僖是羟基喜树碱冻干粉针,其纯度和稳定性明显高于水针剂。本研究的目的是通过用药试验,探索该药临床应用最适剂量以及初步了解其疗效和毒副反应。方法:本多中心研究采用单药拓僖6～8mg/(m2·d),连用5～10天,共治疗各种晚期实体肿瘤60例,其中男性42例,女性18例,年龄17～73岁,中位年龄53岁。初治18例(含6例放疗后),复治42例;肺癌22例,鼻咽癌12例,原发性肝癌9例,胰腺癌2例,结直肠癌9例,其它6例。结果:可评价疗效51例,全组总的有效率为15.7%;6mg/m2组有效率为16%,8mg/m2组有效率为15.4%。按病种计算其有效率肺癌为13.7%(3/22),结直肠癌为33.3%(3/9)以及鼻咽癌为16.6%(2/12);本组60例患者中,总有效率(ITT)为13.3%(8/60),其中初治患者PR3例(16.7%),复治患者PR5例(11.9%)。拓僖的适用剂量为6～8mg/m24小时静脉滴注,连用5～10天,每3周重复;剂量限制性毒性是骨髓抑制,其次为恶性呕吐、腹泻和皮疹,其中Ⅲ+Ⅳ度发生率分别为:WBC下降32%,皮疹8%和血小板8%,恶性呕吐6%,腹泻4%;未发现心脏、肺和肾的毒性反应。结论:拓僖单药(HCPT冻干粉针剂)对复治结直肠癌、非小细胞肺癌和鼻咽癌有较好的疗效,值得在联合化疗中对多种实体肿瘤?
BACKGROUND & OBJECTIVE: HCPT is a topoisomerase I (TOPOI) inhibitor that has antitumor activity against a variety of solid tumors. TQO is hydroxycamptothecin lyophilized powder, of which purity and stability Obviously higher than water injection. The purpose of this study is to explore the optimum dose of clinical application of the drug and preliminary understanding of its efficacy and side effects through the drug test. Methods: The multi-center study of single Tuo Tuo 6 ~ 8mg / (m2 · d), once every 5 to 10 days, a total of 60 cases of various advanced solid tumors, including 42 males and 18 females, aged 17 to 73 The median age is 53. The initial treatment of 18 cases (including 6 cases of radiotherapy), 42 cases of retreatment; lung cancer in 22 cases, nasopharyngeal carcinoma in 12 cases, 9 cases of primary liver cancer, 2 cases of pancreatic cancer, colorectal cancer in 9 cases, the other 6 cases. Results: Fifty-one patients were evaluated. The total effective rate was 15.7%. The effective rate was 16% in 6mg / m2 group and 15.4% in 8mg / m2 group. According to the disease, the effective rate was 13.7% (3/22) for lung cancer, 33.3% (3/9) for colorectal cancer, and 16.6% (2/12) for nasopharyngeal carcinoma. Of the 60 patients in this group, The effective rate (ITT) was 13.3% (8/60), of which PR3 (16.7%) in primary treatment and PR5 in retreatment (11.9%). Extension of the appropriate dose of 6 ~ 8mg / m24 hour intravenous infusion, once every 5 to 10 days, repeated every 3 weeks; dose-limiting toxicity is myelosuppression, followed by vomiting, diarrhea and rash, in which Ⅲ + Ⅳ degree occurred Rates were 32% for WBC, 8% for rash and 8% for platelets, 6% for malignant vomiting and 4% for diarrhea; no toxic reactions were found in heart, lung and kidney. CONCLUSION: Tuoba single drug (HCPT freeze-dried powder injection) has good curative effect on retreatment of colorectal cancer, non-small cell lung cancer and nasopharyngeal carcinoma. It is worth to treat multiple solid tumors in combined chemotherapy.