Look K Y, Blessing J A, Levenback C, Kohler M, Chafe W, Roman L D
Department of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis, Indiana, 46202, USA.
Gynecol Oncol. 1998 Sep;70(3):334-8. doi: 10.1006/gyno.1998.5129.
To determine the response rate and associated toxicity of weekly CPT-11 in squamous carcinoma of the cervix.
From October 1994 to May 1996, the Gynecologic Oncology Group (GOG) conducted a Phase II trial in patients with recurrent squamous cervix carcinoma. The schedule employed weekly x4 intravenous CPT-11 at 125 mg/m2 followed with a 2-week rest, to be repeated until disease progression or unacceptable toxicity. Eligibility criteria were a GOG performance status of 0-2, adequate bone marrow reserve, adequate liver function, and serum creatinine <2 mg%. None of the patients had received prior chemotherapy other than radiation sensitizers. Standard GOG toxicity and response criteria were used.
Fifty-four patients were entered into the trial. Three patients were ineligible because of wrong cell type (N = 2) or inadequate pathology material (N = 1). Two were inevaluable because of inadequate trial of drug. An additional 4 patients were inevaluable for response. Thus, 49 were evaluable for toxicity and 45 were evaluable for response. The median age of patients was 45 years (range, 29-71 years). The median number of weekly doses delivered was 7 (range, 1-46). The incidence of grade 4 neutropenia and anemia was 6.1 and 4.1%, respectively. Nineteen patients (38.8%) developed gastrointestinal (GI) toxicity including 8 with grade 3 and 11 with grade 4 severity. The overall response rate was 13.3% (6/45). There was 1 patient death from GI toxicity. There was one complete response of 8.8 months duration and 5 partial responses.
OFFis schedule of CPT-11 exhibits modest activity with moderate toxicity in patients with recurrent squamous carcinoma of the cervix.
确定每周一次的伊立替康（CPT-11）治疗子宫颈鳞状细胞癌的缓解率及相关毒性。
1994年10月至1996年5月，妇科肿瘤学组（GOG）对复发性子宫颈鳞状细胞癌患者进行了一项II期试验。治疗方案为每周静脉注射CPT-11，剂量为125mg/m²，共4周，随后休息2周，重复进行直至疾病进展或出现不可接受的毒性。入选标准为GOG体能状态0-2、骨髓储备充足、肝功能正常且血清肌酐<2mg%。除放射增敏剂外，所有患者均未接受过先前的化疗。采用标准的GOG毒性和缓解标准。
54例患者进入试验。3例因细胞类型错误（n = 2）或病理材料不足（n = 1）不符合入选标准。2例因药物试验不充分无法评估。另外4例患者无法评估缓解情况。因此，49例可评估毒性，45例可评估缓解情况。患者的中位年龄为45岁（范围29-71岁）。每周给药剂量的中位数为7次（范围1-46次）。4级中性粒细胞减少症和贫血的发生率分别为6.1%和4.1%。19例患者（38.8%）出现胃肠道（GI）毒性，其中8例为3级，11例为4级。总缓解率为13.3%（6/45）。有1例患者死于GI毒性。有1例完全缓解，持续时间为8.8个月，5例部分缓解。
CPT-11的该治疗方案在复发性子宫颈鳞状细胞癌患者中显示出适度的活性和中度毒性。
