Burnett A F, Roman L D, Garcia A A, Muderspach L I, Brader K R, Morrow C P
Division of Gynecologic Oncology, University of Southern California, Los Angeles, California, 90033, USA.
Gynecol Oncol. 2000 Jan;76(1):63-6. doi: 10.1006/gyno.1999.5657.
The aim of this study was to determine the response rate and toxicity of cis-platinum and gemcitabine in advanced, recurrent, or persistent squamous cell carcinoma of the cervix.
From July 1997 to January 1999, we conducted a Phase II trial in patients with advanced, persistent, or recurrent carcinoma of the cervix. The schedule employed 1250 mg/m(2) of gemcitabine on days 1 and 8 and 50 mg/m(2) of cis-platinum on day 1 in a 21-day cycle. Eligibility criteria were a GOG performance status of 0-2, adequate bone marrow reserve, serum creatinine less than 1.8 mg%, and a lesion which could be measured in two dimensions. None of the patients had received prior chemotherapy other than radiation sensitizers. Standard GOG toxicity and response criteria were used.
Nineteen patients were enrolled into the trial. Two patients were inevaluable because of inadequate trial of drug. Seventeen patients were evaluable for response and toxicity. The median age of the patients was 47 years (range 24-72). The median number of cycles delivered was 5 (range 2-8). The incidence of grade 4 neutropenia and anemia was 2.4 and 1.2%, respectively. Two patients developed a single episode of grade 3 gastrointestinal toxicity. The overall response rate was 41% (7/17). There was 1 complete response of 14 months duration and 6 partial responses. Among those patients not previously irradiated, the response rate was 57% (4/7). Among the radiated patients, the response rate was 30% (3/10) with all responses occurring in the radiation field.
This combination of cis-platinum and gemcitabine is a well-tolerated regimen which exhibits high activity in advanced, recurrent, or persistent squamous cell cervical cancer.
本研究旨在确定顺铂和吉西他滨治疗晚期、复发性或持续性宫颈鳞状细胞癌的缓解率及毒性。
1997年7月至1999年1月，我们对晚期、持续性或复发性宫颈癌患者进行了一项II期试验。给药方案为在第1天和第8天给予1250mg/m²吉西他滨，第1天给予50mg/m²顺铂，每21天为一个周期。入选标准为美国妇科肿瘤学组（GOG）体能状态评分为0 - 2、骨髓储备充足、血清肌酐低于1.8mg%，且病灶可进行二维测量。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。
19例患者入组该试验。2例患者因药物试用不充分而无法评估。17例患者可评估缓解情况和毒性。患者的中位年龄为47岁（范围24 - 72岁）。中位给药周期数为5个（范围2 - 8个）。4级中性粒细胞减少症和贫血的发生率分别为2.4%和1.2%。2例患者出现单次3级胃肠道毒性。总缓解率为41%（7/17）。有1例完全缓解，持续14个月，6例部分缓解。在未接受过放疗的患者中，缓解率为57%（4/7）。在接受过放疗的患者中，缓解率为30%（3/10），所有缓解均发生在放疗区域内。
顺铂和吉西他滨的这种联合方案耐受性良好，在晚期、复发性或持续性宫颈鳞状细胞癌中表现出高活性。
