Arseneau J, Blessing J A, Stehman F B, McGehee R
Invest New Drugs. 1986;4(2):187-91. doi: 10.1007/BF00194601.
The Gynecologic Oncology Group conducted a Phase II trial of carboplatin in patients with measurable advanced squamous cell carcinoma of cervix. No prior therapy with cytotoxic drugs was permitted in patients entered into this study. Patients entered were GOG performance status 2 or better. Carboplatin 400 mg/m2 (340 mg/m2 in patients who had had prior pelvic radiotherapy with subsequent escalation to 400 mg/m2 if bone marrow tolerance was good) was administered as a 15-minute IV infusion. Treatments were repeated every four weeks until disease progressed or until toxicity prohibited further therapy. Thirty-nine evaluable patients were treated. Two complete and nine partial responses were observed (response rate 28.2%). No neurotoxicity and only mild reversible nephrotoxicity was seen. Gastrointestinal toxicity was severe in three patients (7.7%). Dose limiting toxicity was myelosuppression. Carboplatin is active against squamous cell carcinoma of cervix and appears to be less nephrotoxic, neurotoxic, and nauseogenic than cisplatin. Randomized studies of this drug against cisplatin are indicated to determine the role of carboplatin in the therapy of squamous cell carcinoma of cervix.
妇科肿瘤研究组对可测量的晚期宫颈鳞状细胞癌患者进行了一项卡铂的II期试验。进入本研究的患者不允许先前接受过细胞毒性药物治疗。入组患者的妇科肿瘤学组（GOG）体能状态为2或更好。卡铂400mg/m²（先前接受过盆腔放疗的患者为340mg/m²，若骨髓耐受性良好则随后增至400mg/m²）通过静脉输注15分钟给药。每四周重复治疗，直至疾病进展或毒性禁止进一步治疗。对39例可评估患者进行了治疗。观察到2例完全缓解和9例部分缓解（缓解率28.2%）。未观察到神经毒性，仅见轻度可逆性肾毒性。3例患者（7.7%）出现严重胃肠道毒性。剂量限制性毒性为骨髓抑制。卡铂对宫颈鳞状细胞癌有活性，且似乎比顺铂的肾毒性、神经毒性和致恶心性更小。需要对该药物与顺铂进行随机研究，以确定卡铂在宫颈鳞状细胞癌治疗中的作用。
