A phase II study of carboplatin in nasopharyngeal carcinoma.
A phase II study of carboplatin in nasopharyngeal carcinoma.
复制标题
卡铂治疗鼻咽癌的 II 期研究。
作者：
K. Chi;Y. Chang;W. Chan;J. M. Liu;C. Law;S. Lo;C. Shu;S. Yen;J. Whang‐Peng;K. Y. Chen
这是一项评价短程卡铂治疗晚期鼻咽癌（NPC）的疗效和毒性的II期研究。研究了33名先前未经治疗的III-IV期NPC患者。卡铂快速静脉注射，每3周一次。根据Egorin公式，根据个体患者的肌酐清除率和75，000/微升的期望血小板最低值计算卡铂的剂量。评价反应和毒性。对32例患者进行了缓解评价。中位年龄为54岁，范围为30-70岁。24例患者有局部区域性疾病，8例患者有转移性疾病。卡铂的中位剂量为415 mg/m2（范围91-791 mg/m2）。14例（44%）患者部分缓解，95%置信区间为26- 62%。15例（47%）患者病情稳定，3例（9%）患者病情进展。43个月时未达到总体中位生存率。总体毒性可耐受。4例（12%）患者发生III-IV级骨髓抑制。无其他重大毒性或治疗相关死亡。我们认为卡铂对晚期鼻咽癌有显著的抗癌作用。卡铂联合化疗治疗鼻咽癌值得临床研究。
This is a phase II study to evaluate the efficacy and toxicity of short-course carboplatin in advanced-stage nasopharyngeal carcinoma (NPC). Thirty-three previously untreated stage III-IV NPC patients were studied. Carboplatin was given as a rapid intravenous injection every 3 weeks. The dose of carboplatin was calculated according to the individual patient's creatinine clearance and desired platelet nadir of 75,000/microliter according to the Egorin formula. Response and toxicity were evaluated. Thirty-two patients were evaluated for response. The median age was 54 years, range 30-70 years. Twenty-four patients had local regional disease and 8 patients had metastatic disease. The median dose of carboplatin given was 415 mg/m2 (range 91-791 mg/m2). Fourteen (44%) patients had a partial response with a 95% confidence interval of 26-62%. Fifteen (47%) patients had stable disease and 3 (9%) progressive disease. The overall median survival rate was not reached at 43 months. Overall toxicity was tolerable. Grade III-IV myelosuppression occurred in 4 (12%) patients. There were no other major toxicity- or treatment-related deaths. We conclude that carboplatin has a significant anticancer effect in advanced NPC. Thus carboplatin combination chemotherapy for the treatment of NPC is worthy of future clinical investigations.