局部晚期鼻咽癌洛铂单周方案同期放疗初探

目的 探讨局部晚期鼻咽癌洛铂单药单周方案同期放疗中洛铂最大耐受剂量(MTD)。方法 选择18例Ⅲ-ⅣA期鼻咽癌初治患者,采用根治性IMRT同时进行洛铂剂量递增试验。洛铂初始剂量10 mg/m²,组间递增剂量为5 mg/m²,每个剂量组至少3位受试者。如无剂量限制性毒性反应则进入下一剂量组直至MTD,定期评价疗效及不良反应。结果 10、15 mg/m²剂量组各3例,20、25 mg/m²剂量组6例。25mg/m²组出现2例剂量限制性毒性反应,因此MTD确定为20 mg/m²。患者治疗结束后3个月,鼻咽部肿瘤和颈部阳性淋巴结临床缓解率为100%。主要毒性反应为骨髓抑制。结论 洛铂单药周方案同期放化疗治疗局部晚期鼻咽癌的MTD为20mg/m²,该方案疗效可靠安全性较好,值得开展进一步临床研究。

Dose-escalation trial of lobaplatin weekly plus concurrent radiotherapy for local-regionally advanced nasopharyngeal carcinoma

Objective To define the maximum-tolerated dose (MTD) of lobaplatin (LBP) in a weekly regimen combined with concurrent radiotherapy in the treatment of locally advanced nasopharyngeal carcinoma (NPC). Methods A total of 18 cases with stage Ⅲ/IV A NPC were enrolled. Concurrent chemoradiotherapy was given to all the patients with a dose escalation of LBP. The initial dose of LBP was 15 mg/m² with an escalating dose of 5 mg/m². At least 3 patients were assigned into each group. Patients were proceeded into the next dose group if no dose-limiting toxicity (DLT) occurred until the MTD was achieved. Efficacy and toxicity were evaluated regularly. Results Three patients were assigned into the 10 mg/m², 3 into the 15 mg/m², and 6 into the 20 mg/m² and 25 mg/m² groups, respectively. Two patients experienced DLT in the 25 mg/m² group. Hence, the MTD was determined as 20 mg/m². At 3 months after corresponding treatment, the remission rate of nasopharyngeal tumors and neck-positive lymph nodes of the patients was 100%. The most common toxicity was reversible bone marrow suppression. Conclusions The MTD of weekly lobaplatin plus concurrent IMRT is 20 mg/m² for locally advanced NPC. This regimen is reliable and safe, which is worthy of further clinical study.