摘要
目的初步探讨洛铂联合5-氟尿嘧啶（5-Fu）诱导化疗加洛铂同期放化疗治疗局部区域中晚期鼻咽癌的安全性、有效性以及同期洛铂放化疗的适宜剂量。方法未行抗肿瘤治疗的初治局部区域中晚期鼻咽癌患者签署知情同意书。诱导化疗方案为洛铂30mg／m2＋5一Fu4g／m2持续静脉滴注120h，每21d为1个疗程，共2个疗程；同期化疗起始剂量为洛铂50mg／m2，每21d重复。每剂量组至少入组患者3例。3例患者中出现2例剂量限制性毒性（DLT）则化疗剂量降5mg／m2，直至达到最大耐受剂量（MTD）。2个疗程诱导化疗后、放疗结束、放疗后3个月及放疗后6个月评价疗效。结果2011年12月至2012年4月，共11例患者入组。2个疗程诱导化疗后完全缓解1例，部分缓解8例，稳定2例。放化疗结束及放疗后3个月评价疗效显示完全缓解10例，部分缓解1例。放疗结束6个月，所有患者均显示为完全缓解。洛铂50mg／m2同期化放疗组的3例患者中2例出现DLT；45mg／m2组的3例患者出现2例DLT；40mg／m2组5例均未出现DLT，因此推荐洛铂联合5一Fu诱导化疗后的洛铂同期放化疗MTD为40mg／m2。主要DLT为血小板抑制。结论洛铂联合5=Fu诱导化疗加洛铂同期放化疗治疗局部区域中晚期鼻咽癌安全性好，可以取得较满意的疗效，诱导化疗后洛铂同期放化疗MTD为40mg／m2，进一步扩大样本量的临床研究值得期待。
Objective To observe the safety and effectiveness of inductive ehemotheray with lobaplatin plus 5-Fu （LF regimen） and concurrent chemoradiotherapy with lobaplatin for local-regionally advanced nasopharyngeal carcinoma （NPC） patients, and investigate the appropriate Iobaplatin dose for the concurrent chemoradiotherapy. Methods Newly diagnosed local-regionally advanced NPC patients signed informed consent. The inductive chemotherapy was lobaplatin 30 mg/m2 ＋ 5-Fu 4 g/m2 civ 120 h for 2 cycles every 21 days, then concurrent lobaplatin chemoradiotherapy was conducted. The initial lobaplatin dose for concurrent chemoradiotherapy was 50 mg/m2 with at least 3 cases in every dose level. If 2 of 3 patients presented dose-limiting toxicity （DLT）, 5 mg/m2 dose decreased for the next level until maximal tolerant dose （MTD） reached. The tumor response was evaluated after inductive chemotherapy, at the end of the chemoradiotherapy, 3 months after chemoradiotherapy and 6 months after chemorafliotherapy. Results From Dec 2011 to Apr 2012, 11 patients were enrolled in this study. After 2 courses of inductive chemoradiotherapy, CR, PR and SD were observed in 1, 8 and 2 patients, respectively. At the end of the chemoradiotherapy and 3 months after chemoradiotherapy, CR and PR were observed in 10 and 1 patients, respectively. Six months after the chemoradiotherapy, all patients were CR. For the patients（3 in each arm） received 50 mg/m2 or 45 mg/m2 lobapaltin concurrent chemoradiotherapy, 2 patients in each arua presented DLT. For the 5 patients received 40 mg/m2 lobapahin concurrent chemoradiotherapy, no patients presented DLT, 40 mg/m2 was suggested as the MTD. Inhibition of platelet was the major DLT. Conclusion Inductive chemotherapy with LF regimen and concurrent chemoradiotherapy with lobaplatin is safe and effective for local-regionally advanced NPC patients and the MTD of lobaplatin for the concurrent chemoradiotherapy is 40 mg/m2. Further clinical trial with large sample is expected.
出处
《肿瘤研究与临床》
CAS
2013年第6期389-392,共4页
Cancer Research and Clinic
关键词
鼻咽肿瘤
洛铂
药物疗法
联合
最大耐受剂量
Nasopharyngeal neoplasms
Lobaplatin
Drug therapy, combination
Maximal tolerant dose
