Randomized Phase II Trial of Concurrent Cisplatin-Radiotherapy With or Without Neoadjuvant Docetaxel and Cisplatin in Advanced Nasopharyngeal Carcinoma
Randomized Phase II Trial of Concurrent Cisplatin-Radiotherapy With or Without Neoadjuvant Docetaxel and Cisplatin in Advanced Nasopharyngeal Carcinoma
复制标题
DOI：
10.1200/jco.2008.18.1545
复制
发表时间：
2009-01-10
影响因子：
45.3
通讯作者：
Chan, Anthony T.
中科院分区：
文献类型：
--
作者：
Hui, Edwin P.;Ma, Brigette B.;Chan, Anthony T.
目的比较鼻咽癌患者序贯新辅助化疗联合顺铂-放射治疗(CRT)和单纯CRT治疗的毒副作用、肿瘤控制率、生存期和生活质量。患者和方法将初治的III~IVB期鼻咽癌患者随机分为(1)新辅助紫杉醇75 mg/m(2)和顺铂75 mg/m(2)，每3周一次，共2个周期；结果2002年11月至2004年11月，65例符合条件的患者随机分为CRT组(n=34)和单纯CRT组(n=31)。在新辅助化疗期间，3/4级中性粒细胞减少的发生率很高(97%)，但中性粒细胞减少热(12%)的发生率不高。CRT期间，两组患者的急性毒性发生率无显著差异。同步顺铂的剂量强度、晚期RT毒性和生活质量评分在两组中都是相似的。新辅助治疗组和对照组的3年无进展生存率分别为88.2%和59.5%(风险比=0.49；95%CI，0.20~1.19；P=.12)。新辅助治疗组和对照组的3年总生存率分别为94.1%和67.7%(风险比分别为0.078.24和0.73，P=0.012)。结论多西紫杉醇-顺铂联合适形放疗的耐受性良好，且毒性可控，可继续全量适量适形放疗。初步结果表明，这对存活率有积极影响。有必要进行第三阶段研究，以明确测试这一新佐剂-并发策略。
PurposeTo compare the toxicities, tumor control, survival, and quality of life of nasopharyngeal cancer (NPC) patients treated with sequential neoadjuvant chemotherapy followed by concurrent cisplatin-radiotherapy (CRT) or CRT alone.Patients and MethodsPreviously untreated stage III to IVB NPC were randomly assigned to (1) neoadjuvant docetaxel 75 mg/m(2) and cisplatin 75 mg/m(2) every 3 weeks for two cycles, followed by cisplatin 40 mg/m(2)/wk concurrent with radiotherapy, or (2) CRT alone. Planned accrual was 30 patients per arm to detect 20% difference of toxicities based on 95% CIs.ResultsFrom November 2002 to November 2004, 65 eligible patients were randomly assigned to neoadjuvant chemotherapy followed by CRT (n = 34) or CRT alone (n = 31). There was a high rate of grade 3/4 neutropenia (97%) but not neutropenic fever (12%) during neoadjuvant chemotherapy. No significant differences in rates of acute toxicities were observed between the two arms during CRT. Dose intensities of concurrent cisplatin, late RT toxicities and quality of life scores were comparable in both arms. The 3-year progression-free survival for neoadjuvant versus control arm was 88.2% and 59.5% (hazard ratio = 0.49; 95% CI, 0.20 to 1.19; P = .12). The 3-year overall survival for neoadjuvant versus control arm was 94.1% and 67.7% (hazard ratio = 0.24; 95% CI, 0.078 to 0.73; P = .012).ConclusionNeoadjuvant docetaxel-cisplatin followed by CRT was well tolerated with a manageable toxicity profile that allowed subsequent delivery of full-dose CRT. Preliminary results suggested a positive impact on survival. A phase III study to definitively test this neoadjuvant-concurrent strategy is warranted.