Early Postoperative Paclitaxel Followed by Concurrent Paclitaxel and Cisplatin With Radiation Therapy for Patients With Resected High-Risk Head and Neck Squamous Cell Carcinoma: Report of the Phase II Trial RTOG 0024
Early Postoperative Paclitaxel Followed by Concurrent Paclitaxel and Cisplatin With Radiation Therapy for Patients With Resected High-Risk Head and Neck Squamous Cell Carcinoma: Report of the Phase II Trial RTOG 0024
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DOI：
10.1200/jco.2008.21.4197
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发表时间：
2009-10-01
影响因子：
45.3
通讯作者：
Ang, K. Kian
中科院分区：
文献类型：
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作者：
Rosenthal, David I.;Harris, Jonathan;Ang, K. Kian
目的探讨高危头颈部鳞状细胞癌(HNSCC)手术切除后早期化疗的可行性和安全性，以及同期放化疗的可行性和安全性。紫杉醇(80 mg/m(2))在术后第2、3、4周每周给药一次，放疗前给药。紫杉醇(30 mg/m(2))和顺铂(20 mg/m(2))在放疗的最后3周(60Gy6周，从术后4~5周开始)每周给药一次。主要终点是治疗的安全性和耐受性，与同期顺铂(100 mg/m(2)每3周)和RT(根据放射治疗肿瘤组试验RTOG 9501进行测试)相比，主要终点是安全性和耐受性。结果纳入研究的70例患者的中位随访时间为3.3年(0.6~4.4年)。所有治疗成分的耐受性与RTOG 9501治疗相当，RTOG 9501治疗是目前的护理标准(遵从率为75%；95%CI为63%至85%)。一名患者死亡，七名患者经历了4级非血液毒性。在调整了重要的预后变量(即阳性切缘、包膜外延伸、原发部位和功能状态)后，局部区域控制率、无瘤存活率和总存活率超过了RTOG 9501。结论术后立即化疗后同步放化疗是可行的，耐受性与标准的术后放化疗一致；该方案导致了良好的局部区域控制率和无病存活率。
PurposeWe sought to improve outcomes for patients with high-risk head and neck squamous cell cancer (HNSCC) after surgical resection by testing the feasibility and safety of early postoperative chemotherapy followed by concurrent chemoradiotherapy.Patients and MethodsEligible patients had resected, stages III to IV HNSCC with positive margins, extracapsular nodal extension, or multiple positive nodes. Paclitaxel (80 mg/m(2)) was given once weekly during postoperative weeks 2, 3, and 4 and was given before radiation therapy (RT). Paclitaxel (30 mg/m(2)) and cisplatin (20 mg/m(2)) were given once weekly during the last 3 weeks of RT (60 Gy over 6 weeks, beginning 4 to 5 weeks after surgery). The primary end points were treatment safety and tolerability compared with concurrent cisplatin (100 mg/m(2) every 3 weeks) and RT, as tested in Radiation Therapy Oncology Group trial RTOG 9501.ResultsThe median follow-up time for the 70 patients enrolled was 3.3 years (range, 0.6 to 4.4 years) for surviving patients. Tolerability of all treatment components was comparable to that of RTOG 9501 treatment, which is the current standard of care (compliance rate, 75%; 95% CI, 63% to 85%). One patient died, and seven patients experienced grade 4 nonhematologic toxicities. Rates of locoregional control, disease-free survival, and overall survival exceeded those of RTOG 9501 after adjustment for important prognostic variables (ie, positive margins, extracapsular extension, primary site, and performance status).ConclusionChemotherapy soon after surgery followed by concurrent chemoradiotherapy therapy was feasible; tolerance was in line with standard postoperative chemoradiotherapy; and this regimen led to excellent rates of locoregional control and disease-free survival.