多西他赛、顺铂和氟尿嘧啶诱导化疗联合加速分割/同期加量放疗及顺铂同期治疗晚期头颈部鳞状细胞癌的西南肿瘤协作组 II 期临床试验（S0216）。
Docetaxel, cisplatin, and fluorouracil induction chemotherapy followed by accelerated fractionation/concomitant boost radiation and concurrent cisplatin in patients with advanced squamous cell head and neck cancer: A Southwest Oncology Group phase II trial (S0216).
机构信息
Department of Solid Tumor Oncology, Cleveland Clinic Taussig Cancer Institute, Cleveland, Ohio, USA.
出版信息
Head Neck. 2010 Feb;32(2):221-8. doi: 10.1002/hed.21179.
BACKGROUND
In an effort to optimize nonoperative therapy in patients with locoregionally advanced head and neck squamous cell cancer, the Southwest Oncology Group conducted a phase II trial combining 3-drug taxane-containing induction chemotherapy with accelerated fractionation/concomitant boost radiation and concomitant single-agent cisplatin.
METHODS
Two induction courses using docetaxel (75 mg/m(2) on day 1), cisplatin (100 mg/m(2) on day 1), and fluorouracil (1000 mg/m(2)/day continuous intravenous infusion days 1-4) were given, with an interval of 21 days. Patients who were stable or responded to the chemotherapy received definitive accelerated fractionation/concomitant boost radiation with concurrent cisplatin (100 mg/m(2)) on days 1 and 22 of radiation.
RESULTS
There were 74 eligible and evaluable patients enrolled between March 1, 2003, and August 15, 2004; 52 (70%) had stage IV disease. At least 1 grade 3-4 toxicity was experienced by 63 patients (85%) during induction. A total of 61 patients completed induction and began concurrent chemoradiotherapy; 50 (68%) completed all planned treatment. At least 1 grade 3-4 toxicity was noted in 53 of the 58 patients (91%) evaluated for toxicity from concurrent chemoradiotherapy. Two patients died during induction, and 2 during chemoradiation. With a median follow-up of 36 months (range, 14-50), the 2-year and 3-year overall survival estimates were 70% and 64%, with 2-year and 3-year progression-free survival estimates of 66% and 61%, respectively.
CONCLUSIONS
Three-drug induction chemotherapy followed by accelerated fractionation/concomitant boost radiation and concurrent cisplatin is toxic but feasible within a cooperative group. In this patient cohort with advanced head and neck squamous cell cancer, overall and progression-free survivals were encouraging, justifying further study of this approach.
背景
为了优化局部晚期头颈部鳞状细胞癌患者的非手术治疗，西南肿瘤协作组进行了一项 II 期试验，该试验将含 3 种药物的紫杉烷类诱导化疗与加速分割/同期加量放疗和同期顺铂单药联合使用。
方法
给予 2 个诱导疗程，使用多西他赛（第 1 天 75mg/m2）、顺铂（第 1 天 100mg/m2）和氟尿嘧啶（1000mg/m2/天持续静脉输注第 1-4 天），间隔 21 天。对化疗稳定或有反应的患者，在放疗第 1 天和第 22 天给予加速分割/同期加量放疗和同期顺铂（100mg/m2）。
结果
2003 年 3 月 1 日至 2004 年 8 月 15 日期间共纳入 74 例可评估患者；52 例（70%）为 IV 期疾病。63 例（85%）患者在诱导期至少出现 1 次 3-4 级毒性。共有 61 例患者完成诱导并开始同期放化疗；50 例（68%）完成了所有计划治疗。58 例接受同期放化疗毒性评估的患者中，至少有 1 例出现 3-4 级毒性。2 例患者在诱导期死亡，2 例患者在放化疗期间死亡。中位随访 36 个月（范围 14-50 个月），2 年和 3 年总生存率估计值分别为 70%和 64%，2 年和 3 年无进展生存率估计值分别为 66%和 61%。
结论
三药诱导化疗后加速分割/同期加量放疗和同期顺铂治疗毒性较大，但在协作组内是可行的。在这组晚期头颈部鳞状细胞癌患者中，总生存率和无进展生存率令人鼓舞，这证明了这种治疗方法值得进一步研究。
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