Docetaxel and cisplatin: an active regimen in patients with locally advanced, recurrent or metastatic squamous cell carcinoma of the head and neck. Results of a phase II study of the EORTC Early Clinical Studies Group.
Docetaxel and cisplatin: an active regimen in patients with locally advanced, recurrent or metastatic squamous cell carcinoma of the head and neck. Results of a phase II study of the EORTC Early Clinical Studies Group.
复制标题
多西紫杉醇和顺铂：治疗局部晚期、复发性或转移性头颈部鳞状细胞癌患者的积极治疗方案。
DOI：
10.1023/a:1008360323986
复制
发表时间：
1999
期刊：
影响因子：
--
通讯作者：
A. Hanauske
中科院分区：
文献类型：
--
作者：
P. Schöffski;G. Catimel;A. Planting;J. Droz;J. Verweij;D. Schrijvers;L. Gras;A. Schrijvers;J. Wanders;A. Hanauske
背景
多西他赛和顺铂是治疗头颈癌最有效的抗肿瘤药物之一，I 期研究发现这两种药物的组合是可行的。 EORTC ECSG 对局部晚期、复发或转移性头颈部鳞状细胞癌患者进行了一项多中心 II 期研究，以评估该组合的抗肿瘤功效和毒性。
患者和方法
资格标准包括书面知情同意书、WHO 体能状态 < 2、预期寿命 > 12 周以及足够的骨髓、肝和肾功能。允许使用基于顺铂的化疗或先前的放疗进行新辅助预处理。如果患者预先接受紫杉烷治疗、患有中枢神经系统受累、并发恶性肿瘤、周围神经病变或没有可测量的疾病，则不符合资格。治疗包括多西紫杉醇 100 mg/m2（静脉输注一小时），然后顺铂 75 mg/m2（静脉输注三小时），每三周重复一次。支持治疗包括水合、5HT3 拮抗剂和皮质类固醇。
结果
44 名患者（中位年龄 55 岁，范围 35-76 岁）参加了试验； 41 名患者符合资格，164 个治疗周期可评估毒性，31 名患者可评估缓解。 14 名患者之前接受过手术，15 名接受过放疗，5 名接受过化疗。给出了四个治疗周期的中位数（范围 1-6）。血液学和非血液学毒性很常见，但由于皮质类固醇预防，过敏反应和液体潴留很少见。 4 名患者因毒性而退出研究，1 名患者因肺炎而中毒性死亡。在 41 名符合条件的患者中，经独立审查确认的客观缓解包括 6 例完全缓解和 16 例部分缓解，总体缓解率为 53.7%（95% 置信区间：37.4%-69.3%）。无论是在接受过治疗还是未接受过治疗的患者中，局部晚期、复发性和转移性疾病均出现缓解。在 22 名可评估、未接受过治疗的局部晚期或转移性疾病患者中，5 名实现完全缓解，14 名部分缓解。在九名可评估的接受过治疗的局部晚期或转移性头颈癌患者中观察到，一名完全缓解，两名部分缓解。
结论
多西紫杉醇和顺铂联合治疗局部晚期、复发性和转移性头颈部鳞状细胞癌是可行且有效的。
BACKGROUND
Docetaxel and cisplatin are among the most active antitumor agents in head and neck cancer, and phase I studies found the combination of the two drugs to be feasible. The EORTC ECSG performed a multicenter phase II study in patients with locally advanced, recurrent or metastatic squamous cell carcinoma of the head and neck to evaluate the antitumor efficacy and toxicity of this combination.
PATIENTS AND METHODS
Eligibility criteria included written informed consent, a WHO performance status < 2, life expectancy of > 12 weeks, and adequate bone marrow, liver and renal function. Neoadjuvant pretreatment with cisplatin-based chemotherapy or prior radiotherapy were allowed. Patients were ineligible if pretreated with taxoids, had CNS involvement, concurrent malignancy, peripheral neuropathy, or no measurable disease. Treatment consisted of docetaxel 100 mg/m2 (one-hour i.v. infusion), followed by cisplatin 75 mg/m2 (three-hour i.v. infusion), repeated every three weeks. Supportive care included hydration, 5HT3-antagonists, and corticosteroids.
RESULTS
Forty-four patients (median age 55 years, range 35-76) entered the trial; 41 patients were eligible, 164 cycles of treatment were evaluable for toxicity, and 31 patients for response. Fourteen patients had undergone prior surgery, 15 had received radiotherapy, and five had had chemotherapy. A median number of four treatment cycles (range 1-6) was given. Hematologic and non-hematologic toxicities were common, but hypersensitivity reactions and fluid retention were very infrequent due to corticosteroid prophylaxis. Four patients were taken off the study due to toxicity, and one toxic death occurred due to pneumonia. Among 41 eligible patients, objective responses as confirmed by independent review included six complete remissions and 16 partial remissions, resulting in an overall response rate of 53.7% (95% confidence interval: 37.4%-69.3%). Responses occurred in locally advanced, recurrent and metastatic disease, both in pre- and non-pretreated patients. Of 22 evaluable, non-pretreated patients with locally advanced or metastatic disease, five achieved complete responses, and 14 partial responses. Observed among nine evaluable pretreated patients with locally advanced or metastatic head and neck cancer were one complete response and two partial responses.
CONCLUSION
The combination of docetaxel and cisplatin is feasible and active in locally advanced, recurrent, and metastatic squamous cell carcinoma of the head and neck.
影响因子：
45.3
作者：
Dreyfuss, AI;Clerk, JR;Posner, MR
通讯作者：
Posner, MR