Induction paclitaxel, carboplatin, and infusional 5-FU followed by concurrent radiation therapy and weekly paclitaxel/carboplatin in the treatment of locally advanced head and neck cancer: A phase II trial of the Minnie Pearl Cancer Research Network
Induction paclitaxel, carboplatin, and infusional 5-FU followed by concurrent radiation therapy and weekly paclitaxel/carboplatin in the treatment of locally advanced head and neck cancer: A phase II trial of the Minnie Pearl Cancer Research Network
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DOI：
10.1097/00130404-200207000-00007
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发表时间：
2002-07-01
期刊：
影响因子：
2.2
通讯作者：
Greco, FA
中科院分区：
文献类型：
--
作者：
Hainsworth, JD;Meluch, AA;Greco, FA
本研究的目的是评估一种新的综合疗法治疗局部晚期头颈鳞癌的可行性、可行性和疗效。方法和方法：在这项多中心、社区为基础的II期研究中，123例未经治疗的局部晚期头颈鳞癌患者接受了6周的诱导化疗，然后同时进行大剂量放射治疗和每周化疗。诱导化疗包括紫杉醇200 mg/m(2)，静脉滴注1h，第1天和第22天，卡铂(AuC6.0)静脉滴注。第1天和第22天，5-氟尿嘧啶225 mg/m(2)，每日1次，24小时连续静脉滴注。输液)，第1-43天。未治疗1周后，原发灶及双侧颈淋巴结行放射治疗，每日1.8Gy5次，总剂量68.4Gy.在放射治疗期间，患者还接受每周6次剂量的紫杉醇(50 mg/m(2))。1小时静脉注射。输液)和卡铂(AuC1.0i.v)。治疗结束后，患者再次接受计算机断层扫描和内窥镜检查；完全缓解的患者在没有进一步治疗的情况下进行随访。结果123名患者(74%患有IV期疾病)进入试验，111名患者(90%)完成了整个疗程。在116名可评估的患者中，有70名(60%，95%，51%-69%)对治疗有临床完全反应。中位随访24个月后，2年和3年精算存活率分别为66%和51%。结论含紫杉醇、不使用顺铂的新型联合治疗方案是可行的、高效的、可接受的社区联合治疗方案。接受该方案的患者应考虑积极的营养支持，以改善急性缓解，并最大限度地发挥联合治疗的效果。有必要对该治疗方案进行进一步评估。加入各种新的生物制剂，特别是表皮生长因子受体拮抗剂，可能会进一步提高疗效。
PURPOSEThe purpose of this study was to evaluate the feasibility, to xi city, and efficacy of a novel combined-modality treatment for patients with locally advanced squamous carcinoma of the head and neck.PATIENTS AND METHODSIn this multicenter, community-based phase II study, 123 previously untreated patients with locally advanced squamous carcinoma of the head and neck received 6 weeks of induction chemotherapy followed by concurrent high-dose radiation therapy and weekly chemotherapy. Induction chemotherapy included paclitaxel (200 mg/m(2), 1-hour i,v. infusion) on days I and 22, carboplatin (AUC 6.0 i.v.) on days I and 22, and 5-fluorouracil (225 mg/m(2) per day, 24-hour continuous i.v. infusion) on days 1-43. After 1 week without therapy, radiation therapy, 1.8 Gy/ day, 5 days weekly, to a total dose of 68.4 Gy, was administered to the primary site and the bilateral cervical lymph nodes. During radiation therapy, patients also received six weekly doses of paclitaxel (50 mg/m(2). 1-hour i.v. infusion) and carboplatin (AUC 1.0 i.v). After completion of therapy, patients were restaged with computed tomographic and endoscopic examination; patients in complete remission were followed up without further treatment.RESULTSOne hundred twenty-three patients (74% with stage IV disease) entered this trial, and 111 patients (90%) completed the entire treatment course. Seventy of 116 evaluable patients (60%; 95% Cl, 51%-69%) had a clinical complete response to treatment. After a median follow-up of 24 months, the 2-and 3-year actuarial survivals were 66% and 51%, respectively. Local toxicity was moderately severe during combined-modality therapy; however, xerostomia has been the only frequent chronic toxicity of this program.CONCLUSIONSThis novel combined-modality treatment program, containing paclitaxel and avoiding the use of cisplatin, is feasible, is highly active, and can be administered with acceptable toxicity in a community-based setting. Aggressive nutritional support should be considered in patients receiving this regimen, to improve acute palliation and to maximize the delivery of combined-modality therapy. Further evaluation of this treatment program is warranted. Incorporation of various novel biologic agents, particularly the epidermal growth factor receptor antagonists, may further improve efficacy.