Final results of a randomized trial comparing chemotherapy plus radiotherapy with chemotherapy plus surgery plus radiotherapy in locally advanced resectable hypopharyngeal carcinomas

Final results of a randomized trial comparing chemotherapy plus radiotherapy with chemotherapy plus surgery plus radiotherapy in locally advanced resectable hypopharyngeal carcinomas
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DOI:
10.1097/00005537-199705000-00017
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发表时间:
1997-05-01
期刊:
影响因子:
2.6
通讯作者:
Wesoluch, M
Wesoluch, M
中科院分区:
医学2区
文献类型:
--
作者:
Beauvillain, C;Mahe, M;Wesoluch, M

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新辅助化疗后,对晚期可能可切除的下咽癌病例的局部控制和生存率进行了评价,评价了常规保守治疗后再行挽救手术的效果。在1985年至1989年期间,92例T3或T4-N 0,N3可手术的下咽鳞状细胞癌患者接受了三个疗程的新辅助化疗,每2周一次,包括第1天顺铂100 mg/m2和第2至5天氟尿嘧啶1 g/m2的联合化疗,A组47例行全喉咽切除术加术后放疗,B组45例单纯放疗。随机化总是在化疗前进行。根治术和淋巴结转移术的有效率分别为67%和54%,而B组分别为79%和73%(P> 0.05)。III级或IV级毒性相似,A组15%的患者和7%的周期受影响,而B组16%的患者和6%的周期受影响。平均随访92个月后,生存率在统计学上更好A组(P = 0.04)(5年总生存率,37%;中位生存期,40个月)比B组局部控制率(63%)较好(39%),差异有显著性(P < 0.01)。无论对新辅助化疗的反应如何,毁损术在局部控制和总生存率方面都获得了更好的结果。
After neoadjuvant chemotherapy, a routine conservative approach followed by salvage surgery was evaluated in terms of local control and survival in cases of advanced potentially resectable hypopharyngeal carcinoma. Between 1985 and 1989, 92 patients with T3 or T4-N0,N3 operable squamous cell hypopharyngeal carcinomas received three courses of neoadjuvant chemotherapy every 2 weeks involving a combination of cisplatin, 100 mg/m(2), on day 1 and fluorouracil, 1 g/m(2), on days 2 to 5, followed by total laryngopharyngectomy plus postoperative radiotherapy in 47 patients (arm A) or radiotherapy alone in 45 patients (arm B). Randomization was always performed prior to chemotherapy. The response rates of turner and node to chemotherapy were, respectively, 67% in arm A versus 79% in arm B (P > 0.05) and 54% in arm A versus 73% in arm B (P > 0.05). Grade III or IV toxicity was similar, affecting 15% of patients and 7% of cycles in rum A versus 16% of patients and 6% of cycles in arm B, After a mean follow-up of 92 months, survival was statistically better (P = 0.04) in arm A (5-year overall survival, 37%; median survival, 40 months) than in arm B (19% and 20 months) because of a better local control rate (63% versus 39%; P < 0.01). Better results were obtained for mutilant surgery in terms of local control and overall survival, regardless of response to neoadjuvant chemotherapy.