Martin M, Hazan A, Vergnes L, Peytral C, Mazeron J J, Sénéchaut J P, Lelièvre G, Peynègre R
Département de Cancérologie, Centre Hospitalier Creteil, France.
Int J Radiat Oncol Biol Phys. 1990 Oct;19(4):973-5. doi: 10.1016/0360-3016(90)90021-b.
A randomized prospective study of 5 fluorouracil (5-FU) and Cis platin preceding definitive local treatment for squamous cell carcinoma of the head and neck region was initiated in September 1986. Seventy-five patients were stratified by site (oral cavity-12, oropharynx-28, larynx-16, hypopharynx-19), and by Stage (Stage II-20, Stage III-43, Stage IV-12) and randomized to receive definitive local treatment (surgery and post-operative radiation or radiation alone) or chemotherapy followed by definitive local treatment. Chemotherapy consisted of three cycles of 120 hr 5-FU infusion 1 g/m2/day plus Cis platin 100 mg/m2 on day 1 on each cycle. Response to chemotherapy was complete in 17 patients (46%) for an overall response rate of 68%. All the patients have completed therapy with a median follow-up of more than 12 months. After local treatment, the complete response rate is 84% for the control group and 86% in the chemotherapy group. Actuarial disease-free survival at 1 year is 61% in the control group and 73% in the chemotherapy group (p = 0.25). These preliminary results show that in spite of initial tumor response, neoadjuvant chemotherapy does not improve long-term control and survival.
1986年9月启动了一项针对头颈部鳞状细胞癌在确定性局部治疗前使用5氟尿嘧啶（5-FU）和顺铂的随机前瞻性研究。75例患者按部位（口腔-12例、口咽-28例、喉-16例、下咽-19例）和分期（II期-20例、III期-43例、IV期-12例）进行分层，随机接受确定性局部治疗（手术及术后放疗或单纯放疗）或化疗后再进行确定性局部治疗。化疗包括三个周期，每个周期第1天静脉输注5-FU 1 g/m²/天，持续120小时，加用顺铂100 mg/m²。17例患者（46%）化疗反应完全，总有效率为68%。所有患者均完成治疗，中位随访时间超过12个月。局部治疗后，对照组的完全缓解率为84%，化疗组为86%。对照组1年无病生存率为61%，化疗组为73%（p = 0.25）。这些初步结果表明，尽管肿瘤有初始反应，但新辅助化疗并未改善长期控制和生存率。
