Spaulding M B, Fischer S G, Wolf G T
Department of Medicine, State University of New York at Buffalo.
J Clin Oncol. 1994 Aug;12(8):1592-9. doi: 10.1200/JCO.1994.12.8.1592.
In 1984, the Department of Veterans Affairs Cooperative Studies Program began a trial in which patients with resectable squamous cell carcinoma of the larynx were randomized to receive standard surgery followed by radiation therapy or to receive neoadjuvant therapy with cisplatin and fluorouracil (5-FU) followed by radiation therapy for those achieving a greater than 50% tumor response to chemotherapy. This analysis reviews the tumor responses, toxicity, compliance, and long-term survival for those patients randomized to the chemotherapy arm.
One hundred sixty-six patients were randomized to the chemotherapy arm. Standard tumor response data, chemotherapy toxicity, and survival have been examined using standard statistical methods.
The high response rates and acceptable toxicity to cisplatin and 5-FU of previously untreated patients were confirmed. Long-term disease-free survival was more likely to occur in patients who achieved a complete response to chemotherapy, particularly in those who had a confirmed histologic response to chemotherapy. Pretreatment histologic growth patterns were highly predictive of responses to chemotherapy.
Neoadjuvant chemotherapy was well tolerated and did not negatively affect the definitive treatment that followed. The survival of nonresponding patients who underwent prompt salvage surgery was also not impaired. The role of organ preservation should be explored in other head and neck sites.
1984年，退伍军人事务部合作研究项目启动了一项试验，将可切除的喉鳞状细胞癌患者随机分为两组，一组接受标准手术加放疗，另一组接受顺铂和氟尿嘧啶（5-FU）新辅助治疗，对于化疗肿瘤反应大于50%的患者随后接受放疗。本分析回顾了随机分配至化疗组的患者的肿瘤反应、毒性、依从性和长期生存情况。
166例患者被随机分配至化疗组。使用标准统计方法检查了标准肿瘤反应数据、化疗毒性和生存情况。
先前未治疗患者对顺铂和5-FU的高反应率及可接受的毒性得到证实。化疗获得完全缓解的患者更有可能实现长期无病生存，尤其是那些化疗有组织学反应证实的患者。治疗前的组织学生长模式对化疗反应具有高度预测性。
新辅助化疗耐受性良好，对随后的确定性治疗没有负面影响。接受及时挽救手术的无反应患者的生存也未受损害。应在其他头颈部位探索器官保留的作用。
