Phase II trial of cisplatin, tegafur plus uracil and leucovorin as neoadjuvant chemotherapy in patients with squamous cell carcinoma of the oropharynx and hypopharynx
Phase II trial of cisplatin, tegafur plus uracil and leucovorin as neoadjuvant chemotherapy in patients with squamous cell carcinoma of the oropharynx and hypopharynx
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DOI：
10.1097/00001813-200504000-00012
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发表时间：
2005-04-01
影响因子：
2.3
通讯作者：
Chang, JTC
中科院分区：
文献类型：
--
作者：
Wang, HM;Hsueh, CT;Chang, JTC
我们评估了顺铂、替加氟加尿嘧啶和亚叶酸作为口咽和下咽部局部晚期鳞状细胞癌（SCC）新辅助化疗的疗效和毒性。46例患者（IV期，83%; N2/3，52%）接受PUL治疗（第1天50 mg/m2顺铂，第1-14天300 mg/m2替加氟+尿嘧啶口服和60 mg甲酰四氢叶酸口服），为期14天。如果原发性肿瘤缓解低于部分缓解，则3个周期后的评估导致化疗终止。否则，在局部区域治疗之前，PUL持续长达6个周期。新辅助化疗后原发部位至少达到良好部分缓解的患者接受放疗以保存器官。按意向治疗分析化疗反应，原发部位反应率为71.7%（33/46），完全反应率为34.8%（16/46）。30例患者（65.2%）在原发部位获得了良好的部分缓解。颈部淋巴结的总缓解率和完全缓解率分别为68.6%（24/35）和25.7%（9/35）。原发部位和颈部淋巴结的联合缓解率为63%（95%可信区间48.5-77.5%），完全缓解率为15.2%。WHO 3-4级毒副反应包括贫血（19.6%）、腹泻（17.4%）和中性粒细胞减少（8.7%）。中位随访36个月，总生存率和无病生存率分别为45.7%（21/46）和41.3%（19/46）;器官保存率为90%（19/21）。我们的结论是，门诊PUL方案是一种中度有效，毒性较小的新辅助化疗口咽和下咽癌。PUL应与其他活性药物或放射治疗进一步研究。(c)2005年利平科特威廉姆斯&威尔金斯。
We evaluated the efficacy and toxicity of cisplatin, tegafur plus uracil and leucovorin as neoadjuvant chemotherapy for locally advanced squamous cell carcinoma (SCC) of the oropharynx and hypopharynx. Forty-six patients (stage IV, 83%; N2/3, 52%) were treated with PUL (50 mg/m(2) cisplatin on day 1, 300 mg/m(2) tegafur plus uracil orally and 60 mg leucovorin orally on days 1-14) over a 14-day cycle. Evaluation after 3 cycles led to chemotherapy termination if primary tumor responses were less than partial responses. Otherwise, PUL was continued up to 6 cycles before locoregional therapy. Patients achieving at least good partial responses at the primary site after neoadjuvant chemotherapy received radiotherapy for organ preservation. Chemotherapy responses were analyzed by intent-to-treat. Response rates of primary sites were 71.7% (33 of 46) with 34.8% (16 of 46) showing a complete response. Thirty patients (65.2%) achieved good partial responses at the primary site. Overall response and complete response rates of neck lymph nodes were 68.6% (24 of 35) and 25.7% (nine of 35). The combined response rate of primary site and neck lymph nodes was 63% (95% confidence interval 48.5-77.5%) with a complete response rate of 15.2%. Toxicities of WHO grade 3-4 included anemia (19.6%), diarrhea (17.4%) and neutropenia (8.7%). With a median follow-up of 36 months, overall survival and disease-free survival rates were 45.7% (21 of 46) and 41.3% (19 of 46); organ preservation rate was 90% (19 of 21). We concluded that the outpatient PUL regimen was a moderately effective, less-toxic neoadjuvant chemotherapy for SCC of the oropharynx and hypopharynx. PUL should be studied further with other active agents or radiotherapy. (c) 2005 Lippincott Williams & Wilkins.