Sequential chemoradiotherapy with docetaxel, cisplatin, and 5-fluorouracil in patients with locally advanced head and neck cancer
Sequential chemoradiotherapy with docetaxel, cisplatin, and 5-fluorouracil in patients with locally advanced head and neck cancer
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DOI：
10.1097/00000421-200106000-00003
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发表时间：
2001-06-01
影响因子：
2.6
通讯作者：
Dokianakis, G
中科院分区：
文献类型：
--
作者：
Janinis, J;Papadakou, M;Dokianakis, G
这项II期试验的目的是评估多西紫杉醇、顺铂和5-氟尿嘧啶（5-FU） （DCF）配合粒细胞集落刺激因子支持的序贯放化疗方法对先前未接受治疗的局部晚期头颈癌（HNC）患者的毒性。次要终点包括反应的初步评估。局部晚期HNC患者，世界卫生组织评分为0 - 2，既往无化疗或放疗史。治疗包括第1天多西他赛80mg /m(2)（1小时输注），第2天和第3天顺铂40mg /m(2)（1小时输注），第1至3天5-氟尿嘧啶1000mg /m(2)（24小时连续输注），每28天重复一次，每位患者最多4个周期。所有患者在第4天至第9天皮下注射粒细胞集落刺激因子。计划在最后一个化疗周期后5周内对原发肿瘤部位和颈部淋巴结进行放射治疗。原发肿瘤部位接受60 ~ 70 Gy。20例患者（中位年龄56岁，范围40-72岁）共接受了60个周期的DCF治疗。中位周期数为3（范围：1-4个周期）。所有患者的毒性和反应均可评估，DCF诱导化疗最常见的急性非血液学毒性包括脱发、粘膜炎、周围感觉神经病变、骨髓瘤溶解和虚弱。2例患者出现发热性中性粒细胞减少症，1例患者出现IV级腹泻。没有与治疗相关的死亡。DCF诱导化疗后总有效率（RR）为90%（95%可信区间[CI]: 76.8-103.1%）。RT完成后，总RR为95%，完全缓解率为73% （95% CI: 49.9 ~ 90.1%）。8例喉癌患者及1例舌底受累患者均获得器官保存。中位随访36个月（范围：5-43个月）后，中位无病生存期和总生存期尚未达到。1年和2年生存率分别为85%和60%。在局部晚期头颈癌患者中，DCF和生长因子支持的序期放化疗是可行且非常有效的，具有持久的反应。在临床试验的背景下，对这种方式的进一步评估是合理的。
The purpose of this phase II trial was to evaluate the toxicity of a sequential chemoradiotherapy approach using docetaxel, cisplatin, and 5-fluorouracil (5-FU) (DCF) with granulocyte colony-stimulating factor support in previously untreated patients with locally advanced head and neck cancer (HNC). Secondary endpoints included preliminary assessment of response. Patients with locally advanced HNC, a World Health Organization performance status 0 to 2, and no prior history of chemotherapy or radiotherapy were included. Treatment consisted of docetaxel 80 mg/m(2) (1-hour infusion) on day 1, cisplatin 40 mg/m(2) (1-hour infusion) on days 2 and 3, and 5-fluorouracil 1,000 mg/m(2) (24-hour continuous infusion), on days 1 to 3, repeated every 28 days for a maximum of 4 cycles per patient. All patients received granulocyte colony stimulating factors subcutaneously between days 4 and 9. Radiation therapy (RT) to the primary tumor site and neck lymph nodes was planned within 5 weeks of the last cycle of chemotherapy. The primary tumor site received 60 to 70 Gy. Twenty patients (median age 56 years, range: 40-72 years) received a total of 60 cycles of DCF. The median number of cycles was 3 (range: 1-4 cycles). All patients were evaluable for toxicity and response, The most common acute nonhematologic toxicities from DCF induction chemotherapy included alopecia, mucositis, peripheral sensory neuropathy, onycholysis, and asthenia. Febrile neutropenia developed in two patients and grade IV diarrhea in one patient. There were no treatment-related deaths. The overall response rate (RR) after DCF induction chemotherapy was 90% (95% confidence interval [CI]: 76.8-103.1%). After the completion of RT, the overall RR was 95% with a complete response rate of 73% (95% CI: 49.9-90.1%). Organ preservation was achieved in eight patients with laryngeal cancer and one patient with base of tongue involvement. After a median follow-up of 36 months (range: 5-43 months) the median disease-free and overall survival have not been reached yet. The 1- and 2-year survival rates were 85% and 60%, respectively. Sequential chemoradiotherapy with DCF and growth factor support is feasible and very active, with durable responses in patients with locally advanced head and neck cancer. Further evaluation of this modality is justified in the context of a clinical trial.