Degardin M, Oliveira J, Geoffrois L, Rolland F, Armand J P, Bastit P, Chauvergne J, Fargeot P, van Glabbeke M, Lentz M A, Tresca P, Boudillet J, Fumoleau P, Cappelaere P
Early Clinical Studies Group of EORTC, Lille, France.
Ann Oncol. 1998 Oct;9(10):1103-7. doi: 10.1023/a:1008446706578.
Vinorelbine is an active drug in the treatment of lung and breast cancers and has a favorable toxicity profile. Many clinical trials have demonstrated its antitumor activity in other tumor types including squamous cell carcinoma of the head and neck (SCCHN). We investigated the efficacy and tolerability of vinorelbine in patients with recurrent and/or metastatic SCCHN, previously untreated by chemotherapy.
Seventy-one patients with locoregional recurrent and/or metastatic SCCHN were treated with vinorelbine at a dose of 30 mg/m2/week i.v. by short-duration infusion on an out-patient basis. Doses were adjusted according to tolerance.
Two complete and seven partial responses were observed among 56 evaluable patients, yielding a response rate of 16% (95% confidence interval (CI): 8%-28%). The overall response rate of all eligible patients (63) was 14%. The responses were seen in recurrent tumors, lymph nodes and in lung metastases, and their median duration was 19 weeks (12-63). The main toxicity, severe and reversible neutropenia (grade 3-4) occurred in 53% of the 69 evaluable (for toxicity) patients. Twelve patients developed severe bronchopulmonary infections, which caused two early deaths. Constipation was observed in 31 patients (45%). Other gastrointestinal toxicities, asthenia, acute pain syndrome and peripheral sensory neuropathy, were mild to moderate. The median number of treatments was seven cycles and the median relative dose intensity of vinorelbine was 85% (25.5 mg/m2/week).
Vinorelbine is an active drug, with acceptable toxicity, in recurrent and/or metastatic SCCHN, at the dose and schedule administered in the present study. Further evaluation in association with other agents and/or radiotherapy is warranted.
长春瑞滨是治疗肺癌和乳腺癌的一种有效药物，且毒性特征良好。许多临床试验已证明其在包括头颈部鳞状细胞癌（SCCHN）在内的其他肿瘤类型中具有抗肿瘤活性。我们研究了长春瑞滨在既往未接受过化疗的复发性和/或转移性SCCHN患者中的疗效和耐受性。
71例局部区域复发和/或转移性SCCHN患者在门诊接受长春瑞滨治疗，剂量为30mg/m²/周，静脉短时间输注。剂量根据耐受性进行调整。
在56例可评估患者中观察到2例完全缓解和7例部分缓解，缓解率为16%（95%置信区间（CI）：8%-28%）。所有符合条件患者（63例）的总缓解率为14%。缓解出现在复发性肿瘤、淋巴结和肺转移灶中，其缓解持续时间中位数为19周（12 - 63周）。主要毒性反应为严重且可逆的中性粒细胞减少（3 - 4级），在69例（针对毒性进行评估）可评估患者中有53%出现。12例患者发生严重支气管肺部感染，导致2例早期死亡。31例患者（45%）出现便秘。其他胃肠道毒性、乏力、急性疼痛综合征和周围感觉神经病变为轻至中度。治疗周期中位数为7个周期，长春瑞滨的相对剂量强度中位数为85%（25.5mg/m²/周）。
在本研究给予的剂量和方案下，长春瑞滨是治疗复发性和/或转移性SCCHN的一种有效药物，毒性可接受。有必要与其他药物和/或放疗联合进行进一步评估。
