Pujol J L, Monnier A, Berille J, Cerrina M L, Douillard J Y, Rivière A, Grandgirard A, Gouva S, Bizzari J P, Le Chevalier T
Service des Maladies Respiratoires, Université de Montpellier, Hôpital Arnaud de Villeneuve, France.
Br J Cancer. 1994 Jun;69(6):1136-40. doi: 10.1038/bjc.1994.223.
A phase II study was designed to evaluate objective response rate and toxicity of fotemustine as single-drug chemotherapy in non-small-cell lung cancer. Eighty-seven patients with unresectable non-small-cell lung cancer took part in the study. Seventy-seven were evaluable for response. Of these, 60% had received prior chemotherapy and 74% had metastatic disease. Moreover, 22 patients had central nervous system metastases (of whom 12 were evaluable for this site). Treatment consisted of fotemustine 100 mg m-2 administered on days 1 and 8 followed by a 5 week rest period. Afterwards, responding or stabilised patients received fotemustine 100 mg m-2 every 3 weeks as a maintenance therapy. Toxicity and quality of life were recorded during therapy. Thirteen patients (17%; 95% CI 9-25%) had an objective response (11% for pretreated, 26% for non-pretreated) with a median duration of 22 weeks (range 7-41 weeks). Two objective responses were observed among the 12 patients with evaluable brain metastases. No response was observed among the 14 patients with adenocarcinoma. Haematological, gastrointestinal, hepatic and renal toxicities were mild to moderate and manageable. The most frequent biological adverse reactions were delayed thrombocytopenia and neutropenia. Quality of life did not significantly decrease during the first 6 treatment weeks. Moreover, it remained stable during the study period in patients with response or stabilisation, whereas it significantly decreased in patients who experienced progression of the disease. Fotemustine is feasible for single-drug chemotherapy in non-small-cell lung cancer even though poor prognostic variables such as brain metastases are present. It can be administered on an outpatient basis and toxicity is moderate and manageable. Thus, fotemustine can be considered as a putative drug in further combinations.
一项II期研究旨在评估福莫司汀作为单药化疗治疗非小细胞肺癌的客观缓解率和毒性。87例不可切除的非小细胞肺癌患者参与了该研究。77例患者可评估缓解情况。其中，60%的患者曾接受过化疗，74%的患者有转移性疾病。此外，22例患者有中枢神经系统转移（其中12例该部位可评估）。治疗方案为第1天和第8天给予福莫司汀100mg/m²，随后休息5周。之后，缓解或病情稳定的患者每3周接受100mg/m²福莫司汀作为维持治疗。治疗期间记录毒性和生活质量。13例患者（17%；95%CI 9-25%）有客观缓解（预处理患者为11%，未预处理患者为26%），中位缓解持续时间为22周（范围7-41周）。12例可评估脑转移的患者中有2例出现客观缓解。14例腺癌患者未观察到缓解。血液学、胃肠道、肝脏和肾脏毒性为轻至中度且可控制。最常见的生物学不良反应是延迟性血小板减少和中性粒细胞减少。在治疗的前6周内生活质量没有显著下降。此外，在缓解或病情稳定的患者中，研究期间生活质量保持稳定，而在疾病进展的患者中显著下降。即使存在脑转移等预后不良因素，福莫司汀用于非小细胞肺癌的单药化疗也是可行的。它可以在门诊给药，毒性为中度且可控制。因此，福莫司汀可被视为进一步联合用药中的一种潜在药物。
