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低剂量顺铂联合13-顺式维甲酸和α干扰素治疗晚期头颈部鳞状细胞癌的II期研究

Phase II study of a combination of low-dose cisplatin with 13-cis-retinoic acid and interferon-alpha in patients with advanced head and neck squamous cell carcinoma.

作者信息

Gravis G, Pech-Gourgh F, Viens P, Alzieu C, Camerlo J, Oziel-Taieb S, Jausseran M, Maraninchi D

机构信息

Medical Oncology Department, Institut Paoli-Calmettes, Marseille, France.

出版信息

Anticancer Drugs. 1999 Apr;10(4):369-74. doi: 10.1097/00001813-199904000-00004.

DOI:10.1097/00001813-199904000-00004
PMID:10378671
Abstract

Preclinical and clinical data have suggested antitumor efficacy in squamous cell carcinoma (SCC) of interferon (IFN)-alpha and 13-cis-retinoic acid (13-c-RA) as single agent with greater activity in combination. Cisplatin was added to potentiate activity. Twenty-three patients with pretreated advanced or metastatic head and neck squamous cell carcinoma were given a combination of IFN-alpha (6 x 10(6) U/day, 84 days s.c.), 13-c-RA (1 mg/kg/day, 84 days) and cisplatin (40 mg/kg/day, day 1, 28 and 56). Seventeen patients had discontinuation of treatment and three patients received overall treatment without dose reduction. Hematological toxicity was more frequent; only three patients experiencing grade 3 or higher extra-hematological toxicity. Four out of 14 evaluable patients were in response, with one in complete pathological response. Median duration of response was 6 months with a 9 month median survival. Association of IFN-alpha, 13-c-RA and cisplatin induces modest but definite antitumor activity with moderate and manageable toxicity. Further studies of different combination modality therapy with chemotherapy and differentiating agents need to be performed in less pretreated patients.

摘要

临床前和临床数据表明,干扰素(IFN)-α和13-顺式维甲酸(13-c-RA)作为单一药物对鳞状细胞癌(SCC)具有抗肿瘤疗效,联合使用时活性更高。加入顺铂以增强活性。23例预处理过的晚期或转移性头颈部鳞状细胞癌患者接受了IFN-α(6×10⁶U/天,皮下注射84天)、13-c-RA(1mg/kg/天,84天)和顺铂(40mg/kg/天,第1、28和56天)的联合治疗。17例患者中断治疗,3例患者接受了全程治疗且未减量。血液学毒性更常见;只有3例患者出现3级或更高的血液学外毒性。14例可评估患者中有4例有反应,1例完全病理缓解。中位缓解持续时间为6个月,中位生存期为9个月。IFN-α、13-c-RA和顺铂联合使用可诱导适度但明确的抗肿瘤活性,毒性中等且可控。需要在预处理较少的患者中对化疗和分化剂的不同联合方式治疗进行进一步研究。

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