Gemcitabine plus metronomic 5-fluorouracil or capecitabine as a second-/third-line chemotherapy in advanced adrenocortical carcinoma: a multicenter phase II study
Gemcitabine plus metronomic 5-fluorouracil or capecitabine as a second-/third-line chemotherapy in advanced adrenocortical carcinoma: a multicenter phase II study
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DOI：
10.1677/erc-09-0281
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发表时间：
2010-06-01
影响因子：
3.9
通讯作者：
Berruti, Alfredo
中科院分区：
文献类型：
--
作者：
Sperone, Paola;Ferrero, Anna;Berruti, Alfredo
肾上腺皮质癌（ACC）是一种罕见的肿瘤，其特点是预后不良。晚期疾病的一线全身治疗包括米托坦，单独使用或与化疗联合使用。评估二线治疗方案的研究获得了令人失望的结果。该试验评估了吉西他滨加节律性氟嘧啶在经过大量预处理的晚期 ACC 患者中的活性和毒性。从 1998 年到 2008 年，28 名晚期 ACC 患者在接受米托坦加一或两种全身化疗后进展。他们接受了静脉注射的组合。吉西他滨（800 mg/m(2)，第 1 天和第 8 天，每 21 天一次）和静脉注射前 6 名患者接受 5-氟尿嘧啶延长输注（200 mg/m(2)/每天，不间断直至病情进展），或随后的患者口服卡培他滨（1500 mg/每天）。所有病例均维持米托坦给药。治疗4个月后无进展患者率为46.3%。 1 名患者（3.5%）观察到完全缓解； 1 名患者（3.5%）获得部分消退，11 名患者（39.3%）获得疾病稳定，15 名患者（53.7%）出现进展。治疗耐受性良好，出现 III 级和 IV 级毒性，包括 6 名患者 (21.4%) 出现白细胞减少、1 名患者 (3.5%) 出现血小板减少和 1 名患者 (3.5%) 出现粘膜炎。患者群体的中位进展时间和总生存期分别为 5.3 个月（范围：1-43）和 9.8 个月（范围：3-73）。对于接受过多次治疗的 ACC 患者来说，吉西他滨加节律性氟嘧啶是一种耐受性良好、中等活性的治疗方案。内分泌相关癌症（2010）17 445-453
Adrenocortical carcinoma (ACC) is a rare neoplasm characterized by poor prognosis. First-line systemic treatments in advanced disease include mitotane, either alone or in combination with chemotherapy. Studies evaluating second-line therapy options have obtained disappointing results. This trial assessed the activity and toxicity of gemcitabine plus metronomic fluoropyrimidines in heavily pretreated advanced ACC patients. From 1998 to 2008, 28 patients with advanced ACC progressing after mitotane plus one or two systemic chemotherapy lines were enrolled. They received a combination of i.v. gemcitabine (800 mg/m(2), on days 1 and 8, every 21 days) and i.v. 5-fluorouracil protracted infusion (200 mg/m(2)/daily without interruption until progression) in the first six patients, or oral capecitabine (1500 mg/daily) in the subsequent patients. Mitotane administration was maintained in all cases. The rate of non-progressing patients after 4 months of treatment was 46.3%. A complete response was observed in 1 patient (3.5%); 1 patient (3.5%) obtained a partial regression, 11 patients (39.3%) obtained a disease stabilization and 15 patients (53.7%) progressed. Treatment was well tolerated, with grade III and IV toxicities consisting of leukopenia in six patients (21.4%), thrombocytopenia in one patient (3.5%), and mucositis in one patient (3.5%). Median time to progression and overall survival in the patient population were 5.3 (range: 1-43) and 9.8 months (range: 3-73) respectively. Gemcitabine plus metronomic fluoropyrimidines is a well-tolerated and moderately active regimen in heavily pretreated ACC patients. Endocrine-Related Cancer (2010) 17 445-453