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首页> 外文期刊>Oncology: International Journal of Cancer Research and Treatment >Vinblastine and interferon-gamma combination with and without 13-cis retinoic acid for patients with advanced renal cell carcinoma. Results of two phase II clinical trials.
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Vinblastine and interferon-gamma combination with and without 13-cis retinoic acid for patients with advanced renal cell carcinoma. Results of two phase II clinical trials.

机译：长春碱和干扰素-γ联合或不联合13-顺式视黄酸治疗晚期肾细胞癌的患者。两项II期临床试验的结果。

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BACKGROUND: The aim of this study is firstly to determine the response rates and toxicity of two regimens containing vinblastine (VBL) in combination with interferon-gamma (IFN-gamma) in the treatment of patients with advanced renal cell carcinoma (RCC), and secondly to evaluate the additional efficacy of 13-cis retinoic acid (13-CRA) in RCC. METHODS: Twenty-nine patients were included in the first trial (Trial 1) and 40 in the second one (Trial 2). The therapy given in Trial 1 consisted of VBL 0.15 mg/kg i.v. every 2 weeks and IFN-gamma 100 microg s.c. 3 times weekly. In Trial 2, the therapy consisted of the same two drugs, in the same doses, plus oral 13-CRA 40 mg/day. RESULTS: In Trial 1 there were 3 (10.3%) patients with complete response, 3 (10.3%) patients with partial response, 8 (27.6%) patients with stable disease and 15 (51.7%) patients with progressive disease. In Trial 2, there was no complete response, however, 3 (7.5%) patients had partial response. Additionally, 15 (37.5%) patients maintained stable disease and 14 (35%) patients had progressive disease. In Trial 1, the median survival was 12.56 months (95% CI, 6.8-18.3, range 0.59-42.49) and the median time to progression was 3.21 months (95% CI, 1.7-4.7, range 0.03-42.49). In Trial 2, the median survival was 9.54 months (95% CI, 5.9-13.1, range 0.43-24.1) and the median time to progression was 3.9 months (95% CI, 0.8-7, range 0.26-24.1). In Trial 1, granulocytopenia grade 3 and 4 appeared in 5 (17.2%) patients and anaemia grade 3 in 1 (3.4%) patient. In Trial 2, there were grade 3 toxicities, as granulocytopenia in 5 (12.5%) patients, anemia in 4 (10.0%) patients, stomatitis in 3 (7.5%) patients, fatigue/malaise in 3 (7.5%) patients and 1 (2.5%) had diarrhea. No toxic deaths occurred in both studies. CONCLUSION: The use of IFN-gamma does not enhance the low response of VBL-based chemotherapy. The additional administration of 13-CRA with the combination of VBL and IFN-gamma does not add to the efficacy of this combination in patients with advanced renal cell carcinoma. New active agents are needed to treat patients with this disease.
机译：背景：这项研究的目的首先是确定两种含有长春碱（VBL）和干扰素-γ（IFN-γ）联合治疗晚期肾细胞癌（RCC）的反应率和毒性，以及其次，评估13-顺式视黄酸（13-CRA）在RCC中的附加疗效。方法：29名患者参加了第一项试验（试验1），第二名试验中包括了40名患者（试验2）。试验1中的治疗方法为静脉内注射VBL 0.15 mg / kg。每2周和IFN-γ100微克s.c.每周3次。在试验2中，该疗法由相同的两种药物组成，剂量相同，外加口服13-CRA 40毫克/天。结果：在试验1中，有3例（10.3％）完全缓解患者，3例（10.3％）部分缓解患者，8例（27.6％）稳定患者和15例（51.7％）进行性疾病。在试验2中，没有完全缓解，但是有3名（7.5％）患者有部分缓解。另外，有15名（37.5％）的患者保持疾病稳定，而14名（35％）的患者患有疾病。在试验1中，中位生存期为12.56个月（95％CI，6.8-18.3，范围0.59-42.49），平均进展时间为3.21个月（95％CI，1.7-4.7，范围0.03-42.49）。在试验2中，中位生存期为9.54个月（95％CI，5.9-13.1，范围0.43-24.1），中位进展时间为3.9个月（95％CI，0.8-7，范围0.26-24.1）。在试验1中，有5名（17.2％）患者出现了3级和4级粒细胞减少症，而1名（3.4％）患者出现了3级贫血。在试验2中，有3级毒性，如5（12.5％）患者的粒细胞减少，4（10.0％）患者的贫血，3（7.5％）患者的口腔炎，3（7.5％）患者和1的疲劳/不适（2.5％）腹泻。两项研究均未发生中毒死亡。结论：IFN-γ的使用不能增强基于VBL的化学疗法的低应答性。将13-CRA与VBL和IFN-γ组合使用时，不会增加这种组合在晚期肾细胞癌患者中的疗效。需要新的活性剂来治疗这种疾病的患者。

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