Vinblastine and Interferon-Gamma Combination with and without 13-Cis Retinoic Acid for Patients with Advanced Renal Cell Carcinoma

Vinblastine and Interferon-Gamma Combination with and without 13-Cis Retinoic Acid for Patients with Advanced Renal Cell Carcinoma
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长春花碱和干扰素-γ 组合(含或不含 13-顺式视黄酸)治疗晚期肾细胞癌患者

DOI:
10.1159/000063806
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发表时间:
2002
期刊:
影响因子:
3.5
通讯作者:
o on behalf of the Hellenic Cooperative Oncology Gro
o on behalf of the Hellenic Cooperative Oncology Gro
中科院分区:
医学3区
文献类型:
--
作者:
C. Bacoyiannis;M. Dimopoulos;H. Kalofonos;C. Nicolaides;G. Aravantinos;D. Bafaloukos;G. Samelis;A. Onyenadum;C. Kiamouris;D. Skarlos;N. Pavlidis;A. Triantafillidis;P. Kosmidis;o on behalf of the Hellenic Cooperative Oncology Gro

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背景资料:本研究旨在观察长春碱(VBL)联合干扰素-γ(IFN-γ)治疗晚期肾细胞癌(RCC)的疗效和毒副反应,并评价13-顺式维甲酸(13-cis retinoic acid,13-CRA)对RCC的增效作用。方法:29例患者被纳入第一试验(试验1),40例患者被纳入第二试验(试验2)。试验1中给予的治疗包括VBL 0.15 mg/kg i. v.每2周一次和IFN-γ 100 µg s.c.每周3次。在试验2中,治疗包括相同剂量的相同两种药物,加上口服13-CRA 40 mg/天。结果如下:在试验1中,3例(10.3%)患者完全缓解,3例(10.3%)患者部分缓解,8例(27.6%)患者疾病稳定,15例(51.7%)患者疾病进展。在试验2中,无完全缓解,但3例(7.5%)患者部分缓解。此外,15例(37.5%)患者病情稳定,14例(35%)患者病情进展。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),中位至进展时间为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),中位至进展时间为3. 9个月(95% CI,0. 8 -7,范围0. 26 - 24. 1)。在试验1中,5例(17.2%)患者出现3级和4级粒细胞减少症,1例(3.4%)患者出现3级贫血。在试验2中,有3级毒性,5例(12.5%)患者发生粒细胞减少症,4例(10.0%)患者发生贫血,3例(7.5%)患者发生口腔炎,3例(7.5%)患者发生疲乏/不适,1例(2.5%)患者发生腹泻。两项研究均未发生中毒性死亡。结论:IFN-γ的使用并不增加VBL为基础的化疗的低应答。另外给予13-CRA与VBL和IFN-γ的组合不会增加该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患有这种疾病的患者。
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-γ) 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-γ 100 µg 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-γ does not enhance the low response of VBL-based chemotherapy. The additional administration of 13-CRA with the combination of VBL and IFN-γ 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.
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DOI: --
发表时间: 1981
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通讯作者: A. Hoffman;D. Engelstein;T. Bogenrieder;C. Papandreou;E. Steckelman;A. Dave;R. Motzer;E. Dmitrovsky;A. Albino;D. Nanus
DOI: 10.1200/jco.2000.18.16.2972
发表时间: 2000-08-01
影响因子: 45.3
作者:
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通讯作者: Mazumdar, M
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DOI: --
发表时间: 1981
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