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首页> 外文期刊>Journal of Clinical Oncology >Southwest oncology group S0008: A Phase III trial of high-dose interferon alfa-2b versus cisplatin, vinblastine, and dacarbazine, plus interleukin-2 and interferon in patients with high-risk melanoma-an intergroup study of cancer and leukemia group B, children's oncology group, eastern cooperative oncology group, and southwest oncology group
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Southwest oncology group S0008: A Phase III trial of high-dose interferon alfa-2b versus cisplatin, vinblastine, and dacarbazine, plus interleukin-2 and interferon in patients with high-risk melanoma-an intergroup study of cancer and leukemia group B, children's oncology group, eastern cooperative oncology group, and southwest oncology group

机译：西南肿瘤学小组S0008：高剂量黑色素瘤患者中高剂量干扰素alfa-2b与顺铂，长春碱和达卡巴嗪联合白细胞介素2和干扰素的III期试验-癌症和白血病B组的儿童间研究肿瘤学组，东部合作肿瘤学组和西南肿瘤学组

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Results In all, 432 patients were enrolled. Grade 3 and 4 adverse events occurred in 57% and 7% of HDI patients and 36% and 40% of biochemotherapy patients, respectively. At a median follow-up of 7.2 years, biochemotherapy improved RFS (hazard ratio [HR], 0.75; 95% CI, 0.58 to 0.97; P = .015), with a median RFS of 4.0 years (95% CI, 1.9 years to not reached [NR]) versus 1.9 years for HDI (95% CI, 1.2 to 2.8 years) and a 5-year RFS of 48% versus 39%. Median OS was not different (HR, 0.98; 95% CI, 0.74 to 1.31; P = .55), with a median OS of 9.9 years (95% CI, 4.62 years to NR) for biochemotherapy versus 6.7 years (95% CI, 4.5 years to NR) for HDI and a 5-year OS of 56% for both arms.Conclusion Biochemotherapy is a shorter, alternative adjuvant treatment for patients with high-risk melanoma that provides statistically significant improvement in RFS but no difference in OS and more toxicity compared with HDI.Purpose High-dose interferon (IFN) for 1 year (HDI) is the US Food and Drug Administration-approved adjuvant therapy for patients with high-risk melanoma. Efforts to modify IFN dose and schedule have not improved efficacy. We sought to determine whether a shorter course of biochemotherapy would be more effective.Patients and Methods S0008 (S0008: Chemotherapy Plus Biological Therapy in Treating Patients With Melanoma) was an Intergroup phase III trial that enrolled high-risk patients (stage IIIA-N2a through IIIC-N3), randomly assigning them to receive either HDI or biochemotherapy consisting of dacarbazine, cisplatin, vinblastine, interleukin-2, IFN alfa-2b (IFN-α-2b) and granulocyte colony-stimulating factor given every 21 days for three cycles. Coprimary end points were relapse-free survival (RFS) and overall survival (OS).
机译：结果共纳入432例患者。 3级和4级不良事件分别发生在57％和7％的HDI患者以及36％和40％的生物化学疗法患者中。中位随访时间为7.2年，生物化学疗法改善了RFS（危险比[HR]，0.75; 95％CI，0.58至0.97; P = .015），中位RFS为4.0年（95％CI，1.9年）。 HDI为1.9年（95％CI为1.2至2.8年）与5年RFS分别为39％和39％。生物化学疗法的中位操作系统无差异（HR，0.98; 95％CI，0.74至1.31; P = .55），生物化学疗法的中位操作系统为9.9年（95％CI，对NR为4.62年），而中位操作系统为6.7年（95％CI）。 ，对于HDI而言，距NR的4.5年），而对两只手臂的5年OS，其5年OS均为56％。结论生物化学疗法是一种针对高危黑色素瘤患者的较短的替代性辅助治疗，其RFS改善有统计学意义，但OS和用途高剂量干扰素（IFN）治疗1年（HDI）是美国食品药品监督管理局批准的用于高危黑色素瘤患者的辅助治疗方法。修改IFN剂量和方案的努力并未改善疗效。患者和方法S0008（S0008：黑色素瘤患者的化学疗法加生物疗法）是一项III期临床试验，招募了高危患者（IIIA-N2a期至IIIC-N3），随机分配它们接受HDI或生物化学疗法，由达卡巴嗪，顺铂，长春碱，白介素-2，IFNα-2b（IFN-α-2b）和粒细胞集落刺激因子组成，每21天给药，持续三个周期。主要终点为无复发生存期（RFS）和总体生存期（OS）。

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