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Multicenter prospective phase II trial of nivolumab in patients with unresectable or metastatic mucosal melanoma.
International Journal of Clinical Oncology ( IF 2.4 ) Pub Date : 2020-01-14 , DOI: 10.1007/s10147-020-01618-9
Motoo Nomura 1 , Isao Oze 2 , Toshiki Masuishi 3 , Tomoya Yokota 4 , Hironaga Satake 5 , Shunichiro Iwasawa 6 , Ken Kato 7 , Masashi Andoh 3
Affiliation  

BACKGROUND Mucosal melanoma is a rare and aggressive malignancy with poorer response compared with cutaneous melanoma. Prospective trials of immune checkpoint inhibitors in unresectable or metastatic mucosal melanoma have not been reported. PURPOSE This phase II trial assessed the efficacy and safety of nivolumab monotherapy for unresectable or metastatic mucosal melanoma. PATIENTS AND METHODS Eligibility criteria were as follows: histological diagnosis of unresectable or metastatic mucosal melanoma; age ≥ 20 years; ECOG performance status 0 or 1; and with measurable lesions. Patients received nivolumab 2 mg/kg every 3 weeks. The primary endpoint was the response rate (RR) according to Response Evaluation Criteria in Solid Tumors version 1.1. The secondary endpoints were overall survival, progression-free survival, disease control rate, and toxicity. RESULTS Twenty patients were enrolled between December 2014 and July 2017. Two patients without measurable lesions and one patient with uveal melanoma were excluded from analysis of efficacy. The best overall RR was 23.5%. One patient achieved a complete response, three partial response, and five stable disease as their best response. The median progression-free survival was 1.4 months (95% CI 1.2-2.8). The median overall survival was 12.0 months (95% CI 3.5 to not reached). The 1-year overall survival was 50.0% (95% CI 25.9-70.0%). Treatment-related adverse events of grades 3 or 4 occurred in 15% (3/20) of the patients. Grade 3 adverse events were resolved by corticosteroid treatment. CONCLUSION Although this trial met the primary endpoint, the RR was still unsatisfactory. Therefore, further treatment development is required.

中文翻译:

不可切除或转移性粘膜黑色素瘤患者接受nivolumab的多中心前瞻性II期临床试验。

背景技术与皮肤黑素瘤相比,粘膜黑素瘤是一种罕见的侵袭性恶性肿瘤,其反应较差。尚未报道在不可切除或转移性粘膜黑色素瘤中使用免疫检查点抑制剂的前瞻性试验。目的这项II期临床试验评估了nivolumab单药治疗不可切除或转移性粘膜黑色素瘤的疗效和安全性。患者和方法入选标准如下:不可切除或转移性粘膜黑色素瘤的组织学诊断;年龄≥20岁;ECOG性能状态0或1;并有可测量的病变。患者每3周接受2 mg / kg的nivolumab治疗。主要终点是根据1.1版实体瘤中的反应评估标准得出的反应率(RR)。次要终点为总体生存期,无进展生存期,疾病控制率,和毒性。结果2014年12月至2017年7月期间招募了20例患者。2例无可测量病变的患者和1例葡萄膜黑色素瘤患者被排除在疗效分析之外。最佳总体RR为23.5%。一名患者获得了完全缓解,三种局部缓解和五种稳定疾病作为最佳缓解。中位无进展生存期为1.4个月(95%CI 1.2-2.8)。中位总生存期为12.0个月(未达到95%CI 3.5)。1年总生存率为50.0%(95%CI 25.9-70.0%)。15%(3/20)的患者发生3或4级与治疗相关的不良事件。通过皮质类固醇激素治疗可解决3级不良事件。结论尽管该试验达到了主要终点,但RR仍不令人满意。因此,需要进一步的治疗方法。结果2014年12月至2017年7月期间招募了20例患者。疗效分析中排除了2例无可测量病变的患者和1例葡萄膜黑色素瘤患者。最佳总体RR为23.5%。一名患者获得了完全缓解,三种局部缓解和五种稳定疾病作为最佳缓解。中位无进展生存期为1.4个月(95%CI 1.2-2.8)。中位总生存期为12.0个月(未达到95%CI 3.5)。1年总生存率为50.0%(95%CI 25.9-70.0%)。15%(3/20)的患者发生3或4级与治疗相关的不良事件。通过皮质类固醇激素治疗可解决3级不良事件。结论尽管该试验达到了主要终点,但RR仍不令人满意。因此,需要进一步的治疗方法。结果2014年12月至2017年7月期间招募了20例患者。2例无可测量病变的患者和1例葡萄膜黑色素瘤患者被排除在疗效分析之外。最佳总体RR为23.5%。一名患者获得了完全缓解,三种局部缓解和五种稳定疾病作为最佳缓解。中位无进展生存期为1.4个月(95%CI 1.2-2.8)。中位总生存期为12.0个月(未达到95%CI 3.5)。1年总生存率为50.0%(95%CI 25.9-70.0%)。15%(3/20)的患者发生3或4级与治疗相关的不良事件。通过皮质类固醇激素治疗可解决3级不良事件。结论尽管该试验达到了主要终点,但RR仍不令人满意。因此,需要进一步的治疗方法。
更新日期:2020-01-14
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