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75 岁及以上的老年黑色素瘤患者对抗 PD-1 治疗仍有反应:一项回顾性单机构队列研究的结果。

Older melanoma patients aged 75 and above retain responsiveness to anti-PD1 therapy: results of a retrospective single-institution cohort study.

机构信息

Department of Medical Oncology, Gustave Roussy Institut, 114 Rue Edouard Vaillant, 94800, Villejuif, France.

Dermatology Department, Gustave Roussy Institut, Villejuif, France.

出版信息

Cancer Immunol Immunother. 2018 Oct;67(10):1571-1578. doi: 10.1007/s00262-018-2219-8. Epub 2018 Jul 28.

Abstract

INTRODUCTION

The utility of immunotherapy in elderly melanoma patients is debated. We aimed in this study to evaluate the efficacy and tolerability of immunotherapy among elderly patients.

METHOD

This is a retrospective single-institution cohort study. Patients aged 75 years and above who had been treated with nivolumab, pembrolizumab or ipilimumab for advanced or metastatic melanoma, were included. Patients and disease characteristics were collected using electronic medical records. Objective response was determined according to the immune-related response criteria. Drug-related toxicities (DRT) were graded according to the CTCAE v4.03.

RESULTS

99 patients were included with a mean age of 80 years (SD = 4). One patient received nivolumab and ipilimumab combination, but died because of drug-related diverticulitis. Median PFS on pembrolizumab, nivolumab or ipilimumab were equal to 11.9 (95% CI 5.4-18.4), 1.4 (95% CI 0.01-2.8), and 2.8 months (95% CI 2.6-3), respectively, while objective response rates were equal to 51.6, 12.5, and 17.3%, respectively. Median OS was not reached in patients who received only pembrolizumab, 8.7 months in the ipilimumab only group, and 23 months in patients receiving several immune therapies sequentially. Pembrolizumab, nivolumab, and ipilimumab grade 3-4 DRT rates were equal to 24.2, 62.5, and 32.7% respectively, while discontinuation rates were equal to 43.5, 62.5, and 28.8%, respectively.

CONCLUSIONS

Our study suggests that immunotherapy is effective and well tolerated in the elderly. The PFS on pembrolizumab was greater than expected, a finding that needs to be investigated further.

摘要

简介

免疫疗法在老年黑色素瘤患者中的应用仍存在争议。本研究旨在评估免疫疗法在老年患者中的疗效和耐受性。

方法

这是一项回顾性单中心队列研究。纳入年龄 75 岁及以上、接受纳武利尤单抗、帕博丽珠单抗或伊匹单抗治疗晚期或转移性黑色素瘤的患者。使用电子病历收集患者和疾病特征。根据免疫相关反应标准确定客观缓解。根据 CTCAE v4.03 分级药物相关毒性(DRT)。

结果

共纳入 99 例患者,平均年龄 80 岁(SD=4)。1 例患者接受纳武利尤单抗和伊匹单抗联合治疗,但因药物相关憩室炎死亡。帕博丽珠单抗、纳武利尤单抗或伊匹单抗的中位 PFS 分别为 11.9(95%CI 5.4-18.4)、1.4(95%CI 0.01-2.8)和 2.8 个月(95%CI 2.6-3),客观缓解率分别为 51.6%、12.5%和 17.3%。仅接受帕博丽珠单抗治疗的患者中位 OS 未达到,仅接受伊匹单抗治疗的患者中位 OS 为 8.7 个月,序贯接受多种免疫治疗的患者中位 OS 为 23 个月。帕博丽珠单抗、纳武利尤单抗和伊匹单抗 3-4 级 DRT 发生率分别为 24.2%、62.5%和 32.7%,停药率分别为 43.5%、62.5%和 28.8%。

结论

本研究表明免疫疗法在老年患者中有效且耐受良好。帕博丽珠单抗的 PFS 大于预期,这一发现需要进一步研究。

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