Ladwa Rahul, Atkinson Victoria
aDepartment of Medical Oncology, Princess Alexandra Hospital bDepartment of Medical Oncology, Greenslopes Private Hospital cSchool of Medicine, University of Queensland, Brisbane, Queensland, Australia.
Melanoma Res. 2017 Apr;27(2):168-170. doi: 10.1097/CMR.0000000000000336.
The optimal duration of PD-1 antibodies for metastatic melanoma is unknown. In previous trials, there has been the potential to cease therapy if the patient achieves a complete response (CR). We aimed to assess the outcomes of patients who had ceased anti-PD-1 antibodies in this setting. A retrospective review was carried out of CR to PD-1-based therapy across two institutions. Patients were from the Pembrolizumab Named Patient Program (PEM NPP), Nivolumab monotherapy (NIVO), and reimbursed Pembrolizumab (r PEM). Patients had to have experienced a CR to PD-1-based therapy and ceased therapy because of this. Disease recurrence was the primary outcome measured. Twenty-nine patients (PEM NPP, N=20; Nivo, N=3; r PEM, N=6) ceased anti-PD-1 therapy after CR for observation. The median age was 64 (27-83) years. All patients had treatment discontinued for observation. The median time to CR was 10.5 months in the PEM NPP, 7.5 months on r PEM groups, and 17 months in the NIVO group. The median time off therapy in PEM NPP was 10 months, NIVO was 9 months, and r PEM was 4.5 months. To date, three patients have shown a relapse at a median follow-up off treatment of 8 months. This is the first report of patients who have intentionally ceased PD-1-based therapy because of CR. With a follow-up of 8 months off treatment, the risk of relapse was low. Data such as these are clinically relevant as we need to be able to discuss cessation of therapy and relevant from a pharmacoeconomic perspective, given the cost of PD-1 antibodies to society.
PD - 1抗体用于转移性黑色素瘤的最佳疗程尚不清楚。在以往的试验中，如果患者达到完全缓解（CR），就有可能停止治疗。我们旨在评估在这种情况下停止使用抗PD - 1抗体的患者的预后。对两家机构接受基于PD - 1治疗达到CR的患者进行了回顾性研究。患者来自帕博利珠单抗指定患者项目（PEM NPP）、纳武利尤单抗单药治疗（NIVO）和报销的帕博利珠单抗（r PEM）。患者必须经历基于PD - 1治疗的CR并因此停止治疗。疾病复发是主要测量结果。29例患者（PEM NPP，n = 20；Nivo，n = 3；r PEM，n = 6）在CR后停止抗PD - 1治疗以进行观察。中位年龄为64（27 - 83）岁。所有患者均停止治疗以进行观察。PEM NPP组达到CR的中位时间为10.5个月，r PEM组为7.5个月，NIVO组为17个月。PEM NPP组停止治疗的中位时间为10个月，NIVO组为9个月，r PEM组为4.5个月。迄今为止，3例患者在停止治疗后的中位随访8个月时出现复发。这是关于因CR而有意停止基于PD - 1治疗的患者的首次报告。在停止治疗8个月的随访中，复发风险较低。鉴于PD - 1抗体对社会的成本，此类数据在临床上具有相关性，因为我们需要能够讨论治疗的停止，并且从药物经济学角度来看也是相关的。
