Shah Rajiv, Klotz Laura V, Chung Inn, Feißt Manuel, Schneider Marc A, Riedel Johanna, Bischoff Helge, Eichhorn Martin E, Thomas Michael
Department of Thoracic Oncology/Internal Medicine, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany; Translational Lung Research Center Heidelberg, German Center for Lung Research, Heidelberg, Germany.
Translational Lung Research Center Heidelberg, German Center for Lung Research, Heidelberg, Germany; Department of Thoracic Surgery, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany.
Clin Lung Cancer. 2021 Mar;22(2):142-146. doi: 10.1016/j.cllc.2020.10.005. Epub 2020 Oct 14.
In selected patients with early-stage malignant pleural mesothelioma (MPM), a multimodal therapy that includes surgical cytoreduction, chemotherapy, and/or radiotherapy is recommended. Several clinical trials have demonstrated the beneficial effects of immune checkpoint inhibitors in pretreated MPM patients with advanced disease. Recent clinical data have suggested that the combination of chemotherapy and checkpoint inhibition might improve efficacy.
The NICITA (nivolumab with chemotherapy in pleural mesothelioma after surgery) trial is a prospective, 1:1 randomized, open-label, multicenter phase II clinical trial (ClinicalTrials.gov identifier, NCT04177953). Ninety-two patients with MPM epithelioid subtype, who had undergone extended pleurectomy and decortication with or without hyperthermic intrathoracic chemoperfusion, will be included to receive adjuvant treatment. All patients will receive ≤ 4 cycles of platinum-based chemotherapy with pemetrexed (arms A and B). Patients in arm B will additionally receive nivolumab, together with the adjuvant chemotherapy, and subsequently for ≤ 12 cycles as maintenance therapy. The primary endpoint of this study is the time-to-next-treatment. The secondary endpoints include progression-free survival, overall survival, proportion of patients with treatment beyond progression, duration of treatment beyond progression in this population, and quality of life.
This prospective trial will contribute data to assess the efficacy of standard chemotherapy combined with nivolumab in the context of multimodal management of early-stage MPM. The study is currently enrolling patients.
对于部分早期恶性胸膜间皮瘤（MPM）患者，推荐采用包括手术细胞减灭术、化疗和/或放疗的多模式治疗。多项临床试验已证明免疫检查点抑制剂对晚期经治MPM患者具有有益效果。近期临床数据表明，化疗与检查点抑制联合使用可能会提高疗效。
NICITA（手术后胸膜间皮瘤使用纳武单抗联合化疗）试验是一项前瞻性、1:1随机、开放标签、多中心II期临床试验（ClinicalTrials.gov标识符，NCT04177953）。将纳入92例MPM上皮样亚型患者，这些患者已接受扩大胸膜切除术和去皮质术，无论是否进行热胸内化疗灌注，均接受辅助治疗。所有患者将接受≤4周期含培美曲塞的铂类化疗（A组和B组）。B组患者将在辅助化疗的基础上额外接受纳武单抗治疗，随后作为维持治疗接受≤12周期治疗。本研究的主要终点是下次治疗时间。次要终点包括无进展生存期、总生存期、疾病进展后接受治疗的患者比例、该人群疾病进展后治疗持续时间以及生活质量。
这项前瞻性试验将提供数据，以评估在早期MPM多模式管理背景下标准化疗联合纳武单抗的疗效。该研究目前正在招募患者。
