Manon De Vries-Brilland, Zineb Hamilou, Sunita Ghosh, Daniel Y C Heng, Lori A Wood, Naveen S Basappa, Christian K Kollmannsberger, Jeffrey Graham, Bimal Bhindi, Antonio Finelli, Georg A Bjarnason, Dominick Bosse, Frederic Pouliot, Vincent Castonguay, Rodney H Breau, Ramy R Saleh, Eric Winquist, Aly-Khan A Lalani, Denis Soulières
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The specific value of IO for metastatic pRCC (mpRCC) remains unquantified.</p><p><strong>Methods: </strong>We analyzed prospectively collected data from the Canadian Kidney Cancer Information System to assess the efficacy of 1L systemic therapy in mpRCC with IO-based regimens vs tyrosine kinase inhibitors (TKI). The primary endpoint was time-to-treatment failure (TTF). Secondary endpoints included overall survival (OS), objective response rate (ORR), and treatment-related adverse events (TRAEs). Analyses were adjusted (adj) for IMDC risk groups.</p><p><strong>Results: </strong>From 2011 to 2024, 197 mpRCC patients received 1L therapy: 70 with IO (alone or in combination) and 127 with TKI. Median follow-up was 21.6 months. Median TTF was 9.9 months with IO vs 5.9 months with TKI (adjHR: 0.62 [0.43-0.91], P = .01). Median OS was 36.9 months with IO vs 23.2 months with TKI (adjHR: 0.54 [0.3-0.9], P = .018). Objective response rate was 37% with IO vs 23% with TKI (adjOR: 2.2 [0.95-5.2], P = .07). The TKI-IO subgroup showed the longest TTF (16.9 months, adjHR: 0.47 [0.26-0.85], P = .01) and OS (not reached, adjHR: 0.26 [0.08-0.83], P = .02), compared to TKI. Grade 3-5 TRAEs occurred in 31% (IO) vs 27% (TKI).</p><p><strong>Conclusions: </strong>This real-world study highlights the benefit of IO-based treatment in mpRCC, particularly in the TKI-IO subgroup. 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Phase 2 trials have evaluated first-line (1L) immunotherapy (IO)-based treatment in nccRCC, but with heterogeneous cohorts and limited comparative data. The specific value of IO for metastatic pRCC (mpRCC) remains unquantified.</p><p><strong>Methods: </strong>We analyzed prospectively collected data from the Canadian Kidney Cancer Information System to assess the efficacy of 1L systemic therapy in mpRCC with IO-based regimens vs tyrosine kinase inhibitors (TKI). The primary endpoint was time-to-treatment failure (TTF). Secondary endpoints included overall survival (OS), objective response rate (ORR), and treatment-related adverse events (TRAEs). Analyses were adjusted (adj) for IMDC risk groups.</p><p><strong>Results: </strong>From 2011 to 2024, 197 mpRCC patients received 1L therapy: 70 with IO (alone or in combination) and 127 with TKI. Median follow-up was 21.6 months. Median TTF was 9.9 months with IO vs 5.9 months with TKI (adjHR: 0.62 [0.43-0.91], P = .01). Median OS was 36.9 months with IO vs 23.2 months with TKI (adjHR: 0.54 [0.3-0.9], P = .018). Objective response rate was 37% with IO vs 23% with TKI (adjOR: 2.2 [0.95-5.2], P = .07). The TKI-IO subgroup showed the longest TTF (16.9 months, adjHR: 0.47 [0.26-0.85], P = .01) and OS (not reached, adjHR: 0.26 [0.08-0.83], P = .02), compared to TKI. Grade 3-5 TRAEs occurred in 31% (IO) vs 27% (TKI).</p><p><strong>Conclusions: </strong>This real-world study highlights the benefit of IO-based treatment in mpRCC, particularly in the TKI-IO subgroup. 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引用次数: 0
摘要
背景：乳头状肾细胞癌（pRCC）是最常见的非透明细胞肾细胞癌（nccRCC），占肾细胞癌病例的15%。ii期试验评估了一线（1l）免疫疗法（IO）在nccRCC中的治疗效果，但采用的是异质队列和有限的比较数据。IO对转移性pRCC （mpRCC）的特异性值仍未量化。方法：我们前瞻性地分析了从加拿大肾癌信息系统（CKCis）收集的数据，以评估1l全身治疗mpRCC与基于碘的方案与酪氨酸激酶抑制剂（TKI）的疗效。主要终点是治疗失败时间（TTF）。次要终点包括总生存期（OS）、客观缓解率（ORR）和治疗相关不良事件（TRAEs）。对IMDC风险组的分析进行调整（adj）。结果：从2011年到2024年，197例mpRCC患者接受了1 L治疗：70例单独或联合使用IO， 127例使用TKI。中位随访时间为21.6个月。IO组的中位TTF为9.9个月，TKI组为5.9个月（adjHR: 0.62 [0.43-0.91] p = 0.01）。IO组的中位OS为36.9个月，TKI组为23.2个月（adjHR: 0.54 [0.3-0.9], p = 0.018）。IO组的ORR为37%，TKI组为23% （adjOR: 2.2 [0.95-5.2] p = 0.07）。TKI- io亚组TTF（16.9个月，adjHR: 0.47 [0.26-0.85], p = 0.01）和OS（未达到，adjHR: 0.26 [0.08-0.83], p = 0.02）较TKI最长。3-5级TRAEs发生率为31% (IO) vs. 27% （TKI）。结论：这项现实世界的研究强调了基于io治疗mpRCC的益处，特别是在TKI-IO亚组中。我们的发现可能为进一步评估mpRCC中1l IO的试验提供信息。
Real-world assessment of clinical outcomes of first-line treatment in metastatic papillary renal cell carcinoma.
Background: Papillary renal cell carcinoma (pRCC) is the most common non-clear cell RCC (nccRCC), representing up to 15% of RCC cases. Phase 2 trials have evaluated first-line (1L) immunotherapy (IO)-based treatment in nccRCC, but with heterogeneous cohorts and limited comparative data. The specific value of IO for metastatic pRCC (mpRCC) remains unquantified.
Methods: We analyzed prospectively collected data from the Canadian Kidney Cancer Information System to assess the efficacy of 1L systemic therapy in mpRCC with IO-based regimens vs tyrosine kinase inhibitors (TKI). The primary endpoint was time-to-treatment failure (TTF). Secondary endpoints included overall survival (OS), objective response rate (ORR), and treatment-related adverse events (TRAEs). Analyses were adjusted (adj) for IMDC risk groups.
Results: From 2011 to 2024, 197 mpRCC patients received 1L therapy: 70 with IO (alone or in combination) and 127 with TKI. Median follow-up was 21.6 months. Median TTF was 9.9 months with IO vs 5.9 months with TKI (adjHR: 0.62 [0.43-0.91], P = .01). Median OS was 36.9 months with IO vs 23.2 months with TKI (adjHR: 0.54 [0.3-0.9], P = .018). Objective response rate was 37% with IO vs 23% with TKI (adjOR: 2.2 [0.95-5.2], P = .07). The TKI-IO subgroup showed the longest TTF (16.9 months, adjHR: 0.47 [0.26-0.85], P = .01) and OS (not reached, adjHR: 0.26 [0.08-0.83], P = .02), compared to TKI. Grade 3-5 TRAEs occurred in 31% (IO) vs 27% (TKI).
Conclusions: This real-world study highlights the benefit of IO-based treatment in mpRCC, particularly in the TKI-IO subgroup. Our findings may inform further trials evaluating 1L IO in mpRCC.
期刊介绍：
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