Introduction & Objectives: pRCC is the most frequent histological subtype of non-clear cell RCC, that, due to its rarity, is often excluded from phase III trials, thus treatment options remain limited. We performed a multicenter retrospective real-world study to investigate the efficacy of first-line treatments in patients with pRCC treated in 40 Centers from 12 countries included in the ARON-1 study (NCT05287464). Materials & Methods: We retrospectively collected data from pts with metastatic pRCC treated with first-line ICI-based combinations (IBC) or TKI. The primary objective was to assess clinical outcomes (overall survival - OS, progression-free survival - PFS, overall response rate - ORR). Results: We included 200 pts with pRCC, 36% (n=73) treated with IBC and 64% (n=127) with TKIs. Median follow-up was 22.9 months (mo). In the overall population, median OS m(OS) and median PFS (mPFS) were 24.8 and 8.7 mo, respectively. mOS was 22.5 mo in the TKI group and 28.8 mo in the IBC one (p=0.081). 1y- (85% vs 73%, p=0.038) and 2years-OS rates (63% vs 47%, p=0.023) were higher for IBC. mPFS was 6.4 mo in the TKI group and 17.4 mo in the IBC one (p<0.001) (Figure 1). ORR was significantly higher for IBC (41% vs 27%, p=0.037). We stratified pts according to type of combination, showing that pembrolizumab plus lenvatinib (P+L) was associated with the highest ORR (75%). mOS was 24.8 mo for pembrolizumab plus axitinib (P+A), 28.8 mo for nivolumab plus ipilimumab (N+I), 11.2 mo for nivolumab plus cabozantinib (N+C) and 36.5 mo for P+L. No statistically significant differences were found in mOS (p=0.655) in pts treated with ICI+TKI (24.8 mo) or ICI+ICI (28.8 mo). mPFS was 17.4, 19.7, 6.9 mo and NR in pts receiving P+A, N+I, N+C or P+L, respectively. In the overall population, bone or liver metastases (mts) were correlated with OS and PFS at multivariate analyses (bone mts: OS p<0.001, PFS 0.040; liver mts: OS 0.005, PFS 0.001). IBCs were significantly associated with longer PFS at multivariate analysis (p<0.001). Conclusions: Our study shows that IBC are superior in term of efficacy outcomes (mPFS, ORR, 1y- and 2y- OS rates) compared to TKIs as first-line treatment of metastatic pRCC.
Papillary Renal Cell Carcinoma (pRCC): Outcomes of patients receiving first-line immune-based combinations or Tyrosine Kinase Inhibitors (TKIs) from the ARON-1 study / Mollica, V.; Massari, F.; Fiala, O.; Kucharz, J.; Molina-Cerrillo, J.; Seront, E.; Bourlon, M. T.; Pichler, R.; Myint, Z. W.; Kanesvaran, R.; Marchetti, A.; Rosellini, M.; Rescigno, P.; de Liano, A. G.; Zakopoulou, R.; Buti, S.; Porta, C.; Grande, E.; Santoni, M.. - In: EUROPEAN UROLOGY. - ISSN 0302-2838. - 85:S1(2024), pp. A0839.S1861-A0839.S1862. [10.1016/s0302-2838(24)01410-6]
Papillary Renal Cell Carcinoma (pRCC): Outcomes of patients receiving first-line immune-based combinations or Tyrosine Kinase Inhibitors (TKIs) from the ARON-1 study
Buti, S.Investigation
;
2024-01-01
Abstract
Introduction & Objectives: pRCC is the most frequent histological subtype of non-clear cell RCC, that, due to its rarity, is often excluded from phase III trials, thus treatment options remain limited. We performed a multicenter retrospective real-world study to investigate the efficacy of first-line treatments in patients with pRCC treated in 40 Centers from 12 countries included in the ARON-1 study (NCT05287464). Materials & Methods: We retrospectively collected data from pts with metastatic pRCC treated with first-line ICI-based combinations (IBC) or TKI. The primary objective was to assess clinical outcomes (overall survival - OS, progression-free survival - PFS, overall response rate - ORR). Results: We included 200 pts with pRCC, 36% (n=73) treated with IBC and 64% (n=127) with TKIs. Median follow-up was 22.9 months (mo). In the overall population, median OS m(OS) and median PFS (mPFS) were 24.8 and 8.7 mo, respectively. mOS was 22.5 mo in the TKI group and 28.8 mo in the IBC one (p=0.081). 1y- (85% vs 73%, p=0.038) and 2years-OS rates (63% vs 47%, p=0.023) were higher for IBC. mPFS was 6.4 mo in the TKI group and 17.4 mo in the IBC one (p<0.001) (Figure 1). ORR was significantly higher for IBC (41% vs 27%, p=0.037). We stratified pts according to type of combination, showing that pembrolizumab plus lenvatinib (P+L) was associated with the highest ORR (75%). mOS was 24.8 mo for pembrolizumab plus axitinib (P+A), 28.8 mo for nivolumab plus ipilimumab (N+I), 11.2 mo for nivolumab plus cabozantinib (N+C) and 36.5 mo for P+L. No statistically significant differences were found in mOS (p=0.655) in pts treated with ICI+TKI (24.8 mo) or ICI+ICI (28.8 mo). mPFS was 17.4, 19.7, 6.9 mo and NR in pts receiving P+A, N+I, N+C or P+L, respectively. In the overall population, bone or liver metastases (mts) were correlated with OS and PFS at multivariate analyses (bone mts: OS p<0.001, PFS 0.040; liver mts: OS 0.005, PFS 0.001). IBCs were significantly associated with longer PFS at multivariate analysis (p<0.001). Conclusions: Our study shows that IBC are superior in term of efficacy outcomes (mPFS, ORR, 1y- and 2y- OS rates) compared to TKIs as first-line treatment of metastatic pRCC.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
