Cabozantinib in advanced non-clear-cell renal cell carcinoma: a multicentre, retrospective, cohort study

Chanzá, Nieves Martínez; Xie, Wanling; Bilen, Mehmet Asım; Dzimitrowicz, Hannah; Burkart, Jarred; Geynisman, Daniel M.; Balakrishnan, Archana; Bowman, I. Alex; Jain, Rohit; Stadler, Walter M.; Zakharia, Yousef; Narayan, Vivek; Beuselinck, Benoît; McKay, Rana R.; Tripathi, Abhishek; Pachynski, Russell K.; Hahn, Andrew W.; Hsu, Jo Ann; Shah, Sumit; Lam, Elaine T.; Rose, Tracy L.; Mega, Anthony; Vogelzang, Nicholas J.; Harrison, Michael R.; Mortazavi, Amir; Plimack, Elizabeth R.; Vaishampayan, Ulka N.; Hammers, Hans J.; George, Saby; Haas, Naomi B.; Agarwal, Neeraj; Pal, Sumanta K.; Srinivas, Sandy; Carneiro, Benedito A.; Heng, Daniel Y.C.; Bossé, Dominick; Choueiri, Toni K.; Harshman, Lauren C.

doi:10.1016/s1470-2045(18)30907-0

Cited by 138 publications

(96 citation statements)

References 34 publications

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“…Data for more recently approved agents in this space is emerging. Although the results for cabozantinib are retrospective, 28,29 the data are promising. In addition, Keynote 427, 30 a phase 2 trial of single‐agent pembrolizumab in treatment‐naïve nccRCC patients, reported an ORR of 25.4% for pRCC (n = 118), adding to a number of retrospective reports with nivolumab in ncRCC 31‐33 .…”

Section: Discussionmentioning

confidence: 99%

Everolimus plus bevacizumab is an effective first‐line treatment for patients with advanced papillary variant renal cell carcinoma: Final results from a phase II trial

Feldman

Ged

Lee

et al. 2020

Cancer

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Background: We previously reported on a phase 2 study of everolimus plus bevacizumab across various nonclear cell renal cell carcinoma (nccRCC) histologies and observed encouraging activity among patients with papillary RCC (pRCC) and unclassified RCC (uRCC) with a major papillary component. We subsequently expanded the study to enroll additional patients with pRCC variants. Methods: Everolimus plus bevacizumab was administered at standard doses until disease progression or intolerance to therapy. The primary endpoint was the 6-month progression-free survival (PFS) rate; secondary endpoints included objective response rate (ORR), progressionfree survival (PFS), overall survival (OS), and safety. Correlative analyses included next-generation sequencing (NGS) from tumor and germline across >341 genes of interest. Results: In addition to 19 patients with pRCC variants in the original cohort, 20 patients with similar features were enrolled on the expansion cohort (uRCC with papillary features [n = 24], pRCC [n = 14], and translocation-associated RCC with papillary features [n = 1]). Among 37 evaluable patients, the 6-month PFS rate was 78%, the median PFS was 13.7 months (95% CI, 10.8-16.4 months), and the ORR was 35%. With a median follow-up of 17.6 months, the median OS was 33.9 months (95% CI, 23.3-71.9). Tolerance was consistent with prior reports for everolimus plus bevacizumab. NGS results (n = 33) identified responses in patients with a wide spectrum of genomic alterations, including ARID1A, FH, and MET mutations. Conclusion: The expansion cohort results confirm robust activity of everolimus plus bevacizumab in metastatic pRCC variants, supporting this regimen as a standard option for this patient population.

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Section: Discussionmentioning

confidence: 99%

Everolimus plus bevacizumab is an effective first‐line treatment for patients with advanced papillary variant renal cell carcinoma: Final results from a phase II trial

Feldman

Ged

Lee

et al. 2020

Cancer

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“…Since the data cutoff for this analysis was May 15, 2017, more recently approved drugs for mRCC treatment had been documented for only a few (such as for nivolumab) or for none of the patients with pmRCC (such as for cabozantinib). Recent retrospective data suggest that CPI and cabozantinib might be interesting treatment strategies in nccRCC. Further prospective data are warranted, and some clinical trials are ongoing in this field .…”

Section: Discussionmentioning

confidence: 99%

Rare patients in routine care: Treatment and outcome in advanced papillary renal cell carcinoma in the prospective German clinical RCC‐Registry

Staehler

Goebell

Müller³

et al. 2019

Intl Journal of Cancer

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Non‐clear cell renal cell carcinoma is a very rare malignancy that includes several histological subtypes. Each subtype may need to be addressed separately regarding prognosis and treatment; however, no Phase III clinical trial data exist. Thus, treatment recommendations for patients with non‐clear cell metastatic RCC (mRCC) remain unclear. We present first prospective data on choice of first‐ and second‐line treatment in routine practice and outcome of patients with papillary mRCC. From the prospective German clinical cohort study (RCC‐Registry), 99 patients with papillary mRCC treated with systemic first‐line therapy between December 2007 and May 2017 were included. Prospectively enrolled patients who had started first‐line treatment until May 15, 2016, were included into the outcome analyses (n = 82). Treatment was similar to therapies used for clear cell mRCC and consisted of tyrosine kinase inhibitors, mechanistic target of rapamycin inhibitors and recently checkpoint inhibitors. Median progression‐free survival from start of first‐line treatment was 5.4 months (95% confidence interval [CI], 4.1–9.2) and median overall survival was 12.0 months (95% CI, 8.1–20.0). At data cutoff, 73% of the patients died, 6% were still observed, 12% were lost to follow‐up, and 9% were alive at the end of the individual 3‐year observation period. Despite the lack of prospective Phase III evidence in patients with papillary mRCC, our real‐world data reveal effectiveness of systemic clear cell mRCC therapy in papillary mRCC. The prognosis seems to be inferior for papillary compared to clear cell mRCC. Further studies are needed to identify drivers of effectiveness of systemic therapy for papillary mRCC.

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“…With 13 patients included, median OS was 4 months, with a response rate of 23% (1 response with Temsirolimus, 1 with Sorafenib and 1 with Sunitinib). Another recent study published in 2019 (19) tested the efficacy of Cabozantinib in metastatic nonn-clear-cell renal cell carcinoma; amongst the 112 patients included, there were 4 cases of CDC, with a 50% response rate to Cabozantinib.…”

Section: Discussionmentioning

confidence: 99%

Collecting Duct Carcinoma of the Kidney: Analysis of Our Experience at the SPANISH ‘Grupo Centro’ of Genitourinary Tumors

Pinto¹,

Garrido

Aguado

et al. 2019

KCA

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Introduction: Collecting duct carcinomas (CDC), also known as Bellini's tumors, are a rare and aggressive subtype of renal cell carcinoma. Therefore, there are very few data about their management, and there is no standard therapy for this malignancy. We report the outcome of CDC patients treated on institutions belonging to the 'Grupo Centro' of Genitourinary Tumors, a novel networking cooperative group in Spain. Material and Methods: Patients with CDC diagnosed between 1995 and 2015 were included. They had to have an appropriate follow-up, as well as available tissue for further correlative studies. Demographic baseline features and therapy outcomes were collected in a retrospective fashion. Approval for this data collection was obtained from a central ethical committee. Results: A total of 43 patients were analysed, with a median overall survival (OS) of 14 months (95% CI: 9.2-18.8 months). 29 of them (67.4%) were diagnosed as localized disease, and 14 (32.6%) as metastatic disease. For the subgroup of patients diagnosed without metastases, median relapse-free survival (RFS) is 22 months (95% CI: 12.4-35.6 months), and median OS, 53 months (95% CI: 35.5-84.3 months). For the subgroup of patients with metastatic disease, median OS is 6 months (95% CI: 4.1-7.8 months). 16 patients (55.2%) with stage IV disease received systemic therapy, mainly platinum-based chemotherapy, with a response rate of 12.5% and a median progression-free survival (PFS) of 2 months. Conclusions: CDC of the kidney is a malignancy with poor prognosis and few responses to therapy. Median OS of our group in the metastatic setting is similar to what has been observed in previous series. There is a clear need to improve the armamentarium we have for the systemic approach of patients with advanced CDC.

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Cabozantinib in advanced non-clear-cell renal cell carcinoma: a multicentre, retrospective, cohort study

Abstract: Contributors NMC and LCH were responsible for study design, study coordination, cumulative data collection, data interpretation, and primary manuscript writing. WX did the statistical analyses and participated in the manuscript drafting.

Cited by 138 publications

References 34 publications

Everolimus plus bevacizumab is an effective first‐line treatment for patients with advanced papillary variant renal cell carcinoma: Final results from a phase II trial

Everolimus plus bevacizumab is an effective first‐line treatment for patients with advanced papillary variant renal cell carcinoma: Final results from a phase II trial

Rare patients in routine care: Treatment and outcome in advanced papillary renal cell carcinoma in the prospective German clinical RCC‐Registry

Collecting Duct Carcinoma of the Kidney: Analysis of Our Experience at the SPANISH ‘Grupo Centro’ of Genitourinary Tumors

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