A Ravaud1, S Oudard2, M De Fromont3, C Chevreau4, G Gravis5, S Zanetta6, C Theodore7, M Jimenez8, E Sevin9, B Laguerre10, F Rolland11, M Ouali12, S Culine13, B Escudier14. 1. Department of Medical Oncology, Bordeaux University Hospital, Bordeaux. Electronic address: alain.ravaud@chu-bordeaux.fr. 2. Department of Medical Oncology, Paris Rene Descartes University, Paris. 3. Pathology Department, SCP Pathology, Marseille. 4. Department of Medical Oncology, Institut Claudius Régaud/Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse. 5. Department of Medical Oncology, Institut Paoli Calmettes, Marseille. 6. Department of Medical Oncology, Centre Georges-François Leclerc, Dijon. 7. Department of Medical Oncology, Hôpital Foch, Suresnes. 8. Research and Development Department, Unicancer, Paris. 9. Department of Medical Oncology, Centre François Baclesse, Caen. 10. Department of Medical Oncology, Centre Eugène Marquis, Rennes. 11. Department of Medical Oncology, Institut de Cancérologie de L'Ouest, Nantes. 12. Department of Biostatistics, Institut Claudius Régaud/Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse. 13. Medical Oncology, Hôpital Saint-Louis, Paris. 14. Department of Medical Oncology, Gustave Roussy, Villejuif, France.
Abstract
BACKGROUND: Papillary renal cell carcinoma (PRCC), type 1 and type 2, represents 10%-15% of renal cell carcinomas (RCC). There is no standard first-line treatment of metastatic PRCC (mPRCC). Anti-angiogenics have shown activity in retrospective studies but no prospective studies in pure papillary histology have been reported, but one with foretinib. PATIENTS AND METHODS: A prospective phase II study evaluated sunitinib in first-line treatment of mPRCC. The primary end point was overall response rate (ORR). Secondary end points were progression-free survival (PFS) and overall survival (OS). RESULTS: Fifteen and 46 patients, respectively, with type 1 and type 2 mPRCC were enrolled. Using the MSKCC scoring system: 12 (20%), 33 (55%) and 9 (15%) patients were, respectively, in the favourable, intermediate or poor risk group and 7 undetermined. Median follow-up is 51.4 months. In type 1, 2 patients 13% [95% confidence interval (CI) 0.1-30.5] had a partial response (PR), 10 had stable disease (SD) with 5 (33%) ≥12 weeks. In type 2, 5 patients 11% (95% CI 1.9-20.3) had a PR, 25 had SD with 10(22%) ≥12 weeks. Median PFS was 6.6 months (95% CI 2.8-14.8) in type 1 and 5.5 months (95% CI 3.8-7.1) in type 2. Median OS was 17.8 (95% CI 5.7-26.1) and 12.4 (95% CI 8.2-14.3) months, respectively, in type 1 and 2. Safety was as expected with sunitinib for metastatic RCC. CONCLUSION: Sunitinib showed activity in treatment of type 1 and 2 mPRCC but lower than in clear-cell mRCC. Both PFS and OS are longer in type I PRCC. Sunitinib represents an acceptable option in first-line treatment of mPRCC.
BACKGROUND:Papillary renal cell carcinoma (PRCC), type 1 and type 2, represents 10%-15% of renal cell carcinomas (RCC). There is no standard first-line treatment of metastatic PRCC (mPRCC). Anti-angiogenics have shown activity in retrospective studies but no prospective studies in pure papillary histology have been reported, but one with foretinib. PATIENTS AND METHODS: A prospective phase II study evaluated sunitinib in first-line treatment of mPRCC. The primary end point was overall response rate (ORR). Secondary end points were progression-free survival (PFS) and overall survival (OS). RESULTS: Fifteen and 46 patients, respectively, with type 1 and type 2 mPRCC were enrolled. Using the MSKCC scoring system: 12 (20%), 33 (55%) and 9 (15%) patients were, respectively, in the favourable, intermediate or poor risk group and 7 undetermined. Median follow-up is 51.4 months. In type 1, 2 patients 13% [95% confidence interval (CI) 0.1-30.5] had a partial response (PR), 10 had stable disease (SD) with 5 (33%) ≥12 weeks. In type 2, 5 patients 11% (95% CI 1.9-20.3) had a PR, 25 had SD with 10(22%) ≥12 weeks. Median PFS was 6.6 months (95% CI 2.8-14.8) in type 1 and 5.5 months (95% CI 3.8-7.1) in type 2. Median OS was 17.8 (95% CI 5.7-26.1) and 12.4 (95% CI 8.2-14.3) months, respectively, in type 1 and 2. Safety was as expected with sunitinib for metastatic RCC. CONCLUSION:Sunitinib showed activity in treatment of type 1 and 2 mPRCC but lower than in clear-cell mRCC. Both PFS and OS are longer in type I PRCC. Sunitinib represents an acceptable option in first-line treatment of mPRCC.
Authors: Giuseppe Rosiello; Carlotta Palumbo; Sophie Knipper; Angela Pecoraro; Stefano Luzzago; Pierre-Antoine St-Hilaire; Zhe Tian; Umberto Capitanio; Francesco Montorsi; Shahrokh F Shariat; Fred Saad; Alberto Briganti; Pierre I Karakiewicz Journal: World J Urol Date: 2020-04-06 Impact factor: 4.226
Authors: Nizar M Tannir; Eric Jonasch; Laurence Albiges; Emre Altinmakas; Chaan S Ng; Surena F Matin; Xuemei Wang; Wei Qiao; Zita Dubauskas Lim; Pheroze Tamboli; Priya Rao; Kanishka Sircar; Jose A Karam; David F McDermott; Christopher G Wood; Toni K Choueiri Journal: Eur Urol Date: 2015-11-26 Impact factor: 20.096