title: First-line treatment with sunitinib for type 1 and type 2 locally advanced or metastatic papillary renal cell carcinoma: a phase II study (SUPAP) by the French Genitourinary Group (GETUG)†.
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.
  
  
  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.
  
  
  CONCLUSIONS
  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: Department of Medical Oncology, Bordeaux University Hospital, Bordeaux. Electronic address: alain.ravaud@chu-bordeaux.fr.
authors: A
authors: A
authors: Ravaud
authors: Department of Medical Oncology, Paris Rene Descartes University, Paris.
authors: S
authors: S
authors: Oudard
authors: Pathology Department, SCP Pathology, Marseille.
authors: M
authors: M
authors: De Fromont
authors: Department of Medical Oncology, Institut Claudius Régaud/Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse.
authors: C
authors: C
authors: Chevreau
authors: Department of Medical Oncology, Institut Paoli Calmettes, Marseille.
authors: G
authors: G
authors: Gravis
authors: Department of Medical Oncology, Centre Georges-François Leclerc, Dijon.
authors: S
authors: S
authors: Zanetta
authors: Department of Medical Oncology, Hôpital Foch, Suresnes.
authors: C
authors: C
authors: Theodore
authors: Research and Development Department, Unicancer, Paris.
authors: M
authors: M
authors: Jimenez
authors: Department of Medical Oncology, Centre François Baclesse, Caen.
authors: E
authors: E
authors: Sevin
authors: Department of Medical Oncology, Centre Eugène Marquis, Rennes.
authors: B
authors: B
authors: Laguerre
authors: Department of Medical Oncology, Institut de Cancérologie de L'Ouest, Nantes.
authors: F
authors: F
authors: Rolland
authors: Department of Biostatistics, Institut Claudius Régaud/Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse.
authors: M
authors: M
authors: Ouali
authors: Medical Oncology, Hôpital Saint-Louis, Paris.
authors: S
authors: S
authors: Culine
authors: Department of Medical Oncology, Gustave Roussy, Villejuif, France.
authors: B
authors: B
authors: Escudier
mesh_terms: D000368:Aged; D020533:Angiogenesis Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D005602:France; D006801:Humans; D007211:Indoles / Q000009:adverse effects / Q000627:therapeutic use*; D053208:Kaplan-Meier Estimate; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011758:Pyrroles / Q000009:adverse effects / Q000627:therapeutic use*; D012307:Risk Factors; D000077210:Sunitinib; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D020533:Angiogenesis Inhibitors; D007211:Indoles; D011758:Pyrroles; D000077210:Sunitinib
keywords: anti-angiogenic; papillary renal cell carcinoma; renal cell carcinoma; sunitinib; type 1 papillary renal cell carcinoma; type 2 papillary renal cell carcinoma