797PD - First line sunitinib in type I and II papillary renal cell carcinoma (PRCC): SUPAP- a phase II study of the French Genito-Urinary Group (GETUG) and...

Date 01 October 2012
Event ESMO Congress 2012
Session Genitourinary tumors, non-prostate (renal cancer)
Topics Anti-Cancer Agents & Biologic Therapy
Renal Cell Cancer
Presenter Alain Ravaud
Authors A. Ravaud1, S. Oudard2, M. De Fromont3, C. Chevreau4, G. Gravis5, S. Zanetta6, C. Theodore7, M. Jimenez8, E. Sevin9, B. Escudier10
  • 1C.H.U. Bordeaux Hopital St. André, 33000 - Bordeaux/FR
  • 2Medical Oncology Service, Georges Pompidou Hospital and Rene Descartes University, Paris/FR
  • 3Pathology, Prado-Pathologie, 13443 - Marseille/FR
  • 4Medical Oncology, Institut Claudius Régaud, 31052 - Toulouse/FR
  • 5Department Of Medical Oncology, Institut Paoli Calmettes, 13009 - Marseille/FR
  • 6Oncology Department, Centre Georges François Leclerc, 21000 - Dijon/FR
  • 7Medical Oncology, HÔPITAL FOCH, 92151 - Suresnes/FR
  • 8R&d, Unicancer, 75013 - Paris/FR
  • 9Medical Oncology, Centre François Baclesse, 14076 - Caen/FR
  • 10Institut Gustave Roussy, FR-94805 - Villejuif/FR

Abstract

Background

Sunitinib has been approved in metastatic clear cell carcinoma due to a prolonged progression-free survival (PFS). Subgroups analysis of previous studies hypothesized that sunitinib may be active in PRCC. This is the first prospective clinical trial reported with an anti-angiogenic agent in PRCC, which is an unmet need.

Methods

SUPAP is a single-arm study using a 2-stage design including 21 patients (pts) to achieve a 20% ORR and if ≥ 2 pts have an OR, 20 additional pts would be included. Type I and II PRCC were included separately with an identical design. Main eligibility criteria included type I and II PRCC confirmed by central pathological review, PS 0-1, measurable disease, 1st line treatment. Sunitinb was given at 50mg/d, 4/6 weeks. Primary endpoint was ORR, while safety, PFS and overall survival (OS) were secondary endpoints.

Results

From 10/07 to 02/11, 15 and 46 pts with type I and II were included, respectively. The median age was 64 year-old. Fifty-three (87%) pts had a nephrectomy. PS was 0 on 31 (50%) pts and 1 in 30 pts. Fifty-five (90%) pts had ≥ 1 metastatic site. Using the MSKCC scoring system: 12 (19%), 33 (54%) and 9 (14%) pts were in the favorable, intermediate or poor risk group and 7 undetermined. With a median follow-up of 12.2 months [0.2-46.4], 60 and 61 pts were evaluable for efficacy and toxicity respectively. The median number of cycles was 4 [1-30] and 23 pts (37.7%) required a dose reduction. In type I PRCC, 2/15 (13%) pts had a partial response (PR), 10 had a stable disease (SD) with 5 (33%) ≥ 12 weeks. In type II PRCC, 5/45 (11%) pts had a PR, 25 had a SD with 10 (22%) ≥ 12 weeks and 15 a progression. The median PFS was 6.6 months [CI 95%: 2.8–14.8] in type I and 5.5 months [CI 95%: 3.8–7.1] in type II. The median overall survival was 17.8 [CI 95%: 5.7–26.1] and 12.4 [CI 95%: 8.2–16] months in type I and II respectively. Toxicity was similar as in pivotal phase III with sunitinib in metastatic RCC. One patient died from a pulmonary embolism eventually due to sunitinib.

Conclusion

Sunitinib has a modest activity in PRCC whatever type I or II, but still represents a treatment option in the lack of better therapy.

Disclosure

A. Ravaud: myself ADVISORY ROLE Pfizer Novartis Bayer Schering GSK Astellas Dendreon Compensated HONORARIA Pfizer Novartis Bayer Schering Roche GSK Astellas Dendreon OTHER Travel financial support Pfizer Novartis Institution RESEARCH FUNDING Pfizer Novartis.

S. Oudard: Myself ADVISORY ROLE Pfizer Bayer-Schering Roche GSK Novartis Sanofi Aventis Compensated HONORARIA Pfizer Bayer-Schering Roche GSK Novartis Sanofi Aventis.

B. Escudier: Honoraria from Pfizer, Novartis, GSK, Bayer, Aveo, BMS.

All other authors have declared no conflicts of interest.