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)
Mené en France sur des patients atteints d'un carcinome papillaire à cellules rénales de stade localement avancé ou métastatique (15 type 1, 46 type 2), cet essai de phase II évalue l'efficacité, du point de vue du taux de réponse globale, et la toxicité du sunitinib en traitement de première ligne
Background : Papillary renal cell carcinoma (PRCC), type 1 and type 2, represents 10 to 15% of renal cell carcinomas (RCC). There is no standard 1st line treatment for 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 1st 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 (pts) respectively with type 1 and type 2 mPRCC were enrolled. Using the MSKCC scoring system: 12 (20%), 33 (55%) and 9 (15%) pts were respectively in the favourable, intermediate or poor risk group and 7 undetermined. Median follow-up is 51.4 months. In type 1, 2 pts 13% (95% CI 0.1-30.5) had a partial response (PR), 10 had stable disease (SD) with 5 (33%)≥12 weeks. In type 2, 5 pts 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 1st line treatment for mPRCC.