Validation of the International Metastatic Renal-Cell Carcinoma Database Consortium (IMDC) prognostic model for first-line pazopanib in metastatic renal carcinoma: The Spanish Oncologic Genitourinary Group (SOGUG) SPAZO study
Menée à partir de données portant sur 278 patients atteints d'un carcinome métastatique à cellules rénales et ayant reçu le pazopanib en traitement de première ligne (âge moyen : 66 ans ; durée médiane de suivi : 23 mois), cette étude évalue la performance du modèle pronostique de l'IMDC (International Metastatic Renal Cell Carcinoma Database Consortium) pour prédire la réponse au traitement
Background : Patients with metastatic renal carcinoma (mRCC) treated with first-line pazopanib were not included in the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) prognostic model. SPAZO (NCT02282579) was a nation-wide retrospective observational study designed to assess the effectiveness and validate the IMDC prognostic model in patients treated with first-line pazopanib in clinical practice.
Patients and Methods : Data of 278 patients, treated with first-line pazopanib for mRCC in 34 centres in Spain, were locally recorded and externally validated. Mean age was 66 years, there were 68.3% male, 93.5% clear cell type, 74.8% nephrectomized, and 81.3% had ECOG 0-1. Metastatic sites were: lung 70.9%, lymph node 43.9%, bone 26.3%, soft tissue/skin 20.1%, liver 15.1%, CNS 7.2%, adrenal gland 6.5%, pleura/peritoneum 5.8%, pancreas 5%, and kidney 2.2%. After median follow-up of 23 months, 76.4% had discontinued pazopanib, (57.2% due to progression), 47.9% had received 2nd-line targeted therapy, and 48.9% had died.
Results : According to IMDC prognostic model, 19.4% had favourable-risk (FR), 57.2% intermediate-risk (IR), and 23.4% poor-risk (PR). No unexpected toxicities were recorded. Response rate was 30.3% (FR: 44%, IR: 30% PR: 17.3%). Median progression-free survival (whole population) was 11 months (32 in FR, 11 in IR, 4 in PR). Median and 2-year overall survival (whole population) were 22 months and 48.1% respectively, (FR: not reached and 81.6%, IR: 22 and 48.7%, PR: 7 and 18.8%). These estimations and their 95% confidence intervals are fully consistent with the outcomes predicted by the IMDC prognostic model.
Conclusion : Our results validate the IMDC model for first-line pazopanib in mRCC, and confirm the effectiveness and safety of this treatment.
Annals of Oncology , résumé, 2015