Researchers have validated the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) prognostic model for first-line pazopanib in metastatic renal cell carcinoma (mRCC), and have confirmed the effectiveness and safety of this treatment strategy, a new study published online ahead of print in the journal Annals of Oncology has shown.1
The IMDC prognostic model did not originally include patients with mRCC treated with first-line pazopanib. Therefore, researchers designed the SPAZO trial, a nation-wide retrospective observational study, to evaluate the effectiveness and validate the IMDC prognostic model in these patients in clinical practice.
For the study, researchers analyzed data from 278 patients with mRCC who were treated with first-line pazopanib in 34 Spanish institutions. Most had clear cell type and about 75% had undergone nephrectomy.
Metastatic sites included lung, lymph node, bone, soft tissue/skin, liver, central nervous system, adrenal gland, pleura/peritoneum, pancreas, and kidney. After a median follow-up of 23 months, 76.4% of patients had discontinued pazopanib, 47.9% had received second-line targeted therapy, and 48.9% had died.
Results showed that 19.4% had favorable-risk, 57.2% had intermediate-risk, and 23.4% had poor-risk according to the IMDC prognostic model. Median overall survival had not been reached in patients with favorable-risk, 22 months in intermediate-risk, and 7 months in poor-risk. The 2-year overall survival rate was 81.6%, 48.7%, and 18.8%, respectively.
Researchers found that overall response rate was 44% for patients with favorable-risk, 30% for those with intermediate-risk, and 17.3% with poor-risk. Median progression-free survival was 32 months, 11 months, and 4 months, respectively.
In regard to safety, researchers observed no unexpected toxicities.
- Pérez-Valderrama B, Arranza Arija JA, Rodriguez Sánchez A, et al. 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 [published online ahead of print December 9, 2015]. Ann Oncol. doi: 10.1093/annonc/mdv601.