Ineligibility for clinical trials (CT) may be an unfavorable prognostic factor in mRC. There is no information about the effectiveness of pazopanib in patients (pt) ineligible for CT. We aimed to assess the effect of ineligibility in outcomes in mRC, and the effectiveness of pazopanib in this setting.
SPAZO2 (NCT03091465) was a retrospective real-world study to analyze the effectiveness of 1st-line pazopanib and subsequent therapies in mRC in several settings. Data from 530 pt treated with frontline pazopanib outside CT in 50 centers in Spain were collected, and externally monitored. Ineligibility criteria: ECOG >1, pure nonclear-cell, brain metastases, Hgb 80 y, stroke, chronic liver disease, or recent neoplasia.
A total of 217 pt (40.9%) fulfilled criteria for ineligibility. There were significant differences (I vs E) in age >75 (39% vs 15%), nephrectomy (61% vs 78%), IMDC (favorable: 8.8% vs 17.9%, intermediate: 50.2% vs 68.4%, poor: 41% vs 13.7%), metastases (lymph nodes: 51% vs 41%, lung: 65% vs 72%, liver: 21% vs 15%, bone: 31% vs 22%, skin/soft-tissue: 30% vs 16%, and CNS (13% vs 0%) but no in sex (68% vs 67% males). Discontinuation due to toxicity or comorbidities was 19% vs 17%. There were also differences (p
In our series, “real world eligible pt” had similar outcome to the obtained in clinical trials. On the contrary, “real world ineligible pt” for clinical trials had significantly lower response rate, and shorter PFS and OS than elegible pt. Pazopanib was safe and effective in both subpopulations of patients.
Clinical trial identification
Legal entity responsible for the study
J. Arranz Arija: Grant for research from Novartis. Participation in advisory boards for Novartis and Pfizer. B. Pérez Valderrama: Consulting/Advisory role for Astellas Pharma, Novartis, Pfizer, Pierre Fabre, Bayer, Sanofi, Bristol-Myers Squib and Roche. J.P. Maroto Rey: Advisory Board for Novartis, Pfizer, Ibsen and Bristol. M.A. Climent Duran: Pfizer and Novartis talks, advisory role for Pfizer. All other authors have declared no conflicts of interest.