MRCC is a devastating disease with poor long-term outcomes. Bevacizumab (BEV) added to chemotherapy (CT) improves significantly overall survival (OS) in MRCC patients (pts). Aim: to characterize clinic-pathologic features associated to CR and its impact on pts outcome.
Single-institution chart review of MRCC pts who were treated with 1st line CT between 2005 and 2016. CR was defined by Response Evaluation Criteria in Solid Tumors (RECIST v1). The prognostic and predictive value of clinic-pathologic features, was evaluated.
Seventy-two pts (62% squamous; 30% adenocarcinoma; 8% others); with median age of 48 years (28-77) were selected. Forty-five pts (62%) had prior CT-radiation; 55 pts (79%) had recurrent/persistent disease (27 pts > 12 months (m) disease free interval) and 15 pts (21%) were stage IVb (90% visceral involvement). Moore risk distribution: 7/44/21 pts were high/medium/low risk, respectively. Eleven pts (15%) received BEV + CT; 57 pts (79%) platinum-based-CT (PCT) (54% Cisplatin; 26% Carboplatin) and 4 (6%) non-PCT. After a median follow-up of 33 m, ORR 51%, median OS 13 m (9.5-NA) and median PFS 6 m (4.6 -7.7) were observed for overall population. Moore criteria correlated with prognosis (high-risk pts had significantly worse OS (HR = 0.04, p 0.2 all comparisons). Higher ORR was observed among low and intermediate risk pts (51%, 67%; p = 0.006). CRs occurred in 13/71 (18%) evaluable pts (BEV group 2/11; non-BEV 11/60, p = 1). Clinic-pathologic features, including Moore criteria, did not correlate with CR in univariate analysis. Median time to CR was 3.5 m (3 –NA) and median duration of CR was 7 m (4.3–NA). Five pts (7%) had CR in the irradiated field. CR significantly impacted on PFS (9.7 m vs 4.7 m non-CR, p = 0.002) and OS (31 m vs 9.5 m non-CR, p = 0.001). Eight pts discontinued treatment due to toxicity.
CR is a meaningful surrogate marker for improved PFS and OS in MRCC pts treated with 1st line CT, but no predictive features have been identified in our cohort. Moore prognostic score was validated in real-word practice but its capability guiding therapy needs further evaluation.
Clinical trial identification
Legal entity responsible for the study
Vall d´Hebron Institute of Oncology
A. Oaknin: Consulting or advisory role for PharmaMar, Clovis, Roche, AstraZeneca. All other authors have declared no conflicts of interest.