MARC‐2, a prospective, multicenter phase IV trial, aimed to investigate clinical outcomes in patients with metastatic renal cell carcinoma (mRCC) treated with everolimus after failure of one initial vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR‐TKI) therapy and to identify subgroups benefiting most, based on clinical characteristics and biomarkers. Patients with clear cell mRCC failing one initial VEGFR‐TKI received everolimus until progression or unacceptable toxicity. Primary endpoint was 6‐month progression‐free survival rate (6moPFS). Secondary endpoints were overall response rate (ORR), PFS, overall survival (OS), and safety. Between 2011 and 2015, 63 patients were enrolled. Median age was 65.4 years (range 43.3‐81.1). 6moPFS was 39.3% (95% confidence interval [CI], 27.0‐51.3) overall, 54.4% (95% CI, 35.2‐70.1) vs 23.7% (95% CI, 10.5‐39.9) for patients aged ≥65 vs <65 years and 51.4% (95% CI, 34.7‐65.7) vs 18.2% (95% CI, 5.7‐36.3) for patients with body mass index (BMI) >25 vs ≤25 kg/m2. A Cox proportional hazards model confirmed a longer PFS for patients aged ≥65 years (hazard ratio [HR] 0.46; 95% CI, 0.26‐0.80) and a longer OS for patients with BMI >25 kg/m2 (HR 0.36; 95% CI, 0.18‐0.71). Median PFS and median OS were 3.8 months (95% CI, 3.2‐6.2) and 16.8 months (95% CI, 14.3‐24.3). ORR was 7.9% and disease control rate was 60.3%. No new safety signals emerged. Most common adverse events were stomatitis (31.7%), fatigue (31.7%), and anemia (30.2%). One patient died from treatment‐related upper gastrointestinal hemorrhage. Everolimus remains a safe and effective treatment option for mRCC patients after one prior VEGFR‐TKI therapy. Patients aged ≥65 years and patients with BMI >25 kg/m2 benefited most.

No abstract

4574 Background: Randomized clinical trials for the implementation of new therapies include only a selection of patients that are later treated with these new options. Thus, real-world evidence is urgently needed not only to monitor the translation of treatment approaches into routine practice but also to improve cancer treatment and survivorship care on a broader scale. Methods: PAZOREAL is a prospective, multicenter, non-interventional study to evaluate effectiveness [primary time on drug (TD)], tolerability, safety, and quality of life (QoL) in patients (pts) with mRCC, treated with 1st L PAZO followed by 2nd L NIVO or everolimus (EVE). Results: Between Dec. 2015 and Sep. 2017, 421 pts were enrolled and 402 pts started 1st L PAZO treatment (Tx), 127 and 5 pts received NIVO and EVE as 2nd L Tx, resp., 56 entered follow-up. At time of data-cut (08 Nov 2018) median TD was 6.6 months (95%CI 6.0-7.9) for 1st L PAZO and 4.1 months (95%CI 3.2-5.8) for 2nd L NIVO (all pts), 8.1 months (95% CI 6.6-9.5) for PAZO and 3.2 (2.7-6.5) for NIVO Tx for trial eligible pts (39.1% of 402 pts). Median TD for pts with or without prior nephrectomy was 7.6 vs 4.5 months, resp. The clinical benefit rate of 1st L PAZO was 58.2 % (95% CI 53.3-62.9) based on investigator assessment. Median OS of PAZO was 29.5 months (95%CI 23.6-NA) for all pts, 28.2 months (95% CI 22.2-NA) for NIVO in 2nd L. The most commonly reported AEs for PAZO Tx were diarrhea (35%), nausea (20.3%) and fatigue (17.5%). Most common PAZO-related grade 3/4 adverse events were hypertension (5%), hypertensive crisis (2.3%) and GGT increase (1.8%). QoL evaluated by EQ-5D-5L remained stable over different Tx lines. Conclusions: The interim results of the PAZOREAL study confirm a favorable overall survival in pts with mRCC treated with 1st L PAZO in a real-world setting, good benefit-risk profile of PAZO and sustained QoL monitored over several treatment lines. In Germany NIVO as 2nd L Tx is commonly applied after 1st L Tx with PAZO.

No abstract

No abstract

No abstract

No abstract