We conducted a retrospective analysis of two clinical trials in treatment-naïve patients (n = 402) with advanced renal cell carcinoma (RCC) treated with axitinib. Our objective was to compare duration of treatment (DT) and clinical outcome in patients who achieved DT >18 months (longer DT) versus ≤18 months (shorter DT).
DT, objective response rate (ORR), tumor shrinkage, and overall survival (OS) were summarized for patients with longer and shorter DT.
Overall, 152 patients (37.8%) had longer DT and 250 (62.2%) had shorter DT (median, 34.7 vs. 6.5 months, respectively). ORR in all 402 patients with advanced RCC was 43.5%. ORR was 75% for longer DT versus 24.4% for shorter DT (p < 0.0001). More patients with longer DT versus shorter DT had ≥10% tumor shrinkage at first scan (74.8% vs. 55.3%; p = 0.0001) and maximum on-study tumor shrinkage was greater in longer-DT versus shorter-DT group (-51.8% vs. -22.1%; p < 0.0001). Median OS was 32.6 months in the overall population while in the patients with longer DT the median was not reached. Treatment-related adverse events (AEs) grade ≥3 were more frequent in longer-DT versus shorter-DT and included hypertension (25.7% vs. 18.8%), diarrhea (15.1% vs. 4.4%), and weight decrease (11.2% vs. 3.2%); however, these AEs decreased over time in both groups. Eastern Cooperative Oncology Group performance status 0, favorable hematology values, no bone or liver metastases, and baseline tumor burden below the overall median were associated with longer DT.
Longer duration (>18 months) of axitinib treatment was associated with increased frequency of early tumor shrinkage, greater magnitude of tumor shrinkage, and a favorable OS.
Targeted oncology. 2017 Mar 30 [Epub ahead of print]
Brian I Rini, Victor Gruenwald, Eric Jonasch, Mayer N Fishman, Yoshihiko Tomita, M Dror Michaelson, Jamal Tarazi, Laura Cisar, Subramanian Hariharan, Angel H Bair, Brad Rosbrook, Thomas E Hutson
Department of Hematology and Oncology, Cleveland Clinic Taussig Cancer Institute, 9500 Euclid Ave., Desk R35, Cleveland, OH, 44195, USA. ., Hannover Medical School, Hannover, Germany., Department of Genitourinary Oncology, Division of Cancer Medicine, The University of Texas M. D. Anderson Cancer Center, Houston, TX, USA., H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA., Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan., Massachusetts General Hospital Cancer Center, Boston, MA, USA., Pfizer Oncology, La Jolla, CA, USA., Pfizer Oncology, Pfizer Inc, New York, NY, USA., Baylor-Sammons Cancer Center, Genitourinary Oncology Program, Dallas, TX, USA.