SAN FRANCISCO, CA USA (UroToday.com) - While the role of sequential sorafenib (SO) and sunitinib (SU) has been examined retrospectively, no prospective trials have been performed to date.
FREE DAILY AND WEEKLY NEWSLETTERS OFFERED BY CONTENT OF INTEREST
Did you find this article relevant? Subscribe to UroToday-GUOncToday!
The fields of GU Oncology and Urology are advancing rapidly including new treatments, enrolling clinical trials, screening and surveillance recommendations along with updated guidelines. Join us as one of our subscribers who rely on UroToday as their must-read source for the latest news and data on drugs. Sign up today for blogs, video conversations, conference highlights and abstracts from peer-review publications by disease and condition delivered to your inbox and read on the go.
Dr. Maurice-Stephan Michel presented results from the first prospective, randomized controlled trial of sequential SO/SU versus SU/SO for metastatic RCC. Patients with metastatic RCC with good PS and no prior exposure to cytokines or systemic therapy were randomized to SO/SU (n=182) or SU/SO (n=183). The primary endpoint examined was total PFS from randomization to event during second-line therapy. Baseline characteristics were well balanced between groups. There was no significant difference in total PFS (HR 1.01, p=0.54) or OS between treatment arms (HR 0.997, p=0.49). Median OS was 31.5 vs 30.2 months for SO/SU and SU/SO, respectively. Fewer patients crossed over to receive SO in the SU/SO arm.
The most frequent adverse events for first-line treatment included alopecia (29% SO vs 4% SU), diarrhea (43% SO vs 29% SU), fatigue (21% SO vs 34% SU), hypertension (24% SO vs 24% SU), nausea (18% SO vs 24% SU), and rash (22% SO vs 3% SU). Overall, adverse events were lower during second-line therapy.
In conclusion, both drugs provided overall benefit regardless of sequence, with no significant difference in total PFS and OS between the two sequential treatments. More patients reached second-line therapy in the SO/SU arm.
Highlights of a presentation by Maurice-Stephan Michel, MD, PhD at the 2014 Genitourinary Cancers Symposium - January 30 - February 1, 2014 - San Francisco Marriott Marquis - San Francisco, California USA
Rhode Island Hospital, Providence, RI USA