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.
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