(HealthDay News) – The monoclonal antibody against epidermal growth factor receptor (EGFR), cetuximab, augments the antitumor activity of paclitaxel in patients with previously treated urothelial cancer, according to a study published online Aug. 27 in the Journal of Clinical Oncology.
Yu-Ning Wong, MD, of the Fox Chase Cancer Center in Philadelphia, and colleagues conducted a phase 2, randomized, noncomparative study involving 39 patients with metastatic urothelial cancer to determine the benefits of salvage chemotherapy with cetuximab with or without paclitaxel.
In the single-agent cetuximab treatment arm, the researchers found that 9 of 11 patients had progressed by 8 weeks, and the arm was closed. For the 28 patients enrolled in the cetuximab plus paclitaxel arm, 12 experienced progression-free survival (PFS) longer than 16 weeks. The overall response rate was 25%, including 3 complete responses and 4 partial responses. The median PFS and overall survival were 16.4 and 42 weeks, respectively. Grade 3 and 4 treatment-related adverse events included rash in 6 patients, fatigue in 5 patients, and low magnesium in 3 cases.
“In conclusion, although cetuximab is inactive as a single agent in advanced urothelial cancer, it may augment the antitumor activity of paclitaxel when given in combination,” the authors write. “The combination of paclitaxel and cetuximab should be compared with single-agent paclitaxel in a randomized controlled trial to establish the role of EGFR inhibition by monoclonal antibodies in advanced urothelial cancers.”
Several authors disclosed financial ties to Bristol-Myers Squibb, which funded the study and manufactures cetuximab.