Pazopanib, paclitaxel nonsuperior to paclitaxel during recurrent ovarian cancer maintenance
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Adding pazopanib to paclitaxel in patients with recurrent ovarian cancer progressing during bevacizumab maintenance therapy was not superior to paclitaxel alone, according to data presented at ESMO Virtual Congress 2020.
“We designed this study because we knew that the combination of chemotherapy plus bevacizumab was efficient among patients who later relapse for ovarian cancer; however, few data were available with rechallenge of anti-angiogenic tyrosine kinase inhibitors with chemotherapy if the patient progressed during the bevacizumab maintenance,” Florence Joly-Lobbedez, MD, PhD, of the Centre Francois Baclesse, Caen, France, said in her presentation.
In the GINECO randomized phase 2 TAPAZ study, researchers examined patients with recurrent ovarian cancer during the first year of bevacizumab maintenance therapy in first or second line. They compared weekly paclitaxel 65 mg/m2 with pazopanib 600 mg to 800 mg daily (PP arm) to weekly paclitaxel 80 mg/m2 (P arm) to determine PFS as the primary endpoint and OS, safety, the pharmacokinetic profile and quality of life as the secondary endpoints.
Seventy-nine patients received paclitaxel and pazopanib and 37 received paclitaxel alone. After a 12.8-month median follow-up, Joly-Lobbedez and colleagues observed a median PFS of 4.6 months in the PP arm vs. 5.5 months in P arm and a median OS of 13.5 months in the PP arm vs. 12.8 months in the P arm.
“There was no difference in progression-free survival between the two groups with the median time of 4.56 months in the PP arm and 5.5 months in the paclitaxel therapy [arm], and no difference in overall survival,” Joly-Lobbedez said.
According to the presentation, 81% of patients in the paclitaxel arm stopped treatment because of progression compared with 66% of patients in the paclitaxel plus pazopanib arm (P = .09).
Grade 3/4 toxicities occurred more frequently in the paclitaxel plus pazopanib arm (87% vs. 70%; P = .03), the researchers reported. Treatment discontinuation due to toxicity was 47% in PP arm vs. 12% in P arm (P < .001), with discontinuation due to digestive disorders (31%), vascular disorders (28%) and hematologic disorders (17%) in the PP arm. Three sepsis and two toxic deaths occurred. Further, the investigators observed more significant deterioration of global quality of life and diarrhea at month in the PP arm.