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- W2245865551 abstract "5550 Background: Pertuzumab, a humanized monoclonal antibody inhibits HER2 receptor heterodimerization by binding to the dimerization domain of the HER2 receptor, and it has shown promising activity in studies of women with platinum resistant ovarian cancer. We report the impact of pertuzumab on patient-reported symptoms evaluated as part of a completed randomized trial of gemcitabine given with pertuzumab versus placebo in this population. Methods: Patients received study treatment (study drug on Day 1 with Gem on Day 1, Day 8, every 3 weeks) until 17 cycles, disease progression, or unmanageable toxicity. Patients completed FOSI questionnaires at baseline and at Day 1 of each 3-week cycle. The FOSI score was derived from 8 items with higher scores indicating better health status (range 0–32). Symptom deterioration was defined as a ≥3 point decrease in FOSI from baseline. Results: A total of 130 patients participated with a median age of 59 years. The majority of women had ECOG PS=0 at baseline. The median time to symptom deterioration was 1.7 months in the Gemcitabine+placebo arm vs. 3.8 months in the gemcitabine+pertuzumab arm (HR=0.62, 95% CI: 0.36–1.05). Symptom improvement (≥3 point increase in FOSI) occurred in 28 women (43%) given Gemcitabine+pertuzumab, compared to 18 (28%) in those receiving Gemcitabine+placebo. Conclusions: In addition to encouraging activity of pertuzumab in this population (PFS HR=0.66, 95% CI: 0.43–1.03), the addition of pertuzumab to gemcitabine may stabilize symptom burden and delay the time to deterioration of symptoms. Due to small sample size and exploratory nature of this trial, further studies are needed to confirm the clinical benefit of gemcitabine+pertuzumab in ovarian cancer. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Genentech, Inc. Genentech, Inc." @default.
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- W2245865551 date "2008-05-20" @default.
- W2245865551 modified "2023-09-27" @default.
- W2245865551 title "Affecting quality of life in ovarian cancer: encouraging results from a randomized phase II trial of gemcitabine ± pertuzumab in women with platinum-resistant disease" @default.
- W2245865551 doi "https://doi.org/10.1200/jco.2008.26.15_suppl.5550" @default.
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