Abstract
Abstract Abstract #4099 Background: In the treatment of breast cancer, combination chemotherapy of AC/EC has been widely used for neoadjuvant, adjuvant chemotherapy or standard treatment of metastatic breast cancer. AC/EC frequently induces severe nausea and vomiting, that it is important to adequately prevent and control. PALO is the first novel serotonine antagonist approved for prevention of delayed nausea and vomiting in moderately emetogenic chemotherapy in US and other countries. Integrated analysis was done on the data from phase 2 and 3 trials that have been completed in Japan. The purpose of this analysis was to assess efficacy and safety of PALO for preventing CINV induced by AC/EC regimens.
 Methods: Three Japanese studies with single/repeated IV dose of PALO in pts receiving AC/EC were used. In all these studies, PALO 0.75 mg IV was administrated 30 min prior to AC/EC. Dexamethasone was administrated before AC/EC on day 1, and also on days 2-3 for the phase 3 trial. This integrated analysis assessed the efficacy and safety by difference in regimens (AC or EC), assessed the efficacy by difference in FEC (EC with 5-FU) or EC regimen and by difference in epirubicin (E) dosage in EC. Apart from the integrated analysis, efficacy of PALO in repeated cycles of chemotherapy was assessed by different regimens (AC or EC).
 Results: Total of 266 pts administrated AC/EC were evaluated for efficacy in single dose. Overall CR(CR = no emesis or rescue medication)% for PALO in acute phase was 70.7%. Overall CR% in delayed phase was 61.3%. CR% in acute and delayed phase for (a) AC (n=76) vs EC (n=190), (b) FEC (n=141) vs EC (n=49), (c) low (n=109) vs high (n=81) dosage of E (<=90, >90 mg/m2) in EC were as follows; (a) acute: 80.3 vs 66.8, delayed: 68.4 vs 58.4, (b) acute: 61.7 vs 81.6, delayed: 56.7 vs 63.3, (c) acute: 72.5 vs 59.3, delayed: 61.5 vs 54.3. Total of 155 pts administrated AC/EC were evaluated for efficacy of PALO in repeated cycles of chemotherapy, and similar efficacy between AC and EC was confirmed. Total of 474 pts administered AC/EC were evaluated for safety in all Japanese studies. There was no significant difference in the incidence of adverse drug reactions between AC and EC.
 Conclusion: This integrated analysis suggested that high antiemetic activity of PALO in CINV was shown for breast cancer pts receiving either AC or EC. In addition, in the FEC regimen and high dosage of E, all showed CR rate of more than 50% in both acute and delayed phases in the efficacy analysis, revealing a long lasting antiemetic activity of palonosetron. Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 4099.
Published Version
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