57 3 CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING | PART TWO cancer. All patients received the same non-AC MEC regimen docetaxel 60 mg/m2, carboplatin 300 mg/m2, and 5-fluorouracil 600 mg/m2 (TPF regimen). Previous exposure to chemotherapy is unknown. Corticosteroids were administered to all patients on day 1. Complete response (CR, defined as no vomiting), and intensity of nausea, in the acute, delayed, and overall phases were the primary efficacy endpoints in this study. There were no significant differences in CR rates in all phases (palonosetron vs. ondansetron: acute phase 83.3% vs. 80%; delayed phase 76.6% vs. 66.7%; overall phase 66.7% vs. 46.7%; p values not provided). Differences in control of nausea were also not statistically significant during all phases. In a multicenter, double-blind, non-inferiority, crossover trial [20], 144 patients with a broad range of tumor types receiving HEC (cisplatin), AC, or non-ACMEC, were randomized to palonosetron in cycle 1, and then switched to granisetron in cycle 2 or vice versa. Both chemotherapy naïve and non-naïve patients were included. Corticosteroids were not allowed. The primary efficacy endpoint was the proportion of patients with CR (no vomiting) during the acute, delayed and overall phases. One hundred and eight patients (75%) received AC or non-AC MEC (63% of patients in this subgroup). One hundred and twenty-two patients received two cycles of chemotherapy. Data of both cycles were pooled. In the mixed AC/non-AC subgroup, differences in CR rates between palonosetron and granisetron were not significant; in the acute phase 72.16% vs. 67.65%; in the delayed phase 67.01% vs. 59.80%; in the overall phase 58.76% vs. 52.9%, respectively. P values not provided. Dexamethasone-reducing study A multicenter, open-label, non-inferiority study published in 2011 [18], was designed to evaluate the efficacy of palonosetron plus single-day dexamethasone compared with multiday dexamethasone. This study included 332 patients receiving AC or non-AC MEC, mainly oxaliplatin, irinotecan, and carboplatin-based regimens. All patients were chemotherapy-naïve. CR (defined as no vomiting, no use of rescue medication) during the overall phase was the primary outcome measure. In the overall population, differences in CR rates during the overall phase were significant (67.5% for single day dexamethasone, and 71.1% for dexamethasone on days 1-3; difference, 95% CI:-3.6% (-13.5 to 6.3)). In the non-AC MEC subgroup analysis, there were no significant differences in CR rates between the single day and multiday dexamethasone groups; (in the acute phase 88.3% vs. 87.0% respectively (difference, 95% CI: 1.3 (-7.6 to 10.2)); in the delayed phase 71.2% vs. 76.0%, respectively (difference, 95% CI:-4.8 (-16.7 to 7)). NK1 receptor antagonists In a multicenter, double-blind study by Rapoport et al [21], 848 patients receiving AC and non-AC MEC for a broad range of tumors, were randomized to compare the efficacy of an oral three-drug regimen of aprepitant, ondansetron and dexamethasone to an oral control regimen of ondansetron and dexamethasone. Fifty-two percent of the patients were given non-AC-based MEC, including oxaliplatin, carboplatin, ifosfamide, and irinotecan. All patients were chemotherapy-naïve. The primary efficacy endpoint was the proportion of patients reporting no vomiting during the overall phase. In the overall population,
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