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• W2080476301 abstract "This 24-hour trial randomized 398 cancer patients at 26 centers to 25, 50, 100, 200 mg DM or OND (8 mg × 4; 8 mg × 3 at four centers) prior to IV CT primarily with cyclophosphamide (≥ 600 mg/m2), doxorubicin (≥ 40 mg/m2), or carboplatin (≥ 300 mg/m2), Efficacy was assessed by complete response (CR: 0 emetic episodes [EE] and no rescue medication [RM]); CR + major response (CMR: 1–2 EE and no RM); and patient ratings of nausea and satisfaction on a 100 mm visual analog scale (VAS). A statistically significant linear trend with dose was observed across the 25, 50, 100, 200 mg doses of DM (P < 0.0001) both for CR (45.0%, 49.4%, 60.5%, and 76.3%), respectively, and for CMR. The CR rate for OND was 72.3%. CR and CMR rates for DM 200 mg were equivalent to OND. Linear trends across the four DM doses were statistically significant for median time to first EE/RM, for patient VAS nausea-level scores, and for the combined parameter of CR + no nausea (< 5 mm VAS), (P < 0.0001 for all parameters). For the stringent CR + no nausea test, DM 200 mg (63.8%) was numerically superior to OND (49.4%). DM and OND were equivalent in the safety analysis and there was no statistically significant trends with dose for adverse events with DM. In conclusion, a single oral dose of DM 200 mg was equivalent to multiple doses of OND in preventing nausea and emesis induced by moderately emetogenic CT. This 24-hour trial randomized 398 cancer patients at 26 centers to 25, 50, 100, 200 mg DM or OND (8 mg × 4; 8 mg × 3 at four centers) prior to IV CT primarily with cyclophosphamide (≥ 600 mg/m2), doxorubicin (≥ 40 mg/m2), or carboplatin (≥ 300 mg/m2), Efficacy was assessed by complete response (CR: 0 emetic episodes [EE] and no rescue medication [RM]); CR + major response (CMR: 1–2 EE and no RM); and patient ratings of nausea and satisfaction on a 100 mm visual analog scale (VAS). A statistically significant linear trend with dose was observed across the 25, 50, 100, 200 mg doses of DM (P < 0.0001) both for CR (45.0%, 49.4%, 60.5%, and 76.3%), respectively, and for CMR. The CR rate for OND was 72.3%. CR and CMR rates for DM 200 mg were equivalent to OND. Linear trends across the four DM doses were statistically significant for median time to first EE/RM, for patient VAS nausea-level scores, and for the combined parameter of CR + no nausea (< 5 mm VAS), (P < 0.0001 for all parameters). For the stringent CR + no nausea test, DM 200 mg (63.8%) was numerically superior to OND (49.4%). DM and OND were equivalent in the safety analysis and there was no statistically significant trends with dose for adverse events with DM. In conclusion, a single oral dose of DM 200 mg was equivalent to multiple doses of OND in preventing nausea and emesis induced by moderately emetogenic CT." @default.
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• W2080476301 date "1995-11-01" @default.
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• W2080476301 title "1217 Double-blind, comparative trial of four single oral doses of dolasetron mesilate (DM) and multiple doses of ondansetron (OND) for emesis prevention after moderately emetogenic chemotherapy (CT)" @default.
• W2080476301 doi "https://doi.org/10.1016/0959-8049(95)96463-n" @default.
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