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A A Fauser - One of the best experts on this subject based on the ideXlab platform.
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The Anti-Emetic Efficiacy of Intravenous Dolasetron Mesilate plus Dexamethasone versus Intravenous Dolasetron Mesilate Alone in Patients Receiving Fractionated Chemotherapy
Oncology Research and Treatment, 1999Co-Authors: A A Fauser, W. Dornoff, V. Briese, B. Knutzen, G. Herzog, W. Schultze, J. NowickiAbstract:Summary Purpose: Fractionated cisplatin-containing regimens are routinely used for chemotherapy of certain types of cancer. Dolasetron has been shown to be effective i
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Oral Dolasetron Mesilate (MDL 73,147EF) for the control of emesis during fractionated total-body irradiation and high-dose cyclophosphamide in patients undergoing allogeneic bone marrow transplantation
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 1997Co-Authors: A A Fauser, W. Russ, M. BischoffAbstract:The purpose of the present study was to evaluate the efficacy and safety of oral Dolasetron Mesilate in the prevention of nausea and vomiting that might otherwise be induced by total-body irradiation (TBI) and high-dose cyclophosphamide. In an open non-comparative study 20 patients who received TBI for 3 days and high-dose cyclophosphamide chemotherapy for 2 days as part of their preparation for bone marrow transplantation were given oral Dolasetron Mesilate at dosages ranging from 50 to 200 mg 1 h before each fraction of radiotherapy and cyclophosphamide administration. Initial rescue therapy consisted of intravenous Dolasetron Mesilate. If nausea and vomiting remained uncontrolled, standard antiemetics were to be used. Of the 20 patients, 13 had only two emetic episodes or fewer in the 3-day TBI period. On days 1 and 2 of cyclophosphamide administration, 11 and 6 patients had fewer than two emetic episodes. From day 1 to day 3, 15 patients experienced no nausea or only mild nausea, and on the days of chemotherapy 8 and 7 patients had mild nausea or none at all. Rescue with i.v. Dolasetron Mesilate was needed by 3 and 6 patients during the TBI and the chemotherapy periods respectively. In 2 patients additional antiemetics were used on days 2–3 and 4–5. Mild to moderate headache was reported in 6 patients. No unexpected abnormalities were observed in haematology, biochemistry or urinalysis, and vital signs were unaffected throughout the study period. The data suggest that oral Dolasetron Mesilate is effective and safe for the prevention of nausea and vomiting during TBI and cyclophosphamide chemotherapy prior to bone marrow transplantation. Future controlled studies should evaluate combination antiemetic therapy with Dolasetron Mesilate for this indication.
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Therapeutic equivalence of single oral doses of Dolasetron Mesilate and multiple doses of ondansetron for the prevention of emesis after moderately emetogenic chemotherapy
European Journal of Cancer, 1996Co-Authors: A A Fauser, B. Duclos, A. Chemaissani, A. Del Favero, Francesco Cognetti, E. Diaz-rubio, H. Cortes-funes, Pierfranco Conte, H.t. DresslerAbstract:This multicentre, randomised, double-blind study was designed to compare the anti-emetic efficacy and safety of single oral doses of Dolasetron Mesilate with that of the approved oral, multiple-dose regimen of ondansetron in 399 cancer patients receiving moderately emetogenic chemotherapy. Single oral doses of 25, 50, 100 or 200 mg of Dolasetron Mesilate were administered 1 h prior to the initiation of moderately emetogenic chemotherapy. Multiple doses of ondansetron (8 mg × 3 or 8 mg × 4) capsules, or matching placebo for patients randomised to Dolasetron, were given 1.5 h before and 6.5, 14.5 and 22.5 h after the start of chemotherapy (total dose = 32 mg). Efficacy was evaluated for 24 h after the initiation of chemotherapy. The most frequently used moderately emetogenic chemotherapeutic agents included cyclophosphamide, doxorubicin and carboplatin (28.4, 23.1 and 20.6% of patients, respectively). A statistically significant (P < 0.001) linear dose-response relationship was observed over the entire Dolasetron dosage range for all efficacy parameters. Complete response rates were 45.0, 49.4, 60.5 and 76.3% for 25, 50, 100 and 200 mg Dolasetron Mesilate, respectively, and 72.3% of ondansetron patients. A single oral 200 mg Dolasetron Mesilate dose was therapeutically equivalent to ondansetron for all efficacy parameters and patient satisfaction was high. Overall, there were no significant differences in the incidence of adverse events between any of the Dolasetron Mesilate doses, or between Dolasetron and ondansetron. Headache was most frequently reported (approximately 15% for each drug). No clinically important changes in vital signs or clinical laboratory parameters were observed with either drug. In conclusion, a single oral 200 mg Dolasetron Mesilate dose was therapeutically equivalent to multiple-dose ondansetron in the prevention of emesis and nausea following moderately emetogenic chemotherapy. Copyright © 1996 Elsevier Science Ltd
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Therapeutic equivalence of single oral doses of Dolasetron Mesilate and multiple doses of ondansetron for the prevention of emesis after moderately emetogenic chemotherapy. European Dolasetron Comparative Study Group.
European journal of cancer (Oxford England : 1990), 1996Co-Authors: A A Fauser, B. Duclos, A. Chemaissani, A. Del Favero, Francesco Cognetti, E. Diaz-rubio, H. Cortes-funes, P F Conte, H DresslerAbstract:This multicentre, randomised, double-blind study was designed to compare the anti-emetic efficacy and safety of single oral doses of Dolasetron Mesilate with that of the approved oral, multiple-dose regimen of ondansetron in 399 cancer patients receiving moderately emetogenic chemotherapy. Single oral doses of 25, 50, 100 or 200 mg of Dolasetron Mesilate were administered 1 h prior to the initiation of moderately emetogenic chemotherapy. Multiple doses of ondansetron (8 mg x 3 or 8 mg x 4) capsules, or matching placebo for patients randomised to Dolasetron, were given 1.5 h before and 6.5, 14.5 and 22.5 h after the start of chemotherapy (total dose = 32 mg). Efficacy was evaluated for 24 h after the initiation of chemotherapy. The most frequently used moderately emetogenic chemotherapeutic agents included cyclophosphamide, doxorubicin and carboplatin (28.4, 23.1 and 20.6% of patients, respectively). A statistically significant (P < 0.001) linear dose-response relationship was observed over the entire Dolasetron dosage range for all efficacy parameters. Complete response rates were 45.0, 49.4, 60.5 and 76.3% for 25, 50, 100 and 200 mg Dolasetron Mesilate, respectively, and 72.3% of ondansetron patients. A single oral 200 mg Dolasetron Mesilate dose was therapeutically equivalent to ondansetron for all efficacy parameters and patient satisfaction was high. Overall, there were no significant differences in the incidence of adverse events between any of the Dolasetron Mesilate doses, or between Dolasetron and ondansetron. Headache was most frequently reported (approximately 15% for each drug). No clinically important changes in vital signs or clinical laboratory parameters were observed with either drug. In conclusion, a single oral 200 mg Dolasetron Mesilate dose was therapeutically equivalent to multiple-dose ondansetron in the prevention of emesis and nausea following moderately emetogenic chemotherapy.
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a double blind randomized parallel study of iv Dolasetron Mesilate versus iv metoclopramide in patients receiving moderately emetogenic chemotherapy
Cancer Journal, 1996Co-Authors: A A Fauser, B. Chevallier, P. Cappelaere, M. Fabbro, Harry Bleiberg, R Favre, A Noble, D Cupissol, M Degardin, D SpaethAbstract:Contexte - Cet essai de 24 heures a compare deux doses uniques de Mesilate de Dolasetron IV (DM) et de metoclopramide (MTC) pour la prevention de vomissements induits par une chimiotherapie emetogene moderee. Methodes - Lors de cette etude multicentrique en double aveugle, les patients atteints de cancer (pts), classes par sexe et selon la chimiotherapie anterieure, ont recu une perfusion continue de MTC 3 mg/kg pendant 8 heures apres une dose unique de 2 mg/kg, ou du DM IV, 1.2 ou 1.8 mg/kg, 30 minutes avant la chimiotherapie (principalement doxorubicine, epirubicine, et cyclophosphamide). Resultats - 309 pts ont ete tires au sort. Pour la population totale de patients, les taux de reponse complete (CR: 0 episodes de vomissements [EE] et pas de medication de secours [RM]) et de reponse complete -plus reponse majeure (CMR: 0-2 EE, pas de RM) n'ont pas ete statistiquement significatifs (p>.05) entre les differents traitements: 53%, 56%, et 64% pour le CR; et 63%, 74%, et 77% pour le CMR avec respectivement 1.2 mg/kg et 1.8 mg/kg de MTC et DM. Les analyses de sous-groupes ont montre que le DM aux doses 1.2 et 1.8 mg/kg etait plus efficace que le MTC pour le CMR chez toutes les femmes (respectivement 55%, 72%, et 77%) et chez les femmes ayant deja subi une chimiotherapie (46%, 74%, et 72%) (p<.05). Aucune difference significative n'a ete observee entre les doses de 1.8 et 1.2 mg/kg. Une incidence plus elevee de diarrhee a ete rapportee dans le groupe traite au MTC. Il y a eu une incidence legerement plus elevee de cephalees moderees avec le DM qu'avec le MTC (16% vs.4%) mais pas de trouble extrapyramidal (1pt avec le MTC). Conclusions - Les trois traitements ont montre une efficacite egale dans l'ensemble de la population. Dans les sous-groupes de femmes, le DM a ete significativement plus efficace que le MTC chez les femmes ayant deja subi une chimiotherapie.
Bruno Audhuy - One of the best experts on this subject based on the ideXlab platform.
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a double blind randomised comparison of the anti emetic efficacy of two intravenous doses of Dolasetron Mesilate and granisetron in patients receiving high dose cisplatin chemotherapy
European Journal of Cancer, 1996Co-Authors: Bruno Audhuy, D Khayat, P. Cappelaere, M. Fabbro, Miquel Martin, Andres Cervantes, Alain Riviere, Harry Bleiberg, Marc Faraldi, Nicole ClaverieAbstract:This multicentre, double-blind, double-dummy, randomised trial was designed to compare the efficacy and safety of single intravenous doses of Dolasetron Mesilate and granisetron in the prevention of acute emesis and nausea due to high-dose (≥80 mg/m2) cisplatin. Single intravenous doses of 1.8 or 2.4 mg/kg of Dolasetron Mesilate or 3 mg of granisetron hydrochloride were administered in a volume of 50 ml over a 5-min period, beginning 30 min prior to cisplatin (≥80 mg/m2) administration. The number and timing of emetic episodes, time to administration of escape anti-emetic medication, severity of nausea by visual analogue scale (VAS), and safety were monitored for 24 h after the start of cisplatin-containing chemotherapy. Investigators' evaluations of overall efficacy and patients' satisfaction with therapy were recorded at the end of the 24-h study period. Of the 474 patients evaluable for efficacy, complete responses were achieved by 54, 47 and 48% of patients given Dolasetron Mesilate 1.8 mg/kg, Dolasetron Mesilate 2.4 mg/kg and granisetron, respectively. Statistically, treatment groups had comparable complete and complete plus major responses, times to first emesis, and use of escape medication; patient maximum nausea severity and treatment satisfaction ratings; and physician nausea severity and overall efficacy assessments. For the majority of efficacy endpoints, 1.8 mg/kg Dolasetron Mesilate produced numerically superior responses compared with the 2.4 mg/kg dose. Gender and prior chemotherapy were significant predictors of complete response; males and chemotherapy-naive patients had higher responses. The overall incidences of adverse events were comparable among the treatment groups; headache and diarrhoea were most common. In conclusion, 1.8 and 2.4 mg/kg of Dolasetron Mesilate and granisetron (3 mg) were equally effective in preventing nausea and vomiting induced by highly emetogenic cisplatin-containing chemotherapy. In addition, because no additional benefit was observed with 2.4 mg/kg of Dolasetron Mesilate and numerically greater responses were observed with the 1.8 mg/kg dose, the lower dose of 1.8 mg/kg is optimal for further clinical development. Copyright © 1996 Elsevier Science Ltd.
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A double-blind, randomised comparison of the anti-emetic efficacy of two intravenous doses of Dolasetron Mesilate and granisetron in patients receiving high dose cisplatin chemotherapy.
European journal of cancer (Oxford England : 1990), 1996Co-Authors: Bruno Audhuy, D Khayat, P. Cappelaere, M. Fabbro, Miquel Martin, Andres Cervantes, Alain Riviere, Harry Bleiberg, Marc Faraldi, Nicole ClaverieAbstract:This multicentre, double-blind, double-dummy, randomised trial was designed to compare the efficacy and safety of single intravenous doses of Dolasetron Mesilate and granisetron in the prevention of acute emesis and nausea due to high-dose (> or = 80 mg/m2) cisplatin. Single intravenous doses of 1.8 or 2.4 mg/kg of Dolasetron Mesilate or 3 mg of granisetron hydrochloride were administered in a volume of 50 ml over a 5-min period, beginning 30 min prior to cisplatin (> or = 80 mg/m2) administration. The number and timing of emetic episodes, time to administration of escape anti-emetic medication, severity of nausea by visual analogue scale (VAS), and safety were monitored for 24 h after the start of cisplatin-containing chemotherapy. Investigators' evaluations of overall efficacy and patients' satisfaction with therapy were recorded at the end of the 24-h study period. Of the 474 patients evaluable for efficacy, complete responses were achieved by 54, 47 and 48% of patients given Dolasetron Mesilate 1.8 mg/kg, Dolasetron Mesilate 2.4 mg/kg and granisetron, respectively. Statistically, treatment groups had comparable complete and complete plus major responses, times to first emesis, and use of escape medication; patient maximum nausea severity and treatment satisfaction ratings; and physician nausea severity and overall efficacy assessments. For the majority of efficacy endpoints, 1.8 mg/kg Dolasetron Mesilate produced numerically superior responses compared with the 2.4 mg/kg dose. Gender and prior chemotherapy were significant predictors of complete response; males and chemotherapy-naive patients had higher responses. The overall incidences of adverse events were comparable among the treatment groups; headache and diarrhoea were most common. In conclusion, 1.8 and 2.4 mg/kg of Dolasetron Mesilate and granisetron (3 mg) were equally effective in preventing nausea and vomiting induced by highly emetogenic cisplatin-containing chemotherapy. In addition, because no additional benefit was observed with 2.4 mg/kg of Dolasetron Mesilate and numerically greater responses were observed with the 1.8 mg/kg dose, the lower dose of 1.8 mg/kg is optimal for further clinical development.
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1213 double blind comparative trial of the antiemetic efficacy of two iv doses of Dolasetron Mesilate dm and granisetron g after infusion of high dose cisplatin chemotherapy ct
European Journal of Cancer, 1995Co-Authors: Bruno Audhuy, P Cappelaeare, N ClaverieAbstract:This 24-hour trial randomized 476 cancer patients at 29 centers to 1. 8 or 2.4 mg/kg IV DM or G (3 mg) 30 minutes prior to ≥ 80 mg/m 2 IV cisplatin CT. Patients were stratified using gender and previous CT to four groups: male naive and non-naive and female naive and non-naive. Efficacy was measured using complete response (CR: 0 emetic episodes [EE] and no rescue medication [RM]); CR + major response (CMR: 12 EE and no RM); ratings of nausea and satisfaction by patients on a 100 mm visual analog scale (VAS); and physician assessment of nausea severity and global efficacy on a discrete scale (DS: none, slight, good, excellent). CR rates were 54%, 47%, and 48%, respectively, for DM 1.8 and 2.4 mg/kg and G. CR rates for both DM doses were statistically equivalent to G and pairwise comparisons of CR rates between DM 1.8 mg/kg and G ( P = 0893) and between the two DM doses ( P = 0602) were not statistically significant. Equivalence between treatments was further confirmed by CMR, by median time to first EE/RM, by patient VAS assessments, by the rigorous CR + no nausea (
H.t. Dressler - One of the best experts on this subject based on the ideXlab platform.
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Therapeutic equivalence of single oral doses of Dolasetron Mesilate and multiple doses of ondansetron for the prevention of emesis after moderately emetogenic chemotherapy
European Journal of Cancer, 1996Co-Authors: A A Fauser, B. Duclos, A. Chemaissani, A. Del Favero, Francesco Cognetti, E. Diaz-rubio, H. Cortes-funes, Pierfranco Conte, H.t. DresslerAbstract:This multicentre, randomised, double-blind study was designed to compare the anti-emetic efficacy and safety of single oral doses of Dolasetron Mesilate with that of the approved oral, multiple-dose regimen of ondansetron in 399 cancer patients receiving moderately emetogenic chemotherapy. Single oral doses of 25, 50, 100 or 200 mg of Dolasetron Mesilate were administered 1 h prior to the initiation of moderately emetogenic chemotherapy. Multiple doses of ondansetron (8 mg × 3 or 8 mg × 4) capsules, or matching placebo for patients randomised to Dolasetron, were given 1.5 h before and 6.5, 14.5 and 22.5 h after the start of chemotherapy (total dose = 32 mg). Efficacy was evaluated for 24 h after the initiation of chemotherapy. The most frequently used moderately emetogenic chemotherapeutic agents included cyclophosphamide, doxorubicin and carboplatin (28.4, 23.1 and 20.6% of patients, respectively). A statistically significant (P < 0.001) linear dose-response relationship was observed over the entire Dolasetron dosage range for all efficacy parameters. Complete response rates were 45.0, 49.4, 60.5 and 76.3% for 25, 50, 100 and 200 mg Dolasetron Mesilate, respectively, and 72.3% of ondansetron patients. A single oral 200 mg Dolasetron Mesilate dose was therapeutically equivalent to ondansetron for all efficacy parameters and patient satisfaction was high. Overall, there were no significant differences in the incidence of adverse events between any of the Dolasetron Mesilate doses, or between Dolasetron and ondansetron. Headache was most frequently reported (approximately 15% for each drug). No clinically important changes in vital signs or clinical laboratory parameters were observed with either drug. In conclusion, a single oral 200 mg Dolasetron Mesilate dose was therapeutically equivalent to multiple-dose ondansetron in the prevention of emesis and nausea following moderately emetogenic chemotherapy. Copyright © 1996 Elsevier Science Ltd
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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
European Journal of Cancer, 1995Co-Authors: A A Fauser, A. Chemaissani, A. Del Favero, J P Bergerat, V Cocquyt, H.t. DresslerAbstract: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
P. Cappelaere - One of the best experts on this subject based on the ideXlab platform.
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A double-blind, multicentre comparison of intravenous Dolasetron Mesilate and metoclopramide in the prevention of nausea and vomiting in cancer patients receiving high-dose cisplatin chemotherapy
Supportive Care in Cancer, 1997Co-Authors: B. Chevallier, D Khayat, P. Cappelaere, T. Splinter, M. Fabbro, J. L. Wendling, L. Cals, G. Catimel, M. Giovannini, P. BastitAbstract:The potent serotonin receptor (5-HT_3) antagonists are new highly selective agents for the prevention and control of chemotherapy-induced nausea and vomiting that have been shown to be comparable to or more effective than traditional metoclopramide regimens. This study was designed to compare the antiemetic efficacy of Dolasetron and metoclopramide in chemotherapy-naive and non-naive cancer patients receiving high-dose cisplatin-containing chemotherapy. This multicentre, double-blind, randomized trial compared the efficacy and safety of single i.v. doses of Dolasetron Mesilate salt (1.2 or 1.8 mg/kg) and metoclopramide (7 mg/kg) in 226 patients for the prevention of acute emesis and nausea associated with the administration of high-dose (≥80 mg/m^2) cisplatin. Efficacy and safety were evaluated for 24 h. Complete responses were achieved by 57%, 48%, and 35% of patients given Dolasetron Mesilate 1.8 mg/kg ( P =0.0009 vs metoclopramide), Dolasetron Mesilate 1.2 mg/kg ( P =0.0058 vs metoclopramide), and metoclopramide, respectively. Overall, Dolasetron was significantly more effective than metoclopramide for time to first emetic episode, nausea, patient satisfaction, and investigator global assessment of efficacy. Males, chemotherapy-naive patients, and alcoholics had higher response rates. Dolasetron was well tolerated, with mild-to-moderate headache most commonly reported. Twelve percent of patients receiving metoclopramide reported extrapyramidal symptoms compared with 0% of patients receiving Dolasetron. In conclusion, Dolasetron Mesilate was effective for the prevention of CINV with high-dose cisplatin. Single i.v. doses of Dolasetron Mesilate were more effective than 7 mg/kg metoclopramide in preventing nausea and vomiting induced by highly emetogenic cisplatin-containing chemotherapy. In addition, 1.8 mg/kg Dolasetron Mesilate consistently produced the highest response rates and appears to be the most effective dose for further clinical development.
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a double blind randomised comparison of the anti emetic efficacy of two intravenous doses of Dolasetron Mesilate and granisetron in patients receiving high dose cisplatin chemotherapy
European Journal of Cancer, 1996Co-Authors: Bruno Audhuy, D Khayat, P. Cappelaere, M. Fabbro, Miquel Martin, Andres Cervantes, Alain Riviere, Harry Bleiberg, Marc Faraldi, Nicole ClaverieAbstract:This multicentre, double-blind, double-dummy, randomised trial was designed to compare the efficacy and safety of single intravenous doses of Dolasetron Mesilate and granisetron in the prevention of acute emesis and nausea due to high-dose (≥80 mg/m2) cisplatin. Single intravenous doses of 1.8 or 2.4 mg/kg of Dolasetron Mesilate or 3 mg of granisetron hydrochloride were administered in a volume of 50 ml over a 5-min period, beginning 30 min prior to cisplatin (≥80 mg/m2) administration. The number and timing of emetic episodes, time to administration of escape anti-emetic medication, severity of nausea by visual analogue scale (VAS), and safety were monitored for 24 h after the start of cisplatin-containing chemotherapy. Investigators' evaluations of overall efficacy and patients' satisfaction with therapy were recorded at the end of the 24-h study period. Of the 474 patients evaluable for efficacy, complete responses were achieved by 54, 47 and 48% of patients given Dolasetron Mesilate 1.8 mg/kg, Dolasetron Mesilate 2.4 mg/kg and granisetron, respectively. Statistically, treatment groups had comparable complete and complete plus major responses, times to first emesis, and use of escape medication; patient maximum nausea severity and treatment satisfaction ratings; and physician nausea severity and overall efficacy assessments. For the majority of efficacy endpoints, 1.8 mg/kg Dolasetron Mesilate produced numerically superior responses compared with the 2.4 mg/kg dose. Gender and prior chemotherapy were significant predictors of complete response; males and chemotherapy-naive patients had higher responses. The overall incidences of adverse events were comparable among the treatment groups; headache and diarrhoea were most common. In conclusion, 1.8 and 2.4 mg/kg of Dolasetron Mesilate and granisetron (3 mg) were equally effective in preventing nausea and vomiting induced by highly emetogenic cisplatin-containing chemotherapy. In addition, because no additional benefit was observed with 2.4 mg/kg of Dolasetron Mesilate and numerically greater responses were observed with the 1.8 mg/kg dose, the lower dose of 1.8 mg/kg is optimal for further clinical development. Copyright © 1996 Elsevier Science Ltd.
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A double-blind, randomised comparison of the anti-emetic efficacy of two intravenous doses of Dolasetron Mesilate and granisetron in patients receiving high dose cisplatin chemotherapy.
European journal of cancer (Oxford England : 1990), 1996Co-Authors: Bruno Audhuy, D Khayat, P. Cappelaere, M. Fabbro, Miquel Martin, Andres Cervantes, Alain Riviere, Harry Bleiberg, Marc Faraldi, Nicole ClaverieAbstract:This multicentre, double-blind, double-dummy, randomised trial was designed to compare the efficacy and safety of single intravenous doses of Dolasetron Mesilate and granisetron in the prevention of acute emesis and nausea due to high-dose (> or = 80 mg/m2) cisplatin. Single intravenous doses of 1.8 or 2.4 mg/kg of Dolasetron Mesilate or 3 mg of granisetron hydrochloride were administered in a volume of 50 ml over a 5-min period, beginning 30 min prior to cisplatin (> or = 80 mg/m2) administration. The number and timing of emetic episodes, time to administration of escape anti-emetic medication, severity of nausea by visual analogue scale (VAS), and safety were monitored for 24 h after the start of cisplatin-containing chemotherapy. Investigators' evaluations of overall efficacy and patients' satisfaction with therapy were recorded at the end of the 24-h study period. Of the 474 patients evaluable for efficacy, complete responses were achieved by 54, 47 and 48% of patients given Dolasetron Mesilate 1.8 mg/kg, Dolasetron Mesilate 2.4 mg/kg and granisetron, respectively. Statistically, treatment groups had comparable complete and complete plus major responses, times to first emesis, and use of escape medication; patient maximum nausea severity and treatment satisfaction ratings; and physician nausea severity and overall efficacy assessments. For the majority of efficacy endpoints, 1.8 mg/kg Dolasetron Mesilate produced numerically superior responses compared with the 2.4 mg/kg dose. Gender and prior chemotherapy were significant predictors of complete response; males and chemotherapy-naive patients had higher responses. The overall incidences of adverse events were comparable among the treatment groups; headache and diarrhoea were most common. In conclusion, 1.8 and 2.4 mg/kg of Dolasetron Mesilate and granisetron (3 mg) were equally effective in preventing nausea and vomiting induced by highly emetogenic cisplatin-containing chemotherapy. In addition, because no additional benefit was observed with 2.4 mg/kg of Dolasetron Mesilate and numerically greater responses were observed with the 1.8 mg/kg dose, the lower dose of 1.8 mg/kg is optimal for further clinical development.
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a double blind randomized parallel study of iv Dolasetron Mesilate versus iv metoclopramide in patients receiving moderately emetogenic chemotherapy
Cancer Journal, 1996Co-Authors: A A Fauser, B. Chevallier, P. Cappelaere, M. Fabbro, Harry Bleiberg, R Favre, A Noble, D Cupissol, M Degardin, D SpaethAbstract:Contexte - Cet essai de 24 heures a compare deux doses uniques de Mesilate de Dolasetron IV (DM) et de metoclopramide (MTC) pour la prevention de vomissements induits par une chimiotherapie emetogene moderee. Methodes - Lors de cette etude multicentrique en double aveugle, les patients atteints de cancer (pts), classes par sexe et selon la chimiotherapie anterieure, ont recu une perfusion continue de MTC 3 mg/kg pendant 8 heures apres une dose unique de 2 mg/kg, ou du DM IV, 1.2 ou 1.8 mg/kg, 30 minutes avant la chimiotherapie (principalement doxorubicine, epirubicine, et cyclophosphamide). Resultats - 309 pts ont ete tires au sort. Pour la population totale de patients, les taux de reponse complete (CR: 0 episodes de vomissements [EE] et pas de medication de secours [RM]) et de reponse complete -plus reponse majeure (CMR: 0-2 EE, pas de RM) n'ont pas ete statistiquement significatifs (p>.05) entre les differents traitements: 53%, 56%, et 64% pour le CR; et 63%, 74%, et 77% pour le CMR avec respectivement 1.2 mg/kg et 1.8 mg/kg de MTC et DM. Les analyses de sous-groupes ont montre que le DM aux doses 1.2 et 1.8 mg/kg etait plus efficace que le MTC pour le CMR chez toutes les femmes (respectivement 55%, 72%, et 77%) et chez les femmes ayant deja subi une chimiotherapie (46%, 74%, et 72%) (p<.05). Aucune difference significative n'a ete observee entre les doses de 1.8 et 1.2 mg/kg. Une incidence plus elevee de diarrhee a ete rapportee dans le groupe traite au MTC. Il y a eu une incidence legerement plus elevee de cephalees moderees avec le DM qu'avec le MTC (16% vs.4%) mais pas de trouble extrapyramidal (1pt avec le MTC). Conclusions - Les trois traitements ont montre une efficacite egale dans l'ensemble de la population. Dans les sous-groupes de femmes, le DM a ete significativement plus efficace que le MTC chez les femmes ayant deja subi une chimiotherapie.
M. Fabbro - One of the best experts on this subject based on the ideXlab platform.
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A double-blind, multicentre comparison of intravenous Dolasetron Mesilate and metoclopramide in the prevention of nausea and vomiting in cancer patients receiving high-dose cisplatin chemotherapy
Supportive Care in Cancer, 1997Co-Authors: B. Chevallier, D Khayat, P. Cappelaere, T. Splinter, M. Fabbro, J. L. Wendling, L. Cals, G. Catimel, M. Giovannini, P. BastitAbstract:The potent serotonin receptor (5-HT_3) antagonists are new highly selective agents for the prevention and control of chemotherapy-induced nausea and vomiting that have been shown to be comparable to or more effective than traditional metoclopramide regimens. This study was designed to compare the antiemetic efficacy of Dolasetron and metoclopramide in chemotherapy-naive and non-naive cancer patients receiving high-dose cisplatin-containing chemotherapy. This multicentre, double-blind, randomized trial compared the efficacy and safety of single i.v. doses of Dolasetron Mesilate salt (1.2 or 1.8 mg/kg) and metoclopramide (7 mg/kg) in 226 patients for the prevention of acute emesis and nausea associated with the administration of high-dose (≥80 mg/m^2) cisplatin. Efficacy and safety were evaluated for 24 h. Complete responses were achieved by 57%, 48%, and 35% of patients given Dolasetron Mesilate 1.8 mg/kg ( P =0.0009 vs metoclopramide), Dolasetron Mesilate 1.2 mg/kg ( P =0.0058 vs metoclopramide), and metoclopramide, respectively. Overall, Dolasetron was significantly more effective than metoclopramide for time to first emetic episode, nausea, patient satisfaction, and investigator global assessment of efficacy. Males, chemotherapy-naive patients, and alcoholics had higher response rates. Dolasetron was well tolerated, with mild-to-moderate headache most commonly reported. Twelve percent of patients receiving metoclopramide reported extrapyramidal symptoms compared with 0% of patients receiving Dolasetron. In conclusion, Dolasetron Mesilate was effective for the prevention of CINV with high-dose cisplatin. Single i.v. doses of Dolasetron Mesilate were more effective than 7 mg/kg metoclopramide in preventing nausea and vomiting induced by highly emetogenic cisplatin-containing chemotherapy. In addition, 1.8 mg/kg Dolasetron Mesilate consistently produced the highest response rates and appears to be the most effective dose for further clinical development.
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a double blind randomised comparison of the anti emetic efficacy of two intravenous doses of Dolasetron Mesilate and granisetron in patients receiving high dose cisplatin chemotherapy
European Journal of Cancer, 1996Co-Authors: Bruno Audhuy, D Khayat, P. Cappelaere, M. Fabbro, Miquel Martin, Andres Cervantes, Alain Riviere, Harry Bleiberg, Marc Faraldi, Nicole ClaverieAbstract:This multicentre, double-blind, double-dummy, randomised trial was designed to compare the efficacy and safety of single intravenous doses of Dolasetron Mesilate and granisetron in the prevention of acute emesis and nausea due to high-dose (≥80 mg/m2) cisplatin. Single intravenous doses of 1.8 or 2.4 mg/kg of Dolasetron Mesilate or 3 mg of granisetron hydrochloride were administered in a volume of 50 ml over a 5-min period, beginning 30 min prior to cisplatin (≥80 mg/m2) administration. The number and timing of emetic episodes, time to administration of escape anti-emetic medication, severity of nausea by visual analogue scale (VAS), and safety were monitored for 24 h after the start of cisplatin-containing chemotherapy. Investigators' evaluations of overall efficacy and patients' satisfaction with therapy were recorded at the end of the 24-h study period. Of the 474 patients evaluable for efficacy, complete responses were achieved by 54, 47 and 48% of patients given Dolasetron Mesilate 1.8 mg/kg, Dolasetron Mesilate 2.4 mg/kg and granisetron, respectively. Statistically, treatment groups had comparable complete and complete plus major responses, times to first emesis, and use of escape medication; patient maximum nausea severity and treatment satisfaction ratings; and physician nausea severity and overall efficacy assessments. For the majority of efficacy endpoints, 1.8 mg/kg Dolasetron Mesilate produced numerically superior responses compared with the 2.4 mg/kg dose. Gender and prior chemotherapy were significant predictors of complete response; males and chemotherapy-naive patients had higher responses. The overall incidences of adverse events were comparable among the treatment groups; headache and diarrhoea were most common. In conclusion, 1.8 and 2.4 mg/kg of Dolasetron Mesilate and granisetron (3 mg) were equally effective in preventing nausea and vomiting induced by highly emetogenic cisplatin-containing chemotherapy. In addition, because no additional benefit was observed with 2.4 mg/kg of Dolasetron Mesilate and numerically greater responses were observed with the 1.8 mg/kg dose, the lower dose of 1.8 mg/kg is optimal for further clinical development. Copyright © 1996 Elsevier Science Ltd.
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A double-blind, randomised comparison of the anti-emetic efficacy of two intravenous doses of Dolasetron Mesilate and granisetron in patients receiving high dose cisplatin chemotherapy.
European journal of cancer (Oxford England : 1990), 1996Co-Authors: Bruno Audhuy, D Khayat, P. Cappelaere, M. Fabbro, Miquel Martin, Andres Cervantes, Alain Riviere, Harry Bleiberg, Marc Faraldi, Nicole ClaverieAbstract:This multicentre, double-blind, double-dummy, randomised trial was designed to compare the efficacy and safety of single intravenous doses of Dolasetron Mesilate and granisetron in the prevention of acute emesis and nausea due to high-dose (> or = 80 mg/m2) cisplatin. Single intravenous doses of 1.8 or 2.4 mg/kg of Dolasetron Mesilate or 3 mg of granisetron hydrochloride were administered in a volume of 50 ml over a 5-min period, beginning 30 min prior to cisplatin (> or = 80 mg/m2) administration. The number and timing of emetic episodes, time to administration of escape anti-emetic medication, severity of nausea by visual analogue scale (VAS), and safety were monitored for 24 h after the start of cisplatin-containing chemotherapy. Investigators' evaluations of overall efficacy and patients' satisfaction with therapy were recorded at the end of the 24-h study period. Of the 474 patients evaluable for efficacy, complete responses were achieved by 54, 47 and 48% of patients given Dolasetron Mesilate 1.8 mg/kg, Dolasetron Mesilate 2.4 mg/kg and granisetron, respectively. Statistically, treatment groups had comparable complete and complete plus major responses, times to first emesis, and use of escape medication; patient maximum nausea severity and treatment satisfaction ratings; and physician nausea severity and overall efficacy assessments. For the majority of efficacy endpoints, 1.8 mg/kg Dolasetron Mesilate produced numerically superior responses compared with the 2.4 mg/kg dose. Gender and prior chemotherapy were significant predictors of complete response; males and chemotherapy-naive patients had higher responses. The overall incidences of adverse events were comparable among the treatment groups; headache and diarrhoea were most common. In conclusion, 1.8 and 2.4 mg/kg of Dolasetron Mesilate and granisetron (3 mg) were equally effective in preventing nausea and vomiting induced by highly emetogenic cisplatin-containing chemotherapy. In addition, because no additional benefit was observed with 2.4 mg/kg of Dolasetron Mesilate and numerically greater responses were observed with the 1.8 mg/kg dose, the lower dose of 1.8 mg/kg is optimal for further clinical development.
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a double blind randomized parallel study of iv Dolasetron Mesilate versus iv metoclopramide in patients receiving moderately emetogenic chemotherapy
Cancer Journal, 1996Co-Authors: A A Fauser, B. Chevallier, P. Cappelaere, M. Fabbro, Harry Bleiberg, R Favre, A Noble, D Cupissol, M Degardin, D SpaethAbstract:Contexte - Cet essai de 24 heures a compare deux doses uniques de Mesilate de Dolasetron IV (DM) et de metoclopramide (MTC) pour la prevention de vomissements induits par une chimiotherapie emetogene moderee. Methodes - Lors de cette etude multicentrique en double aveugle, les patients atteints de cancer (pts), classes par sexe et selon la chimiotherapie anterieure, ont recu une perfusion continue de MTC 3 mg/kg pendant 8 heures apres une dose unique de 2 mg/kg, ou du DM IV, 1.2 ou 1.8 mg/kg, 30 minutes avant la chimiotherapie (principalement doxorubicine, epirubicine, et cyclophosphamide). Resultats - 309 pts ont ete tires au sort. Pour la population totale de patients, les taux de reponse complete (CR: 0 episodes de vomissements [EE] et pas de medication de secours [RM]) et de reponse complete -plus reponse majeure (CMR: 0-2 EE, pas de RM) n'ont pas ete statistiquement significatifs (p>.05) entre les differents traitements: 53%, 56%, et 64% pour le CR; et 63%, 74%, et 77% pour le CMR avec respectivement 1.2 mg/kg et 1.8 mg/kg de MTC et DM. Les analyses de sous-groupes ont montre que le DM aux doses 1.2 et 1.8 mg/kg etait plus efficace que le MTC pour le CMR chez toutes les femmes (respectivement 55%, 72%, et 77%) et chez les femmes ayant deja subi une chimiotherapie (46%, 74%, et 72%) (p<.05). Aucune difference significative n'a ete observee entre les doses de 1.8 et 1.2 mg/kg. Une incidence plus elevee de diarrhee a ete rapportee dans le groupe traite au MTC. Il y a eu une incidence legerement plus elevee de cephalees moderees avec le DM qu'avec le MTC (16% vs.4%) mais pas de trouble extrapyramidal (1pt avec le MTC). Conclusions - Les trois traitements ont montre une efficacite egale dans l'ensemble de la population. Dans les sous-groupes de femmes, le DM a ete significativement plus efficace que le MTC chez les femmes ayant deja subi une chimiotherapie.