[The clinical development of an antiemetic in oncology. A meta-analysis].
BACKGROUND
To perform meta-analysis (MT) on antiemetic efficacy of LAS 30451 (Pancopride) in high and moderately emetogenic chemotherapy (CT).


METHODS
The results of 13 phase II and III clinical trials comparing the efficacy of different doses of the drug under study with or without corticoids, or versus standard treatment (methochlopramide and/or corticosteroids and diphenhydramine) were included. The principal variable was complete protection in the acute phase (0 vomiting following 24 h post treatment).


RESULTS
The design was open in 3, simple blind in 4 and double blind in 6, with 11 being parallel and 2 crossed. The trials were carried out in 39 centers of 5 countries with 999 patients who received 1,292 cycles of antiemetic treatment. On comparison of lower or equal doses at 0.2 mg/kg of pancopride vs higher doses global OR was 0.94 (p = 0.72) with a global percentage difference (GPD) of -4.69% (p = 0.23) and GPD equal to -6.90. On treatment without cysplatin global OFR was equal to 1.10 (p = 0.69) with GPD of -8.99% favoring dosage lower than or equal to 0.2 mg/kg. The dexamethasone increased antiemetic efficacy of pancopride in both treatments with cysplatin (50% vs 76%, p = 0.08) and without cysplatin (50% to 89%, p = 0.02). When pancopride was compared with that of standard antiemetic treatment (methochlopramide and/or corticosteroids) global OR was equal to 0.69 (p = 0.07) with GPD of -6.84% favoring the control treatment. In CT containing cysplatin, global OR was equal to 0.73 (p = 0.38) with GPD of -3.28% and with CT without cysplatin the global OR was 0.66. (p = 0.12) with a GPD of -4.92% in both cases favoring the control treatment.


CONCLUSIONS
No statistically significant differences were observed with regard to the antiemetic efficacy of pancopride on comparison of different doses of the drug. The antiemetic efficacy of pancopride increases when given together with dexamethasone. The efficacy of pancopride is lower to that of methochlopramide in combination with corticosteroids and/or diphenhydramine although the differences are not statistically significant.
Pérez Campos
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División Médica, Laboratorios Almirall, S.A. Barcelona.
D000932:Antiemetics / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects; D001549:Benzamides / Q000008:administration & dosage / Q000627:therapeutic use*; D001643:Bridged Bicyclo Compounds / Q000008:administration & dosage / Q000627:therapeutic use*; D019086:Bridged Bicyclo Compounds, Heterocyclic; D004305:Dose-Response Relationship, Drug; D006801:Humans; D009369:Neoplasms / Q000150:complications / Q000188:drug therapy*; D012702:Serotonin Antagonists / Q000627:therapeutic use*; D014839:Vomiting / Q000139:chemically induced / Q000188:drug therapy
D000932:Antiemetics; D000970:Antineoplastic Agents; D001549:Benzamides; D001643:Bridged Bicyclo Compounds; D019086:Bridged Bicyclo Compounds, Heterocyclic; D012702:Serotonin Antagonists; C078370:pancopride
Desarrollo clínico de un antiemético en oncología. Metaanálisis.