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A Randomized Cross-over Study of High-dose Metoclopramide plus Dexamethasone versus Granisetron plus Dexamethasone in Patients Receiving Chemotherapy with High-dose Cisplatin
Authors:Hironobu Ohmatsu    Kenji Eguchi  Tetsu Shinkai  Tomohide Tamura  Yuichiro Ohe  Masato Nisio  Hiroshi Kunikane  Hitoshi Arioka  Atsuya Karato  Hajime Nakashima  Yasutsuna Sasaki  Kinuko Tajima  Noriko Tada  Nagahiro Saijo
Institution:Department of Internal Medicine and Thoracic Oncology;Division of Drug Therapy and Siostatistics, National Cancer Center Central Hospital, 1-1 Tsukiji 5-chome, Chuo-ku, Tokyo 104;3Division of Drug Therapy, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa 277;8 Division of Pharmacology, National Cancer Center Research Institute, 1-1 Tsukiji 5-chome, Chuo-ku, Tokyo 104
Abstract:We carried out a randomized, single-blind, cross-over trial to compare the antiemetic effect, for both acute and delayed emesis, of granisetron plus dexamethasone (GRN+Dx) with that of high-dose metoclopramide plus dexamethasone (HDMP + Dx). Fifty-four patients with primary or metastatic lung cancer, given single-dose cisplatin (> 80 mg/m2) chemotherapy more than twice, were enrolled in this study. They were treated with both HDMP+Dx and GRN+Dx in two consecutive chemotherapy courses. On day 1, patients experienced a mean of 2.5 (SD=4.3) and 0,1 (SD = 0.4) episodes of vomiting in the HDMP+Dx and the GRN + Dx groups, respectively ( P =0.0008). Complete response rate on day 1 was 45 and 90% in the HDMP+Dx and the GRN+Dx groups, respectively ( P = 0.0001). Patients treated with GRN+Dx had a tendency to suffer more episodes of vomiting than the HDMP+Dx group on days 2–5, but it was not statistically significant. Twenty-four patients (57%) preferred the GRN+Dx treatment and 14 patients (33%), HDMP + Dx. In the HDMP + Dx group, nine patients (21%) had an extrapyramidal reaction, and 5 patients (12%) had constipation that lasted for at least two days. In contrast, no patients had extrapyramidal reactions, and IS patients (43%) had constipation in the GRN+Dx group ( P < 0.01). GRN+Dx was more effective than HDMP+Dx only in preventing the acute emesis induced by cisplatin. An effective treatment for delayed emesis is still needed.
Keywords:Granisetron  Dexamethasone  Antiemetic  Cisplatin  Chemotherapy
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