title: Preliminary experience with a modified premedication protocol that included intravenous diphenhydramine and calcium bromide for the prophylaxis of paclitaxel-related hypersensitivity reactions.
abstract: BACKGROUND
  Paclitaxel often causes severe hypersensitivity reactions (HSRs) rapidly after infusion, even in patients given prophylactic therapy. The purpose of this study was to analyze the incidence of paclitaxel-related HSRs in patients with non-small cell lung cancer (NSCLC) retrospectively, and to assess the feasibility of a modified premedication protocol.
  
  
  METHODS
  One hundred and seven patients who were pretreated with either a conventional premedication regimen (two doses of dexamethasone) or a short premedication regimen (single dose of dexamethasone with oral diphenhydramine and intravenous ranitidine), prior to paclitaxel infusion were retrospectively analyzed. A modified premedication regimen, consisting of 12.5 ml of Rescalmin (intravenous diphenhydramine 50 mg and calcium bromide 437.5 mg), intravenous ranitidine 100 mg, and intravenous dexamethasone 20 mg, was given 30 min prior to paclitaxel, with oral dexamethasone 8 mg given on the night before the paclitaxel. Patients received paclitaxel intravenously at 175 mg/m(2) over 3 h, followed by carboplatin, AUC 5, over 1 h on day 1 every 3 weeks.
  
  
  RESULTS
  In the conventional premedication group, 21 patients had HSRs (32.3%); in 1 of these patients the HSR was considered to be severe (1.5%). In the short premedication group, 19 patients had HSRs (45.2%); in 6 of these patients the HSRs were considered to be severe (14.3%). The incidence of severe HSRs was significantly higher in the short premedication group than in the conventional premedication group (P = 0.027). In the modified premedication protocol study, HSR events were recorded in 14 patients (63.6%); 14 showed flushing, 2 had skin rash, and 1 had tachycardia. No severe HSRs were seen.
  
  
  CONCLUSIONS
  The incidence of HSRs in the short premedication group tended to be higher than that in the conventional premedication group. The modified premedication protocol was found to be feasible for preventing paclitaxel-related HSR, but case accumulation is needed.
authors: Department of Thoracic Malignancy, Osaka Prefectural Medical Center for Respiratory and Allergic Diseases, Habikino 3-7-1, Habikino, Osaka, 583-8588, Japan. s-sasada@hbk.pref.osaka.jp
authors: Shinji
authors: S
authors: Sasada
authors: Tomonori
authors: T
authors: Hirashima
authors: Yukiko
authors: Y
authors: Nakamura
authors: Takayuki
authors: T
authors: Takimoto
authors: Mitsugi
authors: M
authors: Furukawa
authors: Masashi
authors: M
authors: Kobayashi
authors: Takashi
authors: T
authors: Nitta
authors: Kaoru
authors: K
authors: Matsui
authors: Ichiro
authors: I
authors: Kawase
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects* / Q000627:therapeutic use; D001965:Bromides / Q000008:administration & dosage / Q000627:therapeutic use*; D017610:Calcium Compounds / Q000008:administration & dosage / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy; D015331:Cohort Studies; D004155:Diphenhydramine / Q000008:administration & dosage / Q000627:therapeutic use*; D004342:Drug Hypersensitivity / Q000209:etiology / Q000517:prevention & control*; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D008175:Lung Neoplasms / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000009:adverse effects* / Q000627:therapeutic use; D011292:Premedication; D012189:Retrospective Studies
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D001965:Bromides; D017610:Calcium Compounds; C113019:calcium bromide; D004155:Diphenhydramine; D017239:Paclitaxel
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