Palonosetron plus single-dose dexamethasone for the prevention of nausea and vomiting in women receiving anthracycline/cyclophosphamide-containing chemotherapy: meta-analysis of individual patient data examining the effect of age on outcome in two phase III trials |
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Authors: | Luigi Celio Erminio Bonizzoni Emilio Bajetta Silvia Sebastiani Tania Perrone Matti S Aapro |
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Institution: | 1. Medical Oncology Unit 1, Fondazione IRCCS “Istituto Nazionale Tumori”, Via Venezian 1, 20133, Milan, Italy 2. Section of Medical Statistics and Biometry, University of Milan, Milan, Italy 3. Policlinico di Monza, Istituto di Oncologia, Monza, Italy 4. Business Unit Oncology and Cancer Supportive Care, Helsinn Healthcare SA, Lugano, Switzerland 5. Scientific Department, Italfarmaco S.p.A., Cinisello Balsamo, Italy 6. Clinique de Genolier, Multidisciplinary Oncology Institute, Genolier, Switzerland
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Abstract: | Purpose Data from two randomized trials, evaluating a single-day regimen of palonosetron plus dexamethasone against emesis due to moderately emetogenic chemotherapy, were assessed for the impact of age on outcome in a pooled sample of women receiving anthracycline and/or cyclophosphamide (AC)-containing chemotherapy. Methods Chemo-naïve breast cancer patients randomized to receive palonosetron (0.25 mg) plus dexamethasone (8 mg IV) on day 1 of chemotherapy (n?=?200), or the same regimen followed by oral dexamethasone (8 mg) on days 2 and 3 (n?=?205), were included in the analysis. The primary endpoint was complete response (CR: no vomiting and no rescue anti-emetics) in the 5-day study period. The effect of the 1-day regimen and age (<50 and ≥50 years) was investigated by a meta-analysis of individual patient data. Results Younger patients comprised 43 % and 49 % of the 1-day and 3-day regimen groups, respectively; 94 % of the pooled sample received the AC combination. There were no between-treatment differences in CR rate according to age during all observation periods. In the 1-day regimen group, 55.2 % of younger patients achieved overall CR compared with 54 % of older patients. In the 3-day regimen group, 51.5 % of younger patients achieved overall CR compared with 58.7 % of older patients. In the adjusted analysis, younger age was not associated with overall CR to treatment (risk difference, ?3.1 %; 95 % CI, ?13.0 to 6.7 %; P?=?0.533). Conclusions These results provide evidence that, irrespective of age, the dexamethasone-sparing regimen is not associated with a significant loss in overall anti-emetic protection in women undergoing AC-containing chemotherapy. |
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