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

Abstract

PurposeData 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.MethodsChemo-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.ResultsYounger 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).ConclusionsThese 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.

Efficacy of triple antiemetic therapy (palonosetron, dexamethasone, aprepitant) for chemotherapy-induced nausea and vomiting in patients receiving carboplatin-based, moderately emetogenic chemotherapy.

“…They reported that addition of dexamethasone on days 2 and 3 reduced CINV in the delayed phase. Conversely, Celio et al (2013) demonstrated that a dexamethasone-sparing regimen is not associated with a significant loss in overall antiemetic protection in women undergoing AC if palonosetron is used as an antiemetic. The beneficial effect of an NK-1 inhibitor for control of delayed CINV is also controversial.…”

Efficacy of triple antiemetic therapy (palonosetron, dexamethasone, aprepitant) for chemotherapy-induced nausea and vomiting in patients receiving carboplatin-based, moderately emetogenic chemotherapy

“…They reported that addition of dexamethasone on days 2 and 3 reduced CINV in the delayed phase. Conversely, Celio et al (2013) demonstrated that a dexamethasone-sparing regimen is not associated with a significant loss in overall antiemetic protection in women undergoing AC if palonosetron is used as an antiemetic.…”

Effect of increase in duration of aprepitant consumption from 3 to 6 days on the prevention of nausea and vomiting in women receiving combination of anthracycline/cyclophosphamide chemotherapy: A randomized, crossover, clinical trial

“…However, loss of control on days 6 through 8 in the delayed phase remains a challenge, therefore adding aprepitant to the standard antiemetic prophylaxis for 6 days provides a significant improvement in complete control for CINV from 43% to 63%. [ 22 23 24 ] Madsen et al . report that a 5-day dosing regimen of aprepitant is highly effective for preventing CINV, although, single doses of oral aprepitant 40 mg or oral aprepitant 125 mg alone were effective for the prevention of postoperative nausea and vomiting.…”