Is a dexamethasone-sparing strategy capable of preventing acute and delayed emesis caused by combined doxorubicin and paclitaxel for breast cancer? Analysis of a phase II trial

Oncology. 2013;84(6):371-7. doi: 10.1159/000348538. Epub 2013 May 22.

Abstract

Objective: The effectiveness of palonosetron without delayed dexamethasone dosing against emesis was investigated in patients scheduled to receive the corticosteroid-containing combination of doxorubicin and paclitaxel (AT) for 3 cycles.

Methods: Chemo-naïve women with breast cancer receiving doxorubicin (60 mg/m(2)) and paclitaxel (200 mg/m(2)) were eligible. Patients received palonosetron 0.25 mg intravenously before chemotherapy, however, all patients also received a premedication consisting of prednisone (25 mg orally the evening before therapy) and hydrocortisone (250 mg intravenously just before paclitaxel). The primary end point was complete control (CC; no vomiting, no rescue anti-emetics, and no more than mild nausea) during the overall phase (days 1-5) following cycle 1.

Results: Seventy-six patients were enrolled and evaluable (median age 50 years). Fifty-six patients (74%; 95% CI 62-83%) achieved overall CC. Acute (day 1) and delayed (days 2-5) CC rates were 78 and 74%, respectively. No vomiting rates for the acute, delayed and overall phases were 85, 85 and 83%, respectively. An exploratory analysis showed only a small decrease in the probability of achieving CC between cycle 1 (74%) and cycle 3 (66%).

Conclusion: The dexamethasone-sparing strategy prevented emesis in more than 70% of breast cancer patients receiving their initial cycle of AT chemotherapy.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Aged
  • Antiemetics / therapeutic use
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects*
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Breast Neoplasms / drug therapy*
  • Carcinoma / drug therapy*
  • Constipation / chemically induced
  • Dexamethasone / therapeutic use
  • Doxorubicin / administration & dosage
  • Female
  • Headache / chemically induced
  • Humans
  • Isoquinolines / adverse effects
  • Isoquinolines / therapeutic use*
  • Middle Aged
  • Nausea / chemically induced
  • Nausea / prevention & control*
  • Paclitaxel / administration & dosage
  • Palonosetron
  • Quinuclidines / adverse effects
  • Quinuclidines / therapeutic use*
  • Serotonin Antagonists / adverse effects
  • Serotonin Antagonists / therapeutic use*
  • Time Factors
  • Treatment Outcome
  • Vomiting / chemically induced
  • Vomiting / prevention & control*
  • Young Adult

Substances

  • Antiemetics
  • Isoquinolines
  • Quinuclidines
  • Serotonin Antagonists
  • Palonosetron
  • Dexamethasone
  • Doxorubicin
  • Paclitaxel