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A phase II trial of olanzapine, dexamethasone, and palonosetron for the prevention of chemotherapy-induced nausea and vomiting: a Hoosier oncology group study

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Abstract

Objective

The purpose of this study is to determine the control of acute and delayed chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately emetogenic chemotherapy (MEC) and highly emetogenic chemotherapy (HEC) with the combined use of palonosetron and olanzapine, and dexamethasone with the dexamethasone given on day 1 only.

Materials and methods

Forty chemotherapy-naive patients received on the day of chemotherapy, day 1, an anti-emetic regimen consisting of dexamethasone, palonosetron, and olanzapine. Patients continued olanzapine for days 2–4 after chemotherapy administration. Patients recorded daily episodes of emesis, daily symptoms utilizing the M.D. Anderson Symptom Inventory, and the utilization of rescue therapy.

Results

For the first cycle of chemotherapy, the complete response (no emesis, no rescue) for the acute period (24 h post-chemotherapy) was 100%, the delayed period (days 2–5 post-chemotherapy) 75%, and the overall period (0 120 h post-chemotherapy) 75% in 8 patients receiving HEC and was 97, 75, and 72% in 32 patients receiving MEC. Patients with no nausea for the acute period was 100%, the delayed period 50%, and the overall period 50% in 8 patients receiving HEC and was 100, 78, and 78% in 32 patients receiving MEC.

Discussion

The complete response and control of nausea in subsequent cycles of chemotherapy were not significantly different from cycle one.

Conclusion

Olanzapine combined with a single dose of dexamethasone and a single dose of palonosetron was very effective in controlling acute and delayed CINV in patients receiving both HEC and MEC.

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Acknowledgment

This study was supported by the Walther Cancer Institute, MGI Pharma, and Eli Lilly.

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Authors and Affiliations

  1. Notre Dame Cancer Institute, University of Notre Dame, 224 Raclin-Carmichael Hall, Notre Dame, IN 46556, USA

    Rudolph M. Navari

  2. Indiana University School of Medicine South Bend, South Bend, IN, USA

    Rudolph M. Navari

  3. Division of Hematology-Oncology, Indiana University Medical Center, Indianapolis, IN, USA

    Lawrence H. Einhorn, Patrick J. Loehrer Sr & Nasser H. Hanna

  4. Indiana University Cancer Center, Indianapolis, IN, USA

    Lawrence H. Einhorn, Patrick J. Loehrer Sr & Nasser H. Hanna

  5. Memorial Sloan-Kettering Cancer Center, New York, NY, USA

    Steven D. Passik

  6. Hoosier Oncology Group, Indianapolis, IN, USA

    Jake Vinson

  7. Medical and Surgical Specialists, Galesburg, IL, USA

    John McClean

  8. Cancer Care Center, New Albany, IN, USA

    Naveed Chowhan

  9. Division of Biostatistics, Indiana University School of Medicine, Indianapolis, IN, USA

    Cynthia S. Johnson

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  1. Rudolph M. Navari
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  2. Lawrence H. Einhorn
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  4. Steven D. Passik
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  8. Nasser H. Hanna
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Correspondence to Rudolph M. Navari.

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Navari, R.M., Einhorn, L.H., Loehrer, P.J. et al. A phase II trial of olanzapine, dexamethasone, and palonosetron for the prevention of chemotherapy-induced nausea and vomiting: a Hoosier oncology group study. Support Care Cancer 15, 1285–1291 (2007). https://doi.org/10.1007/s00520-007-0248-5

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  • DOI: https://doi.org/10.1007/s00520-007-0248-5

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