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Supportive Care in Cancer

, Volume 24, Issue 10, pp 4365–4375 | Cite as

Phase II study to evaluate the safety and efficacy of intravenous palonosetron (PAL) in primary malignant glioma (MG) patients receiving standard radiotherapy (RT) and concomitant temozolomide (TMZ)

  • Mary Lou AffrontiEmail author
  • Sarah Woodring
  • Karen Allen
  • John Kirkpatrick
  • Katherine B. Peters
  • James E. HerndonII
  • Frances McSherry
  • Patrick N. Healy
  • Annick Desjardins
  • James J. Vredenburgh
  • Henry S. Friedman
Original Article

Abstract

Background

In malignant glioma (MG) patients undergoing radiation therapy (RT) with concomitant temozolomide, chemoradiation-induced nausea and vomiting (cRINV) degrades quality of life (QoL) and reduces treatment adherence, which thereby potentially compromises cancer control.

Methods

We conducted a 6-week phase II single-arm trial of PAL, a second-generation 5-HT3RA antiemetic, for cRINV prevention in MG patients receiving radiation therapy (RT; 54–60 Gy) and concomitant daily temozolomide (TMZ; 75 mg/m2/dX42d). Each week before radiation, patients received single-dose palonosetron (PAL) 0.25 mg IV (total = 6 doses). With safety/tolerability as the primary endpoint, the study was designed to differentiate between toxicity rates of 25 % (unacceptable) and 10 % (acceptable) toxicity rates. Secondary endpoints included the percentage of patients achieving cRINV complete response (CR: no emesis or rescue antiemetic) and QoL. Patients reported adverse effects in Common Toxicity Criteria for Adverse Events diaries; recorded vomiting, nausea, and rescue medication use in diaries (which were used to assess cRINV-CR); and reported QoL 4 days/week using the Modified Functional Living Index-Emesis (M-FLIE) and Osoba nausea and vomiting/retching modules.

Results

We enrolled 38 patients (mean age 59 years, 55 % female, 95 % white, 68 % used oral corticosteroids, 76 % reported low alcohol use). Four patients (10.5 %) experienced unacceptable treatment-related toxicity, defined as any grade 3, 4, or 5 non-hematologic toxicity. M-FLIE and Osoba scores showed no evidence of treatment impact on QoL. Overall, cRINV-CR rates for 6 weeks ranged from 67–79 %.

Conclusion

Single-dose weekly PAL is a safe and tolerable antiemetic for cRINV prevention in MG patients receiving standard RT and concomitant TMZ.

Keywords

Chemotherapy Nausea Emesis Radiation-induced nausea and vomiting Safety Efficacy Supportive care Antiemetic guidelines Evidence-based practice Gliomas 

Notes

Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest.

Disclosures

Eisai pharmaceutical has supported this investigator initiated IRB approved study.

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Copyright information

© Springer-Verlag Berlin Heidelberg 2016

Authors and Affiliations

  • Mary Lou Affronti
    • 1
    • 2
    • 3
    Email author
  • Sarah Woodring
    • 1
    • 3
  • Karen Allen
    • 4
  • John Kirkpatrick
    • 4
  • Katherine B. Peters
    • 3
    • 5
  • James E. HerndonII
    • 6
  • Frances McSherry
    • 6
  • Patrick N. Healy
    • 6
  • Annick Desjardins
    • 3
    • 5
  • James J. Vredenburgh
    • 7
  • Henry S. Friedman
    • 1
    • 3
    • 8
    • 9
    • 10
  1. 1.Department of NeurosurgeryDuke University Health SystemDurhamUSA
  2. 2.Duke University School of NursingDurhamUSA
  3. 3.The Preston Robert Tisch Brain Tumor Center at DukeDuke University Medical CenterDurhamUSA
  4. 4.Department of Radiation OncologyDuke University Health SystemDurhamUSA
  5. 5.Department of NeurologyDuke University Health SystemDurhamUSA
  6. 6.Department of Biostatistics and BioinformaticsDuke University Health SystemDurhamUSA
  7. 7.Saint Francis Cancer CenterHartfordUSA
  8. 8.Department of MedicineDuke University Health SystemDurhamUSA
  9. 9.Department of PediatricsDuke University Health SystemDurhamUSA
  10. 10.Department of PathologyDuke University Health SystemDurhamUSA

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