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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).

Publication ,  Conference
Affronti, ML; Woodring, S; Allen, K; Kirkpatrick, J; Peters, KB; Herndon, JE; McSherry, F; Healy, PN; Desjardins, A; Vredenburgh, JJ; Friedman, HS
Published in: Support Care Cancer
October 2016

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/m(2)/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.

Duke Scholars

Published In

Support Care Cancer

DOI

EISSN

1433-7339

Publication Date

October 2016

Volume

24

Issue

10

Start / End Page

4365 / 4375

Location

Germany

Related Subject Headings

  • Temozolomide
  • Surveys and Questionnaires
  • Quinuclidines
  • Quality of Life
  • Palonosetron
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male
  • Isoquinolines
  • Humans
 

Citation

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Affronti, M. L., Woodring, S., Allen, K., Kirkpatrick, J., Peters, K. B., Herndon, J. E., … Friedman, H. S. (2016). 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). In Support Care Cancer (Vol. 24, pp. 4365–4375). Germany. https://doi.org/10.1007/s00520-016-3276-1
Affronti, Mary Lou, Sarah Woodring, Karen Allen, John Kirkpatrick, Katherine B. Peters, James E. Herndon, Frances McSherry, et al. “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).” In Support Care Cancer, 24:4365–75, 2016. https://doi.org/10.1007/s00520-016-3276-1.
Affronti ML, Woodring S, Allen K, Kirkpatrick J, Peters KB, Herndon JE, McSherry F, Healy PN, Desjardins A, Vredenburgh JJ, Friedman HS. 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). Support Care Cancer. 2016. p. 4365–4375.
Journal cover image

Published In

Support Care Cancer

DOI

EISSN

1433-7339

Publication Date

October 2016

Volume

24

Issue

10

Start / End Page

4365 / 4375

Location

Germany

Related Subject Headings

  • Temozolomide
  • Surveys and Questionnaires
  • Quinuclidines
  • Quality of Life
  • Palonosetron
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male
  • Isoquinolines
  • Humans