| Title |
A Phase II single-arm trial of palonosetron for the prevention of acute and delayed chemotherapy-induced nausea and vomiting in malignant glioma patients receiving multidose irinotecan in combination with bevacizumab
|
|---|---|
| Published in |
Therapeutics and Clinical Risk Management, December 2016
|
| DOI | 10.2147/tcrm.s122480 |
| Pubmed ID | |
| Authors |
Mary Lou Affronti, Sarah Woodring, Katherine B Peters, James E Herndon, Frances McSherry, Patrick N Healy, Annick Desjardins, James J Vredenburgh, Henry S Friedman |
| Abstract |
Given that the prognosis of recurrent malignant glioma (MG) remains poor, improving quality of life (QoL) through symptom management is important. Meta-analyses establishing antiemetic guidelines have demonstrated the superiority of palonosetron (PAL) over older 5-hydroxytryptamine 3-receptor antagonists in chemotherapy-induced nausea and vomiting (CINV) prevention, but excluded patients with gliomas. Irinotecan plus bevacizumab is a treatment frequently used in MG, but is associated with low (55%) CINV complete response (CR; no emesis or use of rescue antiemetic) with commonly prescribed ondansetron. A single-arm Phase II trial was conducted in MG patients to determine the efficacy of intravenous PAL (0.25 mg) and dexamethasone (DEX; 10 mg) received in conjunction with biweekly irinotecan-bevacizumab treatment. The primary end point was the proportion of subjects achieving acute CINV CR (no emesis or antiemetic ≤24 hours postchemotherapy). Secondary end points included delayed CINV CR (days 2-5), overall CINV CR (days 1-5), and QoL, fatigue, and toxicity. A two-stage design of 160 patients was planned to differentiate between CINV CR of 55% and 65% after each dose of PAL-DEX. Validated surveys assessed fatigue and QoL. A total of 63 patients were enrolled, after which enrollment was terminated due to slow accrual; 52 patients were evaluable for the primary outcome of acute CINV CR. Following PAL-DEX dose administrations 1-3, acute CINV CR rates were 62%, 68%, and 70%; delayed CINV CR rates were 62%, 66%, and 70%, and overall CINV CR rates were 47%, 57%, and 62%, respectively. Compared to baseline, there was a clinically meaningful increase in fatigue during acute and overall phases, but not in the delayed phase. There were no grade ≥3 PAL-DEX treatment-related toxicities. Data suggest that PAL-DEX is effective in preventing CINV in MG patients, which ultimately maintains the QoL of patients with glioma. |
X Demographics
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Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Brazil | 1 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 1 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 29 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 29 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Researcher | 5 | 17% |
| Student > Master | 4 | 14% |
| Student > Bachelor | 4 | 14% |
| Other | 3 | 10% |
| Lecturer | 2 | 7% |
| Other | 3 | 10% |
| Unknown | 8 | 28% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 9 | 31% |
| Nursing and Health Professions | 5 | 17% |
| Pharmacology, Toxicology and Pharmaceutical Science | 2 | 7% |
| Neuroscience | 2 | 7% |
| Social Sciences | 2 | 7% |
| Other | 1 | 3% |
| Unknown | 8 | 28% |
Attention Score in Context
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#20,656,161
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Outputs from Therapeutics and Clinical Risk Management
#1,070
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Outputs of similar age from Therapeutics and Clinical Risk Management
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