Rozzi, A., Nardoni, C., Corona, M., Restuccia, M.R., Fabi, A., Bria, E., … Lanzetta, G. (2011). Palonosetron for the prevention of chemotherapy-induced nausea and vomiting in glioblastoma patients treated with temozolomide: A phase II study. Supportive Care in Cancer, 19(5), 697–701.
To investigate the efficacy of palonosetron for prevention of chemotherapy-induced nausea and vomiting (CINV) caused by adjuvant temozolomide (TMZ) in patients affected by glioblastoma
After completion of concomitant radiotherapy plus daily TMZ (75 mg/m2) in patients with stable disease or better, 30 minutes before the beginning of the first cycle of adjuvant TMZ (150-200 mg/m2 per day for five consecutive days every 4 weeks), patients received a single IV bolus of 0.25 mg palonosetron. All patients were receiving oral or parenteral dexamethasone (range 2–8 mg/day) with steady doses from at least 14 days before adjuvant TMZ initiation.
Patient diaries were used to record any emetic episodes, nausea, or rescue medication in daily (24-hour) intervals. The daily rates of emesis and nausea were assessed using a Likert-type scale. The primary endpoint was the percentage of patients with complete response (CR), defined as no emetic episodes and no rescue medication during the overall phase (0–168 hours).
This study was conducted at a single-site, outpatient setting at the Clinical Oncology Unit of Istituto Neurotraumatologico Italiano (I.N.I.) in Rome, Italy.
This was a prospective, open phase II study.
Complete response during the overall treatment period (0–168 hours) was observed in 30 patients (91%). Complete response in the 0–120-hour and 121–168-hour phases was observed in 30 patients (91%). Complete control was seen in 29 patients (88%), in 30 patients (91%), and in 29 patients (88%) during the 0–120-hour, 120–168-hour, and 0–168-hour phases, respectively.
The results suggested that a single dose of palonosetron before the initiation of multiple oral doses of TMZ, in patients receiving treatment with steady doses of dexamethasone, provides a high level of protection against CINV throughout the overall phase (0–168 hours). Discerning the affect of dexamethasone on nausea prevention was difficult in this study. Understanding the full impact of this regimen is challenging. A similar study conducted with ondansetron or another oral 5-HT3 RA would be interesting. If oral antiemetics are able to achieve similar results, they may be more cost effective and convenient for patients.
More antineoplastic drugs are being given orally at home. This study looked at the use of an antiemetic regimen used with an oral drug. Studies like this will become increasingly important as oral continuous-dosing drug regimens emerge. Adequate control of nausea and vomiting is essential for oral therapies, because lack of control can lead to patient noncompliance.