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).

• The study reported on 33 patients with a median age of 57.6 years.
• The sample was 70% male and 30% female.
• Patients had glioblastoma (GBM) with disease control after combined radiochemotherapy; normal hematologic, renal, and hepatic function; and Karnofsky Performance Status (KPS) of 70 or higher.

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.

• Patients were undergoing the active treatment phase of care.
• The study has clinical applicability for elderly care.

This was a prospective, open phase II study.

• Patient diaries were used to record any emetic episodes, nausea, or rescue medication in daily (24 hour) intervals.  Complete response (CR), defined as no vomiting and no use of rescue medications, was measured, as well as complete control (CC), defined as no emetic episodes, no rescue medication, and no more than mild nausea.      
• A Likert-type scale was used to measure 

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.

• The sample size was small with fewer than 100 patients.
• Patients were given different doses of dexamethasone. Although the dose of dexamethasone was required to be stable for 14 days prior to study entry for each patient, the difference in dose may have impacted the antiemetic properties of the dexamethasone/palonsetron regimen.  
• The majority of the sample was men (70%), which may play a role in the rate of effective nausea/vomiting control. Women tend to be at higher risk for chemotherapy induced nausea. Conducting the study using a sample with a more even sex distribution would be interesting.

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.