Massa, E., Astara, G., Madeddu, C., Dessi, M., Loi, C., Lepori, S., & Mantovani, G. (2009). Palonosetron plus dexamethasone effectively prevents acute and delayed chemotherapy-induced nausea and vomiting following highly or moderately emetogenic chemotherapy in pre-treated patients who have failed to respond to a previous antiemetic treatment: Comparison between elderly and non-elderly patient response. Critical Reviews in Oncology/Hematology, 70, 83–91. 

To determine the effectiveness of palonosetron in prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) for highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC) in patients who had failed to respond to a different antiemetic 5-HT₃ antagonist during the first cycle; to determine differences in response between older adults and younger patients

On day 1, patients received 16 mg dexamethasone plus 250 mcg IV palonosetron before chemotherapy administration. For prophylaxis, patients received 8 mg dexamethasone every 12 hours on days 2–3 and 4 mg dexamethasone every 12 hours on days 4–5. Metoclopramide (20 mg) intramuscular was used at a maximum dose of 80 mg as rescue medication to treat CINV. Patients were asked to record daily episodes of vomiting, nausea, and use of rescue medication daily through day 5.

• The study sample consisted of 47 participants.
• Mean age was 60.7 years (SD = 3 years). Older adults (age 65 or older) had a mean age of 72.3 years (SD = 6 years), and those under age 65 had a mean age of 60.7 years (SD = 3 years).
• The majority of patients (59.6%) were male.
• Diagnoses included tumors at various sites (head and neck, lung-pleural mesothelioma, colorectal, ovary, breast, pancreas, prostate, malignant lymphoma, melanoma, sarcoma, biliary ducts, bladder, and stomach), stages II–IV.
• The chemotherapy regimen was the same as that of previous chemotherapy administered for the first cycle and for which the previous antiemetic treatment failed. Regimens were moderately or highly emetogenic.

The setting was not reported.

All patients were in active treatment.

This was a prospective design, phase II, open, nonrandomized trial.

The following were measured.

• Daily episodes of vomiting (number, duration, and time from chemotherapy administration), vomiting according to Common Terminology Criteria for Adverse Events (CTCAE 3.0) for days 1–5
• Nausea (grade 3–4, according to CTCAE 3.0) on days 1–5
• Use of rescue medication on days 1–5
• Complete response (CR), defined as no emetic episodes and no use of rescue medication during the first 24 hours (acute), and during 24–120 hours (delayed) following chemotherapy
• Complete control (CC), defined as no emetic episodes, no need for rescue medication, and no more than mild nausea in the acute, delayed, and overall periods

• CR and CC for the acute, delayed, and overall phases were not statistically different with the intervention between older adult and younger subjects, compared to the subsequent cycles of chemotherapy after intervention.
• Grade 1–2 toxicities were observed without group differences.
• The most frequently reported adverse events were constipation and anxiety.

Single-dose palonosetron (250 mcg) should be considered a safe second generation 5-HT₃ antagonist in the prevention of nausea and vomiting induced by HEC or MEC, irrespective of patient age.

• The study had fewer than 100 participants.
• The study combined HEC and MEC together but did not include aprepitant.
• The authors in this study concluded that palonsetron is older-adult friendly because the comparison between older adult and younger participants found no difference. However, younger age is a well-known predisposing factor for CINV.
• The sample consisted of patients who previously failed 5-HT₃.
• Anticipatory nausea would be likely but was not discussed.

Palonosetron provides control of CINV regardless of patient age.