Suzuki, K., Yamanaka, T., Hashimoto, H., Shimada, Y., Arata, K., Matsui, R., . . . Yamamoto, N. (2016). Randomized, double-blind, phase III trial of palonosetron versus granisetron in the triplet regimen for preventing chemotherapy-induced nausea and vomiting after highly emetogenic chemotherapy: TRIPLE study. Annals of Oncology, 27, 1601–1606. 

DOI Link

Study Purpose

To evaluate the effectiveness of palonosetron versus granisetron in standard triplet antiemetic therapy

Intervention Characteristics/Basic Study Process

The regimens used were IV palonosetron or granisetron on day 1 in additional or oral aprepitant (125 mg on day 1 and 80 mg/day on days 2–3), IV dexamethasone 12 mg on day 1 and 8 mg/day on days 2–4. No other antiemetics were used. Patients were randomly assigned to the palonosetron or granisetron regimen. Patients recorded nausea daily in a diary. Rescue medication of metoclopramide, domperidone, or dexamethasone was used as needed.

Sample Characteristics

  • N = 827   
  • MEDIAN AGE = 63 years
  • MALES: 74.6%, FEMALES: 25.4%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: All patients had solid tumors and were to receive a cisplatin-based highly emetogenic chemotherapy (HEC) regimen. Multiple tumor types existed; lung cancer was most frequent.

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Inpatient    
  • LOCATION: Japan

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Double-blind, randomized, phase-III trial

Measurement Instruments/Methods

  • Complete control defined as no emesis, no use of rescue medication, and only mild nausea
  • Total control defined as no emesis, no use of rescue medication, and no nausea

Results

CR for delayed phase were higher with palonosetron (67.2% versus 59.1%, p = 0.014). Complete and total control rates were higher with palonosetron, in the delayed phase (p < 0.03).

Conclusions

The use of palonosetron as the 5HT3 in triplet antiemetic therapy was associated with somewhat greater chemotherapy-induced nausea and vomiting (CINV) control in the delayed phase and, as a result, in the overall phase.

Limitations

  • Evaluation was done only in the first cycle of chemotherapy.

Nursing Implications

Palonosetron was associated with a slightly higher proportion of patients having better CINV control in the delayed phase compared to granisetron. Further analysis is warranted to evaluate the actual cost benefit of different 5HT3 selections.