Abstract
We previously conducted the TRIPLE study, (phase lll), a double-blind randomized controlled trial, comparing 0.75 mg of Palonosetron (PALO) with 1 mg of Granisetron for the control of highly emetogenic chemotherapy-induced emesis, in 2012.
That study, which included Cisplatin, enrolled 842 patients in Japan and examined which drug should be used as the serotonin receptor antagonist (5-HT3RA) in the standard antiemetic triplet regimen recommended by the Japan Society of Clinical Oncology. PALO was released in 2010 as a long-acting 5-HT3RA, particularly for use in highly emetogenic regimens. However, before conducting the TRIPLE study, we could not find any studies that proved its advantages over conventional 5-HT3RAs; moreover, the use of PALO in clinical settings was controversial. Since PALO is more expensive than another 5-HT3RA, Granisetron (GRA), we opined that PALO should not be used so easily unless its advantages can be verified. Hence, we, a group of pharmacists, performed the TRIPLE study to address these unanswered issues. The results showed a higher anti-emetic efficacy of PALO than GRA, although there was no significant difference in terms of complete response (CR) rate (PALO 65.7%, GRA 59.1% P = 0.0539). We conducted a multicenter study to answer the clinical questions that arose during the course of business. Since then, the results of our cross-institutional, multi-specialty, double-blind TRIPLE study have been adopted in Japanese guidelines. In this report, we use the TRIPLE study to explain the significance of clinical studies conducted by pharmacists.
