Takeshima, N., Matoda, M., Abe, M., Hirashima, Y., Kai, K., Nasu, K., . . . Ito, K. (2014). Efficacy and safety of triple therapy with aprepitant, palonosetron, and dexamethasone for preventing nausea and vomiting induced by cisplatin-based chemotherapy for gynecological cancer: KCOG-G1003 phase II trial. Supportive Care in Cancer, 22(11), 2891–2898.
To evaluate the efficacy of the triple therapy of aprepitant, palonosetron, and dexamethasone in patients with gynecological cancer receiving highly emetogenic chemotherapy
Women with gynecological cancer who were receiving highly emetogenic chemotherapy received 125 mg PO aprepitant before chemotherapy on day 1 and 80 mg on days 2 and 3, 0.75 mg of IV palonosetron before chemotherapy on day 1, and 9.9 mg of PO/IV dexamethasone before chemotherapy on day 1 and at 6.6 mg on days 2–4. The primary aim was to evaluate the number of patients with a complete response (CR) overall, which was defined as no vomiting and no use of rescue medication during the entire study period (0–120 hours postchemotherapy). The secondary aims were (1) to evaluate CR in the acute (0–24 hours postchemotherapy) and delayed (24–120 hours postchemotherapy) phases of treatment and (2) to evaluate complete protection (CP) defined as no vomiting, no rescue therapy, and no significant nausea overall and during the acute and delayed phases of treatment.
Prospective, multi-center study
No information was provided on the measurement of nausea and vomiting. A Visual Analog Scale (VAS) may have been used, although this was not expressly stated and the range and timing of administration of the VAS was undefined.
For the primary aim, overall CR rate was 54.2 %. For the secondary aim, evaluating the number of patients with CR in the acute and delayed phases of treatment, CR was 87.5% in the acute phase of treatment and 56.3% in the delayed phase of treatment. For the secondary aim evaluating CP overall and during the acute and delayed phases of treatment, CP overall was 44.8%, CP during the acute phase of treatment was 82.3%, and CP during the delayed phase of treatment was 45.8%.
CINV is often difficult to control and is especially prevalent in female patients. The combination of aprepitant, palonosetron, and dexamethasone has comparable rates of CR and CP when compared to other antiemetic regimens; however, the population used in this study has been shown to be at greater risk for severe CINV. This should be a recommended antiemetic regimen for gynecological patients receiving highly emetogenic chemotherapy.