Abstract

e20702 Background: Chemotherapy-related nausea and vomiting (N/V) continue to be significant problems for cancer patients. In order to properly design a study leading to control of N/V in patients receiving consecutive days of cisplatin, stage IV melanoma patients who received three consecutive days of a cisplatin-containing chemotherapy were assessed. Methods: Patients were treated with cisplatin (25mg/m2, days 1–3), DTIC (220mg/m2, days 1–3), BCNU (150mg/m2, day 1) and tamoxifen (20mg twice a day, consecutively). The second cycle was given in 4 weeks without BCNU. Appropriate antiemetics were given during chemotherapy and then as needed for symptom control. N/V were assessed with the Functional Living Index-Emesis (FLIE) questionnaire for seven days (days 1–7). The median intensity of N/V during the early phase (days 1–3) and the late phase (days 4–7) was analyzed using the linear mixed effects model, adjusting for the subject random effects. The rates of intractable N/V (total FLIE score equal or less than 108) were analyzed in the random-effects logistic regression model. Results: A total of 14 patients answered the FLIE questionnaire. For nausea in cycle 1, the means of the median FLIE scores were similar in the early (52.7, 95%CI: 44.5, 60.8) and late (50.2, 95%CI: 42.0, 58.3) phases. In cycle 2, lower scores were observed in the late phase (45.2, 95%CI: 36.4, 54.0) than in the early phase (54.1, 95%CI: 45.6, 62.7) with a significant difference of 8.9 points (95%CI: 0.1, 17.7, p=0.049). For vomiting, the means of the median FLIE scores were similar in the early and late phases of either cycle. For the rates of intractable N/V, the differences between cycles and late vs. early phases were borderline significant. Higher odds of intractable N/V were estimated for cycle 2 vs. cycle 1 [OR=2.44 (95%CI: 0.945, 6.29; p=0.065)] and for late vs. early phases [odds ratio OR=2.39 (95%CI: 0.970, 5.870; p=0.058)]. Conclusions: The FLIE questionnaire is useful for objective assessment of N/V in patients who receive consecutive days of emetogenic chemotherapy. The data obtained from this study will form the basis for a future interventional study in which anti-emetics that are effective for late-phase N/V will be tested. No significant financial relationships to disclose.

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