Objective: The aim of this study was to evaluate if addition of metoclopramide to the triplet antiemetic therapy is superior to the triplet antiemetic therapy for prevention of delayed chemotherapy-induced nausea and vomiting. Materials and Methods: A randomized single-blind trial was performed on 200 chemotherapy-naïve breast cancer patients who have to receive anthracycline-based highly emetogenic chemotherapy (HEC). The patients were randomized to study arm (n = 100) and control arm (n = 100). Triplet antiemetic therapy (fosaprepitant on day 1, 5-HT3 antagonist on day 1, and dexamethasone for days 1–4) was used in both the arms and metoclopramide (day 1–5) was added to the study arm. Response to antiemetic prophylaxis was assessed in terms of “complete response (CR),” “only nausea,” and “both nausea and vomiting.” CR is defined as no nausea, no vomiting, and no rescue medication during the overall phase (days 1–5). Nausea/vomiting was detected by using the Visual Analog Scale and its impact on quality of life was determined by using the Functional Living Index Emesis (FLIE) score. Results: The demographical and clinical features were similar in both the groups. Majority of patients in both the arms presented with Eastern Cooperative Oncology Group PS 0, Stage III, and positive hormone receptor status. CR was observed more in the study arm than that of the control arm (51% vs. 37%; P = 0.046). The mean total FLIE score was 29.23 in the study arm and 31.16 in the control arm (P = 0.036). Conclusion: This study resulted in a significant CR and clinically relevant improvement in FLIE score for addition of metoclopramide to triple antiemetic prophylaxis. Therefore, a quadruple antiemetic combination including metoclopramide might be an antiemetic prophylaxis option for breast cancer patients receiving anthracycline-based HEC for better compliance to treatment.

Background: Performance status (PS) is a strong, validated prognostic factor across all cancer types, especially in the advanced phase. It is estimated usually by the Karnofsky (KPS) or the ECOG scale, each of them having peculiar features. Two possible way of comparing KPS and ECOG scales are possibile, differing in the attribution of KPS 90,70, 50 and 30% respectively to PS 0,1,2 and 3 or to 1,2,3 and 4. From the limited data available, the latter comparison seems to better adapt to real-world clinical data (Verger E, Cancer 1992).Methods: From 1st May 2019 to 19th May 2020 all the consecutive values of KPS and ECOG PS were simultaneously recorded from every clinical evaulation of three medical oncologists from the Lung Cancer Unit. In particular, KPS values were estimated with the help of specific questions involving the domain of daily self-dependence and self-care (Schag CC, JCO 1984). The attribution of KPS 90,70,50 and 30% to PS 0,1,2 and 3 or to PS 1,2,3 and 4 was defined respectively as the BOLD or the CONSERVATIVE comparison. Moreover, data about DISCORDANT cases (i.e. very different KPS and ECOG values) were analyzed.Results: Values of KPS and ECOG PS from two-thousand consecutive clinical evaluations were collected, 86.5% conducted in an outpatient setting and 78.3% in patients affected by NSCLC or SCLC. Median age of patients was 68.2 years, male/female ratio was 2.26. Mean values of KPS and ECOG PS for the entire cohort were 79.98% and 1.1. The distribution of the attribution of KPS 90,70,50 and 30% to the BOLD or to the CONSERVATIVE comparison was: Discordant KPS-ECOG values were identified in 16 cases (0.8%): 14 with KPS 60%-PS 3 (all cases with advanced thoracic cancers), 1 with 50%-PS 2, and 1 with 80%-PS 0.Conclusions: In a real-practice population of aggressive cancers the CONSERVATIVE way of comparing ECOG PS and KPS seems to fit better the clinical data, especially when PS worsens (KPS 70, 50 or 30%). Further researches are however needed to improve the correlation of the two PS scales.Legal entity responsible for the study: The authors.