Efficacy and quality of life analysis of palonosetron vs for high and moderate emetogenic chemotherapy for breast cancer Arce-Salinas C, Deneken-Hernandez Z, González JP, Flores-Díaz D, Matus-Santos Ja, Aguilar-Ponce JL, Macedo-Perez O, Calderillo-Ruiz O, Ruiz-García E Instituto Nacional de Cancerologia, Ciudad de Mexico, Mexico.

BACKGROUND METHODS RESULTS Design: 262 patients were included, median age were 50 and 49 years-old respectively p=0.82. There were no differences in clinical stage, and breast Nausea and vomiting are common complications of the - Randomized, open label trial chemotherapy (CINV), and its presence can affect the patient’s cancer subtype. quality of life. Endpoints: Efficacy in actue and delayed control and safety analysis Palnosetron Ondansetron p Also presence of CINV affects treatment adherence and its - Primary, Acude conttrol . N=126 N=128 Acute control nausea 61 (49.6%) 51 (40.8%) 0.376 efficacy due to dose reduction or dose delays. -Secondary end points: Overall control (acute and dalayed) visits to (absence of nausea at all) ER due to CINV, safety and tolerability . Acute vomiting control There are various regiments that varies in both cost (abscence of vomiting at all) 107 (87%) 101 (80.8%) 0.403 Delayed control of nausea and effectiveness Statistical analysis (absence of nausea at all) 48 (39%) 49 (39.8%) 0.888 Delayed control of Group comparison was done with X² test, and U-Mann Whiithey vomitting (absence of 83 (67.5%) 83 (67.5%) 0.359 vomitting at all) OBJECTIVES test. Demographic characteristics were summarized with median an Safety analysis interval range. QTc prolongation grade 1 26 (21.7%) 29 (24.2%) 0.851 Constipation grade ½ 51 (41.5%) 42 (33.6%) 0.401 The aim of this trial is to evaluate the efficacy in acute and Constipation grade 3 13( 10.5%) 15 (12%) Local ethics committee approves the trial. NCT03606369 Fatigue grade 1/2 61 (49.6%) 69 (55.2%) 0.408 delayed CINV of ondansetron vs palonosetron plus Fatigue grado 3 28 (22.7%) 24 (27.2%9 during the firs cycle of moderate or high RESULTS emetogenic risk chemotherapy in (neo)adjuvant setiing There were no differences in acute and daleyd control, as well in overall Patient and Disease Baseline Characteristics control among treatment arms. Adverse events were present in the same Palnosetron Ondansetron p PATIENTS N=126 N=128 proportion. QoL did not showed differences according treatment Median Age 50 (23-78) 49 (23-79) NS Patients candidates to (neo)adjuvant chemotherapy ( TC or AC or Chemotherapy 111 (88.1%) 108 (86.4%) CONCLUSIONS AC NS TCH), with good PS, older than 18 years-old, adequate organ TC 15 (11.9%) 17 (13.6%) Comormidities Palonosetron or ondansetron are equally effective in prevention function and have signed informed consent form were included Diabetes 17 (13.4%) 8 (5.9%) 0.008 Hypertension 27 (21.3%) 242 (17.8%) 0.060 acute and delayed CINV, they also maintain similar quality of Obesity/Overweight 85 (67.5) 87 (70.8) NS life Hormonal status Premenopausal 62 (48.8%) 64 (47.4%) NS R Postmenopausal 65 (51.2%) 71 (52.6%) NS REFERENCES Clinical/pathological stage (AJCC v7) 1. Coates A, Abraham S, Kaye SB, et al.: On the receiving end-patient perception of the side-effects of cancer chemotherapy. Eur J Cancer Clin Oncol 1983; 19 (2): 203-8. 1:1 2. Schnell, F. Chemotherapy-Induced Nausea and Vomiting: The importance of acute antiemetic control. The Oncologist 2003;8:187-198 I 9 (7.1%) 8 (6.4%) NS 3. Ondansetron + vs + dexamethasone + in prevention of cisplatin-induced emesis. Italian Group For Antiemetic Research. Lancet 1992; 340 (8811): 96-9. ii 69 (54.8%) 68 (54%) NS 4. De Mulder PH, Seynaeve C, Vermorken JB, et al.: Ondansetron compared with high-dose metoclopramide in prophylaxis of acute and delayed cisplatin-induced II 48 (38.1%) 50 (39.7%) NS nausea and vomiting. A multicenter, randomized, double-blind, crossover study. Ann Intern Med 1990; 113 (11): 834-40. 5. Hesketh PJ, Grunberg SM, Gralla RJ, et al.: The oral neurokinin-1 antagonist for the prevention of chemotherapy-induced nausea and vomiting: a multinational, randomized, double blind, placebo-controlled trial in patients receiving high-dose cisplatin--the Aprepitant Protocol 052 Study Group. J Clin Oncol 2003;21 (22): 4112-9.

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