Evaluating the impact of chemotherapy-induced nausea and vomiting on daily functioning in patients receiving dexamethasone-sparing antiemetic regimens with NEPA (netupitant/palonosetron) in the cisplatin setting: results from a randomized phase 3 study
Luigi Celio,
Diego Cortinovis,
Alessio Aligi Cogoni,
Luigi Cavanna,
Olga Martelli,
Simona Carnio,
Elena Collovà,
Federica Bertolini,
Fausto Petrelli,
Alessandra Cassano,
Rita Chiari,
Francesca Zanelli,
Salvatore Pisconti,
Isabella Vittimberga,
Antonietta Letizia,
Andrea Misino,
Angela Gernone,
Erminio Bonizzoni,
Sara Pilotto,
Sabino De Placido,
Emilio Bria
Affiliations
Luigi Celio
Medical Oncology Unit, ASST del Garda, Desenzano del Garda Hospital
Diego Cortinovis
Medical Oncology Department, ASST Monza San Gerardo Hospital
Alessio Aligi Cogoni
Medical Oncology Department, Azienda Ospedaliero-Universitaria di Sassari
Luigi Cavanna
Oncology Department, Azienda Ospedaliera di Piacenza
Olga Martelli
Medical Oncology, ASL Frosinone
Simona Carnio
Department of Oncology, San Luigi Gonzaga Hospital, University of Turin
Elena Collovà
Cancer Centre Department – Oncology Unit, ASST Ovest Milanese – Legnano Hospital
Federica Bertolini
Department of Oncology and Hematology, AOU Policlinico di Modena
Fausto Petrelli
Medical Oncology Unit, ASST Bergamo Ovest
Alessandra Cassano
Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS
Rita Chiari
Oncology Unit, AULSS6 Euganea
Francesca Zanelli
Medical Oncology Unit, IRCCS Santa Maria Nuova
Salvatore Pisconti
Medical Oncology Department, San Giuseppe Moscati Hospital
Isabella Vittimberga
Department of Oncology, ASST Lecco
Antonietta Letizia
Department of Pneumology and Oncology, AORN dei Colli-Ospedale Monaldi
Andrea Misino
Medical Oncology, Clinical Cancer Center “Giovanni Paolo II” – IRCCS
Angela Gernone
Medical Oncology Unit, University of Bari, Policlinico di Bari
Erminio Bonizzoni
Department of Clinical Science and Community, Section of Medical Statistics, Biometry and Epidemiology “G.A. Maccacaro”, Faculty of Medicine and Surgery, University of Milan
Sara Pilotto
Section of Oncology, Department of Medicine, University and Hospital Trust of Verona
Sabino De Placido
Clinical Medicine and Surgery Department, University of Naples “Federico II”
Emilio Bria
Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS
Abstract Background The non-inferiority of dexamethasone (DEX) on day 1, with or without low-dose DEX on days 2 and 3, combined with oral NEPA (netupitant/palonosetron), compared with the guideline-consistent use of DEX was demonstrated in cisplatin. Here, we complete the analysis by assessing the impact of emesis on daily lives of patients receiving DEX-sparing regimens using the Functional Living Index-Emesis (FLIE). Methods Chemotherapy-naïve patients undergoing cisplatin (≥70 mg/m2), were given NEPA and DEX (12 mg) on day 1 and randomized to receive either 1) no further DEX (DEX1), 2) oral DEX (4 mg daily) on days 2–3 (DEX3), or 3) DEX (4 mg twice daily) on days 2–4 (DEX4; control). Patients completed the FLIE questionnaire on day 6 of cycle 1. Endpoints included the FLIE nausea domain, vomiting domain, and overall combined domain scores, as well as the proportion of patients with no impact on daily life (NIDL; overall score > 108). This was a protocol-planned analysis. Results In the DEX1 group, no significant differences were observed in the FLIE nausea score (48.9 [±1.8; SE] vs. 53.7 [±1.5]), vomiting score (56.6 [±1.4] vs. 58.7 [±0.8]) and overall score (105.6 [±2.8] vs.112.4 [±1.9]) versus DEX4 control; similar results were observed in the DEX3 group for nausea score (49.6 [±1.7]), vomiting score (58.2 [±1]) and overall score (107.8 [±2.4]) versus control. There were no significant between-group differences in the proportion of patients reporting NIDL. Conclusion Reducing DEX, when administered with NEPA, does not seem to adversely impact the daily functioning in patients undergoing cisplatin. Trial registration ClinicalTrials.gov NCT04201769 . Registration date: 17/12/2019 - Retrospectively registered.
