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
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 i...
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| Format: | Article |
| Language: | English |
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BMC
2022-08-01
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| Series: | BMC Cancer |
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| Online Access: | https://doi.org/10.1186/s12885-022-10018-3 |
| _version_ | 1811188931513810944 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Luigi Celio |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-11T14:27:42Z |
| format | Article |
| id | doaj.art-4ace3d1c9d1743c2a4939c50f0a7fa2e |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-04-11T14:27:42Z |
| publishDate | 2022-08-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj.art-4ace3d1c9d1743c2a4939c50f0a7fa2e2022-12-22T04:18:48ZengBMCBMC Cancer1471-24072022-08-012211810.1186/s12885-022-10018-3Evaluating 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 studyLuigi Celio0Diego Cortinovis1Alessio Aligi Cogoni2Luigi Cavanna3Olga Martelli4Simona Carnio5Elena Collovà6Federica Bertolini7Fausto Petrelli8Alessandra Cassano9Rita Chiari10Francesca Zanelli11Salvatore Pisconti12Isabella Vittimberga13Antonietta Letizia14Andrea Misino15Angela Gernone16Erminio Bonizzoni17Sara Pilotto18Sabino De Placido19Emilio Bria20Medical Oncology Unit, ASST del Garda, Desenzano del Garda HospitalMedical Oncology Department, ASST Monza San Gerardo HospitalMedical Oncology Department, Azienda Ospedaliero-Universitaria di SassariOncology Department, Azienda Ospedaliera di PiacenzaMedical Oncology, ASL FrosinoneDepartment of Oncology, San Luigi Gonzaga Hospital, University of TurinCancer Centre Department – Oncology Unit, ASST Ovest Milanese – Legnano HospitalDepartment of Oncology and Hematology, AOU Policlinico di ModenaMedical Oncology Unit, ASST Bergamo OvestComprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli, IRCCSOncology Unit, AULSS6 EuganeaMedical Oncology Unit, IRCCS Santa Maria NuovaMedical Oncology Department, San Giuseppe Moscati HospitalDepartment of Oncology, ASST LeccoDepartment of Pneumology and Oncology, AORN dei Colli-Ospedale MonaldiMedical Oncology, Clinical Cancer Center “Giovanni Paolo II” – IRCCSMedical Oncology Unit, University of Bari, Policlinico di BariDepartment of Clinical Science and Community, Section of Medical Statistics, Biometry and Epidemiology “G.A. Maccacaro”, Faculty of Medicine and Surgery, University of MilanSection of Oncology, Department of Medicine, University and Hospital Trust of VeronaClinical Medicine and Surgery Department, University of Naples “Federico II”Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli, IRCCSAbstract 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.https://doi.org/10.1186/s12885-022-10018-3CisplatinDexamethasoneNEPAQuality of lifeFunctional living index-EmesisChemotherapy-induced nausea and vomiting (CINV) |
| spellingShingle | 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 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 BMC Cancer Cisplatin Dexamethasone NEPA Quality of life Functional living index-Emesis Chemotherapy-induced nausea and vomiting (CINV) |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Cisplatin Dexamethasone NEPA Quality of life Functional living index-Emesis Chemotherapy-induced nausea and vomiting (CINV) |
| url | https://doi.org/10.1186/s12885-022-10018-3 |
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