Netupitant/palonosetron (NEPA) and dexamethasone for prevention of emesis in breast cancer patients receiving adjuvant anthracycline plus cyclophosphamide: a multi-cycle, phase II study
Abstract Background NEPA is an oral fixed-dose combination of netupitant, a new highly selective neurokinin-1 receptor antagonist, and palonosetron. This study was conducted to evaluate whether the efficacy of NEPA against chemotherapy-induced nausea and vomiting (CINV) in cycle 1 would be maintaine...
| Main Authors: | , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2020-03-01
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| Series: | BMC Cancer |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12885-020-6707-9 |
| _version_ | 1818291864278663168 |
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| author | Roberta Caputo Marina Elena Cazzaniga Andrea Sbrana Rosalba Torrisi Ida Paris Monica Giordano Vincenzo Montesarchio Valentina Guarneri Laura Amaducci Domenico Bilancia Giuseppina Cilenti Alessandra Fabi Elena Collovà Alessio Schirone Erminio Bonizzoni Luigi Celio Sabino De Placido Michelino De Laurentiis |
| author_facet | Roberta Caputo Marina Elena Cazzaniga Andrea Sbrana Rosalba Torrisi Ida Paris Monica Giordano Vincenzo Montesarchio Valentina Guarneri Laura Amaducci Domenico Bilancia Giuseppina Cilenti Alessandra Fabi Elena Collovà Alessio Schirone Erminio Bonizzoni Luigi Celio Sabino De Placido Michelino De Laurentiis |
| author_sort | Roberta Caputo |
| collection | DOAJ |
| description | Abstract Background NEPA is an oral fixed-dose combination of netupitant, a new highly selective neurokinin-1 receptor antagonist, and palonosetron. This study was conducted to evaluate whether the efficacy of NEPA against chemotherapy-induced nausea and vomiting (CINV) in cycle 1 would be maintained over subsequent chemotherapy cycles in breast cancer patients receiving adjuvant anthracycline plus cyclophosphamide (AC). The study also describes the relationship between efficacy on day 1 through 5 (overall period) and control of CINV on day 6 through 21 (very late period) in each cycle. Methods In this multicentre, phase II study, patients received both NEPA and dexamethasone (12 mg intravenously) just before chemotherapy. The primary efficacy endpoint was overall complete response (CR; no emesis and no rescue medication use) in cycle 1. Sustained efficacy was evaluated during the subsequent cycles by calculating the rate of CR in cycles 2–4 and by assessing the probability of sustained CR over multiple cycles. The impact of both overall CR and risk factors for CINV on the control of very late events (vomiting and moderate-to-severe nausea) were also examined. Results Of the 149 patients enrolled in the study, 139 were evaluable for a total of 552 cycles; 97.8% completed all 4 cycles. The proportion of patients with an overall CR was 70.5% (90% CI, 64.1 to 76.9) in cycle 1, and this was maintained in subsequent cycles. The cumulative percentage of patients with a sustained CR over 4 cycles was 53%. NEPA was well tolerated across cycles. In each cycle, patients with CR experienced a significantly better control of very late CINV events than those who experienced no CR. Among the patients with CR, the only predictor for increased likelihood of developing very late CINV was pre-chemotherapy (anticipatory) nausea (adjusted odds ratio = 0.65–0.50 for no CINV events on cycles 3 and 4). Conclusion The high anti-emetic efficacy seen with the NEPA regimen in the first cycle was maintained over multiple cycles of adjuvant AC for breast cancer. Preliminary evidence also suggests that patients achieving a CR during the overall period gain high protection even against very late CINV events in each chemotherapy cycle. Trial registration This trial was retrospectively registered at Clinicaltrials.gov identifier ( NCT03862144 ) on 05/Mar/2019. |
| first_indexed | 2024-12-13T02:50:50Z |
| format | Article |
| id | doaj.art-fb8f35eeef8b488d89697747b69adae4 |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-12-13T02:50:50Z |
| publishDate | 2020-03-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj.art-fb8f35eeef8b488d89697747b69adae42022-12-22T00:02:04ZengBMCBMC Cancer1471-24072020-03-012011910.1186/s12885-020-6707-9Netupitant/palonosetron (NEPA) and dexamethasone for prevention of emesis in breast cancer patients receiving adjuvant anthracycline plus cyclophosphamide: a multi-cycle, phase II studyRoberta Caputo0Marina Elena Cazzaniga1Andrea Sbrana2Rosalba Torrisi3Ida Paris4Monica Giordano5Vincenzo Montesarchio6Valentina Guarneri7Laura Amaducci8Domenico Bilancia9Giuseppina Cilenti10Alessandra Fabi11Elena Collovà12Alessio Schirone13Erminio Bonizzoni14Luigi Celio15Sabino De Placido16Michelino De Laurentiis17Breast Medical Oncology Division, Istituto Nazionale Tumori IRCCS “Fondazione G. Pascale”Medical Oncology Unit & Phase 1 Research Unit, ASST MonzaMedical Oncology Unit, Department of Translational Research and New Technologies in Medicine and Surgery, University of PisaDepartment of Medical Oncology and Hematology, Humanitas Clinical and Research CenterDivision of Gynecologic Oncology, Fondazione Policlinico Universitario A. Gemelli IRCCSMedical Oncology Division, ASST-LarianaOncology Unit, “Monaldi” HospitalDepartment of Surgery, Oncology and Gastroenterology, University of PadovaOncology Department Area Vasta Romagna, Faenza HospitalMedical Oncology Unit, S. Carlo HospitalMedical Oncology Division, Fondazione IRCCS Casa Sollievo Della SofferenzaIRCCS Regina Elena National Cancer InstituteOncology Unit, ASST Ovest Milanese, Legnano HospitalClinical Oncology Division, Azienda Ospedaliero-UniversitariaDepartment of Clinical Science and Community. Section of Medical Statistics, Biometry and Epidemiology “G.A. Maccacaro”. Faculty of Medicine and Surgery, University of MilanMedical Oncology Unit 1, Fondazione IRCCS “Istituto Nazionale dei Tumori”Clinical Medicine and Surgery Department, University of Naples Federico IIBreast Medical Oncology Division, Istituto Nazionale Tumori IRCCS “Fondazione G. Pascale”Abstract Background NEPA is an oral fixed-dose combination of netupitant, a new highly selective neurokinin-1 receptor antagonist, and palonosetron. This study was conducted to evaluate whether the efficacy of NEPA against chemotherapy-induced nausea and vomiting (CINV) in cycle 1 would be maintained over subsequent chemotherapy cycles in breast cancer patients receiving adjuvant anthracycline plus cyclophosphamide (AC). The study also describes the relationship between efficacy on day 1 through 5 (overall period) and control of CINV on day 6 through 21 (very late period) in each cycle. Methods In this multicentre, phase II study, patients received both NEPA and dexamethasone (12 mg intravenously) just before chemotherapy. The primary efficacy endpoint was overall complete response (CR; no emesis and no rescue medication use) in cycle 1. Sustained efficacy was evaluated during the subsequent cycles by calculating the rate of CR in cycles 2–4 and by assessing the probability of sustained CR over multiple cycles. The impact of both overall CR and risk factors for CINV on the control of very late events (vomiting and moderate-to-severe nausea) were also examined. Results Of the 149 patients enrolled in the study, 139 were evaluable for a total of 552 cycles; 97.8% completed all 4 cycles. The proportion of patients with an overall CR was 70.5% (90% CI, 64.1 to 76.9) in cycle 1, and this was maintained in subsequent cycles. The cumulative percentage of patients with a sustained CR over 4 cycles was 53%. NEPA was well tolerated across cycles. In each cycle, patients with CR experienced a significantly better control of very late CINV events than those who experienced no CR. Among the patients with CR, the only predictor for increased likelihood of developing very late CINV was pre-chemotherapy (anticipatory) nausea (adjusted odds ratio = 0.65–0.50 for no CINV events on cycles 3 and 4). Conclusion The high anti-emetic efficacy seen with the NEPA regimen in the first cycle was maintained over multiple cycles of adjuvant AC for breast cancer. Preliminary evidence also suggests that patients achieving a CR during the overall period gain high protection even against very late CINV events in each chemotherapy cycle. Trial registration This trial was retrospectively registered at Clinicaltrials.gov identifier ( NCT03862144 ) on 05/Mar/2019.http://link.springer.com/article/10.1186/s12885-020-6707-9NEPACINVNauseaVomitingBreast cancerAC |
| spellingShingle | Roberta Caputo Marina Elena Cazzaniga Andrea Sbrana Rosalba Torrisi Ida Paris Monica Giordano Vincenzo Montesarchio Valentina Guarneri Laura Amaducci Domenico Bilancia Giuseppina Cilenti Alessandra Fabi Elena Collovà Alessio Schirone Erminio Bonizzoni Luigi Celio Sabino De Placido Michelino De Laurentiis Netupitant/palonosetron (NEPA) and dexamethasone for prevention of emesis in breast cancer patients receiving adjuvant anthracycline plus cyclophosphamide: a multi-cycle, phase II study BMC Cancer NEPA CINV Nausea Vomiting Breast cancer AC |
| title | Netupitant/palonosetron (NEPA) and dexamethasone for prevention of emesis in breast cancer patients receiving adjuvant anthracycline plus cyclophosphamide: a multi-cycle, phase II study |
| title_full | Netupitant/palonosetron (NEPA) and dexamethasone for prevention of emesis in breast cancer patients receiving adjuvant anthracycline plus cyclophosphamide: a multi-cycle, phase II study |
| title_fullStr | Netupitant/palonosetron (NEPA) and dexamethasone for prevention of emesis in breast cancer patients receiving adjuvant anthracycline plus cyclophosphamide: a multi-cycle, phase II study |
| title_full_unstemmed | Netupitant/palonosetron (NEPA) and dexamethasone for prevention of emesis in breast cancer patients receiving adjuvant anthracycline plus cyclophosphamide: a multi-cycle, phase II study |
| title_short | Netupitant/palonosetron (NEPA) and dexamethasone for prevention of emesis in breast cancer patients receiving adjuvant anthracycline plus cyclophosphamide: a multi-cycle, phase II study |
| title_sort | netupitant palonosetron nepa and dexamethasone for prevention of emesis in breast cancer patients receiving adjuvant anthracycline plus cyclophosphamide a multi cycle phase ii study |
| topic | NEPA CINV Nausea Vomiting Breast cancer AC |
| url | http://link.springer.com/article/10.1186/s12885-020-6707-9 |
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