READY: REAl-world Data from an Italian compassionate use program of avelumab first-line maintenance for locallY advanced or metastatic urothelial carcinoma
Background: Avelumab first-line (1L) maintenance is recommended as the standard of care for patients with locally advanced or metastatic urothelial carcinoma (la/mUC) without disease progression following 1L platinum-based chemotherapy (PBC). We report results from READY, a real-world study of avelu...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2024-09-01
|
| Series: | ESMO Real World Data and Digital Oncology |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2949820124000468 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849711632863723520 |
|---|---|
| author | L. Antonuzzo M. Maruzzo U. De Giorgi D. Santini R. Tambaro S. Buti F. Carrozza F. Calabrò G. Di Lorenzo G. Fornarini R. Iacovelli D. Cullurà C. Messina L. Cerbone G. Fazzi F. Venturini R. Colasanto A. Necchi S. Bracarda |
| author_facet | L. Antonuzzo M. Maruzzo U. De Giorgi D. Santini R. Tambaro S. Buti F. Carrozza F. Calabrò G. Di Lorenzo G. Fornarini R. Iacovelli D. Cullurà C. Messina L. Cerbone G. Fazzi F. Venturini R. Colasanto A. Necchi S. Bracarda |
| author_sort | L. Antonuzzo |
| collection | DOAJ |
| description | Background: Avelumab first-line (1L) maintenance is recommended as the standard of care for patients with locally advanced or metastatic urothelial carcinoma (la/mUC) without disease progression following 1L platinum-based chemotherapy (PBC). We report results from READY, a real-world study of avelumab 1L maintenance in an Italian compassionate use program (CUP). Patients and methods: In this prospective, noninterventional CUP, avelumab was provided on physician’s request to patients with la/mUC without disease progression following four to six cycles of 1L PBC, after approval by the local ethics committees, per Italian compassionate use regulations. Results: Between January 2021 and March 2022, 414 patients received avelumab 1L maintenance and were assessable for survival/safety analyses; 79.2% were male and median age was 71 years. At data cut-off (30 July 2023), median follow-up was 20.30 months [95% confidence interval (CI) 19.78-20.93 months]. From the start of avelumab treatment, median overall survival (OS) was 26.22 months [95% CI 19.97 months-not estimable (NE); 12-month OS rate, 65.6%] and median progression-free survival was 7.63 months (95% CI 6.02-9.31 months). In patients who had received 1L carboplatin plus gemcitabine (n = 221) or cisplatin plus gemcitabine (n = 184), median OS (95% CI) was 25.10 months (19.97 months-NE) and not reached (16.05 months-NE), respectively. Clinical benefit was observed across other subgroups, including those based on age and best response to PBC. Any-grade treatment-related adverse events occurred in 112 patients (27.1%). Conclusions: In READY, avelumab 1L maintenance showed clinical benefit in patients in Italy with la/mUC without progression following PBC, including across clinical subgroups, further supporting its use as the standard of care in this setting. |
| format | Article |
| id | doaj-art-319c0ef389f24ecca92dfc1d595fb504 |
| institution | DOAJ |
| issn | 2949-8201 |
| language | English |
| publishDate | 2024-09-01 |
| publisher | Elsevier |
| record_format | Article |
| series | ESMO Real World Data and Digital Oncology |
| spelling | doaj-art-319c0ef389f24ecca92dfc1d595fb5042025-08-20T03:14:35ZengElsevierESMO Real World Data and Digital Oncology2949-82012024-09-01510006810.1016/j.esmorw.2024.100068READY: REAl-world Data from an Italian compassionate use program of avelumab first-line maintenance for locallY advanced or metastatic urothelial carcinomaL. Antonuzzo0M. Maruzzo1U. De Giorgi2D. Santini3R. Tambaro4S. Buti5F. Carrozza6F. Calabrò7G. Di Lorenzo8G. Fornarini9R. Iacovelli10D. Cullurà11C. Messina12L. Cerbone13G. Fazzi14F. Venturini15R. Colasanto16A. Necchi17S. Bracarda18Clinical Oncology Unit, Careggi University Hospital, Florence, Italy; Department of Experimental and Clinical Medicine, University of Florence, Florence, ItalyIstituto Oncologico Veneto, IOV—IRCCS, Padova, ItalyIRCCS Istituto Romagnolo per lo Studio dei Tumori ‘Dino Amadori’—IRST, Meldola, ItalyDepartment of Medical-Surgical Sciences and Biotechnology, Università La Sapienza-Polo Pontino, Rome, ItalyIstituto Nazionale Tumori IRCCS Fondazione G. Pascale, Naples, ItalyDepartment of Medicine and Surgery, University of Parma, Parma, ItalyAUSL della Romagna, Ravenna, ItalyIRCCS Istituto Nazionale Tumori Regina Elena, Rome, ItalyASL Salerno—P.O. ‘A. Tortora’, Pagani, ItalyIRCCS Ospedale Policlinico San Martino, Genoa, ItalyFondazione Policlinico Universitario A. Gemelli IRCCS, Rome, ItalyIstituto Europeo di Oncologia (IEO), Milan, ItalyOspedale ARNAS Civico, Palermo, ItalyAzienda Ospedaliera San Camillo Forlanini, Rome, ItalyMerck Serono S.p.A., Rome, Italy, an affiliate of Merck KGaAMerck Serono S.p.A., Rome, Italy, an affiliate of Merck KGaAMerck Serono S.p.A., Rome, Italy, an affiliate of Merck KGaADepartment of Medical Oncology, IRCCS Ospedale San Raffaele, Milan, Italy; Department of Medicine, Vita-Salute San Raffaele University, Milan, ItalyAzienda Ospedaliera Santa Maria, Terni, Italy; Correspondence to: Dr Sergio Bracarda, Azienda Ospedaliera Santa Maria, 05100 Terni, Italy. Tel: +39 0744 20 5410Background: Avelumab first-line (1L) maintenance is recommended as the standard of care for patients with locally advanced or metastatic urothelial carcinoma (la/mUC) without disease progression following 1L platinum-based chemotherapy (PBC). We report results from READY, a real-world study of avelumab 1L maintenance in an Italian compassionate use program (CUP). Patients and methods: In this prospective, noninterventional CUP, avelumab was provided on physician’s request to patients with la/mUC without disease progression following four to six cycles of 1L PBC, after approval by the local ethics committees, per Italian compassionate use regulations. Results: Between January 2021 and March 2022, 414 patients received avelumab 1L maintenance and were assessable for survival/safety analyses; 79.2% were male and median age was 71 years. At data cut-off (30 July 2023), median follow-up was 20.30 months [95% confidence interval (CI) 19.78-20.93 months]. From the start of avelumab treatment, median overall survival (OS) was 26.22 months [95% CI 19.97 months-not estimable (NE); 12-month OS rate, 65.6%] and median progression-free survival was 7.63 months (95% CI 6.02-9.31 months). In patients who had received 1L carboplatin plus gemcitabine (n = 221) or cisplatin plus gemcitabine (n = 184), median OS (95% CI) was 25.10 months (19.97 months-NE) and not reached (16.05 months-NE), respectively. Clinical benefit was observed across other subgroups, including those based on age and best response to PBC. Any-grade treatment-related adverse events occurred in 112 patients (27.1%). Conclusions: In READY, avelumab 1L maintenance showed clinical benefit in patients in Italy with la/mUC without progression following PBC, including across clinical subgroups, further supporting its use as the standard of care in this setting.http://www.sciencedirect.com/science/article/pii/S2949820124000468avelumaburothelial carcinomareal-world studyimmune checkpoint inhibitormaintenanceimmunotherapy |
| spellingShingle | L. Antonuzzo M. Maruzzo U. De Giorgi D. Santini R. Tambaro S. Buti F. Carrozza F. Calabrò G. Di Lorenzo G. Fornarini R. Iacovelli D. Cullurà C. Messina L. Cerbone G. Fazzi F. Venturini R. Colasanto A. Necchi S. Bracarda READY: REAl-world Data from an Italian compassionate use program of avelumab first-line maintenance for locallY advanced or metastatic urothelial carcinoma ESMO Real World Data and Digital Oncology avelumab urothelial carcinoma real-world study immune checkpoint inhibitor maintenance immunotherapy |
| title | READY: REAl-world Data from an Italian compassionate use program of avelumab first-line maintenance for locallY advanced or metastatic urothelial carcinoma |
| title_full | READY: REAl-world Data from an Italian compassionate use program of avelumab first-line maintenance for locallY advanced or metastatic urothelial carcinoma |
| title_fullStr | READY: REAl-world Data from an Italian compassionate use program of avelumab first-line maintenance for locallY advanced or metastatic urothelial carcinoma |
| title_full_unstemmed | READY: REAl-world Data from an Italian compassionate use program of avelumab first-line maintenance for locallY advanced or metastatic urothelial carcinoma |
| title_short | READY: REAl-world Data from an Italian compassionate use program of avelumab first-line maintenance for locallY advanced or metastatic urothelial carcinoma |
| title_sort | ready real world data from an italian compassionate use program of avelumab first line maintenance for locally advanced or metastatic urothelial carcinoma |
| topic | avelumab urothelial carcinoma real-world study immune checkpoint inhibitor maintenance immunotherapy |
| url | http://www.sciencedirect.com/science/article/pii/S2949820124000468 |
| work_keys_str_mv | AT lantonuzzo readyrealworlddatafromanitaliancompassionateuseprogramofavelumabfirstlinemaintenanceforlocallyadvancedormetastaticurothelialcarcinoma AT mmaruzzo readyrealworlddatafromanitaliancompassionateuseprogramofavelumabfirstlinemaintenanceforlocallyadvancedormetastaticurothelialcarcinoma AT udegiorgi readyrealworlddatafromanitaliancompassionateuseprogramofavelumabfirstlinemaintenanceforlocallyadvancedormetastaticurothelialcarcinoma AT dsantini readyrealworlddatafromanitaliancompassionateuseprogramofavelumabfirstlinemaintenanceforlocallyadvancedormetastaticurothelialcarcinoma AT rtambaro readyrealworlddatafromanitaliancompassionateuseprogramofavelumabfirstlinemaintenanceforlocallyadvancedormetastaticurothelialcarcinoma AT sbuti readyrealworlddatafromanitaliancompassionateuseprogramofavelumabfirstlinemaintenanceforlocallyadvancedormetastaticurothelialcarcinoma AT fcarrozza readyrealworlddatafromanitaliancompassionateuseprogramofavelumabfirstlinemaintenanceforlocallyadvancedormetastaticurothelialcarcinoma AT fcalabro readyrealworlddatafromanitaliancompassionateuseprogramofavelumabfirstlinemaintenanceforlocallyadvancedormetastaticurothelialcarcinoma AT gdilorenzo readyrealworlddatafromanitaliancompassionateuseprogramofavelumabfirstlinemaintenanceforlocallyadvancedormetastaticurothelialcarcinoma AT gfornarini readyrealworlddatafromanitaliancompassionateuseprogramofavelumabfirstlinemaintenanceforlocallyadvancedormetastaticurothelialcarcinoma AT riacovelli readyrealworlddatafromanitaliancompassionateuseprogramofavelumabfirstlinemaintenanceforlocallyadvancedormetastaticurothelialcarcinoma AT dcullura readyrealworlddatafromanitaliancompassionateuseprogramofavelumabfirstlinemaintenanceforlocallyadvancedormetastaticurothelialcarcinoma AT cmessina readyrealworlddatafromanitaliancompassionateuseprogramofavelumabfirstlinemaintenanceforlocallyadvancedormetastaticurothelialcarcinoma AT lcerbone readyrealworlddatafromanitaliancompassionateuseprogramofavelumabfirstlinemaintenanceforlocallyadvancedormetastaticurothelialcarcinoma AT gfazzi readyrealworlddatafromanitaliancompassionateuseprogramofavelumabfirstlinemaintenanceforlocallyadvancedormetastaticurothelialcarcinoma AT fventurini readyrealworlddatafromanitaliancompassionateuseprogramofavelumabfirstlinemaintenanceforlocallyadvancedormetastaticurothelialcarcinoma AT rcolasanto readyrealworlddatafromanitaliancompassionateuseprogramofavelumabfirstlinemaintenanceforlocallyadvancedormetastaticurothelialcarcinoma AT anecchi readyrealworlddatafromanitaliancompassionateuseprogramofavelumabfirstlinemaintenanceforlocallyadvancedormetastaticurothelialcarcinoma AT sbracarda readyrealworlddatafromanitaliancompassionateuseprogramofavelumabfirstlinemaintenanceforlocallyadvancedormetastaticurothelialcarcinoma |