Experience from Turkish centers participating in the Early Access Program (EAP): Preliminary real-world safety data of nivolumab (nivo) combined with ipilimumab (ipi) in pre-treated advanced melanoma patients
Objective: We aimed to evaluate the safety of nivolumab + ipilimumab (nivo + ipi) in advanced melanoma patients who had relapsed after ≥1 line of systemic treatment in a real-world setting. Methods: Adult patients with advanced melanoma who had progressed after ≥1 line of systemic treatment were eli...
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| Format: | Article |
| Language: | English |
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Turkiye Klinikleri
2018-12-01
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| Series: | Journal of Oncological Sciences |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2452336418300542 |
| _version_ | 1797922901953871872 |
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| author | Nuri Karadurmus Mehmet Ali Nahit Sendur Burcak Karaca Omer Fatih Olmez Ilhan Hacibekiroglu Hasan Senol Coskun Serkan Degirmencioglu Yasemin Kemal Saadettin Kilickap Ahmet Taner Sumbul Burc Aydin Hande Turna Muhammet Ali Kaplan Nalan Babacan Umut Demirci Alper Ata Dilek Erdem Ahmet Ozet Huseyin Abali |
| author_facet | Nuri Karadurmus Mehmet Ali Nahit Sendur Burcak Karaca Omer Fatih Olmez Ilhan Hacibekiroglu Hasan Senol Coskun Serkan Degirmencioglu Yasemin Kemal Saadettin Kilickap Ahmet Taner Sumbul Burc Aydin Hande Turna Muhammet Ali Kaplan Nalan Babacan Umut Demirci Alper Ata Dilek Erdem Ahmet Ozet Huseyin Abali |
| author_sort | Nuri Karadurmus |
| collection | DOAJ |
| description | Objective: We aimed to evaluate the safety of nivolumab + ipilimumab (nivo + ipi) in advanced melanoma patients who had relapsed after ≥1 line of systemic treatment in a real-world setting. Methods: Adult patients with advanced melanoma who had progressed after ≥1 line of systemic treatment were eligible for nivo 1 mg/kg + ipi 3 mg/kg Q3W × 4, followed by nivo 3 mg/kg Q2W until progression, or unacceptable toxicity for up to 24 months in the Early Access Program (EAP) in Turkey. Treatment-related adverse events (TRAEs) were recorded and analyzed. Results: Forty patients who received at least one dose of nivo + ipi were included. Median number of doses (Nivo + ipi and nivo alone) were 4 with a median follow-up of 19 weeks. Thirty patients (75%) were alive and 24 patients (60%) were on treatment. TRAEs of any grade and grade 3–4 occurred in 53% and 20% of the patients, respectively. One patient died due to TRAEs (colitis and diarrhea) after the second dose of nivo + ipi. Median times to onset and resolution of TRAEs were 6 and 3 weeks, respectively. Eleven patients (28%) discontinued treatment for reasons other than TRAEs. TRAEs of any grade led to discontinuation in 5 patients (13%). Most of the TRAEs were reversible when managed with available guidelines. Discussion: Safety profile of N + I was found to be consistent with early reports. Increased experience with the management of TRAEs of immunotherapies, short follow-up and ≥2 line real-world setting may account for lower TRAEs rates. Long-term follow is needed. Keywords: Nivolumab, Ipilimumab, Immunotherapy, Melanoma |
| first_indexed | 2024-04-10T14:39:43Z |
| format | Article |
| id | doaj.art-b65969b72b5e41bcac86a08301fd1b4f |
| institution | Directory Open Access Journal |
| issn | 2452-3364 |
| language | English |
| last_indexed | 2024-04-10T14:39:43Z |
| publishDate | 2018-12-01 |
| publisher | Turkiye Klinikleri |
| record_format | Article |
| series | Journal of Oncological Sciences |
| spelling | doaj.art-b65969b72b5e41bcac86a08301fd1b4f2023-02-15T16:08:19ZengTurkiye KlinikleriJournal of Oncological Sciences2452-33642018-12-0143125129Experience from Turkish centers participating in the Early Access Program (EAP): Preliminary real-world safety data of nivolumab (nivo) combined with ipilimumab (ipi) in pre-treated advanced melanoma patientsNuri Karadurmus0Mehmet Ali Nahit Sendur1Burcak Karaca2Omer Fatih Olmez3Ilhan Hacibekiroglu4Hasan Senol Coskun5Serkan Degirmencioglu6Yasemin Kemal7Saadettin Kilickap8Ahmet Taner Sumbul9Burc Aydin10Hande Turna11Muhammet Ali Kaplan12Nalan Babacan13Umut Demirci14Alper Ata15Dilek Erdem16Ahmet Ozet17Huseyin Abali18Health Sciences University, Gulhane Training and Research Hospital, Department of Medical Oncology, Ankara, Turkey; Corresponding author. Gulhane Military Medical Academy, Department of Medical Oncology, Ankara, Turkey.Ankara Yıldırım Beyazıt University, Faculty of Medicine, Department of Medical Oncology, Ankara, TurkeyEge University, Faculty of Medicine, Department of Medical Oncology, Izmir, TurkeyMedipol Mega Hospitals Complex, Faculty of Medicine, Department of Medical Oncology, İstanbul, TurkeySakarya University, Faculty of Medicine, Department of Medical Oncology, Sakarya, TurkeyAkdeniz University, Faculty of Medicine, Department of Medical Oncology, Antalya, TurkeyPamukkale University, Faculty of Medicine, Department of Medical Oncology, Denizli, TurkeyOndokuz Mayıs University, Faculty of Medicine, Department of Medical Oncology, Samsun, TurkeyHacettepe University Cancer Institute, Department of Medical Oncology, Ankara, TurkeyBaskent University Faculty of Medicine, Department of Medical Oncology, Adana, TurkeyMedical Science Liaison, Bristol Myers Squib, İstanbul, TurkeyIstanbul Cerrahpasa University, Faculty of Medicine, Department of Medical Oncology, İstanbul, TurkeyDicle University, Faculty of Medicine, Department of Medical Oncology, Diyarbakır, TurkeyMarmaraUniversity, Faculty of Medicine, Department of Medical Oncology, İstanbul, TurkeyUniversity of Health Sciences, Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, Department of Medical Oncology, Ankara, TurkeyMedical Park Tarsus Hospital, Department of Medical Oncology, Mersin, TurkeyMedical Park Samsun Hospital, Department of Medical Oncology, Samsun, TurkeyGazi University, Faculty of Medicine, Department of Medical Oncology, Ankara, TurkeyAcıbadem University, Faculty of Medicine, Department of Medical Oncology, Istanbul, TurkeyObjective: We aimed to evaluate the safety of nivolumab + ipilimumab (nivo + ipi) in advanced melanoma patients who had relapsed after ≥1 line of systemic treatment in a real-world setting. Methods: Adult patients with advanced melanoma who had progressed after ≥1 line of systemic treatment were eligible for nivo 1 mg/kg + ipi 3 mg/kg Q3W × 4, followed by nivo 3 mg/kg Q2W until progression, or unacceptable toxicity for up to 24 months in the Early Access Program (EAP) in Turkey. Treatment-related adverse events (TRAEs) were recorded and analyzed. Results: Forty patients who received at least one dose of nivo + ipi were included. Median number of doses (Nivo + ipi and nivo alone) were 4 with a median follow-up of 19 weeks. Thirty patients (75%) were alive and 24 patients (60%) were on treatment. TRAEs of any grade and grade 3–4 occurred in 53% and 20% of the patients, respectively. One patient died due to TRAEs (colitis and diarrhea) after the second dose of nivo + ipi. Median times to onset and resolution of TRAEs were 6 and 3 weeks, respectively. Eleven patients (28%) discontinued treatment for reasons other than TRAEs. TRAEs of any grade led to discontinuation in 5 patients (13%). Most of the TRAEs were reversible when managed with available guidelines. Discussion: Safety profile of N + I was found to be consistent with early reports. Increased experience with the management of TRAEs of immunotherapies, short follow-up and ≥2 line real-world setting may account for lower TRAEs rates. Long-term follow is needed. Keywords: Nivolumab, Ipilimumab, Immunotherapy, Melanomahttp://www.sciencedirect.com/science/article/pii/S2452336418300542 |
| spellingShingle | Nuri Karadurmus Mehmet Ali Nahit Sendur Burcak Karaca Omer Fatih Olmez Ilhan Hacibekiroglu Hasan Senol Coskun Serkan Degirmencioglu Yasemin Kemal Saadettin Kilickap Ahmet Taner Sumbul Burc Aydin Hande Turna Muhammet Ali Kaplan Nalan Babacan Umut Demirci Alper Ata Dilek Erdem Ahmet Ozet Huseyin Abali Experience from Turkish centers participating in the Early Access Program (EAP): Preliminary real-world safety data of nivolumab (nivo) combined with ipilimumab (ipi) in pre-treated advanced melanoma patients Journal of Oncological Sciences |
| title | Experience from Turkish centers participating in the Early Access Program (EAP): Preliminary real-world safety data of nivolumab (nivo) combined with ipilimumab (ipi) in pre-treated advanced melanoma patients |
| title_full | Experience from Turkish centers participating in the Early Access Program (EAP): Preliminary real-world safety data of nivolumab (nivo) combined with ipilimumab (ipi) in pre-treated advanced melanoma patients |
| title_fullStr | Experience from Turkish centers participating in the Early Access Program (EAP): Preliminary real-world safety data of nivolumab (nivo) combined with ipilimumab (ipi) in pre-treated advanced melanoma patients |
| title_full_unstemmed | Experience from Turkish centers participating in the Early Access Program (EAP): Preliminary real-world safety data of nivolumab (nivo) combined with ipilimumab (ipi) in pre-treated advanced melanoma patients |
| title_short | Experience from Turkish centers participating in the Early Access Program (EAP): Preliminary real-world safety data of nivolumab (nivo) combined with ipilimumab (ipi) in pre-treated advanced melanoma patients |
| title_sort | experience from turkish centers participating in the early access program eap preliminary real world safety data of nivolumab nivo combined with ipilimumab ipi in pre treated advanced melanoma patients |
| url | http://www.sciencedirect.com/science/article/pii/S2452336418300542 |
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