ORIGINAL RESEARCH ARTICLE
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
Received Date : 02 Aug 2018
Accepted Date : 07 Oct 2018
Nuri Karadurmus a,* , Mehmet Ali Nahit Sendur b, Burcak Karacac, Omer Fatih Olmezd, Ilhan Hacibekiroglu e, Hasan Senol Coskunf, Serkan Degirmencioglu g, Yasemin Kemal h,Saadettin Kilickapi, Ahmet Taner Sumbul j, Burc Aydink, Hande Turnal, Muhammet Ali Kaplanm,Nalan Babacann, Umut Demirci o, Alper Atap, Dilek Erdemq, Ahmet Ozet r, Huseyin Abali s
a Health Sciences University, Gulhane Training and Research Hospital, Department of Medical Oncology, Ankara, Turkey
b Ankara Yıldırım Beyazıt University, Faculty of Medicine, Department of Medical Oncology, Ankara, Turkey
c Ege University, Faculty of Medicine, Department of Medical Oncology, Izmir, Turkey
d Medipol Mega Hospitals Complex, Faculty of Medicine, Department of Medical Oncology, Istanbul, Turkey
e Sakarya University, Faculty of Medicine, Department of Medical Oncology, Sakarya, Turkey
f Akdeniz University, Faculty of Medicine, Department of Medical Oncology, Antalya, Turkey
g Pamukkale University, Faculty of Medicine, Department of Medical Oncology, Denizli, Turkey
h Ondokuz Mayıs University, Faculty of Medicine, Department of Medical Oncology, Samsun, Turkey
i Hacettepe University Cancer Institute, Department of Medical Oncology, Ankara, Turkey
j Baskent University Faculty of Medicine, Department of Medical Oncology, Adana, Turkey
k Medical Science Liaison, Bristol Myers Squib, Istanbul, Turkey
l Istanbul Cerrahpasa University, Faculty of Medicine, Department of Medical Oncology, Istanbul, Turkey
m Dicle University, Faculty of Medicine, Department of Medical Oncology, Diyarbakır, Turkey
n MarmaraUniversity, Faculty of Medicine, Department of Medical Oncology, Istanbul, Turkey
oUniversity of Health Sciences, Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, Department of Medical Oncology, Ankara, Turkey
p Medical Park Tarsus Hospital, Department of Medical Oncology, Mersin, Turkey
qMedical Park Samsun Hospital, Department of Medical Oncology, Samsun, Turkey
rGazi University, Faculty of Medicine, Department of Medical Oncology, Ankara, Turkey
sAcıbadem University, Faculty of Medicine, Department of Medical Oncology, Istanbul, Turkey
Doi: 10.1016/j.jons.2018.10.001 - Article's Language: EN
Journal of Oncological Sciences 4 (2018) 125-129
ABSTRACT
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.
Material and 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
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