PMID- 36289790
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230308
IS  - 2227-9059 (Print)
IS  - 2227-9059 (Electronic)
IS  - 2227-9059 (Linking)
VI  - 10
IP  - 10
DP  - 2022 Oct 10
TI  - Early Effects of Nivolumab and Ipilimumab Combined Immunotherapy in the Treatment 
      of Metastatic Melanoma in Poland: A Multicenter Experience.
LID - 10.3390/biomedicines10102528 [doi]
LID - 2528
AB  - Nivolumab and ipilimumab combination became the first-line standard in advanced 
      melanoma. We assessed its efficacy in a real-life study in Poland. In a one-year 
      follow-up, we evaluated the medical records of 50 melanoma patients treated with 
      that modality in five oncology centers. We recorded therapy outcomes and adverse 
      events (AEs) after 3 and 12 months of therapy. At the first checkpoint, the 
      disease control rate (DCR) was recorded in 58% (n = 29) of patients, but the same 
      number of patients (n = 29, 58%) stopped immunotherapy due to disease progression 
      (PD, n = 14, 48.3%), toxicity (n = 11, 37.9%) or death (n = 4, 13.8%). Among 
      patients with DCR after the induction phase, 8 (27.6%) terminated due to 
      toxicity, and 21 (72.4%) continued. However, at the 12-month checkpoint, only 14 
      patients (27% of all) were still receiving immunotherapy. In 7 (33.3%) it was 
      discontinued due to PD (n = 2), toxicity (n = 2, 28.6% each), or death (n = 3, 
      42.9%). AEs occurred in 66.7% (n = 34) of patients; severe (grade 3 or 4) in half 
      of them. Interestingly, those with AEs had an 80% lower risk of death (hazard 
      ratio [HR] 0.2, 95% confidence interval [CI] 0.07-0.57, p = 0.001) and PD (HR 
      0.2, 95%CI 0.09-0.47, p < 0.0001). In the entire group of patients, after a 
      12-month follow-up, the median overall survival was not reached (NR, range: 6.8 
      months-NR) and progression-free survival was 6.3 (range: 3-NR) months. Our 
      results demonstrate that combined immunotherapy is less effective in real-life 
      than in pivotal trials. However, early responders will likely continue the 
      therapy after a one-year follow-up. AEs occurrence might be a predictor of 
      clinical effectiveness.
FAU - Pacholczak-Madej, Renata
AU  - Pacholczak-Madej R
AUID- ORCID: 0000-0002-6535-4841
AD  - The Maria Sklodowska-Curie National Research Institute of Oncology, Krakow 
      Branch, 31-115 Krako, Poland.
AD  - Department of Anatomy, Jagiellonian University Medical College, 33-332 Krakow, 
      Poland.
FAU - Grela-Wojewoda, Aleksandra
AU  - Grela-Wojewoda A
AD  - The Maria Sklodowska-Curie National Research Institute of Oncology, Krakow 
      Branch, 31-115 Krako, Poland.
FAU - Puskulluoglu, Miroslawa
AU  - Puskulluoglu M
AUID- ORCID: 0000-0002-2647-9625
AD  - The Maria Sklodowska-Curie National Research Institute of Oncology, Krakow 
      Branch, 31-115 Krako, Poland.
FAU - Lompart, Joanna
AU  - Lompart J
AD  - The Maria Sklodowska-Curie National Research Institute of Oncology, Krakow 
      Branch, 31-115 Krako, Poland.
FAU - Las-Jankowska, Manuela
AU  - Las-Jankowska M
AD  - Surgical Oncology, Ludwik Rydygier Collegium Medicum in Bydgoszcz, Nicolaus 
      Copernicus University in Torun, Oncology Centre, 85-067 Bydgoszcz, Poland.
AD  - Department of Clinical Oncology, Oncology Center-Prof Franciszek Lukaszczyk 
      Memorial Hospital, 85-796 Bydgoszcz, Poland.
FAU - Krawczak, Katarzyna
AU  - Krawczak K
AD  - Frederic Chopin Provincial Hospital No. 1, 35-055 Rzeszow, Poland.
FAU - Wrona, Ewa
AU  - Wrona E
AUID- ORCID: 0000-0003-3247-924X
AD  - Department of Clinical and Laboratory Genetics, Medical University of Lodz, 
      92-215 Lodz, Poland.
AD  - Department of Chemotherapy, Medical University of Lodz, Copernicus Memorial 
      Hospital, 90-419 Lodz, Poland.
FAU - Zareba, Lech
AU  - Zareba L
AD  - Interdisciplinary Centre for Computational Modelling, College of Natural 
      Sciences, University of Rzeszow, 35-310 Rzeszow, Poland.
FAU - Zubrowska, Justyna
AU  - Zubrowska J
AUID- ORCID: 0000-0002-7876-2537
AD  - Holy Cross Cancer Centre, 25-734 Kielce, Poland.
FAU - Walocha, Jerzy
AU  - Walocha J
AD  - Department of Anatomy, Jagiellonian University Medical College, 33-332 Krakow, 
      Poland.
FAU - Bazan-Socha, Stanislawa
AU  - Bazan-Socha S
AUID- ORCID: 0000-0001-9634-0963
AD  - Department of Internal Medicine, Jagiellonian University Medical College, 31-066 
      Krakow, Poland.
FAU - Ziobro, Marek
AU  - Ziobro M
AD  - The Maria Sklodowska-Curie National Research Institute of Oncology, Krakow 
      Branch, 31-115 Krako, Poland.
LA  - eng
GR  - N41/DBS/000862/Jagiellonian University/
GR  - not applicable/Maria Sklodowska-Curie National Research Institute of Oncology, 
      Krakow Branch/
PT  - Journal Article
DEP - 20221010
PL  - Switzerland
TA  - Biomedicines
JT  - Biomedicines
JID - 101691304
PMC - PMC9598919
OTO - NOTNLM
OT  - adverse events
OT  - immunotherapy
OT  - melanoma
OT  - nivolumab and ipilimumab
OT  - real-life data
COIS- The authors declare no conflict of interest. The funders had no role in the 
      design of the study; in the collection, analyses, or interpretation of data; in 
      the writing of the manuscript; or in the decision to publish the results.
EDAT- 2022/10/28 06:00
MHDA- 2022/10/28 06:01
PMCR- 2022/10/10
CRDT- 2022/10/27 01:02
PHST- 2022/09/11 00:00 [received]
PHST- 2022/09/29 00:00 [revised]
PHST- 2022/10/03 00:00 [accepted]
PHST- 2022/10/27 01:02 [entrez]
PHST- 2022/10/28 06:00 [pubmed]
PHST- 2022/10/28 06:01 [medline]
PHST- 2022/10/10 00:00 [pmc-release]
AID - biomedicines10102528 [pii]
AID - biomedicines-10-02528 [pii]
AID - 10.3390/biomedicines10102528 [doi]
PST - epublish
SO  - Biomedicines. 2022 Oct 10;10(10):2528. doi: 10.3390/biomedicines10102528.