@article{10.11648/j.ijcems.20230903.11,
  author = {Horacio Fernández Grecco and Pablo Valdemoros and Maria Jose Mela Osorio and Miguel Pavlovsky and Carolina Pavlovsky and Astrid Pavlovsky and Juan Dupont and Dardo Riveros and Juan Altuve and Gonzalo Ferini and Victoria Otero and Fernando Warley and Fernando Bezares and Alicia Enrico and Laura Kornblihtt and Silvana Cugliari and Augusto Miroli and Manuel Bonder and Alicia Bistman and Julio Pose and Marta Zerga and Maria Cabrejo and Jorge Jerez and Maria Cardenas and Patricio Pereyra and Juan Maradei and Ana Portalez and Fernanda Tosin and Virginia Gilli and Rodrigo Vallejo and Noelia Masachessi and Eriberto Roveri and Susana Mari and Magali Colucci and Basilio Pertiné and Noemi Pintos},
  title = {Toxicity and Outcomes of Ibrutinib in Chronic Lymphatic Leukemia-Real-World Results from the Study of 215 Patients in Argentina},
  journal = {International Journal of Clinical and Experimental Medical Sciences},
  volume = {9},
  number = {3},
  pages = {42-48},
  doi = {10.11648/j.ijcems.20230903.11},
  url = {https://doi.org/10.11648/j.ijcems.20230903.11},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ijcems.20230903.11},
  abstract = {Different pivotal works allowed the approval of ibrutinib as a CLL treatment, both in the first line and in relapsed/refractory patients, the adverse effects differ from conventional chemotherapy, the discontinuation rate was 10%, but in different real-life studies, showed a higher number of complications and medication suspension rates of 40 to 50%. To know the reality of the use of ibrutinib in CLL in our environment, we designed this work with the objectives of evaluating the safety profile of the drug with the description of the adverse effects, their incidence, and their severity. The clinical efficacy will also be studied with the determination of the response achieved, calculation of overall survival (OS) and progression-free survival. Also as an additional objective, the discontinuation rate and its causes will be obtained. A total of 215 patients in 26 centers throughout the country were retrospectively analyzed. 189 patients (88%) had a global response, and the majority 58% achieved a partial response. The 5-year overall survival was 60%, with no difference between patients with different numbers of previous lines. The progression-free survival of the entire group was 5.06 years. 44.7% of the population, presented at least 1 adverse effect. The most frequent ones were: bleeding, thrombocytopenia, pneumonia and diarrhea. Others presented: anemia, neutropenia, infections, AF, HTA, arthralgia, rash, opportunistic infections. Most adverse events were mild to moderate in grade and generally occurred within the first 6 months. The main cause of treatment suspension was the appearance of adverse effects, 37 patients had to suspend it, 27 due to adverse effects (72.97%). In our work, we found that ibrutinib, as a single agent, has outstanding activity in CLL, with a significant percentage of overall responses, even in patients with several lines of prior treatment. Most of the adverse effects were of a mild to moderate degree. The cardiovascular effects of TKI, HBP, and AF, are in percentages similar to those reported in other studies. If we analyze the percentage of treatment discontinuation, which is 17%, mostly due to adverse effects, this finding is similar to pivotal studies. In conclusion, our real-life study confirms the important activity of ibrutinib in patients with CLL, in the first line and relapses, highlighting the low percentage of treatment discontinuation in our environment. We believe our work reflects the real life and daily care of patients with CLL, under treatment with ibrutinib in our environment.},
 year = {2023}
}

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TY  - JOUR
T1  - Toxicity and Outcomes of Ibrutinib in Chronic Lymphatic Leukemia-Real-World Results from the Study of 215 Patients in Argentina
AU  - Horacio Fernández Grecco
AU  - Pablo Valdemoros
AU  - Maria Jose Mela Osorio
AU  - Miguel Pavlovsky
AU  - Carolina Pavlovsky
AU  - Astrid Pavlovsky
AU  - Juan Dupont
AU  - Dardo Riveros
AU  - Juan Altuve
AU  - Gonzalo Ferini
AU  - Victoria Otero
AU  - Fernando Warley
AU  - Fernando Bezares
AU  - Alicia Enrico
AU  - Laura Kornblihtt
AU  - Silvana Cugliari
AU  - Augusto Miroli
AU  - Manuel Bonder
AU  - Alicia Bistman
AU  - Julio Pose
AU  - Marta Zerga
AU  - Maria Cabrejo
AU  - Jorge Jerez
AU  - Maria Cardenas
AU  - Patricio Pereyra
AU  - Juan Maradei
AU  - Ana Portalez
AU  - Fernanda Tosin
AU  - Virginia Gilli
AU  - Rodrigo Vallejo
AU  - Noelia Masachessi
AU  - Eriberto Roveri
AU  - Susana Mari
AU  - Magali Colucci
AU  - Basilio Pertiné
AU  - Noemi Pintos
Y1  - 2023/05/17
PY  - 2023
N1  - https://doi.org/10.11648/j.ijcems.20230903.11
DO  - 10.11648/j.ijcems.20230903.11
T2  - International Journal of Clinical and Experimental Medical Sciences
JF  - International Journal of Clinical and Experimental Medical Sciences
JO  - International Journal of Clinical and Experimental Medical Sciences
SP  - 42
EP  - 48
PB  - Science Publishing Group
SN  - 2469-8032
UR  - https://doi.org/10.11648/j.ijcems.20230903.11
AB  - Different pivotal works allowed the approval of ibrutinib as a CLL treatment, both in the first line and in relapsed/refractory patients, the adverse effects differ from conventional chemotherapy, the discontinuation rate was 10%, but in different real-life studies, showed a higher number of complications and medication suspension rates of 40 to 50%. To know the reality of the use of ibrutinib in CLL in our environment, we designed this work with the objectives of evaluating the safety profile of the drug with the description of the adverse effects, their incidence, and their severity. The clinical efficacy will also be studied with the determination of the response achieved, calculation of overall survival (OS) and progression-free survival. Also as an additional objective, the discontinuation rate and its causes will be obtained. A total of 215 patients in 26 centers throughout the country were retrospectively analyzed. 189 patients (88%) had a global response, and the majority 58% achieved a partial response. The 5-year overall survival was 60%, with no difference between patients with different numbers of previous lines. The progression-free survival of the entire group was 5.06 years. 44.7% of the population, presented at least 1 adverse effect. The most frequent ones were: bleeding, thrombocytopenia, pneumonia and diarrhea. Others presented: anemia, neutropenia, infections, AF, HTA, arthralgia, rash, opportunistic infections. Most adverse events were mild to moderate in grade and generally occurred within the first 6 months. The main cause of treatment suspension was the appearance of adverse effects, 37 patients had to suspend it, 27 due to adverse effects (72.97%). In our work, we found that ibrutinib, as a single agent, has outstanding activity in CLL, with a significant percentage of overall responses, even in patients with several lines of prior treatment. Most of the adverse effects were of a mild to moderate degree. The cardiovascular effects of TKI, HBP, and AF, are in percentages similar to those reported in other studies. If we analyze the percentage of treatment discontinuation, which is 17%, mostly due to adverse effects, this finding is similar to pivotal studies. In conclusion, our real-life study confirms the important activity of ibrutinib in patients with CLL, in the first line and relapses, highlighting the low percentage of treatment discontinuation in our environment. We believe our work reflects the real life and daily care of patients with CLL, under treatment with ibrutinib in our environment.
VL  - 9
IS  - 3
ER  - 

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