Intermediate Results of Prospective Observational Study: The 2-year Experience of Ibrutinib Therapy in Relapsed/Refractory Mantle Cell Lymphoma in Clinical Practice
Aim. To assess efficacy and toxicity of ibrutinib monotherapy in patients with relapsed/refractory mantle cell lymphoma (MCL). Materials & Methods. In this group of patients ibrutinib has been used since April 2016. Ibrutinib administration criteria were the age > 18 years and the confirmed...
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Practical Medicine Publishing House
2019-03-01
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| Series: | Клиническая онкогематология |
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| author | VI Vorob’ev VA Zherebtsova EI Dubrovin LA Bychenkova YuB Kochkareva LA Mukha VL Ivanova NK Khuazheva VV Ptushkin |
| author_facet | VI Vorob’ev VA Zherebtsova EI Dubrovin LA Bychenkova YuB Kochkareva LA Mukha VL Ivanova NK Khuazheva VV Ptushkin |
| author_sort | VI Vorob’ev |
| collection | DOAJ |
| description | Aim. To assess efficacy and toxicity of ibrutinib monotherapy in patients with relapsed/refractory mantle cell lymphoma (MCL).
Materials & Methods. In this group of patients ibrutinib has been used since April 2016. Ibrutinib administration criteria were the age > 18 years and the confirmed MCL diagnosis with nuclear hyperexpression of cyclin D1 and t(11;14)(q13;q32) translocation. Poor physical status, pancytopenia, infectious complications (except for life-threatening conditions), blastoid variant, and the number of previous treatment lines were not regarded as contraindications to ibrutinib therapy. Oral ibrutinib was administered once a day at a dose of 560 mg before progression and until intolerable toxicity was observed.
Results. From April 20, 2016 to April 6, 2018 ibrutinib therapy was provided to 42 patients with relapsed/refractory MCL. The median age was 69 years (range 40–81); 64 % of patients were men; ECOG > 2 was registered in 14 % of patients; 38 % of patients had blastoid variant; the median number of previous treatment lines was 2 (range 1–11). The overall response rate was 85 % (35 % were in complete remission); 57 % (24/42) of patients remain on ibrutinib treatment for the period of 4–667 days. The median event-free survival (EFS) was 365 days (95% confidence interval was 31–698 days). The median overall survival was not achieved. In blastoid variant the median EFS was 92 days, in the alternative group the median was not achieved and EFS was 76 % for 12 months (p < 0.001). In the majority of cases ibrutinib was well tolerated by patients. The most common complications were myalgia and muscle cramps (57 % cases), diarrhea (46 %, and grade 3 in 5 % cases), hemorrhagic complications (63 %, all of them of grade 1–2), and arrhythmia (7 %). Infectious complications were reported in 31 % of patients. In one case the start of ibrutinib treatment appeared to be problematic due to neutropenia of grade 4. Relative dose intensity was > 98 % (range 91.6–100 %). In 10 (24 %) patients ibrutinib treatment had to be adjusted (dose reduction or treatment interruption) due to toxicity and planned surgeries. None of ibrutinib recipients had to completely discontinue ibrutinib therapy due to complications.
Conclusion. These data on the use of ibrutinib in actual clinical practice are comparable with the results of international multicenter studies (PCYC-1104, SPARK, and RAY). Reduced toxicity profile and rather high speed of antitumor response allow for ibrutinib administration in cases of poor physical status, low blood count, and even infectious complications. However, some adverse effects are manifested not earlier than after 6-month treatment, which calls for continuous monitoring, especially when preparing for surgeries. |
| format | Article |
| id | doaj-art-792abc4f244d45dba277b5c847352063 |
| institution | Kabale University |
| issn | 1997-6933 2500-2139 |
| language | Russian |
| publishDate | 2019-03-01 |
| publisher | Practical Medicine Publishing House |
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| series | Клиническая онкогематология |
| spelling | doaj-art-792abc4f244d45dba277b5c8473520632025-08-20T03:35:23ZrusPractical Medicine Publishing HouseКлиническая онкогематология1997-69332500-21392019-03-0112216517210.21320/2500-2139-2019-12-2-165-17219976933Intermediate Results of Prospective Observational Study: The 2-year Experience of Ibrutinib Therapy in Relapsed/Refractory Mantle Cell Lymphoma in Clinical PracticeVI Vorob’ev0VA Zherebtsova1EI Dubrovin2LA Bychenkova3YuB Kochkareva4LA Mukha5VL Ivanova6NK Khuazheva7VV Ptushkin8 SP Botkin Municipal Clinical Hospital, 5 2-i Botkinskii pr-d, Moscow, Russian Federation, 125284 SP Botkin Municipal Clinical Hospital, 5 2-i Botkinskii pr-d, Moscow, Russian Federation, 125284 SP Botkin Municipal Clinical Hospital, 5 2-i Botkinskii pr-d, Moscow, Russian Federation, 125284 SP Botkin Municipal Clinical Hospital, 5 2-i Botkinskii pr-d, Moscow, Russian Federation, 125284 SP Botkin Municipal Clinical Hospital, 5 2-i Botkinskii pr-d, Moscow, Russian Federation, 125284 SP Botkin Municipal Clinical Hospital, 5 2-i Botkinskii pr-d, Moscow, Russian Federation, 125284 SP Botkin Municipal Clinical Hospital, 5 2-i Botkinskii pr-d, Moscow, Russian Federation, 125284 SP Botkin Municipal Clinical Hospital, 5 2-i Botkinskii pr-d, Moscow, Russian Federation, 125284 SP Botkin Municipal Clinical Hospital, 5 2-i Botkinskii pr-d, Moscow, Russian Federation, 125284 Aim. To assess efficacy and toxicity of ibrutinib monotherapy in patients with relapsed/refractory mantle cell lymphoma (MCL). Materials & Methods. In this group of patients ibrutinib has been used since April 2016. Ibrutinib administration criteria were the age > 18 years and the confirmed MCL diagnosis with nuclear hyperexpression of cyclin D1 and t(11;14)(q13;q32) translocation. Poor physical status, pancytopenia, infectious complications (except for life-threatening conditions), blastoid variant, and the number of previous treatment lines were not regarded as contraindications to ibrutinib therapy. Oral ibrutinib was administered once a day at a dose of 560 mg before progression and until intolerable toxicity was observed. Results. From April 20, 2016 to April 6, 2018 ibrutinib therapy was provided to 42 patients with relapsed/refractory MCL. The median age was 69 years (range 40–81); 64 % of patients were men; ECOG > 2 was registered in 14 % of patients; 38 % of patients had blastoid variant; the median number of previous treatment lines was 2 (range 1–11). The overall response rate was 85 % (35 % were in complete remission); 57 % (24/42) of patients remain on ibrutinib treatment for the period of 4–667 days. The median event-free survival (EFS) was 365 days (95% confidence interval was 31–698 days). The median overall survival was not achieved. In blastoid variant the median EFS was 92 days, in the alternative group the median was not achieved and EFS was 76 % for 12 months (p < 0.001). In the majority of cases ibrutinib was well tolerated by patients. The most common complications were myalgia and muscle cramps (57 % cases), diarrhea (46 %, and grade 3 in 5 % cases), hemorrhagic complications (63 %, all of them of grade 1–2), and arrhythmia (7 %). Infectious complications were reported in 31 % of patients. In one case the start of ibrutinib treatment appeared to be problematic due to neutropenia of grade 4. Relative dose intensity was > 98 % (range 91.6–100 %). In 10 (24 %) patients ibrutinib treatment had to be adjusted (dose reduction or treatment interruption) due to toxicity and planned surgeries. None of ibrutinib recipients had to completely discontinue ibrutinib therapy due to complications. Conclusion. These data on the use of ibrutinib in actual clinical practice are comparable with the results of international multicenter studies (PCYC-1104, SPARK, and RAY). Reduced toxicity profile and rather high speed of antitumor response allow for ibrutinib administration in cases of poor physical status, low blood count, and even infectious complications. However, some adverse effects are manifested not earlier than after 6-month treatment, which calls for continuous monitoring, especially when preparing for surgeries. http://bloodjournal.ru/wp-content/uploads/2019/03/6-1.pdf mantle cell lymphomaibrutinibrelapserefractory coursetargeted therapy |
| spellingShingle | VI Vorob’ev VA Zherebtsova EI Dubrovin LA Bychenkova YuB Kochkareva LA Mukha VL Ivanova NK Khuazheva VV Ptushkin Intermediate Results of Prospective Observational Study: The 2-year Experience of Ibrutinib Therapy in Relapsed/Refractory Mantle Cell Lymphoma in Clinical Practice Клиническая онкогематология mantle cell lymphoma ibrutinib relapse refractory course targeted therapy |
| title | Intermediate Results of Prospective Observational Study: The 2-year Experience of Ibrutinib Therapy in Relapsed/Refractory Mantle Cell Lymphoma in Clinical Practice |
| title_full | Intermediate Results of Prospective Observational Study: The 2-year Experience of Ibrutinib Therapy in Relapsed/Refractory Mantle Cell Lymphoma in Clinical Practice |
| title_fullStr | Intermediate Results of Prospective Observational Study: The 2-year Experience of Ibrutinib Therapy in Relapsed/Refractory Mantle Cell Lymphoma in Clinical Practice |
| title_full_unstemmed | Intermediate Results of Prospective Observational Study: The 2-year Experience of Ibrutinib Therapy in Relapsed/Refractory Mantle Cell Lymphoma in Clinical Practice |
| title_short | Intermediate Results of Prospective Observational Study: The 2-year Experience of Ibrutinib Therapy in Relapsed/Refractory Mantle Cell Lymphoma in Clinical Practice |
| title_sort | intermediate results of prospective observational study the 2 year experience of ibrutinib therapy in relapsed refractory mantle cell lymphoma in clinical practice |
| topic | mantle cell lymphoma ibrutinib relapse refractory course targeted therapy |
| url |
http://bloodjournal.ru/wp-content/uploads/2019/03/6-1.pdf
|
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