Non-pegylated liposomal doxorubicin based on treatment of diffuse large B cell lymphoma in old patient with increased cardiovascular risk – case report and review of literature Case report
Article Sidebar
Published:
Dec 4, 2018
Keywords:
non-pegylated liposomal doxorubicin, cardiotoxcity, non-Hodgkin lymphoma
Main Article Content
Abstract
The use of anthracyclines in the treatment of patients with diffuse large B cell lymphoma is crucial, however may be sometimes difficult or even contraindicated due to coexisting cardiovascular diseases. An alternative to conventional anthracyclines seems to be liposomal forms that have been registered in the first line of treatment for women with metastatic breast cancer. Data on their use in patients with non-Hodgkin’s lymphomas indicate high efficacy and acceptable toxicity. We present case report of treatment with immunochemotherapy using non-pegylated liposomal doxorubicin in elderly woman with diffuse large B-cell lymphoma coexisting with ischemic heart disease, hypertension, type 2 diabetes. In addition, we present review of literature and the aspects of the use of drugs off-label.
Downloads
Download data is not yet available.
Metrics
Metrics Loading ...
Article Details
How to Cite
1.
Joks M, Urbaniak M. Non-pegylated liposomal doxorubicin based on treatment of diffuse large B cell lymphoma in old patient with increased cardiovascular risk – case report and review of literature. OncoReview [Internet]. 2018Dec.4 [cited 2024Nov.22];8(4(32):120-6. Available from: https://journalsmededu.pl/index.php/OncoReview/article/view/433
Issue
Section
HAEMATOLOGY IN ONCOLOGY
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Copyright: © Medical Education sp. z o.o. This is an Open Access article distributed under the terms of the Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). License (https://creativecommons.org/licenses/by-nc/4.0/), allowing third parties to copy and redistribute the material in any medium or format and to remix, transform, and build upon the material, provided the original work is properly cited and states its license.
Address reprint requests to: Medical Education, Marcin Kuźma (marcin.kuzma@mededu.pl)
References
1. Jurczak W, Szmit S, Sobociński M et al. Premature cardiovascular mortality in lymphoma patients treated with (R)-CHOP regimen – a national multicenter study. Int J Cardiol 2013; 168(6): 5212. https://doi.org/10.1016/j.ijcard.2013.08.033.
2. Levine AM, Tulpule A, Espina B et al. Liposome-encapsulated doxorubicin in combination with standard agents (cyclophosphamide, vincristine, prednisone) in patients with newly diagnosed AIDS-related non-Hodgkin’s lymphoma: results of therapy and correlates of response. J Clin Oncol 2004; 22(13): 2662-2670.
3. Tulpule A, Espina BM, Berman N et al. Phase I/II trial of nonpegylated liposomal doxorubicin, cyclophosphamide, vincristine, and prednisone in the treatment of newly diagnosed aggressive non-Hodgkin’s lymphoma. Clin Lymphoma Myeloma 2006; 7(1): 5.
4. Oki Y, Ewer MS, Lenihan DJ et al. Pegylated liposomal doxorubicin replacing conventional doxorubicin in standard R-CHOP chemotherapy for elderly patients with diffuse large B-cell lymphoma: an open label, single arm, phase II trial. Clin Lymphoma Myeloma Leuk 2015; 15(3): 152-158. https://doi.org/10.1016/j.clml.2014.09.001.
5. Dell’Olio M, Scalzulli RP, Sanpaolo G et al. Non-pegylatedl iposomal doxorubicin (Myocet®) in patients with poor-risk aggressive B-cell non-Hodgkin lymphoma. Leuk Lymphoma 2011; 52(7): 1222-1229. https://doi.org/10.3109/10428194.2011.5723.
6. Fridrik MA, Jaeger U, Petzer A et al. Cardiotoxicity with rituximab, cyclophosphamide,non-pegylated liposomal doxorubicin, vincristine and prednisolone compared to rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone in frontline treatment of patients with diffuse large B-cell lymphoma: A randomised phase-III study from the Austrian Cancer Drug Therapy Working group [Arbeitsgemeinschaft medikamentöse Tumortherapie AgmT ] (NHl-14). Eur J Cancer 2016; 58: 112-121. https://doi.org/10.1016/j.ejca.2016.02.004.
7. Olivieri J, Perna GP, Bocci C et al. Modern Management of Anthracycline-Induced Cardiotoxicity in Lymphoma Patients: Low Occurrence of Cardiotoxicity with Comprehensive Assessment and Tailored Substitution by Nonpegylated Liposomal Doxorubicin. Oncologist 2017; 22: 422-431.
8. Rohlfing S, Aurich M, Schöning T et al. Nonpegylated liposomal Doxorubicin as a Component of R-CHOP Is an effective and Safe Alternative to Conventional Doxorubicin in the Treatment of Patients With Diffuse large B-Cell lymphoma and Preexisting Cardiac Diseases. Clin Lymphoma Myeloma Leuk 2015; 15(8): 458-463. https://doi.org/10.1016/j.clml.2015.03.008.
9. Rigacci l, Mappa S, Nassi l et al. Liposome-encapsulated doxorubicin in combination with cyclophosphamide, vincristine, prednisone and rituximab in patients with lymphoma and concurrent cardiac diseases or pre-treated with anthracyclines. Hematol Oncol 2007; 25(4): 198-203.
10. Luminari S, Viel E, Ferreri AJM et al. Nonpegylated liposomal doxorubicin combination regimen in patients with diffuse large B-cell lymphoma and cardiac comorbidity. Results of the HeART01 phase II trial conducted by the Fondazione Italiana linfomi. Hematol Oncol 2018; 36(1): 68-75. https://doi.org/10.1002/hon.2425.
11. Riciutti G, Finolezzi E, Luciani S et al. Combination of rituximab and nonpegylated liposomal doxorubicin (R-NPlD) as front-line therapy for aggressive non-Hodgkin lymphoma (NHl) in patients 80 years of age or older: a single-center retrospective study. Hematol Oncol 2018; 36(1): 44-48. https://doi.org/10.1002/hon.2386.
12. Visani G, Ferrara F, Alesiani F et al. R-COmP 21 for frail elderly patients with aggressive B-cell non-Hodgkin lymphoma: a pilot study. Leuk Lymphoma 2008; 49(6): 1081-1086. https://doi.org/10.1080/10428190802043853.
13. Szmit S, Jędrzejczak WW, Opolski G. Stanowisko w sprawie stosowania niepegylowanej liposomalnej doksorubicyny u chorych na chłoniaki ze współistniejącymi chorobami sercowo-naczyniowymi. OncoReview 2013; 3(3): 213-215.
14. Ustawa z dnia 5 grudnia 1996 r. o zawodach lekarza i lekarza dentysty. Dz.U. 2018, poz. 617 t.j.
15. Zajdel J, Zajdel R. Dopuszczalność stosowania produktów leczniczych „off-label” a ustawa refundacyjna. Standardy medyczne/Pediatria 2012; 9: 415.
16. Luty O. Zaniechanie zlecenia produktu leczniczego poza wskazaniami a odpowiedzialność cywilnoprawna lekarza. Cz. II. Obowiązek zlecenia leku off label i konsekwencje jego niewykonania. Prawo i Medycyna 2014; 2: 134.
17. Zieliński W. Komentarz do art. 11. W: Kondrat M (ed). Prawo farmaceutyczne. Komentarz. Wyd. II. Online: http://www.lex.pl (Access: 2.12.2018).
18. Online: http://www2.mz.gov.pl/wwwmz/index?mr=m8&ms=630&ml=pl&mi=630&mx=0&mt=&my=26&ma 019230 (Access: 3.12.2018).
19. Szafrański T, Szafrańska A. Przechadzki po polu minowym – uwagi dotyczące stosowania leków niezgodnie z charakterystyką produktu leczniczego. Postępy Psychiatrii i Neurologii 2012; 2: 108.
20. Urbaniak M. Stosowanie leków poza wskazaniami – nowe wyzwania prawne. W: Urbaniak M, Staszewski R (ed). Aktualne problemy przemian systemu ochrony zdrowia w Polsce. Poznań 2017: 186 and next pages.
21. Urbaniak M, Cofta S. Zasady postępowania lekarza wobec pacjenta – komentarz do art. 6 i art. 7 kel. Medyczna Wokanda 2015; 7: 54.
22. Haberko J. Zasady postępowania lekarza w stosunku do pacjenta. Medyczna Wokanda 2016; 8: 50-51.
23. Ustawa z dnia 20 maja 2010 r. o wyrobach medycznych. Dz.U. 2010 nr 107, poz. 679 z późn. zm.
24. Kanturski J. Leczenie off-label: eksperyment medyczny czy stan wyższej konieczności? Prokuratura i Prawo 2012; 10: 97.
2. Levine AM, Tulpule A, Espina B et al. Liposome-encapsulated doxorubicin in combination with standard agents (cyclophosphamide, vincristine, prednisone) in patients with newly diagnosed AIDS-related non-Hodgkin’s lymphoma: results of therapy and correlates of response. J Clin Oncol 2004; 22(13): 2662-2670.
3. Tulpule A, Espina BM, Berman N et al. Phase I/II trial of nonpegylated liposomal doxorubicin, cyclophosphamide, vincristine, and prednisone in the treatment of newly diagnosed aggressive non-Hodgkin’s lymphoma. Clin Lymphoma Myeloma 2006; 7(1): 5.
4. Oki Y, Ewer MS, Lenihan DJ et al. Pegylated liposomal doxorubicin replacing conventional doxorubicin in standard R-CHOP chemotherapy for elderly patients with diffuse large B-cell lymphoma: an open label, single arm, phase II trial. Clin Lymphoma Myeloma Leuk 2015; 15(3): 152-158. https://doi.org/10.1016/j.clml.2014.09.001.
5. Dell’Olio M, Scalzulli RP, Sanpaolo G et al. Non-pegylatedl iposomal doxorubicin (Myocet®) in patients with poor-risk aggressive B-cell non-Hodgkin lymphoma. Leuk Lymphoma 2011; 52(7): 1222-1229. https://doi.org/10.3109/10428194.2011.5723.
6. Fridrik MA, Jaeger U, Petzer A et al. Cardiotoxicity with rituximab, cyclophosphamide,non-pegylated liposomal doxorubicin, vincristine and prednisolone compared to rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone in frontline treatment of patients with diffuse large B-cell lymphoma: A randomised phase-III study from the Austrian Cancer Drug Therapy Working group [Arbeitsgemeinschaft medikamentöse Tumortherapie AgmT ] (NHl-14). Eur J Cancer 2016; 58: 112-121. https://doi.org/10.1016/j.ejca.2016.02.004.
7. Olivieri J, Perna GP, Bocci C et al. Modern Management of Anthracycline-Induced Cardiotoxicity in Lymphoma Patients: Low Occurrence of Cardiotoxicity with Comprehensive Assessment and Tailored Substitution by Nonpegylated Liposomal Doxorubicin. Oncologist 2017; 22: 422-431.
8. Rohlfing S, Aurich M, Schöning T et al. Nonpegylated liposomal Doxorubicin as a Component of R-CHOP Is an effective and Safe Alternative to Conventional Doxorubicin in the Treatment of Patients With Diffuse large B-Cell lymphoma and Preexisting Cardiac Diseases. Clin Lymphoma Myeloma Leuk 2015; 15(8): 458-463. https://doi.org/10.1016/j.clml.2015.03.008.
9. Rigacci l, Mappa S, Nassi l et al. Liposome-encapsulated doxorubicin in combination with cyclophosphamide, vincristine, prednisone and rituximab in patients with lymphoma and concurrent cardiac diseases or pre-treated with anthracyclines. Hematol Oncol 2007; 25(4): 198-203.
10. Luminari S, Viel E, Ferreri AJM et al. Nonpegylated liposomal doxorubicin combination regimen in patients with diffuse large B-cell lymphoma and cardiac comorbidity. Results of the HeART01 phase II trial conducted by the Fondazione Italiana linfomi. Hematol Oncol 2018; 36(1): 68-75. https://doi.org/10.1002/hon.2425.
11. Riciutti G, Finolezzi E, Luciani S et al. Combination of rituximab and nonpegylated liposomal doxorubicin (R-NPlD) as front-line therapy for aggressive non-Hodgkin lymphoma (NHl) in patients 80 years of age or older: a single-center retrospective study. Hematol Oncol 2018; 36(1): 44-48. https://doi.org/10.1002/hon.2386.
12. Visani G, Ferrara F, Alesiani F et al. R-COmP 21 for frail elderly patients with aggressive B-cell non-Hodgkin lymphoma: a pilot study. Leuk Lymphoma 2008; 49(6): 1081-1086. https://doi.org/10.1080/10428190802043853.
13. Szmit S, Jędrzejczak WW, Opolski G. Stanowisko w sprawie stosowania niepegylowanej liposomalnej doksorubicyny u chorych na chłoniaki ze współistniejącymi chorobami sercowo-naczyniowymi. OncoReview 2013; 3(3): 213-215.
14. Ustawa z dnia 5 grudnia 1996 r. o zawodach lekarza i lekarza dentysty. Dz.U. 2018, poz. 617 t.j.
15. Zajdel J, Zajdel R. Dopuszczalność stosowania produktów leczniczych „off-label” a ustawa refundacyjna. Standardy medyczne/Pediatria 2012; 9: 415.
16. Luty O. Zaniechanie zlecenia produktu leczniczego poza wskazaniami a odpowiedzialność cywilnoprawna lekarza. Cz. II. Obowiązek zlecenia leku off label i konsekwencje jego niewykonania. Prawo i Medycyna 2014; 2: 134.
17. Zieliński W. Komentarz do art. 11. W: Kondrat M (ed). Prawo farmaceutyczne. Komentarz. Wyd. II. Online: http://www.lex.pl (Access: 2.12.2018).
18. Online: http://www2.mz.gov.pl/wwwmz/index?mr=m8&ms=630&ml=pl&mi=630&mx=0&mt=&my=26&ma 019230 (Access: 3.12.2018).
19. Szafrański T, Szafrańska A. Przechadzki po polu minowym – uwagi dotyczące stosowania leków niezgodnie z charakterystyką produktu leczniczego. Postępy Psychiatrii i Neurologii 2012; 2: 108.
20. Urbaniak M. Stosowanie leków poza wskazaniami – nowe wyzwania prawne. W: Urbaniak M, Staszewski R (ed). Aktualne problemy przemian systemu ochrony zdrowia w Polsce. Poznań 2017: 186 and next pages.
21. Urbaniak M, Cofta S. Zasady postępowania lekarza wobec pacjenta – komentarz do art. 6 i art. 7 kel. Medyczna Wokanda 2015; 7: 54.
22. Haberko J. Zasady postępowania lekarza w stosunku do pacjenta. Medyczna Wokanda 2016; 8: 50-51.
23. Ustawa z dnia 20 maja 2010 r. o wyrobach medycznych. Dz.U. 2010 nr 107, poz. 679 z późn. zm.
24. Kanturski J. Leczenie off-label: eksperyment medyczny czy stan wyższej konieczności? Prokuratura i Prawo 2012; 10: 97.