Real-world data on the efficacy and safety of daratumumab treatment in Hungarian relapsed/refractory multiple myeloma patients
Daratumumab is a human anti-CD38 monoclonal antibody used in the treatment of refractory and relapsed multiple myeloma. We investigated the efficacy and safety of daratumumab therapy in a real-world setting. Ninety-nine Hungarian patients were included; 48 received monotherapy, while lenalidomide an...
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| Veröffentlicht in: | International journal of hematology 2019-11, Vol.110 (5), p.559-565 |
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| creator | Lovas, Szilvia Varga, Gergely Farkas, Péter Masszi, Tamás Wohner, Nikolett Bereczki, Ágnes Adamkovich, Nóra Borbényi, Zita Szomor, Árpád Alizadeh, Hussain Szaleczky, Erika Wolf, Krisztina Schneider, Tamás Plander, Márk Szendrei, Tamás Csacsovszki, Ottó Csukly, Zoltán Rajnics, Péter Egyed, Miklós Nagy, Zsolt Rejtő, László Illés, Árpád Mikala, Gábor Váróczy, László |
| description | Daratumumab is a human anti-CD38 monoclonal antibody used in the treatment of refractory and relapsed multiple myeloma. We investigated the efficacy and safety of daratumumab therapy in a real-world setting. Ninety-nine Hungarian patients were included; 48 received monotherapy, while lenalidomide and bortezomib combinations were administered in 29 and 19 cases, respectively. Overall response rate was assessable in 88 patients, with 12 complete, 10 very good partial, 34 partial, and seven minor responses. At a median duration of follow-up of 18.6 months, median progression-free survival (PFS) among all patients was 17.0 months. These values were inferior in the bortezomib combination and monotherapy groups. Patients with early-stage disease (ISS1) had better survival results than those with stage 2 or 3 myeloma (
p
= 0.009). Heavily pretreated patients had inferior PFS compared to those with 1–3 therapies (
p
= 0.035). Patients with impaired renal function had PFS results comparable with those having no kidney involvement. There were 10 fatal infections, and the most frequent adverse events were mild infusion-associated reactions and hematologic toxicities. Our results confirm that daratumumab is an effective treatment option for relapsed/refractory MM with an acceptable safety profile in patients with normal and impaired renal function. |
| doi_str_mv | 10.1007/s12185-019-02715-w |
| format | Article |
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p
= 0.009). Heavily pretreated patients had inferior PFS compared to those with 1–3 therapies (
p
= 0.035). Patients with impaired renal function had PFS results comparable with those having no kidney involvement. There were 10 fatal infections, and the most frequent adverse events were mild infusion-associated reactions and hematologic toxicities. Our results confirm that daratumumab is an effective treatment option for relapsed/refractory MM with an acceptable safety profile in patients with normal and impaired renal function.</description><identifier>ISSN: 0925-5710</identifier><identifier>EISSN: 1865-3774</identifier><identifier>DOI: 10.1007/s12185-019-02715-w</identifier><identifier>PMID: 31392600</identifier><language>eng</language><publisher>Tokyo: Springer Japan</publisher><subject>Adult ; Aged ; Antibodies, Monoclonal - therapeutic use ; Antineoplastic Agents - therapeutic use ; Bortezomib ; Bortezomib - therapeutic use ; CD38 antigen ; Female ; Hematology ; Humans ; Hungary ; Immunotherapy ; Lenalidomide - therapeutic use ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Monoclonal antibodies ; Multiple myeloma ; Multiple Myeloma - complications ; Multiple Myeloma - drug therapy ; Multiple Myeloma - mortality ; Oncology ; Original Article ; Progression-Free Survival ; Renal function ; Safety ; Salvage Therapy - methods ; Survival ; Targeted cancer therapy ; Toxicity ; Treatment Outcome</subject><ispartof>International journal of hematology, 2019-11, Vol.110 (5), p.559-565</ispartof><rights>Japanese Society of Hematology 2019</rights><rights>International Journal of Hematology is a copyright of Springer, (2019). All Rights Reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c448t-c40ed1478462519a61e60a874699137946cb11fd2d3e8d33ba53db73303371b93</citedby><cites>FETCH-LOGICAL-c448t-c40ed1478462519a61e60a874699137946cb11fd2d3e8d33ba53db73303371b93</cites><orcidid>0000-0002-2873-5581</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s12185-019-02715-w$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s12185-019-02715-w$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31392600$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lovas, Szilvia</creatorcontrib><creatorcontrib>Varga, Gergely</creatorcontrib><creatorcontrib>Farkas, Péter</creatorcontrib><creatorcontrib>Masszi, Tamás</creatorcontrib><creatorcontrib>Wohner, Nikolett</creatorcontrib><creatorcontrib>Bereczki, Ágnes</creatorcontrib><creatorcontrib>Adamkovich, Nóra</creatorcontrib><creatorcontrib>Borbényi, Zita</creatorcontrib><creatorcontrib>Szomor, Árpád</creatorcontrib><creatorcontrib>Alizadeh, Hussain</creatorcontrib><creatorcontrib>Szaleczky, Erika</creatorcontrib><creatorcontrib>Wolf, Krisztina</creatorcontrib><creatorcontrib>Schneider, Tamás</creatorcontrib><creatorcontrib>Plander, Márk</creatorcontrib><creatorcontrib>Szendrei, Tamás</creatorcontrib><creatorcontrib>Csacsovszki, Ottó</creatorcontrib><creatorcontrib>Csukly, Zoltán</creatorcontrib><creatorcontrib>Rajnics, Péter</creatorcontrib><creatorcontrib>Egyed, Miklós</creatorcontrib><creatorcontrib>Nagy, Zsolt</creatorcontrib><creatorcontrib>Rejtő, László</creatorcontrib><creatorcontrib>Illés, Árpád</creatorcontrib><creatorcontrib>Mikala, Gábor</creatorcontrib><creatorcontrib>Váróczy, László</creatorcontrib><title>Real-world data on the efficacy and safety of daratumumab treatment in Hungarian relapsed/refractory multiple myeloma patients</title><title>International journal of hematology</title><addtitle>Int J Hematol</addtitle><addtitle>Int J Hematol</addtitle><description>Daratumumab is a human anti-CD38 monoclonal antibody used in the treatment of refractory and relapsed multiple myeloma. We investigated the efficacy and safety of daratumumab therapy in a real-world setting. Ninety-nine Hungarian patients were included; 48 received monotherapy, while lenalidomide and bortezomib combinations were administered in 29 and 19 cases, respectively. Overall response rate was assessable in 88 patients, with 12 complete, 10 very good partial, 34 partial, and seven minor responses. At a median duration of follow-up of 18.6 months, median progression-free survival (PFS) among all patients was 17.0 months. These values were inferior in the bortezomib combination and monotherapy groups. Patients with early-stage disease (ISS1) had better survival results than those with stage 2 or 3 myeloma (
p
= 0.009). Heavily pretreated patients had inferior PFS compared to those with 1–3 therapies (
p
= 0.035). Patients with impaired renal function had PFS results comparable with those having no kidney involvement. There were 10 fatal infections, and the most frequent adverse events were mild infusion-associated reactions and hematologic toxicities. Our results confirm that daratumumab is an effective treatment option for relapsed/refractory MM with an acceptable safety profile in patients with normal and impaired renal function.</description><subject>Adult</subject><subject>Aged</subject><subject>Antibodies, Monoclonal - therapeutic use</subject><subject>Antineoplastic Agents - therapeutic use</subject><subject>Bortezomib</subject><subject>Bortezomib - therapeutic use</subject><subject>CD38 antigen</subject><subject>Female</subject><subject>Hematology</subject><subject>Humans</subject><subject>Hungary</subject><subject>Immunotherapy</subject><subject>Lenalidomide - therapeutic use</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Monoclonal antibodies</subject><subject>Multiple myeloma</subject><subject>Multiple Myeloma - complications</subject><subject>Multiple Myeloma - drug therapy</subject><subject>Multiple Myeloma - mortality</subject><subject>Oncology</subject><subject>Original Article</subject><subject>Progression-Free Survival</subject><subject>Renal function</subject><subject>Safety</subject><subject>Salvage Therapy - 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We investigated the efficacy and safety of daratumumab therapy in a real-world setting. Ninety-nine Hungarian patients were included; 48 received monotherapy, while lenalidomide and bortezomib combinations were administered in 29 and 19 cases, respectively. Overall response rate was assessable in 88 patients, with 12 complete, 10 very good partial, 34 partial, and seven minor responses. At a median duration of follow-up of 18.6 months, median progression-free survival (PFS) among all patients was 17.0 months. These values were inferior in the bortezomib combination and monotherapy groups. Patients with early-stage disease (ISS1) had better survival results than those with stage 2 or 3 myeloma (
p
= 0.009). Heavily pretreated patients had inferior PFS compared to those with 1–3 therapies (
p
= 0.035). Patients with impaired renal function had PFS results comparable with those having no kidney involvement. There were 10 fatal infections, and the most frequent adverse events were mild infusion-associated reactions and hematologic toxicities. Our results confirm that daratumumab is an effective treatment option for relapsed/refractory MM with an acceptable safety profile in patients with normal and impaired renal function.</abstract><cop>Tokyo</cop><pub>Springer Japan</pub><pmid>31392600</pmid><doi>10.1007/s12185-019-02715-w</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0002-2873-5581</orcidid></addata></record> |
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| ispartof | International journal of hematology, 2019-11, Vol.110 (5), p.559-565 |
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| subjects | Adult Aged Antibodies, Monoclonal - therapeutic use Antineoplastic Agents - therapeutic use Bortezomib Bortezomib - therapeutic use CD38 antigen Female Hematology Humans Hungary Immunotherapy Lenalidomide - therapeutic use Male Medicine Medicine & Public Health Middle Aged Monoclonal antibodies Multiple myeloma Multiple Myeloma - complications Multiple Myeloma - drug therapy Multiple Myeloma - mortality Oncology Original Article Progression-Free Survival Renal function Safety Salvage Therapy - methods Survival Targeted cancer therapy Toxicity Treatment Outcome |
| title | Real-world data on the efficacy and safety of daratumumab treatment in Hungarian relapsed/refractory multiple myeloma patients |
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