A phase 2 study of concurrent fludarabine and rituximab for the treatment of marginal zone lymphomas
Summary The marginal zone lymphomas (MZLs) are a recently defined group of related diseases that probably arise from a common cell of origin, the marginal zone B cell. Data on therapy for subtypes other than gastric mucosa‐associated lymphoid tissue (MALT) lymphoma has been largely limited to retros...
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| Veröffentlicht in: | British journal of haematology 2009-06, Vol.145 (6), p.741-748 |
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| creator | Brown, Jennifer R. Friedberg, Jonathan W. Feng, Yang Scofield, Sarah Phillips, Kimberly Dal Cin, Paola Joyce, Robin Takvorian, Ronald W. Fisher, David C. Fisher, Richard I. Liesveld, Jane Marquis, Diana Neuberg, Donna Freedman, Arnold S. |
| description | Summary
The marginal zone lymphomas (MZLs) are a recently defined group of related diseases that probably arise from a common cell of origin, the marginal zone B cell. Data on therapy for subtypes other than gastric mucosa‐associated lymphoid tissue (MALT) lymphoma has been largely limited to retrospective case series. This prospective phase 2 study of fludarabine and rituximab for the treatment of marginal zone lymphomas enrolled 26 patients, 14 with nodal MZL, eight with MALT lymphomas and four with splenic MZL; 81% were receiving initial systemic therapy. Only 58% [95% confidence interval (CI) 37–77%] of patients completed the planned six cycles, due to significant haematological, infectious and allergic toxicity. Four late toxic deaths occurred due to infections [15% (95% CI 4·3–35%)], two related to delayed bone marrow aplasia and two related to myelodysplastic syndrome. Nonetheless, the overall response rate was 85% (95% CI 65–96%), with 54% complete responses. The progression‐free survival at 3·1 years of follow‐up is 79·5% (95% CI 63–96%). We conclude that, although concurrent fludarabine and rituximab given at this dose and schedule is a highly effective regimen in the treatment of MZLs, the significant haematological and infectious toxicity observed both during and after therapy is prohibitive in this patient population, emphasizing the need to study MZLs as a separate entity. |
| doi_str_mv | 10.1111/j.1365-2141.2009.07677.x |
| format | Article |
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The marginal zone lymphomas (MZLs) are a recently defined group of related diseases that probably arise from a common cell of origin, the marginal zone B cell. Data on therapy for subtypes other than gastric mucosa‐associated lymphoid tissue (MALT) lymphoma has been largely limited to retrospective case series. This prospective phase 2 study of fludarabine and rituximab for the treatment of marginal zone lymphomas enrolled 26 patients, 14 with nodal MZL, eight with MALT lymphomas and four with splenic MZL; 81% were receiving initial systemic therapy. Only 58% [95% confidence interval (CI) 37–77%] of patients completed the planned six cycles, due to significant haematological, infectious and allergic toxicity. Four late toxic deaths occurred due to infections [15% (95% CI 4·3–35%)], two related to delayed bone marrow aplasia and two related to myelodysplastic syndrome. Nonetheless, the overall response rate was 85% (95% CI 65–96%), with 54% complete responses. The progression‐free survival at 3·1 years of follow‐up is 79·5% (95% CI 63–96%). We conclude that, although concurrent fludarabine and rituximab given at this dose and schedule is a highly effective regimen in the treatment of MZLs, the significant haematological and infectious toxicity observed both during and after therapy is prohibitive in this patient population, emphasizing the need to study MZLs as a separate entity.</description><identifier>ISSN: 0007-1048</identifier><identifier>EISSN: 1365-2141</identifier><identifier>DOI: 10.1111/j.1365-2141.2009.07677.x</identifier><identifier>PMID: 19344412</identifier><identifier>CODEN: BJHEAL</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Antibodies, Monoclonal - adverse effects ; Antibodies, Monoclonal - therapeutic use ; Antibodies, Monoclonal, Murine-Derived ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Biological and medical sciences ; bone marrow aplasia ; Disease-Free Survival ; Female ; fludarabine ; Follow-Up Studies ; Hematologic and hematopoietic diseases ; Humans ; Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis ; Lymphoma - drug therapy ; Lymphoma - mortality ; Lymphoma, B-Cell, Marginal Zone - drug therapy ; Lymphoma, B-Cell, Marginal Zone - mortality ; Lymphoproliferative Disorders - drug therapy ; Lymphoproliferative Disorders - mortality ; Male ; marginal zone lymphoma ; Medical sciences ; Middle Aged ; myelodysplasia ; Prospective Studies ; Rituximab ; Survival Rate ; Vidarabine - adverse effects ; Vidarabine - analogs & derivatives ; Vidarabine - therapeutic use</subject><ispartof>British journal of haematology, 2009-06, Vol.145 (6), p.741-748</ispartof><rights>2009 Blackwell Publishing Ltd</rights><rights>2009 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5337-3cd98253ab6c14188f918caa2ba98b70c8c44df42368da70267ea1c0d55a3ac73</citedby><cites>FETCH-LOGICAL-c5337-3cd98253ab6c14188f918caa2ba98b70c8c44df42368da70267ea1c0d55a3ac73</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fj.1365-2141.2009.07677.x$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fj.1365-2141.2009.07677.x$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>230,314,777,781,882,1412,1428,27905,27906,45555,45556,46390,46814</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=21548633$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19344412$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Brown, Jennifer R.</creatorcontrib><creatorcontrib>Friedberg, Jonathan W.</creatorcontrib><creatorcontrib>Feng, Yang</creatorcontrib><creatorcontrib>Scofield, Sarah</creatorcontrib><creatorcontrib>Phillips, Kimberly</creatorcontrib><creatorcontrib>Dal Cin, Paola</creatorcontrib><creatorcontrib>Joyce, Robin</creatorcontrib><creatorcontrib>Takvorian, Ronald W.</creatorcontrib><creatorcontrib>Fisher, David C.</creatorcontrib><creatorcontrib>Fisher, Richard I.</creatorcontrib><creatorcontrib>Liesveld, Jane</creatorcontrib><creatorcontrib>Marquis, Diana</creatorcontrib><creatorcontrib>Neuberg, Donna</creatorcontrib><creatorcontrib>Freedman, Arnold S.</creatorcontrib><title>A phase 2 study of concurrent fludarabine and rituximab for the treatment of marginal zone lymphomas</title><title>British journal of haematology</title><addtitle>Br J Haematol</addtitle><description>Summary
The marginal zone lymphomas (MZLs) are a recently defined group of related diseases that probably arise from a common cell of origin, the marginal zone B cell. Data on therapy for subtypes other than gastric mucosa‐associated lymphoid tissue (MALT) lymphoma has been largely limited to retrospective case series. This prospective phase 2 study of fludarabine and rituximab for the treatment of marginal zone lymphomas enrolled 26 patients, 14 with nodal MZL, eight with MALT lymphomas and four with splenic MZL; 81% were receiving initial systemic therapy. Only 58% [95% confidence interval (CI) 37–77%] of patients completed the planned six cycles, due to significant haematological, infectious and allergic toxicity. Four late toxic deaths occurred due to infections [15% (95% CI 4·3–35%)], two related to delayed bone marrow aplasia and two related to myelodysplastic syndrome. Nonetheless, the overall response rate was 85% (95% CI 65–96%), with 54% complete responses. The progression‐free survival at 3·1 years of follow‐up is 79·5% (95% CI 63–96%). We conclude that, although concurrent fludarabine and rituximab given at this dose and schedule is a highly effective regimen in the treatment of MZLs, the significant haematological and infectious toxicity observed both during and after therapy is prohibitive in this patient population, emphasizing the need to study MZLs as a separate entity.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antibodies, Monoclonal - adverse effects</subject><subject>Antibodies, Monoclonal - therapeutic use</subject><subject>Antibodies, Monoclonal, Murine-Derived</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>bone marrow aplasia</subject><subject>Disease-Free Survival</subject><subject>Female</subject><subject>fludarabine</subject><subject>Follow-Up Studies</subject><subject>Hematologic and hematopoietic diseases</subject><subject>Humans</subject><subject>Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis</subject><subject>Lymphoma - drug therapy</subject><subject>Lymphoma - mortality</subject><subject>Lymphoma, B-Cell, Marginal Zone - drug therapy</subject><subject>Lymphoma, B-Cell, Marginal Zone - mortality</subject><subject>Lymphoproliferative Disorders - drug therapy</subject><subject>Lymphoproliferative Disorders - mortality</subject><subject>Male</subject><subject>marginal zone lymphoma</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>myelodysplasia</subject><subject>Prospective Studies</subject><subject>Rituximab</subject><subject>Survival Rate</subject><subject>Vidarabine - adverse effects</subject><subject>Vidarabine - analogs & derivatives</subject><subject>Vidarabine - therapeutic use</subject><issn>0007-1048</issn><issn>1365-2141</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkc1u1DAUhS1ERaeFV0DewC7Bf4mdBUilghZUqRtYWzeO0_HIiQc7gRmeHqczGmBXb2zpfuf42AchTElJ83q3KSmvq4JRQUtGSFMSWUtZ7p6h1WnwHK0IIbKgRKhzdJHShhDKSUVfoHPacCEEZSvUXeHtGpLFDKdp7vY49NiE0cwx2nHCvZ87iNC60WIYOxzdNO_cAC3uQ8TT2uIpWpiGhc3KAeKDG8Hj3yEL_H7YrsMA6SU668En--q4X6Lvnz99u74t7u5vvlxf3RWm4lwW3HSNYhWHtjb5AUr1DVUGgLXQqFYSo4wQXS8Yr1UHkrBaWqCGdFUFHIzkl-jDwXc7t4PtTE4VwettzInjXgdw-v_J6Nb6IfzUTFZMMZYN3h4NYvgx2zTpwSVjvYfRhjnp_NeSV0JlUB1AE0NK0fanSyjRS0V6o5cm9NLEImv0Y0V6l6Wv_w35V3jsJANvjgAkA76PMBqXThyjOUDNeebeH7hfztv9kwPoj19vlxP_A6b6rqc</recordid><startdate>200906</startdate><enddate>200906</enddate><creator>Brown, Jennifer R.</creator><creator>Friedberg, Jonathan W.</creator><creator>Feng, Yang</creator><creator>Scofield, Sarah</creator><creator>Phillips, Kimberly</creator><creator>Dal Cin, Paola</creator><creator>Joyce, Robin</creator><creator>Takvorian, Ronald W.</creator><creator>Fisher, David C.</creator><creator>Fisher, Richard I.</creator><creator>Liesveld, Jane</creator><creator>Marquis, Diana</creator><creator>Neuberg, Donna</creator><creator>Freedman, Arnold S.</creator><general>Blackwell Publishing Ltd</general><general>Blackwell</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>H94</scope><scope>5PM</scope></search><sort><creationdate>200906</creationdate><title>A phase 2 study of concurrent fludarabine and rituximab for the treatment of marginal zone lymphomas</title><author>Brown, Jennifer R. ; Friedberg, Jonathan W. ; Feng, Yang ; Scofield, Sarah ; Phillips, Kimberly ; Dal Cin, Paola ; Joyce, Robin ; Takvorian, Ronald W. ; Fisher, David C. ; Fisher, Richard I. ; Liesveld, Jane ; Marquis, Diana ; Neuberg, Donna ; Freedman, Arnold S.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5337-3cd98253ab6c14188f918caa2ba98b70c8c44df42368da70267ea1c0d55a3ac73</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antibodies, Monoclonal - adverse effects</topic><topic>Antibodies, Monoclonal - therapeutic use</topic><topic>Antibodies, Monoclonal, Murine-Derived</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>bone marrow aplasia</topic><topic>Disease-Free Survival</topic><topic>Female</topic><topic>fludarabine</topic><topic>Follow-Up Studies</topic><topic>Hematologic and hematopoietic diseases</topic><topic>Humans</topic><topic>Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis</topic><topic>Lymphoma - drug therapy</topic><topic>Lymphoma - mortality</topic><topic>Lymphoma, B-Cell, Marginal Zone - drug therapy</topic><topic>Lymphoma, B-Cell, Marginal Zone - mortality</topic><topic>Lymphoproliferative Disorders - drug therapy</topic><topic>Lymphoproliferative Disorders - mortality</topic><topic>Male</topic><topic>marginal zone lymphoma</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>myelodysplasia</topic><topic>Prospective Studies</topic><topic>Rituximab</topic><topic>Survival Rate</topic><topic>Vidarabine - adverse effects</topic><topic>Vidarabine - analogs & derivatives</topic><topic>Vidarabine - therapeutic use</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Brown, Jennifer R.</creatorcontrib><creatorcontrib>Friedberg, Jonathan W.</creatorcontrib><creatorcontrib>Feng, Yang</creatorcontrib><creatorcontrib>Scofield, Sarah</creatorcontrib><creatorcontrib>Phillips, Kimberly</creatorcontrib><creatorcontrib>Dal Cin, Paola</creatorcontrib><creatorcontrib>Joyce, Robin</creatorcontrib><creatorcontrib>Takvorian, Ronald W.</creatorcontrib><creatorcontrib>Fisher, David C.</creatorcontrib><creatorcontrib>Fisher, Richard I.</creatorcontrib><creatorcontrib>Liesveld, Jane</creatorcontrib><creatorcontrib>Marquis, Diana</creatorcontrib><creatorcontrib>Neuberg, Donna</creatorcontrib><creatorcontrib>Freedman, Arnold S.</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>British journal of haematology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Brown, Jennifer R.</au><au>Friedberg, Jonathan W.</au><au>Feng, Yang</au><au>Scofield, Sarah</au><au>Phillips, Kimberly</au><au>Dal Cin, Paola</au><au>Joyce, Robin</au><au>Takvorian, Ronald W.</au><au>Fisher, David C.</au><au>Fisher, Richard I.</au><au>Liesveld, Jane</au><au>Marquis, Diana</au><au>Neuberg, Donna</au><au>Freedman, Arnold S.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A phase 2 study of concurrent fludarabine and rituximab for the treatment of marginal zone lymphomas</atitle><jtitle>British journal of haematology</jtitle><addtitle>Br J Haematol</addtitle><date>2009-06</date><risdate>2009</risdate><volume>145</volume><issue>6</issue><spage>741</spage><epage>748</epage><pages>741-748</pages><issn>0007-1048</issn><eissn>1365-2141</eissn><coden>BJHEAL</coden><abstract>Summary
The marginal zone lymphomas (MZLs) are a recently defined group of related diseases that probably arise from a common cell of origin, the marginal zone B cell. Data on therapy for subtypes other than gastric mucosa‐associated lymphoid tissue (MALT) lymphoma has been largely limited to retrospective case series. This prospective phase 2 study of fludarabine and rituximab for the treatment of marginal zone lymphomas enrolled 26 patients, 14 with nodal MZL, eight with MALT lymphomas and four with splenic MZL; 81% were receiving initial systemic therapy. Only 58% [95% confidence interval (CI) 37–77%] of patients completed the planned six cycles, due to significant haematological, infectious and allergic toxicity. Four late toxic deaths occurred due to infections [15% (95% CI 4·3–35%)], two related to delayed bone marrow aplasia and two related to myelodysplastic syndrome. Nonetheless, the overall response rate was 85% (95% CI 65–96%), with 54% complete responses. The progression‐free survival at 3·1 years of follow‐up is 79·5% (95% CI 63–96%). We conclude that, although concurrent fludarabine and rituximab given at this dose and schedule is a highly effective regimen in the treatment of MZLs, the significant haematological and infectious toxicity observed both during and after therapy is prohibitive in this patient population, emphasizing the need to study MZLs as a separate entity.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>19344412</pmid><doi>10.1111/j.1365-2141.2009.07677.x</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adult Aged Aged, 80 and over Antibodies, Monoclonal - adverse effects Antibodies, Monoclonal - therapeutic use Antibodies, Monoclonal, Murine-Derived Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biological and medical sciences bone marrow aplasia Disease-Free Survival Female fludarabine Follow-Up Studies Hematologic and hematopoietic diseases Humans Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis Lymphoma - drug therapy Lymphoma - mortality Lymphoma, B-Cell, Marginal Zone - drug therapy Lymphoma, B-Cell, Marginal Zone - mortality Lymphoproliferative Disorders - drug therapy Lymphoproliferative Disorders - mortality Male marginal zone lymphoma Medical sciences Middle Aged myelodysplasia Prospective Studies Rituximab Survival Rate Vidarabine - adverse effects Vidarabine - analogs & derivatives Vidarabine - therapeutic use |
| title | A phase 2 study of concurrent fludarabine and rituximab for the treatment of marginal zone lymphomas |
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