A phase II trial of bendamustine in combination with rituximab in older patients with previously untreated diffuse large B‐cell lymphoma
Summary Bendamustine in combination with rituximab (BR) has been associated with high response rates and acceptable toxicity in older patients with relapsed/refractory diffuse large B‐cell lymphoma (DLBCL). Evaluation of BR is warranted in the front‐line setting for DLBCL patients not eligible for a...
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| Veröffentlicht in: | British journal of haematology 2016-10, Vol.175 (2), p.281-289 |
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| creator | Park, Steven I. Grover, Natalie S. Olajide, Oludamilola Asch, Adam S. Wall, James G. Richards, Kristy L. Sobol, Anna L. Deal, Allison M. Ivanova, Anastasia Foster, Matthew C. Muss, Hyman B. Shea, Thomas C. |
| description | Summary
Bendamustine in combination with rituximab (BR) has been associated with high response rates and acceptable toxicity in older patients with relapsed/refractory diffuse large B‐cell lymphoma (DLBCL). Evaluation of BR is warranted in the front‐line setting for DLBCL patients not eligible for anthracyclines or for the elderly. In this phase II study, we enrolled DLBCL patients aged ≥65 years who were poor candidates for R‐CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) to determine the efficacy and safety of BR in previously untreated stage II–IV DLBCL. Twenty‐three patients were enrolled with a median age of 80 years. 52% of patients presented with poor functional status (Eastern Cooperative Oncology Group performance score of ≥2). The overall response rate was 78% with 12 complete responses (52%). At a median follow up of 29 months, the median overall survival was 10·2 months and the median progression‐free survival was 5·4 months. The most common grade 3/4 adverse events were haematological. Combination therapy with BR demonstrates high response rates as front‐line therapy in frail older patients with DLBCL, but survival rates were low. BR should be used with caution in future clinical trials involving older DLBCL patients with poor functional status. |
| doi_str_mv | 10.1111/bjh.14232 |
| format | Article |
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Bendamustine in combination with rituximab (BR) has been associated with high response rates and acceptable toxicity in older patients with relapsed/refractory diffuse large B‐cell lymphoma (DLBCL). Evaluation of BR is warranted in the front‐line setting for DLBCL patients not eligible for anthracyclines or for the elderly. In this phase II study, we enrolled DLBCL patients aged ≥65 years who were poor candidates for R‐CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) to determine the efficacy and safety of BR in previously untreated stage II–IV DLBCL. Twenty‐three patients were enrolled with a median age of 80 years. 52% of patients presented with poor functional status (Eastern Cooperative Oncology Group performance score of ≥2). The overall response rate was 78% with 12 complete responses (52%). At a median follow up of 29 months, the median overall survival was 10·2 months and the median progression‐free survival was 5·4 months. The most common grade 3/4 adverse events were haematological. Combination therapy with BR demonstrates high response rates as front‐line therapy in frail older patients with DLBCL, but survival rates were low. BR should be used with caution in future clinical trials involving older DLBCL patients with poor functional status.</description><identifier>ISSN: 0007-1048</identifier><identifier>EISSN: 1365-2141</identifier><identifier>DOI: 10.1111/bjh.14232</identifier><identifier>PMID: 27448091</identifier><language>eng</language><publisher>England</publisher><subject>Age Factors ; Aged ; Aged, 80 and over ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; bendamustine ; Bendamustine Hydrochloride - administration & dosage ; Biomarkers ; Cause of Death ; DLBCL ; elderly patients ; Female ; Humans ; Kaplan-Meier Estimate ; lymphoma ; Lymphoma, Large B-Cell, Diffuse - diagnosis ; Lymphoma, Large B-Cell, Diffuse - drug therapy ; Lymphoma, Large B-Cell, Diffuse - mortality ; Male ; Neoplasm Staging ; Prognosis ; rituximab ; Rituximab - administration & dosage ; Treatment Outcome</subject><ispartof>British journal of haematology, 2016-10, Vol.175 (2), p.281-289</ispartof><rights>2016 John Wiley & Sons Ltd</rights><rights>2016 John Wiley & Sons Ltd.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4482-ff685c3d2f3de31b94775f052140cb7e72e814f7a06c12b315a196496632b7a73</citedby><cites>FETCH-LOGICAL-c4482-ff685c3d2f3de31b94775f052140cb7e72e814f7a06c12b315a196496632b7a73</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%2Fbjh.14232$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fbjh.14232$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>230,314,776,780,881,1411,1427,27901,27902,45550,45551,46384,46808</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27448091$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Park, Steven I.</creatorcontrib><creatorcontrib>Grover, Natalie S.</creatorcontrib><creatorcontrib>Olajide, Oludamilola</creatorcontrib><creatorcontrib>Asch, Adam S.</creatorcontrib><creatorcontrib>Wall, James G.</creatorcontrib><creatorcontrib>Richards, Kristy L.</creatorcontrib><creatorcontrib>Sobol, Anna L.</creatorcontrib><creatorcontrib>Deal, Allison M.</creatorcontrib><creatorcontrib>Ivanova, Anastasia</creatorcontrib><creatorcontrib>Foster, Matthew C.</creatorcontrib><creatorcontrib>Muss, Hyman B.</creatorcontrib><creatorcontrib>Shea, Thomas C.</creatorcontrib><title>A phase II trial of bendamustine in combination with rituximab in older patients with previously untreated diffuse large B‐cell lymphoma</title><title>British journal of haematology</title><addtitle>Br J Haematol</addtitle><description>Summary
Bendamustine in combination with rituximab (BR) has been associated with high response rates and acceptable toxicity in older patients with relapsed/refractory diffuse large B‐cell lymphoma (DLBCL). Evaluation of BR is warranted in the front‐line setting for DLBCL patients not eligible for anthracyclines or for the elderly. In this phase II study, we enrolled DLBCL patients aged ≥65 years who were poor candidates for R‐CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) to determine the efficacy and safety of BR in previously untreated stage II–IV DLBCL. Twenty‐three patients were enrolled with a median age of 80 years. 52% of patients presented with poor functional status (Eastern Cooperative Oncology Group performance score of ≥2). The overall response rate was 78% with 12 complete responses (52%). At a median follow up of 29 months, the median overall survival was 10·2 months and the median progression‐free survival was 5·4 months. The most common grade 3/4 adverse events were haematological. Combination therapy with BR demonstrates high response rates as front‐line therapy in frail older patients with DLBCL, but survival rates were low. BR should be used with caution in future clinical trials involving older DLBCL patients with poor functional status.</description><subject>Age Factors</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>bendamustine</subject><subject>Bendamustine Hydrochloride - administration & dosage</subject><subject>Biomarkers</subject><subject>Cause of Death</subject><subject>DLBCL</subject><subject>elderly patients</subject><subject>Female</subject><subject>Humans</subject><subject>Kaplan-Meier Estimate</subject><subject>lymphoma</subject><subject>Lymphoma, Large B-Cell, Diffuse - diagnosis</subject><subject>Lymphoma, Large B-Cell, Diffuse - drug therapy</subject><subject>Lymphoma, Large B-Cell, Diffuse - mortality</subject><subject>Male</subject><subject>Neoplasm Staging</subject><subject>Prognosis</subject><subject>rituximab</subject><subject>Rituximab - administration & dosage</subject><subject>Treatment Outcome</subject><issn>0007-1048</issn><issn>1365-2141</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kb9u1TAYxS0EopfCwAsgjzCk9Z8kThaktir0okosMFtO8rlx5djBdtrejbkTz8iT4EtKBQNePJyfzneODkKvKTmi-R131-MRLRlnT9CG8roqGC3pU7QhhIiCkrI5QC9ivCaEclLR5-iAibJsSEs36P4Ez6OKgLdbnIJRFnuNO3CDmpaYjANsHO791BmnkvEO35o04mDScmcm1e1VbwcIeM4yuBRXYA5wY_wS7Q4vLgVQCQY8GK2XfMqqcAX49Of3Hz1Yi-1umkc_qZfomVY2wquH_xB9_XD-5eyiuPz8cXt2cln0OTQrtK6bqucD03wATru2FKLSpMqdSd8JEAwaWmqhSN1T1nFaKdrWZVvXnHVCCX6I3q--89JNMPQ5dVBWziEXCjvplZH_Ks6M8srfyIrUvG7KbPD2wSD4bwvEJCcT91WUg9xZ0oYL1rK2Ihl9t6J98DEG0I9nKJH77WTeTv7eLrNv_s71SP4ZKwPHK3BrLOz-7yRPP12slr8A3mim7Q</recordid><startdate>201610</startdate><enddate>201610</enddate><creator>Park, Steven I.</creator><creator>Grover, Natalie S.</creator><creator>Olajide, Oludamilola</creator><creator>Asch, Adam S.</creator><creator>Wall, James G.</creator><creator>Richards, Kristy L.</creator><creator>Sobol, Anna L.</creator><creator>Deal, Allison M.</creator><creator>Ivanova, Anastasia</creator><creator>Foster, Matthew C.</creator><creator>Muss, Hyman B.</creator><creator>Shea, Thomas C.</creator><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>201610</creationdate><title>A phase II trial of bendamustine in combination with rituximab in older patients with previously untreated diffuse large B‐cell lymphoma</title><author>Park, Steven I. ; Grover, Natalie S. ; Olajide, Oludamilola ; Asch, Adam S. ; Wall, James G. ; Richards, Kristy L. ; Sobol, Anna L. ; Deal, Allison M. ; Ivanova, Anastasia ; Foster, Matthew C. ; Muss, Hyman B. ; Shea, Thomas C.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4482-ff685c3d2f3de31b94775f052140cb7e72e814f7a06c12b315a196496632b7a73</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Age Factors</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>bendamustine</topic><topic>Bendamustine Hydrochloride - administration & dosage</topic><topic>Biomarkers</topic><topic>Cause of Death</topic><topic>DLBCL</topic><topic>elderly patients</topic><topic>Female</topic><topic>Humans</topic><topic>Kaplan-Meier Estimate</topic><topic>lymphoma</topic><topic>Lymphoma, Large B-Cell, Diffuse - diagnosis</topic><topic>Lymphoma, Large B-Cell, Diffuse - drug therapy</topic><topic>Lymphoma, Large B-Cell, Diffuse - mortality</topic><topic>Male</topic><topic>Neoplasm Staging</topic><topic>Prognosis</topic><topic>rituximab</topic><topic>Rituximab - administration & dosage</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Park, Steven I.</creatorcontrib><creatorcontrib>Grover, Natalie S.</creatorcontrib><creatorcontrib>Olajide, Oludamilola</creatorcontrib><creatorcontrib>Asch, Adam S.</creatorcontrib><creatorcontrib>Wall, James G.</creatorcontrib><creatorcontrib>Richards, Kristy L.</creatorcontrib><creatorcontrib>Sobol, Anna L.</creatorcontrib><creatorcontrib>Deal, Allison M.</creatorcontrib><creatorcontrib>Ivanova, Anastasia</creatorcontrib><creatorcontrib>Foster, Matthew C.</creatorcontrib><creatorcontrib>Muss, Hyman B.</creatorcontrib><creatorcontrib>Shea, Thomas C.</creatorcontrib><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>Park, Steven I.</au><au>Grover, Natalie S.</au><au>Olajide, Oludamilola</au><au>Asch, Adam S.</au><au>Wall, James G.</au><au>Richards, Kristy L.</au><au>Sobol, Anna L.</au><au>Deal, Allison M.</au><au>Ivanova, Anastasia</au><au>Foster, Matthew C.</au><au>Muss, Hyman B.</au><au>Shea, Thomas C.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A phase II trial of bendamustine in combination with rituximab in older patients with previously untreated diffuse large B‐cell lymphoma</atitle><jtitle>British journal of haematology</jtitle><addtitle>Br J Haematol</addtitle><date>2016-10</date><risdate>2016</risdate><volume>175</volume><issue>2</issue><spage>281</spage><epage>289</epage><pages>281-289</pages><issn>0007-1048</issn><eissn>1365-2141</eissn><abstract>Summary
Bendamustine in combination with rituximab (BR) has been associated with high response rates and acceptable toxicity in older patients with relapsed/refractory diffuse large B‐cell lymphoma (DLBCL). Evaluation of BR is warranted in the front‐line setting for DLBCL patients not eligible for anthracyclines or for the elderly. In this phase II study, we enrolled DLBCL patients aged ≥65 years who were poor candidates for R‐CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) to determine the efficacy and safety of BR in previously untreated stage II–IV DLBCL. Twenty‐three patients were enrolled with a median age of 80 years. 52% of patients presented with poor functional status (Eastern Cooperative Oncology Group performance score of ≥2). The overall response rate was 78% with 12 complete responses (52%). At a median follow up of 29 months, the median overall survival was 10·2 months and the median progression‐free survival was 5·4 months. The most common grade 3/4 adverse events were haematological. Combination therapy with BR demonstrates high response rates as front‐line therapy in frail older patients with DLBCL, but survival rates were low. BR should be used with caution in future clinical trials involving older DLBCL patients with poor functional status.</abstract><cop>England</cop><pmid>27448091</pmid><doi>10.1111/bjh.14232</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Age Factors Aged Aged, 80 and over Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use bendamustine Bendamustine Hydrochloride - administration & dosage Biomarkers Cause of Death DLBCL elderly patients Female Humans Kaplan-Meier Estimate lymphoma Lymphoma, Large B-Cell, Diffuse - diagnosis Lymphoma, Large B-Cell, Diffuse - drug therapy Lymphoma, Large B-Cell, Diffuse - mortality Male Neoplasm Staging Prognosis rituximab Rituximab - administration & dosage Treatment Outcome |
| title | A phase II trial of bendamustine in combination with rituximab in older patients with previously untreated diffuse large B‐cell lymphoma |
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