The use and effectiveness of rituximab maintenance in patients with follicular lymphoma diagnosed between 2004 and 2007 in the United States

BACKGROUND The authors examined the “real‐world” effectiveness of rituximab (R) maintenance therapy (R‐maintenance) compared with observation after R‐based induction therapy in patients with previously untreated follicular lymphoma (FL) in the United States. METHODS The National LymphoCare Study is...

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Veröffentlicht in:Cancer 2014-06, Vol.120 (12), p.1830-1837
Hauptverfasser: Nastoupil, Loretta J., Sinha, Rajni, Byrtek, Michelle, Zhou, Xiaolei, Taylor, Michael D., Friedberg, Jonathan W., Link, Brian K., Cerhan, James R., Dawson, Keith, Flowers, Christopher R.
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container_end_page 1837
container_issue 12
container_start_page 1830
container_title Cancer
container_volume 120
creator Nastoupil, Loretta J.
Sinha, Rajni
Byrtek, Michelle
Zhou, Xiaolei
Taylor, Michael D.
Friedberg, Jonathan W.
Link, Brian K.
Cerhan, James R.
Dawson, Keith
Flowers, Christopher R.
description BACKGROUND The authors examined the “real‐world” effectiveness of rituximab (R) maintenance therapy (R‐maintenance) compared with observation after R‐based induction therapy in patients with previously untreated follicular lymphoma (FL) in the United States. METHODS The National LymphoCare Study is a prospective, multicenter, observational study that enrolled > 2700 untreated patients with FL diagnosed from 2004 to 2007 at 265 sites in the United States. Among these, patients who achieved at least stable disease after R‐based induction therapy were eligible for the current analysis. Patients who initiated R‐maintenance within 215 days of completing induction therapy were categorized as the R‐maintenance group, and those who did not initiate therapy during this period were categorized as the observation group. The objective of the current study was to determine the effect of R‐maintenance on progression‐free survival (PFS), time to next treatment (TTNT), and overall survival (OS). RESULTS A total of 1439 patients completed R‐based induction therapy, 1186 of whom met all inclusion criteria (541 patients received R‐maintenance and 645 patients were observed). Characteristics that were found to be predictive of receiving R‐maintenance were histology grade (1/2), Ann Arbor stage of disease (III/IV), geographic region (region other than the West), and practice setting (community practice). With a median follow‐up of 5.7 years, R‐maintenance was associated with superior PFS (hazards ratio [HR], 0.68; 95% confidence interval [95% CI], 0.56‐0.84 [P = .0003]) and TTNT (HR, 0.66; 95% CI, 0.52‐0.84 [P = .0007]). No significant difference in OS was observed (HR, 0.81; 95% CI, 0.58‐1.14 [P = .23]). CONCLUSIONS R‐maintenance in patients with FL and at least stable disease after R‐based induction therapy provided significantly longer PFS and TTNT in comparison with observation, but no significant difference in OS was observed with 5‐years of follow‐up. This comparative effectiveness study aligns with the results of randomized trials suggesting that similar outcomes occur with R‐maintenance in FL with the treatment variations observed in clinical practice. Cancer 2014;120:1830–1837. © 2014 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society. The authors present what, to their knowledge, is the largest published series to date of prospectively enrolled patients with previously untreated follicular lymphoma in the modern era examinin
doi_str_mv 10.1002/cncr.28659
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METHODS The National LymphoCare Study is a prospective, multicenter, observational study that enrolled &gt; 2700 untreated patients with FL diagnosed from 2004 to 2007 at 265 sites in the United States. Among these, patients who achieved at least stable disease after R‐based induction therapy were eligible for the current analysis. Patients who initiated R‐maintenance within 215 days of completing induction therapy were categorized as the R‐maintenance group, and those who did not initiate therapy during this period were categorized as the observation group. The objective of the current study was to determine the effect of R‐maintenance on progression‐free survival (PFS), time to next treatment (TTNT), and overall survival (OS). RESULTS A total of 1439 patients completed R‐based induction therapy, 1186 of whom met all inclusion criteria (541 patients received R‐maintenance and 645 patients were observed). Characteristics that were found to be predictive of receiving R‐maintenance were histology grade (1/2), Ann Arbor stage of disease (III/IV), geographic region (region other than the West), and practice setting (community practice). With a median follow‐up of 5.7 years, R‐maintenance was associated with superior PFS (hazards ratio [HR], 0.68; 95% confidence interval [95% CI], 0.56‐0.84 [P = .0003]) and TTNT (HR, 0.66; 95% CI, 0.52‐0.84 [P = .0007]). No significant difference in OS was observed (HR, 0.81; 95% CI, 0.58‐1.14 [P = .23]). CONCLUSIONS R‐maintenance in patients with FL and at least stable disease after R‐based induction therapy provided significantly longer PFS and TTNT in comparison with observation, but no significant difference in OS was observed with 5‐years of follow‐up. This comparative effectiveness study aligns with the results of randomized trials suggesting that similar outcomes occur with R‐maintenance in FL with the treatment variations observed in clinical practice. Cancer 2014;120:1830–1837. © 2014 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society. The authors present what, to their knowledge, is the largest published series to date of prospectively enrolled patients with previously untreated follicular lymphoma in the modern era examining the effectiveness of rituximab maintenance in clinical practice. With &gt; 5 years of follow‐up, it was found that, compared with observation, receipt of rituximab maintenance therapy was associated with significantly longer progression‐free survival and time to next treatment in previously untreated patients with follicular lymphoma who achieved at least stable disease after rituximab‐based induction therapy.</description><identifier>ISSN: 0008-543X</identifier><identifier>EISSN: 1097-0142</identifier><identifier>DOI: 10.1002/cncr.28659</identifier><identifier>PMID: 24668580</identifier><identifier>CODEN: CANCAR</identifier><language>eng</language><publisher>Hoboken, NJ: Wiley-Blackwell</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Antibodies, Monoclonal, Murine-Derived - adverse effects ; Antibodies, Monoclonal, Murine-Derived - therapeutic use ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Biological and medical sciences ; Disease-Free Survival ; Female ; follicular lymphoma ; frontline therapy ; Hematologic and hematopoietic diseases ; Humans ; Induction Chemotherapy ; Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis ; Lymphoma, Follicular - drug therapy ; Lymphoma, Follicular - epidemiology ; Lymphoma, Follicular - pathology ; Lymphoma, Follicular - therapy ; Maintenance Chemotherapy ; Male ; Medical sciences ; Middle Aged ; non‐Hodgkin lymphoma ; Original ; outcomes ; Prospective Studies ; Randomized Controlled Trials as Topic ; Rituximab ; rituximab maintenance ; Survival Analysis ; Treatment Outcome ; Tumors ; United States - epidemiology ; Young Adult</subject><ispartof>Cancer, 2014-06, Vol.120 (12), p.1830-1837</ispartof><rights>2014 The Authors.Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society.</rights><rights>2015 INIST-CNRS</rights><rights>2014 The Authors.Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society. 2014</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4509-b677babc02641fdd8ac8a70ae07b78da684cd54050fb1e215a491796874a3f1a3</citedby><cites>FETCH-LOGICAL-c4509-b677babc02641fdd8ac8a70ae07b78da684cd54050fb1e215a491796874a3f1a3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fcncr.28659$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fcncr.28659$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,1411,1427,27901,27902,45550,45551,46384,46808</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&amp;idt=28522399$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24668580$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Nastoupil, Loretta J.</creatorcontrib><creatorcontrib>Sinha, Rajni</creatorcontrib><creatorcontrib>Byrtek, Michelle</creatorcontrib><creatorcontrib>Zhou, Xiaolei</creatorcontrib><creatorcontrib>Taylor, Michael D.</creatorcontrib><creatorcontrib>Friedberg, Jonathan W.</creatorcontrib><creatorcontrib>Link, Brian K.</creatorcontrib><creatorcontrib>Cerhan, James R.</creatorcontrib><creatorcontrib>Dawson, Keith</creatorcontrib><creatorcontrib>Flowers, Christopher R.</creatorcontrib><title>The use and effectiveness of rituximab maintenance in patients with follicular lymphoma diagnosed between 2004 and 2007 in the United States</title><title>Cancer</title><addtitle>Cancer</addtitle><description>BACKGROUND The authors examined the “real‐world” effectiveness of rituximab (R) maintenance therapy (R‐maintenance) compared with observation after R‐based induction therapy in patients with previously untreated follicular lymphoma (FL) in the United States. METHODS The National LymphoCare Study is a prospective, multicenter, observational study that enrolled &gt; 2700 untreated patients with FL diagnosed from 2004 to 2007 at 265 sites in the United States. Among these, patients who achieved at least stable disease after R‐based induction therapy were eligible for the current analysis. Patients who initiated R‐maintenance within 215 days of completing induction therapy were categorized as the R‐maintenance group, and those who did not initiate therapy during this period were categorized as the observation group. The objective of the current study was to determine the effect of R‐maintenance on progression‐free survival (PFS), time to next treatment (TTNT), and overall survival (OS). RESULTS A total of 1439 patients completed R‐based induction therapy, 1186 of whom met all inclusion criteria (541 patients received R‐maintenance and 645 patients were observed). Characteristics that were found to be predictive of receiving R‐maintenance were histology grade (1/2), Ann Arbor stage of disease (III/IV), geographic region (region other than the West), and practice setting (community practice). With a median follow‐up of 5.7 years, R‐maintenance was associated with superior PFS (hazards ratio [HR], 0.68; 95% confidence interval [95% CI], 0.56‐0.84 [P = .0003]) and TTNT (HR, 0.66; 95% CI, 0.52‐0.84 [P = .0007]). No significant difference in OS was observed (HR, 0.81; 95% CI, 0.58‐1.14 [P = .23]). CONCLUSIONS R‐maintenance in patients with FL and at least stable disease after R‐based induction therapy provided significantly longer PFS and TTNT in comparison with observation, but no significant difference in OS was observed with 5‐years of follow‐up. This comparative effectiveness study aligns with the results of randomized trials suggesting that similar outcomes occur with R‐maintenance in FL with the treatment variations observed in clinical practice. Cancer 2014;120:1830–1837. © 2014 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society. The authors present what, to their knowledge, is the largest published series to date of prospectively enrolled patients with previously untreated follicular lymphoma in the modern era examining the effectiveness of rituximab maintenance in clinical practice. With &gt; 5 years of follow‐up, it was found that, compared with observation, receipt of rituximab maintenance therapy was associated with significantly longer progression‐free survival and time to next treatment in previously untreated patients with follicular lymphoma who achieved at least stable disease after rituximab‐based induction therapy.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antibodies, Monoclonal, Murine-Derived - adverse effects</subject><subject>Antibodies, Monoclonal, Murine-Derived - therapeutic use</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Disease-Free Survival</subject><subject>Female</subject><subject>follicular lymphoma</subject><subject>frontline therapy</subject><subject>Hematologic and hematopoietic diseases</subject><subject>Humans</subject><subject>Induction Chemotherapy</subject><subject>Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis</subject><subject>Lymphoma, Follicular - drug therapy</subject><subject>Lymphoma, Follicular - epidemiology</subject><subject>Lymphoma, Follicular - pathology</subject><subject>Lymphoma, Follicular - therapy</subject><subject>Maintenance Chemotherapy</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>non‐Hodgkin lymphoma</subject><subject>Original</subject><subject>outcomes</subject><subject>Prospective Studies</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Rituximab</subject><subject>rituximab maintenance</subject><subject>Survival Analysis</subject><subject>Treatment Outcome</subject><subject>Tumors</subject><subject>United States - epidemiology</subject><subject>Young Adult</subject><issn>0008-543X</issn><issn>1097-0142</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>EIF</sourceid><recordid>eNp9kc9u1DAQxi1ERZfChQdAvnBBSms7duxckNCq_JEqKkErcbMmzrhrlDir2Ntl34GHxtstBS49eaz5zfdp5iPkFWennDFx5qKbT4VpVPuELDhrdcW4FE_JgjFmKiXr78fkeUo_ylcLVT8jx0I2jVGGLcivqxXSTUIKsafoPbocbjFiSnTydA558zOM0NERQswYITqkIdI15IAxJ7oNeUX9NAzBbQaY6bAb16tpBNoHuIlTwp52mLeIkQrG5J1NKfReJBfr6xhyYb5lyJhekCMPQ8KX9-8Juf5wfrX8VF1cfvy8fH9ROalYW3WN1h10jolGct_3BpwBzQCZ7rTpoTHS9UoyxXzHUXAFsuW6bYyWUHsO9Ql5d9Bdb7oRe1c2mWGw67msOu_sBMH-34lhZW-mWytFObJpisDbg4Cbp5Rm9A-znNl9Jnafib3LpMCv_3V7QP-EUIA39wAkB4Ofy5VD-ssZJUTd7oX4gduGAXePWNrll-XXg_lvEXem_Q</recordid><startdate>20140615</startdate><enddate>20140615</enddate><creator>Nastoupil, Loretta J.</creator><creator>Sinha, Rajni</creator><creator>Byrtek, Michelle</creator><creator>Zhou, Xiaolei</creator><creator>Taylor, Michael D.</creator><creator>Friedberg, Jonathan W.</creator><creator>Link, Brian K.</creator><creator>Cerhan, James R.</creator><creator>Dawson, Keith</creator><creator>Flowers, Christopher R.</creator><general>Wiley-Blackwell</general><general>BlackWell Publishing Ltd</general><scope>24P</scope><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>5PM</scope></search><sort><creationdate>20140615</creationdate><title>The use and effectiveness of rituximab maintenance in patients with follicular lymphoma diagnosed between 2004 and 2007 in the United States</title><author>Nastoupil, Loretta J. ; Sinha, Rajni ; Byrtek, Michelle ; Zhou, Xiaolei ; Taylor, Michael D. ; Friedberg, Jonathan W. ; Link, Brian K. ; Cerhan, James R. ; Dawson, Keith ; Flowers, Christopher R.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4509-b677babc02641fdd8ac8a70ae07b78da684cd54050fb1e215a491796874a3f1a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antibodies, Monoclonal, Murine-Derived - adverse effects</topic><topic>Antibodies, Monoclonal, Murine-Derived - therapeutic use</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Disease-Free Survival</topic><topic>Female</topic><topic>follicular lymphoma</topic><topic>frontline therapy</topic><topic>Hematologic and hematopoietic diseases</topic><topic>Humans</topic><topic>Induction Chemotherapy</topic><topic>Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis</topic><topic>Lymphoma, Follicular - drug therapy</topic><topic>Lymphoma, Follicular - epidemiology</topic><topic>Lymphoma, Follicular - pathology</topic><topic>Lymphoma, Follicular - therapy</topic><topic>Maintenance Chemotherapy</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>non‐Hodgkin lymphoma</topic><topic>Original</topic><topic>outcomes</topic><topic>Prospective Studies</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Rituximab</topic><topic>rituximab maintenance</topic><topic>Survival Analysis</topic><topic>Treatment Outcome</topic><topic>Tumors</topic><topic>United States - epidemiology</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Nastoupil, Loretta J.</creatorcontrib><creatorcontrib>Sinha, Rajni</creatorcontrib><creatorcontrib>Byrtek, Michelle</creatorcontrib><creatorcontrib>Zhou, Xiaolei</creatorcontrib><creatorcontrib>Taylor, Michael D.</creatorcontrib><creatorcontrib>Friedberg, Jonathan W.</creatorcontrib><creatorcontrib>Link, Brian K.</creatorcontrib><creatorcontrib>Cerhan, James R.</creatorcontrib><creatorcontrib>Dawson, Keith</creatorcontrib><creatorcontrib>Flowers, Christopher R.</creatorcontrib><collection>Wiley Online Library Open Access</collection><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>PubMed Central (Full Participant titles)</collection><jtitle>Cancer</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Nastoupil, Loretta J.</au><au>Sinha, Rajni</au><au>Byrtek, Michelle</au><au>Zhou, Xiaolei</au><au>Taylor, Michael D.</au><au>Friedberg, Jonathan W.</au><au>Link, Brian K.</au><au>Cerhan, James R.</au><au>Dawson, Keith</au><au>Flowers, Christopher R.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The use and effectiveness of rituximab maintenance in patients with follicular lymphoma diagnosed between 2004 and 2007 in the United States</atitle><jtitle>Cancer</jtitle><addtitle>Cancer</addtitle><date>2014-06-15</date><risdate>2014</risdate><volume>120</volume><issue>12</issue><spage>1830</spage><epage>1837</epage><pages>1830-1837</pages><issn>0008-543X</issn><eissn>1097-0142</eissn><coden>CANCAR</coden><abstract>BACKGROUND The authors examined the “real‐world” effectiveness of rituximab (R) maintenance therapy (R‐maintenance) compared with observation after R‐based induction therapy in patients with previously untreated follicular lymphoma (FL) in the United States. METHODS The National LymphoCare Study is a prospective, multicenter, observational study that enrolled &gt; 2700 untreated patients with FL diagnosed from 2004 to 2007 at 265 sites in the United States. Among these, patients who achieved at least stable disease after R‐based induction therapy were eligible for the current analysis. Patients who initiated R‐maintenance within 215 days of completing induction therapy were categorized as the R‐maintenance group, and those who did not initiate therapy during this period were categorized as the observation group. The objective of the current study was to determine the effect of R‐maintenance on progression‐free survival (PFS), time to next treatment (TTNT), and overall survival (OS). RESULTS A total of 1439 patients completed R‐based induction therapy, 1186 of whom met all inclusion criteria (541 patients received R‐maintenance and 645 patients were observed). Characteristics that were found to be predictive of receiving R‐maintenance were histology grade (1/2), Ann Arbor stage of disease (III/IV), geographic region (region other than the West), and practice setting (community practice). With a median follow‐up of 5.7 years, R‐maintenance was associated with superior PFS (hazards ratio [HR], 0.68; 95% confidence interval [95% CI], 0.56‐0.84 [P = .0003]) and TTNT (HR, 0.66; 95% CI, 0.52‐0.84 [P = .0007]). No significant difference in OS was observed (HR, 0.81; 95% CI, 0.58‐1.14 [P = .23]). CONCLUSIONS R‐maintenance in patients with FL and at least stable disease after R‐based induction therapy provided significantly longer PFS and TTNT in comparison with observation, but no significant difference in OS was observed with 5‐years of follow‐up. This comparative effectiveness study aligns with the results of randomized trials suggesting that similar outcomes occur with R‐maintenance in FL with the treatment variations observed in clinical practice. Cancer 2014;120:1830–1837. © 2014 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society. The authors present what, to their knowledge, is the largest published series to date of prospectively enrolled patients with previously untreated follicular lymphoma in the modern era examining the effectiveness of rituximab maintenance in clinical practice. With &gt; 5 years of follow‐up, it was found that, compared with observation, receipt of rituximab maintenance therapy was associated with significantly longer progression‐free survival and time to next treatment in previously untreated patients with follicular lymphoma who achieved at least stable disease after rituximab‐based induction therapy.</abstract><cop>Hoboken, NJ</cop><pub>Wiley-Blackwell</pub><pmid>24668580</pmid><doi>10.1002/cncr.28659</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record>
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subjects Adult
Aged
Aged, 80 and over
Antibodies, Monoclonal, Murine-Derived - adverse effects
Antibodies, Monoclonal, Murine-Derived - therapeutic use
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Biological and medical sciences
Disease-Free Survival
Female
follicular lymphoma
frontline therapy
Hematologic and hematopoietic diseases
Humans
Induction Chemotherapy
Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis
Lymphoma, Follicular - drug therapy
Lymphoma, Follicular - epidemiology
Lymphoma, Follicular - pathology
Lymphoma, Follicular - therapy
Maintenance Chemotherapy
Male
Medical sciences
Middle Aged
non‐Hodgkin lymphoma
Original
outcomes
Prospective Studies
Randomized Controlled Trials as Topic
Rituximab
rituximab maintenance
Survival Analysis
Treatment Outcome
Tumors
United States - epidemiology
Young Adult
title The use and effectiveness of rituximab maintenance in patients with follicular lymphoma diagnosed between 2004 and 2007 in the United States
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