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New Molecular Assay for the Proliferation Signature in Mantle Cell Lymphoma Applicable to Formalin-Fixed Paraffin-Embedded Biopsies
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| Zeitschriftentitel: | Journal of Clinical Oncology |
|---|---|
| Personen und Körperschaften: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| In: | Journal of Clinical Oncology, 35, 2017, 15, S. 1668-1677 |
| Format: | E-Article |
| Sprache: | Englisch |
| veröffentlicht: |
American Society of Clinical Oncology (ASCO)
|
| Schlagwörter: |
| author_facet |
Scott, David W. Abrisqueta, Pau Wright, George W. Slack, Graham W. Mottok, Anja Villa, Diego Jares, Pedro Rauert-Wunderlich, Hilka Royo, Cristina Clot, Guillem Pinyol, Magda Boyle, Merrill Chan, Fong Chun Braziel, Rita M. Chan, Wing C. Weisenburger, Dennis D. Cook, James R. Greiner, Timothy C. Fu, Kai Ott, German Delabie, Jan Smeland, Erlend B. Holte, Harald Jaffe, Elaine S. Steidl, Christian Connors, Joseph M. Gascoyne, Randy D. Rosenwald, Andreas Staudt, Louis M. Campo, Elias Rimsza, Lisa M. Scott, David W. Abrisqueta, Pau Wright, George W. Slack, Graham W. Mottok, Anja Villa, Diego Jares, Pedro Rauert-Wunderlich, Hilka Royo, Cristina Clot, Guillem Pinyol, Magda Boyle, Merrill Chan, Fong Chun Braziel, Rita M. Chan, Wing C. Weisenburger, Dennis D. Cook, James R. Greiner, Timothy C. Fu, Kai Ott, German Delabie, Jan Smeland, Erlend B. Holte, Harald Jaffe, Elaine S. Steidl, Christian Connors, Joseph M. Gascoyne, Randy D. Rosenwald, Andreas Staudt, Louis M. Campo, Elias Rimsza, Lisa M. |
|---|---|
| author |
Scott, David W. Abrisqueta, Pau Wright, George W. Slack, Graham W. Mottok, Anja Villa, Diego Jares, Pedro Rauert-Wunderlich, Hilka Royo, Cristina Clot, Guillem Pinyol, Magda Boyle, Merrill Chan, Fong Chun Braziel, Rita M. Chan, Wing C. Weisenburger, Dennis D. Cook, James R. Greiner, Timothy C. Fu, Kai Ott, German Delabie, Jan Smeland, Erlend B. Holte, Harald Jaffe, Elaine S. Steidl, Christian Connors, Joseph M. Gascoyne, Randy D. Rosenwald, Andreas Staudt, Louis M. Campo, Elias Rimsza, Lisa M. |
| spellingShingle |
Scott, David W. Abrisqueta, Pau Wright, George W. Slack, Graham W. Mottok, Anja Villa, Diego Jares, Pedro Rauert-Wunderlich, Hilka Royo, Cristina Clot, Guillem Pinyol, Magda Boyle, Merrill Chan, Fong Chun Braziel, Rita M. Chan, Wing C. Weisenburger, Dennis D. Cook, James R. Greiner, Timothy C. Fu, Kai Ott, German Delabie, Jan Smeland, Erlend B. Holte, Harald Jaffe, Elaine S. Steidl, Christian Connors, Joseph M. Gascoyne, Randy D. Rosenwald, Andreas Staudt, Louis M. Campo, Elias Rimsza, Lisa M. Journal of Clinical Oncology New Molecular Assay for the Proliferation Signature in Mantle Cell Lymphoma Applicable to Formalin-Fixed Paraffin-Embedded Biopsies Cancer Research Oncology |
| author_sort |
scott, david w. |
| spelling |
Scott, David W. Abrisqueta, Pau Wright, George W. Slack, Graham W. Mottok, Anja Villa, Diego Jares, Pedro Rauert-Wunderlich, Hilka Royo, Cristina Clot, Guillem Pinyol, Magda Boyle, Merrill Chan, Fong Chun Braziel, Rita M. Chan, Wing C. Weisenburger, Dennis D. Cook, James R. Greiner, Timothy C. Fu, Kai Ott, German Delabie, Jan Smeland, Erlend B. Holte, Harald Jaffe, Elaine S. Steidl, Christian Connors, Joseph M. Gascoyne, Randy D. Rosenwald, Andreas Staudt, Louis M. Campo, Elias Rimsza, Lisa M. 0732-183X 1527-7755 American Society of Clinical Oncology (ASCO) Cancer Research Oncology http://dx.doi.org/10.1200/jco.2016.70.7901 <jats:sec><jats:title>Purpose</jats:title><jats:p> Mantle cell lymphoma is an aggressive B-cell neoplasm that displays heterogeneous outcomes after treatment. In 2003, the Lymphoma/Leukemia Molecular Profiling Project described a powerful biomarker—the proliferation signature—using gene expression in fresh frozen material. Herein, we describe the training and validation of a new assay that measures the proliferation signature in RNA derived from routinely available formalin-fixed paraffin-embedded (FFPE) biopsies. </jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p> Forty-seven FFPE biopsies were used to train an assay on the NanoString platform, using microarray gene expression data of matched fresh frozen biopsies as a gold standard. The locked assay was applied to pretreatment FFPE lymph node biopsies from an independent cohort of 110 patients uniformly treated with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone. Seventeen biopsies were tested across three laboratories to assess assay reproducibility. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> The MCL35 assay, which contained a 17-gene proliferation signature, yielded gene expression of sufficient quality to assign an assay score and risk group in 108 (98%) of 110 archival FFPE biopsies. The MCL35 assay assigned patients to high-risk (26%), standard-risk (29%), and low-risk (45%) groups, with different lengths of overall survival (OS): a median of 1.1, 2.6, and 8.6 years, respectively (log-rank for trend, P < .001). In multivariable analysis, these risk groups and the Mantle Cell Lymphoma International Prognostic Index were independently associated with OS ( P < .001 for both variables). Concordance of risk assignment across the three independent laboratories was 100%. </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> The newly developed and validated MCL35 assay for FFPE biopsies uses the proliferation signature to define groups of patients with significantly different OS independent of the Mantle Cell Lymphoma International Prognostic Index. Importantly, the analytic and clinical validity of this assay defines it as a reliable biomarker to support risk-adapted clinical trials. </jats:p></jats:sec> New Molecular Assay for the Proliferation Signature in Mantle Cell Lymphoma Applicable to Formalin-Fixed Paraffin-Embedded Biopsies Journal of Clinical Oncology |
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10.1200/jco.2016.70.7901 |
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| title |
New Molecular Assay for the Proliferation Signature in Mantle Cell Lymphoma Applicable to Formalin-Fixed Paraffin-Embedded Biopsies |
| title_unstemmed |
New Molecular Assay for the Proliferation Signature in Mantle Cell Lymphoma Applicable to Formalin-Fixed Paraffin-Embedded Biopsies |
| title_full |
New Molecular Assay for the Proliferation Signature in Mantle Cell Lymphoma Applicable to Formalin-Fixed Paraffin-Embedded Biopsies |
| title_fullStr |
New Molecular Assay for the Proliferation Signature in Mantle Cell Lymphoma Applicable to Formalin-Fixed Paraffin-Embedded Biopsies |
| title_full_unstemmed |
New Molecular Assay for the Proliferation Signature in Mantle Cell Lymphoma Applicable to Formalin-Fixed Paraffin-Embedded Biopsies |
| title_short |
New Molecular Assay for the Proliferation Signature in Mantle Cell Lymphoma Applicable to Formalin-Fixed Paraffin-Embedded Biopsies |
| title_sort |
new molecular assay for the proliferation signature in mantle cell lymphoma applicable to formalin-fixed paraffin-embedded biopsies |
| topic |
Cancer Research Oncology |
| url |
http://dx.doi.org/10.1200/jco.2016.70.7901 |
| publishDate |
2017 |
| physical |
1668-1677 |
| description |
<jats:sec><jats:title>Purpose</jats:title><jats:p> Mantle cell lymphoma is an aggressive B-cell neoplasm that displays heterogeneous outcomes after treatment. In 2003, the Lymphoma/Leukemia Molecular Profiling Project described a powerful biomarker—the proliferation signature—using gene expression in fresh frozen material. Herein, we describe the training and validation of a new assay that measures the proliferation signature in RNA derived from routinely available formalin-fixed paraffin-embedded (FFPE) biopsies. </jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p> Forty-seven FFPE biopsies were used to train an assay on the NanoString platform, using microarray gene expression data of matched fresh frozen biopsies as a gold standard. The locked assay was applied to pretreatment FFPE lymph node biopsies from an independent cohort of 110 patients uniformly treated with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone. Seventeen biopsies were tested across three laboratories to assess assay reproducibility. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> The MCL35 assay, which contained a 17-gene proliferation signature, yielded gene expression of sufficient quality to assign an assay score and risk group in 108 (98%) of 110 archival FFPE biopsies. The MCL35 assay assigned patients to high-risk (26%), standard-risk (29%), and low-risk (45%) groups, with different lengths of overall survival (OS): a median of 1.1, 2.6, and 8.6 years, respectively (log-rank for trend, P < .001). In multivariable analysis, these risk groups and the Mantle Cell Lymphoma International Prognostic Index were independently associated with OS ( P < .001 for both variables). Concordance of risk assignment across the three independent laboratories was 100%. </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> The newly developed and validated MCL35 assay for FFPE biopsies uses the proliferation signature to define groups of patients with significantly different OS independent of the Mantle Cell Lymphoma International Prognostic Index. Importantly, the analytic and clinical validity of this assay defines it as a reliable biomarker to support risk-adapted clinical trials. </jats:p></jats:sec> |
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| author | Scott, David W., Abrisqueta, Pau, Wright, George W., Slack, Graham W., Mottok, Anja, Villa, Diego, Jares, Pedro, Rauert-Wunderlich, Hilka, Royo, Cristina, Clot, Guillem, Pinyol, Magda, Boyle, Merrill, Chan, Fong Chun, Braziel, Rita M., Chan, Wing C., Weisenburger, Dennis D., Cook, James R., Greiner, Timothy C., Fu, Kai, Ott, German, Delabie, Jan, Smeland, Erlend B., Holte, Harald, Jaffe, Elaine S., Steidl, Christian, Connors, Joseph M., Gascoyne, Randy D., Rosenwald, Andreas, Staudt, Louis M., Campo, Elias, Rimsza, Lisa M. |
| author_facet | Scott, David W., Abrisqueta, Pau, Wright, George W., Slack, Graham W., Mottok, Anja, Villa, Diego, Jares, Pedro, Rauert-Wunderlich, Hilka, Royo, Cristina, Clot, Guillem, Pinyol, Magda, Boyle, Merrill, Chan, Fong Chun, Braziel, Rita M., Chan, Wing C., Weisenburger, Dennis D., Cook, James R., Greiner, Timothy C., Fu, Kai, Ott, German, Delabie, Jan, Smeland, Erlend B., Holte, Harald, Jaffe, Elaine S., Steidl, Christian, Connors, Joseph M., Gascoyne, Randy D., Rosenwald, Andreas, Staudt, Louis M., Campo, Elias, Rimsza, Lisa M., Scott, David W., Abrisqueta, Pau, Wright, George W., Slack, Graham W., Mottok, Anja, Villa, Diego, Jares, Pedro, Rauert-Wunderlich, Hilka, Royo, Cristina, Clot, Guillem, Pinyol, Magda, Boyle, Merrill, Chan, Fong Chun, Braziel, Rita M., Chan, Wing C., Weisenburger, Dennis D., Cook, James R., Greiner, Timothy C., Fu, Kai, Ott, German, Delabie, Jan, Smeland, Erlend B., Holte, Harald, Jaffe, Elaine S., Steidl, Christian, Connors, Joseph M., Gascoyne, Randy D., Rosenwald, Andreas, Staudt, Louis M., Campo, Elias, Rimsza, Lisa M. |
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| description | <jats:sec><jats:title>Purpose</jats:title><jats:p> Mantle cell lymphoma is an aggressive B-cell neoplasm that displays heterogeneous outcomes after treatment. In 2003, the Lymphoma/Leukemia Molecular Profiling Project described a powerful biomarker—the proliferation signature—using gene expression in fresh frozen material. Herein, we describe the training and validation of a new assay that measures the proliferation signature in RNA derived from routinely available formalin-fixed paraffin-embedded (FFPE) biopsies. </jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p> Forty-seven FFPE biopsies were used to train an assay on the NanoString platform, using microarray gene expression data of matched fresh frozen biopsies as a gold standard. The locked assay was applied to pretreatment FFPE lymph node biopsies from an independent cohort of 110 patients uniformly treated with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone. Seventeen biopsies were tested across three laboratories to assess assay reproducibility. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> The MCL35 assay, which contained a 17-gene proliferation signature, yielded gene expression of sufficient quality to assign an assay score and risk group in 108 (98%) of 110 archival FFPE biopsies. The MCL35 assay assigned patients to high-risk (26%), standard-risk (29%), and low-risk (45%) groups, with different lengths of overall survival (OS): a median of 1.1, 2.6, and 8.6 years, respectively (log-rank for trend, P < .001). In multivariable analysis, these risk groups and the Mantle Cell Lymphoma International Prognostic Index were independently associated with OS ( P < .001 for both variables). Concordance of risk assignment across the three independent laboratories was 100%. </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> The newly developed and validated MCL35 assay for FFPE biopsies uses the proliferation signature to define groups of patients with significantly different OS independent of the Mantle Cell Lymphoma International Prognostic Index. Importantly, the analytic and clinical validity of this assay defines it as a reliable biomarker to support risk-adapted clinical trials. </jats:p></jats:sec> |
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| spelling | Scott, David W. Abrisqueta, Pau Wright, George W. Slack, Graham W. Mottok, Anja Villa, Diego Jares, Pedro Rauert-Wunderlich, Hilka Royo, Cristina Clot, Guillem Pinyol, Magda Boyle, Merrill Chan, Fong Chun Braziel, Rita M. Chan, Wing C. Weisenburger, Dennis D. Cook, James R. Greiner, Timothy C. Fu, Kai Ott, German Delabie, Jan Smeland, Erlend B. Holte, Harald Jaffe, Elaine S. Steidl, Christian Connors, Joseph M. Gascoyne, Randy D. Rosenwald, Andreas Staudt, Louis M. Campo, Elias Rimsza, Lisa M. 0732-183X 1527-7755 American Society of Clinical Oncology (ASCO) Cancer Research Oncology http://dx.doi.org/10.1200/jco.2016.70.7901 <jats:sec><jats:title>Purpose</jats:title><jats:p> Mantle cell lymphoma is an aggressive B-cell neoplasm that displays heterogeneous outcomes after treatment. In 2003, the Lymphoma/Leukemia Molecular Profiling Project described a powerful biomarker—the proliferation signature—using gene expression in fresh frozen material. Herein, we describe the training and validation of a new assay that measures the proliferation signature in RNA derived from routinely available formalin-fixed paraffin-embedded (FFPE) biopsies. </jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p> Forty-seven FFPE biopsies were used to train an assay on the NanoString platform, using microarray gene expression data of matched fresh frozen biopsies as a gold standard. The locked assay was applied to pretreatment FFPE lymph node biopsies from an independent cohort of 110 patients uniformly treated with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone. Seventeen biopsies were tested across three laboratories to assess assay reproducibility. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> The MCL35 assay, which contained a 17-gene proliferation signature, yielded gene expression of sufficient quality to assign an assay score and risk group in 108 (98%) of 110 archival FFPE biopsies. The MCL35 assay assigned patients to high-risk (26%), standard-risk (29%), and low-risk (45%) groups, with different lengths of overall survival (OS): a median of 1.1, 2.6, and 8.6 years, respectively (log-rank for trend, P < .001). In multivariable analysis, these risk groups and the Mantle Cell Lymphoma International Prognostic Index were independently associated with OS ( P < .001 for both variables). Concordance of risk assignment across the three independent laboratories was 100%. </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> The newly developed and validated MCL35 assay for FFPE biopsies uses the proliferation signature to define groups of patients with significantly different OS independent of the Mantle Cell Lymphoma International Prognostic Index. Importantly, the analytic and clinical validity of this assay defines it as a reliable biomarker to support risk-adapted clinical trials. </jats:p></jats:sec> New Molecular Assay for the Proliferation Signature in Mantle Cell Lymphoma Applicable to Formalin-Fixed Paraffin-Embedded Biopsies Journal of Clinical Oncology |
| spellingShingle | Scott, David W., Abrisqueta, Pau, Wright, George W., Slack, Graham W., Mottok, Anja, Villa, Diego, Jares, Pedro, Rauert-Wunderlich, Hilka, Royo, Cristina, Clot, Guillem, Pinyol, Magda, Boyle, Merrill, Chan, Fong Chun, Braziel, Rita M., Chan, Wing C., Weisenburger, Dennis D., Cook, James R., Greiner, Timothy C., Fu, Kai, Ott, German, Delabie, Jan, Smeland, Erlend B., Holte, Harald, Jaffe, Elaine S., Steidl, Christian, Connors, Joseph M., Gascoyne, Randy D., Rosenwald, Andreas, Staudt, Louis M., Campo, Elias, Rimsza, Lisa M., Journal of Clinical Oncology, New Molecular Assay for the Proliferation Signature in Mantle Cell Lymphoma Applicable to Formalin-Fixed Paraffin-Embedded Biopsies, Cancer Research, Oncology |
| title | New Molecular Assay for the Proliferation Signature in Mantle Cell Lymphoma Applicable to Formalin-Fixed Paraffin-Embedded Biopsies |
| title_full | New Molecular Assay for the Proliferation Signature in Mantle Cell Lymphoma Applicable to Formalin-Fixed Paraffin-Embedded Biopsies |
| title_fullStr | New Molecular Assay for the Proliferation Signature in Mantle Cell Lymphoma Applicable to Formalin-Fixed Paraffin-Embedded Biopsies |
| title_full_unstemmed | New Molecular Assay for the Proliferation Signature in Mantle Cell Lymphoma Applicable to Formalin-Fixed Paraffin-Embedded Biopsies |
| title_short | New Molecular Assay for the Proliferation Signature in Mantle Cell Lymphoma Applicable to Formalin-Fixed Paraffin-Embedded Biopsies |
| title_sort | new molecular assay for the proliferation signature in mantle cell lymphoma applicable to formalin-fixed paraffin-embedded biopsies |
| title_unstemmed | New Molecular Assay for the Proliferation Signature in Mantle Cell Lymphoma Applicable to Formalin-Fixed Paraffin-Embedded Biopsies |
| topic | Cancer Research, Oncology |
| url | http://dx.doi.org/10.1200/jco.2016.70.7901 |