Long-Term Patient-Reported Outcomes From a Phase 3 Randomized Prospective Trial of Conventional Versus Hypofractionated Radiation Therapy for Localized Prostate Cancer
To assess the long-term quality of life (QoL) outcomes from a phase 3 trial comparing 2 modes of intensity modulated radiation therapy (IMRT): conventional IMRT (CIMRT) versus hypofractionated IMRT (HIMRT) in patients with localized prostate cancer. Between 2002 and 2006, 303 men with low-risk to hi...
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| Veröffentlicht in: | International journal of radiation oncology, biology, physics biology, physics, 2017-03, Vol.97 (4), p.722-731 |
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| creator | Shaikh, Talha Li, Tianyu Handorf, Elizabeth A. Johnson, Matthew E. Wang, Lora S. Hallman, Mark A. Greenberg, Richard E. Price, Robert A. Uzzo, Robert G. Ma, Charlie Chen, David Geynisman, Daniel M. Pollack, Alan Horwitz, Eric M. |
| description | To assess the long-term quality of life (QoL) outcomes from a phase 3 trial comparing 2 modes of intensity modulated radiation therapy (IMRT): conventional IMRT (CIMRT) versus hypofractionated IMRT (HIMRT) in patients with localized prostate cancer.
Between 2002 and 2006, 303 men with low-risk to high-risk prostate cancer were randomized to 76 Gy in 38 fractions (CIMRT) versus 70.2 Gy in 26 fractions (HIMRT). QoL was compared by use of the Expanded Prostate Cancer Index Composite (EPIC), the International Prostate Symptom Score (IPSS), and EuroQoL (EQ5D) questionnaires. The primary outcome of the QoL analysis was a minimum clinically important difference defined as a 0.5 standard deviation change from baseline for each respective QoL parameter. Treatment effects were evaluated with the use of logistic mixed effects regression models.
A total of 286, 299, and 218 patients had baseline EPIC, IPSS, or EQ5D data available and were included in the analysis. Overall, there was no statistically significant difference between the 2 treatment arms in terms of EPIC, IPSS, or EQ5D scores over time, although there was a trend toward lower EPIC urinary incontinence scores in the HIMRT arm. More patients in the HIMRT arm had a lower EPIC urinary incontinence score relative to baseline versus patients in the CIMRT arm with long-term follow-up. On multivariable analysis, there was no association between radiation fractionation scheme and any QoL parameter. When other clinical factors were examined, lymph node radiation was associated with worse EPIC hormonal scores versus patients receiving no lymph node radiation. In general, QoL outcomes were generally stable over time, with the exception of EPIC hormonal and EQ5D scores.
In this randomized prospective study, there were stable QoL changes in patients receiving HIMRT or CIMRT. Our results add to the growing body of literature suggesting that HIMRT may be an acceptable treatment modality in clinically localized prostate cancer. |
| doi_str_mv | 10.1016/j.ijrobp.2016.12.034 |
| format | Article |
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Between 2002 and 2006, 303 men with low-risk to high-risk prostate cancer were randomized to 76 Gy in 38 fractions (CIMRT) versus 70.2 Gy in 26 fractions (HIMRT). QoL was compared by use of the Expanded Prostate Cancer Index Composite (EPIC), the International Prostate Symptom Score (IPSS), and EuroQoL (EQ5D) questionnaires. The primary outcome of the QoL analysis was a minimum clinically important difference defined as a 0.5 standard deviation change from baseline for each respective QoL parameter. Treatment effects were evaluated with the use of logistic mixed effects regression models.
A total of 286, 299, and 218 patients had baseline EPIC, IPSS, or EQ5D data available and were included in the analysis. Overall, there was no statistically significant difference between the 2 treatment arms in terms of EPIC, IPSS, or EQ5D scores over time, although there was a trend toward lower EPIC urinary incontinence scores in the HIMRT arm. More patients in the HIMRT arm had a lower EPIC urinary incontinence score relative to baseline versus patients in the CIMRT arm with long-term follow-up. On multivariable analysis, there was no association between radiation fractionation scheme and any QoL parameter. When other clinical factors were examined, lymph node radiation was associated with worse EPIC hormonal scores versus patients receiving no lymph node radiation. In general, QoL outcomes were generally stable over time, with the exception of EPIC hormonal and EQ5D scores.
In this randomized prospective study, there were stable QoL changes in patients receiving HIMRT or CIMRT. Our results add to the growing body of literature suggesting that HIMRT may be an acceptable treatment modality in clinically localized prostate cancer.</description><identifier>ISSN: 0360-3016</identifier><identifier>EISSN: 1879-355X</identifier><identifier>DOI: 10.1016/j.ijrobp.2016.12.034</identifier><identifier>PMID: 28244407</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Aged ; Aged, 80 and over ; Causality ; Comorbidity ; Dose Hypofractionation ; Humans ; Longitudinal Studies ; Male ; Middle Aged ; Prevalence ; Prostatic Neoplasms - epidemiology ; Prostatic Neoplasms - psychology ; Prostatic Neoplasms - radiotherapy ; Quality of Life - psychology ; Radiation Injuries - diagnosis ; Radiation Injuries - epidemiology ; Radiation Injuries - psychology ; Radiotherapy, Conformal - methods ; Radiotherapy, Conformal - psychology ; Radiotherapy, Conformal - utilization ; Risk Factors ; Self Report ; Survival Rate ; Treatment Outcome ; United States - epidemiology ; Urinary Incontinence - epidemiology ; Urinary Incontinence - prevention & control ; Urinary Incontinence - psychology</subject><ispartof>International journal of radiation oncology, biology, physics, 2017-03, Vol.97 (4), p.722-731</ispartof><rights>2016 Elsevier Inc.</rights><rights>Copyright © 2016 Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c474t-2e298f9043c14c3e3024135737923ce1b8593c0668eb42e5eb4416be2b53a56c3</citedby><cites>FETCH-LOGICAL-c474t-2e298f9043c14c3e3024135737923ce1b8593c0668eb42e5eb4416be2b53a56c3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.ijrobp.2016.12.034$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,777,781,3537,27905,27906,45976</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28244407$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Shaikh, Talha</creatorcontrib><creatorcontrib>Li, Tianyu</creatorcontrib><creatorcontrib>Handorf, Elizabeth A.</creatorcontrib><creatorcontrib>Johnson, Matthew E.</creatorcontrib><creatorcontrib>Wang, Lora S.</creatorcontrib><creatorcontrib>Hallman, Mark A.</creatorcontrib><creatorcontrib>Greenberg, Richard E.</creatorcontrib><creatorcontrib>Price, Robert A.</creatorcontrib><creatorcontrib>Uzzo, Robert G.</creatorcontrib><creatorcontrib>Ma, Charlie</creatorcontrib><creatorcontrib>Chen, David</creatorcontrib><creatorcontrib>Geynisman, Daniel M.</creatorcontrib><creatorcontrib>Pollack, Alan</creatorcontrib><creatorcontrib>Horwitz, Eric M.</creatorcontrib><title>Long-Term Patient-Reported Outcomes From a Phase 3 Randomized Prospective Trial of Conventional Versus Hypofractionated Radiation Therapy for Localized Prostate Cancer</title><title>International journal of radiation oncology, biology, physics</title><addtitle>Int J Radiat Oncol Biol Phys</addtitle><description>To assess the long-term quality of life (QoL) outcomes from a phase 3 trial comparing 2 modes of intensity modulated radiation therapy (IMRT): conventional IMRT (CIMRT) versus hypofractionated IMRT (HIMRT) in patients with localized prostate cancer.
Between 2002 and 2006, 303 men with low-risk to high-risk prostate cancer were randomized to 76 Gy in 38 fractions (CIMRT) versus 70.2 Gy in 26 fractions (HIMRT). QoL was compared by use of the Expanded Prostate Cancer Index Composite (EPIC), the International Prostate Symptom Score (IPSS), and EuroQoL (EQ5D) questionnaires. The primary outcome of the QoL analysis was a minimum clinically important difference defined as a 0.5 standard deviation change from baseline for each respective QoL parameter. Treatment effects were evaluated with the use of logistic mixed effects regression models.
A total of 286, 299, and 218 patients had baseline EPIC, IPSS, or EQ5D data available and were included in the analysis. Overall, there was no statistically significant difference between the 2 treatment arms in terms of EPIC, IPSS, or EQ5D scores over time, although there was a trend toward lower EPIC urinary incontinence scores in the HIMRT arm. More patients in the HIMRT arm had a lower EPIC urinary incontinence score relative to baseline versus patients in the CIMRT arm with long-term follow-up. On multivariable analysis, there was no association between radiation fractionation scheme and any QoL parameter. When other clinical factors were examined, lymph node radiation was associated with worse EPIC hormonal scores versus patients receiving no lymph node radiation. In general, QoL outcomes were generally stable over time, with the exception of EPIC hormonal and EQ5D scores.
In this randomized prospective study, there were stable QoL changes in patients receiving HIMRT or CIMRT. Our results add to the growing body of literature suggesting that HIMRT may be an acceptable treatment modality in clinically localized prostate cancer.</description><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Causality</subject><subject>Comorbidity</subject><subject>Dose Hypofractionation</subject><subject>Humans</subject><subject>Longitudinal Studies</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Prevalence</subject><subject>Prostatic Neoplasms - epidemiology</subject><subject>Prostatic Neoplasms - psychology</subject><subject>Prostatic Neoplasms - radiotherapy</subject><subject>Quality of Life - psychology</subject><subject>Radiation Injuries - diagnosis</subject><subject>Radiation Injuries - epidemiology</subject><subject>Radiation Injuries - psychology</subject><subject>Radiotherapy, Conformal - methods</subject><subject>Radiotherapy, Conformal - psychology</subject><subject>Radiotherapy, Conformal - utilization</subject><subject>Risk Factors</subject><subject>Self Report</subject><subject>Survival Rate</subject><subject>Treatment Outcome</subject><subject>United States - epidemiology</subject><subject>Urinary Incontinence - epidemiology</subject><subject>Urinary Incontinence - prevention & control</subject><subject>Urinary Incontinence - psychology</subject><issn>0360-3016</issn><issn>1879-355X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kc1q3DAUhUVJaaZJ3yAULbOxqz__bQplyDSFgQzDtGQnZPk60WBb7pU9MH2hvmY1nTTLbiSOdO650v0IueEs5Yznn_ap26Ovx1RElXKRMqnekAUviyqRWfZ4QRZM5iyR8fqSvA9hzxjjvFDvyKUohVKKFQvye-2Hp2QH2NONmRwMU7KF0eMEDX2YJ-t7CHSFvqeGbp5NACrp1gyN792vaNmgDyPYyR2A7tCZjvqWLv1wiEHOD1H_AAxzoPfH0bdo7N_TU_jWNM6cFN09A5rxSFuPdO2t6V6Tp-ikSzNYwGvytjVdgA8v-xX5vrrbLe-T9cPXb8sv68SqQk2JAFGVbcWUtFxZCZIJxWVWyKIS0gKvy6ySluV5CbUSkMVV8bwGUWfSZLmVV-T2nDui_zlDmHTvgoWuMwP4Oeg4XlGWpcqzaFVnq41PDQitHtH1Bo-aM31CpPf6jEifEGkudEQUyz6-dJjrHprXon9MouHz2QDxnwcHqIONYCw0DuOodePd_zv8ATTcpqo</recordid><startdate>20170315</startdate><enddate>20170315</enddate><creator>Shaikh, Talha</creator><creator>Li, Tianyu</creator><creator>Handorf, Elizabeth A.</creator><creator>Johnson, Matthew E.</creator><creator>Wang, Lora S.</creator><creator>Hallman, Mark A.</creator><creator>Greenberg, Richard E.</creator><creator>Price, Robert A.</creator><creator>Uzzo, Robert G.</creator><creator>Ma, Charlie</creator><creator>Chen, David</creator><creator>Geynisman, Daniel M.</creator><creator>Pollack, Alan</creator><creator>Horwitz, Eric M.</creator><general>Elsevier Inc</general><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>7X8</scope></search><sort><creationdate>20170315</creationdate><title>Long-Term Patient-Reported Outcomes From a Phase 3 Randomized Prospective Trial of Conventional Versus Hypofractionated Radiation Therapy for Localized Prostate Cancer</title><author>Shaikh, Talha ; Li, Tianyu ; Handorf, Elizabeth A. ; Johnson, Matthew E. ; Wang, Lora S. ; Hallman, Mark A. ; Greenberg, Richard E. ; Price, Robert A. ; Uzzo, Robert G. ; Ma, Charlie ; Chen, David ; Geynisman, Daniel M. ; Pollack, Alan ; Horwitz, Eric M.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c474t-2e298f9043c14c3e3024135737923ce1b8593c0668eb42e5eb4416be2b53a56c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Causality</topic><topic>Comorbidity</topic><topic>Dose Hypofractionation</topic><topic>Humans</topic><topic>Longitudinal Studies</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Prevalence</topic><topic>Prostatic Neoplasms - epidemiology</topic><topic>Prostatic Neoplasms - psychology</topic><topic>Prostatic Neoplasms - radiotherapy</topic><topic>Quality of Life - psychology</topic><topic>Radiation Injuries - diagnosis</topic><topic>Radiation Injuries - epidemiology</topic><topic>Radiation Injuries - psychology</topic><topic>Radiotherapy, Conformal - methods</topic><topic>Radiotherapy, Conformal - psychology</topic><topic>Radiotherapy, Conformal - utilization</topic><topic>Risk Factors</topic><topic>Self Report</topic><topic>Survival Rate</topic><topic>Treatment Outcome</topic><topic>United States - epidemiology</topic><topic>Urinary Incontinence - epidemiology</topic><topic>Urinary Incontinence - prevention & control</topic><topic>Urinary Incontinence - psychology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Shaikh, Talha</creatorcontrib><creatorcontrib>Li, Tianyu</creatorcontrib><creatorcontrib>Handorf, Elizabeth A.</creatorcontrib><creatorcontrib>Johnson, Matthew E.</creatorcontrib><creatorcontrib>Wang, Lora S.</creatorcontrib><creatorcontrib>Hallman, Mark A.</creatorcontrib><creatorcontrib>Greenberg, Richard E.</creatorcontrib><creatorcontrib>Price, Robert A.</creatorcontrib><creatorcontrib>Uzzo, Robert G.</creatorcontrib><creatorcontrib>Ma, Charlie</creatorcontrib><creatorcontrib>Chen, David</creatorcontrib><creatorcontrib>Geynisman, Daniel M.</creatorcontrib><creatorcontrib>Pollack, Alan</creatorcontrib><creatorcontrib>Horwitz, Eric M.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>International journal of radiation oncology, biology, physics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Shaikh, Talha</au><au>Li, Tianyu</au><au>Handorf, Elizabeth A.</au><au>Johnson, Matthew E.</au><au>Wang, Lora S.</au><au>Hallman, Mark A.</au><au>Greenberg, Richard E.</au><au>Price, Robert A.</au><au>Uzzo, Robert G.</au><au>Ma, Charlie</au><au>Chen, David</au><au>Geynisman, Daniel M.</au><au>Pollack, Alan</au><au>Horwitz, Eric M.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Long-Term Patient-Reported Outcomes From a Phase 3 Randomized Prospective Trial of Conventional Versus Hypofractionated Radiation Therapy for Localized Prostate Cancer</atitle><jtitle>International journal of radiation oncology, biology, physics</jtitle><addtitle>Int J Radiat Oncol Biol Phys</addtitle><date>2017-03-15</date><risdate>2017</risdate><volume>97</volume><issue>4</issue><spage>722</spage><epage>731</epage><pages>722-731</pages><issn>0360-3016</issn><eissn>1879-355X</eissn><abstract>To assess the long-term quality of life (QoL) outcomes from a phase 3 trial comparing 2 modes of intensity modulated radiation therapy (IMRT): conventional IMRT (CIMRT) versus hypofractionated IMRT (HIMRT) in patients with localized prostate cancer.
Between 2002 and 2006, 303 men with low-risk to high-risk prostate cancer were randomized to 76 Gy in 38 fractions (CIMRT) versus 70.2 Gy in 26 fractions (HIMRT). QoL was compared by use of the Expanded Prostate Cancer Index Composite (EPIC), the International Prostate Symptom Score (IPSS), and EuroQoL (EQ5D) questionnaires. The primary outcome of the QoL analysis was a minimum clinically important difference defined as a 0.5 standard deviation change from baseline for each respective QoL parameter. Treatment effects were evaluated with the use of logistic mixed effects regression models.
A total of 286, 299, and 218 patients had baseline EPIC, IPSS, or EQ5D data available and were included in the analysis. Overall, there was no statistically significant difference between the 2 treatment arms in terms of EPIC, IPSS, or EQ5D scores over time, although there was a trend toward lower EPIC urinary incontinence scores in the HIMRT arm. More patients in the HIMRT arm had a lower EPIC urinary incontinence score relative to baseline versus patients in the CIMRT arm with long-term follow-up. On multivariable analysis, there was no association between radiation fractionation scheme and any QoL parameter. When other clinical factors were examined, lymph node radiation was associated with worse EPIC hormonal scores versus patients receiving no lymph node radiation. In general, QoL outcomes were generally stable over time, with the exception of EPIC hormonal and EQ5D scores.
In this randomized prospective study, there were stable QoL changes in patients receiving HIMRT or CIMRT. Our results add to the growing body of literature suggesting that HIMRT may be an acceptable treatment modality in clinically localized prostate cancer.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>28244407</pmid><doi>10.1016/j.ijrobp.2016.12.034</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Aged Aged, 80 and over Causality Comorbidity Dose Hypofractionation Humans Longitudinal Studies Male Middle Aged Prevalence Prostatic Neoplasms - epidemiology Prostatic Neoplasms - psychology Prostatic Neoplasms - radiotherapy Quality of Life - psychology Radiation Injuries - diagnosis Radiation Injuries - epidemiology Radiation Injuries - psychology Radiotherapy, Conformal - methods Radiotherapy, Conformal - psychology Radiotherapy, Conformal - utilization Risk Factors Self Report Survival Rate Treatment Outcome United States - epidemiology Urinary Incontinence - epidemiology Urinary Incontinence - prevention & control Urinary Incontinence - psychology |
| title | Long-Term Patient-Reported Outcomes From a Phase 3 Randomized Prospective Trial of Conventional Versus Hypofractionated Radiation Therapy for Localized Prostate Cancer |
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