A Phase II prospective study of hypofractionated proton therapy of prostate and pelvic lymph nodes: Acute effects on patient‐reported quality of life
Background The objective of this study was to report acute changes in patient‐reported quality of life (PRQOL) using the 26‐item Expanded Prostate Index Composite (EPIC‐26) questionnaire in a prospective study using hypofractionated intensity‐modulated proton beam therapy (H‐IMPT) targeting the pros...
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| Veröffentlicht in: | The Prostate 2022-10, Vol.82 (14), p.1338-1345 |
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| creator | Wong, William W. Hillman, David W. Daniels, Thomas B. Vargas, Carlos E. Rwigema, Jean Claude Corbin, Kimberly S. Keole, Sameer R. Merrell, Kenneth W. Stish, Bradley J. Pisansky, Thomas M. Davis, Brian J. Mitchell, Cecilia M. Choo, Richard |
| description | Background
The objective of this study was to report acute changes in patient‐reported quality of life (PRQOL) using the 26‐item Expanded Prostate Index Composite (EPIC‐26) questionnaire in a prospective study using hypofractionated intensity‐modulated proton beam therapy (H‐IMPT) targeting the prostate and the pelvic lymph nodes for high‐risk or unfavorable intermediate‐risk prostate cancer.
Methods
Fifty‐five patients were enrolled. H‐IMPT consisted of 45 GyE to the pelvic lymph nodes and 67.5 GyE to the prostate and seminal vesicles in 25 fractions. PRQOL was assessed with the urinary incontinence (UI), urinary irritative/obstructive symptoms (UO), and bowel function (BF) domains of EPIC‐26 questionnaire. Mean changes in domain scores were analyzed from pretreatment to the end of treatment and 3 months posttreatment. A clinically meaningful change (or minimum important change) was defined as a score change > 50% of the baseline standard deviation.
Results
The mean scores of UO, UI, and BF at baseline were 84.6, 91.1, and 95.3, respectively. At the end of treatment, there were statistically significant and clinically meaningful declines in UO and BF scores (−13.5 and −2.3, respectively), while the decline in UI score was statistically significant but not clinically meaningful (−13.7). A clinically meaningful decline in UO, UI, and BF scores occurred in 53.5%, 22.7%, and 73.2% of the patients, respectively. At 3 months posttreatment, all three mean scores showed an improvement, with fewer patients having a clinically meaningful decline in UO, UI, and BF scores (18.4%, 20.5%, and 45.0%, respectively). There was no significant reduction in the mean UO and UI scores compared to baseline, although the mean BF score remained lower than baseline and the difference was clinically meaningful.
Conclusions
UO, UI, and BF scores of PRQOL declined at the end of H‐IMPT. UO and UI scores showed improvement at 3 months posttreatment and were similar to the baseline scores. However, BF score remained lower at 3 months posttreatment with a clinically meaningful decline. |
| doi_str_mv | 10.1002/pros.24408 |
| format | Article |
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The objective of this study was to report acute changes in patient‐reported quality of life (PRQOL) using the 26‐item Expanded Prostate Index Composite (EPIC‐26) questionnaire in a prospective study using hypofractionated intensity‐modulated proton beam therapy (H‐IMPT) targeting the prostate and the pelvic lymph nodes for high‐risk or unfavorable intermediate‐risk prostate cancer.
Methods
Fifty‐five patients were enrolled. H‐IMPT consisted of 45 GyE to the pelvic lymph nodes and 67.5 GyE to the prostate and seminal vesicles in 25 fractions. PRQOL was assessed with the urinary incontinence (UI), urinary irritative/obstructive symptoms (UO), and bowel function (BF) domains of EPIC‐26 questionnaire. Mean changes in domain scores were analyzed from pretreatment to the end of treatment and 3 months posttreatment. A clinically meaningful change (or minimum important change) was defined as a score change > 50% of the baseline standard deviation.
Results
The mean scores of UO, UI, and BF at baseline were 84.6, 91.1, and 95.3, respectively. At the end of treatment, there were statistically significant and clinically meaningful declines in UO and BF scores (−13.5 and −2.3, respectively), while the decline in UI score was statistically significant but not clinically meaningful (−13.7). A clinically meaningful decline in UO, UI, and BF scores occurred in 53.5%, 22.7%, and 73.2% of the patients, respectively. At 3 months posttreatment, all three mean scores showed an improvement, with fewer patients having a clinically meaningful decline in UO, UI, and BF scores (18.4%, 20.5%, and 45.0%, respectively). There was no significant reduction in the mean UO and UI scores compared to baseline, although the mean BF score remained lower than baseline and the difference was clinically meaningful.
Conclusions
UO, UI, and BF scores of PRQOL declined at the end of H‐IMPT. UO and UI scores showed improvement at 3 months posttreatment and were similar to the baseline scores. However, BF score remained lower at 3 months posttreatment with a clinically meaningful decline.</description><identifier>ISSN: 0270-4137</identifier><identifier>EISSN: 1097-0045</identifier><identifier>DOI: 10.1002/pros.24408</identifier><language>eng</language><publisher>Hoboken: Wiley Subscription Services, Inc</publisher><subject>Acute effects ; hypofractionation ; Lymph nodes ; Lymphatic system ; Patients ; Prostate ; Prostate cancer ; proton therapy ; Quality of life ; Questionnaires ; Seminal vesicle ; Statistical analysis ; Urinary incontinence</subject><ispartof>The Prostate, 2022-10, Vol.82 (14), p.1338-1345</ispartof><rights>2022 Wiley Periodicals LLC.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3348-555ac6b54691f6574940481cd5f2a5aa3be74731d8594a3658fffb180983d9bb3</citedby><cites>FETCH-LOGICAL-c3348-555ac6b54691f6574940481cd5f2a5aa3be74731d8594a3658fffb180983d9bb3</cites><orcidid>0000-0002-7629-5859</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fpros.24408$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fpros.24408$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids></links><search><creatorcontrib>Wong, William W.</creatorcontrib><creatorcontrib>Hillman, David W.</creatorcontrib><creatorcontrib>Daniels, Thomas B.</creatorcontrib><creatorcontrib>Vargas, Carlos E.</creatorcontrib><creatorcontrib>Rwigema, Jean Claude</creatorcontrib><creatorcontrib>Corbin, Kimberly S.</creatorcontrib><creatorcontrib>Keole, Sameer R.</creatorcontrib><creatorcontrib>Merrell, Kenneth W.</creatorcontrib><creatorcontrib>Stish, Bradley J.</creatorcontrib><creatorcontrib>Pisansky, Thomas M.</creatorcontrib><creatorcontrib>Davis, Brian J.</creatorcontrib><creatorcontrib>Mitchell, Cecilia M.</creatorcontrib><creatorcontrib>Choo, Richard</creatorcontrib><title>A Phase II prospective study of hypofractionated proton therapy of prostate and pelvic lymph nodes: Acute effects on patient‐reported quality of life</title><title>The Prostate</title><description>Background
The objective of this study was to report acute changes in patient‐reported quality of life (PRQOL) using the 26‐item Expanded Prostate Index Composite (EPIC‐26) questionnaire in a prospective study using hypofractionated intensity‐modulated proton beam therapy (H‐IMPT) targeting the prostate and the pelvic lymph nodes for high‐risk or unfavorable intermediate‐risk prostate cancer.
Methods
Fifty‐five patients were enrolled. H‐IMPT consisted of 45 GyE to the pelvic lymph nodes and 67.5 GyE to the prostate and seminal vesicles in 25 fractions. PRQOL was assessed with the urinary incontinence (UI), urinary irritative/obstructive symptoms (UO), and bowel function (BF) domains of EPIC‐26 questionnaire. Mean changes in domain scores were analyzed from pretreatment to the end of treatment and 3 months posttreatment. A clinically meaningful change (or minimum important change) was defined as a score change > 50% of the baseline standard deviation.
Results
The mean scores of UO, UI, and BF at baseline were 84.6, 91.1, and 95.3, respectively. At the end of treatment, there were statistically significant and clinically meaningful declines in UO and BF scores (−13.5 and −2.3, respectively), while the decline in UI score was statistically significant but not clinically meaningful (−13.7). A clinically meaningful decline in UO, UI, and BF scores occurred in 53.5%, 22.7%, and 73.2% of the patients, respectively. At 3 months posttreatment, all three mean scores showed an improvement, with fewer patients having a clinically meaningful decline in UO, UI, and BF scores (18.4%, 20.5%, and 45.0%, respectively). There was no significant reduction in the mean UO and UI scores compared to baseline, although the mean BF score remained lower than baseline and the difference was clinically meaningful.
Conclusions
UO, UI, and BF scores of PRQOL declined at the end of H‐IMPT. UO and UI scores showed improvement at 3 months posttreatment and were similar to the baseline scores. However, BF score remained lower at 3 months posttreatment with a clinically meaningful decline.</description><subject>Acute effects</subject><subject>hypofractionation</subject><subject>Lymph nodes</subject><subject>Lymphatic system</subject><subject>Patients</subject><subject>Prostate</subject><subject>Prostate cancer</subject><subject>proton therapy</subject><subject>Quality of life</subject><subject>Questionnaires</subject><subject>Seminal vesicle</subject><subject>Statistical analysis</subject><subject>Urinary incontinence</subject><issn>0270-4137</issn><issn>1097-0045</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><recordid>eNp9kcFq3DAURUVpoNMkm36BoJsQcPJkSbbV3RDaZiCQkDZrIdtPjIPHciQ5xbt-Qnf5v35J5Zmussjqge65l6f7CPnE4IIB5Jejd-EiFwKqd2TFQJUZgJDvyQryEjLBePmBfAzhESDhkK_Iy5rebU1AutnQxTxiE7tnpCFO7Uydpdt5dNab9OoGE7FdqOgGGrfozbhHFl9MGjVDkrF_7hraz7txSwfXYvhC182UVLQ2hQeazKOJHQ7x7-8_Hkfnl9inyfRd3Of1ncUTcmRNH_D0_zwmD9--_ry6zm5uv2-u1jdZw7moMimlaYpaikIxW8hSKAGiYk0rbW6kMbzGUpSctZVUwvBCVtbamlWgKt6quubH5OyQmz7xNGGIeteFBvveDOimoPOiksBzBSqhn1-hj27yQ9pOp3LLkiueQ6LOD1STWgkerR59tzN-1gz0ciO91KX3N0owO8C_uh7nN0h9d3_74-D5B5polyE</recordid><startdate>20221001</startdate><enddate>20221001</enddate><creator>Wong, William W.</creator><creator>Hillman, David W.</creator><creator>Daniels, Thomas B.</creator><creator>Vargas, Carlos E.</creator><creator>Rwigema, Jean Claude</creator><creator>Corbin, Kimberly S.</creator><creator>Keole, Sameer R.</creator><creator>Merrell, Kenneth W.</creator><creator>Stish, Bradley J.</creator><creator>Pisansky, Thomas M.</creator><creator>Davis, Brian J.</creator><creator>Mitchell, Cecilia M.</creator><creator>Choo, Richard</creator><general>Wiley Subscription Services, Inc</general><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>7TO</scope><scope>8FD</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>P64</scope><scope>RC3</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-7629-5859</orcidid></search><sort><creationdate>20221001</creationdate><title>A Phase II prospective study of hypofractionated proton therapy of prostate and pelvic lymph nodes: Acute effects on patient‐reported quality of life</title><author>Wong, William W. ; Hillman, David W. ; Daniels, Thomas B. ; Vargas, Carlos E. ; Rwigema, Jean Claude ; Corbin, Kimberly S. ; Keole, Sameer R. ; Merrell, Kenneth W. ; Stish, Bradley J. ; Pisansky, Thomas M. ; Davis, Brian J. ; Mitchell, Cecilia M. ; Choo, Richard</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3348-555ac6b54691f6574940481cd5f2a5aa3be74731d8594a3658fffb180983d9bb3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Acute effects</topic><topic>hypofractionation</topic><topic>Lymph nodes</topic><topic>Lymphatic system</topic><topic>Patients</topic><topic>Prostate</topic><topic>Prostate cancer</topic><topic>proton therapy</topic><topic>Quality of life</topic><topic>Questionnaires</topic><topic>Seminal vesicle</topic><topic>Statistical analysis</topic><topic>Urinary incontinence</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Wong, William W.</creatorcontrib><creatorcontrib>Hillman, David W.</creatorcontrib><creatorcontrib>Daniels, Thomas B.</creatorcontrib><creatorcontrib>Vargas, Carlos E.</creatorcontrib><creatorcontrib>Rwigema, Jean Claude</creatorcontrib><creatorcontrib>Corbin, Kimberly S.</creatorcontrib><creatorcontrib>Keole, Sameer R.</creatorcontrib><creatorcontrib>Merrell, Kenneth W.</creatorcontrib><creatorcontrib>Stish, Bradley J.</creatorcontrib><creatorcontrib>Pisansky, Thomas M.</creatorcontrib><creatorcontrib>Davis, Brian J.</creatorcontrib><creatorcontrib>Mitchell, Cecilia M.</creatorcontrib><creatorcontrib>Choo, Richard</creatorcontrib><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>The Prostate</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Wong, William W.</au><au>Hillman, David W.</au><au>Daniels, Thomas B.</au><au>Vargas, Carlos E.</au><au>Rwigema, Jean Claude</au><au>Corbin, Kimberly S.</au><au>Keole, Sameer R.</au><au>Merrell, Kenneth W.</au><au>Stish, Bradley J.</au><au>Pisansky, Thomas M.</au><au>Davis, Brian J.</au><au>Mitchell, Cecilia M.</au><au>Choo, Richard</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Phase II prospective study of hypofractionated proton therapy of prostate and pelvic lymph nodes: Acute effects on patient‐reported quality of life</atitle><jtitle>The Prostate</jtitle><date>2022-10-01</date><risdate>2022</risdate><volume>82</volume><issue>14</issue><spage>1338</spage><epage>1345</epage><pages>1338-1345</pages><issn>0270-4137</issn><eissn>1097-0045</eissn><abstract>Background
The objective of this study was to report acute changes in patient‐reported quality of life (PRQOL) using the 26‐item Expanded Prostate Index Composite (EPIC‐26) questionnaire in a prospective study using hypofractionated intensity‐modulated proton beam therapy (H‐IMPT) targeting the prostate and the pelvic lymph nodes for high‐risk or unfavorable intermediate‐risk prostate cancer.
Methods
Fifty‐five patients were enrolled. H‐IMPT consisted of 45 GyE to the pelvic lymph nodes and 67.5 GyE to the prostate and seminal vesicles in 25 fractions. PRQOL was assessed with the urinary incontinence (UI), urinary irritative/obstructive symptoms (UO), and bowel function (BF) domains of EPIC‐26 questionnaire. Mean changes in domain scores were analyzed from pretreatment to the end of treatment and 3 months posttreatment. A clinically meaningful change (or minimum important change) was defined as a score change > 50% of the baseline standard deviation.
Results
The mean scores of UO, UI, and BF at baseline were 84.6, 91.1, and 95.3, respectively. At the end of treatment, there were statistically significant and clinically meaningful declines in UO and BF scores (−13.5 and −2.3, respectively), while the decline in UI score was statistically significant but not clinically meaningful (−13.7). A clinically meaningful decline in UO, UI, and BF scores occurred in 53.5%, 22.7%, and 73.2% of the patients, respectively. At 3 months posttreatment, all three mean scores showed an improvement, with fewer patients having a clinically meaningful decline in UO, UI, and BF scores (18.4%, 20.5%, and 45.0%, respectively). There was no significant reduction in the mean UO and UI scores compared to baseline, although the mean BF score remained lower than baseline and the difference was clinically meaningful.
Conclusions
UO, UI, and BF scores of PRQOL declined at the end of H‐IMPT. UO and UI scores showed improvement at 3 months posttreatment and were similar to the baseline scores. However, BF score remained lower at 3 months posttreatment with a clinically meaningful decline.</abstract><cop>Hoboken</cop><pub>Wiley Subscription Services, Inc</pub><doi>10.1002/pros.24408</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0002-7629-5859</orcidid></addata></record> |
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| source | Wiley Online Library Journals Frontfile Complete |
| subjects | Acute effects hypofractionation Lymph nodes Lymphatic system Patients Prostate Prostate cancer proton therapy Quality of life Questionnaires Seminal vesicle Statistical analysis Urinary incontinence |
| title | A Phase II prospective study of hypofractionated proton therapy of prostate and pelvic lymph nodes: Acute effects on patient‐reported quality of life |
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