Phase II Clinical Trial of N-(4-Hydroxyphenyl)retinamide and Tamoxifen Administration before Definitive Surgery for Breast Neoplasia
Purpose: Surrogate end point biomarkers (SEBs) that can be measured in ductal carcinoma in situ or early-stage invasive cancer are needed to improve the efficiency and reduce the cost of chemoprevention trials. Experimental Design: We conducted a prospective study to develop SEBs for tamoxifen and N...
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| Veröffentlicht in: | Clinical cancer research 2002-09, Vol.8 (9), p.2835-2842 |
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| creator | SINGLETARY, S. Eva ATKINSON, Edward N STELLING, Carol B LIPPMAN, Scott M HOQUE, Ashraful SNEIGE, Nour SAHIN, Ayse A FRITSCHE, Herbert A LOTAN, Reuben LU, Tao HITTELMAN, Walter N BEVERS, Therese B |
| description | Purpose: Surrogate end point biomarkers (SEBs) that can be measured in ductal carcinoma in situ or early-stage invasive cancer are needed to improve the efficiency and reduce the cost of chemoprevention trials.
Experimental Design: We conducted a prospective study to develop SEBs for tamoxifen and N -[4-hydroxyphenyl]retinamide by administering either a placebo or both drugs for 2–4 weeks to women with ductal carcinoma
in situ or early invasive cancers in the interval between the initial diagnostic core biopsy and definitive surgery. The major statistical
end point of the study was pre- versus posttreatment change in cell proliferation, as measured by changes in Ki67 labeling indices. In addition, estrogen receptor
(ER), HER2/ neu , p53, retinoid receptors, and DNA index were measured.
Results: Between February 1997 and April 200, 52 patients were registered on the study, and 36 (20 in the placebo arm and 16 in the
treatment arm) were available for analysis. No statistically significant pre- versus posttreatment differences in Ki67 labeling index or in the other markers were observed in the treatment arm compared with
the placebo arm. There was a trend toward increased treatment response in ER-positive versus ER-negative patients, but this could not be rigorously analyzed because of the low sample size and the unequal distribution
of ER-positive patients in the two study arms.
Conclusion: Future SEB trials for breast carcinoma must ( a ) incorporate information about patient hormonal status into the study design and ( b ) resolve problems in patient accrual. |
| format | Article |
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Experimental Design: We conducted a prospective study to develop SEBs for tamoxifen and N -[4-hydroxyphenyl]retinamide by administering either a placebo or both drugs for 2–4 weeks to women with ductal carcinoma
in situ or early invasive cancers in the interval between the initial diagnostic core biopsy and definitive surgery. The major statistical
end point of the study was pre- versus posttreatment change in cell proliferation, as measured by changes in Ki67 labeling indices. In addition, estrogen receptor
(ER), HER2/ neu , p53, retinoid receptors, and DNA index were measured.
Results: Between February 1997 and April 200, 52 patients were registered on the study, and 36 (20 in the placebo arm and 16 in the
treatment arm) were available for analysis. No statistically significant pre- versus posttreatment differences in Ki67 labeling index or in the other markers were observed in the treatment arm compared with
the placebo arm. There was a trend toward increased treatment response in ER-positive versus ER-negative patients, but this could not be rigorously analyzed because of the low sample size and the unequal distribution
of ER-positive patients in the two study arms.
Conclusion: Future SEB trials for breast carcinoma must ( a ) incorporate information about patient hormonal status into the study design and ( b ) resolve problems in patient accrual.</description><identifier>ISSN: 1078-0432</identifier><identifier>EISSN: 1557-3265</identifier><identifier>PMID: 12231524</identifier><language>eng</language><publisher>Philadelphia, PA: American Association for Cancer Research</publisher><subject>Adult ; Aged ; Antineoplastic agents ; Antineoplastic Combined Chemotherapy Protocols - administration & dosage ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Biological and medical sciences ; Biomarkers, Tumor ; Breast Neoplasms - drug therapy ; Breast Neoplasms - surgery ; Carcinoma, Ductal, Breast - drug therapy ; Carcinoma, Ductal, Breast - surgery ; Carcinoma, Intraductal, Noninfiltrating - drug therapy ; Carcinoma, Intraductal, Noninfiltrating - surgery ; Chemotherapy ; Chemotherapy, Adjuvant ; Combined Modality Therapy ; DNA, Neoplasm - analysis ; Female ; Fenretinide - administration & dosage ; Fenretinide - pharmacokinetics ; Humans ; Ki-67 Antigen - analysis ; Mastectomy ; Medical sciences ; Middle Aged ; Neoplasm Proteins - analysis ; Pharmacology. Drug treatments ; Premedication ; Prodrugs - administration & dosage ; Prodrugs - pharmacokinetics ; Prospective Studies ; Receptor, ErbB-2 - analysis ; Receptors, Estrogen - analysis ; Receptors, Retinoic Acid - analysis ; Tamoxifen - administration & dosage ; Treatment Outcome ; Tumor Suppressor Protein p53 - analysis</subject><ispartof>Clinical cancer research, 2002-09, Vol.8 (9), p.2835-2842</ispartof><rights>2003 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,777,781</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=13900798$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/12231524$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>SINGLETARY, S. Eva</creatorcontrib><creatorcontrib>ATKINSON, Edward N</creatorcontrib><creatorcontrib>STELLING, Carol B</creatorcontrib><creatorcontrib>LIPPMAN, Scott M</creatorcontrib><creatorcontrib>HOQUE, Ashraful</creatorcontrib><creatorcontrib>SNEIGE, Nour</creatorcontrib><creatorcontrib>SAHIN, Ayse A</creatorcontrib><creatorcontrib>FRITSCHE, Herbert A</creatorcontrib><creatorcontrib>LOTAN, Reuben</creatorcontrib><creatorcontrib>LU, Tao</creatorcontrib><creatorcontrib>HITTELMAN, Walter N</creatorcontrib><creatorcontrib>BEVERS, Therese B</creatorcontrib><title>Phase II Clinical Trial of N-(4-Hydroxyphenyl)retinamide and Tamoxifen Administration before Definitive Surgery for Breast Neoplasia</title><title>Clinical cancer research</title><addtitle>Clin Cancer Res</addtitle><description>Purpose: Surrogate end point biomarkers (SEBs) that can be measured in ductal carcinoma in situ or early-stage invasive cancer are needed to improve the efficiency and reduce the cost of chemoprevention trials.
Experimental Design: We conducted a prospective study to develop SEBs for tamoxifen and N -[4-hydroxyphenyl]retinamide by administering either a placebo or both drugs for 2–4 weeks to women with ductal carcinoma
in situ or early invasive cancers in the interval between the initial diagnostic core biopsy and definitive surgery. The major statistical
end point of the study was pre- versus posttreatment change in cell proliferation, as measured by changes in Ki67 labeling indices. In addition, estrogen receptor
(ER), HER2/ neu , p53, retinoid receptors, and DNA index were measured.
Results: Between February 1997 and April 200, 52 patients were registered on the study, and 36 (20 in the placebo arm and 16 in the
treatment arm) were available for analysis. No statistically significant pre- versus posttreatment differences in Ki67 labeling index or in the other markers were observed in the treatment arm compared with
the placebo arm. There was a trend toward increased treatment response in ER-positive versus ER-negative patients, but this could not be rigorously analyzed because of the low sample size and the unequal distribution
of ER-positive patients in the two study arms.
Conclusion: Future SEB trials for breast carcinoma must ( a ) incorporate information about patient hormonal status into the study design and ( b ) resolve problems in patient accrual.</description><subject>Adult</subject><subject>Aged</subject><subject>Antineoplastic agents</subject><subject>Antineoplastic Combined Chemotherapy Protocols - administration & dosage</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Biomarkers, Tumor</subject><subject>Breast Neoplasms - drug therapy</subject><subject>Breast Neoplasms - surgery</subject><subject>Carcinoma, Ductal, Breast - drug therapy</subject><subject>Carcinoma, Ductal, Breast - surgery</subject><subject>Carcinoma, Intraductal, Noninfiltrating - drug therapy</subject><subject>Carcinoma, Intraductal, Noninfiltrating - surgery</subject><subject>Chemotherapy</subject><subject>Chemotherapy, Adjuvant</subject><subject>Combined Modality Therapy</subject><subject>DNA, Neoplasm - analysis</subject><subject>Female</subject><subject>Fenretinide - administration & dosage</subject><subject>Fenretinide - pharmacokinetics</subject><subject>Humans</subject><subject>Ki-67 Antigen - analysis</subject><subject>Mastectomy</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Neoplasm Proteins - analysis</subject><subject>Pharmacology. Drug treatments</subject><subject>Premedication</subject><subject>Prodrugs - administration & dosage</subject><subject>Prodrugs - pharmacokinetics</subject><subject>Prospective Studies</subject><subject>Receptor, ErbB-2 - analysis</subject><subject>Receptors, Estrogen - analysis</subject><subject>Receptors, Retinoic Acid - analysis</subject><subject>Tamoxifen - administration & dosage</subject><subject>Treatment Outcome</subject><subject>Tumor Suppressor Protein p53 - analysis</subject><issn>1078-0432</issn><issn>1557-3265</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2002</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpF0EtLxDAQAOAiiu-_ILn4OhTSJE3So66vBVHB9Vxmk6mN9LEmXd3e_eFGXPEyMwzfzMBsJLtZnquUM5lvxpoqnVLB2U6yF8IbpZnIqNhOdjLGeJYzsZt8PdUQkEynZNK4zhloyMy7GPuKPKRnIr0bre9X46LGbmzOPQ6ug9ZZJNBZMoO2X7kKO3Jh2zgeBg-D6zsyx6r3SK6wit3BfSB5XvpX9COJfXLpEcJAHrBfNBAcHCRbFTQBD9d5P3m5uZ5N7tL7x9vp5OI-rZkshlQpaefaGAFMcsFpBflcWZErQwujGVNMSKa1xKzSUqKyGc1yqgotLErDBN9PTn73Lnz_vsQwlK0LBpsGOuyXoVSMFowyGuHRGi7nLdpy4V0Lfiz__hbB8RpAiD-rPHTGhX_HC_pzOLrTX1e71_rTeSxNlOg9BgRv6lKXRck0z_k3MZuFNg</recordid><startdate>20020901</startdate><enddate>20020901</enddate><creator>SINGLETARY, S. Eva</creator><creator>ATKINSON, Edward N</creator><creator>STELLING, Carol B</creator><creator>LIPPMAN, Scott M</creator><creator>HOQUE, Ashraful</creator><creator>SNEIGE, Nour</creator><creator>SAHIN, Ayse A</creator><creator>FRITSCHE, Herbert A</creator><creator>LOTAN, Reuben</creator><creator>LU, Tao</creator><creator>HITTELMAN, Walter N</creator><creator>BEVERS, Therese B</creator><general>American Association for Cancer Research</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7X8</scope></search><sort><creationdate>20020901</creationdate><title>Phase II Clinical Trial of N-(4-Hydroxyphenyl)retinamide and Tamoxifen Administration before Definitive Surgery for Breast Neoplasia</title><author>SINGLETARY, S. Eva ; ATKINSON, Edward N ; STELLING, Carol B ; LIPPMAN, Scott M ; HOQUE, Ashraful ; SNEIGE, Nour ; SAHIN, Ayse A ; FRITSCHE, Herbert A ; LOTAN, Reuben ; LU, Tao ; HITTELMAN, Walter N ; BEVERS, Therese B</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-h269t-776db8cc4a263430fa5b7d457c09c82272462886e1f866e7d101507984de6c243</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2002</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Antineoplastic agents</topic><topic>Antineoplastic Combined Chemotherapy Protocols - administration & dosage</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Biomarkers, Tumor</topic><topic>Breast Neoplasms - drug therapy</topic><topic>Breast Neoplasms - surgery</topic><topic>Carcinoma, Ductal, Breast - drug therapy</topic><topic>Carcinoma, Ductal, Breast - surgery</topic><topic>Carcinoma, Intraductal, Noninfiltrating - drug therapy</topic><topic>Carcinoma, Intraductal, Noninfiltrating - surgery</topic><topic>Chemotherapy</topic><topic>Chemotherapy, Adjuvant</topic><topic>Combined Modality Therapy</topic><topic>DNA, Neoplasm - analysis</topic><topic>Female</topic><topic>Fenretinide - administration & dosage</topic><topic>Fenretinide - pharmacokinetics</topic><topic>Humans</topic><topic>Ki-67 Antigen - analysis</topic><topic>Mastectomy</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Neoplasm Proteins - analysis</topic><topic>Pharmacology. Drug treatments</topic><topic>Premedication</topic><topic>Prodrugs - administration & dosage</topic><topic>Prodrugs - pharmacokinetics</topic><topic>Prospective Studies</topic><topic>Receptor, ErbB-2 - analysis</topic><topic>Receptors, Estrogen - analysis</topic><topic>Receptors, Retinoic Acid - analysis</topic><topic>Tamoxifen - administration & dosage</topic><topic>Treatment Outcome</topic><topic>Tumor Suppressor Protein p53 - analysis</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>SINGLETARY, S. Eva</creatorcontrib><creatorcontrib>ATKINSON, Edward N</creatorcontrib><creatorcontrib>STELLING, Carol B</creatorcontrib><creatorcontrib>LIPPMAN, Scott M</creatorcontrib><creatorcontrib>HOQUE, Ashraful</creatorcontrib><creatorcontrib>SNEIGE, Nour</creatorcontrib><creatorcontrib>SAHIN, Ayse A</creatorcontrib><creatorcontrib>FRITSCHE, Herbert A</creatorcontrib><creatorcontrib>LOTAN, Reuben</creatorcontrib><creatorcontrib>LU, Tao</creatorcontrib><creatorcontrib>HITTELMAN, Walter N</creatorcontrib><creatorcontrib>BEVERS, Therese B</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical cancer research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>SINGLETARY, S. Eva</au><au>ATKINSON, Edward N</au><au>STELLING, Carol B</au><au>LIPPMAN, Scott M</au><au>HOQUE, Ashraful</au><au>SNEIGE, Nour</au><au>SAHIN, Ayse A</au><au>FRITSCHE, Herbert A</au><au>LOTAN, Reuben</au><au>LU, Tao</au><au>HITTELMAN, Walter N</au><au>BEVERS, Therese B</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase II Clinical Trial of N-(4-Hydroxyphenyl)retinamide and Tamoxifen Administration before Definitive Surgery for Breast Neoplasia</atitle><jtitle>Clinical cancer research</jtitle><addtitle>Clin Cancer Res</addtitle><date>2002-09-01</date><risdate>2002</risdate><volume>8</volume><issue>9</issue><spage>2835</spage><epage>2842</epage><pages>2835-2842</pages><issn>1078-0432</issn><eissn>1557-3265</eissn><abstract>Purpose: Surrogate end point biomarkers (SEBs) that can be measured in ductal carcinoma in situ or early-stage invasive cancer are needed to improve the efficiency and reduce the cost of chemoprevention trials.
Experimental Design: We conducted a prospective study to develop SEBs for tamoxifen and N -[4-hydroxyphenyl]retinamide by administering either a placebo or both drugs for 2–4 weeks to women with ductal carcinoma
in situ or early invasive cancers in the interval between the initial diagnostic core biopsy and definitive surgery. The major statistical
end point of the study was pre- versus posttreatment change in cell proliferation, as measured by changes in Ki67 labeling indices. In addition, estrogen receptor
(ER), HER2/ neu , p53, retinoid receptors, and DNA index were measured.
Results: Between February 1997 and April 200, 52 patients were registered on the study, and 36 (20 in the placebo arm and 16 in the
treatment arm) were available for analysis. No statistically significant pre- versus posttreatment differences in Ki67 labeling index or in the other markers were observed in the treatment arm compared with
the placebo arm. There was a trend toward increased treatment response in ER-positive versus ER-negative patients, but this could not be rigorously analyzed because of the low sample size and the unequal distribution
of ER-positive patients in the two study arms.
Conclusion: Future SEB trials for breast carcinoma must ( a ) incorporate information about patient hormonal status into the study design and ( b ) resolve problems in patient accrual.</abstract><cop>Philadelphia, PA</cop><pub>American Association for Cancer Research</pub><pmid>12231524</pmid><tpages>8</tpages></addata></record> |
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| issn | 1078-0432 1557-3265 |
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| subjects | Adult Aged Antineoplastic agents Antineoplastic Combined Chemotherapy Protocols - administration & dosage Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biological and medical sciences Biomarkers, Tumor Breast Neoplasms - drug therapy Breast Neoplasms - surgery Carcinoma, Ductal, Breast - drug therapy Carcinoma, Ductal, Breast - surgery Carcinoma, Intraductal, Noninfiltrating - drug therapy Carcinoma, Intraductal, Noninfiltrating - surgery Chemotherapy Chemotherapy, Adjuvant Combined Modality Therapy DNA, Neoplasm - analysis Female Fenretinide - administration & dosage Fenretinide - pharmacokinetics Humans Ki-67 Antigen - analysis Mastectomy Medical sciences Middle Aged Neoplasm Proteins - analysis Pharmacology. Drug treatments Premedication Prodrugs - administration & dosage Prodrugs - pharmacokinetics Prospective Studies Receptor, ErbB-2 - analysis Receptors, Estrogen - analysis Receptors, Retinoic Acid - analysis Tamoxifen - administration & dosage Treatment Outcome Tumor Suppressor Protein p53 - analysis |
| title | Phase II Clinical Trial of N-(4-Hydroxyphenyl)retinamide and Tamoxifen Administration before Definitive Surgery for Breast Neoplasia |
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