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Generation of "Virtual" Control Groups for Single Arm Prostate Cancer Adjuvant Trials
Jia, Zhenyu1,10,17; Lilly, Michael B.2; Koziol, James A.3; Chen, Xin4; Xia, Xiao-Qin5; Wang, Yipeng6; Skarecky, Douglas7; Sutton, Manuel4; Sawyers, Anne4; Ruckle, Herbert8; Carpenter, Philip M.4; Wang-Rodriguez, Jessica9; Jiang, Jun10; Deng, Mingsen10; Pan, Cong10; Zhu, Jian-guo10,11; McLaren, Christine E.12; Gurley, Michael J.13; Lee, Chung1,13; McClelland, Michael14,15; Ahlering, Thomas7; Kattan, Michael W.16; Mercola, Dan4; Jia, ZY (reprint author), Univ Akron, Dept Stat, Akron, OH 44325 USA.
2014-01-21
Source PublicationPLOS ONE
ISSN1932-6203
Volume9Issue:1Pages:e85010
AbstractIt is difficult to construct a control group for trials of adjuvant therapy (Rx) of prostate cancer after radical prostatectomy (RP) due to ethical issues and patient acceptance. We utilized 8 curve-fitting models to estimate the time to 60%, 65%, ... 95% chance of progression free survival (PFS) based on the data derived from Kattan post-RP nomogram. The 8 models were systematically applied to a training set of 153 post-RP cases without adjuvant Rx to develop 8 subsets of cases (reference case sets) whose observed PFS times were most accurately predicted by each model. To prepare a virtual control group for a single-arm adjuvant Rx trial, we first select the optimal model for the trial cases based on the minimum weighted Euclidean distance between the trial case set and the reference case set in terms of clinical features, and then compare the virtual PFS times calculated by the optimum model with the observed PFSs of the trial cases by the logrank test. The method was validated using an independent dataset of 155 post-RP patients without adjuvant Rx. We then applied the method to patients on a Phase II trial of adjuvant chemo-hormonal Rx post RP, which indicated that the adjuvant Rx is highly effective in prolonging PFS after RP in patients at high risk for prostate cancer recurrence. The method can accurately generate control groups for single-arm, post-RP adjuvant Rx trials for prostate cancer, facilitating development of new therapeutic strategies.; It is difficult to construct a control group for trials of adjuvant therapy (Rx) of prostate cancer after radical prostatectomy (RP) due to ethical issues and patient acceptance. We utilized 8 curve-fitting models to estimate the time to 60%, 65%, ... 95% chance of progression free survival (PFS) based on the data derived from Kattan post-RP nomogram. The 8 models were systematically applied to a training set of 153 post-RP cases without adjuvant Rx to develop 8 subsets of cases (reference case sets) whose observed PFS times were most accurately predicted by each model. To prepare a virtual control group for a single-arm adjuvant Rx trial, we first select the optimal model for the trial cases based on the minimum weighted Euclidean distance between the trial case set and the reference case set in terms of clinical features, and then compare the virtual PFS times calculated by the optimum model with the observed PFSs of the trial cases by the logrank test. The method was validated using an independent dataset of 155 post-RP patients without adjuvant Rx. We then applied the method to patients on a Phase II trial of adjuvant chemo-hormonal Rx post RP, which indicated that the adjuvant Rx is highly effective in prolonging PFS after RP in patients at high risk for prostate cancer recurrence. The method can accurately generate control groups for single-arm, post-RP adjuvant Rx trials for prostate cancer, facilitating development of new therapeutic strategies.
SubtypeArticle
KeywordRadical Prostatectomy Postoperative Nomograms Preoperative Nomogram 10-year Probability Disease Recurrence Clinical-trial Follow-up High-risk Docetaxel Efficacy
Department[Jia, Zhenyu; Lee, Chung] Univ Akron, Dept Stat, Akron, OH 44325 USA; [Lilly, Michael B.] Med Univ S Carolina, Div Hematol Oncol, Charleston, SC 29425 USA; [Koziol, James A.] Ashford Univ, Coll Hlth Human Serv & Sci, San Diego, CA 92128 USA; [Chen, Xin; Sutton, Manuel; Sawyers, Anne; Carpenter, Philip M.; Mercola, Dan] Univ Calif Irvine, Dept Pathol & Lab Med, Irvine, CA USA; [Xia, Xiao-Qin] Chinese Acad Sci, Inst Hydrobiol, Wuhan, Peoples R China; [Wang, Yipeng] AltheaDx Inc, San Diego, CA USA; [Skarecky, Douglas; Ahlering, Thomas] Univ Calif Irvine, Dept Urol, Irvine, CA USA; [Ruckle, Herbert] Loma Linda Univ, Dept Urol, Loma Linda, CA 92350 USA; [Wang-Rodriguez, Jessica] Univ Calif San Diego, Dept Pathol, La Jolla, CA 92093 USA; [Jia, Zhenyu; Jiang, Jun; Deng, Mingsen; Pan, Cong; Zhu, Jian-guo] Guizhou Normal Coll, Guizhou Prov Key Lab Computat Nanomat Sci, Guiyang, Peoples R China; [Zhu, Jian-guo] Guizhou Prov Peoples Hosp, Dept Urol, Guiyang, Guizhou, Peoples R China; [McLaren, Christine E.] Univ Calif Irvine, Dept Epidemiol, Irvine, CA USA; [Gurley, Michael J.; Lee, Chung] Northwestern Univ, Dept Urol, Feinberg Sch Med, Chicago, IL 60611 USA; [McClelland, Michael] Univ Calif Irvine, Dept Med, Irvine, CA 92717 USA; [McClelland, Michael] Vaccine Res Inst San Diego, San Diego, CA USA; [Kattan, Michael W.] Cleveland Clin, Dept Quantitat Hlth Sci, Cleveland, OH 44106 USA; [Jia, Zhenyu] Northeast Ohio Med Univ, Dept Family & Community Med, Rootstown, OH USA
DOI10.1371/journal.pone.0085010
WOS HeadingsScience & Technology
Funding OrganizationUnited States National Institutes of Health [NCI UO1CA11480, NCI UO1CA152738]; University of California Irvine Faculty Career Development Award; University of California Chao Family Comprehensive Cancer Center Seed Grant; National Cancer Institute [P30CA062203]; CDMRP [W81XWH-08-1-0720] ; United States National Institutes of Health [NCI UO1CA11480, NCI UO1CA152738]; University of California Irvine Faculty Career Development Award; University of California Chao Family Comprehensive Cancer Center Seed Grant; National Cancer Institute [P30CA062203]; CDMRP [W81XWH-08-1-0720] ; United States National Institutes of Health [NCI UO1CA11480, NCI UO1CA152738]; University of California Irvine Faculty Career Development Award; University of California Chao Family Comprehensive Cancer Center Seed Grant; National Cancer Institute [P30CA062203]; CDMRP [W81XWH-08-1-0720] ; United States National Institutes of Health [NCI UO1CA11480, NCI UO1CA152738]; University of California Irvine Faculty Career Development Award; University of California Chao Family Comprehensive Cancer Center Seed Grant; National Cancer Institute [P30CA062203]; CDMRP [W81XWH-08-1-0720]
Indexed BySCI
Language英语
WOS Research AreaScience & Technology - Other Topics
WOS SubjectMultidisciplinary Sciences
WOS IDWOS:000330244500028
WOS KeywordLOCALLY WEIGHTED REGRESSION ; RADICAL PROSTATECTOMY ; POSTOPERATIVE NOMOGRAMS ; SMOOTHING SCATTERPLOTS ; PREOPERATIVE NOMOGRAM ; 10-YEAR PROBABILITY ; DISEASE RECURRENCE ; CLINICAL-TRIAL ; FOLLOW-UP ; HIGH-RISK
Funding OrganizationUnited States National Institutes of Health [NCI UO1CA11480, NCI UO1CA152738]; University of California Irvine Faculty Career Development Award; University of California Chao Family Comprehensive Cancer Center Seed Grant; National Cancer Institute [P30CA062203]; CDMRP [W81XWH-08-1-0720] ; United States National Institutes of Health [NCI UO1CA11480, NCI UO1CA152738]; University of California Irvine Faculty Career Development Award; University of California Chao Family Comprehensive Cancer Center Seed Grant; National Cancer Institute [P30CA062203]; CDMRP [W81XWH-08-1-0720] ; United States National Institutes of Health [NCI UO1CA11480, NCI UO1CA152738]; University of California Irvine Faculty Career Development Award; University of California Chao Family Comprehensive Cancer Center Seed Grant; National Cancer Institute [P30CA062203]; CDMRP [W81XWH-08-1-0720] ; United States National Institutes of Health [NCI UO1CA11480, NCI UO1CA152738]; University of California Irvine Faculty Career Development Award; University of California Chao Family Comprehensive Cancer Center Seed Grant; National Cancer Institute [P30CA062203]; CDMRP [W81XWH-08-1-0720]
Citation statistics
Document Type期刊论文
Identifierhttp://ir.ihb.ac.cn/handle/342005/20098
Collection水生生物分子与细胞生物学研究中心_期刊论文
Corresponding AuthorJia, ZY (reprint author), Univ Akron, Dept Stat, Akron, OH 44325 USA.
Affiliation1.Univ Akron, Dept Stat, Akron, OH 44325 USA
2.Med Univ S Carolina, Div Hematol Oncol, Charleston, SC 29425 USA
3.Ashford Univ, Coll Hlth Human Serv & Sci, San Diego, CA 92128 USA
4.Univ Calif Irvine, Dept Pathol & Lab Med, Irvine, CA USA
5.Chinese Acad Sci, Inst Hydrobiol, Wuhan, Peoples R China
6.AltheaDx Inc, San Diego, CA USA
7.Univ Calif Irvine, Dept Urol, Irvine, CA USA
8.Loma Linda Univ, Dept Urol, Loma Linda, CA 92350 USA
9.Univ Calif San Diego, Dept Pathol, La Jolla, CA 92093 USA
10.Guizhou Normal Coll, Guizhou Prov Key Lab Computat Nanomat Sci, Guiyang, Peoples R China
11.Guizhou Prov Peoples Hosp, Dept Urol, Guiyang, Guizhou, Peoples R China
12.Univ Calif Irvine, Dept Epidemiol, Irvine, CA USA
13.Northwestern Univ, Dept Urol, Feinberg Sch Med, Chicago, IL 60611 USA
14.Univ Calif Irvine, Dept Med, Irvine, CA 92717 USA
15.Vaccine Res Inst San Diego, San Diego, CA USA
16.Cleveland Clin, Dept Quantitat Hlth Sci, Cleveland, OH 44106 USA
17.Northeast Ohio Med Univ, Dept Family & Community Med, Rootstown, OH USA
Recommended Citation
GB/T 7714
Jia, Zhenyu,Lilly, Michael B.,Koziol, James A.,et al. Generation of "Virtual" Control Groups for Single Arm Prostate Cancer Adjuvant Trials[J]. PLOS ONE,2014,9(1):e85010.
APA Jia, Zhenyu.,Lilly, Michael B..,Koziol, James A..,Chen, Xin.,Xia, Xiao-Qin.,...&Jia, ZY .(2014).Generation of "Virtual" Control Groups for Single Arm Prostate Cancer Adjuvant Trials.PLOS ONE,9(1),e85010.
MLA Jia, Zhenyu,et al."Generation of "Virtual" Control Groups for Single Arm Prostate Cancer Adjuvant Trials".PLOS ONE 9.1(2014):e85010.
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