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JAMA. 2011 Jun 8;305(22):2295-303. doi: 10.1001/jama.2011.766.

Effect of screening on ovarian cancer mortality: the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Randomized Controlled Trial.

Collaborators (804)

Berg CD, Gohagan JK, Prorok PC, Hsing AW, Lacey JV Jr, Purdue M, Hayes RB, Black A, Huang WY, Simpson NK, Cumberlin R, Rossi S, Zhu C, Marquez G, Browne JE, Hoffman S, Coleman DM, Jackson C, Lange E, McMillan D, Papadopoulos E, Sylver-Foust D, Sullivan D, Brown M, Gaegler J, Gray L, Hansborough A, Greenwald P, Fraumeni JF Jr, Fagerstrom RM, Hu P, Izmirlian G, Levin DL, Pinsky P, Xu JL, Kreimer A, Marcus PM, Subar AF, Black A, Hartge P, Hoover RN, Ziegler RG, Costlow R, Laine AF, Miller AB, Pearson D, van Nagell JR, Stallings FL, Miller DS, Kramer BS, Chia D, Dry S, Seligson D, Terasaki P, Reiss J, Tze S, Acalinovich A, Besada S, Chan H, Cheung-Lau G, Corbett S, Durongwong P, Eeva M, Folayan L, Gruebel B, Habeeb O, Huynh K, Kanegai C, Kim H, Kim S, Ko A, Kohlmeier S, Lamb C, Lu M, Martin J, Maynard S, Noravian F, Schirrippa O, Padilla G, Rumbin A, Shevlin L, Ty R, Wang Q, Wong J, Xu S, Yu H, Koci J, Kopp W, Rager H, Smith C, Roser D, Cahill J, O'Brien B, Gardner S, Carrick D, Yurgalevitch S, Dunn M, Bailey C, Bodenstein Y, Burr P, Cutrin J, Eisen J, Frias A, Glashofer S, Hurt-Mullen K, Kavounis K, Ke P, Khanani F, Laimon B, Mechanic L, Mesnard M, Nichaman L, Novey S, Palace C, Peace S, Pettit K, Pratt S, Ragard L, Rosenbaum J, Sanchez D, Schuman S, Stewart M, Waterman MB, Umbel K, Ferrantello D, Havel B, Hasson MA, Bridgeman B, Martinusen E, Sabastianelli M, Miller A, Menacker F, Miedzinski M, Chowdry S, Miesko L, Lease C, Rinehart M, Agamir M, Awatramani K, Barbee J, Barlow WC, Beach D, Bradley B, Brenner K, Butler L, Bristor J, Caughman C, Chanapatna R, Cranson L, Desir J, Donegan K, Fleming J, Florczyk M, Galyon J, Gordon C, Han C, Hendricks A, Hickman D, Ho M, Jackson E, Kahane DC, Khan A, Laio M, Lee A, Lott B, Lucas-Mudd D, Moore D, Morgan A, Neagu G, Ohan P, Revzin M, Rychlec J, Samiel R, Siford E, Simons D, Smith M, Swei L, Theodorou E, Vakhlis A, Walsh JH, Wenzel B, Whitlock M, Williamson S, Wu M, Yang CL, Yoda S, Wu M, Myers MH, Young PA, Lewis DA, Francis RW Jr, Saunders LA, Signes C, Scheck S, Lake W Jr, Riley T, Austin J, Erwin DE, Flynn D, Mabie JE, Clapp JD, Moore MR, Xu F, Jones GC, Rathmell JM, Williams CR, Young M, Goodman A, Hickey TP, Commins JM, Wright P, Shaul SK, Crawford ED, Ogden SL, Tenorio S, Fyles P, Golz D, Hommel S, McCormick D, Pashleigh G, Slimak N, Turner N, Ayodeji NG, Josse D, McAfee J, Meskimen E, Pennington J, Suchey W, Ali-Ahmadi M, Barnett AW, Brothers J, Chronister ND, Cipolla D, Crawford R, Chun S, Gebhart K, Hernandez J, Hunter H, Patel K, Poage W, Pozzetta M, Simms S, Swingler J, Taylor C, Turner M, Wallack A, Curtis K, Pierce D, Borrego PV, Rundus C, Bonde E, Gamito E, Pretzel S, Dahmer J, Deines T, Geske M, Holladay M, Jackson H, Jordan T, Ordonez E, Beechum T, Crawford M, Dittmer K, Donohue A, Garcia F, Giese S, Klenfield A, Kleinman M, Moss W, Motomiya K, Murken R, Neel D, Quintela J, Razook C, Shoaga A, Thompson A, Vargas S, Lynch D, O'Driscoll M, Townsend R, Stamm E, Drose J, Davidson S, Ahnen D, Levine J, Murchison W, Steinberg S, Gelmann EP, Isaacs C, McGuire C, Trocky N, Bourdeau C, Ke P, Martino L, Apostolides I, Elbon-Copp C, Klemm K, Lippman C, Klotz C, McLaurin T, Cantrell S, Marsh G, Tran A, Wray C, Yondonsambu B, Taddeo C, Bennett K, Bowen T, English K, Seaton K, Hammond T, Ford M, Newman K, Kren M, English N, McKenzie D, Yokochi LA, Gilbert F, Curb D, Davis J, Kessel B, Navin J, Petrovich H, Shambaugh V, Tabrah F, Waitzfelder B, Willcox B, Jenkins V, Chasnoff R, Vander Does J, Martin J, Ideta B, Stryker K, Batangan E, Dolan L, Horton K, Taylor K, Tokumine T, Troyer R, Barrow S, Hayashida S, Commander S, Turner L, Hino G, Nakano E, Johnson M, Villaruz L, Chung A, Huynh W, Hickey N, Calulot M, Chun V, Lewis C, Morfit J, Tani J, Banggo K, Brunst A, Francis W, Grove L, Holderbaum B, Holderbaum B, Kinney K, Ogino M, O'Sullivan T, Rowan-Lau P, Bow K, Shiratori H, Tsukamoto J, Hodges H, Hyun S, Kuiee J, Lucente L, Oshiro P, Shota K, Kvale PA, Demers R, Fogel R, Rutt W, Johnson CC, Lamerato L, Bresalier RS, Broski K, Hensley-Alford S, Ford ME, LaFata JE, McCarthy B, Ward R, Andrews T, Day M, Flickinger LM, Hantz T, Talley D, Wilson D, Blount A, Tammemagi CM, Goswami N, Haykus W, Piasecki A, Barr C, Hall T, Stanifer S, Baker P, Montague R, Day C, Nanovski A, Hill C, Boles T, Witherspoon A, Banks G, Green K, Bernardin K, Banks G, Green K, Bernardin K, Kozlowski P, Wells J, Salisbury H, Shepard A, McKeeman J, Jeffery T, Castor C, Boswell M, Hooker C, Ingram L, Mototolea D, Szabo N, Gardner M, Hooker C, Maddy N, Morris J, Berlicz J, Bonds T, Fountain S, Williams M, Djuric B, Gardner M, Cross C, Emmer D, Jagger F, Johnson A, McCarver L, Scharbonneau M, Thomas V, Norwood M, Mobley M, Kokko S, Doute D, Ciccoretti K, Wright KW, Shabazz P, Leyson-Fiel A, Pratt K, Bailey M, Alexander T, Kok JL, Church TR, Mandel J, Oken MM, Engelhard D, Cordes J, Bradley P, Hansen C, Kokubu J, Lee R, Meyer G, McLaughlin H, Palmquist K, Sandley N, Sigal B, Barnes T, Fleishhacker M, Grengs J, Hebner S, Lewis M, Mendez A, Miller D, Nielsen J, Theis L, Bangerter A, Hoffbeck R, Murzyn R, Woodside J, Beckmann P, Boldt M, Jurjans L, Swenson S, Terrien S, Fisher J, Geisser M, Mongin S, Oancea C, Jansen R, Breer S, Collins S, Manuel J, Matous L, Miller L, Muller C, Olsson P, Peterson S, Steele ML, Tonnell S, Halverson J, Hanna M, Hathaway-Ott J, Harper B, Hunter H, Lindall-Hawkins J, Longen C, Nickelson S, Overby D, Rodier M, Smith B, Weiner V, Clement M, Haselhuhn C, Heath D, Julin E, Michels N, Naslund L, Pagidipala S, Swavely D, Syktta C, Warren D, Sitarz J, Steinberg C, Thomas J, Burrell J, Sandell L, Helevik S, Hoard M, Andriole GL, Lowery AA, Charlton E, Desai A, Gardner V, Stanczak D, Taylor K, Freesmeier E, Civitelli K, Ehrhard K, Nieters P, Hilke C, Phillips K, Robinson W, Wehde M, Branam C, Freesmeier K, Kane C, Murphey S, Royal D, Scire J, Bickford K, Fleming E, Goforth J, Graham D, Montani J, Naughton K, Palumbo B, Sicard-Su J, Blanke R, Cashel P, DeFord K, Liddy K, Lieberoff A, Nelson K, Reismeyer L, Ritter B, Robertson S, Standbrook S, Stilts D, Webb J, Carrett K, Laster S, Stolin C, Weissfeld JL, Hill L, Hakala T, Guido R, Fuhrman C, Overly W, Proctor JW, Schoen RE, Sulecki M, Trombetta M, Gahagan B, Bonk J, Yagjian M, Gitchel R, Sufka P, McDonough K, Carl K, Gongloff J, Karl T, Lucas C, Lytle L, Sibbet M, Weinstein J, Coopie B, Dyjak L, Johnson L, Kielty J, Landis G, Misko S, Oleson P, Ritman M, Clement L, Danvers A, Riley MA, Buys SS, Gren LH, Childs J, Andersen A, Bacon J, Bossi M, Briscoe L, Broschinsky M, Callahan B, Conner T, Ernst J, Fischer R, Gregersen J, Hamatake N, Hamatake C, Henrichsen A, lhler N, Jensen L, Jones K, Killian L, Liddle M, Lochner M, Monaco A, Morreal R, Nate A, Nolan K, Olson C, Park A, Ricks S, Sheltra S, Stewart A, Sturges L, Sullenger J, Sullenger J, Taylor K, Toyn C, Van Stam E, Argyle N, Christensen J, Bennett S, Biggs J, Branson D, Bryson M, Childs B, Dalton C, Doi B, Doi J, Foss S, Gudgell P, Hicks L, Hsu P, LaMay D, Montalbo C, Newman L, Randall A, Thompson J, Schliep K, Stanfield K, Watson D, Newman L, Reese M, Whittaker B, Whittaker N, Wicklander E, Wolf J, Varner J, Bennett N, Bonoacci M, Harper A, Reay S, McFadden K, O'Toole K, Butcher T, Walker D, Richardson J, Hong H, Lund B, Rowley J, Tlachac J, VanRy J, Walker C, Hamilton B, Labasky R, Landau S, Middleton R, Stephenson R, Beck TM, Sturges L, Wohlers B, Berreth K, Roberts P, Carter P, Goodman D, Hagerman G, Hon T, Marshock J, Martin R, Jamieson C, Arnone A, Davis D, Dennis K, Hanson D, Hyder J, McCraney D, Michel K, Shahriari F, Sirianni L, Burt TB, Carrasco CR, Daniel EN, Lane RH, Langhus PA, Leymaster CE, Maxwell JR, Thorpe RM, Nelson BD, Marx SV, Hubler B, Waltz JS, DeMordaunt QA, Fisher MT, Battershall P, Burke L, Fortunati L, Werdel JM, Reding D, Greenlee R, Hocking W, Lappe K, Multerer D, Fischer V, Heiting JC, Mueller C, Mathiesen-Viergutz K, Bohman K, Carey L, Vieth A, Aue K, Kriescher D, Miller C, Thums N, Wein S, Kofka K, Mueller C, Dix B, Mueller L, Swensen K, Wachholz S, Kramer R, Bright B, Zahradka S, Fouad M, Oberman A, Partridge E, Urban D, Kiefe C, Shikany J, Higgins D, Thompson J, Johnson M, Moore A, Powell B, McCoy B, Oden C, Khatri R, Pike M, Rafla S, Angelone A, DeStefano V, Varkey J, Watson S, DiVernieri JM, Buring JE, Alberts DS, Carter HB, Chodak G, Hawk E, Malm H, Mayer RJ, Piantadosi S, Silvestri GA, Thompson IM, Westhoff CL, Kahn JP, Levin B, DeMets DL, O'Fallon JR, Porter AT, Ashton MM, Black WC, Miller AB, Eisenberger M, Jatoi I, Glatstein E, Welch HG.

Author information

  • 1Huntsman Cancer Institute, University of Utah Health Sciences Center, Salt Lake City, USA.

Abstract

CONTEXT:

Screening for ovarian cancer with cancer antigen 125 (CA-125) and transvaginal ultrasound has an unknown effect on mortality.

OBJECTIVE:

To evaluate the effect of screening for ovarian cancer on mortality in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial.

DESIGN, SETTING, AND PARTICIPANTS:

Randomized controlled trial of 78,216 women aged 55 to 74 years assigned to undergo either annual screening (n = 39,105) or usual care (n = 39,111) at 10 screening centers across the United States between November 1993 and July 2001. Intervention The intervention group was offered annual screening with CA-125 for 6 years and transvaginal ultrasound for 4 years. Participants and their health care practitioners received the screening test results and managed evaluation of abnormal results. The usual care group was not offered annual screening with CA-125 for 6 years or transvaginal ultrasound but received their usual medical care. Participants were followed up for a maximum of 13 years (median [range], 12.4 years [10.9-13.0 years]) for cancer diagnoses and death until February 28, 2010.

MAIN OUTCOME MEASURES:

Mortality from ovarian cancer, including primary peritoneal and fallopian tube cancers. Secondary outcomes included ovarian cancer incidence and complications associated with screening examinations and diagnostic procedures.

RESULTS:

Ovarian cancer was diagnosed in 212 women (5.7 per 10,000 person-years) in the intervention group and 176 (4.7 per 10,000 person-years) in the usual care group (rate ratio [RR], 1.21; 95% confidence interval [CI], 0.99-1.48). There were 118 deaths caused by ovarian cancer (3.1 per 10,000 person-years) in the intervention group and 100 deaths (2.6 per 10,000 person-years) in the usual care group (mortality RR, 1.18; 95% CI, 0.82-1.71). Of 3285 women with false-positive results, 1080 underwent surgical follow-up; of whom, 163 women experienced at least 1 serious complication (15%). There were 2924 deaths due to other causes (excluding ovarian, colorectal, and lung cancer) (76.6 per 10,000 person-years) in the intervention group and 2914 deaths (76.2 per 10,000 person-years) in the usual care group (RR, 1.01; 95% CI, 0.96-1.06).

CONCLUSIONS:

Among women in the general US population, simultaneous screening with CA-125 and transvaginal ultrasound compared with usual care did not reduce ovarian cancer mortality. Diagnostic evaluation following a false-positive screening test result was associated with complications. Trial Registration clinicaltrials.gov Identifier: NCT00002540.

Comment in

PMID:
21642681
[PubMed - indexed for MEDLINE]
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