Ovarian cancer clinical trial endpoints: Society of Gynecologic Oncology white paper

Gynecologic Oncology

Volumn 132, Issue 1, 2014, Pages 8-17

  Herzog, Thomas J ^a   Armstrong, Deborah K ^b   Brady, Mark F ^c   Coleman, Robert L ^d   Einstein, Mark H ^e   Monk, Bradley J ^f,g   Mannel, Robert S ^h   Thigpen, J Tate ⁱ   Umpierre, Sharee A ^j   Villella, Jeannine A ^k   Alvarez, Ronald D ^l  

^a Och Spine at New York Presbyterian Hospitals   (United States)

^b JOHNS HOPKINS UNIVERSITY   (United States)

^c UNIVERSITY AT BUFFALO   (United States)

^d UNIVERSITY OF TEXAS   (United States)

^e ALBERT EINSTEIN COLLEGE OF MEDICINE   (United States)

^f CREIGHTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^g UNIVERSITY OF ARIZONA   (United States)

^h UNIVERSITY OF OKLAHOMA   (United States)

ⁱ UNIVERSITY OF MISSISSIPPI MEDICAL CENTER   (United States)

^j UNIVERSITY OF PUERTO RICO   (Puerto Rico)

^k WINTHROP UNIVERSITY HOSPITAL   (United States)

^l UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

more..

Author keywords

Clinical trial endpoints; Ovarian cancer; Overall survival; Progression free survival

Indexed keywords

ALTRETAMINE; CARBOPLATIN; CISPLATIN; DOXORUBICIN; GEMCITABINE; PACLITAXEL; TOPOTECAN;

ARTICLE; CANCER SURVIVAL; CLINICAL TRIAL; GYNECOLOGIC CANCER; HUMAN; MEDICAL SOCIETY; OVARY CANCER; OVERALL SURVIVAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; QUALITY OF LIFE;

CLINICAL TRIAL ENDPOINTS; OVARIAN CANCER; OVERALL SURVIVAL; PROGRESSION FREE SURVIVAL;

CLINICAL TRIALS AS TOPIC; DISEASE-FREE SURVIVAL; DRUG APPROVAL; ENDPOINT DETERMINATION; FEMALE; HUMANS; MEDICAL ONCOLOGY; OVARIAN NEOPLASMS; QUALITY OF LIFE; RESEARCH DESIGN; SOCIETIES, MEDICAL; TUMOR MARKERS, BIOLOGICAL;

EID: 84892795291     PISSN: 00908258     EISSN: 10956859     Source Type: Journal    
DOI: 10.1016/j.ygyno.2013.11.008     Document Type: Article

References (49)

1. R. Siegel, D. Naishadham, and A. Jemal Cancer statistics, 2013 CA Cancer J Clin 63 January/February 2013 11 30
2. J. Ferlay, H.R. Shin, F. Bray, D. Forman, C. Mathers, and D.M. Parkin GLOBOCAN 2008 v2.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 10 [Internet] 2010 International Agency for Research on Cancer Lyon, France [Available from: http://globocan.iarc.fr, accessed Aug.3, 2012]
3. L. Huang, K.A. Cronin, K.A. Johnson, A.B. Mariotto, and E.J. Feuer Improved survival time: what can survival cure models tell us about population-based survival improvements in late-stage colorectal, ovarian, and testicular cancer? Cancer 112 2008 2289 2300
4. A.P. Heintz, F. Odicino, P. Maisonneuve, M.A. Quinn, J.L. Benedet, and W.T. Creasman et al. Carcinoma of the ovary. FIGO 26th Annual Report on the Results of Treatment in Gynecological Cancer Int J Gynaecol Obstet 95 Suppl. 1 2006 S161 S192
5. N. Howlader, A.M. Noone, M. Krapcho, N. Neyman, R. Aminou, and S.F. Altekruse et al. SEER Cancer Statistics Review, 1975-2009 (Vintage 2009 Populations) April 2012 National Cancer Institute Bethesda, MD [ http://seer.cancer.gov/csr/1975-2009-pops09/, based on November 2011 SEER data submission, posted to the SEER web site]
6. A.M. van Altena, H.E. Karim-Kos, E. de Vries, R.F. Kruitwagen, L.F. Massuger, and L.A. Kiemeney Trends in therapy and survival of advanced stage epithelial ovarian cancer patients in The Netherlands Gynecol Oncol 125 3 2012 649 654
7. R.E. Bristow, R.S. Tomacruz, D.K. Armstrong, E.L. Trimble, and F.J. Montz Survival impact of maximum cytoreductive surgery for advanced ovarian carcinoma during the platinum-era: a meta-analysis of 6885 patients J Clin Oncol 20 5 2002 1248 1259
8. W.P. McGuire, W.J. Hoskins, M.F. Brady, P.R. Kucera, E.E. Partridge, and K.Y. Look et al. Cyclophosphamide and cisplatin compared with paclitaxel and cisplatin in patients with stage III and stage IV ovarian cancer N Engl J Med 334 1996 1 6
9. M.J. Piccart, K. Bertelsen, K. James, J. Cassidy, C. Mangioni, and E. Simonsen et al. Randomized intergroup trial of cisplatin-paclitaxel versus cisplatin-cyclophosphamide in women with advanced epithelial ovarian cancer: three-year results J Natl Cancer Inst 92 2000 699 708
10. D.S. Alberts, P.Y. Liu, E.V. Hannigan, R. O'Toole, S.D. Williams, and J.A. Young et al. Intraperitoneal cisplatin plus intravenous cyclophosphamide versus intravenous cisplatin plus intravenous cyclophosphamide for stage III ovarian cancer N Engl J Med 335 1996 1950 1955
11. M. Markman, B.N. Bundy, D.S. Alberts, J.M. Fowler, D.L. Clarke-Pearson, and L.F. Carson et al. Phase III trial of standard-dose intravenous cisplatin plus paclitaxel versus moderately high-dose carboplatin followed by intravenous paclitaxel and intraperitoneal cisplatin in small-volume stage III ovarian carcinoma: an intergroup study of the Gynecologic Oncology Group, Southwestern Oncology Group, and Eastern Cooperative Oncology Group J Clin Oncol 19 2001 1001 1007
12. D.K. Armstrong, B. Bundy, L. Wenzel, H.Q. Huang, R. Baergen, and L. Shashikant et al. Intraperitoneal cisplatin and paclitaxel in ovarian cancer N Engl J Med 354 2006 34 43
13. L.M. Landrum, J. Java, C.A. Mathews, G.S. Lanneau Jr., L.J. Copeland, and D.K. Armstrong et al. Prognostic factors for stage III epithelial ovarian cancer treated with intraperitoneal chemotherapy: a Gynecologic Oncology Group Study Gynecol Oncol 130 1 2013 12 18
14. N. Katsumata, M. Yasuda, F. Takahashi, S. Isonishi, T. Jobo, and D. Aoki et al. Dose-dense paclitaxel once a week in combination with carboplatin every 3 weeks for advanced ovarian cancer: a phase 3, open-label, randomised controlled trial Lancet 374 2009 1331 1338
15. R.Y. Zang, P. Harter, D.S. Chi, J. Sehouli, R. Jiang, and C.G. Tropé et al. Predictors of surgery based on the pooled analysis of an international collaborative cohort Br J Cancer 105 7 2011 890 896
16. J. Pfisterer, M. Plante, I. Vergote, A. du Bois, H. Hirte, and A.J. Lacave et al. Gemcitabine plus carboplatin compared with carboplatin in patients with platinum-sensitive recurrent ovarian cancer: an intergroup trial of the AGO-OVAR, the NCIC CTG, and the EORTC GCG 2006 J Clin Oncol 24 29 2006 4699 4707
17. C. Aghajanian, S.V. Blank, B.A. Goff, P.L. Judson, M.G. Teneriello, and A. Husain et al. OCEANS: a randomized, double-blind, placebo-controlled phase III trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer J Clin Oncol 30 17 2012 2039 2045 10.1200/JCO.2012.42.0505 [Epub 2012 Apr 23]
18. A.M. du Bois, M. Quinn, T. Thigpen, J. Vermorken, E. Avall-Lundvist, and M. Bookman et al. 2004 consensus statements on the management of ovarian cancer: final document of the 3rd International Gynecologic Cancer Intergroup Ovarian Cancer Consensus Conference (GCIG OCCC 2004) Ann Oncol 16 Suppl. 8 2005 viii7 viii12
19. G.C. Stuart, H. Kitchener, M. Bacon, A. duBois, M. Friedlander, and J. Ledermann et al. Participants of 4th Ovarian Cancer Consensus Conference (OCCC); Gynecologic Cancer Intergroup. 2010 Gynecologic Cancer InterGroup (GCIG) consensus statement on clinical trials in ovarian cancer: report from the Fourth Ovarian Cancer Consensus Conference Int J Gynecol Cancer 21 4 May 2011 750 755
20. R.L. Erwin Therapy for advanced stage cancer: what do patients want and expect? A patient advocate's perspective The Oncologist 15 S1 2010 11 12 10.1634/theoncologist.2010-S1-11
21. Weeks et al. NEJM 367 2012 [43]
22. FDA Oncologic Drugs Advisory Committee Meeting, NDA 22334 Afinitor (everolimus) Briefing Document April 12, 2011 Retrieved Apr 22, 2013, from http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/ drugs/oncologicdrugsadvisorycommittee/ucm250378.pdf 2011
23. L. Traeger, J.A. Greer, C. Fernandez-Robles, J.S. Temel, and W.F. Pirl Evidence-based treatment of anxiety in patients with cancer J Clin Oncol 30 11 2012 1197 1205
24. M.F. Brady First-line therapy in ovarian cancer - surrogate endpoints for accelerated approval FDA/ASCO/AACR Ovarian Cancer End Points Workshop 2006 [Retrieved April 3, 2013, from http://www.fda.gov/downloads/Drugs/ DevelopmentApprovalProcess/DevelopmentResources/CancerDrugs/ucm094640.pdf ]
25. M. Buyse Is PFS a "valid" surrogate for OS in advanced ovarian cancer? A meta-analysis Marc FDA/ASCO/AACR Ovarian Cancer End Points Workshop 2006 [Retrieved Aug 3, 2012, from http://www.fda.gov/downloads/Drugs/ DevelopmentApprovalProcess/DevelopmentResources/CancerDrugs/ucm094610.pdf ]
26. M.W. Redman, B.H. Goldman, M. LeBlanc, A. Schott, and L.H. Baker Modeling the relationship between progression-free survival and overall survival: the phase II/III trial Clin Cancer Res 19 10 May 15 2013 2646 2656
27. R.A. Burger, M.F. Brady, M.A. Bookman, G.F. Fleming, B.J. Monk, and H. Huang et al. Incorporation of bevacizumab in the primary treatment of ovarian cancer N Engl J Med 365 26 2011 2473 2483
28. T.J. Perren, A.M. Swart, J. Pfisterer, J. Ledermann, E. Pujade-Lauraine, and G. Kristensen et al. A phase 3 trial of bevacizumab in ovarian cancer N Engl J Med 365 26 2011 2484 2496
29. G.J. Rustin, M. Quinn, T. Thigpen, A. du Bois, E. Pujade-Lauraine, and A. Jakobsen et al. New guidelines to evaluate the response to treatment in solid tumors (ovarian cancer) J Natl Cancer Inst 96 6 Mar 17 2004 487 488
30. T. Burzykowski, and M. Buyse Surrogate threshold effect: an alternative measure for meta-analytic surrogate endpoint validation Pharm Stat 5 3 2006 173 186
31. T.J. Herzog, J.B. Vermorken, E. Pujade-Lauraine, D.M. Provencher, A. Jagiello-Gruszfeld, and B. Kong et al. Correlation between CA-125 serum level and response by RECIST in a phase III recurrent ovarian cancer study Gynecol Oncol 122 2 Aug 2011 350 355
32. R. Kay, J. Wu, and J. Wittes On assessing the presence of evaluation-time bias in progression-free survival in randomized trials Pharm Stat 10 3 2011 213 217
33. B. Freidlin, E.L. Korn, S. Hunsberger, R. Gray, S. Saxman, and J.A. Zujewski Proposal for the use of progression-free survival in unblinded randomized trials J Clin Oncol 25 15 2007 2122 2126
34. J.B. Vermorken, M.K.B. Parmar, M.F. Brady, E.A. Eisenhauer, T. Hogberg, and R.F. Ozols et al. Clinical trials in ovarian carcinoma: study methodology Ann Oncol 16 Supp. 8 2005 viii20 viii29
35. B.J. Monk, T.J. Herzog, S.B. Kaye, C.N. Krasner, J.B. Vermorken, and F.M. Muggia et al. Trabectedin plus pegylated liposomal Doxorubicin in recurrent ovarian cancer J Clin Oncol 28 2010 3107 3114
36. M.A. Bookman, M.F. Brady, W.P. McGuire, P.G. Harper, D.S. Albert, and M. Friedlander et al. Evaluation of new platinum-based treatment regimens in advanced-stage ovarian cancer: a phase III trial of the Gynecologic Cancer Intergroup J Clin Oncol 27 2009 1419 1425
37. K.R. Broglio, and D.A. Berry Detecting an overall survival benefit that is derived from progression-free survival J Natl Cancer Inst 101 23 2009 1642 164927
38. S.A. Cannistra Evaluating new regimens in recurrent ovarian cancer: How much evidence is good enough J Clin Oncol 28 19 2010 3101 3103
39. E.L. Korn, B. Freidlin, and J.S. Abrams Overall survival as the outcome for randomized clinical trials with effective subsequent therapies J Clin Oncol 29 17 Jun 10 2011 2439 2442
40. J.K. Chan, I. Amanam, T.K. Kiet, N. Young-Lin, K. Hoth, and D.S. Kapp et al. Progress and trends for cancer drug approval - an analysis of the FDA Advisory Committee Ann Oncol 23 Suppl. 9 2012 460
41. S.J. Wang Editorial: adaptive designs: appealing in development of therapeutics, and where do controversies lie? J Biopharm Stat 20 6 2010 1083 1087
42. M.F. Lopez, J.F. Dupuy, and C.V. Gonzalez Effectiveness of adaptive designs for phase II cancer trials Contemp Clin Trials 33 1 2012 223 227
43. Adaptive design clinical trials for drugs and biologics FDA Guidance for Industry 2010 Center for Drug Evaluation and Research, Food and Drug Administration Silver Spring, MD [ http://www.fda.gov/downloads/Drugs/./ Guidances/ucm201790.pdf ]
44. M.K. Parmar, F.M. Barthel, M. Sydes, R. Langley, R. Kaplan, and E. Eisenhauer et al. Speeding up the evaluation of new agents in cancer J Natl Cancer Inst 100 17 Sep 3 2008 1204 1214
45. I P.T.S. (project leader); S.G., G.G., J.W.G. and E.R.M. (writing team); A.K. Integrated genomic analyses of ovarian carcinoma, Cancer Genome Atlas Research Network, Nature Jun 29 2011; 474(7353):609-15.
46. I. Diaz-Padilla, A.L. Malpica, L. Minig, L.M. Chiva, D.M. Gershenson, and Gonzalez-Martin An ovarian low-grade serous carcinoma: a comprehensive update Gynecol Oncol 126 2 Aug 2012 279 285
47. D. Maeda, and IeM Shih Pathogenesis and the role of ARID1A mutation in endometriosis-related ovarian neoplasms Adv Anat Pathol 20 1 Jan 2013 45 52
48. R.L. Korn, and J. Crowley Overview: progression-free survival as an endpoint in clinical trials with solid tumors Clin Cancer Res 19 10 2013 2607 2612
49. M.C. Pietanza, E.M. Basch, A. Lash, L.H. Schwartz, M.S. Ginsberg, and B. Zhao et al. Harnessing technology to improve clinical trials: study of real-time informatics to collect data, toxicities, image response assessments and patient reported outcomes in a phase II clinical trial J Clin Oncol 31 16 2013 2004 2009