Progression-free survival by local investigator versus independent central review: Comparative analysis of the AGO-OVAR16 Trial

Gynecologic Oncology

Volumn 136, Issue 1, 2015, Pages 37-42

  Floquet, Anne ^a   Vergote, Ignace ^b   Colombo, Nicoletta ^c   Fiane, Bent ^d   Monk, Bradley J ^e   Reinthaller, Alexander ^f   Calvert, Paula ^g   Herzog, Thomas J ^h   Meier, Werner ⁱ   Kim, Jae Weon ^j   Campo, Josep M Del ^k   Friedlander, Michael ^l   Pisano, Carmela ^m   Isonishin, Seiji ⁿ   Crescenzo, Rocco J ^o   Barrett, Catherine ^p   Wang, Karrie ^o   Mitrica, Ionel ^o   Bois, Andreas Du ^q  

^a INSTITUT BERGONIÉ   (France)

^b UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^c UNIVERSITY OF MILANO BICOCCA   (Italy)

^d STAVANGER UNIVERSITY HOSPITAL   (Norway)

^e CREIGHTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^f UNIVERSITY OF VIENNA   (Austria)

^g All Ireland Co operative Oncology Research Group   (Ireland)

^h UNIVERSITY OF CINCINNATI   (United States)

ⁱ Children s Hospital   (Germany)

^j Seoul National University   (South Korea)

^k HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^l The Prince of Wales Cancer Centre   (Australia)

^m NATIONAL CANCER INSTITUTE   (Italy)

ⁿ JIKEI UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^o GLAXOSMITHKLINE   (United States)

^p GLAXOSMITHKLINE   (United Kingdom)

^q KLINIKEN ESSEN MITTE   (Germany)

more..

Author keywords

Disease progression; Independent central review; Ovarian cancer; Progression free survival

Indexed keywords

PAZOPANIB; PLACEBO; ANGIOGENESIS INHIBITOR; PYRIMIDINE DERIVATIVE; SULFONAMIDE;

ADULT; ADVANCED EPITHELIAL OVARY CANCER; ARTICLE; CANCER SURVIVAL; COMPARATIVE STUDY; COMPUTER ASSISTED TOMOGRAPHY; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; FEMALE; HAZARD RATIO; HUMAN; INTENTION TO TREAT ANALYSIS; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; NUCLEAR MAGNETIC RESONANCE IMAGING; OVARY CARCINOMA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT DURATION; TREATMENT RESPONSE; BIOASSAY; CLINICAL TRIAL; DISEASE FREE SURVIVAL; FALLOPIAN TUBE NEOPLASMS; MORTALITY; MULTICENTER STUDY; NEOPLASMS, GLANDULAR AND EPITHELIAL; OVARIAN NEOPLASMS; PERITONEAL NEOPLASMS; PHASE 3 CLINICAL TRIAL; PROCEDURES; STANDARDS;

ANGIOGENESIS INHIBITORS; DISEASE-FREE SURVIVAL; DOUBLE-BLIND METHOD; ENDPOINT DETERMINATION; FALLOPIAN TUBE NEOPLASMS; FEMALE; HUMANS; NEOPLASMS, GLANDULAR AND EPITHELIAL; OVARIAN NEOPLASMS; PERITONEAL NEOPLASMS; PYRIMIDINES; SULFONAMIDES;

EID: 84925228724     PISSN: 00908258     EISSN: 10956859     Source Type: Journal    
DOI: 10.1016/j.ygyno.2014.11.074     Document Type: Article

References (17)

1. Herzog TJ. Recurrent ovarian cancer: how important is it to treat to disease progression? Clin Cancer Res 2004;10:7439-49.
2. Thigpen T, duBois A, McAlpine J, DiSaia P, Fujiwara K, Hoskins W, et al. First-line therapy in ovarian cancer trials. Int J Gynecol Cancer 2011;21:756-62.
3. Cannistra SA. Cancer of the ovary. N Engl J Med 2004;351:2519-29.
4. Burger RA, Brady MF, Bookman MA, Fleming GF, Monk BJ, Huang H, et al. Incorporation of bevacizumab in the primary treatment of ovarian cancer. N Engl J Med 2011; 365:2473-83.
5. Aghajanian C, Blank SV, Goff BA, Judson PL, Teneriello MG, Husain A, 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 2012;30:2039-45.
6. Friedlander M, Hancock KC, Rischin D, Messing MJ, Stringer CA, Matthys GM, et al. A Phase II, open-label study evaluating pazopanib in patients with recurrent ovarian cancer. Gynecol Oncol 2010;119:32-7.
7. du Bois A, Vergote I, Wimberger P, Ray-Coquard I, Harter P, Curtis LB, et al. Open-label feasibility study of pazopanib, carboplatin, and paclitaxel in women with newly diagnosed, untreated, gynaecologic tumours: a phase I/II trial of the AGO study group. Br J Cancer 2012;106:629-32.
8. du Bois A, Floquet A, Kim JW, Rau J, Del Campo JM, Friedlander M, et al. Incorporation of pazopanib in maintenance therapy of ovarian cancer. J Clin Oncol 2014;32: 3374-82.
9. Bast RC, Thigpen JT, Arbuck SG, Basen-Engquist K, Burke LB, Freedman R, et al. Clinical trial endpoints in ovarian cancer: report of an FDA/ASCO/AACR Public Workshop. Gynecol Oncol 2007;107:173-6.
10. Le T, Hopkins L, Fung Kee Fung M. Quality of life assessments in epithelial ovarian cancer patients during and after chemotherapy. Int J Gynecol Cancer 2005;15: 811-6.
11. Zhang JJ, Zhang L, Chen H, Murgo AJ, Dodd LE, Pazdur R, et al. Assessment of audit methodologies for bias evaluation of tumor progression in oncology clinical trials. Clin Cancer Res 2013;19:2637-45.
12. Amit O, Mannino F, Stone AM, Bushnell W, Denne J, Helterbrand J, et al. Blinded independent central review of progression in cancer clinical trials: results from a meta-analysis. Eur J Cancer 2011;47:1772-8.
13. US Food and Drug Administration. Oncologic Drugs Advisory Committee Meeting July 24, 2012: evaluation of radiologic review of progression-free survival in non-hematologic malignancies. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM311141.pdf.
14. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000;92:205-16.
15. Perren TJ, Swart AM, Pfisterer J, Ledermann JA, Pujade-Lauraine E, Kristensen G, et al. A phase 3 trial of bevacizumab in ovarian cancer. N Engl J Med 2011;365:2484-96.
16. Shaw D, Clamp A, Jayson GC. Angiogenesis as a target for the treatment of ovarian cancer. Curr Opin Oncol 2013;25:558-65.
17. Burger RA, Brady MF, Rhee J, Sovak MA, Kong G, Nguyen HP, et al. Independent radiologic review of the Gynecologic Oncology Group Study 0218, a phase III trial of bevacizumab in the primary treatment of advanced epithelial ovarian, primary peritoneal, or fallopian tube cancer. Gynecol Oncol 2013;131:21-6.