Phase III trial of carboplatin plus paclitaxel with or without gemcitabine in first-line treatment of epithelial ovarian cancer

Journal of Clinical Oncology

Volumn 28, Issue 27, 2010, Pages 4162-4169

  Du Bois, Andreas ^a   Herrstedt, Jørn ^a   Hardy Bessard, Anne Claire ^a   Müller, Hans Helge ^a   Harter, Philipp ^a   Kristensen, Gunnar ^a   Joly, Florence ^a   Huober, Jens ^a   Åvall Lundqvist, Elisabeth ^a   Weber, Béatrice ^a   Kurzeder, Christian ^a   Jelic, Svetislav ^a   Pujade Lauraine, Eric ^a   Burges, Alexander ^a   Pfisterer, Jacobus ^a   Gropp, Martina ^a   Staehle, Anne ^a   Wimberger, Pauline ^a   Jackisch, Christian ^a   Sehouli, Jalid ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

CARBOPLATIN; CARBOPLATIN PLUS PACLITAXEL; GEMCITABINE; PACLITAXEL; UNCLASSIFIED DRUG; ANTINEOPLASTIC AGENT; DEOXYCYTIDINE; DRUG DERIVATIVE;

ADD ON THERAPY; ADULT; AGED; ALLERGIC REACTION; ALOPECIA; AREA UNDER THE CURVE; ARTHRALGIA; ARTICLE; BLOOD TOXICITY; CANCER COMBINATION CHEMOTHERAPY; CANCER GRADING; CANCER STAGING; CANCER SURGERY; CANCER SURVIVAL; CONSTIPATION; DIARRHEA; EDEMA; EPITHELIAL OVARY CANCER; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HAZARD RATIO; HEARING IMPAIRMENT; HEMOGLOBIN BLOOD LEVEL; HUMAN; INFECTION; LEUKOCYTE COUNT; MAJOR CLINICAL STUDY; MOTOR NEUROPATHY; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPHIL COUNT; OVARY CANCER; OVERALL SURVIVAL; PAIN; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROSPECTIVE STUDY; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SENSORY NEUROPATHY; SIDE EFFECT; STOMATITIS; THROMBOCYTE COUNT; TREATMENT RESPONSE; VERTIGO; VOMITING; CARCINOMA; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE FREE SURVIVAL; DRUG ADMINISTRATION; DRUG RESISTANCE; EUROPE; KAPLAN MEIER METHOD; MIDDLE AGED; MORTALITY; MULTICENTER STUDY; OVARY TUMOR; PROPORTIONAL HAZARDS MODEL; TIME; TREATMENT OUTCOME;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARBOPLATIN; CARCINOMA; DEOXYCYTIDINE; DISEASE-FREE SURVIVAL; DRUG ADMINISTRATION SCHEDULE; DRUG RESISTANCE, NEOPLASM; EUROPE; FEMALE; HUMANS; KAPLAN-MEIERS ESTIMATE; MIDDLE AGED; OVARIAN NEOPLASMS; PACLITAXEL; PROPORTIONAL HAZARDS MODELS; PROSPECTIVE STUDIES; QUALITY OF LIFE; TIME FACTORS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 77957950128     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2009.27.4696     Document Type: Article

References (39)

1. McGuire WP, Hoskins WJ, Brady MF, et al: Cyclophosphamide and cisplatin compared with paclitaxel and cisplatin in patients with stage III and stage IV ovarian cancer. N Engl J Med 334:1-6, 1996 (Pubitemid 26012496)
2. Piccart MJ, Bertelsen K, James K, 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 92:699-708, 2000 (Pubitemid 30365530)
3. du Bois A, Lü ck HJ, Meier W, et al: A randomized clinical trial of cisplatin/paclitaxel versus carboplatin/ paclitaxel as first-line treatment of ovarian cancer. J Natl Cancer Inst 95:1320-1329, 2003
4. Ozols RF, Bundy BN, Greer BE, et al: Phase III trial of carboplatin and paclitaxel compared with cisplatin and paclitaxel in patients with optimally resected stage III ovarian cancer: A Gynecologic Oncology Group Study. J Clin Oncol 21:3194-3200, 2003 (Pubitemid 46606249)
5. Mutch DG, Orlando M, Goss T, et al: Randomized phase III trial of gemcitabine compared with pegylated liposomal doxorubicin in patients with platinum-resistant ovarian cancer. J Clin Oncol 25:2811-2818, 2007 (Pubitemid 47123191)
6. Ferrandina G, Ludovisi M, Lorusso D, et al: Phase III trial of gemcitabine compared with pegylated liposomal doxorubicin in progressive or recurrent ovarian cancer. J Clin Oncol 26:890-896, 2008 (Pubitemid 351398081)
7. du Bois A, Lü ck HJ, Pfisterer J, et al: :Second-line carboplatin and gemcitabine in platinum sensitive ovarian cancer: A dose-finding study by the Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) Ovarian Cancer Study Group. Ann Oncol 12:1115-1120, 2001
8. Brewer CA, Blessing JA, Nagourney RA, et al: Cisplatin plus gemcitabine in platinum-refractory ovarian or primary peritoneal cancer: A phase II study of the Gynecologic Oncology Group. Gynecol Oncol 103:446-450, 2006 (Pubitemid 44602150)
9. Pfisterer J, Plante M, Vergote I, 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. J Clin Oncol 24:4699-4707, 2006 (Pubitemid 46630933)
10. Gupta SK, John S, Naik R, et al: A multicenter phase II study of gemcitabine, paclitaxel, and cisplatin in chemonaïve advanced ovarian cancer. Gynecol Oncol 98:134-140, 2005 (Pubitemid 40826430)
11. Hensley ML, Correa DD, Thaler H, et al: Phase I/II study of weekly paclitaxel plus carboplatin and gemcitabine as first-line treatment of advanced-stage ovarian cancer: Pathologic complete response and longitudinal assessment of impact on cognitive functioning. Gynecol Oncol 102:270-277, 2006 (Pubitemid 44063582)
12. Friedlander M, Buck M, Wyld D, et al: Phase II study of carboplatin followed by sequential gemcitabine and paclitaxel as first-line treatment for advanced ovarian cancer. Int J Gynecol Cancer 17:350-358, 2007 (Pubitemid 46426766)
13. du Bois A, Belau A, Wagner U, et al: A phase II study of paclitaxel, carboplatin, and gemcitabine in previously untreated patients with epithelial ovarian cancer FIGO stage IC-IV (AGO-OVAR protocol OVAR-8). Gynecol Oncol 96:444-451, 2005
14. Herrstedt J, Huober J, Priou F, et al: A randomized, phase III study (AGO-OVAR-9, GINECO-TCG, NSGO-OC-0102): Gemcitabine-paclitaxel-carboplatin versus paclitaxel-carboplatin as first-line treatment of ovarian cancer - Survival of FIGO stage I-IIA patients. J Clin Oncol 27:279s, 2009 (suppl; abstr LBA5510)
15. International Federation of Gynecology and Obstetrics: Changing in definitions of clinical staging for carcinoma of the cervix and ovary. Am J Obstet Gynecol 156:263-264, 1987
16. Calvert AH, Newell DR, Gumbrell LA, et al: Carboplatin dosage: Prospective evaluation of a simple formula based on renal function. J Clin Oncol 7:1748-1756, 1989 (Pubitemid 19272848)
17. Jelliffe RW: Creatinine clearance: Bedside estimate. Ann Intern Med 79:604-605, 1973
18. National Cancer Institute: Cancer Therapy Evaluation Program: Common Toxicity Criteria. http://ctep.cancer.gov/reporting/ctc.html
19. Aaronson NK, Ahmedzai S, Bergman B, et al: The European Organization for Research and Treatment of Cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 85:365-376, 1993 (Pubitemid 23073154)
20. Greimel E, Bottomley A, Cull A, et al: An international field study of the reliability and validity of a disease-specific questionnaire module (the QLQ-OV28) in assessing the quality of life of patients with ovarian cancer. Eur J Cancer 39:1402-1408, 2003 (Pubitemid 36773783)
21. Fayers PM, Aaronson NK, Bjordal K, et al: The EORTC QLQ-C30 Scoring Manual (ed 2). Brussels, Belgium, European Organization for Research and Treatment of Cancer, 1999
22. Therasse P, Arbuck SG, Eisenhauer EA, 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 92:205-216, 2000
23. du Bois A, Weber B, Rochon J, et al: Addition of epirubicin as a third drug to carboplatin-paclitaxel in first-line treatment of advanced ovarian cancer: A prospectively randomized Gynecologic Cancer Intergroup Trial by the Arbeitsgemeinschaft Gynaekologische Onkologie Ovarian Cancer Study Group and the Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens. J Clin Oncol 24:1127-1135, 2006
24. Schoenfeld DA, Richter JR: Nomograms for calculating the number of patients needed for a clinical trial with survival as an endpoint. Biometrics 38:163-170, 1982
25. DeMets DL, Lan KK: Interim analysis: The alpha spending function approach. Stat Med 13:1341-1352, 1994 (Pubitemid 24236184)
26. Müller HH, Schäfer H: A general statistical principle for changing a design any time during the course of a trial. Stat Med 23:2497-2508, 2004
27. Kristensen GB, Vergote I, Eisenhauer E, et al: First line treatment of ovarian/tubal/peritoneal cancer FIGO stage IIb-IV with paclitaxel/carboplatin with or without epirubicin (TEC vs TC): A Gynecologic Cancer Intergroup study of the NSGO, EORTC GCG, and NCIC CTG - Results on progression free survival. J Clin Oncol 23:448, 2004 (suppl; abstr 5003)
28. Bookman MA, Brady MF, McGuire, 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 27:1419-1425, 2009
29. Pfisterer J, Weber B, Reuss A, et al: Randomized phase III trial of topotecan following carboplatin and paclitaxel in first-line treatment of advanced ovarian cancer: A Gynecologic Cancer Intergroup Trial of the AGO-OVAR and GINECO. J Natl Cancer Inst 98:1036-1045, 2006 (Pubitemid 44288151)
30. Hoskins PJ, Vergote I, Stuart G, et al: A phase III trial of cisplatin plus topotecan followed by paclitaxel plus carboplatin versus standard carboplatin plus paclitaxel as first-line chemotherapy in women with newly diagnosed advanced epithelial ovarian cancer (EOC) (OV. 16): A Gynecologic Cancer Intergroup Study of the NCIC CTG, EORTC GCG, and GEICO. J Clin Oncol 26:294s, 2008 (suppl; abstr LBA5505)
31. Scarfone G, Scambia G, Raspagliesi F, et al: A multicenter, randomized, phase III study comparing paclitaxel/carboplatin (PC) versus topotecan/paclitaxel/carboplatin (TPC) in patients with stage III (residual tumor >1 cm after primary surgery) and IV ovarian cancer (OC). J Clin Oncol 24:256s, 2006 (suppl 5003)
32. Zhang L, Conejo-Garcia JR, Katsaros D, et al: Intratumoral T cells, recurrence, and survival in epithelial ovarian cancer. N Engl J Med 348:203-213,2003 (Pubitemid 36077915)
33. Alberts DS, Marth C, Alvarez RD, et al: Randomized phase 3 trial of interferon gamma-1b plus standard carboplatin/paclitaxel versus carboplatin/paclitaxel alone for first-line treatment of advanced ovarian and primary peritoneal carcinomas: Results from a prospectively designed analysis of progression-free survival. Gynecol Oncol 109:174-181, 2008
34. Hoskins PJ: Triple cytotoxic therapy for advanced ovarian cancer: A failed application, not a failed strategy. J Clin Oncol 27:1355-1358, 2009
35. Zia MI, Siu LL, Pond GR, et al: Comparison of outcomes of phase II studies and subsequent randomized control studies using identical chemotherapeutic regimens. J Clin Oncol 23:6982-6991, 2005
36. Harrison ML, Gore ME, Spriggs D, et al: Duration of second or greater complete clinical remission in ovarian cancer: Exploring potential endpoints for clinical trials. Gynecol Oncol 106:469-475, 2007 (Pubitemid 47302474)
37. Claret L, Girard P, Hoff PM, et al: Model-based prediction of phase III overall survival in colorectal cancer on the basis of phase II tumor dynamics. J Clin Oncol 27:4103-4108, 2009
38. Sauter G, Lee J, Bartlett JM, et al: Guidelines for human epidermal growth factor receptor 2 testing: Biologic and methodologic considerations. J Clin Oncol 27:1323-1333, 2009
39. Linardou H, Dahabreh IJ, Bafaloukos D, et al: Somatic EGFR mutations and efficacy of tyrosine kinase inhibitors in NSCLC. Nat Rev Clin Oncol 6:352-366, 2009