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

Journal of the National Cancer Institute - Tập 98 Số 15 - Trang 1036-1045 - 2006
Jacobus Pfisterer1, B. Weber, Alexander Reuß, Rainer Kimmig, Andreas du Bois, Uwe Wagner, Hugues Bourgeois, Werner Meier, Serban Dan Costa, Jens‐Uwe Blohmer, Alain Lortholary, S. Olbricht, Anne Stähle, Christian Jackisch, Anne‐Claire Hardy‐Bessard, Volker Möbus, J. Quaas, Barbara Richter, W. Schröder, Jean‐François Geay, Hans‐Joachim Lück, Walther Kuhn, Harald Meden, Ulrike Nitz, Éric Pujade-Lauraine
1Klinik für Gynäkologie und Geburtshilfe, Campus Kiel, Universitätsklinikum Schleswig-Holstein, Michaelisstr. 16, D-24105 Kiel, Germany.

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McGuire WP, Hoskins WJ, Brady MF, Kucera PR, Partridge EE, Look KY, et al. Cyclophosphamide and cisplatin compared with paclitaxel and cisplatin in patients with stage III and stage IV ovarian cancer. N Engl J Med1996 ; 334 : 1 –6.

Piccart MJ, Bertelsen K, James K, Cassidy J, Mangioni C, Simonsen E, et al. Randomized intergroup trial of cisplatin-paclitaxel versus cisplatin-cyclophosphamide in women with advanced epithelial ovarian cancer: three-year results. J Natl Cancer Inst2000 ; 92 : 699 –708.

Piccart MJ, Bertelsen K, Stuart G, Cassidy J, Mangioni C, Simonsen E, et al. Long-term follow-up confirms a survival advantage of the paclitaxel-cisplatin regimen over the cyclophosphamide-cisplatin combination in advanced ovarian cancer. Int J Gynecol Cancer2003 ; 13 (Suppl 2): 144 –8.

du Bois A, Luck HJ, Meier W, Adams HP, Mobus V, Costa S, et al. A randomized clinical trial of cisplatin/paclitaxel versus carboplatin/paclitaxel as first-line treatment of ovarian cancer. J Natl Cancer Inst2003 ; 95 : 1320 –9.

Neijt JP, Engelholm SA, Tuxen MK, Sorensen PG, Hansen M, Sessa C, et al. Exploratory phase III study of paclitaxel and cisplatin versus paclitaxel and carboplatin in advanced ovarian cancer. J Clin Oncol2000 ; 18 : 3084 –92.

Ozols RF, Bundy BN, Greer BE, Fowler JM, Clarke-Pearson D, Burger RA, 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 Oncol2003 ; 21 : 3194 –200.

du Bois A, Quinn M, Thigpen T, Vermorken J, Avall-Lundqvist E, Bookmann M, 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 Oncol2005 ; 16 (Suppl 8): viii7 –12.

du Bois A, Weber B, Rochon J, Meier W, Goupil A, Olbricht A, et al. Addition of epirubicin as 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 Oncol2006 ; 24 : 1127 –35.

Kristensen GB, Vergote I, Eisenhauer E, Baekelandt M, Stuart G, Avall-Lundquist 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 Oncol2004 ; 22 : 5003 .

Copeland LJ, Bookman M, Trimble E. Clinical trials of newer regimens for treating ovarian cancer: the rationale for Gynecologic Oncology Group Protocol GOG 182-ICON5. Gynecol Oncol2003 ; 90 (2 Pt 2): 1 –7.

Gore M, ten Bokkel Huinink W, Carmichael J, Gordon A, Davidson N, Coleman R, et al. Clinical evidence for topotecan-paclitaxel non-cross-resistance in ovarian cancer. J Clin Oncol2001 ; 19 : 1893 –900.

Ten Bokkel Huinink W, Gore M, Carmichael J, Gordon A, Malfetano J, Hudson I, et al. Topotecan versus paclitaxel for the treatment of recurrent epithelial ovarian cancer. J Clin Oncol1997 ; 15 : 2183 –93.

Ten Bokkel Huinink W, Lane SR, Ross GA. Long-term survival in a phase III, randomised study of topotecan versus paclitaxel in advanced epithelial ovarian carcinoma. Ann Oncol2004 ; 15 : 100 –3.

Gordon A, Fleagle J, Guthrie D, Parkin D, Gore M, Lacave A. Recurrent Epithelial Ovarian Carcinoma: a randomized phase III study of pegylated liposomal doxorubicin versus topotecan. J Clin Oncol2001 ; 19 : 3312 –22.

Gordon A, Tonda M, Sun S, Rackoff W. Long-term survival advantage for women treated with pegylated liposomal doxorubicin compared with topotecan in a phase 3 randomized study of recurrent and refractory epithelial ovarian cancer. Gynecol Oncol2004 ; 95 : 1 –8.

Chan S, Carmichael J, Ross G, Wheathly A, Howell J, Patterson J. Sequential hycamtin following carboplatin and paclitaxel in advanced ovarian cancer. Proc ASCO1999 ; 18 : 1436 .

Bolis G, Scarfone G, Villa A, Parazzini F. Phase II trial of topotecan, carboplatin, and paclitaxel as front-line therapy in suboptimal advanced ovarian cancer. Gynecol Oncol2001 ; 81 : 331 –3.

Pfisterer J, Lortholary A, Kimmig R, Weber B, du Bois A, Bourgeois H, et al. Paclitaxel/carboplatin (TC) vs. paclitaxel/carboplatin followed by topotecan (TC-Top) in first-line treatment of ovarian cancer FIGO stages IIb-IV. Interim results of a Gynecologic Cancer Intergroup phase III trial of the AGO Ovarian Cancer Study Group and GINECO. Proc ASCO2003 ; 22 : 1793 .

Pfisterer J, Weber B, du Bois A, Lortholary A, Schade-Brittinger C, Wagner U, et al. Paclitaxel/carboplatin (TC) vs. paclitaxel/carboplatin followed by topotecan (Top) in first-line treatment of ovarian cancer FIGO stages IIB-IV. Mature results of a Gynecologic Cancer Intergroup phase III trial of the AGO OVAR and GINECO. J Clin Oncol2005 ; 23 : 5007 .

International Federation of Gynecology and Obstetrics. Changing in definitions of clinical staging for carcinoma of the cervix and ovary. Am J Obstet Gynecol1987 ; 156 : 263 –4.

FIGO Grading System. Acta Obstet Gynecol Scand1971 ; 50 : 1 –7.

Minna JD, Higgins GA, Glatstein EJ. Cancer of the lung. In: V. De Vita, S. Hellmann, and S. Rosenberg, editors. Cancer: principles and practice of oncology. Philadelphia (PA): Lippincott; 1984 . p. 536.

Calvert AH, Newell DR, Gumbrell LA, O'Reilly S, Burnell M, Boxall FE, et al. Carboplatin dosage: prospective evaluation of a simple formula based on renal function. J Clin Oncol1989 ; 7 : 1748 –56.

Jelliffe RW. Creatinine clearance: bedsite estimate. Ann Intern Med1973 ; 79 : 604 –5.

National Cancer Institute. Cancer Therapy Evaluation Program: Common Toxicity Criteria. Available from: http://ctep.cancer.gov/reporting/ctc.html . [Last accessed: May 24, 2006 ].

Trotti A, Byhardt R, Stetz J, Gwede C, Corn B, Fu K, et al. Common toxicity criteria: version 2.0. An improved reference for grading the acute effects of cancer treatment: impact on radiotherapy. Int J Radiat Oncol Biol Phys2000 ; 47 : 13 –47.

Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, 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 Inst1993 ; 85 : 365 –76.

Cull A, Howat S, Greimel E, Waldenstrom AC, Arraras J, Kudelka A, et al. Development of a European Organization for Research and Treatment of Cancer questionnaire module to assess the quality of life of ovarian cancer patients in clinical trials: a progress report. Eur J Cancer2001 ; 37 : 47 –53.

Greimel E, Bottomley A, Cull A, Waldenstrom AC, Arraras J, Chauvenet L, 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 Cancer2003 ; 39 : 1402 –08. [Published erratum appears in Eur J Cancer 2003;39:2570.]

Fayers PM, Aaronson NK, Bjordal K, Curran D, Groenvold M; on behalf of the EORTC Quality of Life Study Group: The EORTC QLQ-C30 Scoring Manual. 2nd ed. Brussels (Belgium): European Organization for Research and Treatment of Cancer; 1999 .

World Health Organization. WHO handbook for reporting results of cancer treatment. Geneva (Switzerland): World Health Organization. 1979 (Offset Publication No. 48). Available from: http://whqlibdoc.who.int/publications/9241700483.pdf . [Last accessed: May 24, 2006.]

Parmar MK, Ledermann JA, Colombo N, du Bois A, Delaloye JF, Kristensen GB, et al. Paclitaxel plus platinum-based chemotherapy versus conventional platinum-based chemotherapy in women with relapsed ovarian cancer: the ICON4/AGO-OVAR-2.2 trial. Lancet2003 ; 361 : 2099 –106.

Thigpen T, Stuart G, du Bois A, Friedlander M, Fujiwara K, Guastalla JP, et al. Clinical trials in ovarian carcinoma: requirements for standard approaches and regimens. Ann Oncol2005 ; 16 (suppl 8): viii13 –19.

De Placido S, Scambia G, Di Vagno G, Naglieri E, Vernaglia Lombardi A, Biamonte R, et al. Topotecan compared with no therapy after response to surgery and carboplatin/paclitaxel in patients with ovarian cancer: Multicenter Italian Trials in Ovarian Cancer (MITO-1) randomized study. J Clin Oncol2004 ; 22 : 2635 –42.

Current Site Committee and Supportive Care Trials. Available from: http://www.ctg.queensu.ca/public/Clinical_Trials/public_ph_3_trial_summary.html#OV16 . [Last accessed: May 24, 2006 .]

Chou TC, Motzer RJ, Tong Y, Bosl GJ. Computerized quantitation of synergism and antagonism of taxol, topotecan, and cisplatin against human teratocarcinoma cell growth: a rational approach to clinical protocol design. J Natl Cancer Inst1994 ; 86 : 1517 –24.