Topotecan versus treosulfan, an alkylating agent, in patients with epithelial ovarian cancer and relapse within 12 months following 1st-line platinum/paclitaxel chemotherapy. A prospectively randomized phase III trial by the Arbeitsgemeinschaft Gynaekologische Onkologie Ovarian Cancer Study Group (AGO-OVAR)

Gynecologic Oncology

Volumn 114, Issue 2, 2009, Pages 199-205

  Meier, Werner ^a   du Bois, Andreas ^b   Reuss, Alexander ^c   Kuhn, Walther ^d,e   Olbricht, Sigrid ^f,g   Gropp, Martina ^a,h   Richter, Barbara ^g,i   Lück, Hans Joachim ^b,j   Kimmig, Rainer ^k,l   Pfisterer, Jacobus ^m  

^a Evangelisches Krankenhaus Duesseldorf   (Germany)

^b DR HORST SCHMIDT KLINIKEN   (Germany)

^c UNIVERSITY HOSPITAL MARBURG   (Germany)

^d TECHNICAL UNIVERSITY OF MUNICH   (Germany)

^e UNIVERSITY OF BONN   (Germany)

^f OTTO VON GUERICKE UNIVERSITY   (Germany)

^g Malteser Krankenhaus Bonn ^*

^h Malteser Krankenhaus Bonn   (Germany)

ⁱ DRESDEN UNIVERSITY OF TECHNOLOGY   (Germany)

^j HANNOVER MEDICAL SCHOOL   (Germany)

^k UNIVERSITY OF DUISBURG ESSEN   (Germany)

^l UNIVERSITY OF MUNICH   (Germany)

^m UNIVERSITY HOSPITAL SCHLESWIG HOLSTEIN   (Germany)

more..

Author keywords

Ovarian cancer; Recurrent; Topotecan versus; Treosulfan

Indexed keywords

PACLITAXEL; PLATINUM DERIVATIVE; TOPOTECAN; TREOSULFAN;

ADULT; AGED; ALOPECIA; ANEMIA; ARTICLE; BONE MARROW SUPPRESSION; CANCER CHEMOTHERAPY; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; CANCER RECURRENCE; CANCER RELAPSE; CANCER SURVIVAL; CHEMOSENSITIVITY; CHEMOTHERAPY INDUCED EMESIS; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG DOSE REDUCTION; DRUG EFFICACY; FEMALE; GERMANY; HOT FLUSH; HUMAN; INFECTION; LEUKOPENIA; MAJOR CLINICAL STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OUTCOME ASSESSMENT; OVARY CANCER; OVERALL SURVIVAL; PAIN; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROGNOSIS; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; REPEATED DRUG DOSE; SKIN TOXICITY; STOMATITIS; THROMBOCYTOPENIA; TREATMENT RESPONSE;

EID: 67549084366     PISSN: 00908258     EISSN: 10956859     Source Type: Journal    
DOI: 10.1016/j.ygyno.2009.04.026     Document Type: Article

References (50)

1. Bristow R.E. Surgical standards in the management of ovarian cancer. Curr. Opin. Oncol. 12 (2000) 474-480
2. Bristow R.E., and Berek J.S. Surgery for ovarian cancer: how to improve survival. Lancet 367 (2006) 1558-1560
3. Du Bois A., Lueck H.J., 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 (2003) 1320-1330
4. McGuire W.P., Hoskins W.J., Brady M.F., 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
5. Ozols R.F., Bundy B.N., Greer B.E., 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 (2003) 3194-3200
6. Bolis G., Villa A., Guanerio P., et al. Survival of women with advanced ovarian cancer and complete pathologic response at second-look laparotomy. Cancer 77 (1996) 123-131
7. Stuart G., Bertelsen K., Mangioni C., et al. Updated analysis shows highly significant improved overall survival (OS) for cisplatin-paclitaxel as first-line treatment of advanced ovarian cancer: mature results of the EORTC-GCCG, NOCOVA, NICIC-CTG and Scottish intergroup trial. Proc. Am. Soc. Clin. Oncol. 17 (1998) 1394
8. Ten Bokkel Huinink W., Gore M., Carmichael J., et al. Topotecan versus paclitaxel for the treatment of recurrent epithelial ovarian cancer. J. Clin. Oncol. 15 (1997) 2183-2193
9. Du Bois A., Lück H.J., Bauknecht T., Pfisterer J., and Meier W. 2nd-line Chemotherapie nach Platin-oder Platin-Paclitaxel-haltiger Primärtherapie beim Ovarialkarzinom: eine systematische Übersicht der publizierten Daten bis 1998. GebFra 60 (2000) 41-58
10. Chen L.M., and Karlan B.Y. Recurrent ovarian carcinoma: is there a place for surgery?. Semin. Surg. Oncol. 19 (2000) 62-68
11. Eisenkop S.M., Friedman R.L., and Wang H. Secondary cytoreductive surgery for recurrent ovarian cancer. Cancer 76 (1995) 1606-1614
12. Eisenkop S.M., Friedman R.L., and Spirtos N.M. The role of secondary cytoreductive surgery in the treatment of patients with recurrent epithelial ovarian carcinoma. Cancer 88 (2000) 144-153
13. Meier W., Kimmig R., and Lichtenegger W. Die operative Therapie des Rezidivs. Gynäkologe 34 (2001) 1024-1028
14. The ICON and AGO Collaborators. Paclitaxel plus platinum-based chemotherapy versus conventional platinum-based chemotherapy in women with relapsed ovarian cancer: the ICON4/AGO-OVAR-2.2 trial. Lancet 361 (2003) 2099-2106
15. Meier W., and du Bois A. Palliative therapeutische Möglichkeiten beim Ovarialkarzinom. Onkologe 4 (1998) 1153-1158
16. Williams C.J. Tamoxifen in relapsed ovarian cancer: A systematic review. Int. J. Gynecol. Cancer 8 (1998) 89-94
17. Du Bois A., Meier W., Lueck H.J., et al. Chemotherapy versus hormonal treatment in platinum- and paclitaxel-refractory ovarian cancer: a randomized trial of the German Arbeitsgemeinschaft Gynaekologische Onkologie (AGO) study group ovarian cancer. Ann. Oncol. 13 (2002) 251-257
18. Markman M., and Hoskins W. Responses to salvage therapy in ovarian cancer: a critical need for precise definitions of the treated population. J. Clin. Oncol. 10 (1992) 513-514
19. Markman M., Webster K., Zanotti K., et al. Survival following the documentation of platinum and taxane resistance in ovarian cancer. A single institution experience involving multiple phase II trials. Gynecol. Oncol. 93 (2004) 699-701
20. Eisenhauer E.A., Vermorken J.B., and van Glabbeke M. Predictors of response to subsequent chemotherapy in platinum pretreated ovarian cancer: a multivariate analysis of 704 patients. Ann. Oncol. 8 (1997) 963-968
21. Burnett A.F., Barter J.F., Potkul R.K., and Barnes W.A. Ineffectiveness of continuous 5-fluorouracil as salvage therapy for ovarian cancer. Am. J. Clin. Oncol. 17 (1994) 490-493
22. Francis P., Schneider J., Hann L., et al. Phase II trial of docetaxel in patients with platinum-refractory advanced ovarian cancer. J. Clin. Oncol. 12 (1994) 2301-2308
23. Goldberg J.M., Piver M.S., Hempling R.H., and Recio F.O. Paclitaxel and cisplatin combination chemotherapy in recurrent epithelial ovarian cancer. Gynecol. Oncol. 63 (1996) 312-317
24. Bajetta E., Di Leo A., Biganzoli L., et al. Phase II study of vinorelbine in patients with pretreated advanced ovarian cancer: activity in platinum-resistant disease. J. Clin. Oncol. 14 (1996) 2546-2551
25. Bookman M.A., Malmström H., Bolis G., et al. Topotecan for the treatment of advanced epithelial ovarian cancer: an open-label phase II study in patients treated after prior chemotherapy that contained cisplatin or carboplatin and paclitaxel. J. Clin. Oncol. 16 (1998) 3345-3352
26. Creemers G.J., Bolis G., Gore M., et al. Topotecan, an active drug in the second-line treatment of epithelial ovarian cancer; results of a large European phase II study. J. Clin. Oncol. 14 (1996) 3056-3061
27. Dunton C.J., Neufeld J., Carlson J.A., et al. Secondary response of ovarian tumors to topotecan treatment. Gynecol. Oncol. 69 (1998) 258-259
28. Gordon A.N., Fleagle J.T., Guthrie D., et al. Recurrent epithelial ovarian carcinoma: a randomized phase III study of pegylated liposomal doxorubicin versus topotecan. J. Clin. Oncol. 19 (2001) 3312-3320
29. Gropp M., Meier W., and Hepp H. Treosulfan as an effective second-line therapy in ovarian cancer. Gynecol. Oncol. 71 (1998) 94-98
30. Havsteen H., Bertelsen K., Gadeberg C.C., et al. A phase 2 study with epirubicin as second-line treatment of patients with advanced epithelial ovarian cancer. Gynecol. Oncol. 63 (1996) 210-215
31. Kudelka A.P., Tresukosol D., Edwards C.L., et al. Phase II study of intravenous topotecan as a 5-day infusion for refractory epithelial ovarian carcinoma. J. Clin. Oncol. 14 (1996) 1552-1557
32. Rose P.G., Blessing J.A., Mayer A.R., et al. Prolonged oral etoposide as second line therapy for platinum resistant and platinum sensitive ovarian carcinomas: a Gynecologic Oncology Group study. J. Clin. Oncol. 16 (1998) 405-410
33. Jänicke F., Hölscher M., Kuhn W., et al. Radical surgical procedure improves survival time in patients with recurrent ovarian cancer. Cancer 70 (1992) 2129-2136
34. Munkarah A., Levenback C., Wolf J.K., et al. Secondary cytoreductive surgery for localized intra-abdominal recurrence in epithelial ovarian cancer. Gynecol. Oncol. 81 (2001) 237-241
35. Rose P.G. Surgery for recurrent ovarian cancer. Semin. Oncol. 27 Suppl (2000) 17-23
36. Vaccarello L., Rubin S.C., Vlamis V., et al. Cytoreductive surgery in ovarian carcinoma patients with a documented previously complete surgical response. Gynecol. Oncol. 57 (1995) 61-65
37. Zang R.Y., Zhang Z.Y., Li Z.T., et al. Impact of secondary cytoreductive surgery on survival of patients with advanced epithelial ovarian cancer. Eur. J. Surg. Oncol. 26 (2000) 798-804
38. Friedlander M., De Gramont A., Millward M.J., et al. Activity of gemictabine in stage 3 or 4 ovarian cancer: patients previously treated with cisplatin (CP)-containing regimens. Eur. J. Cancer 33 (1997) 121-122
39. Swisher E.M., Mutch D.G., Rader J.S., et al. Topotecan in platinum- and paclitaxel-resitant ovarian cancer. Gynecol. Oncol. 66 (1997) 349
40. Sehouli J., Sommer H., Klare P., et al. A randomized multicenter phase III trial of topotecan monotherapy versus topotecan etoposide versus topotecan gemcitabine for second-line treatment of recurrent ovarian cancer. Proc. A.S.C.O. 24 (2006) a 5030
41. Trope C., Kaern J., and Hogberg T. A phase II study of paclitaxel and doxorubicin as second-line treatment in recurrent ovarian cancer after cisplatin failure. Gynecol. Oncol. 68 (1998) 123
42. Kurtz J.E., Deplanque G., Duclos B., et al. Paclitaxel-anthracycline combination chemotherapy in relapsing advanced ovarian cancer after platinum-based chemotherapy: a pilot study. Gynecol. Oncol. 70 (1998) 414-417
43. Wagner U., Blohmer J.U., and Lück H.J. Medikamentöse Rezidivtherapie. Gynäkologe 34 (2001) 1020-1023
44. Ten Bokkel Huinink W., Lane S.R., and Ross G.A. Long-term survival in a phase III randomised study of topotecan versus paclitaxel in advanced epithelial ovarian carcinoma. Ann. Oncol. 15 (2004) 100-103
45. 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 (2008) 890-896
46. Wagner U., du Bois A., Pfisterer J., et al. Gefitinib in combination with tamoxifen in patients with ovarian cancer refractory or resistant to platinum-taxane based therapy: a phase II trial of the AGO Ovarian Cancer Study Group (AGO-OVAR 2.6). Gynecol. Oncol. 105 (2007) 132-137
47. Belau A., Pfisterer J., Wimberger P., et al. Randomized, multicenter, two-dose level, open-label phase IIa study with the intraperitonealinfused trifunctional bispecific antibody catumaxomab to select the better dose level in platinum refractory epithelial ovarian cancer patients. Proc. ASCO 25 (2007) a5556
48. Cohn D.E., Valmadre S., Resnick K.E., et al. Bevacizumab and weekly taxane chemotherapy demonstrates activity in refractory ovarian cancer. Gynecol. Oncol. 102 (2006) 134-139
49. Monk B.J., Han E., Josephs-Cowan C.A., et al. Salvage bevacizumab(rhuMAB VEGF)-based therapy after multiple prior cytotoxic regimens in advanced refractory epithelial ovarian cancer. Gynecol. Oncol. 102 (2006) 140-144
50. Wright J.D., Hagemann A., Rader J.S., et al. Bevacizumab combination therapy in recurrent, platinum-refractory, epithelial ovarian carcinoma: a retrospective analysis. Cancer 107 (2006) 83-89