Association of pegylated liposomal doxorubicin and ifosfamide in early recurrent ovarian cancer patients: A Multicenter Phase II Trial

Gynecologic Oncology

Volumn 116, Issue 3, 2010, Pages 312-316

  Joly, Florence ^a   Sevin, Emmanuel ^a   Lortholary, Alain ^b   Priou, Frank ^c   Paitel, J F ^d   Fabbro, Michel ^e   Henry Amar, Michel ^a   Hamond, Karim ^a   Bourgeois, Hugues ^f  

^a CENTRE FRANÇOIS BACLESSE   (France)

^b Centre Catherine de Sienne   (France)

^c CHD   (France)

^d SAINT LOUIS HOSPITAL   (France)

^e CENTRE VAL D AURELLE   (France)

^f CENTRE JEAN BERNARD   (France)

Author keywords

Ifosfamide; Ovarian carcinoma; Pegylated doxorubicin; Platinum free interval

Indexed keywords

CARBOPLATIN; DOXORUBICIN; EPIRUBICIN; IFOSFAMIDE; MESNA; METHYLPREDNISOLONE; PACLITAXEL; SEROTONIN ANTAGONIST; TOPOTECAN;

ADULT; AGED; ANEMIA; ARTICLE; CANCER CHEMOTHERAPY; CANCER GRADING; CANCER PATIENT; CANCER RELAPSE; CANCER SURVIVAL; CARCINOMATOUS PERITONITIS; CLEAR CELL CARCINOMA; CLINICAL TRIAL; CONTINUOUS INFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRUG SCREENING; DRUG TOLERABILITY; EARLY CANCER; ENDOMETRIOID CARCINOMA; FEBRILE NEUTROPENIA; FEMALE; HAND FOOT SYNDROME; HUMAN; MAJOR CLINICAL STUDY; MUCINOUS CARCINOMA; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OVARY CANCER; OVARY CARCINOMA; PAPILLARY CARCINOMA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RECURRENT CANCER; STOMATITIS; SURVIVAL RATE; THROMBOCYTOPENIA; TREATMENT OUTCOME; TREATMENT RESPONSE; UTERINE TUBE CARCINOMA; UTERUS CARCINOMA; VOMITING;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DISEASE-FREE SURVIVAL; DOXORUBICIN; FEMALE; HUMANS; IFOSFAMIDE; INFUSIONS, INTRAVENOUS; KAPLAN-MEIERS ESTIMATE; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; OVARIAN NEOPLASMS; POLYETHYLENE GLYCOLS; SURVIVAL RATE;

EID: 75749091111     PISSN: 00908258     EISSN: 10956859     Source Type: Journal    
DOI: 10.1016/j.ygyno.2009.09.036     Document Type: Article

References (45)

1. Harries M., and Gore M. Part I: chemotherapy for epithelial ovarian cancer-treatment at first diagnosis. Lancet Oncol. 3 9 (2002) 529-536
2. Ozols R.F. Systemic therapy for ovarian cancer: current status and new treatments. Semin. Oncol. 33 2 Suppl 6 (2006) S3-S11
3. du B.A., Quinn M., Thigpen T., Vermorken J., Avall-Lundqvist E., Bookman 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. Oncol. 16 Suppl 8 (2005) viii7-viii12
4. du B.A., and Pfisterer J. Future options for first-line therapy of advanced ovarian cancer. Int. J. Gynecol. Cancer 15 Suppl 1 (2005) 42-50
5. Piccart M.J., 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 Inst. 92 9 (2000) 699-708
6. Herzog T.J. The current treatment of recurrent ovarian cancer. Curr. Oncol. Rep. 8 6 (2006) 448-454
7. Bukowski R.M., Ozols R.F., and Markman M. The management of recurrent ovarian cancer. Semin. Oncol. 34 2 Suppl 2 (2007) S1-S15
8. Spriggs D. Optimal sequencing in the treatment of recurrent ovarian cancer. Gynecol. Oncol. 90 3 Pt 2 (2003) S39-S44
9. Management of patients with recurrent ovarian cancer, 38th Annual Meeting of Am Soc of Clin Oncol. 2002.
10. Colombo N., and Gore M. Treatment of recurrent ovarian cancer relapsing 6-12 months post platinum-based chemotherapy. Crit. Rev. Oncol. Hematol. 64 2 (2007) 129-138
11. Harries M., and Gore M. Part II: chemotherapy for epithelial ovarian cancer-treatment of recurrent disease. Lancet Oncol. 3 9 (2002) 537-545
12. Gordon A.N., Fleagle J.T., Guthrie D., Parkin D.E., Gore M.E., and Lacave A.J. Recurrent epithelial ovarian carcinoma: a randomized phase III study of pegylated liposomal doxorubicin versus topotecan. J. Clin. Oncol. 19 14 (2001) 3312-3322
13. Muggia F.M., Hainsworth J.D., Jeffers S., Miller P., Groshen S., Tan M., et al. Phase II study of liposomal doxorubicin in refractory ovarian cancer: antitumor activity and toxicity modification by liposomal encapsulation. J. Clin. Oncol. 15 3 (1997) 987-993
14. Ferrandina G., Ludovisi M., Lorusso D., Pignata S., Breda E., Savarese A., et al. Phase III trial of gemcitabine compared with pegylated liposomal doxorubicin in progressive or recurrent ovarian cancer. J. Clin. Oncol. 26 6 (2008) 890-896
15. Joly F., Bourgeois H., Floquet A., Chinet-Charrot P., Meyer F., Lebrun D., et al. Efficacy and tolerability of the ifosfamide-epirubicin combination in relapsed ovarian cancer. Int. J. Gynecol. Cancer 16 1 (2006) 77-82
16. Baur M., Fazeny-Doerner B., Hudec M., Sevelda P., Salzer H., and Dittrich C. Ifosfamide/mesna as salvage therapy in platinum pretreated ovarian cancer patients-long-term results of a phase II study. Cancer Invest. 24 1 (2006) 22-27
17. Markman M., Hakes T., Reichman B., Lewis J.L., Rubin S., Jones W., et al. Ifosfamide and mesna in previously treated advanced epithelial ovarian cancer: activity in platinum-resistant disease. J. Clin. Oncol. 10 2 (1992) 243-248
18. Markman M., Kennedy A., Sutton G., Hurteau J., Webster K., Peterson G., et al. Phase 2 trial of single agent ifosfamide/mesna in patients with platinum/paclitaxel refractory ovarian cancer who have not previously been treated with an alkylating agent. Gynecol. Oncol. 70 2 (1998) 272-274
19. Sutton G.P., Blessing J.A., Homesley H.D., Berman M.L., and Malfetano J. Phase II trial of ifosfamide and mesna in advanced ovarian carcinoma: a Gynecologic Oncology Group Study. J. Clin. Oncol. 7 11 (1989) 1672-1676
20. Dorval T., Soussain C., Beuzeboc P., Garcia-Giralt E., Jouve M., Livartowski A., et al. Ifosfamide seven-day infusion for recurrent and cisplatin refractory ovarian cancer. J. Infus. Chemother. 6 1 (1996) 47-49
21. Willemse P.H., vd Burg M.E., vd G.A., Neijt J.P., Bokkel Huinink W.W., Aalders J.G., et al. Ifosfamide given as a 24-h infusion with mesna in patients with recurrent ovarian cancer: preliminary results. Cancer Chemother. Pharmacol. 26 Suppl (1990) S51-S54
22. Brade W.P., Herdrich K., Kachel-Fischer U., and Araujo C.E. Dosing and side-effects of ifosfamide plus mesna. J. Cancer Res. Clin. Oncol. 117 Suppl 4 (1991) S164-S186
23. Vanhoefer U., Schleucher N., Klaassen U., Seeber S., and Harstrick A. Ifosfamide-based drug combinations: preclinical evaluation of drug interactions and translation into the clinic. Semin. Oncol. 27 1 Suppl 1 (2000) 8-13
24. Bourgeois H., Joly F., Pujade-Lauraine E., Cure H., Guastalla J.P., Ferru A., et al. Phase I study of pegylated liposomal doxorubicin in combination with ifosfamide in pretreated ovarian cancer patients. Am. J. Clin. Oncol. 29 4 (2006) 399-404
25. Therasse P., Arbuck S.G., Eisenhauer E.A., Wanders J., Kaplan R.S., Rubinstein L., et al. New guidelines to evaluate the response to treatment in solid tumors. J. Natl. Cancer Inst. 92 16 (2000) 205-216
26. Rustin G.J., Nelstrop A.E., McClean P., Brady M.F., McGuire W.P., Hoskins W.J., Mitchell H., and Lambert H.E. Defining response of ovarian carcinoma to initial chemotherapy according to serum CA125. J. Clin. Oncol. 14 (1996) 1545-1551
27. Markman M., Markman J., Webster K., Zanotti K., Kulp B., Peterson G., et al. Duration of response to second-line, platinum-based chemotherapy for ovarian cancer: implications for patient management and clinical trial design. J. Clin. Oncol. 22 15 (2004) 3120-3125
28. Fleming T.R. One-sample multiple testing procedure for phase II clinical trials. Biometrics 38 1 (1982) 143-151
29. Rothman K.J., and Boice Jr. J.D. Epidemiologic Analysis with a programmable calculator (1982), Epidemiology Ressources, Boston, Ma
30. Wartelle M., Kramar A., and Jan P. "PIGAS": an interactive statistical database management system. In: Hammond R., McCarthy J.L., and Kruger D. (Eds). Proceedings of the second international workshop on statistical database management (1983), National Technical Information Service, Departement of Commerce, Springfield, VA
31. Alberts D.S., Liu P.Y., Wilczynski S.P., Clouser M.C., Lopez A.M., Michelin D.P., et al. Randomized trial of pegylated liposomal doxorubicin (PLD) plus carboplatin versus carboplatin in platinum-sensitive (PS) patients with recurrent epithelial ovarian or peritoneal carcinoma after failure of initial platinum-based chemotherapy (Southwest Oncology Group Protocol S0200). Gynecol. Oncol. 108 1 (2008) 90-94
32. Ferrero J.M., Weber B., Geay J.F., Lepille D., Orfeuvre H., Combe M., et al. Second-line chemotherapy with pegylated liposomal doxorubicin and carboplatin is highly effective in patients with advanced ovarian cancer in late relapse: a GINECO phase II trial. Ann. Oncol. 18 2 (2007) 263-268
33. Gordon A.N., Tonda M., Sun S., and 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. Oncol. 95 1 (2004) 1-8
34. Mutch D.G., Orlando M., Goss T., Teneriello M.G., Gordon A.N., McMeekin S.D., et al. Randomized phase III trial of gemcitabine compared with pegylated liposomal doxorubicin in patients with platinum-resistant ovarian cancer. J. Clin. Oncol. 25 19 (2007) 2811-2818
35. Brain E.G., Rezai K., Lokiec F., Gutierrez M., and Urien S. Population pharmacokinetics and exploratory pharmacodynamics of ifosfamide according to continuous or short infusion schedules: an n = 1 randomized study. Br. J. Clin. Pharmacol. 65 4 (2008) 607-610
36. Lind M.J., McGown A.T., Hadfield J.A., Thatcher N., Crowther D., and Fox B.W. The effect of ifosfamide and its metabolites on intracellular glutathione levels in vitro and in vivo. Biochem. Pharmacol. 38 11 (1989) 1835-1840
37. Joly F., Bourgeois H., Floquet A., Chinet-Charrot P., Meyer F., Lebrun D., et al. Efficacy and tolerability of the ifosfamide-epirubicin combination in relapsed ovarian cancer. Int. J. Gynecol. Cancer 16 1 (2006) 77-82
38. Sorensen P., Pfeiffer P., and Bertelsen K. A phase 2 trial of ifosfamide/mesna as salvage therapy in patients with ovarian cancer refractory to or relapsing after prior platinum-containing chemotherapy. Gynecol. Oncol. 56 1 (1995) 75-78
39. Chiara S., Tognoni A., Pastrone I., Tomasello L., Brema F., Di Costanzo G., et al. Topotecan and ifosfamide as salvage treatment in advanced ovarian cancer. Gynecol. Oncol. 93 2 (2004) 474-478
40. Dimopoulos M.A., Papadimitriou C., Gennatas C., Akrivos T., Vlahos G., Voulgaris Z., et al. Ifosfamide and paclitaxel salvage chemotherapy for advanced epithelial ovarian cancer. Ann. Oncol. 8 2 (1997) 195-197
41. Lissoni A.A., Fei F., Rossi R., Fruscio R., Villa A., and Zani G. Ifosfamide in the treatment of malignant epithelial ovarian tumors. Oncology 65 Suppl 2 (2003) 59-62
42. Parmar M.K., Ledermann J.A., Colombo N., du B.A., Delaloye J.F., Kristensen G.B., 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. Lancet 361 9375 (2003) 2099-2106
43. Pfisterer J., Vergote I., du B.A., and Eisenhauer E. Combination therapy with gemcitabine and carboplatin in recurrent ovarian cancer. Int. J. Gynecol. Cancer 15 Suppl 1 (2005) 36-41
44. Pignata S., Ferrandina G., Scarfone G., Scollo P., Odicino F., Selvaggi L., et al. Extending the platinum-free interval with a non-platinum therapy in platinum-sensitive recurrent ovarian cancer. Results from the SOCRATES Retrospective Study. Oncology 71 5-6 (2006) 320-326
45. See H.T., Freedman R.S., Kudelka A.P., Burke T.W., Gershenson D.M., Tangjitgamol S., et al. Retrospective review: re-treatment of patients with ovarian cancer with carboplatin after platinum resistance. Int. J. Gynecol. Cancer 15 2 (2005) 209-216