Phase III randomized trial of second-line ixabepilone versus paclitaxel or doxorubicin in women with advanced endometrial cancer

Gynecologic Oncology

Volumn 138, Issue 1, 2015, Pages 18-23

  McMeekin, Scott ^a   Dizon, Don ^b   Barter, James ^c   Scambia, Giovanni ^d   Manzyuk, Lyudmila ^e   Lisyanskaya, Alla ^f   Oaknin, Ana ^g   Ringuette, Sarah ^h   Mukhopadhyay, Pralay ^h   Rosenberg, Julie ⁱ   Vergote, Ignace ^j  

^a UNIVERSITY OF OKLAHOMA   (United States)

^b MASSACHUSETTS GENERAL HOSPITAL   (United States)

^c Women's Health Specialists   (United States)

^d FONDAZIONE POLICLINICO UNIVERSITARIO A GEMELLI IRCCS   (Italy)

^e N N BLOKHIN RUSSIAN CANCER RESEARCH CENTER   (Russian Federation)

^f Municipal Clinical Oncological Dispensary   (Russian Federation)

^g HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^h BRISTOL MYERS SQUIBB   (United States)

ⁱ BAYER CORPORATION   (United States)

^j UNIVERSITY HOSPITALS LEUVEN   (Belgium)

more..

Author keywords

Advanced; Chemotherapy; Endometrial cancer; Ixabepilone; Metastatic; Second line; Single agent

Indexed keywords

ANTHRACYCLINE; DOXORUBICIN; IXABEPILONE; PACLITAXEL; ANTINEOPLASTIC AGENT; EPOTHILONE DERIVATIVE;

ADULT; ADVANCED CANCER; AGED; ALOPECIA; ARTHRALGIA; ARTICLE; BONE MARROW SUPPRESSION; CANCER CHEMOTHERAPY; CANCER FATIGUE; CANCER PATIENT; CANCER RECURRENCE; CANCER SURVIVAL; CHEMOTHERAPY INDUCED ANEMIA; CHEMOTHERAPY INDUCED EMESIS; CLINICAL EFFECTIVENESS; CONTROLLED STUDY; DECREASED APPETITE; DIARRHEA; DRUG WITHDRAWAL; DYSPNEA; ENDOMETRIUM CANCER; FEBRILE NEUTROPENIA; FEMALE; HEART DISEASE; HEART EJECTION FRACTION; HUMAN; MAJOR CLINICAL STUDY; MULTICENTER STUDY; MYALGIA; NAUSEA; NEUTROPHIL COUNT; OPEN STUDY; OVERALL SURVIVAL; PANCYTOPENIA; PATIENT SAFETY; PERIPHERAL NEUROPATHY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SENSORY NEUROPATHY; SEPSIS; THROMBOCYTOPENIA; TREATMENT OUTCOME; CLINICAL TRIAL; ENDOMETRIAL NEOPLASMS; MIDDLE AGED; SURVIVAL RATE; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; DOXORUBICIN; ENDOMETRIAL NEOPLASMS; EPOTHILONES; FEMALE; HUMANS; MIDDLE AGED; PACLITAXEL; SURVIVAL RATE;

EID: 84931578865     PISSN: 00908258     EISSN: 10956859     Source Type: Journal    
DOI: 10.1016/j.ygyno.2015.04.026     Document Type: Article

References (20)

1. American Cancer Society Cancer Facts & Figs. 2015 2015 American Cancer Society Atlanta
2. F. Amant, P. Moerman, and P. Neven Endometrial cancer Lancet 366 9484 2005 491 505
3. G. Plataniotis, and M. Castiglione Endometrial cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up Ann. Oncol. 21 Suppl. 5 2010 v41 v45 10.1093/annonc/mdq245
4. T. Hogberg, M. Signorelli, and C.F. de Oliveira Sequential adjuvant chemotherapy and radiotherapy in endometrial cancer - results from two randomised studies Eur. J. Cancer 46 13 2010 2422 2431 10.1016/j.ejca.2010.06.002
5. M.S. Aapro, F.H. van Wijk, and G. Bolis Doxorubicin versus doxorubicin and cisplatin in endometrial carcinoma: definitive results of a randomised study (55872) by the EORTC Gynaecological Cancer Group Ann. Oncol. 14 3 2003 441 448
6. J.T. Thigpen, M.F. Brady, and H.D. Homesley Phase III trial of doxorubicin with or without cisplatin in advanced endometrial carcinoma: a Gynecologic Oncology Group study J. Clin. Oncol. 22 19 2004 3902 3908
7. G.F. Fleming, V.L. Brunetto, and D. Cella Phase III trial of doxorubicin plus cisplatin with or without paclitaxel plus filgrastim in advanced endometrial carcinoma: a Gynecologic Oncology Group Study J. Clin. Oncol. 22 11 2004 2159 2166
8. D. Miller, V. Filiaci, and G. Fleming Late-breaking abstract 1: randomized phase III noninferiority trial of first line chemotherapy for metastatic or recurrent endometrial carcinoma: a Gynecologic Oncology Group study Gynecol. Oncol. 125 3 2012 771
9. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines®): Uterine Neoplasma, version 3 2012
10. C.L. Vale, J. Tierney, and S.J. Bull Chemotherapy for advanced, recurrent or metastatic endometrial carcinoma Cochrane Database Syst. Rev. 8 2012 10.1002/14651858.CD003915.pub4 (CD003915)
11. A.A. Garcia, J.A. Blessing, and S. Nolte A phase II evaluation of weekly docetaxel in the treatment of recurrent or persistent endometrial carcinoma: a study by the Gynecologic Oncology Group Gynecol. Oncol. 111 1 2008 22 26 10.1016/j.ygyno.2008.06.013
12. Y. Ueda, T. Miyake, and T. Egawa-Takata Second-line chemotherapy for advanced or recurrent endometrial carcinoma previously treated with paclitaxel and carboplatin, with or without epirubicin Cancer Chemother. Pharmacol. 67 4 2011 829 835 10.1007/s00280-010-1384-z
13. M. Harries, and M. Gore Part II: chemotherapy for epithelial ovarian cancer-treatment of recurrent disease Lancet Oncol. 3 9 2002 537 545
14. F.Y. Lee, R. Smykla, and K. Johnston Preclinical efficacy spectrum and pharmacokinetics of ixabepilone Cancer Chemother. Pharmacol. 63 2 2009 201 212 10.1007/s00280-008-0727-5
15. IXEMPRA packaging information Available at http://packageinserts.bms.com/pi/pi-ixempra.pdf November, 2012 (Accessed)
16. D.S. Dizon, J.A. Blessing, and D.S. McMeekin Phase II trial of ixabepilone as second-line treatment in advanced endometrial cancer: gynecologic oncology group trial 129-P J. Clin. Oncol. 27 19 2009 3104 3108 10.1200/JCO.2008.20.6995
17. E.A. Eisenhauer, P. Therasse, and J. Bogaerts New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1) Eur. J. Cancer 45 2 2009 228 247 10.1016/j.ejca.2008.10.026
18. National Cancer Institute Available at http://ctep.cancer.gov/protocolDevelopment/electronic-applications/docs/ctcaev3.pdf November, 2012 (Accessed)
19. E.A. Perez, G. Lerzo, and X. Pivot Efficacy and safety of ixabepilone (BMS-247550) in a phase II study of patients with advanced breast cancer resistant to an anthracycline, a taxane, and capecitabine J. Clin. Oncol. 25 23 2007 3407 3414
20. V. Valero, E. Vrdoljak, and B. Xu Maintenance of clinical efficacy after dose reduction of ixabepilone plus capecitabine in patients with anthracycline- and taxane-resistant metastatic breast cancer: a retrospective analysis of pooled data from 2 phase III randomized clinical trials Clin. Breast Cancer 12 4 2012 240 246 10.1016/j.clbc.2012.03.013