Single-agent trabectedin as second-line therapy of persistent or recurrent endometrial cancer: Results of a multicenter phase II study

Gynecologic Oncology

Volumn 114, Issue 2, 2009, Pages 288-292

  McMeekin, D S ^a   Lisyanskaya, A ^b   Crispens, M ^c   Oza, A M ^d   Braly, P ^e   Doering, D ^f   Bayever, E ^g   Michiels, B ^h   Markman, M ⁱ  

^a UNIVERSITY OF OKLAHOMA COLLEGE OF MEDICINE   (United States)

^b City Oncology Dispensary   (Russian Federation)

^c VANDERBILT UNIVERSITY   (United States)

^d PRINCESS MARGARET HOSPITAL   (Canada)

^e Hematology Oncology Specialists   (United States)

^f Norton Healthcare   (United States)

^g JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

^h JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

ⁱ UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

Author keywords

Endometrial cancer; Overall survival; Progression free survival; Time to progression; Trabectedin; YONDELIS, ET 743

Indexed keywords

CYCLOPHOSPHAMIDE; DEXAMETHASONE; DOXORUBICIN; PACLITAXEL; PLATINUM DERIVATIVE; TAXANE DERIVATIVE; TRABECTEDIN;

ABNORMAL LABORATORY RESULT; ACUTE KIDNEY FAILURE; ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALKALINE PHOSPHATASE BLOOD LEVEL; ALOPECIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; ASTHENIA; BILIRUBIN BLOOD LEVEL; CANCER CHEMOTHERAPY; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CANCER PATIENT; CANCER RADIOTHERAPY; CANCER RECURRENCE; CANCER SURGERY; CANCER SURVIVAL; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATINE KINASE BLOOD LEVEL; CREATININE BLOOD LEVEL; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG WITHDRAWAL; ENDOMETRIUM CANCER; FATIGUE; FEMALE; HEMOGLOBIN BLOOD LEVEL; HEPATITIS; HUMAN; HYPERGLYCEMIA; HYPERKALEMIA; HYPERNATREMIA; HYPOGLYCEMIA; HYPOKALEMIA; HYPONATREMIA; LEUKOPENIA; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RESPIRATORY DISTRESS; RHABDOMYOLYSIS; SIDE EFFECT; SINGLE DRUG DOSE; STOMATITIS; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT OUTCOME; TREATMENT RESPONSE;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS, ALKYLATING; DIOXOLES; DISEASE-FREE SURVIVAL; ENDOMETRIAL NEOPLASMS; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; TETRAHYDROISOQUINOLINES; YOUNG ADULT;

EID: 67549084350     PISSN: 00908258     EISSN: 10956859     Source Type: Journal    
DOI: 10.1016/j.ygyno.2009.04.034     Document Type: Article

References (30)

1. American Cancer Society. Cancer Facts and Figs. 2007. Atlanta: American Cancer Society; 2007 (http:www.cancer.org).
2. Gallion H.H., Brunetto V.L., Cibull M., et al. Randomized phase III trial of standard timed doxorubicin plus cisplatin versus circadian timed doxorubicin plus cisplatin in stage III and IV or recurrent endometrial carcinoma: a Gynecologic Oncology Group study. J. Clin. Oncol. 21 (2003) 3808-3813
3. Fleming G.F., Brunetto V.L., et al. 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 (2004) 2159-2166
4. van Kesteren C.h., de Vooght M.M.M., López-Lázaro L., Mathôt R.A.A., Schellens J.H.M., Jimeno J.M., et al. Yondelis® (trabectedin, ET-743): the development of an anticancer agent of marine origin. Anticancer Drugs 14 (2003) 487-502
5. Krasner C.N., McMeekin D.S., Chan S., Braly P.S., Renshaw F.G., Kaye S., et al. A phase II study of trabectedin single agent in patients with recurrent ovarian cancer previously treated with platinum-based regimens. Br. J. Cancer 97 (2007) 1618-1624
6. Sessa C., De Braud F., Perotti A., Bauer J., Curigliano G., Noberasco C., et al. Trabectedin for women with ovarian carcinoma after treatment with platinum and taxanes fails. J. Clin. Oncol. 23 (2005) 1867-1874
7. Gurtler J.S., Goldstein L., Delprete S., Tjulandin S., Semiglazov V., Sternas L., et al. Trabectedin in third line breast cancer: a multicenter, randomized, phase II study comparing two administration regimens. J. Clin. Oncol. 23 (2005) 34s (abstract 625)
8. Zelek L., Yovine A., Brain E., Turpin F., Taama A., Riofrio M., et al. A phase II study of Yondelis® (trabectedin, ET-743) as a 24-h continuous intravenous infusion in pretreated advanced breast cancer. Br. J. Cancer 94 (2006) 1610-1614
9. Delaloge S., Yovine A., Taamma A., Riofrio M., Brain E., Raymond E., et al. Ecteinascidin-743: a marine-derived compound in advanced, pretreated sarcoma patients-preliminary evidence of activity. J. Clin. Oncol. 19 (2001) 1248-1255
10. Yovine A., Riofrio M., Blay J.Y., Brain E., Alexandre J., Kahatt C., et al. Phase II study of ecteinascidin-743 in advanced pretreated soft tissue sarcoma patients. J. Clin. Oncol. 22 (2004) 890-899
11. 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 (2000) 205-216
12. Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin. Trials 10 (1989) 1-10
13. Muggia F.M., Blessing J.A., Sorosky J., and Reid G.C. Phase II trial of the pegylated liposomal doxorubicin in previously treated metastatic endometrial cancer: a Gynecologic Oncology Group study. J. Clin. Oncol. 20 (2002) 2360-2364
14. Pawinski A., Tumolo S., Hoesel G., Cervantes A., van Oosterom A.T., Boes G.H., et al. Cyclophosphamide or ifosfamide in patients with advanced and/or recurrent endometrial carcinoma: a randomized phase II study of the EORTC Gynecological Cancer Cooperative Group. Eur. J. Obstet. Gynecol. 86 (1999) 179-183
15. Obel J.C., Friberg G., and Fleming G.F. Chemotherapy in endometrial cancer. Clin. Adv. Hematol. Oncol. 4 (2006) 459-468
16. Thigpen J.T., Brady M.F., Homesley H.D., et al. Phase III trial of doxorubicin with or without cisplatin in advanced endometrial carcinoma: a Gynecologic Oncology Group study. J. Clin. Oncol. 22 (2004) 3902-3908
17. Fleming G.F., Brunetto V.L., et al. 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 (2004) 2159-2166
18. Randall M., Filiaci V., Muss H., Spirtos N., Mannel R., Fowler J., Thigpn T., and Benda J. Randomized phase III trial of whole abdominal radiation therapy versus doxorubicin and cisplatin chemotherapy in advanced endometrial carcinoma: a Gynecologic Oncology Group study. J. Clin. Oncol. 24 (2006) 36-44
19. Miller D.S., Blessing J.A., Lentz S.S., and Waggoner S.E. A phase II trial of topotecan in patients with advanced, persistent, or recurrent endometrial carcinoma: a Gynecologic Oncology Group study. Gynecol. Oncol. 87 (2002) 247-251
20. Thigpen J.T., Blessing J.A., Lagasse L.D., DiSaia P.J., and Homesley H.D. Phase II trial of cisplatin as second-line chemotherapy in patients with advanced or recurrent endometrial carcinoma. A Gynecologic Oncology Group study. Am. J. Clin. Oncol. 7 (1984) 253-256
21. Thigpen J.T., Blessing J.A., Homesley H., Creasman W.T., and Sutton G. Phase II trial of cisplatin as first-line chemotherapy in patients with advanced or recurrent endometrial carcinoma: a Gynecologic Oncology Group study. Gynecol. Oncol. 33 (1989) 68-70
22. Seski J.C., Edwards C.L., Herson J., and Rutledge F.N. Cisplatin chemotherapy for disseminated endometrial cancer. Obstet. Gynecol. 59 (1982) 225-228
23. Aapro M.S., van Wijk F.H., Bolis G., Chevallier B., van der Burg M.E.L., Poveda A., et al. Doxorubicin versus doxorubicin and cisplatin in endometrial carcinoma: definitive results of a randomised study (55872) by the EORTC Gynaecological Cancer Group. Ann. Oncol. 14 (2003) 441-448
24. McMeekin S., del Campo J.M., Colombo N., Krasner C., Roszak A., et al. Trabectedin (T) in relapsed advanced ovarian cancer (ROC): a pooled analysis of three phase II studies. J. Clin. Oncol. 25 (2007) 293s (abstract 5579)
25. Garcia-Carbonero R., Supko J.G., Maki J., Manola J., Ryan D.P., Harmon D., et al. Ecteinascidin-743 (ET-743) for chemotherapy-naive patients with advanced soft tissue sarcomas: multicenter phase II pharmacokinetic study. J. Clin. Oncol. 23 (2005) 5484-5492
26. Garcia-Carbonero R., Supko J.G., Manola J., Seiden M.V., Harmon D., Ryan D.P., et al. Phase II and pharmacokinetic study of ecteinascidin 743 in patients with progressive sarcomas of soft tissues refractory to chemotherapy. J. Clin. Oncol. 22 (2004) 1480-1490
27. Le Cesne A., Blay J.Y., Judson I., Van Oosterom A., Verweij J., Radford J., et al. Phase II study of ET-743 in advanced soft tissue sarcomas: a European Organisation for the Research and Treatment of Cancer (EORTC) Soft Tissue and Bone Sarcoma Group trial. J. Clin. Oncol. 23 (2005) 576-584
28. Morgan J.A., Le Cesne A., Chawla S., von Mehren M., Schuetze S., Casali P.G., et al. Randomized phase II study of trabectedin in patients with liposarcoma and leiomyosarcoma (L-sarcomas) after failure of prior anthracyclines (A) and ifosfamide (I). J. Clin. Oncol. 25 (2007) 559s (abstract 10060)
29. Donald S., Verschoyle R.D., Greaves P., Gant T.W., Colombo T., Zaffaroni M., et al. Complete protection by high-dose dexamethasone against the hepatotoxicity of the novel antitumor drug Yondelis (ET-743) in the rat. Cancer Res. 63 (2003) 5902-5908
30. Puchalski T.A., Ryan D.P., Garcia-Carbonero R., Demetri G.D., Butkiewicz L., Harmon D., et al. Pharmacokinetics of ecteinascidin 743 administered as a 24-h continuous intravenous infusion to adult patients with soft tissue sarcomas: associations with clinical characteristics, pathophysiological variables and toxicity. Cancer Chemother. Pharmacol. 50 (2002) 309-319