Trabectedin in combination with doxorubicin for first-line treatment of advanced uterine or soft-tissue leiomyosarcoma (LMS-02): A non-randomised, multicentre, phase 2 trial

The Lancet Oncology

Volumn 16, Issue 4, 2015, Pages 457-464

  Pautier, Patricia ^a   Floquet, Anne ^b   Chevreau, Christine ^c   Penel, Nicolas ^d   Guillemet, Cécile ^e   Delcambre, Corinne ^f   Cupissol, Didier ^g   Selle, Frédéric ^h   Isambert, Nicolas ⁱ   Piperno Neumann, Sophie ^j   Thyss, Antoine ^k   Bertucci, François ^l   Bompas, Emmanuelle ^m   Alexandre, Jerôme ⁿ   Collard, Olivier ^o   Lavau Denes, Sandrine ^p   Soulié, Patrick ^q   Toulmonde, Maud ^b   Le Cesne, Axel ^a   Lacas, Benjamin ^a   Duffaud, Florence ^r   more..

^a INSTITUT GUSTAVE ROUSSY   (France)

^b INSTITUT BERGONIÉ   (France)

^c INSTITUT CLAUDIUS REGAUD   (France)

^d CENTRE OSCAR LAMBRET   (France)

^e CENTRE HENRI BECQUEREL   (France)

^f CENTRE FRANÇOIS BACLESSE   (France)

^g CENTRE VAL D AURELLE   (France)

^h HÔPITAL TENON   (France)

ⁱ CENTRE GEORGES FRANÇOIS LECLERC   (France)

^j INSTITUT CURIE   (France)

^k CENTRE ANTOINE LACASSAGNE   (France)

^l INSTITUT PAOLI CALMETTES   (France)

^m CENTRE RENÉ GAUDUCHEAU   (France)

ⁿ Institut Cochin   (France)

^o Institut de Cancerologie de la Loire   (France)

^p DUPUYTREN UNIVERSITY HOSPITAL   (France)

^q CENTRE PAUL PAPIN   (France)

^r TIMONE HOSPITAL   (France)

more..

Author keywords

[No Author keywords available]

Indexed keywords

1,3 DIOXOLANE DERIVATIVE; ANTINEOPLASTIC AGENT; DOXORUBICIN; TETRAHYDROISOQUINOLINE DERIVATIVE; TRABECTEDIN;

ADULT; AGED; CANCER STAGING; CLINICAL TRIAL; FEMALE; HUMAN; KAPLAN MEIER METHOD; LEIOMYOSARCOMA; MALE; METASTASIS; MIDDLE AGED; MULTICENTER STUDY; PATHOLOGY; PHASE 2 CLINICAL TRIAL; SOFT TISSUE NEOPLASMS; UTERINE NEOPLASMS;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DIOXOLES; DOXORUBICIN; FEMALE; HUMANS; KAPLAN-MEIER ESTIMATE; LEIOMYOSARCOMA; MALE; MIDDLE AGED; NEOPLASM METASTASIS; NEOPLASM STAGING; SOFT TISSUE NEOPLASMS; TETRAHYDROISOQUINOLINES; UTERINE NEOPLASMS;

EID: 84933503980     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(15)70070-7     Document Type: Article

References (28)

1. Ducimetière F, Lurkin A, Ranchere-Vince D, et al. Incidence of sarcoma histotypes and molecular subtypes in a prospective epidemiological study with central pathology review and molecular testing. PLoS One 2011, 6:e20294.
2. Skubitz KM, Skubitz APN Differential gene expression in leiomyosarcoma. Cancer 2003, 98:1029-1038.
3. Italiano A, Mathoulin-Pelissier S, Le Cesne A, et al. Trends in survival for patients with metastatic soft-tissue sarcoma. Cancer 2011, 117:1049-1054.
4. Penel N, Van Glabbeke M, Marreaud S, et al. Testing new regimens in patients with advanced soft tissue sarcoma: analysis of publications from the last 10 years. Ann Oncol 2011, 22:1266-1272.
5. Judson I, Verweij J, Glderblom H, et al. Doxorubicin alone versus intensified doxorubicin plus ifosfamide for first-line treatment of advanced or metastatic soft-tissue sarcoma: a randomised controlled phase 3 trial. Lancet Oncol 2014, 15:415-423.
6. Hensley ML, Blessing JA, Mannel R, et al. Fixed-dose rate gemcitabine plus docetaxel as first-line therapy for metastatic uterine leiomyosarcoma: a Gynecologic Oncology Group phase II study. Gynecol Oncol 2008, 109:329-334.
7. Pautier P, Floquet A, Penel N, et al. Randomized multicenter and stratified phase II study of gemcitabine alone versus gemcitabine and docetaxel in patients with metastatic or relapsed leiomyosarcomas: a Fédération Nationale des Centres de Lutte Contre le Cancer (FNCLCC) French Sarcoma Group Study (TAXOGEM study). Oncologist 2012, 17:1213-1320.
8. Oosten AW, Seynaeve C, Schmitz PI, et al. Outcomes of first-line chemotherapy in patients with advanced or metastatic leiomyosarcoma of uterine and non-uterine origin. Sarcoma 2009, 2009:348910.
9. Le Cesne A, Blay JY, Judson I, 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 2005, 23:576-584.
10. Yovine A, Riofrio M, Blay JY, et al. Phase II study of ecteinascidin-743 in advanced pretreated soft tissue sarcoma patients. J Clin Oncol 2004, 22:890-899.
11. García-Carbonero R, Supko JG, Manola J, et al. Phase II and pharmacokinetic study of ecteinascidin 743 in patients with progressive sarcomas of soft tissues refractory to chemotherapy. J Clin Oncol 2004, 22:1480-1490.
12. Samuels BL, Chawla S, Patel S, et al. Clinical outcomes and safety with trabectedin therapy in patients with advanced soft tissue sarcomas following failure of prior chemotherapy: results of a worldwide expanded access program study. Ann Oncol 2013, 24:1703-1709.
13. Monk BJ, Blessing JA, Street DG, et al. A phase II evaluation of trabectedin in the treatment of advanced, persistent, or recurrent uterine leiomyosarcoma: a gynecologic oncology group study. Gynecol Oncol 2012, 124:48-52.
14. Takahashi N, Li WW, Banerjee D, et al. Sequence-dependent enhancement of cytotoxicity produced by ecteinascidin 743 (ET-743) with doxorubicin or paclitaxel in soft tissue sarcoma cells. Clin Cancer Res 2001, 7:3251-3257.
15. Meco D, Colombo T, Ubezio P, et al. Effective combination of ET-743 and doxorubicin in sarcoma: preclinical studies. Cancer Chemother Pharmacol 2003, 52:131-138.
16. Blay JY, von Mehren M, Samuels BL, et al. Phase I combination study of trabectedin and doxorubicin in patients with soft-tissue sarcoma. Clin Cancer Res 2008, 14:6656-6662.
17. Sessa C, Perotti A, Noberasco C, et al. Phase I clinical and pharmacokinetic study of trabectedin and doxorubicin in advanced soft tissue sarcoma and breast cancer. Eur J Cancer 2009, 45:1153-1161.
18. Le Cesne A, Judson I, Crowther D, et al. Randomized phase III study comparing conventional-dose doxorubicin plus ifosfamide versus high-dose doxorubicin plus ifosfamide plus recombinant human granulocyte-macrophage colony-stimulating factor in advanced soft tissue sarcomas: a trial of the European Organization for Research and Treatment of Cancer/Soft Tissue and Bone Sarcoma Group. J Clin Oncol 2000, 18:2676-2684.
19. Sutton G, Blessing JA, Malfetano JH, et al. Ifosfamide and doxorubicin in the treatment of advanced leiomyosarcomas of the uterus: a Gynecologic Oncology Group study. Gynecol Oncol 1996, 62:226-229.
20. Demetri GD, Chawla SP, von Mehren M, et al. Efficacy and safety of trabectedin in patients with advanced or metastatic liposarcoma or leiomyosarcoma after failure of prior anthracyclines and ifosfamide: results of a randomized phase II study of two different schedules. J Clin Oncol 2009, 27:4188-4196.
21. Simon R Optimal two-stage designs for phase II clinical trials. Control Clin Trials 1989, 10:1-10.
22. Santoro A, Tursz T, Mouridsen H, et al. Doxorubicin versus CYVADIC versus doxorubicin plus ifosfamide in first-line treatment of advanced soft tissue sarcomas: a randomized study of the European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. J Clin Oncol 1995, 13:1537-1545.
23. Penel N, Italiano A, Isambert N, et al. Factors affecting the outcome of patients with metastatic leiomyosarcoma treated with doxorubicin-containing chemotherapy. Ann Oncol 2010, 21:1361-1365.
24. Penel N, Bui BN, Bay JO, et al. Phase II trial of weekly paclitaxel for unresectable angiosarcoma: the ANGIOTAX Study. J Clin Oncol 2008, 26:5269-5274.
25. Hensley M, Maki R, Venkatraman E, et al. Gemcitabine and docetaxel in patients with unresectable leiomyosarcoma: results of a phase II trial. J Clin Oncol 2002, 20:2824-2831.
26. Martin-Broto J, Lopez-Pousa A, Garcai del Muro X, et al. Randomized phase II trial of doxorubicin vs. trabectedin plus doxorubicin in first line treatment of patients with advanced non-resectable or metastatic soft tissue sarcomas: a Spanish Group for Sarcoma Research (GEIS) study. Eur J Cancer 2013, 49:s3800.
27. Blay JY, Italiano A, Ray-Coquard I, et al. Long-term outcome and effect on maintenance therapy in patients with advanced sarcoma treated with trabectedin: an analysis of 181 patients of the French ATU compassionate use program. BMC Cancer 2013, 13:69.
28. Le Cesne A, Blay JY, Domont J, et al. Interruption versus continuation of trabectedin in patients with soft-tissue sarcoma (T-DIS): a randomised phase 2 trial. Lancet Oncol 2015, 16:312-319.