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Management

Novel Therapy - Trabectedin

Reprint Links

To view abstracts of the clinical studies listed below, please click on the required study title.

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
G.D. Demetri, S.P.  Chawla, M. von Mehren, P.  Ritch, L.H. Bake, J.Y.  Blay, K.R. Hande, M.L. Keohan, B.L. Samuels, S. Schuetze, C. Lebedinsky, Y.A. Elsayed, M.A. Izquierdo, J. Gomez, Y.C. Park, A. Le Cesne 
JCO Early Release, published online ahead of print Aug 3 2009.
Journal of Clinical Oncology, Vol 27, No 25 (September 1), 2009; pp. 4188-4196


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
A. Le Cesne, J.Y. Blay, I. Judson, A. Van Oosterom, J. Verweij, J. Radford, P. Lorigan, S. Rodenhuis, I. Ray-Coquard, S. Bonvalot, F. Collin, J. Jimeno, E. Di Paola, M. Van Glabbeke, O.S. Nielsen
J Clin Oncol 2005; 23: 576-584


Phase II Study of Ecteinascidin-743 in Advanced Pretreated Soft Tissue Sarcoma Patients
A. Yovine, M. Riofrio, J.Y. Blay, E. Brain, J. Alexandre, C. Kahatt, A. Taamma, J. Jimeno, C. Martin, Y. Salhi, E. Cvitkovic, J.L. Misset
J Clin Oncol 2004; 22: 890-899


Phase II and Pharmacokinetic Study of Ecteinascidin 743 in Patients With Progressive Sarcomas of Soft Tissues Refractory to Chemotherapy
R. Garcia-Carbonero, J.G. Supko, J. Manola, M.V. Seiden, D. Harmon, D.P. Ryan, M.T. Quigley, P. Merriam, J. Canniff, G. Goss, U. Matulonis, R.G. Maki, T. Lopez, T.A. Puchalski, M.A. Sancho, J. Gomez, C. Guzman, J. Jimeno, G.D. Demetri
J Clin Oncol 2004; 22 : 1480-1490


Randomized phase II study of trabectedin in patients with liposarcoma and leiomyosarcoma (L-sarcomas) after failure of prior anthracylines (A) and ifosfamide (I)
J. A. Morgan, A. Le Cesne, S. Chawla, M. von Mehren, S. Schuetze, P. G. Casali, A. Nieto, Y. Elsayed, M. A. Izquierdo, G. D. Demetri and Yondelis Sarcoma Study Group
2007 ASCO Annual Meeting Proceedings : Abstract 10060


Impact of independent review on efficacy outcomes in a randomised multicenter trial of trabectedin given by two dosing regimens in patients (pts) with progressing leiomyosarcomas or liposarcomas (L-sarcomas)
G.D. Demetri, S. Schuetze, A. Le Cesne, S. Chawla, P.G. Casali, J. Gomez, A. Nieto, Y. Elsayed, M.A. Izquierdo, J.Y. Blay
ECCO 2007: Abstract 7500. European Journal of Cancer Supplements, Vol 5 No 4, Page 401


Assessing the clinical impact of trabectedin in patients with leiomyosarcomas or liposarcomas (L-sarcomas) progressing despite prior conventional chemotherapy: clinical benefit rate, growth modulation index and tumor variation as parameters of treatment efficacy in a randomised international trial of two trabectedin dose regimens
A. Le Cesne, M. von Mehren, S. Chawla, J.Y. Blay, S. Schuetze, A. Nieto, J. Gomez, P. Santabarbara, M.A. Izquierdo, G.D. Demetri on behalf of Yondelis Sarcoma Study Group
ECCO 2007: Abstract 7512.European Journal of Cancer Supplements, Vol 5 No 4, Page 405


Clinical tolerability of trabectedin administered by two different schedules (weekly for 3 of 4 weeks vs q3 weeks) in patients with advancedsmetastatic liposarcoma or leiomyosarcoma (L-sarcomas) progressing despite prior treatment with at least anthracycl anthracycline and ifosfamide
on behalf of Yondelis Sarcoma Study Group, S. Chawla, P.G. Casali, M. von Mehren, A. Le Cesne, J.Y. Blay, C. Lebedinsky, V. Alfaro, Y. Elsayed, B. Michiels, G.D. Demetri
ECCO 2007: Abstract 7517. European Journal of Cancer Supplements, Vol 5 No 4, Page 407


A phase II clinical trial of neoadjuvant trabectedin in patients with nonmetastatic advanced myxoid/round cell liposarcoma (MRCL).
A. Gronchi, A. Le Cesne, N. B. Bui, E. Palmerini, G. Demetri, P. Hohenberger, R. J. Hohl, S. Pilotti, I. Perez, P. Lardelli
2009 ASCO Annual Meeting. Abstract 10525


Rechallenge with trabectedin in patients with responding myxoid liposarcoma.
R. Sanfilippo, F. Grosso, E. Virdis, C. Morosi, J. C. Tercero, A. Gronchi, S. Pilotti, M. D'Incalci, P. G. Casali
2009 ASCO Annual Meeting. Abstract 10575


Efficacy and safety of trabectedin in soft tissue sarcoma (STS) are independent of patient age
G. Demetri, J.Y. Blay, A. Yovine, I. Judson, R. Maki, S. Schuetze, M. von Mehren, S. Chawla, C. Lebedinsky, A. Le Cesne
European Journal of Cancer Supplements, Vol 7 No 2, September
2009, Page 590


Efficacy of second-line trabectedin in patients with advancedliposarcomas and leiomyosarcomas progressing despite prior conventional chemotherapy
S. Chawla, J.Y. Blay, S. Schuetze, D. Morris, P. Ritch, A. Le Cesne,
P.G. Casali, J. Perez, E. Bayever, G. Demetri
European Journal of Cancer Supplements, Vol 7 No 2, September
2009, Page 598


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
A. Le Cesne, J.Y. Blay, I. Judson, A. Van Oosterom, J. Verweij, J. Radford, P. Lorigan, S. Rodenhuis, I. Ray-Coquard, S. Bonvalot, F. Collin, J. Jimeno, E. Di Paola, M. Van Glabbeke, O.S. Nielsen
J Clin Oncol 2005; 23: 576-584


Phase I Combination Study of Trabectedin and Doxorubicin in Patients with Soft-Tissue Sarcoma
J.Y. Blay, M. von Mehren, B. L. Samuels, M. P. Fanucchi, I. Ray-Coquard, B. Buckley, L. Gilles, C. Lebedinsky, Y. A. Elsayed,  A. Le Cesne
Clinical Cancer Research 2008; 14 (20): 6656-6662.


Ecteinascidin-743 (ET-743) for Chemotherapy-Naïve Patients With Advanced Soft Tissue Sarcomas: Multicenter Phase II and Pharmacokinetic Study
R. Garcia-Carbonero, J.G. Supko, R.G. Maki, J. Manola, D.P. Ryan, D. Harmon, T.A. Puchalski, G. Goss, M.V. Seiden, A. Waxman, M.T. Quigley, T. Lopez, M.A. Sancho, J. Jimeno, C. Guzman, G.D. Demetri.
Journal of Clinical Oncology. 2005; 23 (24): 5484-5492.


Steroid premedication markedly reduces liver and bone marrow toxicity of trabectedin in advanced sarcoma
F. Grosso, P.  Dileo, R. Sanfilippo, S.  Stacchiotti, R.  Bertulli, C.  Piovesan,   J. Jimeno,  M.D. Incalcic, A. Gescherd, P.G. Casalia
European Journal of Cancer 2006, vol 42(10), pages 1484-1490.


Trabectedin in myxoid liposarcomas (MLS): a long-term analysis of a single-institution series
F. Grosso, R. Sanfilippo, E. Virdis, C. Piovesan, P. Collini, P. Dileo, C. Morosi, J. C. Tercero, J. Jimeno, M. D’Incalci, A. Gronchi, S. Pilotti, P. G. Casali
Annals of Oncology 2009; 20: 1439-1444


Mapping the literature: Role of trabectedin as a new chemotherapy option in advanced pretreated soft tissue sarcoma
A. Le Cesne, J. Domont, A. Cioffi, S. Bonvalot, P.  Terrier, I. Ray-Coquard, V. Alfaro, C.  Lebedinsky , P.  Santabarbara, J.Y. Blay
Drugs of Today 2009, 45 (6): 403-421


Trabectedin (T) in relapsed advanced ovarian cancer (ROC): A pooled analysis of three phase II studies.
S. McMeekin, J.M.  del Campo, N.  Colombo, C.  Krasner, A.  Roszak, P. Braly, T.E.  Ciuleanu, C.  Lebedinsky, M.A. Izquierdo, C.  Sessa
Trabectedin: An Emerging Therapeutic Option in Soft Tissue Sarcoma
J-Y. Blay. EJCMO 2009; 1:(2). DECEMBER 2009.


A PhaseII study of trabectedin single agent in patients with recurrent ovarian cancer previously treated with platinum-based regimens
C.N. Krasner, D.S. McMeekin, S. Chan, P.S. Braly, F.G. Renshaw, S. Kaye, D.M. Provencher, S. Campos and M.E. Gore for the ET-743-INT-11 study group
British Journal of Cancer 2007; 97:1618-1624.


Phase II randomized study of trabectedin given as two different every 3 weeks dose schedules (1.5 mg/m2 24h or 1.3 mg/m2 3h) to patients with relapsed, platinum-sensitive, advanced ovarian cancer
J.M. Del  Campo,  A. Roszak, M. Bidzinski, T.E.  Ciuleanu,  T. Hogberg, M.Z. Wojtukiewicz, A.  Poveda, K.  Boman ,  A.M. Westermann, C. Lebedinsky  on behalf of the Yondelis Ovarian Cancer Group
Annals of  Oncology  2009; 20: 1794-1802


A randomized phase III study of trabectedin with pegylated liposomal doxorubicin (PLD) versus PLD in relapsed, recurrent ovarian cancer (OC)
B. J. Monk, T. Herzog, S. Kaye, C. N. Krasner, J. Vermorken, F. Muggia,
E. Pujade-Lourraine, F. G. Renshaw, C. Lebedinsky, A. Poveda
33rd ESMO Congress Stockholm, 12-16 Sept. 2008, abstract LBA4


Health-related quality of life/patient-reported outcomes in relapsed ovarian cancer: Results from a randomized phase III study of trabectedin with pegylated liposomal doxorubicin (PLD) versus PLD alone
C. N. Krasner, A. Poveda, T. Herzog, J. Vermorken, B. Monk, P. Zintl, J. Li, Y. Su, R. Dhawan, S. Kaye
2009 ASCO Annual Meeting. J Clin Oncol 27, 2009 (suppl; abstr 5526)


Correlation of CA-125 and RECIST evaluation in recurrent ovarian cancer (ROC): Results from a randomized phase III study of trabectedin (T) with pegylated liposomal doxorubicin (PLD) versus PLD alone
T. J. Herzog, J. B. Vermorken, E. Pujade-Lauraine, J. Li, E. Bayever, J. Gomez,
A. Yovine, B. J.Monk
2009 ASCO Annual Meeting. J Clin Oncol 27, 2009 (suppl; abstr 5550


Circulating tumor cells (CTC) in a study of relapsed/recurrent advanced ovariancancer: An exploratory analysis in the ova-301 phase III study of pegylated liposomal doxorubicin (PLD) compared with trabectedin and PLD
A. Poveda, S. B. Kaye, R. T. McCormack, S. Wang, D. Ricci, E. Broderick,
T. Parekh, C. Lebedinsky, J. C. Tecero, B. J. Monk
ASCO Annual Meeting. J Clin Oncol 27, 2009 (suppl; abstr 5551)


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