Phase II clinical trial of neoadjuvant trabectedin in patients with advanced localized myxoid liposarcoma

A. Gronchi, B. N. Bui, S. Bonvalot, S. Pilotti, S. Ferrari, P. Hohenberger, Raymond Hohl, G. D. Demetri, A. Le cesne, P. Lardelli, I. Pérez, A. Nieto, J. C. Tercero, V. Alfaro, E. Tamborini, J. Y. Blay

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Abstract

Background: To evaluate neoadjuvant trabectedin (1.5 mg/m. 2 24-h i.v. infusion every 3 weeks; three to six cycles) in patients with locally advanced myoxid liposarcoma (ML) previously untreated with chemotherapy or radiation. Patients and methods: Primary efficacy end point was pathological complete response (pCR) or tumoral regression rate. Objective response according to RECIST (v.1.0) was a secondary end point. Results: Three of 23 assessable patients had pCR [13%; 95% confidence interval (CI), 3% to 34%]. Furthermore, very good and moderate histological responses were observed in another 2 and 10 patients, respectively. Histological decrement in the cellular and vascular tumor component and maturation of tumor cells to lipoblasts were observed in both myoxid and myoxid/round cell variants. Seven patients had partial response according to RECIST (objective response rate of 24%; 95% CI, 10% to 44%). No disease progression was reported. Neoadjuvant trabectedin was usually well tolerated, with a safety profile similar to that described in patients with soft tissue sarcoma or other tumor types. Conclusion: Trabectedin 1.5 mg/m. 2 given as a 24-h i.v. infusion every 3 weeks is a therapeutic option in the neoadjuvant setting of ML.

Original languageEnglish (US)
Pages (from-to)771-776
Number of pages6
JournalAnnals of Oncology
Volume23
Issue number3
DOIs
StatePublished - Mar 1 2012

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trabectedin
Myxoid Liposarcoma
Phase II Clinical Trials
Liposarcoma
Confidence Intervals
Neoplasms
Sarcoma
Blood Vessels
Disease Progression

All Science Journal Classification (ASJC) codes

  • Hematology
  • Oncology

Cite this

Gronchi, A., Bui, B. N., Bonvalot, S., Pilotti, S., Ferrari, S., Hohenberger, P., ... Blay, J. Y. (2012). Phase II clinical trial of neoadjuvant trabectedin in patients with advanced localized myxoid liposarcoma. Annals of Oncology, 23(3), 771-776. https://doi.org/10.1093/annonc/mdr265
Gronchi, A. ; Bui, B. N. ; Bonvalot, S. ; Pilotti, S. ; Ferrari, S. ; Hohenberger, P. ; Hohl, Raymond ; Demetri, G. D. ; Le cesne, A. ; Lardelli, P. ; Pérez, I. ; Nieto, A. ; Tercero, J. C. ; Alfaro, V. ; Tamborini, E. ; Blay, J. Y. / Phase II clinical trial of neoadjuvant trabectedin in patients with advanced localized myxoid liposarcoma. In: Annals of Oncology. 2012 ; Vol. 23, No. 3. pp. 771-776.
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abstract = "Background: To evaluate neoadjuvant trabectedin (1.5 mg/m. 2 24-h i.v. infusion every 3 weeks; three to six cycles) in patients with locally advanced myoxid liposarcoma (ML) previously untreated with chemotherapy or radiation. Patients and methods: Primary efficacy end point was pathological complete response (pCR) or tumoral regression rate. Objective response according to RECIST (v.1.0) was a secondary end point. Results: Three of 23 assessable patients had pCR [13{\%}; 95{\%} confidence interval (CI), 3{\%} to 34{\%}]. Furthermore, very good and moderate histological responses were observed in another 2 and 10 patients, respectively. Histological decrement in the cellular and vascular tumor component and maturation of tumor cells to lipoblasts were observed in both myoxid and myoxid/round cell variants. Seven patients had partial response according to RECIST (objective response rate of 24{\%}; 95{\%} CI, 10{\%} to 44{\%}). No disease progression was reported. Neoadjuvant trabectedin was usually well tolerated, with a safety profile similar to that described in patients with soft tissue sarcoma or other tumor types. Conclusion: Trabectedin 1.5 mg/m. 2 given as a 24-h i.v. infusion every 3 weeks is a therapeutic option in the neoadjuvant setting of ML.",
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Gronchi, A, Bui, BN, Bonvalot, S, Pilotti, S, Ferrari, S, Hohenberger, P, Hohl, R, Demetri, GD, Le cesne, A, Lardelli, P, Pérez, I, Nieto, A, Tercero, JC, Alfaro, V, Tamborini, E & Blay, JY 2012, 'Phase II clinical trial of neoadjuvant trabectedin in patients with advanced localized myxoid liposarcoma', Annals of Oncology, vol. 23, no. 3, pp. 771-776. https://doi.org/10.1093/annonc/mdr265

Phase II clinical trial of neoadjuvant trabectedin in patients with advanced localized myxoid liposarcoma. / Gronchi, A.; Bui, B. N.; Bonvalot, S.; Pilotti, S.; Ferrari, S.; Hohenberger, P.; Hohl, Raymond; Demetri, G. D.; Le cesne, A.; Lardelli, P.; Pérez, I.; Nieto, A.; Tercero, J. C.; Alfaro, V.; Tamborini, E.; Blay, J. Y.

In: Annals of Oncology, Vol. 23, No. 3, 01.03.2012, p. 771-776.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Phase II clinical trial of neoadjuvant trabectedin in patients with advanced localized myxoid liposarcoma

AU - Gronchi, A.

AU - Bui, B. N.

AU - Bonvalot, S.

AU - Pilotti, S.

AU - Ferrari, S.

AU - Hohenberger, P.

AU - Hohl, Raymond

AU - Demetri, G. D.

AU - Le cesne, A.

AU - Lardelli, P.

AU - Pérez, I.

AU - Nieto, A.

AU - Tercero, J. C.

AU - Alfaro, V.

AU - Tamborini, E.

AU - Blay, J. Y.

PY - 2012/3/1

Y1 - 2012/3/1

N2 - Background: To evaluate neoadjuvant trabectedin (1.5 mg/m. 2 24-h i.v. infusion every 3 weeks; three to six cycles) in patients with locally advanced myoxid liposarcoma (ML) previously untreated with chemotherapy or radiation. Patients and methods: Primary efficacy end point was pathological complete response (pCR) or tumoral regression rate. Objective response according to RECIST (v.1.0) was a secondary end point. Results: Three of 23 assessable patients had pCR [13%; 95% confidence interval (CI), 3% to 34%]. Furthermore, very good and moderate histological responses were observed in another 2 and 10 patients, respectively. Histological decrement in the cellular and vascular tumor component and maturation of tumor cells to lipoblasts were observed in both myoxid and myoxid/round cell variants. Seven patients had partial response according to RECIST (objective response rate of 24%; 95% CI, 10% to 44%). No disease progression was reported. Neoadjuvant trabectedin was usually well tolerated, with a safety profile similar to that described in patients with soft tissue sarcoma or other tumor types. Conclusion: Trabectedin 1.5 mg/m. 2 given as a 24-h i.v. infusion every 3 weeks is a therapeutic option in the neoadjuvant setting of ML.

AB - Background: To evaluate neoadjuvant trabectedin (1.5 mg/m. 2 24-h i.v. infusion every 3 weeks; three to six cycles) in patients with locally advanced myoxid liposarcoma (ML) previously untreated with chemotherapy or radiation. Patients and methods: Primary efficacy end point was pathological complete response (pCR) or tumoral regression rate. Objective response according to RECIST (v.1.0) was a secondary end point. Results: Three of 23 assessable patients had pCR [13%; 95% confidence interval (CI), 3% to 34%]. Furthermore, very good and moderate histological responses were observed in another 2 and 10 patients, respectively. Histological decrement in the cellular and vascular tumor component and maturation of tumor cells to lipoblasts were observed in both myoxid and myoxid/round cell variants. Seven patients had partial response according to RECIST (objective response rate of 24%; 95% CI, 10% to 44%). No disease progression was reported. Neoadjuvant trabectedin was usually well tolerated, with a safety profile similar to that described in patients with soft tissue sarcoma or other tumor types. Conclusion: Trabectedin 1.5 mg/m. 2 given as a 24-h i.v. infusion every 3 weeks is a therapeutic option in the neoadjuvant setting of ML.

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U2 - 10.1093/annonc/mdr265

DO - 10.1093/annonc/mdr265

M3 - Article

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SP - 771

EP - 776

JO - Annals of Oncology

JF - Annals of Oncology

SN - 0923-7534

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