Aplidin in patients with advanced dedifferentiated liposarcomas: a French Sarcoma Group Single-Arm Phase II study
Preclinical data have suggested a therapeutic role of JUN pathway activation in dedifferentiated liposarcoma (DDLPS) tumorigenesis. Aplidin® is a drug inducing apoptosis through a strong, sustained activation of c-Jun NH2-terminal kinase. This phase II trial included patients with progressive advanc...
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| Published in | Annals of oncology Vol. 26; no. 7; pp. 1465 - 1470 |
|---|---|
| Main Authors | , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
Elsevier Ltd
01.07.2015
Oxford University Press |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0923-7534 1569-8041 1569-8041 |
| DOI | 10.1093/annonc/mdv195 |
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| Abstract | Preclinical data have suggested a therapeutic role of JUN pathway activation in dedifferentiated liposarcoma (DDLPS) tumorigenesis. Aplidin® is a drug inducing apoptosis through a strong, sustained activation of c-Jun NH2-terminal kinase.
This phase II trial included patients with progressive advanced DDLPS. They received Aplidin® 5 mg/m2 days 1–15, 28-day cycle until disease progression or unacceptable toxicity. The primary end point was the 3-month nonprogression rate (PFS3) defined as the proportion of patients with nonprogressive disease at 3 months. A PFS3 of 40% considered as a reasonable objective to claim drug efficacy.
Between August 2012 and May 2013, 24 patients were included. Sixteen had received prior chemotherapy. Twenty-two were assessable for efficacy. The PFS3 was 9.1% [95% confidence interval (CI) 1.1–29.2]. Median progression-free and overall survivals were 1.6 months (95% CI 1.4–2.6) and 9.2 months (95% CI 6.6–). The most frequent adverse events of any grade were nausea, fatigue, anorexia, vomiting and diarrhea.
Aplidin® did not meet the primary end point of this trial and do not deserve further investigation in DDLPS.
NCT01876043. |
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| AbstractList | Preclinical data have suggested a therapeutic role of JUN pathway activation in dedifferentiated liposarcoma (DDLPS) tumorigenesis. Aplidin is a drug inducing apoptosis through a strong, sustained activation of c-Jun NH2-terminal kinase.
This phase II trial included patients with progressive advanced DDLPS. They received Aplidin 5 mg/m(2) days 1-15, 28-day cycle until disease progression or unacceptable toxicity. The primary end point was the 3-month nonprogression rate (PFS3) defined as the proportion of patients with nonprogressive disease at 3 months. A PFS3 of 40% considered as a reasonable objective to claim drug efficacy.
Between August 2012 and May 2013, 24 patients were included. Sixteen had received prior chemotherapy. Twenty-two were assessable for efficacy. The PFS3 was 9.1% [95% confidence interval (CI) 1.1-29.2]. Median progression-free and overall survivals were 1.6 months (95% CI 1.4-2.6) and 9.2 months (95% CI 6.6-). The most frequent adverse events of any grade were nausea, fatigue, anorexia, vomiting and diarrhea.
Aplidin did not meet the primary end point of this trial and do not deserve further investigation in DDLPS.
NCT01876043. Preclinical data have suggested a therapeutic role of JUN pathway activation in dedifferentiated liposarcoma (DDLPS) tumorigenesis. Aplidin® is a drug inducing apoptosis through a strong, sustained activation of c-Jun NH2-terminal kinase. This phase II trial included patients with progressive advanced DDLPS. They received Aplidin® 5 mg/m2 days 1–15, 28-day cycle until disease progression or unacceptable toxicity. The primary end point was the 3-month nonprogression rate (PFS3) defined as the proportion of patients with nonprogressive disease at 3 months. A PFS3 of 40% considered as a reasonable objective to claim drug efficacy. Between August 2012 and May 2013, 24 patients were included. Sixteen had received prior chemotherapy. Twenty-two were assessable for efficacy. The PFS3 was 9.1% [95% confidence interval (CI) 1.1–29.2]. Median progression-free and overall survivals were 1.6 months (95% CI 1.4–2.6) and 9.2 months (95% CI 6.6–). The most frequent adverse events of any grade were nausea, fatigue, anorexia, vomiting and diarrhea. Aplidin® did not meet the primary end point of this trial and do not deserve further investigation in DDLPS. NCT01876043. This paper describes the clinical activity of Aplidin in dedifferentiated liposarcomas. Results show that this drug does not deserve further investigations in this indication. Preclinical data have suggested a therapeutic role of JUN pathway activation in dedifferentiated liposarcoma (DDLPS) tumorigenesis. Aplidin is a drug inducing apoptosis through a strong, sustained activation of c-Jun NH2-terminal kinase.BACKGROUNDPreclinical data have suggested a therapeutic role of JUN pathway activation in dedifferentiated liposarcoma (DDLPS) tumorigenesis. Aplidin is a drug inducing apoptosis through a strong, sustained activation of c-Jun NH2-terminal kinase.This phase II trial included patients with progressive advanced DDLPS. They received Aplidin 5 mg/m(2) days 1-15, 28-day cycle until disease progression or unacceptable toxicity. The primary end point was the 3-month nonprogression rate (PFS3) defined as the proportion of patients with nonprogressive disease at 3 months. A PFS3 of 40% considered as a reasonable objective to claim drug efficacy.METHODSThis phase II trial included patients with progressive advanced DDLPS. They received Aplidin 5 mg/m(2) days 1-15, 28-day cycle until disease progression or unacceptable toxicity. The primary end point was the 3-month nonprogression rate (PFS3) defined as the proportion of patients with nonprogressive disease at 3 months. A PFS3 of 40% considered as a reasonable objective to claim drug efficacy.Between August 2012 and May 2013, 24 patients were included. Sixteen had received prior chemotherapy. Twenty-two were assessable for efficacy. The PFS3 was 9.1% [95% confidence interval (CI) 1.1-29.2]. Median progression-free and overall survivals were 1.6 months (95% CI 1.4-2.6) and 9.2 months (95% CI 6.6-). The most frequent adverse events of any grade were nausea, fatigue, anorexia, vomiting and diarrhea.RESULTSBetween August 2012 and May 2013, 24 patients were included. Sixteen had received prior chemotherapy. Twenty-two were assessable for efficacy. The PFS3 was 9.1% [95% confidence interval (CI) 1.1-29.2]. Median progression-free and overall survivals were 1.6 months (95% CI 1.4-2.6) and 9.2 months (95% CI 6.6-). The most frequent adverse events of any grade were nausea, fatigue, anorexia, vomiting and diarrhea.Aplidin did not meet the primary end point of this trial and do not deserve further investigation in DDLPS.CONCLUSIONAplidin did not meet the primary end point of this trial and do not deserve further investigation in DDLPS.NCT01876043.CLINICALTRIALSGOV IDENTIFIERNCT01876043. |
| Author | Toulmonde, M. Penel, N. Bellera, C. Le Cesne, A. Piperno-Neumann, S. Italiano, A. Chevreau, C. Duffaud, F. |
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| Copyright | 2015 European Society for Medical Oncology The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com. The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com. 2015 |
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| Keywords | treatment plitidepsin dedifferentiated liposarcoma JUN Aplidin |
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| Snippet | Preclinical data have suggested a therapeutic role of JUN pathway activation in dedifferentiated liposarcoma (DDLPS) tumorigenesis. Aplidin® is a drug inducing... Preclinical data have suggested a therapeutic role of JUN pathway activation in dedifferentiated liposarcoma (DDLPS) tumorigenesis. Aplidin is a drug inducing... This paper describes the clinical activity of Aplidin in dedifferentiated liposarcomas. Results show that this drug does not deserve further investigations in... |
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| SubjectTerms | Aged Aged, 80 and over Aplidin dedifferentiated liposarcoma Depsipeptides - therapeutic use Disease Progression Female Follow-Up Studies Humans JUN Liposarcoma - drug therapy Liposarcoma - mortality Liposarcoma - pathology Male Middle Aged Neoplasm Metastasis Neoplasm Staging Original Peptides, Cyclic plitidepsin Prognosis Survival Rate treatment |
| Title | Aplidin in patients with advanced dedifferentiated liposarcomas: a French Sarcoma Group Single-Arm Phase II study |
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