Five-year results of a randomized phase III trial of pre-operative vs post-operative radiotherapy in extremity soft tissue sarcoma

e22550 Background: Olaratumab is a humanized monoclonal anti platelet-derived growth factor receptor α antibody that has been approved in combination with doxorubicin for the treatment of patients with metastatic soft tissue sarcoma (STS). The purpose of this retrospective study was to assess the clinical efficacy in STS patients treated with olaratumab in a real-world setting in Austria. Methods: Retrospectively collected, longitudinal data from patients treated between November 2016 and September 2018 at 9 Austrian centers were obtained from respective medical charts. Eligible patients were all patients who received at least one dose of olaratumab. Parameters of most interest collected were response rates, progression-free survival (PFS) and overall survival (OS). Results: Altogether 55 patients were included into analysis. Median age was 58 years. In total, 65.5% (n = 36), 21.8% (n = 12) and 12.7% (n = 7) received olaratumab as first-, second- or ≥ third-line treatment, respectively. Olaratumab was administered either in combination with doxorubicin (81.8%, n = 45) or liposomal doxorubicin (16.4%, n = 9); 1 patient received olaratumab as upfront monotherapy. Median PFS and OS were 2.6 and 11.4 months. The objective response rate was 11.4 % and the disease control rate was 40.9 %. Conclusions: In this real-world analysis outcome was less pronounced compared to the results of the Phase Ib/II approval trial ( Tap WD et al. Lancet 2016). Thus, the results of the ongoing phase III trial (NCT02451943) are urgently needed to confirm the efficacy of the combination of olaratumab and doxorubicin in STS patients.

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Results of Hrqol Data from Palette: A Randomized Double Blind Phase III Trial of Pazopanib Versus Placebo in Metastatic Soft Tissue Sarcoma (STS) Patients. An Eortc Stbsg Global Network Study (EORTC 62072)

Annals of Oncology ◽

10.1016/s0923-7534(20)34038-2 ◽

2012 ◽

Vol 23 ◽

pp. ix483

Author(s):

C. Coens ◽

W.T.A. van der Graaf ◽

J. Blay ◽

S.P. Chawla ◽

D. Kim ◽

...

Keyword(s):

Soft Tissue ◽

Soft Tissue Sarcoma ◽

Global Network ◽

Phase Iii ◽

Double Blind ◽

Phase Iii Trial ◽

Hrqol Data ◽

Metastatic Soft Tissue Sarcoma

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Phase III Trial of Two Investigational Schedules of Ifosfamide Compared With Standard-Dose Doxorubicin in Advanced or Metastatic Soft Tissue Sarcoma: A European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group Study

Journal of Clinical Oncology ◽

10.1200/jco.2006.09.7717 ◽

2007 ◽

Vol 25 (21) ◽

pp. 3144-3150 ◽

Cited By ~ 178

Author(s):

Paul Lorigan ◽

Jaap Verweij ◽

Zsuzsa Papai ◽

Sjoerd Rodenhuis ◽

Axel Le Cesne ◽

...

Keyword(s):

Overall Survival ◽

Soft Tissue ◽

Soft Tissue Sarcoma ◽

Standard Dose ◽

Single Agent ◽

Progression Free Survival ◽

Phase Iii ◽

Advanced Soft Tissue Sarcoma ◽

Phase Iii Trial ◽

Free Survival

Purpose Single-agent doxorubicin remains the standard treatment for advanced soft tissue sarcomas. Combining doxorubicin with standard-dose ifosfamide has not been shown to improve survival and is associated with a significantly increased toxicity; it is not known whether higher dose single-agent ifosfamide is superior to doxorubicin. Patients and Methods This randomized prospective multicenter phase III trial was designed to compare progression-free survival of patients with advanced soft tissue sarcoma receiving either regimen of standard doxorubicin 75 mg/m2 every 21 days, ifosfamide 9 g/m2 over 3 days continuous infusion, or ifosfamide 3 g/m2 per day in 3 hours over 3 days. The primary end point was progression-free survival. Secondary end points included overall survival, response rate, and toxicity. Results The study included 326 patients. Grade 4 leukopenia, neutropenia, febrile neutropenia, and encephalopathy were more frequent in the ifosfamide arms. Progression-free survival, overall survival, and response rates were not significantly different between the three arms. An independent data monitoring committee reviewed the interim data and recommended early closure of the trial for futility (ie, no significant difference would be shown). Conclusion Single-agent doxorubicin remains the treatment of choice for patients with advanced soft tissue sarcoma.

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