Doxorubicin plus evofosfamide versus doxorubicin alone in locally advanced, unresectable or metastatic soft-tissue sarcoma (TH CR-406/SARC021): an international, multicentre, open-label, randomised phase 3 trial

Abstract

Threshold Pharmaceuticals.

Outcomes of Elderly Patients with Advanced Soft Tissue Sarcoma Treated with First-Line Chemotherapy: A Pooled Analysis of 12 EORTC Soft Tissue and Bone Sarcoma Group Trials

“…The median follow-up time for elderly patients who were still alive at the time of their analyses was 9.5 months (IQR, [6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25]. Of note, the median follow-up time for patients treated with trabectedin who were still alive at the time of the clinical cutoff date was considerably shorter than for the other treatment groups (trabectedin, 6 Response Rates (Table 2) In total, 48 patients (13.8%) had a partial response and 4 patients (1.1%) had complete response.…”

“…STSs are common in elderly patients aged ≥65 years, with an age‐adjusted incidence of 11.3 cases per 100,000 population compared with 2.3 cases per 100,000 in those aged <65 years . Although approximately 40%–50% of all patients diagnosed with STS are aged >65 years, the median age of patients in prospective first‐line chemotherapy trials for advanced STS ranges from 48 to 60 years . The objective of this study is to examine outcomes of elderly patients treated with first‐line chemotherapy within European Organization for Research and Treatment of Cancer (EORTC) Soft Tissue and Bone Sarcoma Group (STBSG) clinical trials.…”

Making the Best of Available Options for Optimal Sarcoma Treatment

“…1) [12], differences in the histological profiles of patient populations in phase II and subsequent confirmatory clinical trials can lead to inconclusive results. Indeed, histological variation is thought to explain in part the absence of efficacy confirmation in phase III studies of doxorubicin ± palifosfamide (an active metabolite of ifosfamide) [13], and doxorubicin ± evofosfamide (a hypoxia-activated prodrug of ifosfamide) [14], after positive results had been demonstrated in phase II studies.…”

GeDDiS: insight into frontline therapy in soft tissue sarcoma

“…For example, miR-193a-3p EDV minicells have been identified as apoptosis inducers via MCL1 silencing, with evidence of growth inhibition in mesothelioma xenografts. 4 In the past few years, the range of promising molecular targets being investigated in mesothelioma-including gen etic or epigenetically stratified synthetic lethal approaches, 7,8 PD-1-targeted immune checkpoint blockade, 9 and mesothelin-directed antibody-directed conjugate therapy 10 -has expanded rapidly. miR-16 targomiRs can be added to this growing list, each member of which has the potential to improve outcomes and transform a setting of unmet clinical need.…”

“…6 Recently, several phase 3 studies have provided substantial insight into the use of anthracyclines and alkylators as first-line treatments for patients with advanced sarcoma. [7][8][9] The GeDDiS 6 trial iis the first to shed comparative light on the efficacy of gemcitabine and docetaxel versus doxorubicin alone in this setting. The primary endpoint of the trial-progression-free survival at 24 weeks-did not differ between the two treatment groups (46·3% [95% CI 37·5-54·6] in the doxorubicin group vs 46·4% [37·5-54·8] in the gemcitabine and docetaxel group).…”