1499P - The routine real-life use of trabectedin (T) in patients with advanced soft tissue sarcoma (STS) across Europe: an analysis of overall vs. per coun...

Date 11 September 2017
Event ESMO 2017 Congress
Session Poster display session
Topics Cytotoxic agents
Soft Tissue Sarcomas
Sarcoma
Therapy
Biological therapy
Presenter Nicolas Penel
Citation Annals of Oncology (2017) 28 (suppl_5): v521-v538. 10.1093/annonc/mdx387
Authors N. Penel1, C. Benson2, B. Kasper3, A. Buonadonna4
  • 1Medical Oncology, Centre Oscar Lambret, 59020 - Lille/FR
  • 2Medical Oncology, Royal Marsden Hospital NHS Foundation Trust, SW3 6JJ - London/GB
  • 3Interdisziplinäres Tumorzentrum, Universitätsklinikum Mannheim, 68167 - Mannheim/DE
  • 4Medical Oncology, Centro di Riferimento Oncologico, 33081 - Aviano/IT

Abstract

Background

The prospective, non-interventional, phase IV Y-IMAGE study evaluated the use of T in real-life clinical practice across Europe in patients with advanced STS.

Methods

Data from adult STS patients treated with T 1.5 mg/m2 given as 24-h i.v. infusion q3w were collected. Patients must have received at least 1 cycle of T and currently be on T treatment. The primary endpoint was progression-free survival (PFS) as defined by investigators. The analyses were conducted in the overall population (OP) and separately in countries with the highest recruiting rate to cover inter-country variations: France (F), Germany (G), Italy (I) and the UK.

Results

A total of 218 patients from 41 centers and 9 European countries were evaluated. Demographics and baseline characteristics of patients recruited in the 4 countries of interest were well-balanced and comparable to those observed in OP. Patients received a median of 6 cycles of T (range: 1-44), mostly on an outpatient basis (n = 132; 60.6%). Across all centers the median cycle duration, and median dose and dose intensity were similar to those observed in OP. Analysis of PFS data showed a similar outcome in G (median PFS: 5.9 months) to that observed in OP (5.9 months), and a rather higher PFS in the UK (8.3 months), F (7.6 months) and I (6.8 months). The patients from the UK received the highest median number of cycles (10.5) and cumulative dose of T (26.2 mg) as compared to F, G and I. This was associated with favorable efficacy outcomes in those patients, particularly in terms of improved PFS (8.3 months), responses (ORR: 38.5%; DCR: 84.6%) and a high growth modulation index of 2.3. T treatment resulted in a comparable median overall survival in all patients (21.3 months), being somewhat larger among patients treated in sites across G (27.3 months). Febrile neutropenia (2.3% of patients), neutropenia, nausea, and pneumonia (1.4% each) were the most common T-related grade 3/4 adverse drug reactions.Table:

1499P

Full analysis set, n (%)
France (n = 26)Germany (n = 29)Italy (n = 69)UK (n = 26)Overall population (n = 218)
Age at study entry (years); Median (range)58.5 (22-77)58 (23-79)59 (26-79)56.6 (25-73)58.0 (21.0-79.0)
Female15(57.7)15 (51.7)44 (63.8)13 (50.0)123 (56.4)
Histology (≥10% of patients)
Leiomyosarcoma11 (42.3)11 (37.9)29 (42.0)16 (61.5)92 (42.2%)
Liposarcoma5 (19.2)23 (33.3)7 (26.9)51 (23.4)
Synovial sarcoma4 (15.4)5 (17.2)23 (10.6%)
Cycles per patient Median (range)5.5 (2-29)6.0 (2-18)6.0 (1-30)10.5 (1-44)6.0 (1-44)
Cumulative dose received mg/patient12.1 (3.7-48.2)20.8 (5.6-51.0)14.3 (1.9-60)26.2 (3-116.4)14.7 (1.8-116.4)
Cycle duration (days)24.9 (21-41)26.8 (21-44.4)23.7 (20.5-32.5)24.2 (21-30.6)24.1 (20-47.5)
Dose intensity (mg/m2/week)0.7 (0.2-1.0)0.6 (0.4-1.1)0.6 (0.3-1.0)0.7 (0.5-1.0)0.7 (0.2-1.1)
Median PFS (months) [95% Confidence interval]7.6 [3.3-NR]5.9 [3.4-11.2]6.8 [3.4-10.2]8.3 [5.5-11.4]5.9 [4.9-7.8]
Objective response rate (ORR) (Complete + partial response) [95% Confidence interval]6 (23.1) [9.0-43.6]9 (31.0) [15.3-50.8]15 (21.7) [12.7-33.3]10 (38.5) [20.2-59.4]58 (26.6) [20.9-33.0]
Disease control rate (DCR) (ORR + stable disease) [95% Confidence interval]17 (65.4) [44.3-82.8]20 (69.0) [49.2-84.7]48 (69.6) [57.3-80.1]22 (84.6) [65.1-95.6]143 (65.6) [58.9-71.9]
Time to progression (TTP), median (months) [95% Confidence interval]7.8 [4.9-NR]6.9 [4.2-11.2]6.8 [3.4-10.2]8.3 [5.5-11.4]5.9 [4.9-8.1]
Overall survival (OS), median (months) [95% Confidence interval]20.3 [9.6-NR]27.3 [9.2-NR]22.5 [19.0-NR]20.0 [18.2-23.6]21.3 [18.8-24.3]
Growth modulation index (GMI), median a Range (min-max) ≤1.1, n (%) >1.1 -

Conclusions

In real-life setting T confers meaningful benefits to patients with multiple STS histotypes with a manageable safety profile regardless of small country variations.

Clinical trial identification

Y-IMAGE; ET-D-020-12

Legal entity responsible for the study

PharmaMar

Funding

PharmaMar

Disclosure

C. Benson: Honoraria from PharmaMar for speaking and travel grants. B. Kasper: Honoraria from PharmaMar. All other authors have declared no conflicts of interest.