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 Anti-Cancer Agents & Biologic Therapy
Soft Tissue Sarcomas
Sarcoma
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.