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Sarcoma

4090 - Results of the LMS03 phase II study evaluating gemcitabine combined with pazopanib as a 2nd-line treatment for metastatic/relapsed leiomyosarcomas (uterine or soft tissue) after failure of anthracycline-based chemotherapy: the UNICANCER SARCOME 11 study.

Date

11 Sep 2017

Session

Sarcoma

Presenters

Patricia Pautier

Citation

Annals of Oncology (2017) 28 (suppl_5): v605-v649. 10.1093/annonc/mdx440

Authors

P. Pautier1, N. Penel2, I. Ray-Coquard3, A. Italiano4, E. Bompas5, C. Delcambre6, J. Bay7, F. Bertucci8, J. Delaye9, C. Chevreau10, D. Cupissol11, L. Bozec Le Moal12, J. Eymard13, A. Thyss14, N. Isambert15, C. Guillemet16, M. Rios17, S. Piperno-Neumann18, G. Chenuc19, F. Duffaud20

Author affiliations

  • 1 Medical Oncology, Gustave Roussy Cancer Campus, 94805 - Villejuif/FR
  • 2 Medical Oncology, Centre Oscar Lambret, 59020 - Lille/FR
  • 3 Medical Oncology, Centre Léon Bérard, Lyon/FR
  • 4 Medical Oncology, Institute Bergonié, 33076 - Bordeaux/FR
  • 5 Medical Oncology, ICO Institut de Cancerologie de l'Ouest René Gauducheau, 44805 - Saint-Herblain/FR
  • 6 Medical Oncology, Centre Francois Baclesse, 14076 - Caen/FR
  • 7 Medical Oncology, Centre Jean Perrin, Clermont-Ferrand/FR
  • 8 Medical Oncology, Institut Paoli Calmettes, 13274 - Marseille/FR
  • 9 Sarcoma Group, Unicancer R&D, 75654 - Paris/FR
  • 10 Medical Oncology, Institut Claudius-Regaud, 31059 - Toulouse/FR
  • 11 Oncology, Institut régional du Cancer de Montpellier, Montpellier/FR
  • 12 Medical Oncology, Hôpital René Huguenin - Institut Curie, 92210 - St. Cloud/FR
  • 13 Medical Oncology, Institut Jean Godinot, 51056 - Reims/FR
  • 14 Medical Oncology, Centre Antoine Lacassagne, 6100 - Nice/FR
  • 15 Medical Oncology, Centre Georges-François Leclerc, 21000 - Dijon/FR
  • 16 Medical Oncology, Centre Henri Becquerel, 76038 - Rouen/FR
  • 17 Medical Oncology, Institut de Cancérologie de Lorraine - Alexis Vautrin, 54519 - Vandoeuvre les Nancy/FR
  • 18 Medical Oncology, Institut Curie, 75248 cedex5 - Paris/FR
  • 19 Biostatistics, Capionis, Paris/FR
  • 20 Medical Oncology, CHU La Timone, 13385 - Marseille/FR
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Abstract 4090

Background

Leiomyosarcomas (LMS) represent 10-15% of soft tissue and visceral sarcomas, most frequently uterine. LMS are moderately chemosensitive. Options in 2nd-line therapy after anthracycline-based chemotherapy for metastatic/advanced disease include Gemcitabine (G), trabectedin and pazopanib (P) monotherapy. Currently no combination therapy is better than monochemotherapy. LMS03 is an open-label multicentre single-group phase II study designed to assess the efficacy and tolerance of G+P in this 2nd-line setting.

Methods

Patients (pts) aged ≥18 years, ECOG ≤2 with metastatic or relapsed LMS (uterine or soft tissue) after 1st-line anthracycline chemotherapy failure were eligible. Pts were treated with G 1,000 mg/m2 on days 1 and 8 of each 21 day cycle (maximum 8 cycles), in combination with oral daily P (800 mg/day), until disease progression/unacceptable toxicity. Tumour response was assessed every 6 weeks (RECIST) with 9-month PFS rate as primary endpoint. Inacceptable and promising 9-month PFS rates were defined, in Intention-To-Treat (ITT), as 32% (Median PFS=5.5 months (mo)) and 44% (Median PFS=7.5 mo). Secondary objectives included control rate (CR/PR/SD), overall survival, toxicity.

Results

From 2011 to 2016, 18 French centres included 106 pts: mean age of 59.8 years, mainly women (85.8%), ECOG 0 (63.5%), and uterine LMS (61%). Pts were treated with P+G for a median of 3.8 mo; 40 pts (38%) completed the 8 cycles of combination. Pts were treated with P for a median of 4.2 mo. The 9-mo PFS was 32.1% (CI 95% 23.2-41.4; n = 105, ITT) and 34.6% (CI 95% 24.9-44.4; n = 95, per-protocol). Median PFS was 6.5 mo (CI 95% 5.6-8.2; n = 105, ITT) and 7.1 mo (CI 95% 5.7-8.3; n = 95, per-protocol). The 12-week control rate was 83.6% (11 PR and 45 SD; 67 pts evaluable). Grade 3-4 AE (>30%) with P+G were: neutropenia (76 [72.4%]), leucopenia (59 [56.2%]) and thrombocytopenia (40 [38.1%]).

Conclusions

The study results are negative in ITT with median PFS < 7.5 mo but nearly positive when considering per protocol results. In term of safety the combination P+G could be well managed, without unexpected toxicity.

Clinical trial identification

NCT01442662

Legal entity responsible for the study

UNICANCER R&D

Funding

GSK, Novartis

Disclosure

N. Isambert: Congress participations supported by PharmaMar, AZ, Roche, Novartis, Celgene. Board: Lilly. All other authors have declared no conflicts of interest.

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