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Sarcoma

3924 - A randomized clinical trial of adjuvant chemotherapy with doxorubicin, ifosfamide and cisplatin (API), followed by radiotherapy versus radiotherapy alone in patients with localized uterine sarcomas (SARCGYN study). Update at 10 years.

Date

11 Sep 2017

Session

Sarcoma

Presenters

Patricia Pautier

Citation

Annals of Oncology (2017) 28 (suppl_5): v521-v538. 10.1093/annonc/mdx387

Authors

P. Pautier1, C. Brard2, A. Floquet3, L. Gladieff4, M. Rios5, S. Piperno-Neumann6, D. Berton-Rigaud7, J. Blay8, M. Fabbro9, J. Lotz10, A. Vinceneux11, F. Bertucci12, T. De La Motte Rouge13, C. Guillemet14, C. Genestie15, F. Duffaud16

Author affiliations

  • 1 Department Of Cancer Medicine, Institut de cancérologie Gustave Roussy, 94800 - Villejuif/FR
  • 2 Department Of Biostatistics, Institut de cancérologie Gustave Roussy, 94800 - Villejuif/FR
  • 3 Medical Oncology, Institute Bergonié, 33076 - Bordeaux/FR
  • 4 Medical Oncology, Institut Universitaire du Cancer -Toulouse- Oncopole, 31059 - Toulouse/FR
  • 5 Medical Oncology, Institut de Cancérologie de Lorraine - Alexis Vautrin, 54519 - Vandoeuvre les Nancy/FR
  • 6 Medical Oncology, Institut Curie, 75248 cedex5 - Paris/FR
  • 7 Medical Oncology, ICO Institut de Cancerologie de l'Ouest René Gauducheau, 44805 - Saint-Herblain/FR
  • 8 Medical Oncology, Centre Leon Berard, 69008 - Lyon/FR
  • 9 Medical Oncology, ICM Regional Cancer Institute of Montpellier, 34298 - Montpellier/FR
  • 10 Medical Oncology, APHP, CancerEst, Tenon University Hospital, 75020 - Paris/FR
  • 11 Medical Oncology, CHRU Bretonneau, 37044 - Tours/FR
  • 12 Medical Oncology, Institut Paoli Calmettes, 13274 - Marseille/FR
  • 13 Medical Oncology, Centre Eugène Marquis, Rennes/FR
  • 14 Medical Oncology, Centre Henri Becquerel, 76038 - Rouen/FR
  • 15 Department Of Pathology, Institut Gustave Roussy, 94800 - Villejuif/FR
  • 16 Medical Oncology, CHU La Timone Adultes, 13385 - Marseille/FR
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Resources

Abstract 3924

Background

There is no proven benefit of adjuvant treatment in uterine sarcoma (US). SARCGYN was a phase-III study which compared adjuvant polychemotherapy followed by pelvic radiotherapy (RT) (arm A) versus RT alone (arm B). The study met its primary end point (3-year progression-free survival (PFS)) and showed a statistical increase of the 3-year PFS in the chemo+RT arm (A) vs radiation arm (B) (55% and 41% respectively, [P = 0.048]) after a median follow-up of 4.3 years (Ann Oncol 2013). Secondary end-point was overall survival (OS) that required a longer follow-up.

Methods

Patients with FIGO stage ≤III US, and physiological age ≤65 years were randomized after complete surgery and normal thoracic, abdominal and pelvic CT scans between CT and no CT, with a stratification between carcinosarcomas (CS) versus others. Study was stopped earlier because of lack of recruitment. All patients received pelvic RT (45 grays); vaginal brachytherapy was optional. Chemotherapy consisted in four cycles of doxorubicin 50 mg/m2, d1; ifosfamide 3 g/m2/day d1-2; cisplatin 75 mg/m2, d3; + G-CSF q 3 weeks.

Results

Eighty-one patients were included: 39 in arm A and 42 in arm B; 52 stage I, 16 stage II, and 13 stage III; 53 leiomyosarcomas, 9 undifferenciated sarcomas, and 19 carcinosarcomas. API was toxic with two toxic deaths and one acute leukemia. After a median FU of 9.9 years [0.3-15.1], 42/81 patients relapsed, 16 in arm A, and 26 in arm B, and 38 died, 16 in arm A, and 22 in arm B. The 5-year OS is 74% in arm A and 60% in arm B, and the difference is not significant (p = 0.16).

Conclusions

In this trial interrupted at an early stage and with a longer follow-up, there is no statistical impact of API adjuvant CT on OS. The two toxic deaths and the integration of carcinosarcomas may have impacted on the global prognosis. A selection of a specific uterine population and a less toxic chemotherapy for future studies are mandatory.

Clinical trial identification

NCT00162721

Legal entity responsible for the study

Institut de Cancérologie Gustave Roussy

Funding

Association pour la Recherche contre le Cancer; Chugaï Pharma

Disclosure

P. Pautier: Advisory board: Roche and Pharmamar. S. Piperno-Neumann: Travel grants PharmaMar, Novartis. F. Bertucci: Traveling grants, PharmaMar, Novartis. F. Duffaud: Consultancy work: Lilly, Pharmamar, Bayer, Novartis Travel grants: Pfizer, Pharmamar. All other authors have declared no conflicts of interest.

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