1475PD - A randomized clinical trial of adjuvant chemotherapy with doxorubicin, ifosfamide and cisplatin (API), followed by radiotherapy versus radiotherapy...

Date 11 September 2017
Event ESMO 2017 Congress
Session Sarcoma
Topics Anti-Cancer Agents & Biologic Therapy
Cancer in Adolescents
Surgery and/or Radiotherapy of Cancer
Presenter 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
  • 1Department Of Cancer Medicine, Institut de cancérologie Gustave Roussy, 94800 - Villejuif/FR
  • 2Department Of Biostatistics, Institut de cancérologie Gustave Roussy, 94800 - Villejuif/FR
  • 3Medical Oncology, Institute Bergonié, 33076 - Bordeaux/FR
  • 4Medical Oncology, Institut Universitaire du Cancer -Toulouse- Oncopole, 31059 - Toulouse/FR
  • 5Medical Oncology, Institut de Cancérologie de Lorraine - Alexis Vautrin, 54519 - Vandoeuvre les Nancy/FR
  • 6Medical Oncology, Institut Curie, 75248 cedex5 - Paris/FR
  • 7Medical Oncology, ICO Institut de Cancerologie de l'Ouest René Gauducheau, 44805 - Saint-Herblain/FR
  • 8Medical Oncology, Centre Leon Berard, 69008 - Lyon/FR
  • 9Medical Oncology, ICM Regional Cancer Institute of Montpellier, 34298 - Montpellier/FR
  • 10Medical Oncology, APHP, CancerEst, Tenon University Hospital, 75020 - Paris/FR
  • 11Medical Oncology, CHRU Bretonneau, 37044 - Tours/FR
  • 12Medical Oncology, Institut Paoli Calmettes, 13274 - Marseille/FR
  • 13Medical Oncology, Centre Eugène Marquis, Rennes/FR
  • 14Medical Oncology, Centre Henri Becquerel, 76038 - Rouen/FR
  • 15Department Of Pathology, Institut Gustave Roussy, 94800 - Villejuif/FR
  • 16Medical Oncology, CHU La Timone Adultes, 13385 - Marseille/FR



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.


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.


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).


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


Legal entity responsible for the study

Institut de Cancérologie Gustave Roussy


Association pour la Recherche contre le Cancer; Chugaï Pharma


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.