Journal
ANNALS OF ONCOLOGY
Volume 24, Issue 4, Pages 1099-1104Publisher
OXFORD UNIV PRESS
DOI: 10.1093/annonc/mds545
Keywords
adjuvant; chemotherapy; sarcoma; treatment; uterine
Categories
Funding
- Association pour la Recherche contre le Cancer
- Chugai Pharma
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There is no proven benefit of adjuvant treatment of uterine sarcoma (US). SARCGYN phase III study compared adjuvant polychemotherapy followed by pelvic radiotherapy (RT) (arm A) versus RT alone (arm B) conducted to detect an increase >= 20% of 3-year PFS. Patients with FIGO stage < III US, physiological age < 65 years; chemotherapy: four cycles of doxorubicin 50 mg/m superset of d1, ifosfamide 3 g/m superset of/day d1-2, cisplatin 75 mg/m superset of d3, (API) + G-CSF q 3 weeks. Study was stopped because of lack of recruitment. Eighty-one patients were included: 39 in arm A and 42 in arm B; 52 stage I, 16 stage II, 13 stage III; 53 leiomyosarcomas, 9 undifferenciated sarcomas, 19 carcinosarcomas. Gr 3-4 toxicity during API (/37 patients): thrombopenia (76%), febrile neutropenia (22%) with two toxic deaths; renal gr 3 (1 patient). After a median follow-up of 4.3 years, 41/81 patients recurred, 15 in arm A, 26 in arm B. The 3 years DFS is 55% in arm A, 41% in arm B (P = 0.048). The 3-year overall survival (OS) is 81% in arm A and 69% in arm B (P = 0.41). API adjuvant CT statistically increases the 3 year-DFS of patients with US.
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