BACKGROUND: 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. METHODS:Patients with FIGO stage ≤ III US, physiological age ≤ 65 years; chemotherapy: four cycles of doxorubicin 50 mg/m² d1, ifosfamide 3 g/m²/day d1-2, cisplatin 75 mg/m² d3, (API) + G-CSF q 3 weeks. Study was stopped because of lack of recruitment. RESULTS: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). CONCLUSION: API adjuvant CT statistically increases the 3 year-DFS of patients with US.
RCT Entities:
BACKGROUND: 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. METHODS:Patients with FIGO stage ≤ III US, physiological age ≤ 65 years; chemotherapy: four cycles of doxorubicin 50 mg/m² d1, ifosfamide 3 g/m²/day d1-2, cisplatin 75 mg/m² d3, (API) + G-CSF q 3 weeks. Study was stopped because of lack of recruitment. RESULTS: 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). CONCLUSION: API adjuvant CT statistically increases the 3 year-DFS of patients with US.
Authors: Martee L Hensley; Brigitte A Barrette; Klaus Baumann; David Gaffney; Anne L Hamilton; Jae-Weon Kim; Johanna U Maenpaa; Patricia Pautier; Nadeem Ahmad Siddiqui; Anneke M Westermann; Isabelle Ray-Coquard Journal: Int J Gynecol Cancer Date: 2014-11 Impact factor: 3.437
Authors: Khalid El-Khalfaoui; Andreas du Bois; Florian Heitz; Christian Kurzeder; Jalid Sehouli; Philipp Harter Journal: Ther Adv Med Oncol Date: 2014-01 Impact factor: 8.168
Authors: Syed Nusrath; Sandeep Bafna; R Rajagopalan; Subramanyeshwar Rao Thammineedi; K V V N Raju; Sujit Chyau Patnaik; Satish Pawar; Yugandhar Reddy; Ramachandra Nagaraju Chavali; Sudha S Murthy Journal: Indian J Surg Oncol Date: 2019-01-05
Authors: Hyun Ju Kim; Yong Jin Cho; Soo Hee Kim; Sun Young Rha; Joong Bae Ahn; Woo Ick Yang; Young Han Lee; Jin-Suck Suh; Jae Kyung Roh; Kyung Sik Kim; Young Deuk Choi; Kyoo-Ho Shin; Hyo Song Kim Journal: Int J Clin Oncol Date: 2015-06-28 Impact factor: 3.402
Authors: Martee L Hensley; Danielle Enserro; Helen Hatcher; Petronella B Ottevanger; Anders Krarup-Hansen; Jean-Yves Blay; Cyril Fisher; Katherine M Moxley; Shashikant B Lele; Jayanthi S Lea; Krishnansu S Tewari; Premal H Thaker; Oliver Zivanovic; David M O'Malley; Katina Robison; David S Miller Journal: J Clin Oncol Date: 2018-10-05 Impact factor: 44.544