511P - Retrospective study of sarcoma in practical and developmental therapeutics in Japan
|Date||18 December 2016|
|Event||ESMO Asia 2016 Congress|
|Topics|| Drug Development
|Citation||Annals of Oncology (2016) 27 (suppl_9): ix163-ix168. 10.1093/annonc/mdw597|
T. Nishikawa1, K. Yonemori2, A. Kitano1, T. Shimoi2, E. Noguchi1, M. Yunokawa1, C. Shimizu2, Y. Fujiwara2, A. Yoshida3, E. Kobayashi4, F. Nakatani4, A. Kawai4, H. Chuman4, T. Koyama5, A. Shimomura5, S. Kitano5, T. Shimizu5, Y. Fujiwara5, N. Yamamoto5, K. Tamura2
Sarcoma consists of over 50 subtypes. Each subtype is rare and is known to be clinically highly aggressive. In Japan, approximately 1,500 patients are newly diagnosed with sarcoma every year, accompanied with increasing tendency of the annual number of deaths. In 2014, the National Cancer Center Hospital (NCCH) launched the “Rare Cancer Center” to integrate rare cancer patients together as a central part functioning of both treatment and clinical research. Efficacy of new agents for sarcoma has been reported recently, but treatment options are not still sufficient. For effective development against urgent unmet medical needs with sarcoma patients, we have to recognize the clinical outcome of sarcoma in Japan.
We retrospectively examined sarcoma patients who were treated with chemotherapy including investigational agents in NCCH between January 2010 and June 2016. In clinical trials, efficacy assessment were performed in accordance with RECIST and adverse events were in accordance with CTCAE.
Two hundred and fifty-five patients were treated with chemotherapy and 231 patients were evaluable for response. One hundred and fifty-six patients were treated with conventional chemotherapy, a total of 55 patients were enrolled in phase 2 or 3, and a total of 57 patients in phase 1. Five patients were excluded from evaluation because of toxicity in clinical trials. Distribution of major subtypes was the following: leiomyosarcoma (n = 47, 18%), liposarcoma (n = 40, 16%), rhabdomyosarcoma (n = 37, 14%), Ewing sarcoma (n = 26, 10%). synovial sarcoma (n = 18, 7%), angiosarcoma (n = 18, 7%), and others (n = 70, 27%). In conventional first line chemotherapy, clinical tumor shrinkage was observed in 42 patients (33%). On the other hand, in clinical trials, complete response (CR) was observed in 1 patient (1.9%) and partial response (PR) was in 5 (9.4%) in phase 2 or 3, CR was not observed in patients (0%) and PR was in 5 (9.3%) in phase 1. Six types of anticancer agents were administered in phase 2 or 3, and 20 types of new agents were in phase 1.
Despite recent advances with various anticancer agents, their efficacy against sarcoma is still limited. Further research for novel therapies for sarcoma will be necessary in the future.
Clinical trial indentification
Legal entity responsible for the study
All authors have declared no conflicts of interest.