RT Journal Article
SR Electronic
T1 ATL: Results of a Multi-Institutional Phase 2 Study (JGOG1066)
JF International Journal of Gynecologic Cancer
JO Int J Gynecol Cancer
FD BMJ Publishing Group Ltd
SP 1420
OP 1426
DO 10.1097/IGC.0b013e3182647265
VO 22
IS 8
A1 Takafumi Toita
A1 Ryo Kitagawa
A1 Tetsutaro Hamano
A1 Kenji Umayahara
A1 Yasuyuki Hirashima
A1 Yoichi Aoki
A1 Masahiko Oguchi
A1 Mikio Mikami
A1 Ken Takizawa
YR 2012
UL http://ijgc.bmj.com/content/22/8/1420.abstract
AB Objective To assess the feasibility and acute toxicity of concurrent chemoradiotherapy (CCRT) with high–dose rate intracavitary brachytherapy (HDR-ICBT) and standard dose delivery of cisplatin for Japanese patients with cervical cancer.Materials and Methods The phase 2 study included Japanese patients with International Federation of Gynecology and Obstetrics stage III to IVA uterine cervical cancer who had no para-aortic lymphadenopathy (>10 mm) assessed by computed tomography. Patients were 20 to 70 years of age and had Eastern Cooperative Oncology Group performance status of 0 to 1. The radiotherapy protocol consisted of whole-pelvis external beam radiotherapy and HDR-ICBT. The cumulative linear quadratic equivalent dose (EQD2) was 62 to 65 Gy prescribed at point A. Cisplatin was administered weekly at a dose of 40 mg/m2 for 5 courses.Results Between March 2008 and January 2009, 72 patients from 25 institutions were enrolled, and 71 patients were eligible and evaluable for compliance and severe toxicity. The median age of the patients was 57 years (range, 32–70 years). Sixty-five patients (92%) received the planned 5 courses of chemotherapy. Four patients had cisplatin dose reduction according to the protocol. Radiotherapy was completed per protocol in 68 patients (96%). Median overall treatment time was 50 days (range, 37–66 days). The following grade 3 or 4 acute adverse events were observed: neutropenia in 31 patients (44%), anemia in 10 patients (14%), diarrhea in 4 patients (6%), and anorexia in 3 patients (4%).Conclusions Concurrent chemoradiotherapy with HDR-ICBT and standard weekly delivery of cisplatin was feasible with acceptable toxicity in Japanese patients with cervical cancer.