Feasibility and acute toxicity of Concurrent Chemoradiotherapy (CCRT) with high-dose rate intracavitary brachytherapy (HDR-ICBT) and 40-mg/m2 weekly cisplatin for Japanese patients with cervical cancer: results of a Multi-Institutional Phase 2 Study (JGOG

TitleFeasibility and acute toxicity of Concurrent Chemoradiotherapy (CCRT) with high-dose rate intracavitary brachytherapy (HDR-ICBT) and 40-mg/m2 weekly cisplatin for Japanese patients with cervical cancer: results of a Multi-Institutional Phase 2 Study (JGOG
Publication TypeJournal Article
Year of Publication2012
AuthorsToita, T, Kitagawa, R, Hamano, T, Umayahara, K, Hirashima, Y, Aoki, Y, Oguchi, M, Mikami, M, Takizawa, K, Group, CCancer Vul
JournalInt J Gynecol Cancer
Volume22
Pagination1420-6
KeywordsAdenocarcinoma/mortality/pathology/*therapy Adult Aged Antineoplastic Agents/adverse effects Brachytherapy/*adverse effects Carcinoma, Adenosquamous/mortality/pathology/*therapy Carcinoma, Squamous Cell/mortality/pathology/*therapy Chemoradiotherapy/*adverse effects Cisplatin/*adverse effects Feasibility Studies Female Follow-Up Studies Hearing Loss/etiology/prevention & control Humans Middle Aged Neoplasm Staging Neutropenia/etiology/prev
Abstract

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/m(2) 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.