title: 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 (JGOG1066).
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.
  
  
  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.
authors.affiliation: Department of Radiology, Graduate School of Medical Science, University of the Ryukyus, Okinawa, Japan.
authors.forename: Takafumi
authors.initials: T
authors.lastname: Toita
authors.forename: Ryo
authors.initials: R
authors.lastname: Kitagawa
authors.forename: Tetsutaro
authors.initials: T
authors.lastname: Hamano
authors.forename: Kenji
authors.initials: K
authors.lastname: Umayahara
authors.forename: Yasuyuki
authors.initials: Y
authors.lastname: Hirashima
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Aoki
authors.forename: Masahiko
authors.initials: M
authors.lastname: Oguchi
authors.forename: Mikio
authors.initials: M
authors.lastname: Mikami
authors.forename: Ken
authors.initials: K
authors.lastname: Takizawa
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects; D001918:Brachytherapy / Q000009:adverse effects*; D018196:Carcinoma, Adenosquamous / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D002294:Carcinoma, Squamous Cell / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D059248:Chemoradiotherapy / Q000009:adverse effects*; D002945:Cisplatin / Q000009:adverse effects*; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D034381:Hearing Loss / Q000209:etiology / Q000517:prevention & control; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D009503:Neutropenia / Q000209:etiology / Q000517:prevention & control; D011379:Prognosis; D011446:Prospective Studies; D011879:Radiotherapy Dosage; D015996:Survival Rate; D002583:Uterine Cervical Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D014839:Vomiting / Q000209:etiology / Q000517:prevention & control; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D002945:Cisplatin