title: Chemoradiation in cervical cancer with cisplatin and high-dose rate brachytherapy combined with external beam radiotherapy. Results of a phase-II study.
abstract: BACKGROUND
  In 1999, five randomized studies demonstrated that chemoradiation with cisplatin and low-dose rate (LDR) brachytherapy has a benefit in locally advanced cervical cancer and for surgically treated patients in high-risk situations. We evaluated the safety and efficacy of concomitant chemoradiation with cisplatin and high-dose rate (HDR) brachytherapy in patients with cervical cancer.
  
  
  METHODS
  27 patients were included in our phase-II trial: 13 locally advanced cases (group A) and 14 adjuvant-therapy patients in high-risk situations (group B). A definitive radiotherapy was performed with 25 fractions of external beam therapy (1.8 Gy per fraction/middle shielded after eleven fractions). Brachytherapy was delivered at HDR schedules with 7 Gy in point A per fraction (total dose 35 Gy) in FIGO Stages IIB-IIIB. The total dose of external and brachytherapy was 70 Gy in point A and 52-54 Gy in point B. All patients in stage IVA were treated without brachytherapy. Adjuvant radiotherapy was performed with external beam radiotherapy of the pelvis with 1.8 Gy single-dose up to 50.4 Gy. Brachytherapy was delivered at HDR schedules with two fractions of 5 Gy only in patients with tumor-positive margins or tumor involvement of the upper vagina. The chemotherapeutic treatment schedule provided six courses of cisplatin 40 mg/m2 weekly recommended in the randomized studies GOG-120 and -123.
  
  
  RESULTS
  A total of 18/27 patients (66.7%) completed all six courses of chemotherapy. Discontinuation of radiotherapy due to therapy-related morbidity was not necessary in the whole study group. G3 leukopenia (29.6%) was the only relevant acute toxicity. There were no differences in toxicity between group A and B. Serious late morbidity occurred in 2/27 patients (7.4%). 12/13 patients (92.3%) with IIB-IVA cervical cancer showed a complete response (CR). 13/14 adjuvant cases (92.8%) are free of recurrence (median follow up: 19.1 months).
  
  
  CONCLUSIONS
  Concomitant chemoradiation with cisplatin 40 mg/m2 weekly x 6 using HDR brachytherapy represents a promising treatment of cervical cancer with an acceptable toxicity.
authors.affiliation: Department of Gynecology, Martin-Luther University, Halle-Wittenberg, Germany. hans.strauss@medizin.uni-halle.de
authors.forename: Hans-Georg
authors.initials: HG
authors.lastname: Strauss
authors.forename: Thomas
authors.initials: T
authors.lastname: Kuhnt
authors.forename: Cornelia
authors.initials: C
authors.lastname: Laban
authors.forename: Daniela
authors.initials: D
authors.lastname: Puschmann
authors.forename: Steffi
authors.initials: S
authors.lastname: Pigorsch
authors.forename: Juergen
authors.initials: J
authors.lastname: Dunst
authors.forename: Heinz
authors.initials: H
authors.lastname: Koelbl
authors.forename: Gabriele
authors.initials: G
authors.lastname: Haensgen
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy / Q000601:surgery; D000328:Adult; D000368:Aged; D001918:Brachytherapy; D018196:Carcinoma, Adenosquamous / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy / Q000601:surgery; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage*; D003131:Combined Modality Therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007044:Hysterectomy; D008875:Middle Aged; D009367:Neoplasm Staging; D011838:Radiation-Sensitizing Agents / Q000008:administration & dosage*; D018714:Radiotherapy, Adjuvant; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery
chemical_list: D011838:Radiation-Sensitizing Agents; D002945:Cisplatin