title: A phase II study of weekly neoadjuvant chemotherapy followed by radical chemoradiation for locally advanced cervical cancer.
abstract: BACKGROUND
  We investigated the feasibility of dose-dense neoadjuvant chemotherapy (NACT) with paclitaxel and carboplatin before radical chemoradiation (CRT) and assessed the response rate to such a regimen.
  
  
  METHODS
  CxII is a single-arm phase II trial of 46 patients, with locally advanced cervical cancer (stage Ib2-IVa). Patients received dose-dense carboplatin (AUC2) and paclitaxel (80 mg m⁻²) weekly for six cycles followed by CRT (40 mg m⁻² of weekly cisplatin, 50.4 Gy, 28 fractions plus brachytherapy). The primary end point was response rate 12 weeks post-CRT.
  
  
  RESULTS
  Baseline characteristics were: median age at diagnosis 43 years; 72% squamous, 22% adenocarcinoma and 7% adenosquamous histologies; FIGO stage IB2 (11%), II (50%), III (33%), IV (7%). Complete or partial response rate was 70% (95% CI: 54-82) post-NACT and 85% (95% CI: 71-94) post-CRT. The median follow-up was 39.1 months. Overall and progression-free survivals at 3 years were 67% (95% CI: 51-79) and 68% (95% CI: 51-79), respectively. Grade 3/4 toxicities were 20% during NACT (11% haematological, 9% non-haematological) and 52% during CRT (haematological: 41%, non-haematological: 22%).
  
  
  CONCLUSIONS
  A good response rate is achieved by dose-dense weekly NACT with carboplatin and paclitaxel followed by radical CRT. This treatment regimen is feasible as evidenced by the acceptable toxicity of NACT and by the high compliance to radiotherapy (98%).
authors.affiliation: University College London Hospitals, 250 Euston Road, London NW1 2PG, UK. mary.mccormack@uclh.nhs.uk
authors.forename: M
authors.initials: M
authors.lastname: McCormack
authors.forename: L
authors.initials: L
authors.lastname: Kadalayil
authors.forename: A
authors.initials: A
authors.lastname: Hackshaw
authors.forename: M A
authors.initials: MA
authors.lastname: Hall-Craggs
authors.forename: R P
authors.initials: RP
authors.lastname: Symonds
authors.forename: V
authors.initials: V
authors.lastname: Warwick
authors.forename: H
authors.initials: H
authors.lastname: Simonds
authors.forename: I
authors.initials: I
authors.lastname: Fernando
authors.forename: M
authors.initials: M
authors.lastname: Hammond
authors.forename: L
authors.initials: L
authors.lastname: James
authors.forename: A
authors.initials: A
authors.lastname: Feeney
authors.forename: J A
authors.initials: JA
authors.lastname: Ledermann
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002294:Carcinoma, Squamous Cell / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D059248:Chemoradiotherapy; D003131:Combined Modality Therapy; D018450:Disease Progression; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D016019:Survival Analysis; D002583:Uterine Cervical Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D055815:Young Adult
chemical_list: D016190:Carboplatin; D017239:Paclitaxel