title: A prospective phase II study of topotecan (Hycamtin®) and cisplatin as neoadjuvant chemotherapy in locally advanced cervical cancer.
abstract: OBJECTIVE
  To evaluate the feasibility, toxicity and activity of neoadjuvant chemotherapy (NACT) using cisplatin and topotecan in patients affected by locally advanced cervical cancer (IB2-IIIB).
  
  
  METHODS
  Patients with histologically confirmed FIGO stage IB2-IIIB uterine cervical cancer were treated with topotecan 0.75 mg/m(2)/day (days 1-3) followed by cisplatin 75 mg/m(2) (day 1), every 21 days for three consecutive cycles. After the last cycle of chemotherapy, within 3 or 4 weeks, patients underwent radical surgery with lymph node dissection.
  
  
  RESULTS
  In the years 2007-2010, 46 women were enrolled into the study. Hematologic toxicity was the most relevant side effect. Thirty-eight patients (82.6%) underwent radical surgery after neoadjuvant chemotherapy (NACT) and were assessable for pathologic responses; surgery was not performed in 8 (17.4%) non-responder patients or with progression disease. Objective pathological response was recorded in 34 patients (89.5%); 6 patients (15.8%) achieved a complete response (CR), 28 (73.7%) patients achieved a partial response (PR); stable disease (SD) occurred in 2 patients (5.3%) with IIA initial disease and progression disease (PD) was registered in 2 patients (5.3%) with IIIB initial disease. The cumulative 2-year progression free survival (PFS) and overall survival (OS) of the 46 enrolled patients in the study were 70% and 81%, respectively; the 2-year PFS and OS of the 38 operated patients were respectively 79% and 95%.
  
  
  CONCLUSIONS
  The cisplatin-topotecan combination seems to be feasible and with an acceptable toxicity profile and a promising response rate for the treatment of locally advanced cervical cancer (LACC). Phase II and III studies are needed to compare this combination with other platinum-based chemotherapeutic associations.
authors.affiliation: Department of Obstetrics-Gynecology and Urology, Sapienza University of Rome, 155, Viale del Policlinico, Rome, Italy.
authors.forename: N
authors.initials: N
authors.lastname: Manci
authors.forename: C
authors.initials: C
authors.lastname: Marchetti
authors.forename: C
authors.initials: C
authors.lastname: Di Tucci
authors.forename: M
authors.initials: M
authors.lastname: Giorgini
authors.forename: F
authors.initials: F
authors.lastname: Esposito
authors.forename: I
authors.initials: I
authors.lastname: Palaia
authors.forename: A
authors.initials: A
authors.lastname: Musella
authors.forename: G
authors.initials: G
authors.lastname: Perniola
authors.forename: A
authors.initials: A
authors.lastname: Carrone
authors.forename: P
authors.initials: P
authors.lastname: Benedetti Panici
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D011446:Prospective Studies; D019772:Topotecan / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology
chemical_list: D019772:Topotecan; D002945:Cisplatin