title: Experience with single-agent paclitaxel consolidation following primary chemotherapy with carboplatin, paclitaxel, and gemcitabine in advanced ovarian cancer.
abstract: OBJECTIVE
  Twelve cycles of single-agent paclitaxel have been demonstrated to prolong progression-free survival in women with advanced ovarian cancer whom achieved a clinical complete response to a primary platinum/paclitaxel chemotherapy regimen. This trial was conducted to compare the toxicity and disease-free interval of 3 cycles vs. 12 cycles of paclitaxel consolidation in patients treated with an intensive three-drug front-line regimen of carboplatin, paclitaxel, and gemcitabine.
  
  
  METHODS
  Following cytoreductive surgery, 26 ovarian cancer patients received primary chemotherapy with carboplatin (AUC = 5, day 1), paclitaxel (175 mg/m(2) over 1 h, day 1), and gemcitabine (800 mg/m(2), day 1 day 8), with treatment repeated every 21 days x 6 cycles. The first 13 patients (group A) received three additional cycles of paclitaxel (175 mg/m(2) over 1 h every 21 days). The second set of 13 patients (group B) also received three cycles of paclitaxel (175 mg/m(2) over 1 h every 21 days) and then received nine additional cycles of paclitaxel (135 mg/m(2) over 1 h every 21 days) consolidation therapy. The change from 3 cycles to 12 cycles of consolidation therapy for group B was made following the published results of GOG 178.
  
  
  RESULTS
  In group A, all 13 patients completed three courses of consolidation therapy. One patient experienced grade 3 neutropenia and two patients exhibited both grade 4 neutropenia and thrombocytopenia. Grade > or = 2 neuropathy developed in 3 patients (23%). In group B, 9 of the 13 patients whom were intended to receive 12 total cycles of paclitaxel consolidation were able to complete the program. There was no grade 3-4 neutropenia or anemia in this population, although 1 patient developed grade 3 thrombocytopenia. Grade > or = 2 neuropathy developed in 7 patients (54%). Although not a randomized experience, median progression-free interval was 76 weeks for group B, and 47 weeks for group A.
  
  
  CONCLUSIONS
  Single-agent paclitaxel consolidation therapy can be administered for 12 cycles following first-line carboplatin, paclitaxel, and gemcitabine induction therapy, but there is considerable risk for development of a moderately severe peripheral neuropathy.
authors.affiliation: Gynecologic Oncology Associates, Hoag Cancer Center, 351 Hospital Road, Suite 507, Newport Beach, CA 92663, USA. research@gynoncology.com
authors.forename: John P
authors.initials: JP
authors.lastname: Micha
authors.forename: Bram H
authors.initials: BH
authors.lastname: Goldstein
authors.forename: Julie A
authors.initials: JA
authors.lastname: Mattison
authors.forename: Kathy
authors.initials: K
authors.lastname: Bader
authors.forename: Cheri
authors.initials: C
authors.lastname: Graham
authors.forename: Mark A
authors.initials: MA
authors.lastname: Rettenmaier
authors.forename: John V
authors.initials: JV
authors.lastname: Brown
authors.forename: Maurie
authors.initials: M
authors.lastname: Markman
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000093542:Gemcitabine
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D003841:Deoxycytidine; D016190:Carboplatin; D017239:Paclitaxel; D000093542:Gemcitabine