title: Phase II study of weekly paclitaxel/carboplatin in combination with prophylactic G-CSF in the treatment of gynecologic cancers: A study in 108 patients by the Belgian Gynaecological Oncology Group.
abstract: OBJECTIVE
  To investigate the addition of prophylactic G-CSF to each weekly paclitaxel/carboplatin course in patients with recurrent platinum-resistant ovarian (OC), or recurrent or advanced endometrial (EC) or cervical carcinoma (CC).
  
  
  METHODS
  108 patients were enrolled i.e. 36 in each cohort. Eighteen courses of paclitaxel (60 mg/m(2)) and carboplatin (AUC 2.7) were administered weekly. G-CSF (filgrastim) was given to all patients on day 5 (and if needed on day 6).
  
  
  RESULTS
  For patients with OC, 91% had platinum-resistant and 9% platinum-refractory disease. Median number of prior chemotherapy lines was 3 for OC, 1 for EC, and 1 for CC. Grade 3-4 neutropenia was observed in 34% of patients (95% CI: 26%-44%, P<0,0001) (OC 29%, EC 36%, CC 38%). This is lower compared to historical data in all cohorts (84%). Confirmed sepsis was observed in 5%, grade 3-4 thrombocytopenia in 41%, grade 2-3 peripheral neuropathy in 17% of patients. In 71% of patients dose was delayed. Dose reduction was necessary for carboplatin in 47% and paclitaxel in 18% of patients. ORR was 51% (OC 48%, EC 45%, CC 58%). Median (95% CI) PFS and OS was 7.1 (5.1-8.1) and 12.7 (10.2-16.3) months, respectively (OC 7 and 13, EC 6 and 19, CC 6 and 14).
  
  
  CONCLUSIONS
  Weekly paclitaxel/carboplatin with G-CSF is an effective treatment with acceptable toxicity in patients with platinum-resistant or platinum-refractory OC, advanced or recurrent EC and CC. The incidence of grade 3-4 neutropenia is lower with the addition of weekly G-CSF compared with earlier studies without routine use of prophylactic G-CSF.
authors.affiliation: Gynecologic Oncology, University Hospital Leuven, Leuven Cancer Institute, Leuven, Belgium. Electronic address: Ignace.vergote@uzleuven.be.
authors.forename: Ignace
authors.initials: I
authors.lastname: Vergote
authors.affiliation: AZ Groeninge, Kortrijk, Belgium.
authors.forename: Philip
authors.initials: P
authors.lastname: Debruyne
authors.affiliation: CHU de Liège, Liège, Belgium.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Kridelka
authors.affiliation: Gynecologic Oncology, University Hospital Leuven, Leuven Cancer Institute, Leuven, Belgium.
authors.forename: Patrick
authors.initials: P
authors.lastname: Berteloot
authors.affiliation: Gynecologic Oncology, University Hospital Leuven, Leuven Cancer Institute, Leuven, Belgium.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Amant
authors.affiliation: Grand Hôpital de Charleroi, Charleroi, Belgium.
authors.forename: Brigitte
authors.initials: B
authors.lastname: Honhon
authors.affiliation: AZ Nikolaas, St. Niklaas, Belgium.
authors.forename: Willem
authors.initials: W
authors.lastname: Lybaert
authors.affiliation: Gynecologic Oncology, University Hospital Leuven, Leuven Cancer Institute, Leuven, Belgium.
authors.forename: Karin
authors.initials: K
authors.lastname: Leunen
authors.affiliation: Jan Yperman ziekenhuis, Ieper, Belgium.
authors.forename: Kurt
authors.initials: K
authors.lastname: Geldhof
authors.affiliation: AZ Klina, Brasschaat, Belgium.
authors.forename: Didier
authors.initials: D
authors.lastname: Verhoeven
authors.affiliation: CHA - Centre Hospitalier de l'Ardenne, Libramont, Belgium.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Forget
authors.affiliation: Clinique et Maternité Sainte Elisabeth, Namur, Belgium.
authors.forename: Peter
authors.initials: P
authors.lastname: Vuylsteke
authors.affiliation: Cliniques universitaires UCL de Mont-Godinne, Yvoir, Belgium.
authors.forename: Lionel
authors.initials: L
authors.lastname: D'Hondt
authors.affiliation: UZ Antwerpen, Edegem, Belgium.
authors.forename: Manon
authors.initials: M
authors.lastname: Huizing
authors.affiliation: Imeldaziekenhuis, Bonheiden, Belgium.
authors.forename: Heidi
authors.initials: H
authors.lastname: Van den Bulck
authors.affiliation: Leuvens Biostatistiek en Statistische Bioinformatica Centrum, Leuven, Belgium.
authors.forename: Annouschka
authors.initials: A
authors.lastname: Laenen
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D015331:Cohort Studies; D018572:Disease-Free Survival; D005260:Female; D005833:Genital Neoplasms, Female / Q000188:drug therapy*; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced / Q000517:prevention & control; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D011446:Prospective Studies; D015996:Survival Rate
chemical_list: D016179:Granulocyte Colony-Stimulating Factor; D016190:Carboplatin; D017239:Paclitaxel
keywords: Carboplatin; Cervical cancer; Endometrial cancer; G-CSF; Ovarian cancer; Paclitaxel