The published studies suggest that for selected women with stage IIIC or IV epithelial ovarian cancer , neoadjuvant chemotherapy and interval cytoreduction are non-inferior to primary cytoreduction and adjuvant chemotherapy with respect to overall and progression-free survival and are associated with less perioperative morbidity and mortality .
PURPOSE To provide guidance to clinicians regarding the use of neoadjuvant chemotherapy and interval cytoreduction among women with stage IIIC or IV epithelial ovarian cancer .
Carboplatin plus paclitaxel once a week versus every 3 weeks in patients with advanced ovarian cancer (MITO-7): a randomised, multicentre, open-label, phase 3 trial.
BACKGROUND Carboplatin plus paclitaxel administered every 3 weeks is st and ard first-line chemotherapy for patients with advanced ovarian cancer . A weekly paclitaxel schedule combined with carboplatin every 3 weeks prolonged progression-free survival and overall survival in a Japanese phase 3 trial . The aim of our study was to assess whether a weekly schedule of carboplatin plus paclitaxel is more effective than the same drugs given every 3 weeks . METHODS We did a multicentre , r and omised , phase 3 study at 67 institutions in Italy and France . Women with FIGO stage IC-IV ovarian cancer , an ECOG performance status of 2 or lower , and who had never received chemotherapy were r and omly allocated in a 1:1 ratio to receive either carboplatin ( AUC 6 mg/mL per min ) plus paclitaxel ( 175 mg/m(2 ) ) every 3 weeks for six cycles or carboplatin ( AUC 2 mg/mL per min ) plus paclitaxel ( 60 mg/m(2 ) ) every week for 18 weeks . R and omisation was done by computer-based minimisation , stratified by centre , residual disease after surgery , and ECOG performance status . The study was not blinded . Co primary endpoints were progression-free survival and quality of life ( assessed by the Functional Assessment of Cancer Therapy Ovarian Trial Outcome Index [ FACT-O/TOI ] score ) , and analysis was by modified intention to treat . This report presents the final analysis . The study is registered with Clinical Trials.gov , number NCT00660842 . FINDINGS 822 patients were enrolled into the study between Nov 20 , 2008 , and March 1 , 2012 ; 12 withdrew their consent immediately after r and omisation and were excluded , and 810 were eligible for analysis . 404 women were allocated treatment every 3 weeks and 406 were assigned to the weekly schedule . After median follow-up of 22·3 months ( IQR 16·2 - 30·9 ) , 449 progression-free survival events were recorded . Median progression-free survival was 17·3 months ( 95 % CI 15·2 - 20·2 ) in patients assigned to treatment every 3 weeks , versus 18·3 months ( 16·8 - 20·9 ) in women allocated to the weekly schedule ( hazard ratio 0·96 , 95 % CI 0·80 - 1·16 ; p=0·66 ) . FACT-O/TOI scores differed significantly between the two schedules ( treatment-by-time interaction p<0·0001 ) ; with treatment every 3 weeks , FACT-O/TOI scores worsened at every cycle ( weeks 1 , 4 , and 7 ) , whereas for the weekly schedule , after transient worsening at week 1 , FACT-O/TOI scores remained stable . Fewer patients assigned to the weekly group than those allocated treatment every 3 weeks had grade 3 - 4 neutropenia ( 167 [ 42 % ] of 399 patients vs 200 [ 50 % ] of 400 patients ) , febrile neutropenia ( two [ 0·5 % ] vs 11 [ 3 % ] ) , grade 3 - 4 thrombocytopenia ( four [ 1 % ] vs 27 [ 7 % ] ) , and grade 2 or worse neuropathy ( 24 [ 6 % ] vs 68 [ 17 % ] ) . Three deaths during the study were attributed to chemotherapy ; two women died who were allocated treatment every 3 weeks and one death was recorded in the group assigned the weekly regimen . INTERPRETATION A weekly regimen of carboplatin and paclitaxel might be a reasonable option for first-line treatment of women with advanced ovarian cancer . FUNDING None
The published studies suggest that for selected women with stage IIIC or IV epithelial ovarian cancer , neoadjuvant chemotherapy and interval cytoreduction are non-inferior to primary cytoreduction and adjuvant chemotherapy with respect to overall and progression-free survival and are associated with less perioperative morbidity and mortality .
PURPOSE To provide guidance to clinicians regarding the use of neoadjuvant chemotherapy and interval cytoreduction among women with stage IIIC or IV epithelial ovarian cancer .