MITO-7 Study
Carboplatin plus paclitaxel once a week versus every 3 weeks in patients with advanced ovarian cancer; A randomized, multicentre, open-label, phase 3 trial

Disease site


Publication month/year

February, 2014

Study question

To assess whether a weekly schedule of carboplatin plus paclitaxel is more effective than the same drug combination given every 3 weeks

Type of study

Randomised controlled trial (RCT)

Interventions compared

Weekly vs every 3 weeks regimens of Carboplatin plus Paclitaxel

Experimental arm (Intervention)

Weekly Carboplatin plus Paclitaxel

Control arm

Standard Carboplatin plus Paclitaxel every 3 weeks

Primary outcome
  • Quality of Life
  • Progression-free survival
Secondary outcome
  • Overall survival 
  • Toxic effects 
  • The proportion of patients who achieved an objective response
Inclusion criteria
  • Women older than 18 years of age
  • Cytological or histological diagnosis of the epithelial ovarian, fallopian tube, or peritoneal cancer
  • Stage IC – IV disease (Based on FIGO)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower 
  • Life Expectancy of at least 3 months
  • Adequate bone marrow, kidney, and liver functions
Exclusion criteria
  • History of clinically relevant heart disease or any disorders that pose contraindications to treatment drugs.
  • Previous or concomitant malignant disease (except non-melanoma skin cancer or in-situ carcinoma of the uterine cervix) 
  • Previous history of chemotherapy
Intervention arm Control arm
Randomised (n)
Received treatment
Weekly Carboplatin plus Paclitaxel
Carboplatin plus Paclitaxel every 3 weeks
Progression-free survival (months)
1-year Overall Survival
Mortality due to chemotherapy
Objective response
  • No significant difference between groups was found on multivariate analysis.
  • Residual disease and FIGO stage were independent predictors of progression-free survival.

The proposed weekly regimen of carboplatin and paclitaxel improves quality of life and has a better toxicity profile yet it does not alter progress-free or overall survival. Despite how challenging it to adhere to and provide such regimen, it is a reasonable alternative first-line treatment for advanced ovarian cancer.

Study limitations

The study’s sample is not representative enough to account for differences in treatment endpoints such as those caused by genetic polymorphism. In addition, the usage of consistent dosing to accurately predict treatment effect might have led to inefficient and ineffective outcomes. 

Reviewer name