100P - Phase III of study of docetaxel and carboplatin with or without doxorubicin hydrochloride and cyclophosphamide in treating women with triple negati...

Date 18 December 2016
Event ESMO Asia 2016 Congress
Session Poster lunch
Topics Anti-Cancer Agents & Biologic Therapy
Breast Cancer, Locally Advanced
Presenter Safa Najafi
Citation Annals of Oncology (2016) 27 (suppl_9): ix30-ix34. 10.1093/annonc/mdw576
Authors S. Najafi1, M. Payandeh2, M. Sadeghi3, F. Zahra Shojaiyan4, F. Abbasvandi4, V. Shafahi4
  • 1Medical Oncology, Iranian Centre for Breast Cancer (ICBC), 674512500 - Tehran/IR
  • 2Medical Oncology, KUMS Kermanshah University, 676941251 - Kermanshah/IR
  • 3Medical Biology Research Center, KUMS Kermanshah University, 676941251 - Kermanshah/IR
  • 4Medical Oncology, Iranian Centre for Breast Cancer (ICBC), Tehran/IR

Abstract

Background

A combination of docetaxel and carboplatin with or without doxorubicin hydrochloride and cyclophosphamide is one of the most effective front-line therapies to triple negative breast cancer. The aim of this trial was to evaluate overall survival (OS), progression free survival (PFS) and toxicity of docetaxel and carboplatin compared to docetaxel and carboplatin with doxorubicin hydrochloride and cyclophosphamide in triple negative patients with Iranian ethnicity.

Methods

In a phase III trial, patients with previously untreated triple negative were randomly assigned by using docetaxel 70 mg/m2 and Carboplatin 7 AUS every three weeks with granulocyte colony-stimulating factor (G-CSF) for 6 course (Arm A) or Doxorubicin Hydrochloride 60 mg/m2 and Cyclophosphamide 600mg/m2 every three weeks with G-CSF for 4 course followed by docetaxel 70 mg/m2 and Carboplatin 7 AUS every three weeks with G-CSF for 4 course (Arm B).

Results

A total of 119 patients were randomly enrolled in our study (60 patients in Arm A and 59 patients in Arm B), between 2010 and 2015. The mean follow-up was 43 months at the time of treatment analysis. The 2-year and 5-year PFS rates for Arm A were 92.7% vs. 85% and for Arm B were 82.6% vs. 64.4%. The 2-year and 5-year OS rates for Arm A were 96.5% vs. 91.7% and for Arm B were 90.5% vs. 81.3%. The 5-year OS in arm A was better than arm B, but the difference was no significant. Also, there was a significant difference for the 5-year PFS in the two arms, arm A had less progression. There was no significant difference between adverse events with the two regimens.

Conclusions

In our research, less progression was found with Arm A as compared to Arm B. Therefore, adding of doxorubicin hydrochloride and cyclophosphamide to chemotherapy regimen increase the progression.

Clinical trial indentification

Legal entity responsible for the study

Iranian Centre for Breast Cancer

Funding

Iranian Centre for Breast Cancer

Disclosure

All authors have declared no conflicts of interest.