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Phase II study of adjuvant docetaxel and carboplatin with/without doxorubicin and cyclophosphamide in triple negative breast cancer: a randomised controlled clinical trial

View Article: PubMed Central - PubMed

ABSTRACT

Aim of the study: The aim of this trial was to compare overall survival (OS), disease-free survival (DFS), and toxicity of two adjuvant regimens in triple negative patients with Iranian ethnicity.

Material and methods: In a phase II trial, patients with previously untreated triple negative breaststroke cancer were randomly assigned by using docetaxel 70 mg/m2 and carboplatin AUC = 7 every three weeks with granulocyte colony-stimulating factor for sin courses (arm A) or doxorubicin hydrochloride 60 mg/m2 and cyclophosphamide 600 mg/m2 every three weeks with G-CSF for four courses followed by docetaxel 70 mg/m2 and carboplatin AUC = 7 every three weeks with G-CSF for four courses (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 2011 and 2016. The mean follow-up was 40 months at the time of treatment analysis. The 2-year and 5-year DFS 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%. There was a significant correlation for DFS and OS in the two arms. 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. Adding of anthracyclines such as doxorubicin hydrochloride did not increase OS and DFS in triple negative breast cancer (TNBC) patients.

No MeSH data available.


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Mentions: This randomised phase II clinical trial was approved by the Ethics Committee of Kermanshah University of Medical Sciences, Kermanshah, Iran, and registered at http://www.irct.ir (registration number: IRCT2016070325791N2). The range of participants’ recruitment was from Feb 2011 to Jul 2011. During Aug 2011 to Sep 2016 the patients referred to the Breast Cancer Research Centre, Tehran University of Medical Sciences, Tehran, Iran. All patients gave written, informed consent before enrolment. Figure 1 shows the consort flow chart, which details the number of participants. The patients were divided into two groups: 60 patients in Arm A, treated with adjuvant docetaxel 70 mg/m2 and carboplatin AUC = 7 every three weeks with granulocyte colony-stimulating factor (G-CSF) for six courses; and 59 patients in Arm B, treated with adjuvant doxorubicin hydrochloride 60 mg/m2 and cyclophosphamide 600 mg/m2 every three weeks with G-CSF for 4 courses followed by docetaxel 70 mg/m2 and carboplatin AUC = 7 every three weeks with G-CSF for four courses. The mutations of BRCA 1 and 2 were not checked due to their high price, and all patients did R0 resection. The OS was defined as the time from randomisation to death, irrespective of cause, and disease-free survival (DFS) was defined as the time from randomisation to local or distant relapse or death.


Phase II study of adjuvant docetaxel and carboplatin with/without doxorubicin and cyclophosphamide in triple negative breast cancer: a randomised controlled clinical trial
Consort flow chart
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC5385483&req=5

f0001: Consort flow chart
Mentions: This randomised phase II clinical trial was approved by the Ethics Committee of Kermanshah University of Medical Sciences, Kermanshah, Iran, and registered at http://www.irct.ir (registration number: IRCT2016070325791N2). The range of participants’ recruitment was from Feb 2011 to Jul 2011. During Aug 2011 to Sep 2016 the patients referred to the Breast Cancer Research Centre, Tehran University of Medical Sciences, Tehran, Iran. All patients gave written, informed consent before enrolment. Figure 1 shows the consort flow chart, which details the number of participants. The patients were divided into two groups: 60 patients in Arm A, treated with adjuvant docetaxel 70 mg/m2 and carboplatin AUC = 7 every three weeks with granulocyte colony-stimulating factor (G-CSF) for six courses; and 59 patients in Arm B, treated with adjuvant doxorubicin hydrochloride 60 mg/m2 and cyclophosphamide 600 mg/m2 every three weeks with G-CSF for 4 courses followed by docetaxel 70 mg/m2 and carboplatin AUC = 7 every three weeks with G-CSF for four courses. The mutations of BRCA 1 and 2 were not checked due to their high price, and all patients did R0 resection. The OS was defined as the time from randomisation to death, irrespective of cause, and disease-free survival (DFS) was defined as the time from randomisation to local or distant relapse or death.

View Article: PubMed Central - PubMed

ABSTRACT

Aim of the study: The aim of this trial was to compare overall survival (OS), disease-free survival (DFS), and toxicity of two adjuvant regimens in triple negative patients with Iranian ethnicity.

Material and methods: In a phase II trial, patients with previously untreated triple negative breaststroke cancer were randomly assigned by using docetaxel 70 mg/m2 and carboplatin AUC = 7 every three weeks with granulocyte colony-stimulating factor for sin courses (arm A) or doxorubicin hydrochloride 60 mg/m2 and cyclophosphamide 600 mg/m2 every three weeks with G-CSF for four courses followed by docetaxel 70 mg/m2 and carboplatin AUC = 7 every three weeks with G-CSF for four courses (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 2011 and 2016. The mean follow-up was 40 months at the time of treatment analysis. The 2-year and 5-year DFS 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%. There was a significant correlation for DFS and OS in the two arms. 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. Adding of anthracyclines such as doxorubicin hydrochloride did not increase OS and DFS in triple negative breast cancer (TNBC) patients.

No MeSH data available.