Docetaxel-Cisplatin and Docetaxel-Capecitabine in TNBC
Docetaxel-Cisplatin and Docetaxel-Capecitabine in TNBC
This was a prospective, open-label, randomized phase II clinical trial carried out in the Cancer Hospital, Chinese Academy of Medical Sciences. Eligible locally advanced or metastatic TNBC women without prior treatment for advanced disease were randomized (1 : 1) to receive either TP regimen (docetaxel 75 mg/m plus cisplatin 75 mg/m i.v. infusion day 1) or TX regimen (docetaxel 75 mg/m i.v. infusion day 1 plus capecitabine 1000 mg/m bid, 2 weeks on, 1 week off) every 3 weeks for up to six cycles, until disease progression, unacceptable toxicity or patient consent withdrawal (Figure 1). The primary end point was to compare the objective response rates (ORRs); the secondary end points were progression-free survival (PFS), overall survival (OS) and safety. Tumor response was evaluated in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) guidelines by computed tomography scanning (or magnetic resonance imaging if indicated) every two cycles during treatment and every 3 months after discontinuation of study treatment. Toxic effects were graded according to the National Cancer Institute Common Toxicity Criteria for adverse events, version 3.0. The study was conducted in accordance with the Declaration of Helsinki and approved by the local ethical committee, and informed consent was obtained from all the patients.
(Enlarge Image)
Figure 1.
Study design.
The major inclusion criteria included patients aged ≥18 years with histologically confirmed ER-, PR-, and HER2- primary breast cancer (ER- and PR- were first defined as <10% positive tumor cells with nuclear staining in Immunohistochemistry [IHC] and then <1% after April 2010 according to new College of American Pathologists guidelines at that time. HER2- was defined as IHC scoring 0 or 1+ or FISH nonamplied according to the ASCO guidelines); patients must have at least one measurable lesion according to RECIST 1.0; No prior treatment of advanced disease; Anthracyclines should have been given in the neoadjuvant or adjuvant setting; An Eastern Cooperative Oncology Group (ECOG) score ≤1 was required. Patients must have adequate organ function. Previous paclitaxel was allowed. Patients were excluded if original primary tumor or subsequent relapse was known to be positive for any of ER, PR or HER2 or if they had been treated for advanced disease. Previous treatment with a platinum or docetaxel was not allowed.
PFS was defined as the time from the start of the treatment until disease progression or death. OS was calculated from the date of first administration of treatment to death by any cause or censored at the last date the patient was known to be alive. When the study was designed, the expected response rate of TP regimen was 50%. To detect a difference of 0.35 in response rate between groups with a power of 80% and two-sided significance level at 0.05, at least 26 patients were needed in each group. Patients' characteristics were compared with chi-square test or Fisher exact test. Median TTP, OS were all estimated by the Kaplan–Meier method compared by log-rank test. Response rates of different regimens were compared by chi-squared testing.
Patients and Methods
Study Design
This was a prospective, open-label, randomized phase II clinical trial carried out in the Cancer Hospital, Chinese Academy of Medical Sciences. Eligible locally advanced or metastatic TNBC women without prior treatment for advanced disease were randomized (1 : 1) to receive either TP regimen (docetaxel 75 mg/m plus cisplatin 75 mg/m i.v. infusion day 1) or TX regimen (docetaxel 75 mg/m i.v. infusion day 1 plus capecitabine 1000 mg/m bid, 2 weeks on, 1 week off) every 3 weeks for up to six cycles, until disease progression, unacceptable toxicity or patient consent withdrawal (Figure 1). The primary end point was to compare the objective response rates (ORRs); the secondary end points were progression-free survival (PFS), overall survival (OS) and safety. Tumor response was evaluated in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) guidelines by computed tomography scanning (or magnetic resonance imaging if indicated) every two cycles during treatment and every 3 months after discontinuation of study treatment. Toxic effects were graded according to the National Cancer Institute Common Toxicity Criteria for adverse events, version 3.0. The study was conducted in accordance with the Declaration of Helsinki and approved by the local ethical committee, and informed consent was obtained from all the patients.
(Enlarge Image)
Figure 1.
Study design.
Patient Selection
The major inclusion criteria included patients aged ≥18 years with histologically confirmed ER-, PR-, and HER2- primary breast cancer (ER- and PR- were first defined as <10% positive tumor cells with nuclear staining in Immunohistochemistry [IHC] and then <1% after April 2010 according to new College of American Pathologists guidelines at that time. HER2- was defined as IHC scoring 0 or 1+ or FISH nonamplied according to the ASCO guidelines); patients must have at least one measurable lesion according to RECIST 1.0; No prior treatment of advanced disease; Anthracyclines should have been given in the neoadjuvant or adjuvant setting; An Eastern Cooperative Oncology Group (ECOG) score ≤1 was required. Patients must have adequate organ function. Previous paclitaxel was allowed. Patients were excluded if original primary tumor or subsequent relapse was known to be positive for any of ER, PR or HER2 or if they had been treated for advanced disease. Previous treatment with a platinum or docetaxel was not allowed.
Statistics
PFS was defined as the time from the start of the treatment until disease progression or death. OS was calculated from the date of first administration of treatment to death by any cause or censored at the last date the patient was known to be alive. When the study was designed, the expected response rate of TP regimen was 50%. To detect a difference of 0.35 in response rate between groups with a power of 80% and two-sided significance level at 0.05, at least 26 patients were needed in each group. Patients' characteristics were compared with chi-square test or Fisher exact test. Median TTP, OS were all estimated by the Kaplan–Meier method compared by log-rank test. Response rates of different regimens were compared by chi-squared testing.
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