初治晚期乳腺癌紫杉醇卡铂周方案序贯卡培他滨治疗单臂单中心Ⅱ期临床研究
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摘要
目的大肿块乳腺癌患者往往合并有远处转移,预后差。本研究前瞻性观察紫杉醇联合卡铂周方案序贯卡培他滨一线治疗晚期大肿块乳腺癌的有效性与安全性。方法 2015-01-01-2018-04-30就诊安徽医科大学第一附属医院的初诊Ⅳ期大肿块乳腺癌患者16例,乳腺原发肿块分期T3～T4,且合并远处器官转移,给予紫杉醇75mg/m2联合卡铂AUC=2方案,每7d重复,用药≤12周,客观疗效评价达到完全缓解(complete remission,CR)、部分缓解(partial response,PR)患者序贯卡培他滨单药2 000mg/m2,口服,2次/d,d1～d14,21d为1个周期。近期客观疗效评价采用RECIST 1.1标准,不良反应评价采用NCI-CTCAE 4.0标准。结果可评价疗效16例患者,使用紫杉醇卡铂周方案化疗达CR 1例(6.3%),PR 13例(81.3%),稳定(stable disease,SD)2例(12.5%),CR+PR患者共14例进入卡培他滨序贯治疗,1例患者达到CR,中位无进展生存时间(progression free survival time,PFS)达到9.8个月,中位总生存时间尚未达到,1年生存率93.7%。Ⅲ～Ⅳ度不良反应为白细胞下降11例(78.6%),血小板下降2例(14.3%),恶心2例(14.3%),转氨酶升高1例(7.1%)。结论紫杉醇联合卡铂周方案序贯卡培他滨一线治疗晚期大肿块乳腺癌起效快,疗效好,不良反应可控。
OBJECTIVE Breast cancer patients with large masses often have distant metastasis with poor prognosis.This study aimed to prospectively observe the efficacy and safety of paclitaxel plus carboplatin weekly followed by capecitabine in the treatment of advanced large-lump breast cancer.METHODS From January 1,2015 to April 30,2018,we presented 16 patients with advanced large-lump breast cancer in our hospital.All patients were newly diagnosed with T3-T4 stage,and distant organ metastases M1.Patients received a maximum of 12 weeks of paclitaxel(75 mg/m2,weekly)combined with carboplatin(AUC=2,weekly).Patients who had complete response or partial response followed by capecitabine 2 000 mg/m2 orally a day for 14 days of a 21-day cycle.The recent objective evaluation of the efficacy is RECIST1.1,evaluation of adverse events using NCI-CTCAE4.0.RESULTS Sixteen patients were evaluated for efficacy.After treatment with paclitaxel plus carboplatin regimen,one patient(6.3%)had complete response(CR),thirteen patients(81.3%)achieved partial response(PR)and two patients(12.5%)had stable disease(SD).A total of 14 patients with CR+PR followed by capecitabine.In the treatment,one patient achieved CR with a median PFS of 9.8 months.The median overall survival was not yet reached,and the 1-year survival rate was 93.7%.Grade Ⅲ-Ⅳ toxicity was leukopenia(11/14,78.6%),thrombocytopenia(2/14,14.3%),nausea(2/14,14.3%)and elevated transaminase(1/14,7.1%).CONCLUSION Paclitaxel plus carboplatin weekly regimen followed by capecitabine as first-line treatment of advanced largelump breast cancer has good curative effect,controllable toxicity,rapid onset.
OBJECTIVE Breast cancer patients with large masses often have distant metastasis with poor prognosis.This study aimed to prospectively observe the efficacy and safety of paclitaxel plus carboplatin weekly followed by capecitabine in the treatment of advanced large-lump breast cancer.METHODS From January 1,2015 to April 30,2018,we presented 16 patients with advanced large-lump breast cancer in our hospital.All patients were newly diagnosed with T3-T4 stage,and distant organ metastases M1.Patients received a maximum of 12 weeks of paclitaxel(75 mg/m2,weekly)combined with carboplatin(AUC=2,weekly).Patients who had complete response or partial response followed by capecitabine 2 000 mg/m2 orally a day for 14 days of a 21-day cycle.The recent objective evaluation of the efficacy is RECIST1.1,evaluation of adverse events using NCI-CTCAE4.0.RESULTS Sixteen patients were evaluated for efficacy.After treatment with paclitaxel plus carboplatin regimen,one patient(6.3%)had complete response(CR),thirteen patients(81.3%)achieved partial response(PR)and two patients(12.5%)had stable disease(SD).A total of 14 patients with CR+PR followed by capecitabine.In the treatment,one patient achieved CR with a median PFS of 9.8 months.The median overall survival was not yet reached,and the 1-year survival rate was 93.7%.Grade Ⅲ-Ⅳ toxicity was leukopenia(11/14,78.6%),thrombocytopenia(2/14,14.3%),nausea(2/14,14.3%)and elevated transaminase(1/14,7.1%).CONCLUSION Paclitaxel plus carboplatin weekly regimen followed by capecitabine as first-line treatment of advanced largelump breast cancer has good curative effect,controllable toxicity,rapid onset.
引文
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[2]田丽军,徐兵河.136例大肿块女性乳腺癌的临床特点及预后分析[J].中国肿瘤临床与康复,2006,13(2):117-120.
[3]中国抗癌协会乳腺癌专业委员会.中国抗癌协会乳腺癌诊治指南与规范(2017年版)[J].中国癌症杂志,2017,27(9):695-759.
[4] Cardoso F,Senkus E,Costa A,et al.4th ESO-ESMO International Consensus Guidelines for Advanced Breast Cancer(ABC 4)[J].Ann Oncol,2018,29(8):1634-1657.
[5] Burris H 3rd,Yardley D,Jones S,et al.PhaseⅡTrial of Trastuzumab Followed by Weekly Paclitaxel/Carboplatin As First-Line Treatment for Patients With Metastatic Breast Cancer[J].J Clin Oncol,2004 22(9):1621-1629.
[6] Bayo J,Avi1óV,Toscano F,et al.Toxicity of docetaxel,carboplatin,and trastuzumab combination as adjuvant or neo-adjuvant treatment for Her2positive breast cancer patients and impact of colony-stimulating factor prophylaxis[J].Breast J,2018,24(4):462.
[7] Gluz O,Nitz U,Liedtke C,et al.Comparison of neoadjuvant nab-paclitaxel+carboplatin vs nab-paclitaxel+gemcitabine in triple-negative breast cancer:Randomized WSG-ADAPT-TN trial results[J].J Nat Cancer Ins,2018,110(6):628-637.
[8] Saloustros E,Nikolaou M,Kalbakis K,et al.Weekly Paclitaxel and carboplatin plus bevacizumab as first-line treatment of metastatic triple-negative breast cancer.A multicenter phaseⅡtrial by the hellenic oncology research group[J].Clin Breast Cancer,2018,18(1):88-94.
[9] Palazzo A,Dellapasqua S,Munzone E,et al.PhaseⅡtrial of bevacizumab plus weekly paclitaxel,carboplatin,and metronomic cyclophosphamide with or without trastuzumab and endocrine therapy as preoperative treatment of inflammatory breast cancer[J].Clin Breast Cancer,2018,18(4):328-335.
[10]徐兵河,王树森,江泽飞.中国晚期乳腺癌维持治疗专家共识[J].中华医学杂志,2018,98(2):87-90.
[11]马文玥,张频,张柏林,等.卡铂联合紫杉醇治疗局部晚期三阴性乳腺癌的Ⅱ期临床研究[J].中华肿瘤杂志,2012,34(10):770-774.
[12] Perez EA,Suman VJ,Rowland KM,et al.Two concurrent phaseⅡtrials of paclitaxel/carboplatin/trastuzumab(weekly or every-3-week schedule)as first-line therapy in women with HER2-overexpressing metastatic breast cancer:NCCTG study 983252[J].Clin Breast Cancer,2005,6(5):425-432.
[13]宋彬,成苏兰.T4期乳腺癌术前尺动脉插管化疗22例临床分析[J].肿瘤防治杂志,2000,7(6):629-630.
[2]田丽军,徐兵河.136例大肿块女性乳腺癌的临床特点及预后分析[J].中国肿瘤临床与康复,2006,13(2):117-120.
[3]中国抗癌协会乳腺癌专业委员会.中国抗癌协会乳腺癌诊治指南与规范(2017年版)[J].中国癌症杂志,2017,27(9):695-759.
[4] Cardoso F,Senkus E,Costa A,et al.4th ESO-ESMO International Consensus Guidelines for Advanced Breast Cancer(ABC 4)[J].Ann Oncol,2018,29(8):1634-1657.
[5] Burris H 3rd,Yardley D,Jones S,et al.PhaseⅡTrial of Trastuzumab Followed by Weekly Paclitaxel/Carboplatin As First-Line Treatment for Patients With Metastatic Breast Cancer[J].J Clin Oncol,2004 22(9):1621-1629.
[6] Bayo J,Avi1óV,Toscano F,et al.Toxicity of docetaxel,carboplatin,and trastuzumab combination as adjuvant or neo-adjuvant treatment for Her2positive breast cancer patients and impact of colony-stimulating factor prophylaxis[J].Breast J,2018,24(4):462.
[7] Gluz O,Nitz U,Liedtke C,et al.Comparison of neoadjuvant nab-paclitaxel+carboplatin vs nab-paclitaxel+gemcitabine in triple-negative breast cancer:Randomized WSG-ADAPT-TN trial results[J].J Nat Cancer Ins,2018,110(6):628-637.
[8] Saloustros E,Nikolaou M,Kalbakis K,et al.Weekly Paclitaxel and carboplatin plus bevacizumab as first-line treatment of metastatic triple-negative breast cancer.A multicenter phaseⅡtrial by the hellenic oncology research group[J].Clin Breast Cancer,2018,18(1):88-94.
[9] Palazzo A,Dellapasqua S,Munzone E,et al.PhaseⅡtrial of bevacizumab plus weekly paclitaxel,carboplatin,and metronomic cyclophosphamide with or without trastuzumab and endocrine therapy as preoperative treatment of inflammatory breast cancer[J].Clin Breast Cancer,2018,18(4):328-335.
[10]徐兵河,王树森,江泽飞.中国晚期乳腺癌维持治疗专家共识[J].中华医学杂志,2018,98(2):87-90.
[11]马文玥,张频,张柏林,等.卡铂联合紫杉醇治疗局部晚期三阴性乳腺癌的Ⅱ期临床研究[J].中华肿瘤杂志,2012,34(10):770-774.
[12] Perez EA,Suman VJ,Rowland KM,et al.Two concurrent phaseⅡtrials of paclitaxel/carboplatin/trastuzumab(weekly or every-3-week schedule)as first-line therapy in women with HER2-overexpressing metastatic breast cancer:NCCTG study 983252[J].Clin Breast Cancer,2005,6(5):425-432.
[13]宋彬,成苏兰.T4期乳腺癌术前尺动脉插管化疗22例临床分析[J].肿瘤防治杂志,2000,7(6):629-630.