Cisplatin plus gemcitabine versus paclitaxel plus gemcitabine as first-line therapy for metastatic triple-negative breast cancer (CBCSG006): A randomised, open-label, multicentre, phase 3 trial

The Lancet Oncology

Volumn 16, Issue 4, 2015, Pages 436-446

  Hu, Xi Chun ^a,b   Zhang, Jian ^a,b   Xu, Bing He ^d   Cai, Li ^e   Ragaz, Joseph ^f   Wang, Zhong Hua ^a,b   Wang, Bi Yun ^a,b   Teng, Yue E ^g   Tong, Zhong Sheng ^h   Pan, Yue Yin ⁱ   Yin, Yong Mei ^j   Wu, Chang Ping ^k   Jiang, Ze Fei ^l   Wang, Xiao Jia ^m   Lou, Gu Yin ⁿ   Liu, Dong Geng ^o   Feng, Ji Feng ^p   Luo, Jian Feng ^c   Sun, Kang ^q   Gu, Ya Jia ^a,b   Wu, Jiong ^a,b   Shao, Zhi Min ^a,b   more..

^a FUDAN UNIVERSITY SHANGHAI CANCER CENTER   (China)

^b FUDAN UNIVERSITY   (China)

^c FUDAN UNIVERSITY   (China)

^d CANCER HOSPITAL   (China)

^e HARBIN MEDICAL UNIVERSITY   (China)

^f UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^g CHINA MEDICAL UNIVERSITY   (China)

^h TIANJIN MEDICAL UNIVERSITY   (China)

ⁱ ANHUI MEDICAL UNIVERSITY   (China)

^j THE FIRST AFFILIATED HOSPITAL OF NANJING MEDICAL UNIVERSITY   (China)

^k THE THIRD AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY   (China)

^l Beijing 307 Hospital   (China)

^m ZHEJIANG CANCER HOSPITAL   (China)

ⁿ SHANGHAI JIAO TONG UNIVERSITY SCHOOL OF MEDICINE   (China)

^o SUN YAT SEN UNIVERSITY   (China)

^p JIANGSU CANCER HOSPITAL   (China)

^q Clinical Development   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; CISPLATIN; DEOXYCYTIDINE; GEMCITABINE; PACLITAXEL;

ADULT; ANALOGS AND DERIVATIVES; CANCER STAGING; CHINA; CLINICAL TRIAL; CONTROLLED STUDY; DISEASE FREE SURVIVAL; FEMALE; HUMAN; MIDDLE AGED; PATHOLOGY; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME; TRIPLE NEGATIVE BREAST NEOPLASMS;

ADULT; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CHINA; CISPLATIN; DEOXYCYTIDINE; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; MIDDLE AGED; NEOPLASM STAGING; PACLITAXEL; TREATMENT OUTCOME; TRIPLE NEGATIVE BREAST NEOPLASMS;

EID: 84933500899     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(15)70064-1     Document Type: Article

References (30)

1. Foulkes WD, Smith IE, Reis-Filho JS Triple-negative breast cancer. N Engl J Med 2010, 363:1938-1948.
2. Dent R, Trudeau M, Pritchard KI, et al. Triple-negative breast cancer: clinical features and patterns of recurrence. Clin Cancer Res 2007, 13:4429-4434.
3. Kassam F, Enright K, Dent R, et al. Survival outcomes for patients with metastatic triple-negative breast cancer: implications for clinical practice and trial design. Clin Breast Cancer 2009, 9:29-33.
4. Clark O, Botrel TE, Paladini L, Ferreira MB Targeted therapy in triple-negative metastatic breast cancer: a systematic review and meta-analysis. Core Evid 2014, 9:1-11.
5. Ma CX, Ellis MJ, Petroni GR, et al. A phase II study of UCN-01 in combination with irinotecan in patients with metastatic triple negative breast cancer. Breast Cancer Res Treat 2013, 137:483-492.
6. Gelmon K, Dent R, Mackey JR, Laing K, McLeod D, Verma S Targeting triple-negative breast cancer: optimising therapeutic outcomes. Ann Oncol 2012, 23:2223-2234.
7. Couch FJ, Hart SN, Sharma P, et al. Inherited mutations in 17 breast cancer susceptibility genes among a large triple-negative breast cancer cohort unselected for family history of breast cancer. J Clin Oncol 2014, published online Dec 1. 10.1200/JCO.2014.57.1414.
8. Andre F, Job B, Dessen P, et al. Molecular characterization of breast cancer with high-resolution oligonucleotide comparative genomic hybridization array. Clin Cancer Res 2009, 15:441-451.
9. Bergamaschi A, Kim YH, Wang P, et al. Distinct patterns of DNA copy number alteration are associated with different clinicopathological features and gene-expression subtypes of breast cancer. Genes Chromos Cancer 2006, 45:1033-1040.
10. von Minckwitz G, Schneeweiss A, Loibl S, et al. Neoadjuvant carboplatin in patients with triple-negative and HER2-positive early breast cancer (GeparSixto; GBG 66): a randomised phase 2 trial. Lancet Oncol 2014, 15:747-756.
11. Sikov WM, Berry DA, Perou CM, et al. Impact of the addition of carboplatin and/or bevacizumab to neoadjuvant once-per-week paclitaxel followed by dose-dense doxorubicin and cyclophosphamide on pathologic complete response rates in stage II to III triple-negative breast cancer: CALGB 40603 (Alliance). J Clin Oncol 2015, 33:13-21.
12. Hurley J, Reis IM, Rodgers SE, et al. The use of neoadjuvant platinum-based chemotherapy in locally advanced breast cancer that is triple negative: retrospective analysis of 144 patients. Breast Cancer Res Treat 2013, 138:783-794.
13. Isakoff SJ, Goss PE, Mayer EL, et al. TBCRC009: a multicenter phase II study of cisplatin or carboplatin for metastatic triple-negative breast cancer and evaluation of p63/p73 as a biomarker of response. Proc Am Soc Clin Oncol 2011, 29(suppl). abstr 1025.
14. Wang Z, Hu X, Chen L, et al. Efficacy of gemcitabine and cisplatin (GP) as first-line combination therapy in patients with triple-negative metastatic breast cancer: preliminary results report of a phase II trial. Proc Am Soc Clin Oncol 2010, 28(suppl 15). abstr 1100.
15. Bergman AM, Ruiz VHV, Veerman G, Kuiper CM, Peters GJ Synergistic interaction between cisplatin and gemcitabine in vitro. Clin Cancer Res 1996, 2:521-530.
16. van Moorsel CJ, Kroep JR, Pinedo HM, et al. Pharmacokinetic schedule finding study of the combination of gemcitabine and cisplatin in patients with solid tumors. Ann Oncol 1999, 10:441-448.
17. Albain KS, Nag SM, Calderillo-Ruiz G, et al. Gemcitabine plus paclitaxel versus paclitaxel monotherapy in patients with metastatic breast cancer and prior anthracycline treatment. J Clin Oncol 2008, 26:3950-3957.
18. Freidlin B, Korn EL, George SL, Gray R Randomized clinical trial design for assessing noninferiority when superiority is expected. J Clin Oncol 2007, 25:5019-5023.
19. Koyama T, Westfall PH Decision-theoretic views on simultaneous testing of superiority and noninferiority. J Biopharm Stat 2005, 15:943-955.
20. Lewis JA Statistical principles for clinical trials (ICH E9): an introductory note on an international guideline. Stat Med 1999, 18:1903-1942.
21. Tassone P, Tagliaferri P, Perricelli A, et al. BRCA1 expression modulates chemosensitivity of BRCA1-defective HCC1937 human breast cancer cells. Br J Cancer 2003, 88:1285-1291.
22. Leong CO, Vidnovic N, DeYoung MP, Sgroi D, Ellisen LW The p63/p73 network mediates chemosensitivity to cisplatin in a biologically defined subset of primary breast cancers. J Clin Invest 2007, 117:1370-1380.
23. Fan Y, Xu BH, Yuan P, et al. Docetaxel-cisplatin might be superior to docetaxel-capecitabine in the first-line treatment of metastatic triple-negative breast cancer. Ann Oncol 2013, 24:1219-1225.
24. O'Shaughnessy J, Schwartzberg L, Danso MA, et al. Phase III study of iniparib plus gemcitabine and carboplatin versus gemcitabine and carboplatin in patients with metastatic triple-negative breast cancer. J Clin Oncol 2014, 32:3840-3847.
25. Miles DW, Dieras V, Cortes J, Duenne AA, Yi J, O'Shaughnessy J First-line bevacizumab in combination with chemotherapy for HER2-negative metastatic breast cancer: pooled and subgroup analyses of data from 2447 patients. Ann Oncol 2013, 24:2773-2780.
26. Park YH, Jung KH, Im SA, et al. Phase III, multicenter, randomized trial of maintenance chemotherapy versus observation in patients with metastatic breast cancer after achieving disease control with six cycles of gemcitabine plus paclitaxel as first-line chemotherapy: KCSG-BR07-02. J Clin Oncol 2013, 31:1732-1739.
27. Tutt A, Ellis P, Kilburn L, et al. The TNT trial: a randomized phase III trial of carboplatin (C) compared with docetaxel (D) for patients with metastatic or recurrent locally advanced triple negative or BRCA1/2 breast cancer (CRUK/07/012). San Antonio Breast Cancer Symposium, 2014: abstr S3-01.
28. Peshkin BN, Alabek ML, Isaacs C BRCA1/2 mutations and triple negative breast cancers. Breast Dis 2010, 32:25-33.
29. Lips EH, Mulder L, Hannemann J, et al. Indicators of homologous recombination deficiency in breast cancer and association with response to neoadjuvant chemotherapy. Ann Oncol 2011, 22:870-876.
30. Telli ML, Jensen KC, Abkevich V, et al. Homologous recombination deficiency (HRD) score predicts pathologic response following neoadjuvant platinum-based therapy in triple-negative and BRCA1/2 mutation-associated breast cancer. San Antonio Breast Cancer Symposium, 2012: abstr PD09-04.