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Table 1 Study outcomes of TNBC patients treated with NCCN-recommended (v1.2016) monotherapy and combination therapy

From: Current treatment landscape for patients with locally recurrent inoperable or metastatic triple-negative breast cancer: a systematic literature review

AuthorStudy descriptionTreatmentPatient population% 1L% 2L% 3L+NORR %DOR, monthsPFS, monthsOS, months% TNBC patients
NCCN-recommended (v1.2016) monotherapies
 Aftimos et al. [23]Retrospective phase III sub-group analysisEri2L+ MBC w/mTNBC01002218N/RN/RN/R17
 Awada et al. [24]Phase IIPac1L mTNBC100002828.6N/R3.513.1100
 Baselga et al. [25]Phase IICis1L–2L mTNBC722806010N/R1.59.4100
Phase IICis1L mTNBC   4212N/RN/RN/R100
Phase IICis2L mTNBC   166N/RN/RN/R100
 Brufsky et al. [26]RIBBON-2Physician’s choice chemo2L MBC w/mTNBC010004718N/R2.712.621
 Isakoff et al. [27]Phase IICar/cis1L–2L mTNBC802008625.6N/R2.911100
Phase IICar/cis1L mTNBC   6929N/RN/RN/R100
Phase IICar/cis2L mTNBC   1711.8N/RN/RN/R100
 Miles et al. [28]RIBBON-1 + AVADO + E2100 pooled subgroupCap/doc/pac1L MBC w/mTNBC1000025523.3N/R5.417.526
 Perez et al. [29]BEACONPhysician’s choice chemo3L+ MBC w/mTNBC00100117N/RN/RN/R8.828
 Pivot et al. [30]Prespecified phase III subgroupCap1L–3L+ MBC w/mTNBC94943969N/R2.1N/R25
 Sparano et al. [31]Phase IIICap1L–3L+ MBC w/mTNBC196318134N/RN/R1.81N/R22
 Study 301Phase III subgroupCap1L MBC w/mTNBC   40124.4N/R9.924.5
Eri1L MBC w/mTNBC   4010.46.6N/R13.127.1
Phase III subgroupCap2L+ MBC w/mTNBC   96~
Eri2L+ MBC w/mTNBC   110~ 104.23.415.227.1
 Tredan et al. [32]Phase IIIxa1L mTNBC1000040304.54.1N/R100
 Twelves et al. [9] and Pivot et al. [13]EMBRACE + 301 pooled subgroupEri1L–3L+ MBC w/mTNBC11276224312N/R2.812.922.9
EMBRACE + 301 pooled subgroupEri2L+ MBC w/mTNBC   19911N/R2.812.422.9
 Twelves et al. [9] and Pivot et al. [13]EMBRACE + 301 pooled subgroupPhysician’s choice chemo1L–3L+ MBC w/mTNBC13375018510.3N/R2.68.223.1
EMBRACE + 301 pooled subgroupPhysician’s choice chemo2L+ MBC w/mTNBC   1539N/R2.58.123.1
 von Minckwitz et al. [33]TANIAPhysician’s choice chemo2L MBC w/mTNBC0100057N/RN/R2.1N/R23
NCCN-v1.2016-recommended combination therapies
 Brodowicz et al. [34]§TURANDOTBev+pac1L MBC w/mTNBC100006349N/R924.222
 Dieras et al. [35]Phase IIBev+pac1L–2L mTNBC811906147.537.57.217.4100
Phase IIBev+pac1L mTNBC   46N/RN/R7.2N/R100
Phase IIBev+pac2L mTNBC   16N/RN/R7N/R100
 Fan et al. [36]Phase IIDoc+cap1L mTNBC100002615.4N/R4.821.5100
 Halim et al. [37]Phase IICar+pac2L+ mTNBC01005060N/RN/RN/R100
 Li et al. [38]Phase IICap+cis1L–3L mTNBC84.912.133363.6N/R8.217.8100
Phase IICap+cis1L mTNBC   2864.3N/R8.219.6100
Phase IICap+cis2L–3L mTNBC   560N/R5.116.5100
 Liao et al. [39]Phase IIDoc+cap1L mTNBC100002714.8N/R4.921.5100
 Liao et al. [39]Phase IIVin+cap1L mTNBC100001827.8N/R5.218.2100
 Miles et al. [28]* (many combinations with high ORR—OS is still not much higher)Pooled phase III (E2100, AVADO, RIBBON-1)Bev+(cap/doc/pac/nab-pac/(dox/epi/CP/ FU))1L MBC w/mTNBC1000036042.3N/R8.118.925
 O’Shaughnessy et al. [40]Phase IIIGem+car1L–3L mTNBC584224432N/R4.111.1100
Phase IIIGem+car1L mTNBC   149N/RN/R4.613.9100
Phase IIIGem+car2L–3L mTNBC   109N/RN/R2.98.1100
 Pivot et al. [30]Prespecified phase III subgroupIxa+cap1L–3L+ MBC w/mTNBC748459127N/R4.1N/R24.3
 Rugo et al. [41]Phase IIIBev+nab-pac1L MBC w/mTNBC1000065N/RN/R7.4N/R24
 Rugo et al. [41]Phase IIIBev+ixa1L MBC w/mTNBC1000063N/RN/R5.6N/R26
 Rugo et al. [41]Phase IIIBev+pac1L MBC w/mTNBC1000073N/RN/R6.5N/R26
 Sparano et al. [31]Phase IIIIxa+cap1L–3L+ MBC w/mTNBC206119122N/RN/R4.2N/R20
  1. 1L first-line, 2L second-line, 3L third-line, APaT all patients as treated, Bev bevacizumab, Cap capecitabine, Car carboplatin, chemo chemotherapy, Cis cisplatin, CP cyclophosphamide, Doc docetaxel, Dox doxorubicin, Epi epirubicin, Eri eribulin, FU fluorouracil, Gem gemcitabine, Ixa ixabepilone, MBC metastatic breast cancer, mTNBC metastatic triple-negative breast cancer, N/R not reported, ORR objective response rate, Pac paclitaxel, TNBC triple-negative breast cancer, Vin vinorelbine
  2. *Paclitaxel in E2100, docetaxel in AVADO, capecitabine in one cohort of RIBBON-1, and either a single-agent taxane or an anthracycline-based combination in the second cohort of RIBBON-1. Of the total n = 255 in the meta-analysis, n = 46 belong to the taxane/anthracycline cohort of RIBBON-1; the number (< 46) of this subset of patients receiving anthracycline combination is unknown
  3. Based on internal communication with trial sponsor (Eisai); not published results
  4. n and ORR based on APaT population
  5. §2L+ MBC with mTNBC outcomes are available in a separate study from Pivot et al. [13]