Table 1.

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

Author	Study description	Treatment	Patient population	% 1L	% 2L	% 3L+	N‡	ORR‡ %	DOR, months	PFS, months	OS, months	% TNBC patients
NCCN-recommended (v1.2016) monotherapies
Aftimos et al. [23]	Retrospective phase III sub-group analysis	Eri	2L+ MBC w/mTNBC	0	100		22	18	N/R	N/R	N/R	17
Awada et al. [24]	Phase II	Pac	1L mTNBC	100	0	0	28	28.6	N/R	3.5	13.1	100
Baselga et al. [25]	Phase II	Cis	1L–2L mTNBC	72	28	0	60	10	N/R	1.5	9.4	100
	Phase II	Cis	1L mTNBC				42	12	N/R	N/R	N/R	100
	Phase II	Cis	2L mTNBC				16	6	N/R	N/R	N/R	100
Brufsky et al. [26]	RIBBON-2	Physician’s choice chemo	2L MBC w/mTNBC	0	100	0	47	18	N/R	2.7	12.6	21
Isakoff et al. [27]	Phase II	Car/cis	1L–2L mTNBC	80	20	0	86	25.6	N/R	2.9	11	100
	Phase II	Car/cis	1L mTNBC				69	29	N/R	N/R	N/R	100
	Phase II	Car/cis	2L mTNBC				17	11.8	N/R	N/R	N/R	100
Miles et al. [28]	RIBBON-1 + AVADO + E2100 pooled subgroup	Cap/doc/pac	1L MBC w/mTNBC	100	0	0	255	23.3	N/R	5.4	17.5	26
Perez et al. [29]	BEACON	Physician’s choice chemo	3L+ MBC w/mTNBC	0	0	100	117	N/R	N/R	N/R	8.8	28
Pivot et al. [30]	Prespecified phase III subgroup	Cap	1L–3L+ MBC w/mTNBC	9	49	43	96	9	N/R	2.1	N/R	25
Sparano et al. [31]	Phase III	Cap	1L–3L+ MBC w/mTNBC	19	63	18	134	N/R	N/R	1.81	N/R	22
Study 301†	Phase III subgroup	Cap	1L MBC w/mTNBC				40	12	4.4	N/R	9.9	24.5
		Eri	1L MBC w/mTNBC				40	10.4	6.6	N/R	13.1	27.1
	Phase III subgroup	Cap	2L+ MBC w/mTNBC				96	~ 10	5.9	2.8	9.2	24.5
		Eri	2L+ MBC w/mTNBC				110	~ 10	4.2	3.4	15.2	27.1
Tredan et al. [32]	Phase II	Ixa	1L mTNBC	100	0	0	40	30	4.5	4.1	N/R	100
Twelves et al. [9] and Pivot et al. [13]	EMBRACE + 301 pooled subgroup	Eri	1L–3L+ MBC w/mTNBC	11	27	62	243	12	N/R	2.8	12.9	22.9
	EMBRACE + 301 pooled subgroup	Eri	2L+ MBC w/mTNBC				199	11	N/R	2.8	12.4	22.9
Twelves et al. [9] and Pivot et al. [13]	EMBRACE + 301 pooled subgroup	Physician’s choice chemo	1L–3L+ MBC w/mTNBC	13	37	50	185	10.3	N/R	2.6	8.2	23.1
	EMBRACE + 301 pooled subgroup	Physician’s choice chemo	2L+ MBC w/mTNBC				153	9	N/R	2.5	8.1	23.1
von Minckwitz et al. [33]	TANIA	Physician’s choice chemo	2L MBC w/mTNBC	0	100	0	57	N/R	N/R	2.1	N/R	23
NCCN-v1.2016-recommended combination therapies
Brodowicz et al. [34]§	TURANDOT	Bev+pac	1L MBC w/mTNBC	100	0	0	63	49	N/R	9	24.2	22
Dieras et al. [35]	Phase II	Bev+pac	1L–2L mTNBC	81	19	0	61	47.53	7.5	7.2	17.4	100
	Phase II	Bev+pac	1L mTNBC				46	N/R	N/R	7.2	N/R	100
	Phase II	Bev+pac	2L mTNBC				16	N/R	N/R	7	N/R	100
Fan et al. [36]	Phase II	Doc+cap	1L mTNBC	100	0	0	26	15.4	N/R	4.8	21.5	100
Halim et al. [37]	Phase II	Car+pac	2L+ mTNBC	0	100		50	60	N/R	N/R	N/R	100
Li et al. [38]	Phase II	Cap+cis	1L–3L mTNBC	84.9	12.1	3	33	63.6	N/R	8.2	17.8	100
	Phase II	Cap+cis	1L mTNBC				28	64.3	N/R	8.2	19.6	100
	Phase II	Cap+cis	2L–3L mTNBC				5	60	N/R	5.1	16.5	100
Liao et al. [39]	Phase II	Doc+cap	1L mTNBC	100	0	0	27	14.8	N/R	4.9	21.5	100
Liao et al. [39]	Phase II	Vin+cap	1L mTNBC	100	0	0	18	27.8	N/R	5.2	18.2	100
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/mTNBC	100	0	0	360	42.3	N/R	8.1	18.9	25
O’Shaughnessy et al. [40]	Phase III	Gem+car	1L–3L mTNBC	58	42		244	32	N/R	4.1	11.1	100
	Phase III	Gem+car	1L mTNBC				149	N/R	N/R	4.6	13.9	100
	Phase III	Gem+car	2L–3L mTNBC				109	N/R	N/R	2.9	8.1	100
Pivot et al. [30]	Prespecified phase III subgroup	Ixa+cap	1L–3L+ MBC w/mTNBC	7	48	45	91	27	N/R	4.1	N/R	24.3
Rugo et al. [41]	Phase III	Bev+nab-pac	1L MBC w/mTNBC	100	0	0	65	N/R	N/R	7.4	N/R	24
Rugo et al. [41]	Phase III	Bev+ixa	1L MBC w/mTNBC	100	0	0	63	N/R	N/R	5.6	N/R	26
Rugo et al. [41]	Phase III	Bev+pac	1L MBC w/mTNBC	100	0	0	73	N/R	N/R	6.5	N/R	26
Sparano et al. [31]	Phase III	Ixa+cap	1L–3L+ MBC w/mTNBC	20	61	19	122	N/R	N/R	4.2	N/R	20

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

*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

^†Based on internal communication with trial sponsor (Eisai); not published results

^‡n and ORR based on APaT population

^§2L+ MBC with mTNBC outcomes are available in a separate study from Pivot et al. [13]