nab-Paclitaxel for the treatment of breast cancer: an update across treatment settings

Brufsky, Adam

doi:10.1186/s40164-017-0066-5

Experimental Hematology & Oncology

Table 1 Pathologic complete response in recent neoadjuvant studies of nab-paclitaxel in early-stage breast cancer

From: nab-Paclitaxel for the treatment of breast cancer: an update across treatment settings

Study, author, year	Type of study	N (ITT)	Patient population or stage of disease	Regimen	pCR definition	Overall pCR, %	Subgroup pCR, %	P
Unselected (all subtypes; n = 7)
GeparSepto, Untch, 2016 [11]	Phase III	1229	High-risk early-stage BC	nab-P 125 (150 before amendment) mg/m² qw	ypT0 ypN0	38.4	TNBC, 48.2%	Overall, <0.001
GeparSepto, Untch, 2016 [11]	Phase III	1229	High-risk early-stage BC	Pac 80 mg/m² qw	ypT0 ypN0	29.0	TNBC, 26.3%	TNBC, <0.001
Huang, 2015 [9]	Phase II	120	Stage II–III	nab-P 125 mg/m² + carbo AUC 2 qw every 21 days (+trastuz if HER2+)	ypT0/is ypN0	nab-P, 26.7	NR	0.904
Huang, 2015 [9]	Phase II	120	Stage II–III	Pac 80 mg/m² + carbo AUC 2 qw every 21 days (+trastuz if HER2+)	ypT0/is ypN0	Pac, 25.6	NR	0.904
Shigematsu, 2015 [10]	Phase II	55	Operable T1c3N02M0	nab-P 260 mg/m² q3w + cyclophosphamide 600 mg/m² → FEC q3w	Necrosis and/or absence of all tumor cells or replacement of cancer cells with granulation and/or fibrosis in breast and axilla	37	HR+/HER2−: 8 HR+/HER2+: 56 HR−/HER2+: 63 TNBC: 62	NA
Seki, 2015 [57]	Phase II	40	Stage I–III	nab-P 80 mg/m² qw 3/4 → FEC q3w	ypT0/is ypN0	40	Luminal A: 20 Luminal B/HER2−: 15.4 Luminal B/HER2+: 60 HER2 enriched: 80 TNBC: 42.9	NA
Neonab, Khasraw, 2015 [58]	Phase II	40	Stage II–III	EC → nab-P 125 mg/m² qw 3/4 (+trastuz if HER2+)	NR	NA	NA	NA
Tsugawa, 2014 [59]	Phase II	34	cT1c-3/N0-1/M0 or T1/N1/M0	nab-P 150 mg/m² qw 3/4 → FEC q3w	ypT0/is N0	27	ER+: 9 ER−: 58	NA
Khan, 2015 [12]	Phase II	32	Stage II–III operable BC with low HER2 expression	nab-P 100 mg/m² + trastuz (4 mg/kg, then 2 mg/kg) qw → ddAC	In breast and axilla	22	In axilla of patients with positive axillary biopsy: 53 In breast of patients with grade 3 tumors: 41	NA
HER2− or TNBC (n = 9)
SWOG S0800, Nahleh, 2014 [14]	Phase II	215	HER2− IBC or LABC	nab-P 100 mg/m² qw + bev → ddAC + PEG-G	ypT0 ypN0	28	With bev: 36	0.021
SWOG S0800, Nahleh, 2014 [14]	Phase II	215	HER2− IBC or LABC	nab-P 100 mg/m² → ddAC + PEG-G vs AC + PEG-G followed by nab-P	ypT0 ypN0	28	No bev: 21	0.021
Kuwayama, 2015 [19]	Phase II	152	Stage II–III HER2−	nab-P 100 mg/m² qw 3/4 → FE100C	ypT0/is ypN0	17	TNBC: 30	Overall, 0.323 TNBC, 0.866
Kuwayama, 2015 [19]	Phase II	152	Stage II–III HER2−	Docetaxel 75 mg/m² q3w → FE100C	ypT0/is ypN0	12	TNBC: 28	Overall, 0.323 TNBC, 0.866
ADAPT TN, Gluz, 2015 [17, 18]	Phase II	130	TNBC	nab-P 125 mg/m² qw 2/3 + carbo AUC 2	ypT0 ypN0	49.2		<0.001006
ADAPT TN, Gluz, 2015 [17, 18]	Phase II	130	TNBC	nab-P 125 mg/m² qw 2/3 + gem 1000 mg/m² qw 2/3	ypT0 ypN0	25.0		<0.001006
GEICAM, Martin, 2014 [13]	Phase II	81	HER2−/ER+	nab-P 150 mg/m² qw 3/4	RCB 0 + 1	24.7	ER+: 23.3 HER2−: 23.3	NA
TBCRC 008, Connolly, 2015 [15]	Phase II	62	Operable stage II–III T1c, cN1-3 or T2-4, any N (all M0) HER2−	nab-P 100 mg/m² + carbo AUC 2 qw + vorinostat 400 mg qd on days 1–3 of each week	No invasive cancer in breast and axilla	25.8		NR
TBCRC 008, Connolly, 2015 [15]	Phase II	62		nab-P 100 mg/m² + carbo AUC 2 qw + placebo	No invasive cancer in breast and axilla	29.0		NR
Somlo, 2015 [60]	Phase II	49	Stage II-III LABC or IBC	nab-P 100 mg/m² d1, 8, 15, and 22 + carbo AUC 6 d1 (4 × 28-day cycles)	pCR; RCB 0 + 1	53; 65	NR	NA
Mrozek, 2014 [61]	Phase II	33	Stage II–III HER2−	nab-P 100 mg/m² + carbo AUC 2 qw 3/4 + bev q2w 10 mg/kg	ypT0 ypN0	18	TNBC: 50	NA
Matsuda, 2015 [62]	Phase II	25	HER2− IBC	Panitumumab 2.5 mg/kg + nab-P 100 mg/m² + carbo AUC 2 → FEC	RCB 0	33	HR+: 38 TNBC: 62	NA
Shimada, 2015 [20]	Institutional	53	Stage II–III HER2−	nab-P 260 mg/m² q3w → by EC	ypT0/is ypN_any	5.7	HR+: 2.9 TNBC: 10.5	NA
HER2+ (n = 3)
Sinclair, 2013 [21]	Phase II	60	Stage II–III	Carbo + nab-P 100 mg/m² qw + trastuz qw (4 mg/kg loading, then 2 mg/kg/wk)	No invasive cancer in breast and axilla	45	ER+: 40 ER−: 52	NA
Tanaka, 2015 [22]	Phase II	46	Stage I–III	Anthracycline → nab-P 260 mg/m² + trastuz q3w	ypT0/is ypN0	49	ER+: 36 ER−: 71	NA
Zelnak, 2015 [23]	Phase II	27	Stage I–III	nab-P 260 mg/m² q2w → vinorelbine 25 mg/m² qw + trastuz qw (4 mg/kg loading, then 2 mg/kg/wk)	No invasive cancer in breast and axilla	48.1	ER/PR+: 18.2 ER/PR−: 68.8	NA

1c tumor >10 mm but ≤20 mm, AC doxorubicin + cyclophosphamide, AUC area under the curve, BC breast cancer, bev bevacizumab, carbo, carboplatin, ddAC dose-dense AC, EC epirubicin + cyclophosphamide, ER estrogen receptor, FEC fluorouracil, epirubicin, and cyclophosphamide, FE100C FEC with epirubicin at 100 mg/m², gem gemcitabine, HER2 human epidermal growth factor receptor 2, HR hormone receptor, IBC inflammatory breast cancer, ITT intention to treat, LABC locally advanced breast cancer, M distant metastasis, N regional lymph nodes, NA not applicable, nab-P nab-paclitaxel, NR not reported, pac paclitaxel, pCR pathological complete response, PEG-G pegfilgrastim, qd once daily, qw weekly, qw 2/3 first 2 of 3 weeks, qw 3/4 first 3 of 4 weeks, q2w every 2 weeks, q3w every 3 weeks, RCB residual cancer burden, T primary tumor, TNBC triple-negative breast cancer, trastuz trastuzumab, yp postneoadjuvant therapy

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