World J Oncol

World Journal of Oncology, ISSN 1920-4531 print, 1920-454X online, Open Access

Article copyright, the authors; Journal compilation copyright, World J Oncol and Elmer Press Inc

Journal website https://www.wjon.org

Original Article

Volume 11, Number 5, October 2020, pages 197-203

Nab-Paclitaxel Followed by 5-Fluorouracil, Epirubicin and Cyclophosphamide in Neoadjuvant Chemotherapy for Resectable Breast Cancer: A Phase II Trial

**Table 1.** Patients Characteristics
Characteristics	Patients (n = 41)
Data presented as n (%). Nab-PTX: nab-paclitaxel; ER: estrogen receptor; PgR: progesterone receptor; HER2: human epidermal growth factor receptor 2.
Median age (range)	55 (35 - 70)	53 (37 - 62)
Performance status = 0	32 (100)	9 (100)
Menopausal status
Pre-menopausal	14 (43)	5 (56)
Post-menopausal	18 (57)	4 (44)
Clinical tumor stage
T1	0	1 (10)
T2	28 (88)	5 (56)
T3	2 (6)	3 (34)
T4	2 (6)	0
Clinical nodal stage
N0	13 (40)	1 (10)
N1	11 (34)	4 (44)
N2	4 (13)	2 (23)
N3	4 (13)	2 (23)
Clinical stage
IIA	11 (34)	1 (10)
IIB	13 (40)	3 (34)
IIIA	3 (10)	3 (34)
IIIB	1 (3)	0
IIIC	4 (13)	2 (23)
Grade
I	8 (25)	0
II	8 (25)	3 (34)
III	16 (50)	6 (66)
ER status
Positive	17 (53)	7 (77)
Negative	15 (47)	2 (23)
PgR status
Positive	13 (40)	6 (66)
Negative	19 (60)	3 (34)
Subtype
Luminal A	2 (6)	0
Luminal B	14 (44)	0
Luminal HER2	0	7 (77)
HER2	0	2 (23)
Triple-negative	16 (50)	0

Table 1. Patients Characteristics

Characteristics

Patients (n = 41)

Nab-PTX (n = 32)

Nab-PTX + trastuzumab (n = 9)

Data presented as n (%). Nab-PTX: nab-paclitaxel; ER: estrogen receptor; PgR: progesterone receptor; HER2: human epidermal growth factor receptor 2.

Median age (range)

55 (35 - 70)

53 (37 - 62)

Performance status = 0

32 (100)

9 (100)

Menopausal status

Pre-menopausal

14 (43)

5 (56)

Post-menopausal

18 (57)

4 (44)

Clinical tumor stage

1 (10)

28 (88)

5 (56)

2 (6)

3 (34)

2 (6)

Clinical nodal stage

13 (40)

1 (10)

11 (34)

4 (44)

4 (13)

2 (23)

4 (13)

2 (23)

Clinical stage

IIA

11 (34)

1 (10)

IIB

13 (40)

3 (34)

IIIA

3 (10)

3 (34)

IIIB

1 (3)

IIIC

4 (13)

2 (23)

Grade

8 (25)

3 (34)

III

16 (50)

6 (66)

ER status

Positive

17 (53)

7 (77)

Negative

15 (47)

2 (23)

PgR status

Positive

13 (40)

6 (66)

Negative

19 (60)

3 (34)

Subtype

Luminal A

2 (6)

Luminal B

14 (44)

Luminal HER2

7 (77)

HER2

2 (23)

Triple-negative

16 (50)

**Table 2.** Response
	N (%)
RR: response rate; cCR: clinical complete response; cPR: clinical partial response; pCR: pathological complete response; HER2: human epidermal growth factor receptor 2.
Clinical response
Overall RR	37/41 (90)
cCR	4/41 (9)
cPR	33/41 (81)
HER2-positive	9/9 (100)
cCR	2/9 (22)
cPR	7/9 (78)
Pathological response
Overall pCR rate	10/41 (24)
Luminal A	0/2 (0)
Luminal B	1/14 (7)
Luminal HER2	3/7 (42)
Triple-negative	4/16 (25)
HER2	2/2 (100)

Table 2. Response

N (%)

RR: response rate; cCR: clinical complete response; cPR: clinical partial response; pCR: pathological complete response; HER2: human epidermal growth factor receptor 2.

Clinical response

Overall RR

37/41 (90)

cCR

4/41 (9)

cPR

33/41 (81)

HER2-positive

9/9 (100)

cCR

2/9 (22)

cPR

7/9 (78)

Pathological response

Overall pCR rate

10/41 (24)

Luminal A

0/2 (0)

Luminal B

1/14 (7)

Luminal HER2

3/7 (42)

Triple-negative

4/16 (25)

HER2

2/2 (100)

Table 3. Adverse Events

Nab-PTX (n = 41)

FEC (n = 41)

Grade 2

Grade 3

Grade 4

Grade 2

Grade 3

Grade 4

Grade 5

Data presented as n (%). Nab-PTX: nanoparticle albumin-bound paclitaxel; FEC: 5-fluorouracil, epirubicin and cyclophosphamide.

Hematologic

Neutropenia

8 (19)

9 (21)

2 (4)

10 (24)

5 (12)

Febrile neutropenia

4 (9)

Hepatic dysfunction

3 (7)

1 (2)

4 (9)

Anemia

2 (4)

4 (9)

Non-hematologic

Peripheral sensory neuropathy

9 (21)

1 (2)

10 (24)

Joint pain

7 (17)

3 (7)

Hypertension

1 (2)

Rash

2 (4)

Nausea

2 (4)

9 (21)

4 (9)

Vomiting

1 (2)

Stomatitis

2 (4)

Anorexia

1 (2)

9 (21)

4 (9)

Dysgeusia

1 (2)

Death

1 (2)