Phase II trial of weekly nab-paclitaxel and carboplatin treatment with or without trastuzumab as nonanthracycline neoadjuvant chemotherapy for locally advanced breast cancer

Figures & data

Table 1 Patient characteristics

	Nab-paclitaxel cohort	Paclitaxel cohort	P-value
Age, years			0.285
≥45	20	50
<45	10	40
ECOG			1.000
0	29	88
1	1	2
Menopause			0.241
Yes	10	41
No	20	49
BMI			/
≥25	8	24
<25	22	66
Clinical tumor stage			/
1	2	6
2	17	51
3	11	33
Clinical nodal stage			/
Positive	21	63
Negative	9	27
ER			/
Positive	20	60
Negative	10	30
PR			0.915
Positive	17	52
Negative	13	38
HER2			/
Positive	17	51
Negative	13	39
Ki67			0.482
≥14%	26	82
<14%	4	8
Target therapy			/
Yes	16	48
No	14	42

Abbreviations: BMI, body mass index; ECOG, Eastern Cooperative Oncology Group; ER, estrogen receptor; PR, progesterone receptor; HER2, human epidermal receptor-2.

Table 2 Clinical and pathological responses

	Nab-paclitaxel cohort	Paclitaxel cohort	P-value
Finished cycles			0.151
Completed four cycles	24	81
Did not complete four cycles	6	9
Clinical response			0.212
CR/PR	27	72
SD/PD	3	18
Breast pathological evaluation			0.736
pCR	9	30
Non-pCR	21	60
Overall pathological evaluation			0.904
pCR	8	23
Non-pCR	22	67

Abbreviations: CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; pCR, pathological complete response.

Figure 1 Comparison of the efficacy of nab-paclitaxel and paclitaxel in subgroup analysis.

Abbreviations: BMI, body mass index; CI, confidence interval; ER, estrogen receptor; HR, hazard ratio; PR, progesterone receptor; HER2, human epidermal receptor-2; cT, clinical tumor stage; cN, clinical lymph nodal stage.

Table 3 Common treatment-related grade 1–4 adverse events

Adverse event (grade)	Nab-paclitaxel cohort				Paclitaxel cohort
	1	2	3	4	1	2	3	4
Anemia	9	14	5	0	59	7	3	0
Thrombocytopenia	3	7	8	0	10	5	0	0
Leukopenia	0	6	21	2	10	43	35	0
Neutropenia	0	0	13	17	10	26	33	19
Diarrhea/constipation	10	8	0	0	42	11	2	0
Cardiac toxicity	2	0	0	0	11	1	0	0
Rash	7	3	1	0	22	1	0	0
Hand–foot syndrome	4	0	0	0	19	2	0	0
Nausea/vomiting	15	13	2	0	72	9	1	0
Peripheral neurotoxicity	13	0	0	0	28	3	0	0
Increased liver enzyme	12	3	0	0	39	2	1	0
Increased bilirubin	3	0	0	0	6	0	0	0