Nanosomal Docetaxel Lipid Suspension-Based Chemotherapy in Breast Cancer: Results from a Multicenter Retrospective Study

Figures & data

Table 1 Patient Disposition and Baseline Characteristics

Parameters	All patients (N=91)	Neoadjuvant Setting (N=12)	Adjuvant Setting (N=61)	Metastatic Setting (N=18)
Age (years), mean ± SD, range	51.3 ± 11.2 (26–76)	51.3 ± 13.3 (31–76)	49.1 ± 10.8 (26–74)	58.9 ± 7.8 (41–75)
BSA, kg/m^2, mean ± SD	1.60 ± 0.2	1.71 ± 0.1	1.59 ± 0.2	1.60 ± 0.2
Women, n (%)
Premenopausal	29 (31.9)	4 (33.3)	24 (39.3)	1 (5)
Post-menopausal	62 (68.1)	8 (66.7)	37 (60.7)	17 (94.4)
Cancer Stage, n (%)
I	3 (3.3)	1 (8.3)	2 (3.3)	-
II	31 (34.1)	2 (16.7)	29 (47.4)	-
III	39 (42.9)	9 (75.0)	30 (49.3)	-
IV	18 (19.8)	-	-	18 (100)
Metastasis Site, n (%)^a
Lymph node	4 (4.4)	-	4 (6.6)	-
Bone	4 (4.4)	-	-	4 (22.2)
Brain	1 (1.1)	-	-	1 (5.6)
Liver	1 (1.1)	-	-	1 (5.6)
Lung	4 (4.4)	-	-	4 (22.2)
Hormonal Receptor Status^b
ER+/PR+	43 (47.3)	8 (66.7)	24 (39.3)	11 (61.1)
HER2+	38 (41.8)	5 (41.7)	24 (39.3)	9 (50)
TNBC	25 (27.5)	2 (16.7)	18 (29.5)	5 (27.8)
ECOG Score, n (%)^c
0	4 (4.4)		2 (3.3)	2 (11.1)
1	50 (54.9)	6 (50)	36 (59)	8 (44.4)
2	34 (37.4)	6 (50)	21 (34.4)	7 (38.9)
3	1 (1.1)	-	1 (1.6)	-
Comorbid Disease, n (%)
Hypertension	10 (11)	2 (16.7)	6 (9.8)	2 (11.1)
Diabetes	19 (20.9)	3 (25)	10 (16.4)	6 (33.3)

Notes:^aMetastasis sites were not available for four patients. ^bNumber of patients in ER+/PR+ and HER2+ may overlap. ^cECOG score not available for two patients in adjuvant setting. Other comorbid diseases included hypothyroidism, arthritis, coronary artery disease, dyslipidemia, and ischemic heart disease.

Abbreviations: BSA, body surface area; ER, estrogen receptor, HER2, human epidermal growth factor receptor 2; PR, progesterone receptor, SD, standard deviation; TNBC, triple-negative breast cancer.

Figure 1 Response rate of NDLS-based chemotherapy in breast cancer in (A) neoadjuvant setting (n=12), and (B) metastatic setting (n=17).

Abbreviations: CR, complete response; DCR, disease control rate; NDLS, nanosomal docetaxel lipid suspension; ORR, overall response rate; PR, partial response; SD, stable disease.

Figure 2 Kaplan–Meier estimates of overall survival in breast cancer patients: (A) neoadjuvant (n=12), (B) adjuvant (n=61), and (C) metastatic (n=18) settings. The mean survival time and its standard error were underestimated because the largest observation was censored and estimation was restricted to the largest event time.

Table 2 Safety Profile of NDLS-Based Chemotherapy in Breast Cancer (n=54)

Adverse Event	All Grades, n (%)	Grade III, n (%)	Grade IV, n (%)
Hematological AEs
Anemia	40 (74.1)	2 (3.7)	-
Thrombocytopenia	25 (46.3)	2 (3.7)	2 (3.7)
Lymphopenia	17 (31.5)	3 (5.6)	-
Neutropenia	5 (9.3)	2 (3.7)	2 (3.7)
Non-Hematological AEs
Hyperglycemia	13 (24.1)	-	-
Alteration in liver function test	6 (11.1)	2 (3.7)	-
Alopecia	2 (3.7)	-	-
Diarrhea	1 (1.9)	-	-
Hypotension	1 (1.9)	-	-
Mucositis	1 (1.9)	-	-
Rash	1 (1.9)	-	-

Notes: AEs in different grades may occur in ≥1 patients; hence, the cumulative number of patients in different grades may exceed the total number of patients with individual AEs.