Body mass index in HER2-negative metastatic breast cancer treated with first-line paclitaxel and bevacizumab

Figures & data

Table 1. Main patient and tumor characteristics (N: 196 pts).

Main patient and disease characteristics	N(%)
Age in years, Median (range)	56 (31-82)
ECOG PS0 1-2	121 (61.7) 75 (38.3)
Histology Ductal Lobular Other	166 (84.7) 28 (14.3) 2 (1)
Hormone receptor status at diagnosis ER and/or PgR positive Triple negative Unknown	146 (74.5) 43 (22.0) 7 (3.5)
KI67%	134 (68.4) 62 (31.6)
>14
≤14
Prior treatment Neo/adjuvant chemotherapy Adjuvant endocrine therapy Adjuvant radiotherapy	138 (70.4) 120 (61.2) 109 (55.6)
Metastatic at diagnosis Yes No	36 (18.4) 160 (81.6)
Number of metastatic sites 12 ≥ 3	67 (34.2) 62 (31.6) 67 (34.2)
Metastatic pattern Viscera Bones Other sites	119 (60.7) 23 (11.7) 54 (27.6)

N (%), number and percentage; ECOG PS, Eastern Cooperative Oncology Group Performance Status; ER and/or PgR: Estrogen Receptor and/or Progesterone Receptor.

^† Only bones involved.

Table 2. Main patient and tumor characteristics by categories of body mass index (N: 196 pts).

Main patient and disease characteristics	BMI <25 (108) N(%)	BMI ≥25 (88) N(%)	p value
Age in years, Median (range)	52 (31-76)	59 (32-82)	0.04
ECOG PS 0 1-2	63 (58.3) 45 (41.7)	58 (66.0) 30 (34.0)	0.28
Histology Ductal Lobular Other	91 (84.2) 16 (14.8) 1 (1.0)	75 (85.3) 12 (13.6) 1 (1.1)	0.96
Hormone receptor status at diagnosis ER and/or PgR positive Triple negative Unknown	83 (76.9) 20 (18.5) 5 (4.6)	63 (71.6) 23 (26.1) 2 (2.3)	0.33
KI67%>14≤14	69 (63.9) 39 (36.1)	65 (73.9) 23 (26.1)	0.14
Prior treatment Neo-/adjuvant chemotherapy Adjuvant endocrine therapy Adjuvant radiotherapy	69 (63.9) 67 (62.0) 51 (47.0)	69 (78.4) 53 (60.0) 58 (66.0)	0.03 0.80 0.009
Metastatic at diagnosis Yes No	21 (19.4) 87 (80.6)	15 (17.0) 73 (83.0)	0.67
Number of metastatic sites 1 2≥3	34 (31.5) 30 (27.8) 44 (40.7)	33 (37.5) 32 (36.4) 23 (26.1)	0.08
Metastatic pattern Viscera Bones Other	65 (60.2) 12 (11.1) 31 (28.7)	54 (61.4) 11 (12.5) 23 (26.1)	0.90

BMI, body mass index; N(%), number and percentage of patients; ECOG PS, Eastern Cooperative Oncology Group Performance Status; ER, Estrogen Receptor; PgR, Progesterone Receptor.

^† Only bones involved.

Table 3. Response and disease control rate in the overall study population and subgroups defined upon molecular subtype across BMI strata (N:196).

	BMI	N	CR/PR, N(%)	p value	DCR, N(%)	p value
Overall population	<25≥25	108 88	69 (64) 59 (67)	0.64	90 (83) 80 (91)	0.12
ER and/or PgR positive	<25≥25	83 63	56 (68) 43 (68)	0.99	74 (89) 57 (91)	0.79
Triple negative	<25≥25	20 23	11 (55) 15 (65)	0.49	12 (60) 21 (91)	0.03

BMI, body mass index; CR/PR, complete response/PR, partial response; N(%), number and percentage; DCR, disease control rate; ER and/or PgR: Estrogen Receptor and/or Progesterone Receptor.

Table 4. Multivariate analysis of factors impacting treatment outcomes in the overall study population (N:196).

	Progression-free Survival p value		Overall Survival p value
Variables	HR (CI95%)	p value	HR (CI95%)	p value
Molecular Subtype TN vs ER/PgR pos	1.57 (1.07-2.33)	0.02	2.82 (1.61-5.18)	<0.0001
PFS 1^st line <12 vs ≥12 months	—	—	2.08 (1.23-3.51)	0.006
N. of met sites >2 vs ≤2	—	—	6.50 (3.61-11.71)	<0.0001

PFS, progression-free survival; OS, overall survival; HR, Hazard Ratio; CI95%, confidence interval; ER, estrogen receptor; PgR, progesterone receptor.

Interaction BMI/molsub OS p=0.008.

Interaction BMI/molsub PFS p=0.002.

Figure 1. Progression-Free Survival (A) and Overall Survival (B) by molecular subtype in the overall study population (N:196).

Figure 2. Progression-Free Survival (A) and Overall Survival (B) in triple negative cancer cases (N:43) across strata of body mass index (BMI).

Figure 3. Overall Survival by number of metastatic sites (A) and length of progression free survival in the overall study population (N: 196).

Miller K, Wang M, Gralow J, Dickler M, Cobleigh M, Perez EA, Shenkier T, Cella D, Davidson NE. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med. 2007;357:2666–76. doi:10.1056/NEJMoa072113. PMID:18160686.

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