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Table 2 Pathologic response per protocol arm

From: TBCRC 002: a phase II, randomized, open-label trial of preoperative letrozole with or without bevacizumab in postmenopausal women with newly diagnosed stage 2/3 hormone receptor-positive and HER2-negative breast cancer

Group

Letrozole, n = 24

Letrozole/bevacizumab, n = 45

n (%)

95% CI†

n (%)

95% CI†

Pathologic CR (pCR)

none (0)

0, 14.2%

5^ (11)

3.7%, 24.1%

pCR and microscopic residual disease

none (0)

0, 14.2%

9 (20)

9.6%, 34.7%

pCR and microscopic residual disease—(ITT)*

none (0)

0, 14.2%

9 (18)

8.6%, 31.4%

Partial response

9 (37.5)

18.8%, 59.4%

20 (44.4)

29.6%, 60.0%

Objective response rate

9 (37.5)

18.8%, 59.4%

29 (64.4)

48.8%, 78.1%

Stable disease

12 (50)

29.1%, 70.9%

13 (28.8)

16.4%, 44.3%

Progressive disease

3 (12.5)

2.7, 32.4%

3 (6.6)

1.4%, 18.3%

Downstage (3/2 to 0/1)

9 (37.5)

18.8%, 59.4%

20 (44.4)

29.6%, 60.0%

Node reversion

(positive to negative)

4/15 (26.6)

7.8%, 55.1%

10/25 (40)

21.1%, 61.3%

  1. †Exact (Clopper-Pearson) confidence interval
  2. ^One of the 5 patients who achieved a pCR had residual ductal carcinoma in situ
  3. *ITT (intention to treat population): this analysis assumes that none of the patients who did not undergo surgery (letrozole group, n = 1; letrozole/bevacizumab group, n = 5) achieved a pCR or microscopic residual disease