Patient characteristics and stratification according to CEC count
. | CEC at baseline . | . | . | CEC at 2 mo . | . | . | ||||
---|---|---|---|---|---|---|---|---|---|---|
. | 11/μL or less . | More than 11/μL . | P . | 11/μL or less . | More than 11/μL . | P . | ||||
No. entered or eligible | 42 | 62 | 44 | 37 | ||||||
Median age, y (range) | 54 (32-78) | 54 (34-78) | .71 | 53 (36-76) | 55 (34-73) | .87 | ||||
Progressive disease at study entry, no. | ||||||||||
No | 14 | 19 | 15 | 7 | ||||||
Yes | 28 | 43 | .83 | 29 | 30 | .13 | ||||
Baseline performance status, no. | ||||||||||
0 | 37 | 53 | 36 | 32 | ||||||
1 | 5 | 9 | .78 | 8 | 5 | .76 | ||||
Pretreatment (chemotherapy), no. | ||||||||||
No | 17 | 20 | 22 | 18 | ||||||
Yes | 25 | 42 | .41 | 22 | 19 | > .999 | ||||
Metastatic sites, no. | ||||||||||
1 | 17 | 34 | 22 | 22 | ||||||
2 | 13 | 21 | 14 | 15 | ||||||
3+ | 12 | 7 | .04* | 8 | 0 | .06 | ||||
Tumor sites, no. | ||||||||||
Lung | 4 | 20 | .009* | 12 | 7 | .44 | ||||
Liver | 21 | 24 | .31 | 20 | 10 | .11 | ||||
Bone | 26 | 26 | .07 | 19 | 14 | .66 | ||||
Other sites | 24 | 23 | .048* | 19 | 19 | .51 | ||||
Estrogen receptors, no. | ||||||||||
Absent | 16 | 24 | 16 | 12 | ||||||
Present | 23 | 32 | > .999 | 26 | 21 | > .999 | ||||
Progesterone receptors, no. | ||||||||||
Absent | 22 | 27 | 19 | 16 | ||||||
Present | 17 | 28 | .53 | 21 | 15 | .81 | ||||
Ki67, no. | ||||||||||
Less than 20% | 14 | 18 | 9 | 14 | ||||||
20% or more | 8 | 9 | > .999 | 7 | 2 | .11 | ||||
Her-2/Neu, no. | ||||||||||
0/+/++ | 24 | 27 | 17 | 18 | ||||||
+++ | 2 | 6 | .45 | 4 | 2 | .66 | ||||
pT, no. | ||||||||||
pT1 | 6 | 17 | 11 | 8 | ||||||
pT2 | 14 | 20 | 12 | 12 | ||||||
pT3-4 | 4 | 4 | .17 | 4 | 1 | .70 | ||||
pN, no. | ||||||||||
pNo | 4 | 14 | 8 | 5 | ||||||
pN1-pN2 | 17 | 27 | .25 | 21 | 14 | > .999 | ||||
Epidermal growth factor receptor at baseline, no. | ||||||||||
Less than 52 fmol/mg | 27 | 5 | 11 | 21 | ||||||
Greater than or equal to 52 fmol/mg | 27 | 10 | .38 | 20 | 22 | .34 | ||||
Median (range) | 56 (38-71) | 52 (39-64) | .07 | 52 (34-64) | 55 (39-71) | .12 |
. | CEC at baseline . | . | . | CEC at 2 mo . | . | . | ||||
---|---|---|---|---|---|---|---|---|---|---|
. | 11/μL or less . | More than 11/μL . | P . | 11/μL or less . | More than 11/μL . | P . | ||||
No. entered or eligible | 42 | 62 | 44 | 37 | ||||||
Median age, y (range) | 54 (32-78) | 54 (34-78) | .71 | 53 (36-76) | 55 (34-73) | .87 | ||||
Progressive disease at study entry, no. | ||||||||||
No | 14 | 19 | 15 | 7 | ||||||
Yes | 28 | 43 | .83 | 29 | 30 | .13 | ||||
Baseline performance status, no. | ||||||||||
0 | 37 | 53 | 36 | 32 | ||||||
1 | 5 | 9 | .78 | 8 | 5 | .76 | ||||
Pretreatment (chemotherapy), no. | ||||||||||
No | 17 | 20 | 22 | 18 | ||||||
Yes | 25 | 42 | .41 | 22 | 19 | > .999 | ||||
Metastatic sites, no. | ||||||||||
1 | 17 | 34 | 22 | 22 | ||||||
2 | 13 | 21 | 14 | 15 | ||||||
3+ | 12 | 7 | .04* | 8 | 0 | .06 | ||||
Tumor sites, no. | ||||||||||
Lung | 4 | 20 | .009* | 12 | 7 | .44 | ||||
Liver | 21 | 24 | .31 | 20 | 10 | .11 | ||||
Bone | 26 | 26 | .07 | 19 | 14 | .66 | ||||
Other sites | 24 | 23 | .048* | 19 | 19 | .51 | ||||
Estrogen receptors, no. | ||||||||||
Absent | 16 | 24 | 16 | 12 | ||||||
Present | 23 | 32 | > .999 | 26 | 21 | > .999 | ||||
Progesterone receptors, no. | ||||||||||
Absent | 22 | 27 | 19 | 16 | ||||||
Present | 17 | 28 | .53 | 21 | 15 | .81 | ||||
Ki67, no. | ||||||||||
Less than 20% | 14 | 18 | 9 | 14 | ||||||
20% or more | 8 | 9 | > .999 | 7 | 2 | .11 | ||||
Her-2/Neu, no. | ||||||||||
0/+/++ | 24 | 27 | 17 | 18 | ||||||
+++ | 2 | 6 | .45 | 4 | 2 | .66 | ||||
pT, no. | ||||||||||
pT1 | 6 | 17 | 11 | 8 | ||||||
pT2 | 14 | 20 | 12 | 12 | ||||||
pT3-4 | 4 | 4 | .17 | 4 | 1 | .70 | ||||
pN, no. | ||||||||||
pNo | 4 | 14 | 8 | 5 | ||||||
pN1-pN2 | 17 | 27 | .25 | 21 | 14 | > .999 | ||||
Epidermal growth factor receptor at baseline, no. | ||||||||||
Less than 52 fmol/mg | 27 | 5 | 11 | 21 | ||||||
Greater than or equal to 52 fmol/mg | 27 | 10 | .38 | 20 | 22 | .34 | ||||
Median (range) | 56 (38-71) | 52 (39-64) | .07 | 52 (34-64) | 55 (39-71) | .12 |
pT and pN refer to the TNMUICC classification on primary tumory regional nodes and metastases. The definition of characteristics of the disease is focused on features related to the primary tumor (T), to the regional lymph nodes—including those of the ipsilateral axilla, supraclavicular, and internal mammary sites (N)—and of distant metastases.