Table 5 Univariate (log-rank) and multivariate analysis (Cox regression) for OS

From: A retrospective analysis of clinical outcome of patients with chemo-refractory metastatic breast cancer treated in a single institution phase I unit

Variable ( N =70 patients, died 53)

N

Median OS (months)

95% CI

Univariate P- value a

MVA P- value b

HR (95% CI)

Age 50years

40

8.7

6.7–10.8

0.350

 

Age< 50 years

30

8.7

7.1–10.4

   

ECOG PS 2

8

1.7

1.0–2.3

<0.0001

0.013

3.3 (1.2–8.6)

ECOG PS 0–1

62

8.9

8.2–9.6

   

TNBC

26

8.5

4.9–12.2

0.471

HER2-positive disease

21

8.7

7.3–10.2

   

ER-positive disease

23

8.7

3.9–13.5

   

Previous chemo lines 4

23

6.8

1.6–12.0

0.223

Previous chemo lines < 4

47

9.0

8.4–9.6

   

Previous total 5 lines

30

4.2

1.3–7.0

0.015

0.003

2.5 (1.3–4.8)

Previous total <5 lines

40

10.2

8.7–11.7

   

Number MTX sites >2

45

8.4

7.1–9.7

0.637

Number MTX sites 2

25

10.2

4.8–15.6

   

Liver metastases

37

6.0

3.0–9.0

0.001

0.003

2.6 (1.3–4.9)

No liver metastases

33

10.2

7.8–12.6

   

Serum albumin 35 mg per 100 ml

42

10.4

8.6–12.3

<0.0001

0.002

0.35 (0.1–0.6)

Serum albumin <35 mg per 100 ml

28

3.2

2.4–4.1

   

Normal serum LDH

30

10.6

7.6–13.6

<0.0001

<0.0001

3.2 (1.7–6.2)

Abnormal serum LDH

40

4.7

0.0–10.2

   

Chemo-combination trial

9

7.3

0.0–19.2

0.342

First in human trial

61

8.7

7.6–9.9

   

PARP inhibitor trial

17

10.6

8.4–12.8

0.055

Non-PARP trial

53

8.4

6.7–10.2

   
  1. Abbreviations: CI=confidence interval; ECOG=Eastern Cooperative Group; ER=oestrogen receptor; HER2=epidermal growth factor receptor 2; HR= hazard ratio; LDH=lactate dehydrogenase; MTX=metastatic; MVA=multivariate analysis; OS=overall survival; PARP=poly(ADP-ribose) polymerase; PS=performance status; TNBC=triple-negative breast cancer.
  2. aLog-rank P-value.
  3. bHR obtained in proportional hazards model (Cox regression) with the following terms: ECOG PS, previous chemo and treatment lines, liver metatases, albumin, LDH and PARP trial.
  4. The table shows that ECOG PS2, serum albumin <35 mg per 100 ml, presence of liver metastases, 5 previous chemotherapy lines to phase 1 treatment and high serum LDH are associated with a poor OS in the univariate and multivariate analysis.