Background
Methods
Patient’s enrollment
Specimen collection and tumor marker assays
Statistical analysis
Results
Patients and tumor characteristics
No. of patients (70) | % | |
---|---|---|
Age, median (range, year) | 70 (44–85) | |
Gender
| ||
Male | 48 | 69 |
Female | 22 | 31 |
Histology
| ||
Adenocarcinoma | 54 | 77 |
Squamous | 15 | 22 |
NOS | 1 | 1 |
Stage
| ||
IIIB | 3 | 4 |
IV | 67 | 96 |
ECOG PS
| ||
0 | 25 | 36 |
1 | 39 | 56 |
2 | 6 | 8 |
Smoking habits
| ||
Never smoker | 9 | 13 |
Former smoker | 35 | 50 |
Smoker | 26 | 37 |
Prior lines of therapy
| Median 2 (range 1–6) | |
1 | 28 | 40 |
2 | 20 | 29 |
3 | 13 | 19 |
≥ 4 | 9 | 12 |
CEA (ng/ml) baseline
| ||
Median (range) | 6.6 (0.80–2615) | |
Normal (< 5) | 30 | 43 |
Elevated (≥ 5) | 40 | 57 |
CYFRA 21-1 (ng/ml) baseline | ||
Median (range) | 5.0 (0.2–126.4) | |
Normal (< 3.3) | 25 | 36 |
Elevated (≥ 3.3) | 45 | 64 |
NSE (ng/ml) baseline
| ||
Median (range) | 7.5 (3.1–46.8) | |
Normal (< 3.3) | 56 | 80 |
Elevated (≥ 3.3) | 14 | 20 |
Correlation between serum markers levels, clinic-pathologic features and tumor response
Median (%) | Range (%) | p-value | |
---|---|---|---|
CEA
| |||
No responder | + 31 | − 79; + 498 | 0.005 |
Responder | − 9 | − 92: + 88 | |
CYFRA21-1
| |||
No responder | + 72 | − 62; + 508 | < 0.001 |
Responder | − 37 | − 98; + 2220 | |
NSE
| |||
No responder | + 20 | − 64; + 182 | 0.012 |
Responder | − 14 | − 79; + 71 |
No-R n (%) | R n (%) | p-value | |
---|---|---|---|
CEA reduction ≥ 20%
| |||
No | 23 (88.5) | 13 (56.5) | 0.021 |
Yes | 3 (11.5) | 10 (43.5) | |
CYFRA21-1 reduction ≥ 20%
| |||
No | 24 (92.3) | 9 (37.5) | < 0.001 |
Yes | 2 (7.7) | 15 (62.5) | |
NSE reduction ≥ 20%
| |||
No | 17 (73.9) | 11 (52.4) | 0.21 |
Yes | 6 (26.1) | 10 (47.6) |
Odds ratio | 95% CI | p-value | |
---|---|---|---|
Gender
| |||
Male | 1.0 | 0.13 | |
Female | 1.85 | (0.8–4.1) | |
Age
| |||
≤ 70 | 1.0 | 0.48 | |
> 70 | 1.31 | (0.6–2.8) | |
CEA reduction ≥ 20%
| |||
No | 1.0 | 0.32 | |
Yes | 1.58 | (0.6–3.9) | |
CYFRA 21-1 reduction ≥ 20%
| |||
No | 1.0 | 0.002 | |
Yes | 4.36 | (1.7–11.3) |
Association between CEA, CYFRA 21-1, NSE and PFS
Association between CEA, CYFRA 21-1, NSE and OS
Mean OS (95% CI)a (months) | p-value | |
---|---|---|
Overall | 9.2 (5.3–13.2) | |
Age (years)
| ||
≤ 70 | 6.1 (0.3–11.8) | 0.27 |
> 70 | 10.0 (7.2–12.8) | |
Gender
| ||
Male | 8.9 (5.1–12.8) | 0.76 |
Female | 9.2 (2.3–16.1) | |
Histology
| ||
Adenocarcinoma | 9.2 (4.6–13.9) | 0.56 |
Squamous | 9.8 (2.5–17.2) | |
PS ECOG
| ||
0 | 9.2 (5.6–12.8) | 0.65 |
> 1 | 2.0 (0.1–5.4) | |
Smoke
| ||
Never smoker | 9.9 (0.1–20.5) | 0.80 |
Smoker | 8.9 (4.7–13.2) | |
Prior treatment lines, n
| ||
1 | 6.1 (3.6–8.5) | 0.036 |
≥ 2 | 12.2 (8.2–13.3) | |
RECIST response
| ||
No response | 6.4 (4.8–8.0) | < 0.001 |
Response | 13.5 (11.2–15.7) |
Mean OS (95% CI)a (months) | p-value | |
---|---|---|
Baseline CEA
| ||
< 5 | 12.2 (8.1–16.0) | 0.035 |
≥ 5 | 5.6 (2.9–8.2) | |
Baseline CYFRA21-1
| ||
< 3.3 | 13.2 (11.0–14.3) | 0.005 |
≥ 3.3 | 5.6 (3.4–7.7) | |
Baseline NSE
| ||
< 13.4 | 10.0 (6.2–13.7) | 0.028 |
≥ 13.4 | 2.2 (0.2–5.0) | |
CEA reduction ≥ 20%
a
| ||
No | 9.9 (8.5–11.3) | 0.026 |
Yes | 15.0 (12.7–17.3) | |
CYFRA21-1 reduction ≥ 20%
a
| ||
No | 10.0 (8.4–11.6) | 0.019 |
Yes | 14.6 (12.4–16.8) | |
NSE reduction ≥ 20%
a
| ||
No | 11.6 (9.9–13.4) | 0.950 |
Yes | 12.4 (9.8–15.0) |