Department of Internal Medicine, Kosin University Gospel Hospital, Kosin University College of Medicine, Busan Korea
Copyright © 2022 Yeungnam University College of Medicine, Yeungnam University Institute of Medical Science
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Conflicts of interest
No potential conflict of interest relevant to this article was reported.
Funding
None.
Author contributions
Conceptualization, Data curation, EML; Writing-original draft: EML, HyJ; Writing-review & editing: EML, HyJ.
Characteristic | Data |
---|---|
No. of patients | 104 |
Age (yr)a) | 62 (57–62) |
Sex, male:female | 61 (58.7):43 (41.3) |
Smoking | |
Never | 74 (71.2) |
Current or former smoking | 30 (28.8) |
Diabetes mellitus | 42 (40.4) |
EGOG PSa) | |
0–1 | 89 (85.6) |
≥2 | 15 (14.4) |
Primary tumor location | |
Head | 43 (41.3) |
Body | 27 (26.0) |
Tail | 34 (32.7) |
Disease extenta) | |
Locally advanced | 22 (21.2) |
Metastatic | 82 (78.8) |
Metastasisa) | |
Liver | 53 (51.0) |
Peritoneal | 30 (28.8) |
Lung | 25 (24.0) |
Bone | 9 (8.7) |
Anemiaa) | 87 (83.7) |
Hypoalbuminemiaa) | 18 (17.3) |
CA19-9a) (U/mL) | 221 (41–2,166) |
CEAa) (ng/mL) | 6.95 (3.63–25.2) |
Regimen of first-line chemotherapy | |
Gemcitabine±erlotinib | 38 (36.5) |
Gemcitabine+nab-paclitaxel | 26 (25.0) |
FOLFIRINOX | 34 (32.7) |
Othersb) | 6 (5.8) |
Response rate of first-line chemotherapy (n=82) | 17 (20.7) |
Duration of first-line chemotherapy (mo) | 4.5 (2.4–7.1) |
Values are presented as number only, median (interquartile range), or number (%).
ECOG PS, Eastern Cooperative Oncology Group performance status; CA19-9, carbohydrate antigen 19-9; CEA, carcinoembryonic antigen; FOLFIRINOX, 5-fluorouracil/leucovorin, irinotecan, and oxaliplatin.
a)At start of second-line chemotherapy.
b)Gemcitabine+cisplatin, 5-fluorouracil (FU), 5-FU+leucovorin, 5-FU+cisplatin (one patient each), gemcitabine+capecitabine (two patients).
Treatment | Data |
---|---|
Chemotherapy regimen | |
FOLFIRINOX | 33 (31.7) |
Gemcitabine+nab-paclitaxel | 29 (27.9) |
Gemcitabine±erlotinib | 13 (12.5) |
FOLFOX | 12 (11.5) |
5-FU+cisplatin | 7 (6.7) |
5-FU+doxorubicin+mitomycin | 3 (2.9) |
Gemcitabine+cisplatin | 2 (1.9) |
Othersa) | 5 (4.8) |
Cycle of chemotherapy | 3 (2–6) |
Tumor response (n=86) | |
Partial response | 2 (2.3) |
Stable disease | 33 (38.4) |
Progressive disease | 31 (36.0) |
Not evaluable | 20 (23.3) |
Duration of clinical benefit (mo) (n=35) | 4.5 (2.1–7.0) |
Reason for treatment discontinuation | |
Disease progression | 52 (50.0) |
Toxicity/PS deterioration | 47 (45.2) |
Others | 5 (4.8) |
Duration of second-line chemotherapy (mo) | 1.9 (0.6–4.6) |
Values are presented as number (%) or median (interquartile range).
FOLFIRINOX, 5-fluorouracil (FU)/leucovorin, irinotecan, and oxaliplatin; FOLFOX, 5-FU/leucovorin+oxaliplatin; PS, performance status.
a)5-FU+doxorubicin, 5-FU+liposomal irinotecan+leucovorin, 5-FU, S-1, and atezolizumab (one patient each).
The second-line regimen |
First-line regimen |
|||
---|---|---|---|---|
Gemcitabine (±erlotinib) | Gemcitabine+nab-paclitaxel | FOLFIRINOX | Others | |
Gemcitabine (±erlotinib) | 0 (0) | 1 (3.8) | 12 (35.3) | 0 (0) |
Gemcitabine+nab-paclitaxel | 7 (18.4) | 0 (0) | 21 (61.8) | 0 (0) |
FOLFIRINOX | 12 (31.6) | 17 (65.4) | 0 (0) | 4 (66.7) |
FOLFOX | 8 (21.1) | 3 (11.5) | 0 (0) | 1 (16.7) |
5-FU+cisplatin | 6 (15.8) | 1 (3.8) | 0 (0) | 0 (0) |
Others | 5 (13.2)a) | 4 (15.4)b) | 1 (2.9) | 1 (16.7) |
Total | 38 (100) | 26 (100) | 34 (100) | 6 (100) |
Values are presented as number (%).
FOLFIRINOX, 5-fluorouracil (FU)+leucovorin, irinotecan, and oxaliplatin; FOLFOX, 5-FU/leucovorin+oxaliplatin.
a)5-FU+doxorubicin+mitomycin (3 patients), 5-FU+doxorubicin, gemcitabine+cisplatin (one patient each).
b)Nanoliposomal irinotecan+5-FU+leucovorin, 5-FU+leucovorin, gemcitabine+cisplatin, S-1 (one patient each).
Variable | Median PFS (mo) |
Univariate analysis |
Multivariate analysis |
||
---|---|---|---|---|---|
HR (95% CI) | p-value | HR (95% CI) | p-value | ||
EGOG PSa) | |||||
0–1 | 4.5 | 1.070 (0.426–2.684) | 0.886 | ||
≥2 | 6.0 | ||||
Diabetes mellitus | |||||
No | 3.4 | 0.577 (0.345–0.965) | 0.033 | 0.608 (0.355–1.043) | 0.071 |
Yes | 6.8 | ||||
Disease extenta) | |||||
Locally advanced | 9.8 | 3.082 (1.588–5.984) | 0.001 | 2.728 (1.205–6.178) | 0.016* |
Metastatic | 3.6 | ||||
Liver metastasisa) | |||||
No | 6.1 | 1.811 (1.103–2.976) | 0.017 | 1.080 (0.580–2.011) | 0.808 |
Yes | 3.2 | ||||
Lung metastasisa) | |||||
No | 4.9 | 1.797 (1.005–3.215) | 0.045 | 1.158 (0.606–2.211) | 0.657 |
Yes | 3.4 | ||||
Bone metastasisa) | |||||
No | 5.4 | 5.512 (2.094–12.677) | <0.001 | 3.143 (1.150–8.592) | 0.026* |
Yes | 1.8 | ||||
CA19-9 (U/mL) | |||||
<221 | 5.7 | 1.016 (0.618–1.670) | 0.951 | ||
≥221 | 3.7 | ||||
CEAa) (ng/mL) | |||||
Normal (≤5.5) | 5.7 | 1.197 (0.705–2.033) | 0.507 | ||
Elevation (>5.5) | 4.2 |
Variable | Median OS (mo) |
Univariate analysis |
Multivariate analysis |
||
---|---|---|---|---|---|
HR (95% CI) | p-value | HR (95% CI) | p-value | ||
EGOG PSa) | |||||
0-1 | 7.2 | 2.367 (1.330–5.217) | 0.004 | 2.247 (1.129–4.474) | 0.021* |
≥2 | 2.3 | ||||
Diabetes mellitus | |||||
No | 5.9 | 0.784 (0.488–1.258) | 0.311 | ||
Yes | 8.3 | ||||
Disease extenta) | 0.011* | ||||
Locally advanced | 29.4 | 3.380 (1.719–6.644) | <0.001 | 2.745 (1.260–5.983) | 0.011* |
Metastatic | 5.5 | ||||
Liver metastasisa) | |||||
No | 8.0 | 2.780 (1.678–4.607) | <0.001 | 1.324 (0.714–2.456) | 0.373 |
Yes | 5.5 | ||||
Lung metastasisa) | |||||
No | 8.0 | 1.340 (0.793–2.264) | 0.272 | ||
Yes | 4.8 | ||||
Bone metastasisa) | |||||
No | 8.0 | 2.596 (1.215–5.547) | 0.011 | 2.136 (0.964–4.737) | 0.062 |
Yes | 4.9 | ||||
CA19-9 (U/mL) | |||||
<221 | 8.0 | 1.396 (0.875–2.226) | 0.16 | ||
≥221 | 5.7 | ||||
CEAa) (ng/mL) | |||||
Normal (≤5.5) | 9.3 | 2.006 (1.177–6.419) | 0.009 | 1.939 (1.065–3.530) | 0.030* |
Elevation (>5.5) | 5.4 |
Characteristic | Data |
---|---|
No. of patients | 104 |
Age (yr) |
62 (57–62) |
Sex, male:female | 61 (58.7):43 (41.3) |
Smoking | |
Never | 74 (71.2) |
Current or former smoking | 30 (28.8) |
Diabetes mellitus | 42 (40.4) |
EGOG PS |
|
0–1 | 89 (85.6) |
≥2 | 15 (14.4) |
Primary tumor location | |
Head | 43 (41.3) |
Body | 27 (26.0) |
Tail | 34 (32.7) |
Disease extent |
|
Locally advanced | 22 (21.2) |
Metastatic | 82 (78.8) |
Metastasis |
|
Liver | 53 (51.0) |
Peritoneal | 30 (28.8) |
Lung | 25 (24.0) |
Bone | 9 (8.7) |
Anemia |
87 (83.7) |
Hypoalbuminemia |
18 (17.3) |
CA19-9 |
221 (41–2,166) |
CEA |
6.95 (3.63–25.2) |
Regimen of first-line chemotherapy | |
Gemcitabine±erlotinib | 38 (36.5) |
Gemcitabine+nab-paclitaxel | 26 (25.0) |
FOLFIRINOX | 34 (32.7) |
Others |
6 (5.8) |
Response rate of first-line chemotherapy (n=82) | 17 (20.7) |
Duration of first-line chemotherapy (mo) | 4.5 (2.4–7.1) |
Treatment | Data |
---|---|
Chemotherapy regimen | |
FOLFIRINOX | 33 (31.7) |
Gemcitabine+nab-paclitaxel | 29 (27.9) |
Gemcitabine±erlotinib | 13 (12.5) |
FOLFOX | 12 (11.5) |
5-FU+cisplatin | 7 (6.7) |
5-FU+doxorubicin+mitomycin | 3 (2.9) |
Gemcitabine+cisplatin | 2 (1.9) |
Others |
5 (4.8) |
Cycle of chemotherapy | 3 (2–6) |
Tumor response (n=86) | |
Partial response | 2 (2.3) |
Stable disease | 33 (38.4) |
Progressive disease | 31 (36.0) |
Not evaluable | 20 (23.3) |
Duration of clinical benefit (mo) (n=35) | 4.5 (2.1–7.0) |
Reason for treatment discontinuation | |
Disease progression | 52 (50.0) |
Toxicity/PS deterioration | 47 (45.2) |
Others | 5 (4.8) |
Duration of second-line chemotherapy (mo) | 1.9 (0.6–4.6) |
The second-line regimen | First-line regimen |
|||
---|---|---|---|---|
Gemcitabine (±erlotinib) | Gemcitabine+nab-paclitaxel | FOLFIRINOX | Others | |
Gemcitabine (±erlotinib) | 0 (0) | 1 (3.8) | 12 (35.3) | 0 (0) |
Gemcitabine+nab-paclitaxel | 7 (18.4) | 0 (0) | 21 (61.8) | 0 (0) |
FOLFIRINOX | 12 (31.6) | 17 (65.4) | 0 (0) | 4 (66.7) |
FOLFOX | 8 (21.1) | 3 (11.5) | 0 (0) | 1 (16.7) |
5-FU+cisplatin | 6 (15.8) | 1 (3.8) | 0 (0) | 0 (0) |
Others | 5 (13.2) |
4 (15.4) |
1 (2.9) | 1 (16.7) |
Total | 38 (100) | 26 (100) | 34 (100) | 6 (100) |
Variable | Median PFS (mo) | Univariate analysis |
Multivariate analysis |
||
---|---|---|---|---|---|
HR (95% CI) | p-value | HR (95% CI) | p-value | ||
EGOG PS |
|||||
0–1 | 4.5 | 1.070 (0.426–2.684) | 0.886 | ||
≥2 | 6.0 | ||||
Diabetes mellitus | |||||
No | 3.4 | 0.577 (0.345–0.965) | 0.033 | 0.608 (0.355–1.043) | 0.071 |
Yes | 6.8 | ||||
Disease extent |
|||||
Locally advanced | 9.8 | 3.082 (1.588–5.984) | 0.001 | 2.728 (1.205–6.178) | 0.016 |
Metastatic | 3.6 | ||||
Liver metastasis |
|||||
No | 6.1 | 1.811 (1.103–2.976) | 0.017 | 1.080 (0.580–2.011) | 0.808 |
Yes | 3.2 | ||||
Lung metastasis |
|||||
No | 4.9 | 1.797 (1.005–3.215) | 0.045 | 1.158 (0.606–2.211) | 0.657 |
Yes | 3.4 | ||||
Bone metastasis |
|||||
No | 5.4 | 5.512 (2.094–12.677) | <0.001 | 3.143 (1.150–8.592) | 0.026 |
Yes | 1.8 | ||||
CA19-9 (U/mL) | |||||
<221 | 5.7 | 1.016 (0.618–1.670) | 0.951 | ||
≥221 | 3.7 | ||||
CEAa) (ng/mL) | |||||
Normal (≤5.5) | 5.7 | 1.197 (0.705–2.033) | 0.507 | ||
Elevation (>5.5) | 4.2 |
Variable | Median OS (mo) | Univariate analysis |
Multivariate analysis |
||
---|---|---|---|---|---|
HR (95% CI) | p-value | HR (95% CI) | p-value | ||
EGOG PS |
|||||
0-1 | 7.2 | 2.367 (1.330–5.217) | 0.004 | 2.247 (1.129–4.474) | 0.021 |
≥2 | 2.3 | ||||
Diabetes mellitus | |||||
No | 5.9 | 0.784 (0.488–1.258) | 0.311 | ||
Yes | 8.3 | ||||
Disease extent |
0.011 |
||||
Locally advanced | 29.4 | 3.380 (1.719–6.644) | <0.001 | 2.745 (1.260–5.983) | 0.011 |
Metastatic | 5.5 | ||||
Liver metastasis |
|||||
No | 8.0 | 2.780 (1.678–4.607) | <0.001 | 1.324 (0.714–2.456) | 0.373 |
Yes | 5.5 | ||||
Lung metastasis |
|||||
No | 8.0 | 1.340 (0.793–2.264) | 0.272 | ||
Yes | 4.8 | ||||
Bone metastasis |
|||||
No | 8.0 | 2.596 (1.215–5.547) | 0.011 | 2.136 (0.964–4.737) | 0.062 |
Yes | 4.9 | ||||
CA19-9 (U/mL) | |||||
<221 | 8.0 | 1.396 (0.875–2.226) | 0.16 | ||
≥221 | 5.7 | ||||
CEA |
|||||
Normal (≤5.5) | 9.3 | 2.006 (1.177–6.419) | 0.009 | 1.939 (1.065–3.530) | 0.030 |
Elevation (>5.5) | 5.4 |
Values are presented as number only, median (interquartile range), or number (%). ECOG PS, Eastern Cooperative Oncology Group performance status; CA19-9, carbohydrate antigen 19-9; CEA, carcinoembryonic antigen; FOLFIRINOX, 5-fluorouracil/leucovorin, irinotecan, and oxaliplatin. At start of second-line chemotherapy. Gemcitabine+cisplatin, 5-fluorouracil (FU), 5-FU+leucovorin, 5-FU+cisplatin (one patient each), gemcitabine+capecitabine (two patients).
Values are presented as number (%) or median (interquartile range). FOLFIRINOX, 5-fluorouracil (FU)/leucovorin, irinotecan, and oxaliplatin; FOLFOX, 5-FU/leucovorin+oxaliplatin; PS, performance status. 5-FU+doxorubicin, 5-FU+liposomal irinotecan+leucovorin, 5-FU, S-1, and atezolizumab (one patient each).
Values are presented as number (%). FOLFIRINOX, 5-fluorouracil (FU)+leucovorin, irinotecan, and oxaliplatin; FOLFOX, 5-FU/leucovorin+oxaliplatin. 5-FU+doxorubicin+mitomycin (3 patients), 5-FU+doxorubicin, gemcitabine+cisplatin (one patient each). Nanoliposomal irinotecan+5-FU+leucovorin, 5-FU+leucovorin, gemcitabine+cisplatin, S-1 (one patient each).
PFS, progression-free survival; HR, hazard ratio; CI, confident interval; ECOG PS, Eastern Cooperative Oncology Group performance status; CA19-9, carbohydrate antigen 19-9; CEA, carcinoembryonic antigen. At start of second-line chemotherapy.
OS, overall survival; HR, hazard ratio; CI, confident interval; ECOG PS, Eastern Cooperative Oncology Group performance status; CA19-9, carbohydrate antigen 19-9; CEA, carcinoembryonic antigen. At start of second-line chemotherapy.