1Departments of Medical Oncology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
2Departments of Gastroenterology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
3Departments of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
Copyright © 2015 by the Korean Cancer Association
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Characteristic | Total (n=127) | GEM (n=47) | GEM-T (n=44) | GEM-X (n=36) |
---|---|---|---|---|
Age (yr) | ||||
Median (range) | 65 (32-84) | 68 (41-84) | 63 (32-78) | 63 (38-77) |
Gender | ||||
Male | 72 (56.7) | 25 (53.2) | 25 (56.8) | 22 (61.1) |
ECOG performance status | ||||
0 or 1 | 116 (91.3) | 41 (87.2) | 41 (93.2) | 34 (94.5) |
2 | 11 (8.7) | 6 (12.8) | 3 (6.8) | 2 (5.5) |
Extent of disease | ||||
Locally advanced | 46 (36.2) | 21 (44.7) | 11 (25) | 14 (38.9) |
Distant metastatic | 68 (53.5) | 25 (53.2) | 26 (59.1) | 17 (47.2) |
Recurred | 13 (10.3) | 1 (2.1) | 7 (15.9) | 5 (13.9) |
CA 19-9 >500 U/mL | 64 (51.2) | 25 (54.3) | 23 (53.5) | 16 (44.4) |
Primary site | ||||
Head | 73 (57.5) | 30 (63.8) | 22 (50) | 21 (58.3) |
Body | 36 (28.3) | 12 (25.5) | 14 (31.8) | 10 (27.8) |
Tail | 14 (11) | 4 (8.5) | 6 (13.6) | 4 (11) |
Total | 2 (1.5) | 1 (2.1) | 0 | 1 (2.8) |
Metastatic site | ||||
Liver | 49 (38.6) | 13 (27.7) | 21 (47.7) | 15 (41.7) |
Peritoneum | 22 (17.3) | 9 (19.1) | 7 (15.9) | 6 (16.7) |
Lung | 16 (12.6) | 11 (23.4) | 4 (9) | 1 (2.8) |
Distant lymph node | 8 (6.3) | 3 (6.4) | 2 (4.5) | 3 (8.3) |
Other | 7 (5.5) | 2 (4.2) | 4 (9) | 1 (2.8) |
Prior therapy | ||||
Chemotherapya) | 11 (8.7) | 0 (0) | 6 (13.6) | 5 (13.9) |
Radiotherapy | 7 (5.5) | 1 (2.1) | 4 (9) | 2 (5.5) |
Factor | No. |
PFS |
OS |
||||
---|---|---|---|---|---|---|---|
HR | 95% CI | p-value | HR | 95% CI | p-value | ||
GEM-X:GEM-T | 80 | 0.36 | 0.20-0.64 | 0.001a) | 0.52 | 0.28-0.96 | 0.037a) |
Age (yr) | |||||||
≤65 | 46 | 0.36 | 0.16-0.81 | 0.013a) | 0.33 | 0.14-0.76 | 0.01a) |
>65 | 34 | 0.24 | 0.08-0.68 | 0.007a) | 0.94 | 0.35-2.48 | 0.903 |
ECOG performance status | |||||||
0 or 1 | 75 | 0.38 | 0.21-0.70 | 0.002a) | 0.57 | 0.30-1.10 | 0.095 |
2 | 5 | 0.01 | 0.00-153.5 | 0.36 | 0.01 | 0.00-153.5 | 0.36 |
Disease status | |||||||
Locally advanced | 25 | 0.25 | 0.07-0.85 | 0.027a) | 0.43 | 0.13-1.46 | 0.179 |
Distant metastatic | 43 | 0.36 | 0.16-0.77 | 0.009a) | 0.45 | 0.19-1.07 | 0.074 |
CA 19-9 (U/mL) | |||||||
≤500 | 40 | 0.27 | 0.11-0.62 | 0.002a) | 0.6 | 0.24-1.52 | 0.285 |
>500 | 39 | 0.58 | 0.26-1.28 | 0.182 | 0.45 | 0.19-1.05 | 0.067 |
Characteristic | Total (n=127) | GEM (n=47) | GEM-T (n=44) | GEM-X (n=36) |
---|---|---|---|---|
Age (yr) | ||||
Median (range) | 65 (32-84) | 68 (41-84) | 63 (32-78) | 63 (38-77) |
Gender | ||||
Male | 72 (56.7) | 25 (53.2) | 25 (56.8) | 22 (61.1) |
ECOG performance status | ||||
0 or 1 | 116 (91.3) | 41 (87.2) | 41 (93.2) | 34 (94.5) |
2 | 11 (8.7) | 6 (12.8) | 3 (6.8) | 2 (5.5) |
Extent of disease | ||||
Locally advanced | 46 (36.2) | 21 (44.7) | 11 (25) | 14 (38.9) |
Distant metastatic | 68 (53.5) | 25 (53.2) | 26 (59.1) | 17 (47.2) |
Recurred | 13 (10.3) | 1 (2.1) | 7 (15.9) | 5 (13.9) |
CA 19-9 >500 U/mL | 64 (51.2) | 25 (54.3) | 23 (53.5) | 16 (44.4) |
Primary site | ||||
Head | 73 (57.5) | 30 (63.8) | 22 (50) | 21 (58.3) |
Body | 36 (28.3) | 12 (25.5) | 14 (31.8) | 10 (27.8) |
Tail | 14 (11) | 4 (8.5) | 6 (13.6) | 4 (11) |
Total | 2 (1.5) | 1 (2.1) | 0 | 1 (2.8) |
Metastatic site | ||||
Liver | 49 (38.6) | 13 (27.7) | 21 (47.7) | 15 (41.7) |
Peritoneum | 22 (17.3) | 9 (19.1) | 7 (15.9) | 6 (16.7) |
Lung | 16 (12.6) | 11 (23.4) | 4 (9) | 1 (2.8) |
Distant lymph node | 8 (6.3) | 3 (6.4) | 2 (4.5) | 3 (8.3) |
Other | 7 (5.5) | 2 (4.2) | 4 (9) | 1 (2.8) |
Prior therapy | ||||
Chemotherapy |
11 (8.7) | 0 (0) | 6 (13.6) | 5 (13.9) |
Radiotherapy | 7 (5.5) | 1 (2.1) | 4 (9) | 2 (5.5) |
Variable | GEM (n=47) | GEM-T (n=44) | GEM-X (n=33) |
---|---|---|---|
Objective response rate | |||
Partial response | 6 (12.7) | 7 (15.9) | 7(21.2) |
Stable disease | 24 (51) | 19 (43.1) | 17 (47.2) |
Progressive disease | 17 (36.1) | 18 (40.1) | 9 (27.3) |
Disease control rate | 30 (63.8) | 26 (59.1) | 24 (72.7) |
Treatment duration (wk) | 17 | 10.4 | 22.8 |
95% CI | 10.6-23.3 | 7.7-13.0 | 12.7-32.9 |
Factor | No. | PFS |
OS |
||||
---|---|---|---|---|---|---|---|
HR | 95% CI | p-value | HR | 95% CI | p-value | ||
GEM-X:GEM-T | 80 | 0.36 | 0.20-0.64 | 0.001 |
0.52 | 0.28-0.96 | 0.037 |
Age (yr) | |||||||
≤65 | 46 | 0.36 | 0.16-0.81 | 0.013 |
0.33 | 0.14-0.76 | 0.01 |
>65 | 34 | 0.24 | 0.08-0.68 | 0.007 |
0.94 | 0.35-2.48 | 0.903 |
ECOG performance status | |||||||
0 or 1 | 75 | 0.38 | 0.21-0.70 | 0.002 |
0.57 | 0.30-1.10 | 0.095 |
2 | 5 | 0.01 | 0.00-153.5 | 0.36 | 0.01 | 0.00-153.5 | 0.36 |
Disease status | |||||||
Locally advanced | 25 | 0.25 | 0.07-0.85 | 0.027 |
0.43 | 0.13-1.46 | 0.179 |
Distant metastatic | 43 | 0.36 | 0.16-0.77 | 0.009 |
0.45 | 0.19-1.07 | 0.074 |
CA 19-9 (U/mL) | |||||||
≤500 | 40 | 0.27 | 0.11-0.62 | 0.002 |
0.6 | 0.24-1.52 | 0.285 |
>500 | 39 | 0.58 | 0.26-1.28 | 0.182 | 0.45 | 0.19-1.05 | 0.067 |
Variable | GEM (n=47) |
GEM-T (n=44) |
GEM-X (n=36) |
|||
---|---|---|---|---|---|---|
Total | G3/4 | Total | G3/4 | Total | G3/4 | |
Hematologic toxicity | ||||||
Anemia | 47 (100) | 9 (19.1) | 44 (100) | 7 (15.9) | 34 (94.4) | 3 (8.3) |
Neutropenia | 33 (70.2) | 15 (31.9) | 30 (68.2) | 15 (34.1) | 30 (83.3) | 16 (44.4) |
Thrombocytopenia | 41 (87.2) | 5 (10.6) | 28 (63.6) | 1 (2.3) | 23 (63.8) | 2 (5.6) |
Non-hematologic toxicity | ||||||
Diarrhea | 9 (19.1) | 0 | 16 (36.4) | 0 | 5 (13.9) | 0 |
Hand-foot syndrome | 0 | 0 | 0 | 0 | 3 (8.3) | 0 |
Skin rash | 1 (2.1) | 0 | 11 (25) | 0 | 2 (5.6) | 0 |
Anorexia/nausea | 33 (70.2) | 0 | 30 (68.2) | 0 | 27 (75) | 0 |
Vomiting | 6 (12.7) | 0 | 6 (13.6) | 0 | 4 (11.2) | 0 |
Infection | 16 (34) | 11 (23.4) | 5 (11.4) | 4 (9.1) | 5 (13.9) | 5 (13.9) |
Dose reduction | ||||||
Gemcitabine | 13 (27.6) | 12 (27.2) | 12 (33.3) | |||
Erlotinib or capecitabine | - | 0 | 9 (25) | |||
Treatment discontinuation | ||||||
Progressive disease | 43 (91.5) | 38 (86.4) | 32 (88.9) | |||
Toxicity | 1 (2.1) | 1 (2.3) | 1 (2.8) | |||
Refuse | 3 (6.4) | 5 (11.4) | 3 (8.3) |
Values are presented as number (%). GEM, gemcitabine; GEM-T, gemcitabine plus erlotinib; GEM-X, gemcitabine plus capecitabine; ECOG, Eastern Cooperative Oncology Group; CA 19-9, carbohydrate antigen 19-9 (normal range, 0.8 to 24.0). Used as a radiosensitizer or adjuvant treatment.
Values are presented as number (%). GEM, gemcitabine; GEM-T, gemcitabine plus erlotinib; GEM-X, gemcitabine plus capecitabine; CI, confidence interval.
GEM-X, gemcitabine plus capecitabine; GEM-T, gemcitabine plus erlotinib; PFS, progression-free survival; HR, hazard ratio; CI, confidence interval; OS, overall survival; ECOG, Eastern Cooperative Oncology Group; CA 19-9, carbohydrate antigen 19-9. p<0.05.
Values are presented as number (%). GEM, gemcitabine; GEM-T, gemcitabine plus erlotinib; GEM-X, gemcitabine plus capecitabine.