Retrospective Cohort Study
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©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Sep 26, 2020; 8(18): 4022-4033
Published online Sep 26, 2020. doi: 10.12998/wjcc.v8.i18.4022
Table 1 Baseline characteristics before propensity score matching
Variable Elderly group: 65-74 yr Very elderly group: 75+ yr Gemcitabine mono, n = 25GA and FOLFIRINOX, n = 49 P valueGemcitabine mono, n = 20GA and FOLFIRINOX, n = 10 P valueAge in year 70.9 ± 3.2 69.2 ± 2.7 0.020a 77.5 (76.8-78.9) 76.5 (75.6-78.8) 0.397 Male 10 (40.0) 40 (81.6) 0.000a 14 (70.0) 7 (70.0) 0.999 Body weight in kg 54.8 ± 9.0 59.8 ± 8.8 0.026a 56.0 (43.1-62.7) 54.3 (49.1-68.3) 0.856 Height in m 1.58 ± 0.09 1.65 ± 0.08 0.001a 1.63 (1.57-1.67) 1.62 (1.56-1.69) 0.979 Body mass index in kg/m2 22.0 ± 2.7 22.1 ± 3.0 0.977 22.1 (20.7-23.5) 21.6 (19.9-24.2) 0.775 Metastasis no > 2 18 (72.0) 23 (46.9) 0.041a 13 (65.0) 4 (40.0) 0.206 Site of metastasis Liver 18 (72.0) 30 (61.2) 0.256 12 (60.0) 3 (30.0) 0.130 Peritoneal carcinomatosis 10 (40.0) 20 (40.8) 0.574 6 (30.0) 4 (40.0) 0.599 Lung 5 (20.0) 9 (18.4) 0.548 4 (20.0) 2 (20.0) 0.999 Primary tumor site 0.671 0.467 Head 10 (40.0) 26 (53.1) 9 (45.0) 3 (30.0) Body 10 (40.0) 11 (22.4) 5 (25.0) 3 (30.0) Tail 5 (20.0) 12 (24.5) 6 (30.0) 4 (40.0) Biliary stenting due to obstruction 11 (44.0) 20 (40.8) 0.796 6 (30.0) 3 (30.0) 0.999 Tumor burden 81.8 ± 43.3 61.4 ± 32.5 0.025a 81.5 (21.0-159.0) 50.0 (15.0-225.0) 0.109 ECOG performance status 0.007a 0.027a 0 5 (20.0) 22 (44.9) 2 (10.0) 4 (40.0) 1 14 (56.0) 24 (49.0) 10 (50.0) 5 (50.0) 2 6 (24.0) 3 (6.1) 8 (40.0) 1 (10.0) Diabetes 13 (52.0) 24 (49.0) 0.809 7 (35.0) 2 (20.0) 0.416 Hypertension 10 (40.0) 18 (36.7) 0.788 9 (45.0) 2 (20.0) 0.193 Laboratory findings White blood cell as /μL 6648.0 ± 2411.7 6793.5 ± 2606.2 0.817 8175.0 (6432.4-10546.6) 7985.0 (5824.6-9631.4) 0.880 Platelet as 103 /μL 197.1 ± 68.0 244.6 ± 124.7 0.081 191.5 (168.5-217.5) 243.5 (205.1-291.3) 0.028a N/L ratio 3.9 ± 3.0 3.4 ± 2.8 0.532 3.91 (3.23-6.49) 2.19 (1.22-4.09) 0.055 Platelet/lymphocyte ratio 159.2 ± 74.5 166.6 ± 90.9 0.724 125.6 (120.5-198.4) 136.1 (94.3-176.3) 0.559 C-related protein in mg/dL 1.9 ± 3.0 1.1 ± 1.9 0.175 1.22 (0.96-4.72) 0.75 (0.12-3.04) 0.448 Albumin in g/dL 3.6 ± 0.7 4.0 ± 0.5 0.005a 3.5 (3.2-3.8) 4.3 (3.9-4.5) 0.001a Total bilirubin in mg/dL 0.98 ± 1.10 1.31 ± 2.10 0.464 0.49 (0.42-0.78) 0.41 (-0.03-2.14) 0.948 CA 19-9 in U/mL 3448.1 ± 8082.3 11073.9 ± 55832.2 0.501 666.4 (-2198.6-21079.9) 341.7 (-11731.7-33174.5) 0.328
Table 2 Baseline characteristics after propensity score matching
Variable Elderly group: 65-74 yr Very elderly group: 75+ yr Gemcitabine mono, n = 25 GA and FOLFIRINOX, n = 25 P valueGemcitabine mono, n = 10 GA and FOLFIRINOX, n = 10 P valueAge in year 70.9 ± 3.2 70.5 ± 2.6 0.626 77.0 (75.9-78.5) 76.5 (75.6-78.8) 0.853 Male 10 (40.0) 16 (64.0) 0.093 7 (70.0) 7 (70.0) 0.999 Body weight in kg 54.8 ± 9.0 59.7 ± 8.8 0.062 54.8 (49.4-65.5) 54.3 (49.1-68.3) 0.762 Height in m 1.58 ± 0.09 1.62 ± 0.09 0.060 1.64 (1.51-1.68) 1.62 (1.56-1.69) 0.696 Body mass index in kg/m2 22.0 ± 2.7 22.6 ± 2.7 0.438 22.6 (20.7-24.4) 21.6 (19.9-24.2) 0.633 Metastasis no > 2 18 (72.0) 16 (64.0) 0.554 4 (40.0) 4 (40.0) 0.999 Site of metastasis Liver 18 (72.0) 16 (64.0) 0.554 5 (50.0) 3 (30.0) 0.388 Peritoneal carcinomatosis 10 (40.0) 7 (28.0) 0.381 3 (30.0) 4 (40.0) 0.660 Lung 5 (20.0) 7 (28.0) 0.518 0 (0) 2 (20.0) 0.151 Primary tumor site 0.603 0.464 Head 10 (40.0) 14 (56.0) 5 (50.0) 3 (30.0) Body 10 (40.0) 5 (20.0) 2 (20.0) 3 (30.0) Tail 5 (20.0) 6 (24.0) 3 (30.0) 4 (40.0) Biliary stenting due to obstruction 11 (44.0) 12 (48.0) 0.782 4 (40.0) 3 (30.0) 0.660 Tumor burden 81.8 ± 43.3 68.0 ± 34.4 0.217 67.5 (44.1-98.7) 50.0 (23.5-109.9) 0.436 ECOG Performance status 0.101 0.145 0 5 (20.0) 10 (40.0) 2 (20.0) 4 (40.0) 1 14 (56.0) 12 (48.0) 4 (40.0) 5 (50.0) 2 6 (24.0) 3 (12.0) 4 (40.0) 1 (10.0) Diabetes 13 (52.0) 15 (60.0) 0.578 5 (50.0) 2 (20.0) 0.177 Hypertension 10 (40.0) 10 (40.0) 0.999 6 (60.0) 2 (20.0) 0.074 Laboratory findings White blood cell as /μL 6648.0 ± 2411.7 7122.4 ± 2777.8 0.522 6195.0 (4330.2-11393.8) 7985.0 (5824.6-9631.4) 0.912 Platelet as 103 /μL 197.1 ± 68.0 248.7 ± 125.8 0.078 171.5 (140.7-236.5) 243.5 (205.1-291.3) 0.089 N/L ratio 3.9 ± 3.0 3.8 ± 2.9 0.937 2.32 (1.60-5.36) 2.20 (1.22-4.09) 0.684 Platelet/lymphocyte ratio 159.2 ± 74.5 172.8 ± 102.3 0.594 121.6 (93.2-165.9) 136.1 (94.3-176.3) 0.853 C-related protein in mg/dL 1.9 ± 3.0 1.7 ± 2.4 0.800 0.45 (0.18-2.00) 0.75 (0.12-3.04) 0.796 Albumin in g/dL 3.6 ± 0.7 3.8 ± 0.5 0.182 4.0 (3.7-4.1) 4.3 (3.9-4.5) 0.123 Total bilirubin in mg/dL 0.98 ± 1.10 1.7 ± 2.4 0.246 0.44 (0.30-0.63) 0.41 (-0.03-2.14) 0.684 CA 19-9 in U/mL 3448.1 ± 8082.3 5260.9 ± 20304.3 0.681 482.9 (78.7-3297.4) 341.7 (-11731.7-33174.5) 0.393
Table 3 Result of chemotherapy response of each regimen
Elderly group: 65-74 yr Very elderly group: 75+ yr Gemcitabine mono, n = 25 GA and FOLFIRINOX, n = 25 P valueGemcitabine mono, n = 10 GA and FOLFIRINOX, n = 10P valueChemo response1 0.069 0.355 PR 0 (0.0) 3 (12.5) 0 (0.0) 0 (0.0) SD 10 (67.7) 16 (66.7) 6 (60.0) 8 (80.0) PD 7 (41.2) 5 (20.8) 4 (40.0) 2 (20.0) DCR, PR + SD 10 (58.8) 19 (79.2) 0.166 6 (60.0) 8 (80.0) 0.355 Tumor burden change, % 11.4 ± 22.8 -4.1 ± 23.1 0.049a 7.0 (-9.1-39.7) 3.5 (-5.9-13.4) 0.633 Tumor burden change, % in patients with PR or SD 1.1 ± 7.1 -10.7 ± 19.5 0.091 -7.0 (-23.9-8.6) 0.0 (-7.7-10.0) 0.366 Dose reduction 10 (40.0) 18 (72.0) 0.022a 7 (70.0) 9 (90.0) 0.288 Delivery dose 89.6 ± 12.4 84.4 ± 15.3 0.196 81.9 (73.1-93.4) 67.7 (64.6-84.6) 0.218 Total over 80% dose 17 (68.0) 15 (60.0) 0.565 6 (60.0) 4 (40.0) 0.398 Chemotherapy days 56.0 (29.7-82.3) 112.0 (43.5-180.5) 0.001a 98.0 (0.0-206.5) 112.0 (27.0-197.0) 0.790 Progression-free survival 62.0 (55.3-125.4) 206.0 (158.1-300.5) 0.000a 147.0 (86.4-263.0) 174.0 (94.6-270.4) 0.796 Overall survival 102.0 (75.6-155.1) 302.0 (215.9-388.4) 0.000a 227.0 (108.9-342.1) 211.0 (125.3-314.3) 0.739 2nd chemotherapy 3 (12.0) 12 (48.0) 0.005a 1 (10.0) 3 (30.0) 0.288 TS-1 1 (4.0) 6 (24.0) 1 (10.0) 2 (20.0) Gemcitabine mono 0 (0.0) 4 (16.0) 0 (0.0) 1 (10.0) GA 0 (0.0) 1 (4.0) 0 (0.0) 0 (0.0) FOLFIRINOX 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Onivyde 1 (4.0) 0 (0.0) 0 (0.0) 0 (0.0) 5-FU base 1 (4.0) 1 (4.0) 0 (0.0) 0 (0.0) 2nd chemotherapy PFS in d 86.0 (23.7-125.6) 83.0 (45.5-123.4) 0.572 75 (N/A) 74 (-17.5-136.9) 0.999
Table 4 Adverse events of each regimen
Adverse events Gemcitabine mono, n = 45 GA, n = 34 FOLFIRINOX, n = 25 P valueAdmission 13 (28.9) 11 (32.4) 10 (40.0) 0.359 Thromboembolism 4 (8.9) 2 (5.9) 7 (28.0) 0.041a Neuropathy (Grade 1,2/3,4) 0 (0.0) (0/0) 21 (61.8) (7/14) 7 (28.0) (6/1) 0.006a Neutropenia (Grade 1,2/3,4) 18 (40.0) (9/9) 26 (76.5) (9/17) 21 (84.0) (7/14) 0.000a Thrombocytopenia (Grade 1,2/3,4) 24 (53.3) (14/10) 16 (47.0) (10/6) 7 (28.0) (1/6) 0.241 Nausea (Grade 1,2/3,4) 12 (26.6) (11/1) 7 (21.6) (5/2) 9 (36.0) (7/2) 0.344 Fatigue (Grade 1,2/3,4) 22 (48.9) (12/10) 24 (64.7) (12/10) 16 (64.0) (9/7) 0.245 Diarrhea (Grade 1,2/3,4) 8 (17.8) (7/1) 7 (20.6) (5/2) 8 (32.0) (4/4) 0.065 Colitis/pneumonia 9 (20.0) (2/7) 7 (20.5) (1/6) 6 (24.0) (3/3) 0.959
Table 5 Adverse events of each regimen according to elderly and very elderly
Adverse events Gemcitabine mono, n = 45 GA & FOLFIRINOX, n = 59 P valueElderly, n = 25 Very elderly, n = 20 Elderly, n = 49 Very elderly, n = 10 Elderly Very elderly Admission 13 (28.9) 21 (35.6) 0.475 6 (24.0) 7 (35.0) 18 (36.7) 3 (30.0) 0.275 0.793 Thromboembolism 4 (8.9) 9 (15.3) 0.336 2 (8.0) 2 (10.0) 7 (14.3) 2 (20.0) 0.441 0.465 Neuropathy (Grade 1,2/3,4) 0 (0.0) 28 (47.5) 0.000* (0/0) (13/15) 0 (0.0) 0 (0.0) 23 (46.9) 5 (50.0) 0.000* 0.001a (0/0) (0/0) (9/14) (4/1) Neutropenia (Grade 1,2/3,4) 18 (40.0) 47 (79.7) 0.000* (9/9) (16/31) 9 (36.0) 9 (45.0) 38 (77.6) 9 (90.0) 0.000* 0.038a (4/5) (5/4) (11/27) (5/4) Thrombocytopenia (Grade 1,2/3,4) 24 (53.3) 23 (39.0) 0.312 (14/10) (11/12) 12 (48.0) (8/4) 12 (60.0) (6/6) 19 (38.8) (9/10) 4 (40.0) (2/2) 0.806 0.370 Nausea (Grade 1,2/3,4) 12 (26.6) 16 (27.1) 0.655 (11/1) (12/4) 5 (20.0) 7 (35.0) 14 (28.6) 2 (20.0) 0.236 0.354 (5/0) (6/1) (10/4) (2/0) Fatigue (Grade 1,2/3,4) 22 (48.9) 38 (64.4) 0.171 (12/10) (21/17) 11 (44.0) 11 (55.0) 32 (65.3) 6 (60.0) 0.101 0.669 (7/4) (5/6) (19/13) (2/4) Diarrhea (Grade 1,2/3,4) 8 (17.8) 15 (25.4) 0.180 (7/1) (9/6) 5 (20.0) 3 (15.0) 12 (24.5) 3 (30.0) 0.635 0.074 (4/1) (3/0) (9/3) (0/3) Colitis/pneumonia 9 (20.0) 13 (22.0) 0.906 (2/7) (4/9) 3 (12.0) 6 (30.0) 12 (24.5) 1 (10.0) 0.205 0.134 (1/2) (1/5) (3/9) (1/0)