Characteristics of the whole patient population (n = 147) and the population receiving FOLFIRI (n = 66) or 5FU maintenance (n = 52)
Characteristics . | Overall population (n = 147) . | FOLFIRI (n = 66) . | 5FU (n = 52) . | p value . |
---|---|---|---|---|
Demographic parameters | ||||
Center, n (%) | ||||
Besançon | 60 (40.8) | 20 (30.3) | 20 (38.5) | |
Lille | 55 (37.4) | 36 (54.6) | 11 (21.1) | |
Rennes | 32 (21.8) | 10 (15.1) | 21 (40.4) | |
Age, median [IQR], years | 60.0 [53.1–65.7] | 66.2 [55.1–65.4] | 56.4 [51.2–64.7] | .0411 |
Gender, n (%) | .9748 | |||
Male | 80 (54.4) | 37 (56.1) | 29 (55.8) | |
Female | 67 (45.6) | 29 (43.9) | 23 (44.2) | |
Familial history of cancer, n (%) | .9497 | |||
No | 46 (42.2) | 19 (43.2) | 17 (42.5) | |
Yes | 63 (57.8) | 25 (56.8) | 23 (57.5) | |
Missing | 38 | 22 | 12 | |
Personal history of cancer, n (%) | .0605 | |||
No | 123 (86.0) | 53 (82.8) | 49 (94.2) | |
Yes | 20 (14.0) | 11 (17.2) | 3 (5.8) | |
Missing | 4 | 2 | 0 | |
Pathologic parameters | ||||
Stage at diagnosis, n (%) | .2323 | |||
Localized | 21 (14.3) | 12 (18.2) | 4 (7.7) | |
Locally advanced | 35 (23.8) | 12 (18.2) | 9 (17.3) | |
Metastatic | 91 (61.9) | 42 (63.6) | 39 (75.0) | |
Primary tumor site, n (%) | .0908 | |||
Head | 79 (56.7) | 29 (43.9) | 31 (59.6) | |
Body and/or tail | 68 (46.3) | 37 (56.1) | 21 (40.4) | |
Histological grade, n (%) | .7230 | |||
Well or moderately differentiated | 52 (78.8) | 27 (84.4) | 17 (77.3) | |
Poorly differentiated or undifferentiated | 14 (21.2) | 5 (15.6) | 5 (22.7) | |
Missing | 81 | 34 | 30 | |
Tumor extension | ||||
Stage at chemotherapy initiation, n (%) | .8508 | |||
Locally advanced | 32 (21.8) | 11 (16.7) | 8 (15.4) | |
Metastatic | 115 (78.2) | 55 (83.3) | 44 (84.6) | |
Number of metastatic sites, n (%) | .9811 | |||
0 | 32 (21.8) | 11 (16.7) | 8 (15.4) | |
1 | 87 (59.2) | 41 (62.1) | 33 (63.5) | |
≥2 | 28 (19.0) | 14 (21.2) | 11 (21.1) | |
Lymph node metastases, n (%) | .1604 | |||
No | 133 (90.5) | 57 (86.4) | 49 (94.2) | |
Yes | 14 (9.5) | 9 (13.6) | 3 (5.8) | |
Liver metastases, n (%) | .7166 | |||
No | 57 (38.8) | 22 (33.3) | 19 (36.5) | |
Yes | 90 (61.2) | 44 (66.7) | 33 (63.5) | |
Peritoneal metastases, n (%) | .5576 | |||
No | 124 (84.4) | 56 (84.9) | 42 (80.8) | |
Yes | 23 (15.6) | 10 (15.1) | 10 (19.2) | |
Lung metastases, n (%) | .9780 | |||
No | 129 (88.8) | 57 (86.4) | 45 (86.5) | |
Yes | 18 (12.2) | 9 (13.6) | 7 (13.5) | |
Other metastases, n (%) | .6294 | |||
No | 143 (97.3) | 63 (95.5) | 51 (98.1) | |
Yes | 4 (2.7) | 3 (4.5) | 1 (1.9) | |
Clinical parameters | ||||
Performance status (WHO), n (%) | .0258 | |||
0 | 56 (38.6) | 22 (34.4) | 25 (48.1) | |
1 | 85 (58.6) | 41 (64.1) | 25 (48.1) | |
≥2 | 4 (2.8) | 1 (1.5) | 2 (3.8) | |
Missing | 2 | 2 | 0 | |
Body mass index, kg/m2 | 23.1 [20.7–25.6] | 23.0 [20.4–25.7] | 23.2 [21.2–26.2] | .3500 |
Missing, n (%) | 2 | 2 | 0 | |
Pain, n (%) | .7355 | |||
No | 90 (63.8) | 45 (70.3) | 33 (67.4) | |
Yes | 51 (36.2) | 19 (29.7) | 16 (32.6) | |
Missing | 6 | 2 | 3 | |
Jaundice, n (%) | .9999 | |||
No | 135 (94.4) | 59 (92.2) | 47 (94.0) | |
Yes | 8 (5.6) | 5 (7.8) | 3 (6.0) | |
Missing | 4 | 2 | 2 | |
Ascites, n (%) | .6938 | |||
No | 136 (95.8) | 60 (93.8) | 48 (96.0) | |
Yes | 6 (4.2) | 4 (6.2) | 2 (4.0) | |
Missing | 5 | 0 | 2 | |
Biological parameters | ||||
Albumin, median [IQR], g/L | 40.0 [35.0–43.0] | 39.3 [35.5–42.1] | 41.0 [38.5–44.0] | .1266 |
<35 | 18 (20.7) | 9 (22.5) | 2 (7.1) | .1083 |
≥35 | 69 (79.3) | 31 (77.5) | 26 (92.9) | |
Missing | 60 | 26 | 24 | |
Lymphocytes, median [IQR], mm3 | 1,530.0 [1,270.0–2,100.0] | 1,510.0 [1,200.0–2,184.0] | 1,540.0 [1,280.0–1,720.0] | .6683 |
<1,000 | 9 (9.5) | 6 (12.8) | 2 (6.1) | .4595 |
≥1,000 | 86 (90.5) | 41 (87.2) | 31 (93.9) | |
Missing | 52 | 19 | 19 | |
Neutrophil‐to‐lymphocyte ratio, median [IQR] | 2.93 [2.13–4.46] | 2.95 [2.14–5.85] | 3.06 [2.13–4.30] | .7150 |
<5 | 74 (77.9) | 34 (72.3) | 27 (81.8) | .3268 |
≥5 | 21 (22.1) | 13 (27.7) | 6 (18.2) | |
Missing | 52 | 19 | 19 | |
CA19‐9, median [IQR], UI/mL | 605.0 [69.0–4,756.0] | 310.0 [25.0–3,528.0] | 562.5 [238.0–4,000.0] | .3818 |
<37 | 30 (23.1) | 19 (32.2) | 8 (17.4) | .0849 |
≥37 | 100 (76.9) | 40 (67.8) | 38 (82.6) | |
Missing | 17 | 7 | 6 | |
Previous treatment | ||||
Primary tumor resection, n (%) | .1883 | |||
Yes | 22 (15.0) | 12 (18.2) | 5 (9.6) | |
No | 125 (85.0) | 54 (81.8) | 47 (90.4) | |
Adjuvant chemotherapy, n (%) | .4294 | |||
Yes | 17 (11.6) | 8 (12.1) | 48 (92.3) | |
No | 130 (88.4) | 58 (87.9) | 4 (7.7) | |
Radiotherapy, n (%) | .9999 | |||
Yes | 2 (1.4) | 1 (1.5) | 0 (0.0) | |
No | 145 (98.6) | 65 (98.5) | 52 (100.0) | |
First‐line chemotherapy | ||||
Number of cycles of FOLFIRINOX, median [IQR] | 9.0 [6.0–11.0] | .1056 | ||
<8 cycles | 16 (24.2) | 6 (11.5) | ||
8–11 cycles | 29 (44.0) | 32 (61.6) | ||
>12 cycles | 21 (31.8) | 14 (26.9) | ||
Regimen after FOLFIRINOX, n (%) | ||||
FOLFIRI | 66 (44.9) | |||
FP monotherapy (capecitabine or LV5FU2) | 52 (35.4) | |||
FOLFOX | 25 (17.0) | |||
Other | 4 (2.7) | |||
RECIST best response, n (%) | .3339 | |||
Complete or partial response | 69 (51.9) | 31 (50.0) | 31 (60.8) | |
Stability | 61 (45.9) | 29 (46.8) | 20 (39.2) | |
Progression | 3 (2.2) | 2 (3.2) | 0 (0.0) | |
Missing | 14 | 4 | 1 | |
Toxicity of grade 3 or 4, n (%) | .0302 | |||
No | 88 (62.4) | 37 (58.7) | 39 (78.0) | |
Yes | 53 (37.6) | 26 (41.3) | 11 (22.0) | |
Digestive | 21 (39.6) | 0 (0.0) | 3 (27.3) | |
Hematology | 8 (15.1) | 1 (3.9) | 5 (45.5) | |
Neurology | 16 (30.2) | 19 (73.1) | 1 (9.1) | |
Other | 8 (15.1) | 6 (23.1) | 2 (18.2) | |
Missing | 6 | 3 | 2 | |
Reason for discontinuation, n (%) | .8714 | |||
Progression | 107 (73.3) | 49 (75.4) | 42 (80.8) | |
Toxicity | 7 (4.8) | 3 (4.6) | 2 (3.8) | |
Other | 32 (21.9) | 13 (20.0) | 8 (15.4) | |
Missing | 1 | 1 | 0 | |
Reintroduction of oxaliplatin and/or irinotecan, n (%) | <.001 | |||
No | 61 (92.4) | 25 (48.1) | ||
Yes | 5 (7.6) | 27 (51.9) | ||
FOLFIRINOX | 4 (80.0) | 19 (70.4) | ||
FOLFIRI or FOLFIRI‐3 | 1 (20.0) | 6 (22.2) | ||
FOLFOX | 0 (0.0) | 2 (7.4) | ||
Second‐line chemotherapy administration, n (%) | .3059 | |||
No | 15 (22.7) | 27 (51.9) | ||
Yes | 51 (77.3) | 25 (48.1) | ||
Gemcitabine | 43 (84.3) | 24 (96.0) | ||
FOLFIRI | 2 (3.9) | 0 (0.0) | ||
FOLFOX | 3 (5.9) | 0 (0.0) | ||
Cisplatin | 2 (3.9) | 1 (4.0) | ||
GEMOX | 1 (2.0) | 0 (0.0) |
Characteristics . | Overall population (n = 147) . | FOLFIRI (n = 66) . | 5FU (n = 52) . | p value . |
---|---|---|---|---|
Demographic parameters | ||||
Center, n (%) | ||||
Besançon | 60 (40.8) | 20 (30.3) | 20 (38.5) | |
Lille | 55 (37.4) | 36 (54.6) | 11 (21.1) | |
Rennes | 32 (21.8) | 10 (15.1) | 21 (40.4) | |
Age, median [IQR], years | 60.0 [53.1–65.7] | 66.2 [55.1–65.4] | 56.4 [51.2–64.7] | .0411 |
Gender, n (%) | .9748 | |||
Male | 80 (54.4) | 37 (56.1) | 29 (55.8) | |
Female | 67 (45.6) | 29 (43.9) | 23 (44.2) | |
Familial history of cancer, n (%) | .9497 | |||
No | 46 (42.2) | 19 (43.2) | 17 (42.5) | |
Yes | 63 (57.8) | 25 (56.8) | 23 (57.5) | |
Missing | 38 | 22 | 12 | |
Personal history of cancer, n (%) | .0605 | |||
No | 123 (86.0) | 53 (82.8) | 49 (94.2) | |
Yes | 20 (14.0) | 11 (17.2) | 3 (5.8) | |
Missing | 4 | 2 | 0 | |
Pathologic parameters | ||||
Stage at diagnosis, n (%) | .2323 | |||
Localized | 21 (14.3) | 12 (18.2) | 4 (7.7) | |
Locally advanced | 35 (23.8) | 12 (18.2) | 9 (17.3) | |
Metastatic | 91 (61.9) | 42 (63.6) | 39 (75.0) | |
Primary tumor site, n (%) | .0908 | |||
Head | 79 (56.7) | 29 (43.9) | 31 (59.6) | |
Body and/or tail | 68 (46.3) | 37 (56.1) | 21 (40.4) | |
Histological grade, n (%) | .7230 | |||
Well or moderately differentiated | 52 (78.8) | 27 (84.4) | 17 (77.3) | |
Poorly differentiated or undifferentiated | 14 (21.2) | 5 (15.6) | 5 (22.7) | |
Missing | 81 | 34 | 30 | |
Tumor extension | ||||
Stage at chemotherapy initiation, n (%) | .8508 | |||
Locally advanced | 32 (21.8) | 11 (16.7) | 8 (15.4) | |
Metastatic | 115 (78.2) | 55 (83.3) | 44 (84.6) | |
Number of metastatic sites, n (%) | .9811 | |||
0 | 32 (21.8) | 11 (16.7) | 8 (15.4) | |
1 | 87 (59.2) | 41 (62.1) | 33 (63.5) | |
≥2 | 28 (19.0) | 14 (21.2) | 11 (21.1) | |
Lymph node metastases, n (%) | .1604 | |||
No | 133 (90.5) | 57 (86.4) | 49 (94.2) | |
Yes | 14 (9.5) | 9 (13.6) | 3 (5.8) | |
Liver metastases, n (%) | .7166 | |||
No | 57 (38.8) | 22 (33.3) | 19 (36.5) | |
Yes | 90 (61.2) | 44 (66.7) | 33 (63.5) | |
Peritoneal metastases, n (%) | .5576 | |||
No | 124 (84.4) | 56 (84.9) | 42 (80.8) | |
Yes | 23 (15.6) | 10 (15.1) | 10 (19.2) | |
Lung metastases, n (%) | .9780 | |||
No | 129 (88.8) | 57 (86.4) | 45 (86.5) | |
Yes | 18 (12.2) | 9 (13.6) | 7 (13.5) | |
Other metastases, n (%) | .6294 | |||
No | 143 (97.3) | 63 (95.5) | 51 (98.1) | |
Yes | 4 (2.7) | 3 (4.5) | 1 (1.9) | |
Clinical parameters | ||||
Performance status (WHO), n (%) | .0258 | |||
0 | 56 (38.6) | 22 (34.4) | 25 (48.1) | |
1 | 85 (58.6) | 41 (64.1) | 25 (48.1) | |
≥2 | 4 (2.8) | 1 (1.5) | 2 (3.8) | |
Missing | 2 | 2 | 0 | |
Body mass index, kg/m2 | 23.1 [20.7–25.6] | 23.0 [20.4–25.7] | 23.2 [21.2–26.2] | .3500 |
Missing, n (%) | 2 | 2 | 0 | |
Pain, n (%) | .7355 | |||
No | 90 (63.8) | 45 (70.3) | 33 (67.4) | |
Yes | 51 (36.2) | 19 (29.7) | 16 (32.6) | |
Missing | 6 | 2 | 3 | |
Jaundice, n (%) | .9999 | |||
No | 135 (94.4) | 59 (92.2) | 47 (94.0) | |
Yes | 8 (5.6) | 5 (7.8) | 3 (6.0) | |
Missing | 4 | 2 | 2 | |
Ascites, n (%) | .6938 | |||
No | 136 (95.8) | 60 (93.8) | 48 (96.0) | |
Yes | 6 (4.2) | 4 (6.2) | 2 (4.0) | |
Missing | 5 | 0 | 2 | |
Biological parameters | ||||
Albumin, median [IQR], g/L | 40.0 [35.0–43.0] | 39.3 [35.5–42.1] | 41.0 [38.5–44.0] | .1266 |
<35 | 18 (20.7) | 9 (22.5) | 2 (7.1) | .1083 |
≥35 | 69 (79.3) | 31 (77.5) | 26 (92.9) | |
Missing | 60 | 26 | 24 | |
Lymphocytes, median [IQR], mm3 | 1,530.0 [1,270.0–2,100.0] | 1,510.0 [1,200.0–2,184.0] | 1,540.0 [1,280.0–1,720.0] | .6683 |
<1,000 | 9 (9.5) | 6 (12.8) | 2 (6.1) | .4595 |
≥1,000 | 86 (90.5) | 41 (87.2) | 31 (93.9) | |
Missing | 52 | 19 | 19 | |
Neutrophil‐to‐lymphocyte ratio, median [IQR] | 2.93 [2.13–4.46] | 2.95 [2.14–5.85] | 3.06 [2.13–4.30] | .7150 |
<5 | 74 (77.9) | 34 (72.3) | 27 (81.8) | .3268 |
≥5 | 21 (22.1) | 13 (27.7) | 6 (18.2) | |
Missing | 52 | 19 | 19 | |
CA19‐9, median [IQR], UI/mL | 605.0 [69.0–4,756.0] | 310.0 [25.0–3,528.0] | 562.5 [238.0–4,000.0] | .3818 |
<37 | 30 (23.1) | 19 (32.2) | 8 (17.4) | .0849 |
≥37 | 100 (76.9) | 40 (67.8) | 38 (82.6) | |
Missing | 17 | 7 | 6 | |
Previous treatment | ||||
Primary tumor resection, n (%) | .1883 | |||
Yes | 22 (15.0) | 12 (18.2) | 5 (9.6) | |
No | 125 (85.0) | 54 (81.8) | 47 (90.4) | |
Adjuvant chemotherapy, n (%) | .4294 | |||
Yes | 17 (11.6) | 8 (12.1) | 48 (92.3) | |
No | 130 (88.4) | 58 (87.9) | 4 (7.7) | |
Radiotherapy, n (%) | .9999 | |||
Yes | 2 (1.4) | 1 (1.5) | 0 (0.0) | |
No | 145 (98.6) | 65 (98.5) | 52 (100.0) | |
First‐line chemotherapy | ||||
Number of cycles of FOLFIRINOX, median [IQR] | 9.0 [6.0–11.0] | .1056 | ||
<8 cycles | 16 (24.2) | 6 (11.5) | ||
8–11 cycles | 29 (44.0) | 32 (61.6) | ||
>12 cycles | 21 (31.8) | 14 (26.9) | ||
Regimen after FOLFIRINOX, n (%) | ||||
FOLFIRI | 66 (44.9) | |||
FP monotherapy (capecitabine or LV5FU2) | 52 (35.4) | |||
FOLFOX | 25 (17.0) | |||
Other | 4 (2.7) | |||
RECIST best response, n (%) | .3339 | |||
Complete or partial response | 69 (51.9) | 31 (50.0) | 31 (60.8) | |
Stability | 61 (45.9) | 29 (46.8) | 20 (39.2) | |
Progression | 3 (2.2) | 2 (3.2) | 0 (0.0) | |
Missing | 14 | 4 | 1 | |
Toxicity of grade 3 or 4, n (%) | .0302 | |||
No | 88 (62.4) | 37 (58.7) | 39 (78.0) | |
Yes | 53 (37.6) | 26 (41.3) | 11 (22.0) | |
Digestive | 21 (39.6) | 0 (0.0) | 3 (27.3) | |
Hematology | 8 (15.1) | 1 (3.9) | 5 (45.5) | |
Neurology | 16 (30.2) | 19 (73.1) | 1 (9.1) | |
Other | 8 (15.1) | 6 (23.1) | 2 (18.2) | |
Missing | 6 | 3 | 2 | |
Reason for discontinuation, n (%) | .8714 | |||
Progression | 107 (73.3) | 49 (75.4) | 42 (80.8) | |
Toxicity | 7 (4.8) | 3 (4.6) | 2 (3.8) | |
Other | 32 (21.9) | 13 (20.0) | 8 (15.4) | |
Missing | 1 | 1 | 0 | |
Reintroduction of oxaliplatin and/or irinotecan, n (%) | <.001 | |||
No | 61 (92.4) | 25 (48.1) | ||
Yes | 5 (7.6) | 27 (51.9) | ||
FOLFIRINOX | 4 (80.0) | 19 (70.4) | ||
FOLFIRI or FOLFIRI‐3 | 1 (20.0) | 6 (22.2) | ||
FOLFOX | 0 (0.0) | 2 (7.4) | ||
Second‐line chemotherapy administration, n (%) | .3059 | |||
No | 15 (22.7) | 27 (51.9) | ||
Yes | 51 (77.3) | 25 (48.1) | ||
Gemcitabine | 43 (84.3) | 24 (96.0) | ||
FOLFIRI | 2 (3.9) | 0 (0.0) | ||
FOLFOX | 3 (5.9) | 0 (0.0) | ||
Cisplatin | 2 (3.9) | 1 (4.0) | ||
GEMOX | 1 (2.0) | 0 (0.0) |
The population of the FOLFIRI group was older and performance status was higher than those of the 5FU group.
Abbreviations: 5FU, 5‐fluorouracil; CA19‐9, cancer antigen 19‐9; FP, fluoropyrimidine; GEMOX, gemcitabin oxaliplatin; IQR, interquartile range; LV5FU2, 5‐fluorouracil leucovorin; WHO, World Health Organization.
Characteristics of the whole patient population (n = 147) and the population receiving FOLFIRI (n = 66) or 5FU maintenance (n = 52)
Characteristics . | Overall population (n = 147) . | FOLFIRI (n = 66) . | 5FU (n = 52) . | p value . |
---|---|---|---|---|
Demographic parameters | ||||
Center, n (%) | ||||
Besançon | 60 (40.8) | 20 (30.3) | 20 (38.5) | |
Lille | 55 (37.4) | 36 (54.6) | 11 (21.1) | |
Rennes | 32 (21.8) | 10 (15.1) | 21 (40.4) | |
Age, median [IQR], years | 60.0 [53.1–65.7] | 66.2 [55.1–65.4] | 56.4 [51.2–64.7] | .0411 |
Gender, n (%) | .9748 | |||
Male | 80 (54.4) | 37 (56.1) | 29 (55.8) | |
Female | 67 (45.6) | 29 (43.9) | 23 (44.2) | |
Familial history of cancer, n (%) | .9497 | |||
No | 46 (42.2) | 19 (43.2) | 17 (42.5) | |
Yes | 63 (57.8) | 25 (56.8) | 23 (57.5) | |
Missing | 38 | 22 | 12 | |
Personal history of cancer, n (%) | .0605 | |||
No | 123 (86.0) | 53 (82.8) | 49 (94.2) | |
Yes | 20 (14.0) | 11 (17.2) | 3 (5.8) | |
Missing | 4 | 2 | 0 | |
Pathologic parameters | ||||
Stage at diagnosis, n (%) | .2323 | |||
Localized | 21 (14.3) | 12 (18.2) | 4 (7.7) | |
Locally advanced | 35 (23.8) | 12 (18.2) | 9 (17.3) | |
Metastatic | 91 (61.9) | 42 (63.6) | 39 (75.0) | |
Primary tumor site, n (%) | .0908 | |||
Head | 79 (56.7) | 29 (43.9) | 31 (59.6) | |
Body and/or tail | 68 (46.3) | 37 (56.1) | 21 (40.4) | |
Histological grade, n (%) | .7230 | |||
Well or moderately differentiated | 52 (78.8) | 27 (84.4) | 17 (77.3) | |
Poorly differentiated or undifferentiated | 14 (21.2) | 5 (15.6) | 5 (22.7) | |
Missing | 81 | 34 | 30 | |
Tumor extension | ||||
Stage at chemotherapy initiation, n (%) | .8508 | |||
Locally advanced | 32 (21.8) | 11 (16.7) | 8 (15.4) | |
Metastatic | 115 (78.2) | 55 (83.3) | 44 (84.6) | |
Number of metastatic sites, n (%) | .9811 | |||
0 | 32 (21.8) | 11 (16.7) | 8 (15.4) | |
1 | 87 (59.2) | 41 (62.1) | 33 (63.5) | |
≥2 | 28 (19.0) | 14 (21.2) | 11 (21.1) | |
Lymph node metastases, n (%) | .1604 | |||
No | 133 (90.5) | 57 (86.4) | 49 (94.2) | |
Yes | 14 (9.5) | 9 (13.6) | 3 (5.8) | |
Liver metastases, n (%) | .7166 | |||
No | 57 (38.8) | 22 (33.3) | 19 (36.5) | |
Yes | 90 (61.2) | 44 (66.7) | 33 (63.5) | |
Peritoneal metastases, n (%) | .5576 | |||
No | 124 (84.4) | 56 (84.9) | 42 (80.8) | |
Yes | 23 (15.6) | 10 (15.1) | 10 (19.2) | |
Lung metastases, n (%) | .9780 | |||
No | 129 (88.8) | 57 (86.4) | 45 (86.5) | |
Yes | 18 (12.2) | 9 (13.6) | 7 (13.5) | |
Other metastases, n (%) | .6294 | |||
No | 143 (97.3) | 63 (95.5) | 51 (98.1) | |
Yes | 4 (2.7) | 3 (4.5) | 1 (1.9) | |
Clinical parameters | ||||
Performance status (WHO), n (%) | .0258 | |||
0 | 56 (38.6) | 22 (34.4) | 25 (48.1) | |
1 | 85 (58.6) | 41 (64.1) | 25 (48.1) | |
≥2 | 4 (2.8) | 1 (1.5) | 2 (3.8) | |
Missing | 2 | 2 | 0 | |
Body mass index, kg/m2 | 23.1 [20.7–25.6] | 23.0 [20.4–25.7] | 23.2 [21.2–26.2] | .3500 |
Missing, n (%) | 2 | 2 | 0 | |
Pain, n (%) | .7355 | |||
No | 90 (63.8) | 45 (70.3) | 33 (67.4) | |
Yes | 51 (36.2) | 19 (29.7) | 16 (32.6) | |
Missing | 6 | 2 | 3 | |
Jaundice, n (%) | .9999 | |||
No | 135 (94.4) | 59 (92.2) | 47 (94.0) | |
Yes | 8 (5.6) | 5 (7.8) | 3 (6.0) | |
Missing | 4 | 2 | 2 | |
Ascites, n (%) | .6938 | |||
No | 136 (95.8) | 60 (93.8) | 48 (96.0) | |
Yes | 6 (4.2) | 4 (6.2) | 2 (4.0) | |
Missing | 5 | 0 | 2 | |
Biological parameters | ||||
Albumin, median [IQR], g/L | 40.0 [35.0–43.0] | 39.3 [35.5–42.1] | 41.0 [38.5–44.0] | .1266 |
<35 | 18 (20.7) | 9 (22.5) | 2 (7.1) | .1083 |
≥35 | 69 (79.3) | 31 (77.5) | 26 (92.9) | |
Missing | 60 | 26 | 24 | |
Lymphocytes, median [IQR], mm3 | 1,530.0 [1,270.0–2,100.0] | 1,510.0 [1,200.0–2,184.0] | 1,540.0 [1,280.0–1,720.0] | .6683 |
<1,000 | 9 (9.5) | 6 (12.8) | 2 (6.1) | .4595 |
≥1,000 | 86 (90.5) | 41 (87.2) | 31 (93.9) | |
Missing | 52 | 19 | 19 | |
Neutrophil‐to‐lymphocyte ratio, median [IQR] | 2.93 [2.13–4.46] | 2.95 [2.14–5.85] | 3.06 [2.13–4.30] | .7150 |
<5 | 74 (77.9) | 34 (72.3) | 27 (81.8) | .3268 |
≥5 | 21 (22.1) | 13 (27.7) | 6 (18.2) | |
Missing | 52 | 19 | 19 | |
CA19‐9, median [IQR], UI/mL | 605.0 [69.0–4,756.0] | 310.0 [25.0–3,528.0] | 562.5 [238.0–4,000.0] | .3818 |
<37 | 30 (23.1) | 19 (32.2) | 8 (17.4) | .0849 |
≥37 | 100 (76.9) | 40 (67.8) | 38 (82.6) | |
Missing | 17 | 7 | 6 | |
Previous treatment | ||||
Primary tumor resection, n (%) | .1883 | |||
Yes | 22 (15.0) | 12 (18.2) | 5 (9.6) | |
No | 125 (85.0) | 54 (81.8) | 47 (90.4) | |
Adjuvant chemotherapy, n (%) | .4294 | |||
Yes | 17 (11.6) | 8 (12.1) | 48 (92.3) | |
No | 130 (88.4) | 58 (87.9) | 4 (7.7) | |
Radiotherapy, n (%) | .9999 | |||
Yes | 2 (1.4) | 1 (1.5) | 0 (0.0) | |
No | 145 (98.6) | 65 (98.5) | 52 (100.0) | |
First‐line chemotherapy | ||||
Number of cycles of FOLFIRINOX, median [IQR] | 9.0 [6.0–11.0] | .1056 | ||
<8 cycles | 16 (24.2) | 6 (11.5) | ||
8–11 cycles | 29 (44.0) | 32 (61.6) | ||
>12 cycles | 21 (31.8) | 14 (26.9) | ||
Regimen after FOLFIRINOX, n (%) | ||||
FOLFIRI | 66 (44.9) | |||
FP monotherapy (capecitabine or LV5FU2) | 52 (35.4) | |||
FOLFOX | 25 (17.0) | |||
Other | 4 (2.7) | |||
RECIST best response, n (%) | .3339 | |||
Complete or partial response | 69 (51.9) | 31 (50.0) | 31 (60.8) | |
Stability | 61 (45.9) | 29 (46.8) | 20 (39.2) | |
Progression | 3 (2.2) | 2 (3.2) | 0 (0.0) | |
Missing | 14 | 4 | 1 | |
Toxicity of grade 3 or 4, n (%) | .0302 | |||
No | 88 (62.4) | 37 (58.7) | 39 (78.0) | |
Yes | 53 (37.6) | 26 (41.3) | 11 (22.0) | |
Digestive | 21 (39.6) | 0 (0.0) | 3 (27.3) | |
Hematology | 8 (15.1) | 1 (3.9) | 5 (45.5) | |
Neurology | 16 (30.2) | 19 (73.1) | 1 (9.1) | |
Other | 8 (15.1) | 6 (23.1) | 2 (18.2) | |
Missing | 6 | 3 | 2 | |
Reason for discontinuation, n (%) | .8714 | |||
Progression | 107 (73.3) | 49 (75.4) | 42 (80.8) | |
Toxicity | 7 (4.8) | 3 (4.6) | 2 (3.8) | |
Other | 32 (21.9) | 13 (20.0) | 8 (15.4) | |
Missing | 1 | 1 | 0 | |
Reintroduction of oxaliplatin and/or irinotecan, n (%) | <.001 | |||
No | 61 (92.4) | 25 (48.1) | ||
Yes | 5 (7.6) | 27 (51.9) | ||
FOLFIRINOX | 4 (80.0) | 19 (70.4) | ||
FOLFIRI or FOLFIRI‐3 | 1 (20.0) | 6 (22.2) | ||
FOLFOX | 0 (0.0) | 2 (7.4) | ||
Second‐line chemotherapy administration, n (%) | .3059 | |||
No | 15 (22.7) | 27 (51.9) | ||
Yes | 51 (77.3) | 25 (48.1) | ||
Gemcitabine | 43 (84.3) | 24 (96.0) | ||
FOLFIRI | 2 (3.9) | 0 (0.0) | ||
FOLFOX | 3 (5.9) | 0 (0.0) | ||
Cisplatin | 2 (3.9) | 1 (4.0) | ||
GEMOX | 1 (2.0) | 0 (0.0) |
Characteristics . | Overall population (n = 147) . | FOLFIRI (n = 66) . | 5FU (n = 52) . | p value . |
---|---|---|---|---|
Demographic parameters | ||||
Center, n (%) | ||||
Besançon | 60 (40.8) | 20 (30.3) | 20 (38.5) | |
Lille | 55 (37.4) | 36 (54.6) | 11 (21.1) | |
Rennes | 32 (21.8) | 10 (15.1) | 21 (40.4) | |
Age, median [IQR], years | 60.0 [53.1–65.7] | 66.2 [55.1–65.4] | 56.4 [51.2–64.7] | .0411 |
Gender, n (%) | .9748 | |||
Male | 80 (54.4) | 37 (56.1) | 29 (55.8) | |
Female | 67 (45.6) | 29 (43.9) | 23 (44.2) | |
Familial history of cancer, n (%) | .9497 | |||
No | 46 (42.2) | 19 (43.2) | 17 (42.5) | |
Yes | 63 (57.8) | 25 (56.8) | 23 (57.5) | |
Missing | 38 | 22 | 12 | |
Personal history of cancer, n (%) | .0605 | |||
No | 123 (86.0) | 53 (82.8) | 49 (94.2) | |
Yes | 20 (14.0) | 11 (17.2) | 3 (5.8) | |
Missing | 4 | 2 | 0 | |
Pathologic parameters | ||||
Stage at diagnosis, n (%) | .2323 | |||
Localized | 21 (14.3) | 12 (18.2) | 4 (7.7) | |
Locally advanced | 35 (23.8) | 12 (18.2) | 9 (17.3) | |
Metastatic | 91 (61.9) | 42 (63.6) | 39 (75.0) | |
Primary tumor site, n (%) | .0908 | |||
Head | 79 (56.7) | 29 (43.9) | 31 (59.6) | |
Body and/or tail | 68 (46.3) | 37 (56.1) | 21 (40.4) | |
Histological grade, n (%) | .7230 | |||
Well or moderately differentiated | 52 (78.8) | 27 (84.4) | 17 (77.3) | |
Poorly differentiated or undifferentiated | 14 (21.2) | 5 (15.6) | 5 (22.7) | |
Missing | 81 | 34 | 30 | |
Tumor extension | ||||
Stage at chemotherapy initiation, n (%) | .8508 | |||
Locally advanced | 32 (21.8) | 11 (16.7) | 8 (15.4) | |
Metastatic | 115 (78.2) | 55 (83.3) | 44 (84.6) | |
Number of metastatic sites, n (%) | .9811 | |||
0 | 32 (21.8) | 11 (16.7) | 8 (15.4) | |
1 | 87 (59.2) | 41 (62.1) | 33 (63.5) | |
≥2 | 28 (19.0) | 14 (21.2) | 11 (21.1) | |
Lymph node metastases, n (%) | .1604 | |||
No | 133 (90.5) | 57 (86.4) | 49 (94.2) | |
Yes | 14 (9.5) | 9 (13.6) | 3 (5.8) | |
Liver metastases, n (%) | .7166 | |||
No | 57 (38.8) | 22 (33.3) | 19 (36.5) | |
Yes | 90 (61.2) | 44 (66.7) | 33 (63.5) | |
Peritoneal metastases, n (%) | .5576 | |||
No | 124 (84.4) | 56 (84.9) | 42 (80.8) | |
Yes | 23 (15.6) | 10 (15.1) | 10 (19.2) | |
Lung metastases, n (%) | .9780 | |||
No | 129 (88.8) | 57 (86.4) | 45 (86.5) | |
Yes | 18 (12.2) | 9 (13.6) | 7 (13.5) | |
Other metastases, n (%) | .6294 | |||
No | 143 (97.3) | 63 (95.5) | 51 (98.1) | |
Yes | 4 (2.7) | 3 (4.5) | 1 (1.9) | |
Clinical parameters | ||||
Performance status (WHO), n (%) | .0258 | |||
0 | 56 (38.6) | 22 (34.4) | 25 (48.1) | |
1 | 85 (58.6) | 41 (64.1) | 25 (48.1) | |
≥2 | 4 (2.8) | 1 (1.5) | 2 (3.8) | |
Missing | 2 | 2 | 0 | |
Body mass index, kg/m2 | 23.1 [20.7–25.6] | 23.0 [20.4–25.7] | 23.2 [21.2–26.2] | .3500 |
Missing, n (%) | 2 | 2 | 0 | |
Pain, n (%) | .7355 | |||
No | 90 (63.8) | 45 (70.3) | 33 (67.4) | |
Yes | 51 (36.2) | 19 (29.7) | 16 (32.6) | |
Missing | 6 | 2 | 3 | |
Jaundice, n (%) | .9999 | |||
No | 135 (94.4) | 59 (92.2) | 47 (94.0) | |
Yes | 8 (5.6) | 5 (7.8) | 3 (6.0) | |
Missing | 4 | 2 | 2 | |
Ascites, n (%) | .6938 | |||
No | 136 (95.8) | 60 (93.8) | 48 (96.0) | |
Yes | 6 (4.2) | 4 (6.2) | 2 (4.0) | |
Missing | 5 | 0 | 2 | |
Biological parameters | ||||
Albumin, median [IQR], g/L | 40.0 [35.0–43.0] | 39.3 [35.5–42.1] | 41.0 [38.5–44.0] | .1266 |
<35 | 18 (20.7) | 9 (22.5) | 2 (7.1) | .1083 |
≥35 | 69 (79.3) | 31 (77.5) | 26 (92.9) | |
Missing | 60 | 26 | 24 | |
Lymphocytes, median [IQR], mm3 | 1,530.0 [1,270.0–2,100.0] | 1,510.0 [1,200.0–2,184.0] | 1,540.0 [1,280.0–1,720.0] | .6683 |
<1,000 | 9 (9.5) | 6 (12.8) | 2 (6.1) | .4595 |
≥1,000 | 86 (90.5) | 41 (87.2) | 31 (93.9) | |
Missing | 52 | 19 | 19 | |
Neutrophil‐to‐lymphocyte ratio, median [IQR] | 2.93 [2.13–4.46] | 2.95 [2.14–5.85] | 3.06 [2.13–4.30] | .7150 |
<5 | 74 (77.9) | 34 (72.3) | 27 (81.8) | .3268 |
≥5 | 21 (22.1) | 13 (27.7) | 6 (18.2) | |
Missing | 52 | 19 | 19 | |
CA19‐9, median [IQR], UI/mL | 605.0 [69.0–4,756.0] | 310.0 [25.0–3,528.0] | 562.5 [238.0–4,000.0] | .3818 |
<37 | 30 (23.1) | 19 (32.2) | 8 (17.4) | .0849 |
≥37 | 100 (76.9) | 40 (67.8) | 38 (82.6) | |
Missing | 17 | 7 | 6 | |
Previous treatment | ||||
Primary tumor resection, n (%) | .1883 | |||
Yes | 22 (15.0) | 12 (18.2) | 5 (9.6) | |
No | 125 (85.0) | 54 (81.8) | 47 (90.4) | |
Adjuvant chemotherapy, n (%) | .4294 | |||
Yes | 17 (11.6) | 8 (12.1) | 48 (92.3) | |
No | 130 (88.4) | 58 (87.9) | 4 (7.7) | |
Radiotherapy, n (%) | .9999 | |||
Yes | 2 (1.4) | 1 (1.5) | 0 (0.0) | |
No | 145 (98.6) | 65 (98.5) | 52 (100.0) | |
First‐line chemotherapy | ||||
Number of cycles of FOLFIRINOX, median [IQR] | 9.0 [6.0–11.0] | .1056 | ||
<8 cycles | 16 (24.2) | 6 (11.5) | ||
8–11 cycles | 29 (44.0) | 32 (61.6) | ||
>12 cycles | 21 (31.8) | 14 (26.9) | ||
Regimen after FOLFIRINOX, n (%) | ||||
FOLFIRI | 66 (44.9) | |||
FP monotherapy (capecitabine or LV5FU2) | 52 (35.4) | |||
FOLFOX | 25 (17.0) | |||
Other | 4 (2.7) | |||
RECIST best response, n (%) | .3339 | |||
Complete or partial response | 69 (51.9) | 31 (50.0) | 31 (60.8) | |
Stability | 61 (45.9) | 29 (46.8) | 20 (39.2) | |
Progression | 3 (2.2) | 2 (3.2) | 0 (0.0) | |
Missing | 14 | 4 | 1 | |
Toxicity of grade 3 or 4, n (%) | .0302 | |||
No | 88 (62.4) | 37 (58.7) | 39 (78.0) | |
Yes | 53 (37.6) | 26 (41.3) | 11 (22.0) | |
Digestive | 21 (39.6) | 0 (0.0) | 3 (27.3) | |
Hematology | 8 (15.1) | 1 (3.9) | 5 (45.5) | |
Neurology | 16 (30.2) | 19 (73.1) | 1 (9.1) | |
Other | 8 (15.1) | 6 (23.1) | 2 (18.2) | |
Missing | 6 | 3 | 2 | |
Reason for discontinuation, n (%) | .8714 | |||
Progression | 107 (73.3) | 49 (75.4) | 42 (80.8) | |
Toxicity | 7 (4.8) | 3 (4.6) | 2 (3.8) | |
Other | 32 (21.9) | 13 (20.0) | 8 (15.4) | |
Missing | 1 | 1 | 0 | |
Reintroduction of oxaliplatin and/or irinotecan, n (%) | <.001 | |||
No | 61 (92.4) | 25 (48.1) | ||
Yes | 5 (7.6) | 27 (51.9) | ||
FOLFIRINOX | 4 (80.0) | 19 (70.4) | ||
FOLFIRI or FOLFIRI‐3 | 1 (20.0) | 6 (22.2) | ||
FOLFOX | 0 (0.0) | 2 (7.4) | ||
Second‐line chemotherapy administration, n (%) | .3059 | |||
No | 15 (22.7) | 27 (51.9) | ||
Yes | 51 (77.3) | 25 (48.1) | ||
Gemcitabine | 43 (84.3) | 24 (96.0) | ||
FOLFIRI | 2 (3.9) | 0 (0.0) | ||
FOLFOX | 3 (5.9) | 0 (0.0) | ||
Cisplatin | 2 (3.9) | 1 (4.0) | ||
GEMOX | 1 (2.0) | 0 (0.0) |
The population of the FOLFIRI group was older and performance status was higher than those of the 5FU group.
Abbreviations: 5FU, 5‐fluorouracil; CA19‐9, cancer antigen 19‐9; FP, fluoropyrimidine; GEMOX, gemcitabin oxaliplatin; IQR, interquartile range; LV5FU2, 5‐fluorouracil leucovorin; WHO, World Health Organization.
This PDF is available to Subscribers Only
View Article Abstract & Purchase OptionsFor full access to this pdf, sign in to an existing account, or purchase an annual subscription.