Background
Methods
Patient selection
Initial staging and induction chemotherapy
Treatment after restaging
Study parameters
Statistical analysis
Results
Induction treatment, restaging, and strategy after restaging
Sex ratio (M/F) | 2 (121/103) | |
Mean age (range) | 67 (29–89) | |
Performance statusa(%) | ||
0–1 | 215 (92) | |
2–3 | 19 (8) | |
Mean BMIa(range) | 24 (14–42) | |
Weight loss > 5% body weighta(%) | 160 (68) | |
Diabetes (%) | 15 (36) | |
Back paina(%) | 152 (65) | |
Jaundice (%) | 136 (84)b | |
CA 19–9 serum levela(UI) (range) | 2292 (7–88,300) | |
Tumour location (%) | ||
Head | 161 (69) | |
Body | 57 (24) | |
Tail | 16 (7) | |
Tumour classification (%) | ||
Borderline | 158 (68) | |
Locally advanced | 76 (32) | |
Arterial invasiona(%) | 93 (40) | |
Induction regimen (%) | ||
FOLFIRINOX | 168 (72) | |
Gemcitabine | 66 (28) | |
Mean number of cycles before restaging (range) | 6 (4–8) | |
Explorative laparotomy (%) | 45 (19) | |
Treatment after restaging/laparotomy (%) and mean number of cycles (range) after restaging/laparotomy | ||
FOLFIRINOX | 78 (33) | 4 (0–18) |
Gemcitabine | 30 (12) | 4 (0–15) |
Chemoradiation | 126 (54) | 2 (0–19) |
FOLFIRINOX (n = 168) | Gemcitabine (n = 66) | P-value | |
---|---|---|---|
Mean age + SD | 64 ± 9.55 | 75 ± 8.76 | < 0.01 |
Performance status score 2–3 (%) | 8 (5) | 11 (17) | < 0.01 |
Mean BMI + SD | 23.5 ± 3.81 | 23.5 ± 4.41 | ns |
Weight loss > 5% body weight * (%) | 110 (65) | 50 (76) | ns |
Diabetes (%) | 10 (6) | 5 (7.5) | ns |
Back pain (%) | 108 (64) | 44 (67) | ns |
Serum CA 19–9 level* (IU) (+SD) | 3884 ± 13,137 | 1743 ± 4916 | ns |
Tumour location (%) | ns | ||
Head | 117 (70) | 44 (65) | |
Body | 40 (24) | 17 (26) | |
Tail | 11 (6) | 5 (9) | |
Tumour classification (%) | ns | ||
Borderline | 116 (69) | 42 (64) | |
Locally advanced | 52 (31) | 24 (36) | |
Arterial invasion (%) | 68 (40.5) | 25 (38) | ns |
CRT (n = 126) | Chemotherapy (n = 61) | P-value | |
---|---|---|---|
Mean age + SD | 66.1 ± 9.85 | 71.4 + 9.97 | < 0.01 |
Performance statusa(%) ≥ 2 | 7 (5.6) | 8 (13) | 0.089 |
Mean BMI + SD | 23.1 ± 3.77 | 23.2 ± 4.78 | 0.89 |
Weight loss > 5% body weighta(%) | 92 (73) | 42 (69) | 0.55 |
Diabetes (%) | 19 (15) | 8 (13) | 0.72 |
Back paina(%) | 88 (70%) | 38 (62%) | 0.3 |
Serum CA 19–9 levela(IU) (range) | 2180 ± 5718 | 1886 ± 4785 | 0.74 |
Tumour location (%) | |||
Head | 82 (65) | 43 (70) | 0.46 |
Body | 36 (29) | 16 (26) | 0.66 |
Tail | 8 (6.3) | 2 (3.3) | 0.5 |
Arterial invasiona(%) | 63 (50) | 21 (34) | 0.045 |
Continued regimen (%) | |||
FOLFIRINOX | 29 | ||
Gemcitabine | 32 | ||
5 FU | 126 | ||
Mean number of cycles after restaging (range) | |||
Toxicity | |||
Grade ≥ 3 | 7 (5.5) | 15 (25) | < 0.01 |
Neutropenia | 10 (8) | 20 (33) | < 0.01 |
Diarrhoea | 6 (5) | 4 (7) | Ns |
Polyneuropathy | 0 | 10 (16) | < 0.01 |
Survival
P-value | Hazard ratio [95% CI] | P-value | |
---|---|---|---|
Performance status score ≥ 2 | < 0.01 | 1.92 [1.06–3.46] | 0.031 |
Borderline status at diagnosis | 0.35 | ns | |
Arterial invasion at diagnosis | 0.48 | ns | |
Back pain | 0.041 | ns | |
Weight loss | 0.037 | 1.49 [1.02–2.19] | 0.041 |
CA 19–9 level > 500 IU | 0.087 | 1.79 [1.25–2.57] | < 0.01 |
Continuous chemotherapy | 0.065 | ns |