Table 1:
Randomized trials of adjuvant radiation therapy in pancreatic cancer
| Trial | Treatment | n | Local recurrence | Distant metastases | Disease-free survival | Overall survival | Median survival |
|---|---|---|---|---|---|---|---|
| GITSG2 | (A) RTa and CT (bolus 5-FU during RTb, then once weekly for 2 yrs starting one mo after RT) | 21 | 47% | 40% (liver)c | 48% (2 yr) | 14% (5 yr) | 20 mo |
| (B) Observation | 22 | 33% | 52% (liver)c | 14%d (2 yr) | 4%d (5 yr) | 11 mod | |
| EORTC5 | (A) RTa and CT (CI 5-FU during RTe) | 104 | 36% (14% LR only) | 49% (31% DM only) | 37% (2 yr) | 28% (5 yr, all) 20% (5 yr, pancreas)f | 24.5 mo (all) 17.1 mo (pancreas)f |
| (B) Observation | 103 | 36% (15% LR only) | 49% (28% DM only) | 38% (2 yr) | 22% (5 yr, all) | 19 mo (all) | |
| 10% (5 yr, pancreas)f | 12.6 mo (pancreas)f | ||||||
| ESPAC-14,g | (A) RTa and CT (bolus 5-FU during RTb) | 73 | For all patients:
62% (35% LR only) |
For all patients:
61% (34% DM only) |
7% (5 yr) | 13.9 mo | |
| (B) RT and CT (bolus 5-FU during RTg followed by 5-FU and folinic acid monthly for 6 moh) | 75 | 29% (5 yr) | 21.6 mo | ||||
| (C) CTh (5-FU and folinic acid monthly for 6 mo) | 72 | 13% (5 yr) | 19.9 mo | ||||
| (D) Observation | 69 | 11% (5 yr) | 16.9 mo | ||||
Abbreviations: CI = continuous infusion; CT = chemotherapy; DM = distant metastases; 5-FU = 5 fluorouracil; mo = month; LR = local recurrence; yr = year.
All trials used 40 Gy RT delivered split course, with a 2-week break after 20 Gy.
Bolus 5-FU 500 mg/m2 on days 1–3 of each 20 Gy course of RT.
Rate of liver metastases was reported, but not rate of any metastases.
P < .05.
CI 5-FU 25 mg/kg/24 hr during first course of RT and for 0, 3, or 5 days during 2nd course of RT, depending on toxicity during first course.
Periampullary tumors were allowed in EORTC trial. When the subgroup of patients with only pancreas adenocarcinoma (n = 114) was evaluated, the difference in overall survival with the addition of adjuvant chemoradiotherapy approached, but did not reach, statistical significance (P = .09).
Groups C and D (combined) were compared to groups A and B (combined), and the overall survival was higher in groups C and D (median survival 17.9 months, 5-yr overall survival 29%) compared to groups A and B (median survival 15.9 months, 5-yr overall survival 10%) (P = .05). Groups A and D (combined) were compared with groups B and C (combined), and overall survival was lower in groups A and D (median survival 15.5 months, 5-yr overall survival 8%) compared to groups B and C (median survival 20.1 months, 5-yr overall survival 21%) (P = .009).
IV 5-FU 425 mg/m2 and folinic acid 20 mg/m2 daily for 5 days, monthly for 6 months.