Table 2.
OS outcomes of the published randomized, controlled trials of adjuvant CRT in PDAC.
| Trial, Year of Publication; n; Geographical Region | Treatment Arms | Study Population | OS | Subgroups | ||||
|---|---|---|---|---|---|---|---|---|
| N0 | R0 | Median (mts) | HR, p | 5-Year Rate (Actual or Estimated) | Nodal Involvement | Resection Margins | ||
| GITSG 9173, 1985 [29,37]; 43; Western | CRT (20 Gy x2, 5FU) + 5FU vs. Obs | na | na | 21.0 vs. 10.9 | p 0.03 | 18% vs. 5% | na | na |
| EORTC 40891, 1999 [31,32]; 218 (PDAC 55%); Western | CRT (40 Gy/20 fr, 5FU) | 39% | 77% | 15.6 vs. 12.0 | 0.91 (0.68–1.23), p 0.54 | 25% vs. 22% | na | na |
| ESPAC-1 and exp, 2004 and 2001 [10,27]; 289 and 541; Western | CT (LV, 5FU; 6 cycles) vs. CRT (20 Gy/10 fr, 5FU) vs. CRT + CT vs. Obs | 41% 47% (exp) | 82% 81% (exp) |
CRT vs. no CRT | ||||
| 15.9 vs. 17.9 | 1.28 (0.99–1.66), p 0.05 | 10% vs. 20% | phet 0.85 | R0: 15.9 vs. 16.9, p ns R1: 10.9 vs. 12.1, p ns | ||||
| RTOG 9704, 2008 [33,34]; 451; Western | CRT (50.4 Gy/28 fr, 5FU) + Gem (1 + 3 cycles) vs. CRT + 5FU (1 + 2 cycles) | 34% | 42% | Pancreatic head | ||||
| 20.5 vs. 17.1 | 0.84 (0.67–1.05), p 0.12 | 22% vs. 18% | na | na | ||||
| Morak et al., 2008 [30]; 120 (PDAC 52%); Western | RT (54 Gy/30 fr) + i.a. Mit, FA, 5FU, Cis (1 + 5 cycles) vs. Obs | 47% | 73% | na | p 0.66 | na | na | na |
| EORTC-40013-22012/FFCD-9203/GERCOR, 2010 [36]; 90; Western | Gem (2 cycles) + CRT (50.4 Gy/28 fr, Gem) vs. Gem (4 cycles) | 30% | 100% | 24.3 vs. 24.4 | na | na | na | na |
| CapRI, 2012 [38]; 110; Western | CRT (50.4 Gy/28 fr, 5FU, Cis, IFNα-2b) + 5FU (2 cycles) vs. FA, 5FU (6 cycles) | 21% | 61% | 26.5 vs. 28.5 | 1.04 (0.66–1.53), p 0.99 | na | na | na |
Abbreviations: 5FU = 5-fluorouracil; Cis = cisplatin; CRT = chemoradiation therapy; CT, chemotherapy; FA = folinic acid; fr = fractions; Gem = gemcitabine; i.a. = intra-arterial; IFN, interferon; LV = leucovorin; Mit = mitoxantrone; mts = months; na = not available; Obs = observation; OS = overall survival; PDAC = pancreatic ductal adenocarcinoma; phet = p for heterogeneity; GITSG: Gastrointestinal Tumor Study Group; EORTC: European Organization for Research and Treatment of Cancer; RTOG: Radiation Therapy Oncology Group; FFCD: Federation Francophone de Cancérologie Digestive; GERCOR: Groupe Coopérateur Multidisciplinaire en Oncologie.