Table 5.
Study | Regimen | Sample size |
Positive margins (%) |
Nodal involvement (%) |
Local recurrence (%)* |
RFS (mo) |
Median (mo) |
---|---|---|---|---|---|---|---|
GITSG, 1985 | 5-FU+XRT → 5-FU | 21 | 0 | 28 | 33 | 11 | 20 |
EORTC, 1999 | 5-FU+XRT | 104 | 19 | 47 | 36 | 17.4† | 17.1 |
ESPAC-1, 2001 | 5-FU+XRT → 5-FU + LV | 75 | - | - | - | - | 19.9 |
CONKO-001, 2007 | Gem | 179 | 19 | 71 | 34 | 13.4‡ | 22.1‡ |
ROTG 97-04, 2008 | Gem; 5-FU/XRT → gem | 221 | 35 | 68 | 23 | - | 20.6 |
ESPAC-3, 2010 | Gem | 537 | 35 | 73 | - | 14.3 | 23.6 |
Bao et al, 2011 (9) | Erlotinib+FDR gem | 25 | 0 | 64 | 59 | 14§ | ~24§, ‖ |
This study | Erlotinib+capecitabine+IMRT → erlotinib+gem | 48 | 17 | 85 | 27 | 15.6 | 24.4 |
Abbreviations 5-FU = 5-fluorouracil; CONKO = Charité Onkologie; ESPAC = European Study Group for Pancreatic Cancer; EORTC = European Organization for Research and Treatment of Cancer; FDR = fixed dose rate; Gem = gemcitabine; GITSG = Gastro-Intestinal Study Group; IMRT = intensity modulated radiation therapy; LV = leukovorin; RFS = recurrence-free survival; ROTG = Radiation Therapy Oncology Group; XRT = radiation therapy. Unless otherwise indicated, event times for RFS and median survival were measured from the date of surgical resection.
Including synchronous local and distant recurrences.
Including periampullary cancer.
Event time from randomization.
Event time from the start of adjuvant therapy.
Median survival was not reached in this study, but the 2-year overall survival was 53%, suggesting a median survival of approximately 24 months