Table 3 Phase III randomized trials comparing radiochemotherapy plus surgery versus surgery alone
N° Pts | Accrual | Rate adeno | Tumor site | Dose/Fx (Gy) | Concurrent CT | % pCR | 3 yy OS % | 5 yy OS % | Median SVV (mth) | Median fup (mth) | |
|---|---|---|---|---|---|---|---|---|---|---|---|
(N° pts RTCT arm) | [RTCT+ surg vs. surg alone] | [RTCT+ surg vs surg alone] | [RTCT+ surg vs surg alone] | ||||||||
Walsh[43] | 113 | 1990-1995 | 100% | Middle+ Lower Esophagus + Cardias | 40/2.7 | CDDP + 5Fu | 25% (13/52) | 32 vs. 6 | - | 16 vs 11 | 10 (0.1-59) |
(p=0.01) | |||||||||||
Urba[46] | 100 | 1989-1994 | 75% | Proximal+ Middle + Lower Esophagus + GEJ | 45/1.5 (twice daily) | CDDP+ 5Fu+ Vimblastine | 28% (14/50) | 30 vs. 16 | - | 16.9 vs 17.6 | 98.4 (72-118.8) |
(p=0.15) | |||||||||||
Burmeister[48] | 256 | 1994-2000 | 62% | Proximal +Middle+ Lower Esophagus | 35/2.4 | CDDP + 5Fu | 16% (16/103) | 42 vs. 36 | 21 vs. 19 | 22.2 vs. 19.3 | 65 (0.4-120) |
(p=0.57) | |||||||||||
Tepper[49] | 56 | 1997-2000 | 75% | Toracic Esophagus (below 20 cm)+ GEJ <2cm distal spread in cardia | 50.4/1.8 | CDDP + 5Fu | 40% (10/25) | - | 39 vs. 16 (p=0.002) | 53.8 vs. 21.5 | 72 (NR) |
Van Hagen[50] | 366 | 2004-2008 | 75% | Proximal +Middle+ Lower Esophagus + GEJ | 41.2/1.8 | Carboplatin + Paclitaxel | 29% (47/161) | 58 vs. 44 | 47 vs. 34 | 49.4 vs. 24 | 45.4 (25.5-80.9) |
(p=0.003) |