Abad et al Table 5 Studies of adjuvant radiochemotherapy Study Treatment Lim et al 2004 5FU/LV + RT D2 Surgery Park et al 2003 5FU/LV + RT D2 Surgery Macdonald et al 5FU/LV + RT 2001 Control INT-0116 D2 Surgery 10% D1 Surgery 36% Abbreviations: FU, ﬂuorouracil; LT, leucovorin; RT, radiotherapy. P 291 261 281 Sup % 58 60 50%* 41%* *3 years p - - Criticism Not comparative Not comparative Low compliance with protocol (64%) 17% abandoned due to toxicity 35% revision of RT plan 3 toxic deaths Poor quality of surgery at 5 years. It is worth highlighting that this survival is not different from that reached in some adjuvant chemotherapy studies, such as that by Cirera et al in which there was 56% survival in the treated group at 5 years. The study by Mac- donald et al (2001) (INT-0116) compared one treatment arm (5FU/LV + RT) with a group of surgery only. The results of survival and the disease-free interval (DFI) at 3 and 5 years show signiﬁcant improvement in favor of the treatment group, with a survival of 50% and 40%. (Although the results at 5 years have not been published, they show an 11.6% increase in survival beneﬁt, 40% vs 28.4% (p < 0.001), and survival free of relapse increased from 25% to 31% (p < 0.001) in the radiochemotherapy arm). These were lower than the results found by Hagiwara et al (1992) and Cirera et al (1999) with chemotherapy alone, comparing 41% and 28.4% in the control group (p < 0.005) and with DFI of 48% and 31% as against 31% and 25% (p < 0.005) The results of this study have led to post-operative radiochemotherapy being considered by many as standard in the treatment of gastric cancer, in spite of the fact that it is widely considered reprehensible. The most signiﬁcant criticism (see Table 4) is convincing. Compliance with the protocol was under 64%, and 26% were abandoned due to toxicity or patient rejection. Due to the complexity of the radiotherapy protocol, in 35% of cases the treatment schedule had to be corrected. The most important criticism was that the surgery was very low quality, with only 10% D2 surgery and 36% D1, ie, more than half the patients received non-curative surgery with D0 resections, a fact that the authors defend as the reality of gastric surgery in the USA. Survival at 3 years for the patients who had undergone D1 or D2 resection in the Dutch study reached 60%, 20% more than in Macdonald’s study, by which we can conclude that poor surgery was a poor prognostic factor in the INT-0116 study. What would the results of this study have been with R0 D2 surgery in all patients? Another aspect for discussion is the real effect of radio- therapy on local relapses. Table 6 shows the percentages of locoregional relapse in studies with surgery alone, chemo- therapy alone and radiochemotherapy. We can see that the rates of local relapse are similar in any of these situations. Table 6 Locoregional relapses according to treatment Study P Treatment No. rel/(Total no.) Schwarz et al 35/(73) Surgery R0D2 2002 Cirera et al 37/(76) Surgery D2 + CT 1999 50/(72) Surgery D2 Lim et al 114/(291) Surgery 2004 D2 + CT + RT Park et al 114/(261) Surgery 2003 D2 + CT + RT Macdonald 120(281) 10% D2 Surgery et al 2001 + CT + RT (INT-0116) 177/(275) 10% D2 Surgery Abbreviations: CT, chemotherapy; RT, radiotherapy. Locoregional relapses 23% only local 6% 26% 33% 19% only local 7% 29% 19% 29%** Relapse* predictors N3 T3/T4 – N3 T3/T4 III/IV (M0) – p* 0.005 0.008 – <0.0001 <0.0001 <0.001 **NS 566 Therapeutics and Clinical Risk Management 2007:3(4)