randomized study 0116, which demonstrated a 15% improvement in 5-year overall survival (OS) [LOE I, SOR A]. (For treatment details, see APPENDIX I) Two other phase III studies on Asian patients have been recently published and showed that adjuvant chemotherapy, with S-1 (an oral fluoropyrimidine) for 12 months or capecitabine plus oxaliplatin for six months, resulted in a significant improvement of survival. [Sakuramoto et al., 2007; Bang et al., 2011] (For treatment details, see APPENDIX I) Two meta-analyses of RCTs on adjuvant chemotherapy in gastric cancer have been published over the last few years. The first meta-analysis demonstrated a small survival benefit for adjuvant chemotherapy, with an apparently greater benefit noted in the five studies from Asia [relative risk 0.74, 95% confidence interval (CI) 0.64–0.85] compared with the 14 studies conducted outside Asia (relative risk 0.90, 95% CI [LOE I, SOR A] [Liu et al., 2008]. The second meta-analysis from the GASTRIC (Global Advanced/Adjuvant Stomach Tumor Research International Collaboration) Group analyzed data from 17 RCTs (3838 patients) and confirmed the survival benefit from the addition of adjuvant chemotherapy over surgery alone [HR, 0.82; CI, p<0.001]. Though there was heterogeneity of the chemotherapy regimens used in all these trials, it was reported that fluoropyrimidine-based regimens were active and associated with reduced risk of death in resected gastric cancer compared to surgery alone. [GASTRIC Group, Paoletti et al., 2010] Targeted therapies There is no evidence, so far, regarding potential benefit from the addition of a targeted agent in the adjuvant setting GC. Therefore, use of any targeted agent should be considered only in the context of a clinical trial.
randomized study 0116, which demonstrated a 15% improvement in 5-year overall survival (OS) [LOE I, SOR A]. (For treatment details, see APPENDIX I) Two other phase III studies on Asian patients have been recently published and showed that adjuvant chemotherapy, with S-1 (an oral fluoropyrimidine) for 12 months or capecitabine plus oxaliplatin for six months, resulted in a significant improvement of survival. [Sakuramoto et al., 2007; Bang et al., 2011] (For treatment details, see APPENDIX I) Two meta-analyses of RCTs on adjuvant chemotherapy in gastric cancer have been published over the last few years. The first meta-analysis demonstrated a small survival benefit for adjuvant chemotherapy, with an apparently greater benefit noted in the five studies from Asia [relative risk 0.74, 95% confidence interval (CI) 0.64–0.85] compared with the 14 studies conducted outside Asia (relative risk 0.90, 95% CI [LOE I, SOR A] [Liu et al., 2008]. The second meta-analysis from the GASTRIC (Global Advanced/Adjuvant Stomach Tumor Research International Collaboration) Group analyzed data from 17 RCTs (3838 patients) and confirmed the survival benefit from the addition of adjuvant chemotherapy over surgery alone [HR, 0.82; CI, p<0.001]. Though there was heterogeneity of the chemotherapy regimens used in all these trials, it was reported that fluoropyrimidine-based regimens were active and associated with reduced risk of death in resected gastric cancer compared to surgery alone. [GASTRIC Group, Paoletti et al., 2010] Targeted therapies There is no evidence, so far, regarding potential benefit from the addition of a targeted agent in the adjuvant setting GC. Therefore, use of any targeted agent should be considered only in the context of a clinical trial.
Teliko_Keimeno_Consensus_Karkinou_Stomaxou_0.docx