Capecitabine/cisplatin versus 5-fluorouracil/cisplatin as first-line therapy in patients with advanced gastric cancer: a randomised phase III noninferiority trial

Abstract

XP showed significant noninferiority for PFS versus FP in the first-line treatment of AGC. XP can be considered an effective alternative to FP.

Phase II study of sequential cisplatin plus 5-fluorouracil/leucovorin (5-FU/LV) followed by irinotecan plus 5-FU/LV followed by docetaxel plus 5-FU/LV in patients with metastatic gastric or gastro-oesophageal junction adenocarcinoma

“…The safety profile of the sequential treatment was extremely favourable with no toxicities exceeding the incidence of 9% except for neutropenia that was febrile only in one case. That patient died as consequence of treatment-related toxicity, but this occurred after the first cycle of 5-FU/ cisplatin and therefore cannot be ascribed to the sequential strategy, nevertheless this is consistent even with most recent series of patients treated with such combination, reporting 1-5% incidence of toxic deaths, mainly for infections [8,14]. One can argue that a possible limitation of our study could reside in the choice of switching to a different regimen in patients responding to the previous doublet after only three cycles.…”

“…This means a balance between survival prolongation and symptoms' relief and improvement in quality of life, so that toxicity profile of adopted treatments is of major importance. The combination of 5-FU and cisplatin still represents an accepted compromise between efficacy and tolerability, so that it has been chosen as standard comparator arm in many ongoing or recently closed phase III trials [14][15][16].…”

Modified Docetaxel and Cisplatin in Combination with Capecitabine (DCX) as a First-Line Treatment in HER2-Negative Advanced Gastric Cancer

“…To date, there is no study in the literature that has evaluated the efficacy and safety of a modified DCX regimen in patients with HER2-negative AGC. Although our results should be confirmed by prospective, randomized, phase III trials, we believe that our study has made contributions to the literature because of the comparable efficacy and tolerability with previous studies (Van Cutsem et al, 2006;Kang et al, 2009;Kang et al, 2011;Polyzos et al, 2012) In conclusion, the DCX regimen offers pronounced anti-tumor activity with low toxicity making it to be considered an effective first-line treatment, for patients with HER2-negative AGC. Furthermore, capecitabine is also an effective and well-tolerated oral alternative to the continuous infusion of 5-fluorouracil, which requires placement of a central venous access device.…”

“…Modifications of this triple regimen provided promising efficacy and improved the tolerability (Lorenzen et al, 2007;Ozdemir et al, 2010;Kos et al, 2011;Alici et al, 2013). Another modification is the introduction of capecitabine into the treatment regimen to replace continuous infusion of fluorouracil (Cunningham et al, 2008;Kang et al, 2009).…”

“…In addition, substitution of capecitabine, an orally administered fluoropyrimidine, for the continuous infusion of fluorouracil prevents the inconvenience of additional cost and morbidity with no negative impact on efficacy and safety in both early and advanced gastric cancer (Hong et al, 2004;Kang et al, 2009: Yoney andIsikli, 2013). Kang et al (2009) compared the combination of cisplatin and capecitabine (CX) with CF in AGC patients in the first-line setting in ML17032 trial. They showed that both response rate and median OS time were superior for patients treated with the CX regimen [overall response rate (RR): 41% vs 29%; OS: 10.5 vs 9.3 months], although the median progression-free survival (PFS) time was found to be similar for both regimens.…”