Journal Club : SALTO ; Randomised phase III trial of S-1 versus capecitabine in the first-line treatment of metastatic colorectal cancer: SALTO study by the Dutch Colorectal Cancer Group.

Journal Club : SALTO ; Randomised phase III trial of S-1 versus capecitabine in the first-line treatment of metastatic colorectal cancer: SALTO study by the Dutch Colorectal Cancer Group.

www.ncbi.nlm.nih.gov

今週のプレゼンターは、薬学部5年生！

2017年4月、Ann Oncol に報告された、オランダ27施設による大腸がんに対するS-1とカペシタビンによる手足症候群（HFS）の差を確認した第３相RCT。

SALTO trial

P :

Patients with previously untreated mCRC and planned treatment with fluoropyrimidine monochemotherapy

E : 

capecitabine (1250 mg/m 2 orally for patients <70 years; 1000 mg/m 2 for patients ≥70 years, twice-daily on days 1-14) in 3-weekly cycles, with bevacizumab optional 

C :

S-1 (30 mg/m 2 orally twice-daily on days 1-14) in 3-weekly cycles, with bevacizumab optional 

O :

 The incidence of any grade HFS as assessed by physicians was 73% in the capecitabine group ( n =80) and 45% in the S-1 group ( n =80) (odds ratio [95% confidence interval] 0.31 [0.16-0.60], p =0.0005).

T : RCT, Phases3

S-1 contains the DPD- inhibitor gimeracil and indeed the concentration of the 5-FU catabolite α-fluoro-β-alanine (FBAL) was shown to be 18-fold lower after the administration of S-1 compared to capecitabine

感想・皆さんの意見

・S1はカペシタビンと比べHFSが少ない。一方、食欲低下が多い。

・単剤治療レジメンを臨床で選択することは少ないのでは？

・下痢は、S1が多い傾向。有意差はなし。

・治療初期からHFSの差があるように見える。