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Poster Display session 2

2037 - Updated survival analysis of the randomized phase III trial comparing S-1 versus capecitabine in the first-line treatment of metastatic colorectal cancer (SALTO) by the Dutch Colorectal Cancer Group.

Date

29 Sep 2019

Session

Poster Display session 2

Presenters

Johannes Kwakman

Citation

Annals of Oncology (2019) 30 (suppl_5): v198-v252. 10.1093/annonc/mdz246

Authors

J.J. Kwakman1, E. Van Werkhoven2, L.H. Simkens3, J.M. van Rooijen4, A. van de Wouw5, A.J. Ten Tije6, G. Creemers7, M.P. Hendriks8, M. Los9, R. van Alphen10, M.B. Polee11, E.W. Muller12, A. Van der Velden13, T. Van Voorthuizen14, M. Koopman15, L. Mol16, C.J.A. Punt17

Author affiliations

  • 1 Medical Oncology, Amsterdam University Medical Centers, location AMC, 1105AZ - Amsterdam/NL
  • 2 Department Of Biometrics, The Netherlands Cancer Institute, 1066CX - Amsterdam/NL
  • 3 Medical Oncology, Maxima Medical Center, 5631BM - Eindhoven/NL
  • 4 Medical Oncology, Martini Hospital, 9728NT - Groningen/NL
  • 5 Medical Oncology, VieCuri MC, 5912 BL - Venlo/NL
  • 6 Medical Oncology, Amphia Ziekenhuis, 4818 CK - Breda/NL
  • 7 Medical Oncology, Catharina Hospital, 5602 ZA - Eindhoven/NL
  • 8 Medical Oncology, NorthWest Clinics, 1800 AM - Alkmaar/NL
  • 9 Medical Oncology, Sint Antonius Hospital, 3435CM - Nieuwegein/NL
  • 10 Medical Oncology, Elisabeth-TweeSteden Hospital, 5042 AD - Tilburg/NL
  • 11 Medical Oncology, Medical Center Leeuwarden, 8934 AD - Leeuwarden/NL
  • 12 Medical Oncology, Slingeland Hospital, 7009BL - Doetinchem/NL
  • 13 Medical Oncology, Tergooi Hospital, 1213XZ - Hilversum/NL
  • 14 Medical Oncology, Rijnstate Hospital, 6900 - Arnhem/NL
  • 15 Medical Oncology, University Hospital Utrecht, 3508 GA - Utrecht/NL
  • 16 Clinical Trial Department, Netherlands Comprehensive Cancer Organisation, 6533AA - Nijmegen/NL
  • 17 Medical Oncology, Amsterdam University Medical Centers, location AMC, 1100 DD - Amsterdam/NL
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Resources

Abstract 2037

Background

SALTO is a multi-center, open-label phase III trial in which 161 Western patients with metastatic colorectal cancer (mCRC) were randomized between capecitabine and S-1. The primary endpoint, a lower incidence of hand-foot syndrome (HFS) for S-1, was met (all grade 73% for capecitabine versus 45% for S-1, odds ratio 0.31 [95% confidence interval (CI) 0.16-0.60], p = 0.0005; grade 3 21% for capecitabine versus 4% for S-1, p = 0.003). There was no significant difference in median progression-free survival (PFS), data on overall survival (OS) were immature. We here present updated results on survival.

Methods

mCRC patients in whom first-line fluoropyrimidine monochemotherapy was indicated were randomized between capecitabine twice-daily on day 1 to 14 at a dose of 1250 mg/m2 for patients <70 years or 1000 mg/m2 for patients ≥70 years of age, or S-1 twice-daily on day 1 to 14 at a dose of 30 mg/m2, irrespective of age. Co-treatment with bevacizumab, 7.5 mg/kg intravenously on day 1, was optional. Cycles were repeated every 3 weeks. The primary endpoint was the incidence of HFS, secondary endpoints included PFS and OS.

Results

A total of 161 patients were randomized between January 2014 - July 2015, 81 in the capecitabine group and 80 in the S-1 group. Bevacizumab was administered to 59% of patients in both arms. At data cut-off (6 August 2018, median follow-up 40.3 months), 71 (88%) patients in the capecitabine group and 68 (85%) patients in the S-1 group had died. Median PFS was 8.2 months (95% CI 6.4-10.3) for capecitabine and 8.4 months (95% CI 6.4-10.6) for S-1 (HR 1.02, 95% CI 0.75-1.40, p = 0.89). Median OS was 17.1 months (95% CI 14.3-23.5) and 17.0 months (13.0-20.1), respectively (HR 1.07, 95% CI 0.76-1.49, p = 0.70).

Conclusions

This study demonstrated a significantly lower incidence of HFS for S-1 compared to capecitabine in Western mCRC patients. Although the study was not powered to demonstrate non-inferiority, these data suggest comparable efficacy of S-1 and capecitabine in terms of PFS and OS.

Clinical trial identification

NCT01918852.

Editorial acknowledgement

Legal entity responsible for the study

Dutch Colorectal Cancer Group.

Funding

Nordic Pharma.

Disclosure

J.J. Kwakman: Honoraria (self), Research grant / Funding (institution): Nordic Pharma; Advisory / Consultancy, Research grant / Funding (institution): Servier. R. van Alphen: Advisory / Consultancy: Nordic Pharma; Travel / Accommodation / Expenses: Roche. C.J.A. Punt: Advisory / Consultancy: Nordic Pharma; Advisory / Consultancy: Servier. All other authors have declared no conflicts of interest.

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