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Clinical Trial
. 2013 Oct 15;109(8):2079-86.
doi: 10.1038/bjc.2013.555. Epub 2013 Sep 17.

Randomised phase II study of S-1/cisplatin plus TSU-68 vs S-1/cisplatin in patients with advanced gastric cancer

W Koizumi  1 , K Yamaguchi, H Hosaka, Y Takinishi, N Nakayama, T Hara, K Muro, H Baba, Y Sasaki, T Nishina, N Fuse, T Esaki, M Takagi, M Gotoh, T Sasaki
Affiliations
Clinical Trial

Randomised phase II study of S-1/cisplatin plus TSU-68 vs S-1/cisplatin in patients with advanced gastric cancer

W Koizumi et al. Br J Cancer. .

Erratum in

  • Br J Cancer. 2014 Dec 9;111(12):2382

Abstract

Background: This study aimed to determine whether combination S-1 plus cisplatin (CDDP) therapy, the most widely used therapy for Japanese patients with advanced gastric cancer, and the novel oral antiangiogenic agent TSU-68 could contribute to gastric cancer treatment.

Methods: Ninety-three patients with chemotherapy-naïve unresectable or recurrent advanced gastric cancers were randomised into two groups: TSU-68 plus S-1/CDDP (group A) and S-1/CDDP (group B) groups. Both patient groups received identical S-1 and CDDP dosages. TSU-68 was orally administered for 35 consecutive days. Group B patients received S-1 orally twice daily for three consecutive weeks, followed by intravenous CDDP on day 8. The primary endpoint was progression-free survival (PFS).

Results: Median PFS periods were 208 and 213 days in groups A and B, respectively (P=0.427). Median survival periods for groups A and B were 497.0 and 463.5 days, respectively (P=0.219). No statistically significant differences were noted for PFS, survival or the adverse event (AE) incidence rate. All AEs were expected according to previous reports for TSU-68, TS-1, and CDDP.

Conclusion: Combination therapy involving TSU-68, S-1, and CDDP was safe and well tolerated in patients with chemotherapy-naïve unresectable or recurrent advanced gastric cancers. However, factors related to therapeutic efficacy should be investigated further.

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Figures

Figure 1
Figure 1
Study design. Two patients were excluded from the full analysis set by an independent data monitoring committee.
Figure 2
Figure 2
CONSORT diagram. A total of 93 patients (group A, n=46; group B, n=47) were randomised. One patient from group A did not receive treatment, and 1 patient from group B was ineligible. Therefore, a total of 91 patients (group A, n=45; group B, n=46) were included in the FAS used for the efficacy and safety analyses.
Figure 3
Figure 3
Kaplan–Meier analysis of PFS and OS. Of the 93 total patients, 46 were placed into group A and 47 were placed into group B. The median PFS times of the patients in group A and group B were 208.0 days (95% CI: 141.0–274.0 days) and 213.0 days (95% CI: 178.0–309.0 days), respectively. The HR for radiological progression or death in group A was 1.23 (95% CI: 0.74–2.05). The median OS times of the patients in group A and group B were 497.0 days (95% CI: 371.0–635.0 days) and 463.5 days (95% CI: 359.0–554.0 days), respectively. The HR for death in group A was 0.74 (95% CI: 0.46–1.19).
Figure 4
Figure 4
Forest plot for PFS. No prolongation of PFS was observed in any of the subgroups.
See this image and copyright information in PMC

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