An ancillary biomarker study in the SAMIT randomized trial: Sequential paclitaxel followed by UFT or S-1 versus UFT or S-1 alone as adjuvant chemotherapy for T4a/b gastric cancer

Oshima, Takashi; Tsuburaya, Akira; Yoshida, Kazuhiro; Yoshikawa, Takaki; Miyagi, Yohei; Guan, Jia; Tan, Patrick; Sakamoto, Junichi; Tanaka, Shiro

doi:10.4993/acrt.26.39

Cited by 2 publications

(3 citation statements)

References 3 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The pre-de ned statistical analysis plan for this study has been reported previously 40 . The primary and secondary endpoints were the OS and DFS, respectively.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Post-hoc biomarker analyses of T4a/T4b gastric cancer from patients recruited into SAMIT, a phase III randomized controlled trial

Oshima¹,

Tsuburaya²,

Yoshida³

et al. 2021

Preprint

Self Cite

View full text Add to dashboard Cite

Biomarkers for selecting gastric cancer (GC) patients likely to benefit from sequential paclitaxel treatment followed by fluorinated-pyrimidine-based adjuvant chemotherapy were searched for using samples of patients recruited into SAMIT, a phase III randomized controlled trial. Total RNA was extracted from 556 GC patients and the expression of 105 genes were quantified using real-time PCR. Genes predicting positive effects of sequential paclitaxel on overall survival (OS), disease-free survival (DFS), or cumulative incidence of relapse were identified based on p-values associated with the interaction between the biomarker and sequential paclitaxel or monotherapy group. Low VSNL1 and CD44v expression predicted the positive effects of sequential paclitaxel in all above three endpoints. In the patient subgroup with combined low expression of both genes, sequential paclitaxel therapy was associated with a significantly improved OS (hazard ratio [HR] = 0.48 [95% confidence interval (CI), 0.30–0.78]; p < 0.01; interaction p-value < 0.01), particularly in patients with stage IIIB GC (HR = 0.39 [95% CI, 0.20–0.75]; p < 0.01; interaction p-value < 0.01). In this study, two biomarkers were identified. Our findings might open up the way for clinical trials on biomarker-oriented postoperative adjuvant chemotherapy for locally advanced cancer.

show abstract

“…The pre-de ned statistical analysis plan for this study has been reported previously 40 . The primary and secondary endpoints were the OS and DFS, respectively.…”

Section: Discussionmentioning

confidence: 99%

“…The mRNA expression level of each gene was classi ed as low versus high using the median mRNA expression level as a cut-off point, as described previously 40 . If the mRNA expression level of a particular gene was below 1.0×10 -8 ng/μL, the expression level was set to '0.00'.…”

Section: De Ning the Predictive Value Of The Biomarkersmentioning

confidence: 99%

Post-hoc biomarker analyses of T4a/T4b gastric cancer from patients recruited into SAMIT, a phase III randomized controlled trial

Oshima¹,

Tsuburaya²,

Yoshida³

et al. 2021

Preprint

Self Cite

View full text Add to dashboard Cite

show abstract

“…We adopted an internal validation strategy, as proposed by Wahl et al 47 , to address the potential overestimation of the standard error owing to multiple imputations and optimism in the predictive performance. We used Harrell’s C statistics to analyze the predictive performance of the survival data and addressed the optimistic bias by Harrell’s C statistics using the bootstrap 0.632 + method with 20 bootstrap samples from the original dataset with replacement, followed by multiple imputations.…”

Section: Methodsmentioning

confidence: 99%

Gastric cancer biomarker analysis in patients treated with different adjuvant chemotherapy regimens within SAMIT, a phase III randomized controlled trial

Oshima

Tsuburaya²,

Yoshida

et al. 2022

Sci Rep

Self Cite

View full text Add to dashboard Cite

Biomarkers for selecting gastric cancer (GC) patients likely to benefit from sequential paclitaxel treatment followed by fluorinated-pyrimidine-based adjuvant chemotherapy (sequential paclitaxel) were investigated using tissue samples of patients recruited into SAMIT, a phase III randomized controlled trial. Total RNA was extracted from 556 GC resection samples. The expression of 105 genes was quantified using real-time PCR. Genes predicting the benefit of sequential paclitaxel on overall survival, disease-free survival, and cumulative incidence of relapse were identified based on the ranking of p-values associated with the interaction between the biomarker and sequential paclitaxel or monotherapy groups. Low VSNL1 and CD44 expression predicted the benefit of sequential paclitaxel treatment for all three endpoints. Patients with combined low expression of both genes benefitted most from sequential paclitaxel therapy (hazard ratio = 0.48 [95% confidence interval, 0.30–0.78]; p < 0.01; interaction p-value < 0.01). This is the first study to identify VSNL1 and CD44 RNA expression levels as biomarkers for selecting GC patients that are likely to benefit from sequential paclitaxel treatment followed by fluorinated-pyrimidine-based adjuvant chemotherapy. Our findings may facilitate clinical trials on biomarker-oriented postoperative adjuvant chemotherapy for patients with locally advanced GC.

show abstract

An ancillary biomarker study in the SAMIT randomized trial: Sequential paclitaxel followed by UFT or S-1 versus UFT or S-1 alone as adjuvant chemotherapy for T4a/b gastric cancer

Cited by 2 publications

References 3 publications

Post-hoc biomarker analyses of T4a/T4b gastric cancer from patients recruited into SAMIT, a phase III randomized controlled trial

Post-hoc biomarker analyses of T4a/T4b gastric cancer from patients recruited into SAMIT, a phase III randomized controlled trial

Gastric cancer biomarker analysis in patients treated with different adjuvant chemotherapy regimens within SAMIT, a phase III randomized controlled trial

Contact Info

Product

Resources

About