Phase II study of neoadjuvant chemotherapy with S-1 plus oxaliplatin for gastric cancer clinical T4 or N2-3

Serizawa, Akiko; Kuramochi, Hidekazu; Taniguchi, Kiyoaki; Ota, Masaho; Katagiri, Seiji; Yamada, Takuji; Kotake, Sho; Ito, Shunichi; Suzuki, Kazuomi; Yamamoto, Masakazu

doi:10.1007/s12032-021-01549-z

Cited by 4 publications

(8 citation statements)

References 14 publications

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“…17 In Asian countries, the SOX regimen as perioperative treatment for resectable gastric cancers is more commonly used than the FLOT regimen, since it was considered more tolerant. 13,18,19 In the RESOLVE study, a pCR rate of 5.6% was reported. 13 Furthermore, in a recent phase III, randomized clinical trial, 3.4% patients in the SOX group achieved pCR, with 95.5% R0 resection rate.…”

Section: Discussionmentioning

confidence: 99%

“…A phase II trial compared these two regimens in the Chinese population, and no significant differences were found between these two groups in clinical benefits 17 . In Asian countries, the SOX regimen as perioperative treatment for resectable gastric cancers is more commonly used than the FLOT regimen, since it was considered more tolerant 13,18,19 . In the RESOLVE study, a pCR rate of 5.6% was reported 13 .…”

Section: Discussionmentioning

confidence: 99%

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Efficacy and safety of camrelizumab combined with oxaliplatin and S‐1 as neoadjuvant treatment in locally advanced gastric or gastroesophageal junction cancer: A phase II, single‐arm study

Zhong,

Lin,

et al. 2024

Cancer Medicine

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PurposeIn the present study, we aimed to evaluate the efficacy and safety of camrelizumab combined with oxaliplatin plus S‐1 in patients with resectable gastric or gastroesophageal junction cancer.MethodsIn this single‐arm, phase II clinical trial, patients with locally advanced gastric or gastroesophageal junction adenocarcinoma were enrolled to receive three cycles of neoadjuvant camrelizumab and oxaliplatin plus S‐1 every 3 weeks, followed by surgical resection and adjuvant therapy with the same regimen. The primary endpoint was pathological complete response (pCR) (ypT0) rate and secondary endpoints were R0 resection rate, total pCR (tpCR, ypT0N0) rate, major pathological response (MPR) rate, downstaging, objective response rate (ORR), disease control rate (DCR), event‐free survival (EFS), overall survival (OS), and safety.ResultsBetween September, 2020 and January, 2022, a total of 29 patients were enrolled in the present study, all of whom completed neoadjuvant therapy and underwent surgery. Three (10.3%) (95% CI: 2.2–27.4) patients achieved pCR as well as tpCR, 20 (69.0%) patients had MPR and 28 (96.6%) patients achieved R0 resection. Treatment‐emergent adverse events (AEs) of any grade were observed in 24 (82.8%) patients. Immune‐related adverse events of any grade were reported in 13 (44.8%) patients, whereas no grade 3 or higher adverse events occurred.ConclusionThe neoadjuvant therapy with camrelizumab in combination with oxaliplatin and S‐1 showed a modest pCR rate, and favorable MPR rate and safety profile in patients with gastric or gastroesophageal junction cancer.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of camrelizumab combined with oxaliplatin and S‐1 as neoadjuvant treatment in locally advanced gastric or gastroesophageal junction cancer: A phase II, single‐arm study

Zhong,

Lin,

et al. 2024

Cancer Medicine

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“…We have previously reported a single-arm, prospective, multicenter, phase II study designed to examine the e cacy and safety of SOX as a NAC for cT4 or N2-3 M0 advanced GC [5]. In the previous analysis, all patients could complete two courses of NAC with SOX, and the R0 resection rate was 93.3% (28/30, 95% con dence interval (CI): 77.9-99.2%).…”

Section: Discussionmentioning

confidence: 99%

“…The grade ≥ 3 surgical morbidities were anastomotic leakage and pancreatic stula (both 6.7%). The pathological response (Grade 1b-3) rate was 63.3% (19/30) [5]. Therefore, the SOX NAC was feasible and effective for advanced GC, with high R0 resection and acceptable pathological response rates.…”

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confidence: 91%

“…Yamada et al reported that for unresectable advanced or recurrent GC, oxaliplatin, a third-generation platinum compound, and S-1 (SOX) was safer than and almost as effective as CS; therefore, SOX could replace CS [4]. Furthermore, due to the adverse events associated with cisplatin, compliance with and e cacy of chemotherapy are poor; therefore, we concluded that SOX was better than CS as a NAC.We have previously reported a single-arm, prospective, multicenter, phase II study designed to examine the e cacy and safety of SOX as a NAC for cT4 or N2-3 M0 advanced GC [5]. In the previous analysis, all patients could complete two courses of NAC with SOX, and the R0 resection rate was 93.3% (28/30, 95% con dence interval (CI): 77.9-99.2%).…”

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confidence: 97%

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Long-term results of a phase II study of two courses of neoadjuvant chemotherapy with S-1 plus oxaliplatin for cT4 or N2-3 gastric cancer

Ito

Kuramochi

Serizawa

et al. 2023

Preprint

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Purpose To evaluate the long-term survival outcomes from our previous study: the phase II study of neoadjuvant chemotherapy with S-1 plus oxaliplatin for cT4 or N2-3 advanced gastric cancer. Methods The patients with clinical T4 and/or N2 or more lymph nodes received two cycles of neoadjuvant chemotherapy with S-1 plus oxaliplatin (oxaliplatin at 130 mg/m2 on day 1 and S-1 at 80–120 mg/day for 2 weeks, q 3 weeks), followed by gastrectomy with D2 lymphadenectomy. The final preplanned analysis of long-term outcomes, including overall and relapse-free survival, was performed. This trial has been completed and registered with the University Hospital Medical Information Network Clinical Trials Registry under number UMIN 000024656. Results Between May 2016 and March 2019, 30 patients were enrolled. All patients could complete the protocol. After a median follow-up of 50 months for surviving patients, the 3-year overall and recurrence-free survival rates were 80.0% and 76.7%, respectively, at the last follow-up in March 2023, whereas the 5-year overall and recurrence-free survival rates were 72.7% and 73.0%, respectively. Conclusion Two cycles of neoadjuvant chemotherapy with S-1 plus oxaliplatin, followed by D2 gastrectomy, was associated with relatively good long-term oncologic outcomes for patients with high-risk gastric cancer.

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Association between the apparent diffusion coefficient and the preoperative chemotherapy response of patients with locally advanced gastric cancer

Zhu¹,

Zhou²,

Wang³

et al. 2023

J Gastrointest Oncol

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Background:The apparent diffusion coefficient is a parameter measured by magnetic resonance imaging (MRI). Studies in breast cancer and osteosarcoma have shown that the apparent diffusion coefficient has a good correlation with the efficacy of neoadjuvant chemotherapy. However, to date, no studies have evaluated the association between the apparent diffusion coefficient and the preoperative chemotherapy response of patients with locally advanced gastric cancer. Methods:The data of 143 patients with locally advanced gastric cancer admitted to Zhejiang Medical and Health Group Quzhou Hospital (Zhejiang Quhua Hospital) from January 2018 to January 2019 were retrospectively collected. All the patients underwent preoperative chemotherapy and dynamic enhanced MRI to analyze the correlation between the apparent diffusion coefficient and preoperative chemotherapy response.Results: Compared to the control group, the apparent diffusion coefficient of the objective remission group was significantly increased [(1.16±0.26) ×10 −3 vs. (0.95±0.26) ×10 −3 mm 2 /s, P<0.001]; the rate of the apparent diffusion coefficient >1.095×10 −3 mm 2 /s was significantly increased (61.29% vs. 30.00%, P<0.001).The apparent diffusion coefficient was valuable in predicting objective remission after preoperative chemotherapy in patients with locally advanced gastric cancer, the area under the curve (AUC) was 0.708 [95% confidence interval (CI): 0.621-0.796, P<0.001], the best diagnostic cut-off value was 1.095×10 −3 mm 2 /s, and the sensitivity and specificity were 0.613 and 0.700, respectively. The multivariate logistics regression analysis showed that the apparent diffusion coefficient of >1.095×10 −3 mm 2 /s was associated with the objective response of patients with locally advanced gastric cancer after preoperative chemotherapy [P=0.004, relative risk =3.135 (95% CI: 1.452-6.768)]. The apparent diffusion coefficient was valuable in predicting the non-recurrence of locally advanced gastric cancer patients, and the AUC was 0.647 (95% CI: 0.557-0.738, P=0.003). The apparent diffusion coefficient was also valuable in predicting the postoperative survival of patients with locally advanced gastric cancer, and the AUC was 0.630 (95% CI: 0.537-0.723, P=0.007). Conclusions:The elevated apparent diffusion coefficient was associated with objective remission of the preoperative chemotherapy response and prognosis of patients with locally advanced gastric cancer.

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Phase II study of neoadjuvant chemotherapy with S-1 plus oxaliplatin for gastric cancer clinical T4 or N2-3

Cited by 4 publications

References 14 publications

Efficacy and safety of camrelizumab combined with oxaliplatin and S‐1 as neoadjuvant treatment in locally advanced gastric or gastroesophageal junction cancer: A phase II, single‐arm study

Efficacy and safety of camrelizumab combined with oxaliplatin and S‐1 as neoadjuvant treatment in locally advanced gastric or gastroesophageal junction cancer: A phase II, single‐arm study

Long-term results of a phase II study of two courses of neoadjuvant chemotherapy with S-1 plus oxaliplatin for cT4 or N2-3 gastric cancer

Association between the apparent diffusion coefficient and the preoperative chemotherapy response of patients with locally advanced gastric cancer

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