S-1 chemotherapy and intensity-modulated radiotherapy after D1/D2 lymph node dissection in patients with node-positive gastric cancer: a phase I/II study

Wang, X; Zhao, Dongbing; Yang, Lin; Chi, Yihebali; Tang, Yu; Li, N; Wang, S L; Song, Yang; Liu, Y P; Liu, W Y; Ren, Hua; Zhang, T; Wang, J Y; Chen, X S; Fang, Hui; Wang, W H; Li, Y X; Jin, Jie

doi:10.1038/bjc.2017.424

Cited by 16 publications

(21 citation statements)

References 21 publications

(33 reference statements)

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“…Second, the fourth-generation oral fluoropyrimidine S-1 yielded a higher tumor response than and was non-inferior to infusional 5-fluorouracil and UFT (a combination of tegafur and uracil) in phase III trials of patients with gastrointestinal cancer ( 7 , 8 ). We verified the promising efficacy and safety of S-1 combined with radiotherapy in an adjuvant setting in patients with gastric cancer ( 9 ). Third, no consensus has been established regarding target volume delineation in elderly patients with ESCC, and a strict delineation protocol was needed to decrease inter-observer variability in our multicenter phase III ESCC trial ( 10 ).…”

Section: Introductionmentioning

confidence: 59%

“…S-1 has been widely used in East Asia since several studies have reported promising results of S-1–based combination therapy or monotherapy in patients with digestive system tumors ( 7 , 30 , 31 ). Our previous phase I/II study showed that concurrent S-1 chemotherapy (dose, 80 mg/m 2 /d) with SIB-RT after surgery for gastric and esophagogastric junction cancer had a low rate of toxicity ( 9 ). Considering these results and the poor tolerance of elderly patients, we used S-1 monotherapy in the present study and reduced the dose to 40–60 mg/m 2 /d based on the body surface area.…”

Section: Discussionmentioning

confidence: 99%

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S-1–Based Chemoradiotherapy Followed by Consolidation Chemotherapy With S-1 in Elderly Patients With Esophageal Squamous Cell Carcinoma: A Multicenter Phase II Trial

Wang

et al. 2020

Front. Oncol.

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Introduction: Intensive treatments can often not be administered to elderly patients with esophageal squamous cell carcinoma (ESCC), leading to a poorer prognosis. This multi-center phase II trial aimed to determine the toxicity profile and efficiency of S-1–based simultaneous integrated boost radiotherapy (SIB-RT) followed by consolidation chemotherapy with S-1 in elderly ESCC patients and to evaluate the usefulness of comprehensive geriatric assessment (CGA). Patients and Methods: We prospectively enrolled 46 elderly patients (age ≥ 70 years) with histopathologically proven ESCC. The patients underwent pretreatment CGA followed by SIB-RT (dose, 59.92 Gy/50.4 Gy) in 28 daily fractions administered using intensity-modulated radiotherapy or volumetric-modulated arc therapy. S-1 was orally administered (40–60 mg/m 2 ) concurrently with radiotherapy and 4–8 weeks later, for up to four 3-week cycles at the same dose. Results: The median survival time was 22.6 months. The 1- and 2-year overall survival rates were 80.4 and 47.8%, respectively. The overall response rate was 78.3% (36/46). The incidence of grade 3–4 toxicities was 28% (13/46). The most common grade 3–4 toxicities were radiation esophagitis (5/46, 10.9%), nausea (4/46, 8.7%), anorexia (3/46, 6.5%), and radiation pneumonitis (3/46, 6.5%). There were no grade 5 toxicities. CGA identified that 48.8% of patients were at risk for depression and 65.5% had malnutrition. Conclusion: Concurrent S-1 treatment with SIB-RT followed by 4 cycles of S-1 monotherapy yielded satisfactory tumor response rates and manageable toxicities in selected elderly patients with ESCC. Pretreatment CGA uncovered numerous health problems and allowed the provision of appropriate supportive care. Clinical Trial Registration: www.ClinicalTrials.gov , identifier: NCT02979691.

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Section: Introductionmentioning

confidence: 59%

Section: Discussionmentioning

confidence: 99%

S-1–Based Chemoradiotherapy Followed by Consolidation Chemotherapy With S-1 in Elderly Patients With Esophageal Squamous Cell Carcinoma: A Multicenter Phase II Trial

Wang

et al. 2020

Front. Oncol.

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“…The pCR rate of the preoperative CRT group was 14.1%, which was better than that of the neoadjuvant chemotherapy group (11.1%). The 2-year DFS and LRFS rates were better in the CRT group than in the neoadjuvant chemotherapy group (87.1% and 100% vs 63.9% and 79.3%, p = 0.005, 0.014) (14). The present study examined the therapeutic modalities of concurrent chemoradiotherapy and perioperative chemotherapy plus radical surgery.…”

Section: Discussionmentioning

confidence: 85%

Downstaging depth score as a better surrogate endpoint than pCR, histological response and ypN0 for long-term outcomes in locally advanced gastric cancer patients after preoperative chemo-radiotherapy

Li¹,

Wang²,

Tang³

et al. 2020

Preprint

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Background: The prediction effect of preoperative chemo-radiotherapy(CRT) is not high and difficult to guide individualized treatment. We explored a surrogate endpoint for long-term outcomes in locally advanced gastric cancer patients after preoperative CRT. Methods: From April 2012 to April 2019, 95 patients enrolled in 4 prospective studies with locally advanced gastric cancer who received preoperative concurrent radio-chemotherapy were included. All patients were stage T3/4, N+. Local control (LC), distant metastasis-free survival (DMFS), disease-free survival (DFS) and overall survival (OS) were evaluated. The clinicopathological factors related to the long-term prognosis were analysed by uni- and multivariant analyses. The downstaging depth score (DDS), a novel method of evaluating the CRT response, was used to predict long-term outcomes. Results: The median follow-up period for survivors was 30 months. The area under the curve (AUC) of the receiver operating characteristic (ROC) curve predicted by the DDS was 0.728, which was better than that of pathological complete response (pCR), histological response and ypN0 (AUC= 0.634, 0.640 and 0.643, respectively). The DDS cut-off value was 4. pCR and ypN0 were associated with OS (p = 0.026, 0.049). Surgery and the DDS were correlated with DMFS, DFS and OS (p = 0.001, 0.000, and 0.000 and 0.009, 0.013, and 0.032, respectively). The multivariate analysis showed that the DDS was an independent prognostic factor of DFS (p = 0.021). Conclusion: The DDS, a simple, short-term indicator, seems to be a better surrogate endpoint than pCR, histological response and ypN0 for DFS.

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“…In the perioperative treatment of gastric cancer, S-1 has been widely used in Asia [ 16 , 17 ]. The previous phase I study from our center assessed the MTD of S-1 in postoperative chemoradiotherapy for gastric cancer [ 18 ]. The conventional fraction radiotherapy dose of 45 Gy/1.8 Gy was delivered, and the MTD was 80 mg/m 2 .…”

Section: Discussionmentioning

confidence: 99%

A prospective phase I study of hypo-fractionated neoadjuvant radiotherapy for locally advanced gastric cancer

Wang

Tang

et al. 2018

BMC Cancer

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BackgroundPrevious studies have reported that neoadjuvant chemoradiotherapy can downstage the advanced gastric cancer. However, no studies are available on the application of hypo-radiotherapy to neoadjuvant radiotherapy. This study sought to assess the maximum tolerated dose (MTD) and dose-limited toxicity (DLT) of hypo-fractionated chemoradiotherapy for local advanced gastric cancer.MethodPatients with cT3–4 and/or lymph node-positive locally advanced gastric cancer or Siewert II/III esophagogastric junction adenocarcinoma were enrolled. Preoperative chemoradiation was followed by 3 cycles of oxaliplatin + S-1 neoadjuvant chemotherapy with an interval duration of 3–4 weeks. D2 resection was performed 2–4 weeks after neoadjuvant therapy. Three cycles of adjuvant chemotherapy were planned after surgery. Intensity-modulated radiotherapy (IMRT) was used. The radiotherapy dose level was defined using three levels, namely, 40.0 Gy/2.5 Gy, 41.6 Gy/2.6 Gy, 43.2 Gy/2.7 Gy delivered concurrently with S-1 at 80 mg/m2.ResultsFrom May 2016 to Dec 2016, nine patients with a median age of 63 years were enrolled in this study. The most common grade I-III adverse events were leukopenia (88.9%), nausea (88.9%), vomiting (77.8%) and weight loss (66.7%). Grade III adverse events consisted of vomiting and weight loss.ConclusionThe MTD of hypo-fractionated radiotherapy for locally advanced gastric cancer was 40.0 Gy/2.5 Gy, and the DLTs were vomiting and weight loss.Trial registrationClinicaltrials.gov ID: NCT03427684 (Retrospectively registered on February 9, 2018).

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S-1 chemotherapy and intensity-modulated radiotherapy after D1/D2 lymph node dissection in patients with node-positive gastric cancer: a phase I/II study

Abstract: S-1 combined with IMRT adjuvant chemoradiotherapy is safe and efficacious for advanced gastric cancer.

Cited by 16 publications

References 21 publications

S-1–Based Chemoradiotherapy Followed by Consolidation Chemotherapy With S-1 in Elderly Patients With Esophageal Squamous Cell Carcinoma: A Multicenter Phase II Trial

S-1–Based Chemoradiotherapy Followed by Consolidation Chemotherapy With S-1 in Elderly Patients With Esophageal Squamous Cell Carcinoma: A Multicenter Phase II Trial

Downstaging depth score as a better surrogate endpoint than pCR, histological response and ypN0 for long-term outcomes in locally advanced gastric cancer patients after preoperative chemo-radiotherapy

A prospective phase I study of hypo-fractionated neoadjuvant radiotherapy for locally advanced gastric cancer

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