Phase I study of postoperative radiotherapy combined with capecitabine for gastric cancer

Wang, Xin; Jin, Jing; Li, Yexiong; Ren, Hua; Fang, Hui; Wang, Shulian; Liu, Yueping; Wang, Weihu; Yu, Zi-Hao; Song, Yang; Liu, Xin-Fan

doi:10.3748/wjg.v20.i4.1067

Cited by 11 publications

(19 citation statements)

References 22 publications

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“…The toxicity profile in this study was similar to that observed in other postoperative chemoradiotherapy trials [17][18][19][20], and most of these adverse events were at grade 1 or 2. The most common adverse events in this study were anorexia, nausea, fatigue and leucopenia.…”

Section: Discussionsupporting

confidence: 74%

Phase I study of postoperative radiotherapy concurrent with S-1 in patients with gastric cancer

Meng

Peng

et al. 2015

Med Oncol

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Postoperative chemoradiotherapy (CRT) with concurrent 5-fluorouracil is the standard care for gastric cancer patients after curative surgery. The previous studies revealed that the subgroup of patients with high recurrence risk would benefit most from adjuvant CRT. S-1, a novel oral fluorouracil, has showed very effective in metastatic gastric cancer and became the standard option for gastric cancer with D2 dissection. The safety and dosage of S-1 combined with postoperative radiotherapy have not yet been evaluated. This study is to determine the maximum tolerate dose (MTD) and dose-limiting toxicity (DLT) of S-1 given concurrently with postoperative high-dose radiotherapy in gastric cancer. Patients with more advanced stage (pT4 and/or pN+) after R0 resection were recruited. Eligible patients received one cycle standard SOX (S-1 plus oxaliplatin) chemotherapy, then S-1 monotherapy with concurrent radiotherapy for 6 weeks, followed by additional three cycles of SOX. During the concurrent CRT, S-1 was administered on every radiotherapy treatment day according to a predefined dose-escalation schedule. Radiotherapy (3D-RT or IMRT) was given to a total dose of 50.4 Gy in 28 fractions. DLT was defined as grade 3 or 4 hematologic and non-hematologic toxicity. From March 2011 to October 2012, 21 patients were enrolled at five dose levels: 40 (n = 3), 50 (n = 3), 60 (n = 6), 70 (n = 6) and 80 mg/m(2)/day (n = 3). D2-dissection was performed in 18 patients (85.7 %) and 15 patients (71.4 %) had stage III disease. The most common dose-related toxicity was anorexia, nausea and vomiting, fatigue and leucopenia. DLT was occurred in one patient at 60 mg/m(2)/day (grade 3 fatigue), one patient at 70 mg/m(2)/day (grade 3 vomiting and anorexia), two patients at 80 mg/m(2)/day (one with grade 3 vomiting and anorexia; another with grade 3 febrile leucopenia). Four patients did not complete CRT as planned. Overall, this phase I study demonstrated that postoperative CRT with daily S-1 was feasible in gastric cancer and the MTD of S-1 concurrent with radiotherapy was 70 mg/m(2)/day. This S-1-based postoperative CRT will be investigated in a multicenter phase III study in West China.

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Section: Discussionsupporting

confidence: 74%

Phase I study of postoperative radiotherapy concurrent with S-1 in patients with gastric cancer

Meng

Peng

et al. 2015

Med Oncol

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“…In patients receiving capecitabine-containing adjuvant chemotherapy (XELOX), CRT, or capecitabine maintenance therapy following D2 dissection, the 3-year DFS in various studies has been reported to be 67.2-78% (with a similar 5-year DFS) [11], 55.3-72.2% [29][30][31][32][33][34][35][36] and 57% [49,50]. A comparison of DFS rates among different capecitabine-based regimens has not proved feasible as the baseline characteristics of AGC patients in the various studies are often different, and patients who receive CRT or maintenance capecitabine therapy often have a higher risk of relapse.…”

Section: Discussionmentioning

confidence: 99%

“…The incidence of grade III or IV hematological toxicity ranged from 8.3 to 24.4% in five evaluable trials (total number of patients 221 [29][30][31][32][33], while that of gastrointestinal toxicity (including nausea, vomiting and diarrhea) ranged from 8.1 to 42% in seven evaluable trials (total number of patients 338) [23,27,[29][30][31][32][33], and grade III-IV hand-foot syndrome (HFS) ranged from 1.8 to 2.7% in two evaluable trials [23,29].…”

Section: Capecitabine-based Concurrent Chemoradiotherapymentioning

confidence: 99%

A Review of Capecitabine-Based Adjuvant Therapy for Gastric Cancer in the Chinese Population

Cheng

2017

Future Oncol.

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In China, the treatment of locally advanced gastric cancer (AGC) faces unique challenges. Chinese patients may harbor more unfavorable prognostic factors than western populations and, in comparison with other Asian populations such as Japan and South Korea, a higher proportion of Chinese patients are diagnosed with AGC due to inadequate early diagnosis of the malignancy. This review summarizes the use of combination chemotherapy regimens with capecitabine as adjuvant therapy in the Chinese AGC population. Based on the available domestic data in China, the review concludes that capecitabine-based chemotherapy regimens, especially XELOX, offer good efficacy following radical gastrectomy in patients with AGC, with a low incidence of adverse events, acceptable tolerance, greater patient convenience and a lower overall cost than other regimens.

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“…Oral Capecitabine was delivered twice daily (after breakfast and after dinner) at the dose of 800 mg/m² from the beginning to the end of the radiation period based on the results of previous phase I study [9]. Adjuvant chemotherapy (ACT) was required for a maximum of 6 months and was conducted before or after ACRT depending on the performance status, clinical comorbidities, and toxicity pro le of the patient; however, the regimens were open.…”

Section: Chemotherapymentioning

confidence: 99%

“…In our previous phase I study, we found out ACRT regimen of 45Gy radiotherapy concurrent with oral capecitabine was well tolerated in patients with local advanced gastric cancer who had received partial or total gastrectomy. The maximum tolerated dose and recommended dose of capecitabine was 800 mg/m 2 twice daily with oral administration [9]. We performed this phase II study to further assess the e cacy and toxicity of this ACRT regimen as an adjuvant therapy after radical resection and D1/D2 LND for local advanced gastric cancer patients.…”

Section: Introductionmentioning

confidence: 99%

Phase II Study of Capecitabine Combined With Intensity-Modulated Radiotherapy After D1/D2 Lymph Node Dissection in Patients with Gastric Cancer

Ren

Wang

et al. 2020

Preprint

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Background: Adjuvant chemoradiotherapy (ACRT) with oral capecitabine and intensity-modulated radiotherapy (IMRT) was well tolerated in a phase I study in patients who had undergone partial or total gastrectomy for locally advanced gastric cancer. This phase II study aimed to further determine the efficacy and toxicity of this combination after radical resection and D1/D2 lymph node dissection (LND) for local advanced gastric patients.Methods: Forty patients (median age, 53 years; range, 24–71 years) with pathologically confirmed adenocarcinoma who underwent D1/D2 LND were included in this study. The patients received ACRT comprising IMRT (total irradiation dose: 45 Gy delivered in daily 1.8-Gy fractions on 5 days a week over 5 weeks) and capecitabine chemotherapy (dose: 800 mg/m² twice daily throughout the duration of RT). The primary study endpoint was disease-free survival (DFS) and the secondary endpoints were overall survival (OS), toxic effects, and treatment compliance.Results: The 3-year DFS and OS were 66.2% and 75%, respectively. The median time to recurrence was 19.5 months (range, 6.1–68 months). Peritoneal implantation (n = 10) was the most common recurrence pattern, and the lung was the most common site of extra-abdominal metastases (n = 5). Nine patients developed grade 3 or 4 toxicities during ACRT. Two patients discontinued ACRT, while 11 underwent ACRT without receiving the entire course of capecitabine. There were no treatment-related deaths.Conclusion: The ACRT protocol described herein showed acceptable safety and efficacy for local advanced gastric cancer received radical gastrectomy and D1/2 LND.Trial registration: ClinicalTrials.gov, NCT01674959. Registered August 2012 - Retrospectively registered, http://www.isrctn.com/ISRCTN12345678

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Phase I study of postoperative radiotherapy combined with capecitabine for gastric cancer

Abstract: The MTD of capecitabine was 800 mg/m² twice daily concurrent with IMRT for gastric cancer after surgery. The DLTs were anorexia/nausea, vomiting, neutropenia and radiation esophagitis.

Cited by 11 publications

References 22 publications

Phase I study of postoperative radiotherapy concurrent with S-1 in patients with gastric cancer

Phase I study of postoperative radiotherapy concurrent with S-1 in patients with gastric cancer

A Review of Capecitabine-Based Adjuvant Therapy for Gastric Cancer in the Chinese Population

Phase II Study of Capecitabine Combined With Intensity-Modulated Radiotherapy After D1/D2 Lymph Node Dissection in Patients with Gastric Cancer

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