Prospective, randomized trial comparing 5-FU/LV with or without oxaliplatin as adjuvant treatment following curative resection of gastric adenocarcinoma

Zhang, X.-L.; Shi, Huijuan; Cui, Shuzhong; Tang, Yi-Hui; Ba, Mingchen

doi:10.1016/j.ejso.2011.01.027

Cited by 17 publications

(12 citation statements)

References 31 publications

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“…Maybe the patients with advanced stage would benefit from dual regimens, and for those with tumors in early stage, monotherapy turns to be a better choice. Markedly, after matching, median DFS was statistically significantly different between arm A and arm B (median, 67.5 vs 101.0 months, respectively; HR, 0.95; P =0.027), which was consistent with the results from previous trial [10, 11]. Consistently, a meta-analysis by Iacovelli et al, reported a significant reduction of risk of death and relapse by 13% and 23% in combined chemotherapy, respectively, when compared to monotherapy [16].…”

Section: Discussionsupporting

confidence: 90%

“…Nevertheless, our study failed to collect the adverse events between two arms due to the loss of records. Yet, several trials showed that the adverse events in both monotherapy and two-drug regimens were manageable [10, 11, 27]. …”

Section: Discussionmentioning

confidence: 99%

“…Another randomized phase III trial (ARTIST trial) suggested that the addition of XRT (capecitabine plus radiotherapy) to XP (capecitabine plus cisplatin) chemotherapy did not significantly reduce recurrence after curative resection and D2 lymph node dissection in gastric cancer [9]. Furthermore, a randomized trial to investigate the efficacy and toxicity of FOLFOX4 and LV5Fu2 regimens in patients with advanced gastric adenocarcinoma after curative gastrectomy demonstrated that the FOLFOX4 group were better than the 5-FU/LV group in 3-year recurrence free and the 3-year overall survival rate [10]. The study shown a statistically significant overall survival for FOLFOX4 group over control group, with a median 3-yr RFS and 3-yr OS of 30.0 and 36.0 moths for FOLFOX4 group, versus 16.0 and 28.0 months in the control group, respectively.…”

Section: Introductionmentioning

confidence: 99%

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Comparison of efficacy in adjuvant chemotherapy regimens in patients with radically resected gastric cancer: a propensity-matched analysis

et al. 2016

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BackgroundWe conducted the retrospective study to compare the efficacy of monotherapies versus two-drug regimens as postoperative chemotherapy for patients with radically resected gastric cancer.ResultAt a median follow-up of 5.3 years, no significant difference in terms of OS was observed between two groups, neither before nor after matching. After matching, median DFS was statistically significant between group A and B (median, 67.5 vs 101.0 months, respectively; hazard ratio [HR], 0.65; 95% CI, 0.45 to 0.95; P=0.027), which meant doublets prolonged DFS. In subgroup analysis, the patients of stage III receiving doublet achieved better OS than those receiving monotherapy. People who received doublet and were less than 65 years old, or male patients, or in T4 stage, or in N2 stage, or receiving subtotal gastrectomy had better DFS than those with monotherapy.MethodA data set including 501 patients (monotherapy, n=107; doublet, n=394) was matched between the two groups (n=107 patients per group) using the propensity-matched study. The primary and secondary endpoint was overall survival(OS) and disease-free survival(DFS), respectively. Survival data was compared using the Kaplan-Meier method and Cox proportion hazards models for univariate and multivariate analyses.ConclusionThe dual regimens seemed not to add overall survival benefits to patients receiving curative gastrectomy, compared with single-agent fluoropyrimidine as postoperative chemotherapy. However, dual regimens showed better disease-free survival.

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Section: Discussionsupporting

confidence: 90%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Comparison of efficacy in adjuvant chemotherapy regimens in patients with radically resected gastric cancer: a propensity-matched analysis

et al. 2016

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“…Thus, HIPEC improves the effect of treatment of peritoneal micrometastases from gastric cancer and peritoneal carcinomatosis-induced ascites (14). Previous clinical studies have demonstrated the effectiveness of HIPEC in treating refractory gastric cancer with malignant ascites (15)(16)(17). Currently, HIPEC has been widely used in the treatment of malignant ascites, but the treatment protocol remains under debate.…”

Section: Discussionmentioning

confidence: 99%

Autophagic death induced by thermo-chemotherapy in gastric cancer cells results from the reactive oxygen species pathway

Pan

Cui

et al. 2016

Molecular Medicine Reports

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Gastric cancer is the third leading type of cancer and has the third leading cancer‑associated mortality in China. The mechanism of thermo‑chemotherapy in gastric cancer cells remains to be elucidated. The present study aimed to investigate the role of autophagic cell death in the thermo‑chemotherapy of gastric cancer. The current study included four groups: An empty control group, a hyperthermia group, a chemotherapy (oxaliplatin) group, and a thermo‑chemotherapy group. Cell viability was analyzed by the MTS assay. Production of intracellular reactive oxygen species (ROS) was quantified by flow cytometry. Autophagy‑associated proteins, Beclin 1, microtubule‑associated protein 1A/1B‑light chain (LC3B) and mammalian target of rapamycin (mTOR), were determined by western blot analysis. The results indicated that thermo‑chemotherapy markedly increased intracellular ROS production, and decreased mitochondrial membrane potential. The transmission electron microscopy results indicated that thermo‑chemotherapy induced production of autophagic bodies. In addition, thermo‑chemotherapy‑induced cell damage at the cellular and animal levels indicated a notable increase in the expression of the autophagy‑associated genes, LC3B and Beclin 1. A negative correlation between mTOR expression and autophagy was also identified, which demonstrates that thermo‑chemotherapy induces autophagic cell death by activating the autophagy‑associated signaling pathways. The results of the present study demonstrated that the ROS level is important in autophagic death of the gastric carcinoma cells, and the increased ROS level, induced by thermo‑chemotherapy treatment, induced autophagy in gastric carcinoma cells.

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“…As is well known, the FOLFOX regimen, which contains oxaliplatin, leucovorin and 5-fluorouracil, is the standard treatment for colon cancer. A prospective randomized phase II trial reported that adjuvant FOLFOX could result in significantly better 3-year OS than 5-FU/FA (30.0 vs. 16.0 months, p \ 0.05) in gastric cancer patients after curative-intent gastrectomy [15]. Further studies have demonstrated that the FOLFOX regimen is an effective and well-tolerated treatment for patients with gastric cancer [16].…”

Section: Introductionmentioning

confidence: 99%

A phase II trial of concurrent 3D-CRT/IMRT and oxaliplatin, 5-fluorouracil and leucovorin (FOLFOX) in gastric cancer patients with R0 gastrectomy and D2 lymph node dissection

et al. 2015

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Background To evaluate the safety and efficacy of a concurrent three-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) plus oxaliplatin, 5-fluorouracil and leucovorin (FOLFOX) regimen in completely resected gastric cancer patients with D2 lymph node dissection. Materials and methods Patients with stage IB-IIIC gastric cancer (per the AJCC, 7th edition) who had undergone R0 and D2 gastrectomy were recruited. Two cycles of FOLFOX with concurrent 3D-CRT or IMRT (50.4 Gy/28f) were administered. One and an additional five cycles of FOLFOX were delivered before and after concurrent chemoradiotherapy, respectively. Primary endpoints were relapse-free survival (RFS) and overall survival (OS), with adverse events as secondary endpoints. Results From 2008 to 2011, 110 patients were evaluable. The 1-, 2-and 3-year RFS and OS were 86.2, 72.2, 67.8 and 94.7, 87.2, 77.6 %, respectively. On multivariate analysis, stage (BIIIA vs. [IIIA) was a statistically significant factor affecting both RFS and OS. Additionally, the T-category (BT4a vs. =T4b) was a statistically significant factor affecting only the RFS. The most commonly observed grade 3 or 4 adverse events were nausea and vomiting, decreased appetite, leukopenia/neutropenia and fatigue, each of which occurred in 14.5, 11.8, 9.1 and 6.4 % patients, respectively. Conclusions Adjuvant 3D-CRT/IMRT to a dose of 50.4 Gy/28f with concurrent FOLFOX is safe and effective in patients following radical gastrectomy with D2 lymph node dissection.

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Prospective, randomized trial comparing 5-FU/LV with or without oxaliplatin as adjuvant treatment following curative resection of gastric adenocarcinoma

Cited by 17 publications

References 31 publications

Comparison of efficacy in adjuvant chemotherapy regimens in patients with radically resected gastric cancer: a propensity-matched analysis

Comparison of efficacy in adjuvant chemotherapy regimens in patients with radically resected gastric cancer: a propensity-matched analysis

Autophagic death induced by thermo-chemotherapy in gastric cancer cells results from the reactive oxygen species pathway

A phase II trial of concurrent 3D-CRT/IMRT and oxaliplatin, 5-fluorouracil and leucovorin (FOLFOX) in gastric cancer patients with R0 gastrectomy and D2 lymph node dissection

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