Dataset Information

XELOX doublet regimen versus EOX triplet regimen as first-line treatment for advanced gastric cancer: An open-labeled, multicenter, randomized, prospective phase III trial (EXELOX).

ABSTRACT:

Background

There is no consensus on whether triplet regimen is better than doublet regimen in the first-line treatment of advanced gastric cancer (AGC). We aimed to compare the efficacy and safety of oxaliplatin plus capecitabine (XELOX) and epirubicin, oxaliplatin, plus capecitabine (EOX) regimens in treating AGC.

Methods

This phase III trial enrolled previously untreated patients with AGC who were randomly assigned to receive the XELOX or EOX regimen. The primary endpoint was non-inferiority in progression-free survival (PFS) for XELOX as compared with EOX on an intention-to-treat basis.

Results

Between April 10, 2015 and August 20, 2020, 448 AGC patients were randomized to receive XELOX (n = 222) or EOX (n = 226). The median PFS (mPFS) was 5.0 months (95% confidence interval [CI] = 4.5-6.0 months) in the XELOX arm and 5.5 months (95% CI = 5.0-6.0 months) in the EOX arm (hazard ratio [HR] = 0.989, 95% CI = 0.812-1.203; P_{non-inferiority} = 0.003). There was no significant difference in median overall survival (mOS) (12.0 vs. 12.0 months, P = 0.384) or objective response rate (37.4% vs. 45.1%, P = 0.291) between the two groups. In patients with poorly differentiated adenocarcinoma and liver metastasis, the EOX arm had a significantly longer mOS (P = 0.021) and a trend of longer mPFS (P = 0.073) than the XELOX arm. The rate of grade 3/4 adverse events (AEs) was 42.2% (90/213) in the XELOX arm and 72.5% (156/215) in the EOX arm (P = 0.001). The global health-related quality of life (QoL) score was significantly higher in the XELOX arm than in the EOX arm during chemotherapy.

Conclusions

This non-inferiority trial demonstrated that the doublet regimen was as effective as the triplet regimen and had a better safety profile and QoL as a first-line treatment for AGC patients. However, the triplet regimen might have a survival advantage in patients with poorly differentiated adenocarcinoma and liver metastasis.

SUBMITTER: Zhu XD

PROVIDER: S-EPMC9017757 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature

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Publications

XELOX doublet regimen versus EOX triplet regimen as first-line treatment for advanced gastric cancer: An open-labeled, multicenter, randomized, prospective phase III trial (EXELOX).

Zhu Xiao-Dong XD Huang Ming-Zhu MZ Wang Yu-Sheng YS Feng Wan-Jing WJ Chen Zhi-Yu ZY He Yi-Fu YF Zhang Xiao-Wei XW Liu Xin X Wang Chen-Chen CC Zhang Wen W Ying Jie-Er JE Wu Jun J Yang Lei L Qin Yan-Ru YR Luo Jian-Feng JF Zhao Xiao-Ying XY Li Wen-Hua WH Zhang Zhe Z Qiu Li-Xin LX Geng Qi-Rong QR Zou Jian-Ling JL Zhang Jie-Yun JY Zheng Hong H Song Xue-Feng XF Wu Shu-Sheng SS Zhang Cheng-Yan CY Gong Zhe Z Liu Qin-Qin QQ Wang Xiao-Feng XF Xu Qi Q Wang Qi Q Ji Jian-Mei JM Zhao Jian J Guo Wei-Jian WJ

Cancer communications (London, England) 20220225 4

<h4>Background</h4>There is no consensus on whether triplet regimen is better than doublet regimen in the first-line treatment of advanced gastric cancer (AGC). We aimed to compare the efficacy and safety of oxaliplatin plus capecitabine (XELOX) and epirubicin, oxaliplatin, plus capecitabine (EOX) regimens in treating AGC.<h4>Methods</h4>This phase III trial enrolled previously untreated patients with AGC who were randomly assigned to receive the XELOX or EOX regimen. The primary endpoint was no ...[more]

PMID: 35212487

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Project description:BACKGROUND:A fixed 8-cycle oxaliplatin and capecitabine (XELOX) regimen has been the standard adjuvant therapy for patients with stage III colon cancer. However, completing the full-cycle of oxaliplatin is often associated with severe neurotoxicity. To spare patients from the toxic effects, without comprising the required efficacy, we evaluated the safety and efficacy of a modified XELOX (mXELOX) adjuvant chemotherapy regimen with 6 cycles of oxaliplatin and a full cycle of capecitabine. METHODS:We retrospectively analyzed 330 eligible patients with stage III colon cancer who underwent curative tumor resection followed by mXELOX, standard XELOX or unfinished XELOX adjuvant chemotherapy between December 2007 and April 2015. Associated prognostic factors were investigated and their disease-free survival (DFS) and overall survival (OS) rates were also determined and compared among the different regimen groups. RESULTS:Compared with the standard XELOX group, the mXELOX group had lower total incidence rates of neurotoxicity (39.3% vs. 76.2%, P?<?0.001), leucopenia (53.6% vs. 69.8%, P?=?0.017) and thrombocytopenia (38.1% vs. 56.3%, P?=?0.011). The standard XELOX and mXELOX adjuvant chemotherapy regimens presented with comparable 3-year DFS rates (86.3% vs. 89.2%; P?=?0.838) and 3-year OS rates (92.7% vs. 97.6%; P?=?0.227). Compared to unfinished XELOX chemotherapy, the oncologic benefits of the mXELOX regimen were greater for patients with T4 tumors (3-year DFS: Hazard ratio [HR], 2.184; 95% confidence interval [CI], 1.051-4.540; P?=?0.036; 3-year OS: HR, 4.529; 95% CI 1.245-16.479; P?=?0.022) and for high-risk patients (3-year DFS: HR, 1.962; 95% CI 0.964-3.993; P?=?0.044; 3-year OS: HR, 4.193; 95% CI 1.182-14.874; P?=?0.026). CONCLUSIONS:The mXELOX adjuvant chemotherapy presented a comparable survival benefit and lower incidence of toxicity than standard XELOX chemotherapy. It could be an alternative treatment for high-risk patients with operated stage III colon cancer.

Project description:BackgroundThe 5-fuorouracil, oxaliplatin and irinotecan (FOLFOXIRI) regimen is the standard first-line treatment for advanced pancreatic cancer (APC). Capecitabine, an oral prodrug of 5-fluorouracil, offers a more convenient and potentially safer alternative. We evaluated the efficacy and safety of the XELOXIRI regimen (capecitabine, oxaliplatin, irinotecan) in Chinese patients with APC.MethodsThis real-world study evaluated consecutive patients treated with the XELOXIRI regimen as first-line chemotherapy for APC at a national cancer center in China from August 2019 to June 2024. Treatment efficacy was assessed using the objective response rate (ORR), overall survival (OS), and progression-free survival (PFS), and safety was assessed using adverse events (AEs).ResultsFifty-six patients were enrolled (median age, 60 years [range, 33-71]; 35 males, 21 females). Seventeen had locally advanced unresectable disease and 39 had metastatic disease. After a median follow-up of 19.8 months, the ORR was 33.9% (95% confidence interval [CI]: 21.8-47.8), disease control rate was 82.1% (95% CI: 69.6-91.1), and median response duration was 6.2 months (95% CI: 3.6-NA). Six patients with locally advanced disease and one with lung metastasis underwent R0 resection, with one achieving a pathological complete response. Median OS for the entire cohort was 16.2 months (95% CI: 10.6-23.2) and median PFS was 6.3 months (95% CI: 5.3-9.0). OS rates at 6, 12, and 18 months were 92.2%, 56.7%, and 35.6%, respectively; PFS rates were 53.9%, 20.2%, and 6.7%. For those who underwent R0 resection, median OS was not reached and median PFS was 12.3 months (95% CI: 11.9-NA).Treatment-related AEs (TRAEs)occurred in 94.6% of patients, with Grade 3 or higher TRAEs in 44.6%. No Grade 5 TRAEs or treatment-related deaths were observed.ConclusionThe XELOXIRI regimen demonstrated promising efficacy and manageable toxicity in the treatment of APC, providing a practical alternative to FOLFOXIRI, with similar outcomes and easier administration.

Dataset Information

XELOX doublet regimen versus EOX triplet regimen as first-line treatment for advanced gastric cancer: An open-labeled, multicenter, randomized, prospective phase III trial (EXELOX).

Background

Methods

Results

Conclusions

Publications

XELOX doublet regimen versus EOX triplet regimen as first-line treatment for advanced gastric cancer: An open-labeled, multicenter, randomized, prospective phase III trial (EXELOX).

Similar Datasets

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