Impact of maintenance therapy with fluoropyrimidines in advanced esophageal-gastric adenocarcinoma: a retrospective study in Mexican population
Abdel Karim Dip Borunda1
, Alberto Pimentel Rentería1, Rafael Medrano Guzmán2, Lizbeth Enríquez Román1, Ana Elena Martin Aguilar1, Rocío Grajales Álvarez1, María Teresa De Jesús Cervantes Diaz3
Contributions: (I) Conception and design: AK Dip Borunda, A Pimentel Rentería; (II) Administrative support: R Medrano Guzmán; (III) Provision of study materials or patients: None; (IV) Collection and assembly of data: All authors; (V) Data analysis and interpretation: AK Dip Borunda; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors.
Background: Gastric carcinoma ranks as one of the most prevalent gastrointestinal malignancies globally, with heterogeneous clinical-biological behavior significantly affecting prognosis and treatment outcomes. In advanced stages, systemic chemotherapy remains the cornerstone of treatment, but associated toxicities often limit their duration. Maintenance therapy with fluoropyrimidines has shown promise in improving survival and quality of life in colorectal and other cancers. However, its role in advanced gastric cancer, particularly in the Mexican population, remains underexplored. This study aimed to evaluate the survival benefit and toxicity profile of maintenance therapy with fluoropyrimidines in this population.
Methods: This retrospective study analyzed data from 190 patients with metastatic adenocarcinoma of the esophago-gastric junction and stomach treated between 2018 and 2023 at the Oncology Hospital, National Medical Center Century XXI. Patients with at least stable disease after induction chemotherapy based on fluoropyrimidines and platinum salts or camptothecins were included. Maintenance therapy with fluoropyrimidines (capecitabine or 5-fluorouracil) was evaluated. Progression-free survival (PFS), overall survival (OS), and toxicity profiles were assessed. Survival estimates were generated using the Kaplan-Meier method, and multivariate analyses employed Cox proportional hazards models, with significance set at P<0.05.
Results: The median follow-up was 17.4 months. Median PFS was 11.4 months [95% confidence interval (CI): 10.38–12.55], and median OS was 17.0 months (95% CI: 13.8–20.2). Patients with G1 tumors showed significantly longer PFS (22.8 months) compared to G3 tumors [10.8 months; hazard ratio (HR) =1.41, P<0.001]. Maintenance therapy with capecitabine was predominant (75.8%), with a median of six cycles administered. Common adverse events included neuropathy (52.6%), hand-foot syndrome (47.4%), and fatigue (43.7%). Grades 3–4 toxicities were rare, with hand-foot syndrome (7.4%) and fatigue (5.3%) being the most reported.
Conclusions: Maintenance therapy with fluoropyrimidines demonstrates a favorable survival benefit and manageable toxicity profile in advanced esophago-gastric adenocarcinoma. Despite limitations, including the study’s retrospective design and the absence of direct comparisons with non-maintenance groups, these findings align with international studies, suggesting that fluoropyrimidines offer an effective strategy to prolong the benefits of first-line treatment in gastric cancer. Further studies incorporating human epidermal growth factor receptor 2 (HER2) and immune checkpoint inhibitors are warranted to enhance therapeutic personalization.
Keywords: Gastric adenocarcinoma; maintenance therapy; fluoropyrimidines; progression-free survival (PFS); overall survival (OS)
Submitted Nov 29, 2024. Accepted for publication Apr 10, 2025. Published online Oct 30, 2025.
doi: 10.21037/jgo-2024-924
Highlight box
Key findings
• The study reports a median progression-free survival (PFS) of 11.4 months and a median overall survival (OS) of 17.0 months in patients with advanced gastric cancer. High-grade (G3) tumors were associated with significantly shorter PFS compared to low-grade (G1) tumors (hazard ratio =1.41, P<0.001). Common toxicities included neuropathy, hand-foot syndrome, fatigue, and nausea, with low rates of grades 3–4 toxicities (e.g., hand-foot syndrome at 7.4%).
What is known and what is new?
• Gastric carcinoma is a prevalent malignancy with poor prognosis in advanced stages. Chemotherapy remains the main treatment, with emerging evidence supporting maintenance chemotherapy with fluoropyrimidines (e.g., S1, 5-fluorouracil) in Asian cohorts.
• This study expands evidence to non-Asian cohorts, demonstrating the effectiveness of capecitabine as maintenance therapy. It highlights the prognostic impact of tumor grade on survival and provides real-world toxicity data, supporting the tolerability of maintenance regimens.
What is the implication, and what should change now?
• Maintenance therapy with fluoropyrimidines should be considered for patients achieving disease stability or response after induction chemotherapy. Tumor grade should guide treatment discussions and personalized strategies. Prospective studies and comparative trials are needed to validate findings and optimize regimens. Toxicity management protocols should prioritize common adverse events to improve adherence and quality of life. National guidelines may incorporate maintenance chemotherapy for advanced gastric cancer based on emerging evidence.
Introduction
Background
Gastric carcinoma is a leading cause of cancer-related morbidity and mortality, ranking fourth globally in incidence and death rates (1). Its most common histological type, adenocarcinoma, accounts for 95% of cases. However, its clinical and biological behavior varies significantly, influenced by the pathological distinctions of Lauren’s classification (intestinal vs. diffuse subtypes) (2).
Rationale and knowledge gap
Advanced gastric adenocarcinoma has poor prognosis due to patient-related clinical conditions and the disease’s inherent biological challenges. Systemic treatments, such as chemotherapy, anti-human epidermal growth factor receptor 2 (HER2) therapy, and immunotherapy, have been used, but chemotherapy remains the cornerstone despite its significant toxicity. Evidence from colorectal cancer treatment suggests that reducing the intensity of highly toxic drugs while maintaining fluoropyrimidine therapy can improve outcomes. However, in gastric cancer, data on maintenance chemotherapy with fluoropyrimidines are limited, primarily emerging from Asian studies (e.g., S1 regimens) and select Western cohorts [e.g., Mayo Clinic studies on 5-fluorouracil (5-FU)] (3). This underscores a significant gap in evidence regarding its broader applicability and efficacy.
Objective
To evaluate the outcomes of maintenance chemotherapy with fluoropyrimidines in patients with advanced gastric adenocarcinoma, focusing on progression-free survival (PFS), overall survival (OS), and toxicity. The study aims to address the knowledge gap by providing real-world data from a non-Asian cohort treated at a tertiary care center. We present this article in accordance with the STROBE reporting checklist (available at https://jgo.amegroups.com/article/view/10.21037/jgo-2024-924/rc).
Methods
Study design
A retrospective analysis was conducted on patients diagnosed with metastatic adenocarcinoma of the esophago-gastric junction and stomach, treated with systemic chemotherapy at the Oncology Hospital, National Medical Center Century XXI, between 2018 and 2023.
Inclusion criteria
Eligible patients were those with advanced gastric or esophago-gastric junction adenocarcinoma who achieved at least stable disease (SD) following a primary or induction chemotherapy regimen. Patients were required to have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less.
Treatment protocol
Patients received systemic chemotherapy comprising fluoropyrimidines combined with platinum salts or camptothecins. Following induction treatment for 16 weeks, clinical response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Patients demonstrating SD or better transitioned to maintenance therapy with fluoropyrimidines (capecitabine or 5-FU).
Data collection
Clinical records were reviewed to extract data on PFS, OS, and treatment-related toxicities. OS was defined as the duration from chemotherapy initiation to death from any cause, while PFS spanned from chemotherapy initiation to either disease progression or death. Toxicities were classified and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Statistical analysis
Central tendency measures were calculated for continuous variables. Kaplan-Meier survival analysis was conducted to estimate PFS and OS curves. Cox proportional hazards models with inverse probability weighting were applied to identify predictors of survival. Poisson regression models adjusted for age, sex, chemotherapy regimen, maintenance therapy, and recurrence. Statistical significance was set at P<0.05.
Ethical statement
The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by Ethics and Research Committee of the Oncology Hospital (ID: R-2023-3602-026). The need for informed consent was waived due to the retrospective nature of the study, as only de-identified patient data were utilized to ensure confidentiality and protect patient privacy. All procedures adhered to applicable ethical and legal standards.
Results
A total of 278 patients with advanced or metastatic gastric adenocarcinoma were treated during the study period. Following first-line chemotherapy, 190 patients (68%) achieved at least SD according to RECIST 1.1 criteria, while the remaining 32% experienced progressive disease (PD). Among responders, 8 patients (4.2%) achieved a complete response (CR), 49 patients (25.8%) had a partial response (PR), and 133 patients (70%) maintained SD. Induction chemotherapy regimens were selected based on patient performance status and baseline disease characteristics. Patients with poorer performance status were more likely to receive single-agent chemotherapy, while doublet regimens such as CAPOX (capecitabine and oxaliplatin) (82 patients, 43.2%) and FOLFOX (folinic acid, fluorouracil and oxaliplatin) (80 patients, 42.1%) were the most used. The three-drug regimen FLOT (5-FU, leucovorin, oxaliplatin, and docetaxel) (19 patients, 10%) was primarily reserved for patients initially considered potentially resectable. Additionally, a small proportion of patients received EOX (epirubicin, oxaliplatin and capecitabine) (8 patients, 4.2%) or TCX (paclitaxel, carboplatin and capecitabine) (1 patient, 0.5%). The number of induction chemotherapy cycles varied depending on patient tolerance, response to treatment, and institutional protocols. The median number of cycles administered was 6 (range, 4–8 cycles). One hundred and ninety patients receiving maintenance therapy were analyzed. Median age was 58 years (range, 29–86 years), and 71.1% had an ECOG performance status of 1 (P<0.001). The diffuse histological subtype predominated (49.5%), with 55.8% having high-grade tumors (P<0.001). The gastric body was the most common subsite (41%), and 82.6% presented with metastatic disease; only 10% underwent primary gastrectomy. CAPOX was the most used primary chemotherapy (43.2%), and capecitabine was the primary maintenance therapy (75.8%), with a median of 6 cycles (range, 1–80 cycles) (Table 1).
Table 1
| Variables | Value (N=190) | P |
|---|---|---|
| Age (years) | 58 [29–86] | – |
| Gender | 0.56 | |
| Male | 91 (47.9) | |
| Female | 99 (52.1) | |
| ECOG | 0.001 | |
| 0 | 35 (18.4) | |
| 1 | 135 (71.1) | |
| 2 | 20 (10.5) | |
| Histology | 0.001 | |
| Diffuse | 94 (49.5) | |
| Intestinal | 52 (27.4) | |
| Mixed | 10 (5.3) | |
| Not reported | 34 (17.9) | |
| Histologic grade | – | |
| Well-differentiated | 6 (3.2) | |
| Moderately-differentiated | 47 (24.7) | |
| Poorly-differentiated | 106 (55.8) | |
| Not reported | 31 (16.3) | |
| Primary site | 0.001 | |
| Esophagogastric joint | 25 (13.2) | |
| Cardias | 14 (7.4) | |
| Corpus | 78 (41.1) | |
| Antrum | 32 (16.8) | |
| Pylorous | 9 (4.7) | |
| Esophagus | 3 (1.6) | |
| Not reported | 29 (15.3) | |
| Disease stage at diagnosis | – | |
| Non resectable | 33 (17.4) | |
| Metastatic | 157 (82.6) | |
| Previous gastrectomy | 20 (10.5) | – |
| Ascites | 35 (18.4) | – |
| Albumin (mg/dL) | – | |
| <3.3 | 27 (14.2) | |
| 3.3–5.5 | 160 (84.2) | |
| Not reported | 3 (1.6) | |
| Alkaline phosphatase (IU/L) | – | |
| ≤41 | 0 | |
| 42–141 | 146 (76.8) | |
| ≥142 | 39 (20.5) | |
| Primary chemotherapy | – | |
| FOLFOX | 80 (42.1) | |
| CAPOX | 82 (43.2) | |
| FLOT | 19 (10.0) | |
| EOX | 8 (4.2) | |
| TCX | 1 (0.5) | |
| Objective response RECIST 1.1 | – | |
| Complete response | 8 (4.2) | |
| Partial responses | 49 (25.8) | |
| Stable disease | 133 (70.0) | |
| Maintenance chemotherapy | – | |
| Capecitabine | 144 (75.8) | |
| 5-FU/LV | 46 (24.2) | |
| Maintenance cycles | – | |
| Range | 1–80 | |
| Median | 6 |
Data are presented as mean [range] or n (%). 5-FU, 5-fluorouracil; CAPOX, capecitabine and oxaliplatin; ECOG, Eastern Cooperative Oncology Group Performance Status; EOX, epirubicin, oxaliplatin, and capecitabine; FLOT, 5-fluorouracil, leucovorin, oxaliplatin, and docetaxel; FOLFOX, leucovorin, 5-fluorouracil, and oxaliplatin; LV, leucovorin; RECIST, Response Evaluation Criteria in Solid Tumors; TCX, paclitaxel, carboplatin, and capecitabin.
The median follow-up was 17.4 months. Median PFS was 11.4 months [95% confidence interval (CI): 10.38–12.55] (Figure 1). Response to primary chemotherapy showed no significant difference in PFS between CR (14.2 months) and SD (11.3 months, P=0.91). Tumor differentiation significantly affected PFS: poorly-differentiated tumors had a median PFS of 10.8 months (95% CI: 9.5–12.0), compared to 18.4 months (95% Confidence Interval (CI): 14.9-21.9) in well and moderately differentiated tumors (P<0.001) (Figure 2).
Median OS was 17.0 months (95% CI: 13.8–20.2). Poorly-differentiated tumors were associated with poorer OS [hazard ratio (HR) =1.54, 95% CI: 1.213–1.956, P<0.001] (Figure 3).
Treatment-related toxicities included neuropathy (52.6%), hand-foot syndrome (47.4%), fatigue (43.7%), and nausea (42.6%). Grades 3–4 toxicities were most frequent for hand-foot syndrome (7.4%) and fatigue (5.3%) (Table 2).
Table 2
| Adverse event | All grades | Grades 3–4 |
|---|---|---|
| Neuropathy | 100 (52.6) | 7 (3.7) |
| Diarrhea | 55 (28.9) | 2 (1.0) |
| Hand-foot syndrome | 90 (47.4) | 14 (7.4) |
| Fatigue | 83 (43.7) | 10 (5.3) |
| Anemia | 35 (18.4) | 5 (2.6) |
| Neutropenia | 14 (7.4) | 6 (3.2) |
| Thrombocytopenia | 7 (3.7) | 1 (0.5) |
| Nausea | 81 (42.6) | 6 (3.2) |
| Emesis | 32 (16.8) | 5 (2.6) |
Data are presented as n (%).
Discussion
Key findings
Systemic platinum/fluroquinolone-based therapy is the cornerstone of treatment for recurrent or metastatic gastric cancer. Wagner’s meta-analysis confirms that treatment with at least 2 agents is superior to monotherapy (4). However, most patients do not tolerate more than 6–8 cycles of treatment due to associated toxicity. For this reason, maintenance treatments have been attempted; maintenance refers to using additional treatments until progression in patients who have response or SD to first-line treatment. The efficacy of maintenance is well established in colorectal, lung, breast and ovarian cancer (5). However, the role of maintenance in gastric cancer is still unclear.
In this study, 190 patients with recurrent or metastatic gastric or gastroesophageal junction cancer treated with oxaliplatin and fluoropyrimidine duplex and then continued with fluoropyrimidine maintenance therapy for a median of 6 cycles were analyzed. PFS was 11.4 months, and OS was 17 months. The results are slightly better than those reported in the literature in patients with HER2-negative (6,7) and HER2-positive (8).
Strengths and limitations
Strengths
The study includes a relatively large sample size (190 patients) and focuses on a treatment approach (maintenance fluoropyrimidine therapy) increasingly relevant in modern oncology.
The findings are consistent with other studies, including those by Petrioli, Walden, Qiu, and Lu (9-12), providing a strong comparative framework.
Median survival outcomes are favorable compared to historical controls.
Limitations
Retrospective nature
The study design limits the ability to infer causality and control for confounding variables.
Lack of control group
No direct comparison was made with patients who did not receive maintenance therapy, which restricts the interpretability of the maintenance benefit.
Biomarker information
Absence of HER2, MSS/MSI or Combined Positive Score (CPS) status determination and use of anti-HER2 therapies or immunotherapy limits the study’s applicability to contemporary patient populations.
Toxicity analysis
The study does not perform an extensive evaluation of the toxicity associated with maintenance therapy, which is a critical factor for clinical decision-making.
Comparison with similar researches
The role of fluoropyrimidine in maintenance after first-line palliation in gastric cancer has been reported in some studies. Petrioli et al. conducted a prospective study in patients with esophagogastric cancer older than 75 years with ECOG greater than 1, chemotherapy with FOLOFOX4 (folinic acid, fluorouracil, and oxaliplatin) was administered for a maximum of 6 cycles and subsequently, if there was no evidence of progression, maintenance treatment with leucovorin boluses and 5-FU in continuous infusion every 2 weeks was continued, 38 patients were included, 32 patients (84.3%) received maintenance with a median of 8 cycles (range, 1–26 cycles). PFS was 5.9 months, and OS was 9.6 month. Grade 3 neuropathy occurred in 15.7% of cases (9).
In the study by Walden et al., a retrospective analysis was made of patients with gastric and gastroesophageal junction cancer treated with platinum and fluoropyrimidine between 2007–2017 after 16 weeks of treatment the patients are categorized as continuous or maintenance treatment. Ninety patients were analyzed, 48 in the continuous group and 42 in the maintenance group. No difference was observed in PFS (9.9 vs. 8.4 months, P=0.28) or OS (16.1 vs. 21.3 months, P=0.3) between both groups; however, the continuous group showed a higher percentage of grade 3 neuropathy 42.5% vs. 9.8% (12).
Capecitabine, which is an oral fluoropyrimidine, has also been evaluated for maintenance. Qiu et al. reported a retrospective study of 624 patients with gastric adenocarcinoma treated in first-line palliative care with XELOX (capecitabine and oxaliplatin). After 6 cycles of treatment, 64 patients received maintenance capecitabine and 222 did not receive maintenance. The median number of cycles in those patients who received maintenance was 4 cycles. Maintenance showed a benefit in PFS of 11.4 vs. 7.1 months and OS of 23 vs. 14.7 months (P<0.001) compared to not receiving maintenance (10).
For their part, Lu et al. reported a phase II study with the results of 72 patients with gastroesophageal junction cancer who received first-line treatment with capecitabine, paclitaxel with or without oxaliplatin after 2–6 cycles of treatment. Sixty patients who had disease control were randomized to receive maintenance with capecitabine or observation. Maintenance showed benefit in PFS (11 vs. 7 months, P<0.05) and OS (17 vs. 11 months, P<0.05) (11).
Explanations of findings
The improved PFS and OS with maintenance therapy reflect the ability of fluoropyrimidines to sustain disease control after initial systemic therapy.
Differences in survival outcomes across studies may be influenced by variations in patient characteristics, treatment regimens, and study design.
The absence of significant toxicities in many studies suggests that maintenance therapy is generally well-tolerated, especially compared to continuous treatment.
Implications and actions needed
Clinical practice
Maintenance therapy should be considered as a viable strategy for patients who respond or achieve SD after first-line therapy, particularly in resource-limited settings where biomarker testing is unavailable.
Future research: prospective randomized studies are needed to confirm these findings, incorporating modern treatments like anti-HER2 therapies and immunotherapy.
Toxicity management
Further investigation into the toxicity profile of maintenance therapy is necessary to ensure patient safety and adherence.
Biomarker studies: incorporating HER2 and CPS status into future studies could enhance treatment personalization and applicability.
Conclusions
This study highlights the potential role of maintenance therapy with fluoropyrimidines in the management of recurrent or metastatic gastric cancer in a non-Asian cohort. The observed improvements in PFS and OS reinforce the feasibility and effectiveness of this approach, aligning with findings from studies conducted in diverse populations.
However, the retrospective nature of the analysis and the absence of a comparator group limit definitive conclusions. Additionally, the lack of biomarker analysis and modern targeted therapies, such as anti-HER2 and immunotherapy, restricts the generalizability of these results to contemporary treatment paradigms. Future research should focus on validating these findings in prospective trials with biomarker-guided treatment strategies and addressing the unique characteristics of non-Asian populations to further optimize patient outcomes.
Acknowledgments
None.
Footnote
Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://jgo.amegroups.com/article/view/10.21037/jgo-2024-924/rc
Data Sharing Statement: Available at https://jgo.amegroups.com/article/view/10.21037/jgo-2024-924/dss
Peer Review File: Available at https://jgo.amegroups.com/article/view/10.21037/jgo-2024-924/prf
Funding: None.
Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jgo.amegroups.com/article/view/10.21037/jgo-2024-924/coif). The authors have no conflicts of interest to declare.
Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by Ethics and Research Committee of the Oncology Hospital (ID: R-2023-3602-026). The need for informed consent was waived due to the retrospective nature of the study, as only de-identified patient data were utilized to ensure confidentiality and protect patient privacy. All procedures adhered to applicable ethical and legal standards.
Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.
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