A real-world study of oxaliplatin-induced hypersensitivity in colorectal cancer treatment based on the pharmacovigilance system in China: a cohort study
Jing Xue1,2,3, Chengcui Huang1,2,3, Chunmei Dai1,2,3, Jingwen Xie1,2,3, Mateusz Jagielski4, Emmanuel Gabriel5, Xiaoyan Li1,2,3
Contributions: (I) Conception and design: J Xue, X Li; (II) Administrative support: X Li; (III) Provision of study materials or patients: X Li; (IV) Collection and assembly of data: C Huang, C Dai, J Xie; (V) Data analysis and interpretation: C Huang; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors.
Background: Oxaliplatin (OXA), a third-generation platinum-based chemotherapeutic agent, is commonly used in the treatment of colorectal cancer (CRC). However, there is growing recognition that OXA induced hypersensitivity poses a challenge to the continuity and safety of patient treatment. However, the risk factors for OXA-induced hypersensitivity reactions (HSRs) are not clear. This study aimed to investigate the incidence, characteristics, severity, and risk factors of OXA-induced HSRs among Chinese CRC patients, using data from the China Hospital Pharmacovigilance System (CHPS).
Methods: This retrospective study analyzed adverse drug reaction reports related to OXA from the CHPS, focusing on patients treated for CRC between 2018 and 2022. The incidence rates of HSRs were assessed, and the demographic, clinical, and risk factors associated with HSRs were explored.
Results: This study analyzed the records of 383 CRC patients who were treated with OXA-based regimens. A total of 124 (32.37%) HSRs related to OXA were reported, the majority of which were cutaneous reactions. Severe reactions, including anaphylaxis, occurred in 8% of the HSR cases. In this study, male gender, the eosinophil count, and serum albumin levels were risk factors associated with the occurrence of OXA-induced HSRs.
Conclusions: OXA-induced HSRs are a significant adverse effect in the treatment of CRC. This study emphasizes the importance of identifying the risk factors associated with the occurrence of OXA-induced HSRs to optimize patient safety and treatment efficacy.
Keywords: Oxaliplatin (OXA); hypersensitivity reactions (HSRs); colorectal cancer (CRC); pharmacovigilance; China
Submitted Apr 21, 2025. Accepted for publication Jun 10, 2025. Published online Jun 20, 2025.
doi: 10.21037/jgo-2025-312
Highlight box
Key findings
• This study found that male gender, the eosinophil count, and serum albumin levels were risk factors associated with oxaliplatin (OXA)-induced hypersensitivity. No significant difference in the incidence of hypersensitivity reactions (HSRs) was found between the patients who received dexamethasone as a preventive measure and those who did not.
What is known, and what is new?
• Studies have shown that the main risk factors for HSRs caused by platinum-based drugs include age, gender, previous medication history and allergy history. Nevertheless, the research findings remain inconclusive.
• Our study found that the following risk factors were associated with OXA-induced hypersensitivity: male gender, the eosinophil count, and serum albumin levels. No significant difference in the incidence of HSRs was found between the patients who received dexamethasone as a preventive measure and those who did not.
What is the implication, and what should change now?
• The risk factors associated with OXA-induced HSR were identified. Our findings could help promote the safer treatment of patients. More research is needed to explore strategies for reducing HSRs, and improving patient safety and treatment effectiveness.
Introduction
Colorectal cancer (CRC) is the fourth most common cancer and the second leading cause of cancer-related death worldwide (1). The oxaliplatin (OXA)-containing regimen is the first-line treatment for CRC and is recommended by the United States National Comprehensive Cancer Network (2). OXA exerts an anti-cancer effect by interfering with the proliferation of tumor cells. However, OXA is also likely to interact with normal cells with high proliferation rates, which can result in adverse side effects (3).
Over the years, various studies have revealed the adverse side effects of OXA on various organs and tissues (4,5). Common side effects of OXA include neurotoxicity, hypersensitivity reactions (HSRs), and cytopenia (5). HSRs are a known complication associated with platinum agents (6). However, the incidence of OXA-induced HSRs, which may endanger the life and safety of patients, have been growing in recent years (7).
OXA can induce HSRs in about 10–19% (8). The exact mechanism of OXA-induced HSRs is not clear (6). OXA-associated hypersensitivity usually occurs immediately after OXA administration, which suggests that OXA-associated hypersensitivity is an immunoglobulin E-mediated hypersensitivity (9). Studies have indicated that the primary risk factors for HSRs to platinum-based drugs encompass prior exposure to the medication, a history of HSRs to other pharmaceuticals, heightened severity of previous reactions, younger age (below 60 years), female gender, and more intense prior reactions (10-12). Nevertheless, the research findings remain inconclusive. HSR may cause serious problems for patients, resulting in hospitalization, and even death (13). Since OXA is one of the main drugs used in the treatment of CRC, it is very important to identify patients at high risk of HSRs (14). Melato et al. discovered that OXA-induced HSRscan lead to interruptions or changes in the treatment protocol, directly impacting patients’ survival and subsequent quality of life. Thus,prevention and/or treatment of OXA-induced HSRs is essential (15). Therefore, this study aimed to investigate the incidence, characteristics, severity and risk factors of OXA-induced HSRs among Chinese CRC patients, using data from the China Hospital Pharmacovigilance System (CHPS). We present this article in accordance with the STROBE reporting checklist (available at https://jgo.amegroups.com/article/view/10.21037/jgo-2025-312/rc).
Methods
A retrospective pharmacovigilance study of CRC patients who were treated with an OXA-based regimen was conducted between January 1, 2018 and December 31, 2022. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the Ethics Committee of The Sixth Affiliated Hospital, Sun Yat-sen University (No. 2023ZSLYEC-297). Individual consent for this retrospective analysis was waived. This study used data from the CHPS. CHPS is an information system organized and developed by the National Center for Adverse Drug Reaction Monitoring. CHPS can be integrated with hospital information systems, laboratory information management systems, and electronic medical records and other information systems. Besides enabling functions such as assisting in the reporting and management of adverse drug reaction information, it can also utilize search engine technology to retrieve unstructured electronic medical records in hospitals, develop evaluation models, and assist in conducting drug evaluation research. The OXA-induced HSRs were identified and classified according to the National Cancer Institute Common Criteria (NCI-CTCAE, version 5.0) (16).
To be eligible for inclusion in the study, the patients had to meet the following inclusion criteria: (I) have been diagnosed with CRC; (II) have been treated with an OXA-based chemotherapy regimen; and (III) have experienced HSRs during treatment. Patients with incomplete medical records were excluded from the study.
The gender, age, past medical history, allergy history, chemotherapy purpose, chemotherapy regimen, main laboratory data, symptoms of HSR, grade of HSR, and other important information of the patients were recorded.
Statistical analysis
The quantitative data are reported as the mean and standard deviation, and the qualitative data are reported as the number and percentage. A multivariate logistic regression model was used to analyze the risk factors for OXA-induced HSRs, including gender, allergy history, whether there is metastasis and laboratory test results. All the statistical analyses were conducted using SPSS software (version 25.0), and a P value of less than 0.05 was considered statistically significant.
Results
Patient characteristics
A retrospective analysis of the data of 383 CRC patients treated with OXA-based regimens was conducted. The patients had a median age of 52 years (range, 15–75 years), and 53.17% of the patients were male. Nearly 78% received OXA and 5-fluorouracil. The purpose of treatment, metastasis, drug dosage, prophylactic use of dexamethasone, main laboratory data, and background of the patients are presented in Table 1. The patients were classified into two groups based on whether or not they experienced HSRs. As detailed in Table 1, no statistically significant difference was observed between the two groups of patients in terms of age, drug dosage, and history of drug hypersensitivity. The male patients exhibited a higher susceptibility to HSRs than the female patients. The main laboratory data indicated that the eosinophil counts and serum albumin levels differed significantly between the two groups.
Table 1
| Variable | Patients without HSR (n=259) | Patients with HSR (n=124) | P |
|---|---|---|---|
| Age (years) | 53.38±11.68 | 50.14±10.32 | 0.55 |
| Gender | 0.004* | ||
| Male | 124 (47.88) | 80 (64.52) | |
| Female | 135 (52.12) | 44 (35.48) | |
| History of drug hypersensitivity | 0.34 | ||
| Yes | 63 (24.32) | 32 (25.81) | |
| No | 196 (75.68) | 92 (74.19) | |
| Metastasis | 0.19 | ||
| Yes | 154 (59.46) | 66 (53.23) | |
| No | 105 (40.54) | 58 (46.77) | |
| Regimen | |||
| Oxaliplatin combined with 5-fluorouracil | 201 (77.61) | 97 (78.23) | 0.36 |
| Irinotecan combined with oxaliplatin and 5-fluorouracil | 43 (16.60) | 19 (15.32) | 0.23 |
| Oxaliplatin combined with capecitabine | 15 (5.79) | 8 (6.45) | 0.22 |
| Purpose | |||
| Adjuvant | 117 (45.17) | 58 (46.77) | 0.27 |
| Neoadjuvant | 39 (15.06) | 15 (12.10) | 0.37 |
| Palliative | 103 (39.77) | 51 (41.13) | 0.40 |
| Dose (mg) | 144.82±83.07 | 136.13±30.32 | 0.24 |
| Prophylactic use of dexamethasone | 0.14 | ||
| Yes | 157 (60.62) | 65 (52.42) | |
| No | 102 (39.38) | 59 (47.58) | |
| Previous medical history | 0.16 | ||
| Yes | 142 (54.83) | 68 (54.84) | |
| No | 117 (45.17) | 56 (45.16) | |
| Serum albumin (g/dL) | 3.86±0.43 | 3.42±0.52 | 0.004* |
| Serum creatinine (mg/dL) | 0.79±0.16 | 0.83±0.18 | 0.20 |
| Monocyte count (cell/mm3) | 469.21±198.36 | 454.57±206.27 | 0.18 |
| Eosinophil count (cell/mm3) | 172.31±154.14 | 183.42±162.21 | 0.02* |
| Lymphocyte count (cell/mm3) | 1,590.73±813.46 | 1,569.29±749.44 | 0.23 |
Data are presented as mean ± standard deviation or n (%). *, P<0.05. HSR, hypersensitivity reaction.
Occurrence of HSRs
During the 5-year follow-up period, 124 patients experienced OXA-induced HSRs. The incidence rates of HSRs according to the NCI-CTCAE (version 5) are set out in Table 2. Grade 1 HSRs accounted for 70% of cases, the most frequent severity grade. The most common HSRs were cutaneous reactions, including flushing, rash, itching, and erythema. Ten patients were diagnosed with anaphylactic shock.
Table 2
| Occurrence of hypersensitivity | Values (n=124), n (%) |
|---|---|
| Severity | |
| Grade 1 | 87 (70.16) |
| Grade 2 | 22 (17.74) |
| Grade 3/4 | 15 (12.10) |
| Symptom | |
| Cutaneous reactions | 56 (45.16) |
| Digestive symptom | 14 (11.29) |
| Respiratory symptoms | 16 (12.90) |
| Cardiovascular symptoms | 17 (13.71) |
| Fever/chills | 11 (8.87) |
| Anaphylactic shock | 10 (8.07) |
HSR, hypersensitivity reaction; OXA, oxaliplatin.
Risk factors for HSRs
This study used a multivariate logistic regression model to analyze the risk factors associated with OXA-induced HSRs. The conditional forward method was used to input the variables. To investigate the potential risk factors associated with the development of OXA-induced HSRs, a logistic regression model was used that included the following factors: age, gender, presence of metastasis, history of drug hypersensitivity, dosage of OXA, purpose of chemotherapy, chemotherapy regimen, use of dexamethasone, and key laboratory data. The results of the logistic regression analysis indicated that male gender, the eosinophil count, and serum albumin levels were risk factors for OXA-induced HSRs. The odds ratios (95% confidence intervals) for the multivariate model are shown in Table 3.
Table 3
| Variable | Odds ratio | 95% confidence interval | P |
|---|---|---|---|
| Gender | 2.397 | 1.154–3.639 | <0.001 |
| Eosinophil count | 1.012 | 1.003–1.020 | <0.001 |
| Serum albumin | 0.589 | 0.358–0.821 | <0.001 |
Discussion
OXA is a third-generation platinum-based drug commonly used to treat various cancers. However, increasing reports of HSRs caused by this drug have limited the use of OXA (9). OXA-induced HSRs can lead to the discontinuation of chemotherapy and reduce the number of available therapeutic options (17). The incidence of OXA-induced HSRs in this study was 32.37%. In this study, 15 patients experienced grade 3 or 4 OXA-induced HSRs. Identifying the risk factors of OXA-induced HSRs is crucial. This study identified the risk factors to help identify patients at risk of OXA-related HSRs. In this study, male gender, the eosinophil count, and serum albumin levels were identified as risk factors associated with the incidence of OXA-related hypersensitivity.
Palapinyo et al. reported that male gender, prior exposure to platinum-based chemotherapy, and an increased eosinophil count were associated with a higher risk of OXA-related hypersensitivity. Conversely, an increased monocyte count and elevated serum albumin levels were identified as factors protecting against the development of OXA-induced HSRs (9). Okayama et al. reported that male gender and an elevated eosinophil count were risk factors for OXA-related HSRs (18), which aligns with our findings. Conversely, Parel et al., Seki et al., and Kim et al. reported that females were at a higher risk of OXA-related HSRs; however, this was likely due to hormonal effects (19-21). Multiple studies have reported no relationship between gender and the occurrence of HSRs (22,23). Kim et al. suggested that younger patients and female patients may be more susceptible to OXA-induced HSRs (19). Eosinophils are immunological cells that play a role in drug HSRs, particularly drug eruptions. Patients with elevated eosinophil counts had a greater chance of developing OXA-induced HSRs (9,24).
Serum albumin is often used as an indicator of nutritional status (25). Malnutrition compromises the immune system (26). Low serum albumin levels lead to increased vascular permeability and greater interstitial volume, which contributes to the development of HSRs (27). This mechanism explains the findings of our study. However, Nishihara et al. proposed that high serum albumin levels may be a potential risk factor for OXA-associated HSRs (28).
Finally, we found that the treatment regimen and dosage of OXA were not linked to an increased risk of OXA-related HSRs.
Our study revealed common clinical symptoms associated with OXA-induced HSRs. The majority of these symptoms were cutaneous reactions. Severe reactions (8% of HSR cases) included anaphylaxis. This finding aligns with those of previous studies (4,6).
In this study, 222 patients (57.96%) were administered 10 mg of dexamethasone 30 min before OXA to prevent HSRs. However, the logistic regression did not show a significant difference in the incidence of HSRs between the patients who received dexamethasone prophylactically and those who did not. Siu et al. showed that the prophylactic use of dexamethasone could not completely prevent OXA-induced HSRs (29). Shen et al. found that premedication with dexamethasone and antihistamines may reduce the risk of low-grade HSRs (7). Yamauchi et al. reported that the incidence of HSRs was significantly higher in patients who received less than 12 mg of dexamethasone prophylactically compared to those who received more than 12 mg (22). The dose of dexamethasone in this study was 10 mg, which may not be sufficient to prevent allergic effects. Therefore, further studies need to be conducted to evaluate the effectiveness of dexamethasone in preventing OXA-induced HSRs.
Melato et al. examined the effects of omega-3-enriched fish oil supplementation on the hypersensitivity induced by PTX or OXA in mice (15) and found that fish oil supplementation, either before or during chemotherapy, could be an important aid in the prevention and treatment of chemotherapy-induced peripheral neuropathy, improving the quality of life of patients’ post-cancer treatment (15). Micheli et al. proposed that unripe carob pods exert a protective effect against pain resulting from OXA-induced hypersensitivity (30). Antunes et al. indicate that T-type channels differentially contribute to the regulation of OXA hypersensitivity, and speculate that T-type channel blockers could promote OXA hypersensitivity (31).
Strengths and limitations
This retrospective study aimed to identify the risk factors of OXA-induced HSRs among Chinese CRC patients, using data from the CHPS in a real-world setting. The study had some limitations, including its retrospective design and incomplete clinical data. Additionally, because this was a retrospective study, we were unable to analyze the mechanisms underlying OXA-induced HSRs, as it was not possible to assess the cytokine levels of the patients.
Suggestions
Carefully designed prospective studies should be conducted to more accurately identify the risk factors of OXA-induced HSRs.
Conclusions
OXA-related hypersensitivity is a notable potential adverse reaction. The incidence rate of OXA-induced HRSs in this study was approximately 33%. This rate is consistent with the incidence rates reported by other studies. This study identified male gender, the eosinophil count, and serum albumin levels as risk factors for OXA-related hypersensitivity. This study found no significant difference in the incidence of HSRs between the patients who received dexamethasone as a preventive measure and those who did not. This issue requires further investigation. Additionally, more research needs to be conducted to explore strategies for reducing HSRs, and improving patient safety and treatment effectiveness. The research findings empower clinicians to perform a more precise pre-treatment risk assessment of patients. For individuals exhibiting high-risk characteristics, clinical protocols can be proactively enhanced by formulating stringent monitoring plans. During the course of treatment, intensifying the real-time surveillance of vital signs and allergic manifestations enables the early detection and timely intervention of HSRs, thereby mitigating the likelihood of severe adverse events.Notably, although this study demonstrated that dexamethasone failed to significantly reduce the incidence of HRSs, this outcome does not undermine the importance of prophylactic medications. Instead, it serves as an impetus for clinical exploration into more efficacious preventive strategies. This includes re-evaluating existing prophylaxis regimens, conducting comparative studies on alternative or combination preventive medications, and driving the development of novel preventive agents or improved administration methods. In the long run, these research results play a pivotal role in advancing clinical practice. They foster interdisciplinary collaboration and communication, encouraging the joint efforts of clinicians, pharmacists, researchers, and other professionals in the research, prevention, and management of OXA-related HSRs. Such collaborative endeavors are instrumental in elucidating the underlying mechanisms of HSRs, facilitating the development of more effective preventive and therapeutic approaches, and ultimately enhancing the quality and safety of clinical care for patients undergoing OXA treatment.
Acknowledgments
None.
Footnote
Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://jgo.amegroups.com/article/view/10.21037/jgo-2025-312/rc
Data Sharing Statement: Available at https://jgo.amegroups.com/article/view/10.21037/jgo-2025-312/dss
Peer Review File: Available at https://jgo.amegroups.com/article/view/10.21037/jgo-2025-312/prf
Funding: This study received funding from
Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jgo.amegroups.com/article/view/10.21037/jgo-2025-312/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 reviewed and approved by the Ethics Committee of The Sixth Affiliated Hospital, Sun Yat-sen University (No. 2023ZSLYEC-297). Individual consent for this retrospective analysis was waived.
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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