Efficacy and safety of National Centralized Drug Procurement-procured versus non-National Centralized Drug Procurement oxaliplatin in unresectable or metastatic pancreatic cancer: a retrospective cohort study

Introduction

Pancreatic cancer remains one of the leading causes of cancer-related mortality worldwide and is often termed the “king of cancers” due to its aggressive nature and dismal prognosis (1). Surgical resection offers the only potential for cure; however, approximately 80% of patients present with locally advanced or metastatic disease at diagnosis, precluding curative intervention. Even among those who undergo successful resection and receive standard adjuvant therapy, postoperative recurrence rates remain high (2).

Chemotherapy constitutes the cornerstone of systemic treatment for pancreatic cancer. First-line standard regimens include FOLFIRINOX (oxaliplatin, irinotecan, and fluorouracil), NALIRIFOX (oxaliplatin, liposomal irinotecan, and fluorouracil), and the AG regimen (gemcitabine plus nab-paclitaxel) (3). Despite their established efficacy, these combination chemotherapies are associated with substantial toxicity, leading to treatment discontinuation in a considerable proportion of patients. Thus, ensuring both the efficacy and safety of essential chemotherapeutic agents has become a critical priority in contemporary clinical oncology.

To reduce drug costs and enhance medication accessibility, many countries have implemented National Centralized Drug Procurement (NCDP) policies. Brazil, Saudi Arabia, and India have each established distinct models, aiming to secure cost-effective essential medicines while controlling healthcare expenditures (4-6). China launched its NCDP policy in 2018 (7). Procured drugs include both originator products and generic formulations that have passed rigorous consistency evaluations. Although these generics have demonstrated pharmaceutical quality and bioequivalence, their therapeutic equivalence in real-world clinical practice may vary (8). Anecdotal reports of suboptimal efficacy or increased toxicity following NCDP drug use have raised concerns among patients, pharmacists, and physicians, sometimes attributed to perceived inferior drug quality (9). In response, national authorities have called for strengthened clinical monitoring and comprehensive evaluation of NCDP drugs to verify their real-world equivalence to reference products (10). Such real-world comparative evaluations are increasingly recognized as a cornerstone of precision medicine, leveraging clinical big data and multidisciplinary collaboration to inform evidence-based formulary decisions (11). In parallel, retrospective cohort studies comparing different formulations of the same active ingredient, such as amphotericin B for invasive fungal disease, have demonstrated that efficacy, safety, and economic profiles can vary across formulations, underscoring the value of systematic post-marketing comparisons (12).

Oxaliplatin, a cornerstone agent in pancreatic cancer chemotherapy, is associated with significant toxicities including gastrointestinal reactions, myelosuppression, peripheral neurotoxicity, and hypersensitivity reactions, which can compromise treatment completion and patient outcomes (13,14). With the nationwide implementation of the NCDP policy, NCDP-procured oxaliplatin has become the primary choice in Chinese medical institutions (15). However, this widespread adoption has generated critical questions regarding its real-world therapeutic equivalence to more expensive non-NCDP originator or branded alternatives. Such concerns, if unaddressed, may influence physician prescribing behavior and patient adherence, potentially undermining the policy’s intended benefits.

Therefore, a rigorous real-world evaluation of clinical outcomes associated with NCDP-procured anticancer drugs is urgently needed to provide evidence-based reassurance and guide clinical practice. The present retrospective cohort study was conducted to systematically compare the efficacy and safety of NCDP-procured versus non-NCDP oxaliplatin in patients with advanced pancreatic cancer, while also quantifying the direct economic impact of the procurement policy. By moving beyond pharmaceutical equivalence to investigate therapeutic equivalence in real-world settings, this study aims to determine whether cost savings from the NCDP policy translate into maintained patient care. To our knowledge, this represents the first systematic assessment of real-world clinical equivalence for a nationally procured anticancer agent. The findings are expected to provide critical evidence supporting the safe and effective translation of this national policy into routine oncology practice. We present this article in accordance with the STROBE reporting checklist (available at https://tcr.amegroups.com/article/view/10.21037/tcr-2026-0486/rc).

Methods

Study design

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 First Affiliated Hospital, Zhejiang University School of Medicine ([2025B] IIT Ethics approval No. 0582), and individual consent for this retrospective analysis was waived. This retrospective cohort study enrolled adult patients with unresectable or metastatic pancreatic cancer treated with the mFOLFIRINOX regimen at The First Affiliated Hospital, Zhejiang University School of Medicine between May 2022 and March 2025. Patients were stratified into an NCDP group or a non-NCDP group based on the procurement status of the oxaliplatin used. Baseline demographic, clinical, laboratory, and imaging data were extracted from electronic medical records. Detailed definitions and data sources for all collected variables are provided in Table S1. Follow-up continued until June 30, 2025, with the observational endpoint defined as the first occurrence of death or loss to follow-up.

Inclusion and exclusion criteria

Inclusion criteria were: (I) age ≥18 years; (II) histologically or cytologically confirmed unresectable or metastatic pancreatic cancer [American Joint Committee on Cancer (AJCC) 8th edition]; (III) treatment with standard first-line mFOLFIRINOX (oxaliplatin 85 mg/m² IV over 2 hours, irinotecan 150 mg/m² IV over 30–90 minutes, leucovorin 400 mg/m² IV over 2 hours on day 1; fluorouracil 2,400 mg/m² continuous IV infusion over 46 hours; repeated every 2 weeks); and (IV) at least one measurable lesion at baseline per RECIST version 1.1.

Exclusion criteria were: (I) crossover between different oxaliplatin procurement sources during treatment; (II) prior adjuvant chemotherapy with disease recurrence or metastasis within 12 months of completion; (III) pregnancy or lactation at treatment initiation; (IV) known human immunodeficiency virus (HIV) infection; (V) diagnosis of any other active malignancy within 2 years prior to first mFOLFIRINOX cycle, except for completely resected carcinoma in situ, adequately treated basal cell or squamous cell skin carcinoma, other malignancies with ≥2 years disease-free status, or concurrent stable malignancies not requiring active therapy.

Outcome measures

Primary efficacy endpoints were objective response rate (ORR) and progression-free survival (PFS). ORR was defined as the proportion of patients achieving complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. PFS was defined as time from mFOLFIRINOX initiation to first radiographically documented disease progression or death from any cause, whichever occurred first. Patients without events by the follow-up cutoff (June 30, 2025) were censored at the date of last radiographic assessment.

For safety analysis, adverse drug reactions (ADRs) were evaluated and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. All ADRs were documented until 30 days after the final treatment dose.

Statistical analysis

Continuous variables were assessed for normality and homogeneity of variance. Normally distributed variables were compared using analysis of variance (ANOVA) and presented as mean ± standard deviation (SD); otherwise, the Kruskal-Wallis H test was employed, with data presented as median (interquartile range). Categorical variables were compared using Fisher’s exact test. Key variables had less than 5% missing data; complete-case analysis was performed without imputation.

For survival analysis, Kaplan-Meier curves were constructed to estimate median PFS with 95% confidence intervals (CIs), and between-group differences were assessed using the log-rank test. Cox proportional hazards regression was used to calculate hazard ratio (HR) and 95% CI. To minimize information bias, radiologists and attending physicians assessing treatment response and adverse events were blinded to patients’ group assignment. Multivariable Cox or logistic regression models were employed to adjust for baseline imbalances were indicated. To reduce confounding from baseline differences, we used propensity score matching (PSM). Propensity scores were calculated using logistic regression based on 12 clinically relevant variables: age, sex, body mass index (BMI), Eastern Cooperative Oncology Group performance status (ECOG PS), tumor stage, prior surgery, prior systemic therapy, treatment line, liver disease, hypertension, smoking, and alcohol drinking. Patients in the NCDP group were matched 1:1 to non-NCDP patients using nearest-neighbor matching without replacement, with a caliper of 0.2 SD of the logit of the propensity score. In the matched cohort, continuous variables were compared using paired t-test or Wilcoxon signed-rank test, and categorical variables using McNemar’s or McNemar-Bowker test as appropriate. PFS was analyzed using a stratified Cox model with matched pairs as strata, reporting HRs with 95% CIs. All statistical analyses were performed using R software version 4.3.1, with two-sided P<0.05 considered statistically significant.

Results

Patient characteristics

Among 2,272 screened patients treated with oxaliplatin, 168 patients with advanced pancreatic cancer met the eligibility criteria and were enrolled, comprising 77 in the NCDP group and 91 in the non-NCDP group. To minimize selection bias, all consecutive patients meeting eligibility criteria during the study period were included. Main reasons for exclusion were: non-pancreatic primary tumor (n=1,704); perioperative adjuvant or neoadjuvant chemotherapy (n=97); deviation from standard mFOLFIRINOX protocol (n=211); absence of locally advanced or metastatic disease (n=9); other active malignancies (n=14); HIV infection (n=1); crossover between NCDP and non-NCDP oxaliplatin (n=37); and lack of evaluable efficacy or safety data (n=31). Baseline clinical characteristics are detailed in Table 1, and the patient selection flowchart is presented in Figure 1. No missing data were present for categorical variables; missingness for continuous variables was below 5% and unlikely to bias results.

Figure 1 The flow chart of this study. HIV, human immunodeficiency virus; NCDP, national centralized drug procurement.

The NCDP and non-NCDP groups were generally well-balanced at baseline, although the NCDP group had significantly lower proportions of patients with smoking history (1.3% vs. 12.1%, P=0.007), alcohol consumption history (2.6% vs. 18.7%, P=0.001), and hypertension (26.0% vs. 45.1%, P=0.02) (Table 1). After PSM, 63 well-balanced pairs were obtained, and baseline characteristics were well-balanced between groups (all P>0.10) (Table 1).

Efficacy outcomes

Median follow-up for the entire cohort was 6.2 months (95% CI: 5.6–7.2). No CRs were observed in either group. The ORR was 13.2% (12 PR) in the non-NCDP group and 9.1% (7 PR) in the NCDP group (P=0.47). Disease control rate (DCR) was 63.7% (58 patients with PR or SD) in the non-NCDP group and 57.1% (44 patients with PR or SD) in the NCDP group (P=0.43) (Table 2). After multivariate adjustment for imbalanced baseline factors (smoking history, alcohol consumption, and hypertension), efficacy differences remained non-significant (Figure 2).

Figure 2 Results of multivariate-adjusted analysis of efficacy and adverse drug reactions between the two groups. *, P<0.05. ADR, adverse drug reaction; ALT, alanine aminotransferase; AST, aspartate aminotransferase; CI, confidence interval; DCR, disease control rate; NCDP, national centralized drug procurement; OR, odds ratio; ORR, objective response rate; TBIL, total bilirubin.

Median PFS was 6.0 months in the non-NCDP group and 6.5 months in the NCDP group (unadjusted HR =1.178, 95% CI: 0.803–1.728; P=0.40). After adjustment for baseline confounders, the HR was 1.034 (95% CI: 0.691–1.547; P=0.87), indicating no significant between-group difference in PFS (Figure 3A). PSM analysis (63 matched pairs) confirmed these findings, showing no significant differences in ORR (9.5% vs. 12.7%, P=0.79), DCR (58.7% vs. 58.7%, P>0.99) (Table 2), or median PFS (6.0 vs. 6.4 months; HR =1.000, 95% CI: 0.546–1.831, P>0.99) (Figure 3B). These findings demonstrate comparable therapeutic efficacy between NCDP-procured and non-NCDP oxaliplatin in advanced pancreatic cancer.

Figure 3 Kaplan-Meier analysis of PFS in the two groups before and after PSM. (A) Before PSM. (B) After PSM. CI, confidence interval; HR, hazard ratio; NCDP, national centralized drug procurement; PFS, progression-free survival; PSM, propensity score matching.

Safety outcomes

Safety profiles are summarized in Table 3. In the non-NCDP group, 90.1% (82/91) experienced ADRs of any grade, most commonly anemia (60.4%), hepatic injury (53.8%), and leukopenia (49.5%); grade ≥3 ADRs occurred in 29.7%, predominantly anemia (15.4%) and leukopenia (13.2%). In the NCDP group, 85.7% (66/77) experienced any-grade ADRs, most frequently anemia (57.1%), hepatic injury (36.4%), and leukopenia (36.4%); grade ≥3 ADRs occurred in 15.6%, mainly thrombocytopenia and hepatic injury (6.5% each).

Univariable analysis revealed significantly lower incidences in the NCDP group for all-grade hepatic injury (36.4% vs. 53.8%, P=0.03), elevated aspartate aminotransferase (AST) (28.6% vs. 45.1%, P=0.04), any grade ≥3 ADRs (15.6% vs. 29.7%, P=0.04), and grade ≥3 anemia (2.6% vs. 15.4%, P=0.007). Following multivariable adjustment, the risks of elevated AST [odds ratio (OR) =0.489, 95% CI: 0.248–0.962; P=0.04], any grade ≥3 ADRs (OR =0.447, 95% CI: 0.201–0.991, P=0.048), and severe anemia (OR =0.164, 95% CI: 0.034–0.775; P=0.02) remained significantly lower in the NCDP group (Figure 2). Importantly, the incidence of oxaliplatin-specific peripheral neuropathy did not differ significantly between groups (all-grade—OR =0.721, 95% CI: 0.361–1.439, P=0.35). No ADR-related deaths occurred. PSM analysis confirmed these safety findings, with the NCDP group showing significantly lower rates of all-grade elevated AST (OR =0.489, 95% CI: 0.248–0.962, P=0.04) and severe anemia (OR =0.164, 95% CI: 0.034–0.775, P=0.02) (Figure 2).

Economic analysis

The unit price of NCDP oxaliplatin was ¥ 76 per vial, representing 45% of the cost of non-NCDP oxaliplatin (¥ 170 per vial). This substantial price difference highlights a clear pharmacoeconomic advantage for the NCDP product, even without accounting for potential additional costs related to ADR management.

Discussion

This real-world retrospective study systematically compared the clinical efficacy and safety of NCDP-procured versus non-NCDP oxaliplatin in patients with advanced pancreatic cancer. Our findings demonstrate that NCDP-procured oxaliplatin offers comparable efficacy to non-NCDP alternatives, with no significant differences in ORR, DCR, and PFS. Notably, the NCDP group exhibited significantly lower incidences of specific ADRs, including hepatic injury, elevated transaminases, and severe anemia, suggesting a more favorable safety profile. The robustness of these findings was further supported by PSM analyses, which yielded consistent effect estimates for both efficacy and safety outcomes. Given the substantial cost advantage, these results provide robust evidence supporting the selection of cost-effective NCDP oxaliplatin in clinical practice. For clinicians and patients concerned about the efficacy of lower-cost generic alternatives, these findings offer reassuring evidence; for policymakers, they provide clinical data supporting the continued expansion of the NCDP program.

Regarding efficacy, the median PFS of 6.5 months in the NCDP group and 6.0 months in the non-NCDP group aligns closely with previously reported real-world outcomes. A multicenter Japanese randomized trial reported a median PFS of 5.8 months with mFOLFIRINOX, although with a higher ORR of 32.4% (16). This discrepancy in response rates likely reflects differences between trial and real-world populations, including patient selection, adherence, and assessment methods. Our PFS findings are consistent with other real-world studies reporting median PFS ranging from 5.3 to 6.0 months for first-line mFOLFIRINOX in pancreatic cancer (17-19). Thus, irrespective of procurement source, the PFS benefit observed in our cohort appears reliable and generalizable to routine clinical practice.

The safety advantages observed with NCDP-procured oxaliplatin warrant consideration. The significant lower incidence of elevated AST and severe anemia in the NCDP group compared to both the non-NCDP group and historical benchmarks (16,17) raises intriguing questions about potential underlying mechanisms. Crucially, the incidence of oxaliplatin-specific peripheral neuropathy, a toxicity directly attributed to the platinum agent itself, did not differ between the two formulations, suggesting bioequivalence of the active pharmaceutical ingredient. While bioequivalence studies ensure comparable pharmacokinetic parameters for the active ingredient, differences in excipients, impurities, or manufacturing processes between generic and originator formulations may influence toxicity profile. Notably, the NCDP product is an aqueous solution (water for injection as the vehicle), whereas the non-NCDP product is a lyophilized powder containing lactose. However, the proportion and absolute quantity of lactose in the non-NCDP formulation are not publicly available. Therefore, although the absence of lactose in the NCDP product could hypothetically contribute to the observed lower rates of hepatic injury and severe anemia, this remains speculative. Other factors, such as differences in impurity profiles or container leachables cannot be excluded. Our retrospective design precludes mechanistic conclusions, but these findings highlight the need for prospective investigations integrating drug quality metrics and pharmacokinetic-pharmacodynamic assessments.

The economic implications of our findings are substantial. The 55% price reduction for NCDP oxaliplatin translates into meaningful cost savings for healthcare systems and patients, particularly in resource-constrained settings. When coupled with comparable efficacy and potentially favorable safety for certain toxicities, the pharmacoeconomic case for NCDP adoption becomes compelling. These data support the translation of national procurement policy into clinical practice, demonstrating that cost containment need not compromise patient care quality.

This study has several limitations. First, its single-center retrospective design introduces potential selection bias and unmeasured confounding, despite our efforts to include consecutive patients and adjust for known confounders. Second, the relatively short median follow-up of 6.2 months limits assessment of long-term outcomes such as overall survival. Third, while we observed lower incidences of specific ADRs in the NCDP group, the retrospective design precludes definitive mechanistic explanation; we hypothesize that subtle differences in excipients or manufacturing processes may contribute, warranting further investigation in prospective pharmacokinetic-pharmacodynamic studies. Fourth, while the use of the multi-agent mFOLFIRINOX regimen precludes definitive isolation of oxaliplatin-specific effects, both groups received identical background chemotherapy (irinotecan, fluorouracil, and leucovorin), ensuring that any between-group differences are attributable to the oxaliplatin procurement source. Nevertheless, future studies employing oxaliplatin monotherapy or simpler regimens such as mFOLFOX6 could provide complementary evidence on formulation-specific toxicity profiles. Fifth, the modest sample size may limit statistical power for detecting small differences in efficacy outcomes. Future multicenter prospective studies with extended follow-up, comprehensive drug quality assessments, and larger sample sizes are needed to validate these findings and provide higher-level evidence for policy decisions.

Despite these limitations, this study represents the first systematic evaluation of real-world clinical equivalence for a nationally procured anticancer agent. The inclusion of consecutive patients, blinded outcome assessment, multivariable adjustment for confounders, and transparent reporting of variable definitions strengthen the validity of our conclusions.

Conclusions

NCDP-procured oxaliplatin demonstrates comparable efficacy to non-NCDP alternatives in patients with advanced pancreatic cancer, with a more favorable safety profile for specific hepatic and hematologic toxicities. Given its substantial cost advantage, this real-world evidence supports the clinical adoption of NCDP oxaliplatin and reinforces the value of the NCDP policy. These findings provide reassurance to clinicians and patients regarding the use of cost-effective generic anticancer therapies and offer policymakers robust clinical data supporting the continued expansion of the NCDP program.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://tcr.amegroups.com/article/view/10.21037/tcr-2026-0486/rc

Data Sharing Statement: Available at https://tcr.amegroups.com/article/view/10.21037/tcr-2026-0486/dss

Peer Review File: Available at https://tcr.amegroups.com/article/view/10.21037/tcr-2026-0486/prf

Funding: This research was supported by the Fund of Zhejiang Pharmaceutical Association (Nos. 2024ZYYJ03, 2025ZYJ07, and 2025ZGYY13). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tcr.amegroups.com/article/view/10.21037/tcr-2026-0486/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 the Ethics Committee of The First Affiliated Hospital, Zhejiang University School of Medicine ([2025B] IIT Ethics approval No. 0582), and 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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