Safety and Efficacy Analysis of PD-1 Inhibitors in Combination with Gemcitabine Plus Nab-Paclitaxel for Advanced Pancreatic Cancer: A Real-World, Single-Center Study

Abstract

Background

Pancreatic cancer is a deadly disease with a low five years survival rate, and chemotherapy remains the standard treatment for advanced cases. However, the efficacy of chemotherapy alone is limited, and there is a need for new treatment options. Recently, immune checkpoint inhibitors (ICIs), particularly programmed death-1 (PD-1) inhibitors, have shown promising results in various cancers, including pancreatic cancer. In this study, we explore the safety and efficacy of PD-1 inhibitors in combination with chemotherapy for advanced pancreatic cancer.

Materials and Methods

A retrospective analysis was conducted on clinical data from 27 patients with advanced pancreatic cancer who were administered a combination of anti-PD-1 antibody and gemcitabine plus nab-paclitaxel (GnP) regimen. The study evaluated the safety of the treatment as well as the objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS).

Results

In this study, treatment with a combination of anti-PD-1 antibody and GnP regimen for pancreatic cancer resulted in partial response (PR) for 10 out of 27 (37.04%) patients, stable disease (SD) for 10 (37.04%) patients, and progressive disease (PD) for 7 (25.92%) patients. The study found that the median OS (mOS) for these patients was 16.4 months [standard error (SE) = 1.117, 95% confidence interval (CI) 14.211–18.589], while the median PFS (mPFS) was 6.4 months (SE = 1.217, 95% CI 3.981–8.752). Subgroup analysis revealed that pancreatic cancer patients’ Eastern Cooperative Oncology Group (ECOG) performance status (PS) (0 vs 1) and treatment cycles (≤6 cycles vs >6 cycles) significantly affected OS and PFS. Patients experienced mostly grade 1–2 adverse events (AEs), which were relieved through clinical treatment.

Conclusion

The combination of GnP with anti-PD-1 antibodies shows promise as a potential treatment option for advanced pancreatic cancer.

Keywords:

• pancreatic cancer
• immune checkpoint inhibitors
• PD-1
• gemcitabine
• nab-paclitaxel
• chemotherapy

Abbreviations

ICIs immune checkpoint inhibitors, PD-1 programmed death-1, GnP gemcitabine plus nab-paclitaxel, ORR objective response rate, DCR disease control rate, PFS progression-free survival, OS overall survival, PR partial response, SD stable disease, PD progressive disease, ECOG Eastern Cooperative Oncology Group, PS performance status, PDAC Pancreatic ductal adenocarcinoma, NCCN National Cancer Comprehensive Network, IO immune-oncology, mAbs monoclonal antibodies, FDA Food and Drug Administration, RECIST Response Evaluation Criteria in Solid Tumors.

Data Sharing Statement

The data that support the findings of this study are available from corresponding author but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are however available from the authors upon reasonable request and with permission of corresponding author.

Ethics Approval and Consent to Participate

This study conforms to the principles outlined in the Declaration of Helsinki (World Medical Association Declaration of Helsinki), all the cases used in this study were approved by the Academic Committee of Shulan (Hangzhou) Hospital (KY2023010). Written informed consent was obtained from the study participants prior to the study commencement.

Acknowledgments

All authors express our gratitude to all the doctors in the Department of Hepatobiliary and Pancreatic Surgery, Department of Oncology, and Department of Radiology at Shulan (Hangzhou) Hospital, Zhejiang Shuren University, for their support.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

The authors declare that they have no competing interests in this work.

Additional information

Funding

There is no funding to report.