Pancreatic Resection in Fit Octogenarians With Nonmetastatic Pancreatic Cancer

This study is a retrospective, population-based cohort analysis designed to evaluate treatment outcomes in patients with non-metastatic pancreatic cancer, with a particular focus on older individuals aged 80 years and above who have a good functional status.

Pancreatic cancer is one of the most serious forms of cancer, with generally poor survival outcomes. Surgical removal of the tumor represents the only potentially curative treatment option. However, the use of surgery in elderly patients remains controversial. In routine clinical practice, treatment decisions are often influenced by chronological age rather than a patient's actual physical condition. As a result, older patients are less likely to undergo surgical treatment, even when they may be fit enough to tolerate it.

In addition to surgery, chemotherapy administered after tumor removal is commonly recommended to improve long-term outcomes. Evidence from clinical trials suggests that this additional treatment can prolong survival. However, these trials typically include highly selected patients who have recovered well from surgery and meet strict eligibility criteria. In contrast, in everyday clinical practice, many patients-especially older ones-may not receive such treatment due to complications, slower recovery, or reduced tolerance.

This study aims to address these gaps by analyzing real-world data from the Clinical-Epidemiological Cancer Registry of Berlin and Brandenburg, Germany. The registry collects standardized information on cancer diagnosis, treatments, and outcomes across both hospital and outpatient settings. Data completeness is ensured through mandatory reporting requirements and validation processes.

The study includes patients diagnosed with pancreatic cancer between January 1, 2017, and December 31, 2023. Only patients with disease that has not spread to distant organs (stages I to III) are included. To ensure comparability and reduce the influence of frailty, the analysis is limited to patients with good general condition, defined as being fully active or only slightly restricted in physical activity. Patients aged 90 years and older are excluded due to small numbers and expected heterogeneity.

Two main research questions are addressed:

First, the study evaluates whether surgical removal of the tumor is associated with improved overall survival, particularly in patients aged 80 years and older. Patients are grouped according to whether they underwent surgery or not, and survival outcomes are compared between these groups. Analyses are adjusted for relevant patient and disease characteristics to reduce potential confounding.

Second, the study examines the association between postoperative chemotherapy and survival in patients who underwent complete tumor removal without prior treatment. This part of the analysis focuses on patients who had no remaining visible tumor after surgery and did not receive treatment before surgery.

A key methodological challenge in evaluating postoperative treatments is that only patients who recover sufficiently after surgery can receive additional therapy. This introduces a potential bias, as these patients may already have a better prognosis. To address this issue, the study applies two complementary analytical strategies.

In the first approach, survival is measured starting from the time of surgery, and patients are grouped based on whether they received postoperative treatment. In the second approach, a so-called landmark analysis is performed. In this analysis, patients who die within the first 90 days after surgery are excluded, and survival is measured starting from this fixed time point. This method helps to reduce bias related to early postoperative mortality and differences in recovery.

Statistical analyses include survival estimation using time-to-event methods and multivariable regression models to adjust for differences between patient groups. Key variables considered in the analysis include age, sex, tumor stage, and general health status.

The findings of this study are intended to provide clinically relevant evidence for treatment decision-making in older patients with pancreatic cancer. By focusing on real-world data and applying methods to address potential biases, the study aims to improve understanding of how surgery and postoperative treatment affect survival in this growing patient population.

Inclusion criteria

• Diagnosis of invasive pancreatic carcinoma
• UICC stage I-III
• No distant metastases (M0)
• ECOG performance status 0-1
• Diagnosis between Jan 1, 2017 and Dec 31, 2023
• Residence in Berlin or Brandenburg

Exclusion criteria

• Neuroendocrine tumors
• Sarcomas