Borderline Pancreatic Inoperable Cancer, Elderly, Neoadjuvant Therapy, Pancreatic Cancer Resectable, Pancreatic Cancer Stage II
Conditions
Brief summary
The goal of this observational retrospective cohort study is to evaluate the efficacy and safety of neoadjuvant chemotherapy (NAT) in elderly patients with resectable or borderline resectable (BR) pancreatic ductal adenocarcinoma (PDAC). The study includes patients aged ≥70 years who have undergone NAT followed by surgery or upfront surgery. The main questions it aims to answer are: Does NAT improve overall survival (OS) and progression-free survival (PFS) in elderly patients compared to upfront surgery? What is the impact of NAT on R0 resection rates, conversion rates in BR tumors, and the need for vascular resection? How does the toxicity profile of different NAT regimens affect treatment outcomes and patient tolerability? Researchers will compare NAT followed by surgery vs. upfront surgery to determine differences in oncologic outcomes and postoperative complications. Participants will: Be retrospectively identified from hospital records. Be classified based on treatment received (NAT vs. upfront surgery). Undergo data collection on tumor characteristics, treatment regimens, surgical details, and survival outcomes. This study aims to refine patient selection criteria for NAT in elderly patients, guiding personalized treatment strategies to optimize survival and quality of life.
Interventions
DRUGNeoadjuvant Chemotherapy (NAT) Group
This cohort includes elderly patients (≥70 years) with resectable or borderline resectable (BR) pancreatic ductal adenocarcinoma (PDAC) who underwent neoadjuvant chemotherapy (NAT). The NAT regimens include 5-FluoroUracil, Irinotecan, Oxaliplatin (FOLFIRINOX), gemcitabine/nab-paclitaxel (GnP), and other standard chemotherapy protocols. The study aims to evaluate the impact of NAT on overall survival (OS), progression-free survival (PFS), R0 resection rates, and postoperative outcomes, as well as the toxicity profile of different NAT regimens.
Sponsors
Azienda Unita Sanitaria Locale di Piacenza
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
70 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged ≥ 70 years * Patients with resectable or BR PDAC who underwent curative treatment (NAT followed by surgery and upfront surgery) * Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) \> 2 * Patients able to provide informed consent, whenever possible
Exclusion criteria
* Patients not meeting the inclusion criteria. * Pancreatic cancer of pancreatic body and tail. * Patients with metastatic disease. * Patients with locally advanced or metastatic pancreatic cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to 2 years from treatment initiation | OS is defined as the time from the initiation of treatment (NAT or upfront surgery) to death from any cause. Patients still alive at the end of the study period will be censored at the last follow-up date. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | Up to 1 years from treatment initiation | PFS is defined as the time from the initiation of treatment to disease progression or death from any cause, whichever occurs first. Disease progression is assessed based on RECIST v1.1 criteria using imaging studies. |
| Resection Rate and R0 Resection Rate | At the time of surgery | The proportion of patients who successfully undergo surgical resection after NAT compared to upfront surgery. Resection margins will be classified as: R0 (complete resection, negative margins) R1 (microscopic residual disease) R2 (macroscopic residual disease) |
| Major Toxicities and NAT Dropout Rate | At the end of each cycle (each cycle is 28 days) | Toxicity will be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. The study will report grade 3-4 toxicities, dose reductions, treatment interruptions, and patient dropout rates due to adverse events. |
| Conversion Rate of NAT in Borderline Resectable (BR) PDAC | At the time of surgery | The proportion of patients initially classified as borderline resectable (BR) who are successfully converted to resectable status after NAT and undergo curative-intent surgery. |
| Vascular Resection Rate | At the time of surgery | Comparison of the frequency of vascular resections (e.g., portal vein or superior mesenteric vein resection) between the NAT and upfront surgery groups, assessing the impact of NAT on vascular involvement. |
Contacts
Primary ContactMario Giuffrida, MD
Outcome results
None listed