Safety and biologic response of pre-operative autophagy inhibition in combination with gemcitabine in patients with pancreatic adenocarcinoma
Open accessAbstract
Purpose Autophagy is a cell survival mechanism that plays a critical role in pancreatic carcinogenesis. Murine studies have previously demonstrated that treatment with the late-autophagy inhibitor chloroquine in combination with chemotherapy limited tumor growth.Methods In this phase 1/2 trial, we examined treatment with hydroxychloroquine (HCQ) and gemcitabine for patients with pancreatic adenocarcinoma. The primary endpoints were safety and tolerability, evaluated by Storer's dose escalation design. Secondary endpoints were CA 19-9 biomarker response, R0 resection rates, survival, and correlative studies of autophagy.Results Thirty-five patients were enrolled. There were no dose-limiting toxicities and no grade 4/5 events related to treatment. Nineteen patients (61 %) had a decrease in CA 19-9 after treatment. Twenty-nine patients (94 %) underwent surgical resection as scheduled, with a 77 % R0 resection rate. Median overall survival was 34.8 months (95 % confidence interval, 11.57 to not reached). Patients who had more than a 51 % increase in the autophagy marker LC3-II in circulating peripheral blood mononuclear cells had improvement in disease-free survival (15.03 vs. 6.9 months, p < 0.05) and overall survival (34.83 vs. 10.83 months, p < 0.05). No outcome differences were demonstrated in the 81 % of patients with abnormal p53 expression assessed by immunohistochemistry in the resected specimens.Conclusions Preoperative autophagy inhibition with HCQ plus gemcitabine is safe and well tolerated. Surrogate biomarker responses (CA 19-9) and surgical oncologic outcomes were encouraging. p53 status was not associated with adverse outcomes.
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Mitophagy is important in PDAC tumorigenesis in mice and organoid models.
“Mitophagy, the selective engulfment and degradation of mitochondria through autophagy, has also been shown to be important in PDAC tumorigenesis in mice and organoid models211”
From Pancreatic cancer: Advances and challenges (2023) · cites this paper as [211]
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- Authors
- Boone, B. A., Bahary, N., Zureikat, A. H., Moser, A. J., Normolle, D. P., Wu, W.-C., Singhi, A. D., Bao, P., Bartlett, D. L., Liotta, L. A., Espina, V., Loughran, P., Lotze, M. T., & Zeh, H. J.
- Affiliations
- University of Pittsburgh (US)
- Beth Israel Deaconess Medical Center (US)
- George Mason University (US)
- Corresponding author
- Lotze, Michael T.
- Zeh, Herbert J.
- ORCID
- Venue
- Annals of Surgical Oncology
- Published
- 2015-04-24
- Volume
- 22
- Issue
- 13
- Pages
- 4402-4410
- ISSN
- 1068-9265 (ISSN-L)
- 1534-4681
- PMC
- PMC4663459
- OpenAlex
- W2018872699
- Cited by
- 234
- References
- 52
- Citations by year
- 2026: 9 · 2025: 13 · 2024: 24 · 2023: 21 · 2022: 23 · 2021: 37 · 2020: 32 · 2019: 20 · 2018: 27 · 2017: 18 · 2016: 8 · 2015: 2
- FWCI
- 8.01
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Licence
- www.springer.com/tdm (tdm)
- Locations
- Annals of Surgical Oncology (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Cancer Institute (L30 CA170992, R01CA181450, P30CA047904, T32CA113263)
- Topics
- Health Sciences › Medicine › Oncology › Pancreatic and Hepatic Oncology Research
- Health Sciences › Medicine › Epidemiology › Autophagy in Disease and Therapy
- Health Sciences › Medicine › Surgery › Pancreatitis Pathology and Treatment
- Keywords
- pancreatic ductal adenocarcinoma, autophagy inhibition, hydroxychloroquine, gemcitabine, neoadjuvant therapy, CA19-9, LC3-II, p53, R0 resection, overall survival, safety and tolerability, biomarker response
- MeSH terms
- Gemcitabine, Adenocarcinoma, Adult, Aged, Aged, 80 and over, Antimetabolites, Antineoplastic, Autophagy, Deoxycytidine, Drug Therapy, Combination, Female, Follow-Up Studies, Humans, Hydroxychloroquine, Immunoenzyme Techniques, Male, Middle Aged, Neoplasm Staging, Pancreatic Neoplasms, Prognosis, Prospective Studies, Safety, Biomarkers, Survival Rate, CA-19-9 Antigen, Antirheumatic Agents
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