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• W2604381385 abstract "e15213 Background: Autophagy is important for sustained growth of pancreatic cancer (PDAC) human cell lines and xenograft models. Inhibition of autophagy with drugs such as chloroquine results in tumor growth retardation and increased survival in preclinical models. Hydroxychloroquine (HCQ), an antimalarial drug that inhibits autophagy, has acceptable toxicity at maximal doses in cancer patients (pts). We performed a phase 1/2 study of HCQ in combination with gemcitabine/nab-paclitaxel in patients with metastatic PDAC and here we report the initial phase 1 results. Methods: We enrolled 24 pts with untreated stage IV PDAC - 17M/7F, median age 65 – at three sites (Penn, JHU, TGEN). Two dose levels of HCQ were investigated: 400mg (7 pts) and 600mg (17 pts) BID. Results: The most common adverse events (AEs) were fatigue, nausea, anorexia, and neuropathy. Grade 4 toxicities, including elevated glucose, AST/ALT, and Tbili (1 each), sepsis (2), nausea (1), neutropenia (1), pneumothorax (1), bowel obstruction (1), and limb ischemia (1), were not thought to be related to the addition of HCQ, and therefore not dose-limiting. One pt died of respiratory failure unrelated to treatment. One pt (1st cohort) and 9 pts (2ndcohort) withdrew from the study prior to completion of 2 cycles due to AEs (3), clinical progression (3), pt decision (3), and poor compliance (1) and were included only in the AE assessment. Of 14 evaluable pts by RECIST v1.1, 50% had partial response, 36% had stable disease, and 14% had progressive disease. The median number of cycles was 7.5 (2-17) and median PFS 6.4 months (1.2–15.5 months). TP53 mutation status was obtained on tumor biopsies. We completed Western blot analysis of LC3B-II, a protein that is increased in autophagosome vesicles, showing an increase in LC3B-II expression in PMNs after the start of therapy, suggesting inhibition of autophagy. Conclusions: Full doses of gemcitabine/nab-paclitaxel are well tolerated in combination with HCQ 600mg BID and there is pharmacodynamic evidence of autophagy inhibition with this combination. Enrollment in the randomized phase 2 study with HCQ 600mg BID is proceeding. Clinical trial information: NCT01506973." @default.
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• W2604381385 date "2015-05-20" @default.
• W2604381385 modified "2023-09-26" @default.
• W2604381385 title "Phase 1 trial of gemcitabine/nab-paclitaxel in combination with the autophagy inhibitor hydroxychloroquine in previously untreated patients with metastatic pancreatic adenocarcinoma." @default.
• W2604381385 doi "https://doi.org/10.1200/jco.2015.33.15_suppl.e15213" @default.
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