Abstract | IMPORTANCE: Patients with locally advanced pancreatic cancer have historically poor outcomes. Evaluation of a total neoadjuvant approach is warranted. OBJECTIVE: DESIGN, SETTING, AND PARTICIPANTS: A single-arm phase 2 clinical trial was conducted at a large academic hospital from August 22, 2013, to May 22, 2018, among 49 patients with previously untreated locally advanced unresectable pancreatic cancer as determined by multidisciplinary review. Patients had Eastern Cooperative Oncology Group performance status 0 or 1 and adequate hematologic, renal, and hepatic function. Median follow-up for the analysis was 17.1 months (range, 5.0-53.7) among 27 patients still alive at study completion. INTERVENTIONS: MAIN OUTCOMES AND MEASURES: R0 resection rate. RESULTS: Of the 49 patients (26 women and 23 men; median age 63 years [range, 42-78 years]), 39 completed 8 cycles of FOLFIRINOX and losartan; 10 patients had fewer than 8 cycles due to progression (5 patients), losartan intolerance (3 patients), and toxicity (2 patients). Seven patients (16%) had short-course chemoradiotherapy while 38 (84%) had long-course chemoradiotherapy. Forty-two (86%) patients underwent attempted surgery, with R0 resection achieved in 34 of 49 patients (69%; 95% CI, 55%-82%). Overall median progression-free survival was 17.5 months (95% CI: 13.9-22.7) and median overall survival was 31.4 months (95% CI, 18.1-38.5). Among patients who underwent resection, median progression-free survival was 21.3 months (95% CI, 16.6-28.2), and median overall survival was 33.0 months (95% CI, 31.4 to not reached). CONCLUSIONS AND RELEVANCE: TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01821729.
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Authors | Janet E Murphy, Jennifer Y Wo, David P Ryan, Jeffrey W Clark, Wenqing Jiang, Beow Y Yeap, Lorraine C Drapek, Leilana Ly, Christian V Baglini, Lawrence S Blaszkowsky, Cristina R Ferrone, Aparna R Parikh, Colin D Weekes, Ryan D Nipp, Eunice L Kwak, Jill N Allen, Ryan B Corcoran, David T Ting, Jason E Faris, Andrew X Zhu, Lipika Goyal, David L Berger, Motaz Qadan, Keith D Lillemoe, Nilesh Talele, Rakesh K Jain, Thomas F DeLaney, Dan G Duda, Yves Boucher, Carlos Fernández-Del Castillo, Theodore S Hong |
Journal | JAMA oncology
(JAMA Oncol)
Vol. 5
Issue 7
Pg. 1020-1027
(Jul 01 2019)
ISSN: 2374-2445 [Electronic] United States |
PMID | 31145418
(Publication Type: Clinical Trial, Phase II, Journal Article)
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Chemical References |
- folfirinox
- Oxaliplatin
- Irinotecan
- Losartan
- Leucovorin
- Fluorouracil
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Topics |
- Adult
- Aged
- Antineoplastic Combined Chemotherapy Protocols
(administration & dosage, adverse effects)
- Chemoradiotherapy
(adverse effects)
- Female
- Fluorouracil
(administration & dosage, adverse effects)
- Humans
- Irinotecan
(administration & dosage, adverse effects)
- Leucovorin
(administration & dosage, adverse effects)
- Losartan
(administration & dosage, adverse effects)
- Male
- Middle Aged
- Neoadjuvant Therapy
(adverse effects)
- Oxaliplatin
(administration & dosage, adverse effects)
- Pancreatic Neoplasms
(pathology, therapy)
- Treatment Outcome
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