Treatment of locally advanced pancreatic cancer using localized trans-arterial micro perfusion of gemcitabine: combined analysis of RR1 and RR2.
Autor: | Hatoum H; Department of Internal Medicine Hematology-Oncology Section, University of Oklahoma College of Medicine, Oklahoma City, OK, United States., Rosemurgy A 2nd; Florida Hospital, Tampa, Tampa, FL, United States., Bastidas JA; National Surgical Associates, Los Gatos, CA, United States., Zervos E; Division of Surgical Oncology, Brody School of Medicine, East Carolina University, Greenville, NC, United States., Muscarella P 2nd; Montefiore Medical Center, Bronx, NY, United States.; Niagara Falls Memorial Medical Center, Niagara Falls, NY, United States., Edil BH; Department of Surgery, University of Oklahoma College of Medicine, Oklahoma City, OK, United States., Cynamon J; Montefiore Medical Center, Bronx, NY, United States., Johnson DT; University of Colorado Hospital, Aurora, CO, United States.; Sarah Cannon, Nashville, TN, United States., Thomas C; East Carolina University Health, Greenville, NC, United States., Swinson BM; East Carolina University Health, Greenville, NC, United States., Nordgren A; Fawcett Memorial Hospital, Port Charlotte, FL, United States., Vitulli P; Florida Hospital, Tampa, Tampa, FL, United States.; Duval Vascular Center, Jacksonville, FL, United States., Nutting C; Endovascular Consultants of Colorado, Lone Tree, CO, United States., Gipson M; RIA Endovascular, Greenwood Village, CO, United States., Tsobanoudis A; RenovoRx, Inc., Los Altos, CA, United States., Agah R; RenovoRx, Inc., Los Altos, CA, United States. |
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Jazyk: | angličtina |
Zdroj: | The oncologist [Oncologist] 2024 Aug 05; Vol. 29 (8), pp. 690-698. |
DOI: | 10.1093/oncolo/oyae178 |
Abstrakt: | Background: Locally advanced pancreatic cancer (LAPC) comprises 40% of pancreatic cancer diagnoses and has a relatively poor prognosis. Trans-arterial micro perfusion (TAMP)-mediated chemotherapy delivery to the primary tumor is a novel approach worthy of investigation. The RR1 (dose escalation) and RR2 (observational) studies examined the safety and preliminary efficacy of TAMP-delivered gemcitabine for LAPC. Patients and Methods: RR1 and RR2 data were pooled. Both studies enrolled patients with LAPC with histologically confirmed adenocarcinoma. Participant data, including age, sex, race, stage, previous treatments, toxicity, disease progression, and death, were collected. Median number of cycles and average treatment dosage were calculated. Overall survival (OS) was determined for the whole group and separately for patients who received and did not receive previous treatments. Aims of the analysis were to assess procedure safety, OS, and evaluate factors associated with OS. Results: The median age of the 43 patients enrolled in RR1 and RR2 was 72 years (range, 51-88 years). Median OS for the 35 eligible patients with stage III disease was 12.6 months (95% CI, 2.1-54.2 months). Previous chemoradiation was associated with significantly longer OS [27.1 months (95% CI, 8.4-40.6 months)] compared to previous systemic chemotherapy [14.6 months (95% CI, 6.4-54.2 months)] or no prior treatment [7.0 months (95% CI, 2.1-35.4 months)] (P < .001). The most common adverse events were GI related (abdominal pain, emesis, and vomiting); the most common grade 3 toxicity was sepsis. Conclusion: Study results indicate that TAMP-mediated gemcitabine delivery in patients with LAPC is potentially safe, feasible, and provides potential clinical benefits. Clinical Trial Registration: NCT02237157 (RR1) and NCT02591082 (RR2). (© The Author(s) 2024. Published by Oxford University Press.) |
Databáze: | MEDLINE |
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