Phase 2 study of preoperative chemotherapy with nab-paclitaxel and gemcitabine followed by chemoradiation for borderline resectable or node-positive pancreatic ductal adenocarcinoma.

Autor: Chen EY; Division of Hematology and Medical Oncology, Oregon Health & Science University, Knight Cancer Institute, Portland, Oregon, USA., Kardosh A; Division of Hematology and Medical Oncology, Oregon Health & Science University, Knight Cancer Institute, Portland, Oregon, USA., Nabavizadeh N; Department of Radiation Medicine, Oregon Health & Science University, Portland, Oregon, USA., Foster B; Department of Diagnostic Radiology, Oregon Health & Science University, Portland, Oregon, USA., Mayo SC; Division of Surgical Oncology, Oregon Health & Science University, Knight Cancer Institute, Portland, Oregon, USA., Billingsley KG; Yale Cancer Center, New Haven, Connecticut, USA., Gilbert EW; Division of Gastrointestinal and General Surgery, Oregon Health & Science University, Portland, Oregon, USA., Lanciault C; Providence Cancer Institute, Portland, Oregon, USA., Grossberg A; Department of Radiation Medicine, Oregon Health & Science University, Portland, Oregon, USA., Bensch KG; Portland VA Medical Center, Portland, Oregon, USA., Maynard E; Portland VA Medical Center, Portland, Oregon, USA., Anderson EC; Division of Hematology and Medical Oncology, Oregon Health & Science University, Knight Cancer Institute, Portland, Oregon, USA., Sheppard BC; Division of Gastrointestinal and General Surgery, Oregon Health & Science University, Portland, Oregon, USA., Thomas CR Jr; Department of Radiation Medicine, Oregon Health & Science University, Portland, Oregon, USA.; Radiation Oncology, Geisel School of Medicine at Dartmouth and Dartmouth Cancer Center, New Hampshire, Lebanon, USA., Lopez CD; Division of Hematology and Medical Oncology, Oregon Health & Science University, Knight Cancer Institute, Portland, Oregon, USA., Vaccaro GM; Division of Hematology and Medical Oncology, Oregon Health & Science University, Knight Cancer Institute, Portland, Oregon, USA.; Providence Cancer Institute, Portland, Oregon, USA.
Jazyk: angličtina
Zdroj: Cancer medicine [Cancer Med] 2023 Jun; Vol. 12 (12), pp. 12986-12995. Date of Electronic Publication: 2023 May 03.
DOI: 10.1002/cam4.5971
Abstrakt: Background: Neoadjuvant treatment with nab-paclitaxel and gemcitabine for potentially operable pancreatic adenocarcinoma has not been well studied in a prospective interventional trial and could down-stage tumors to achieve negative surgical margins.
Methods: A single-arm, open-label phase 2 trial (NCT02427841) enrolled patients with pancreatic adenocarcinoma deemed to be borderline resectable or clinically node-positive from March 17, 2016 to October 5, 2019. Patients received preoperative gemcitabine 1000 mg/m 2 and nab-paclitaxel 125 mg/m 2 on Days 1, 8, 15, every 28 days for two cycles followed by chemoradiation with 50.4 Gy intensity-modulated radiation over 28 fractions with concurrent fluoropyrimidine chemotherapy. After definitive resection, patients received four additional cycles of gemcitabine and nab-paclitaxel. The primary endpoint was R0 resection rate. Other endpoints included treatment completion rate, resection rate, radiographic response rate, survival, and adverse events.
Results: Nineteen patients were enrolled, with the majority having head of pancreas primary tumors, both arterial and venous vasculature involvement, and clinically positive nodes on imaging. Among them, 11 (58%) underwent definitive resection and eight of 19 (42%) achieved R0 resection. Disease progression and functional decline were primary reasons for deferring surgical resection after neoadjuvant treatment. Pathologic near-complete response was observed in two of 11 (18%) resection specimens. Among the 19 patients, the 12-month progression-free survival was 58%, and 12-month overall survival was 79%. Common adverse events were alopecia, nausea, vomiting, fatigue, myalgia, peripheral neuropathy, rash, and neutropenia.
Conclusion: Gemcitabine and nab-paclitaxel followed by long-course chemoradiation represents a feasible neoadjuvant treatment strategy for borderline resectable or node-positive pancreatic cancer.
(© 2023 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)
Databáze: MEDLINE
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