Surgical Outcome Results From SWOG S1505
-
- Syed A. Ahmad
- University of Cincinnati, Cincinnati, Ohio
-
- Mai Duong
- SWOG Statistical and Data Management Center, Seattle, Washington
-
- Davendra P. S. Sohal
- University of Cincinnati, Cincinnati, Ohio
-
- Namita S. Gandhi
- Cleveland Clinic, Cleveland, Ohio
-
- Muhammad Shaalan Beg
- UT Southwestern Medical Center, Dallas, Texas
-
- Andrea Wang-Gillam
- Washington University Siteman Cancer Center, St. Louis, Missouri
-
- James L. Wade
- Heartland NCORP/Cancer Care Specialists of Illinois, Decatur, Illinois
-
- Elena Gabriela Chiorean
- University of Washington, Fred Hutchinson Cancer Research Center, Seattle, Washington
-
- Katherine A. Guthrie
- SWOG Statistical and Data Management Center, Seattle, Washington
-
- Andrew M. Lowy
- University of California, San Diego, La Jolla, California
-
- Philip A. Philip
- Wayne State University/Karmanos Cancer Institute, Detroit, Michigan
-
- Howard S. Hochster
- Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey.
Bibliographic Information
- Other Title
-
- A Randomized Clinical Trial of mFOLFIRINOX Versus Gemcitabine/Nab-paclitaxel for Perioperative Treatment of Resectable Pancreatic Ductal Adenocarcinoma
Description
<jats:sec> <jats:title>Objective:</jats:title> <jats:p>The optimal neoadjuvant therapy for resectable pancreatic ductal adenocarcinoma (PDA) and the impact on surgical outcomes remains unclear.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods:</jats:title> <jats:p>S1505 (NCT02562716) was a randomized phase II study of perioperative chemotherapy with mFOLFIRINOX (Arm 1) or gemcitabine/nab-paclitaxel (Arm 2). Measured parameters included resection rate, margin positivity, pathologic response, and toxicity.</jats:p> </jats:sec> <jats:sec> <jats:title>Results:</jats:title> <jats:p>Between 2015 and 2018, 147 patients were randomized. Of these, 44 (30%) were deemed ineligible (43 by central review). Of the 103 eligible patients, 77 (76%) completed preoperative therapy and underwent surgery; reasons patients did not undergo surgery included toxicity related to preoperative therapy (n = 9), progression (n = 9), or other (n = 7). Of the 77, 73 (95%) underwent successful resection; 21 (29%) required vascular reconstruction, 62 (85%) had negative (R0) margins, and 24 (33%) had a complete or major pathologic response to therapy. The grade 3–5 postoperative complication rate was 16%. Of the 73 patients completing surgery, 57 (78%) started and 46 (63%) completed postoperative therapy. This study represents the first prospective trial evaluating modern systemic therapy delivered in a neoadjuvant/perioperative format for resectable PDA.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions:</jats:title> <jats:p>We have demonstrated: (1) Based on the high percentage of enrolled, but ineligible patients, it is clear that adherence to strict definitions of resectable PDA is challenging; (2) Patients can tolerate modern systemic therapy and undergo successful surgical resection without prohibitive perioperative complications; (3) Completion of adjuvant therapy in the perioperative format is difficult; (4) Major pathologic response rate of 33% is encouraging.</jats:p> </jats:sec>
Journal
-
- Annals of Surgery
-
Annals of Surgery 272 (3), 481-486, 2020-07-24
Ovid Technologies (Wolters Kluwer Health)
- Tweet
Details 詳細情報について
-
- CRID
- 1361137044376937216
-
- ISSN
- 15281140
- 00034932
-
- Data Source
-
- Crossref