A pilot phase II multicenter study of nab-paclitaxel (Nab-P) and gemcitabine (G) as preoperative therapy for potentially resectable pancreatic cancer (PC).

Authors

null

Shawn MacKenzie

Virginia G. Piper Cancer Center at Scottsdale Healthcare/TGen, Minneapolis, MN

Shawn MacKenzie , Herbert Zeh III, Laurence E. McCahill , Timothy D. Sielaff , Nathan Bahary , Thomas Edward Gribbin , John E. Seng , Joseph W. Leach , Jocelyn Harmon , Michael J. Demeure , Daniel D. Von Hoff , A Jim Moser , Ramesh K. Ramanathan

Organizations

Virginia G. Piper Cancer Center at Scottsdale Healthcare/TGen, Minneapolis, MN, University of Pittsburgh Medical Center, Pittsburgh, PA, The Lacks Cancer Center at Saint Mary's, Grand Rapids, MI, Lacks Cancer Center, Saint Mary's Health Care, Grand Rapids, MI, MOHPA, Minneapolis, MN, Park Nicollet Institute, St. Louis Park, MN, TD2, Scottsdale, AZ, Translational Genomic Research Institute, Phoenix, AZ, Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare/TGen, Scottsdale, AZ, Department of Surgery, Division of Surgical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA

Research Funding

Pharmaceutical/Biotech Company

Background: Nab-P plus G is a new option for advanced PC. This combination was evaluated as a preoperative regimen for potentially resectable PC. Methods: Patients (pts, n=25) with resectable PC (NCCN criteria) were treated with 3 cycles of Nab-P (125mg/m2) & G (1000mg/m2) on day 1, 8, and 15, followed by surgical resection. The chosen endpoint was Grade III/IV histological changes (Arch Surg.127:1335-39:1992) in > 30% of resected tumor specimens. Results: Accrual is complete with 25 pts (median age 65, 10 F:15 M), 14/25 completed 3 cycles of treatment. Early drug discontinuation or drug interruption prior to the completion of 3 cycles occurred in 11 pts due to azotemia, cholangitis, pneumonia, catheter infection and pt decision. One pt had a fatal (grade 5) non-neutropenic aspergillus pneumonia. There was one episode of neutropenic fever (4%), and 3 episodes of cholangitis (12%) due to biliary stent malfunction. Other adverse events (grade 3/4) include neutropenia 64%, anemia 20%, dehydration 12%, nausea 12% and thrombocytopenia 12%. Dose reductions due to AEs were required in 5 pts, (3-neutropenia, 2-rash). Surgical resection was successful in 20/25 pts: 12- Pancreaticoduodenectomy, 8- Distal Pancreatectomy, 19/20 pts underwent an R0 resection. Surgical resection was not done in 5/25 pts due to: pre-operatively identified metastatic disease (2), blood vessel involvement at surgery (1), pt declined (1) and a pre-operative death (1).Post-operative tumor staging identified a complete response (n=1); stage IA (n=1); stage IIA (n=6); and stage IIB (n=12). Radiological partial response (PR) was documented in 4 pts prior to surgery. CA19-9 levels decreased from baseline by > 50% in 60% (n=15) of pts and by > 90% in 16% (n=4). Post-operative > 90% histological tumor response (Grade 3/4) was seen in 6 of 20 (30%) resected specimens. Conclusions: Preoperative therapy with Nab-P plus G is feasible with evidence of activity by radiological (PR in 16%), CA19-9 (decrease > 50% in 60% of pts) and pathological down staging (Grade 3/4 in 30% in resected tumor specimens). A larger study is warranted. Supported by Abraxis/Celgene Pharmaceuticals and the TGen foundation. Clinical trial information: NCT01298011.

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Abstract Details

Meeting

2013 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gastrointestinal (Noncolorectal) Cancer

Track

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Sub Track

Pancreatic Cancer

Clinical Trial Registration Number

NCT01298011

Citation

J Clin Oncol 31, 2013 (suppl; abstr 4038)

DOI

10.1200/jco.2013.31.15_suppl.4038

Abstract #

4038

Poster Bd #

15H

Abstract Disclosures