A multicenter, phase II trial of preoperative gemcitabine and nab-paclitaxel for resectable pancreas cancer: The AGITG GAP study.

Authors

null

Andrew Barbour

University of Queensland, Brisbane, Australia

Andrew Barbour , Nicholas O'Rourke , Jaswinder S. Samra , Koroush S Haghighi , James Kench , Jenna Mitchell , Nick Pavlakis , Matthew E. Burge , Jonathan Fawcett , Sivikumar Gananadha , Marion Harris , Morteza Aghmesheh , Yu Jo Chua , Warren Lance Joubert , Matthew MK Chan , Manju Dashini Chandrasegaram , Sonia Yip , John Simes , Val Gebski , David Goldstein

Organizations

University of Queensland, Brisbane, Australia, Royal Brisbane and Women's Hospital, Herston, Australia, Royal North Shore Hospital, University of Sydney, Sydney, Australia, University of South Wales, Prince of Wales Hospital, Randwick, Sydney, Australia, Department of Tissue Pathology and Diagnostic Oncology, Royal Prince Alfred Hospital, Sydney, Australia, NHMRC Clinical Trials Centre, Sydney, Australia, Department of Medical Oncology, Royal North Shore Hospital, The University of Sydney, Sydney, Australia, Queensland Liver Transplant Service, Brisbane, Australia, ANU Medical School, The Canberra Hospital, Garran, Australia, Monash Medical Centre, Melbourne, Australia, Illawarra Cancer Care Centre, Wollongong, Australia, Canberra Hospital, Garran, Australia, Princess Alexandra Hospital, Brisbane, Australia, Prince of Wales Hospital, Sydney, Australia

Research Funding

Other

Background: Pancreatic cancer (PC) outcomes remain poor, recent series show approximately 37% of patients achieve R0 resection (all margins ≥ 1mm) for resectable disease. Recent data in metastatic disease shows that nab-paclitaxel (nab-PC) and gemcitabine (GEM) chemotherapy (CX) is an active regimen. We aimed to determine the feasibility and R0 resection rate with peri-operative nab-PC and GEM for resectable PC. Methods: A multicentre, single arm, phase 2 trial. Patients with operable PC received 2 cycles of neo-adjuvant GEM 1000mg/m2 and nab-PC 125mg/m2CX on days 1, 8 and 15 of a 28 day cycle followed by surgical resection and then 4 cycles of post-operative CX. The primary endpoint was R0 resection with the aim to assess if a rate of 85% could be achieved. Secondary endpoints included feasibility, toxicity, pathological response (College of American Pathologists Cancer Reporting Protocol for Exocrine Pancreatic Cancer, 2009), recurrence and survival. Results: Forty-one patients were enrolled from 2012-14. Median age was 65 (range 43-79), 41% male, 49% stage I and 51% stage II. Twenty nine (71%) patients underwent resection with evaluable cancer: 1 did not have proven cancer on central pathology review; 5 did not go to surgery (2 disease progression, 2 refused surgery, 1 due to cholangitis); and in 6 patients surgery was abandoned (unresectable disease). No deaths were surgery-related. Median tumor size was 27.5mm (IQR = 25-35). Pre-operative GEM and nab-PC produced an R0 rate of 52% (15/29) (95% CI 34-69%). 15/29 (52%) of resected tumors showed grade 0-2 tumor regression grade. Twenty-nine patients (71%) experienced >1 grade 3/4 toxicities (total 52 events) during pre-operative CX, neutropenia (46%) being most frequent with 8% febrile neutropenia. 39/41 (95%) patients received 2 cycles of pre-operative CX. Conclusions: Peri-operative GEM and nab-PC CX is feasible and well tolerated. The pre-operative regimen was associated with an R0 resection rate comparable or higher than surgical series without pre-operative therapy, although the primary endpoint of 85% could not be met. The value of this regimen will also depend on longer term outcomes related to recurrence and survival. Clinical trial information: 12611000848909.

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Abstract Details

Meeting

2015 Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

General Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract

Track

Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract

Sub Track

Multidisciplinary Treatment

Clinical Trial Registration Number

12611000848909

Citation

J Clin Oncol 33, 2015 (suppl 3; abstr 387)

DOI

10.1200/jco.2015.33.3_suppl.387

Abstract #

387

Poster Bd #

D6

Abstract Disclosures