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29.01.2020 | Pancreatic Tumors

The AGITG GAP Study: A Phase II Study of Perioperative Gemcitabine and Nab-Paclitaxel for Resectable Pancreas Cancer

verfasst von: Andrew P. Barbour, MBBS PhD FRACS FACS, Jaswinder S. Samra, D Phil (Oxon) FRACS, Koroush S. Haghighi, MBBS FRACS FACS, Mark W. Donoghoe, PhD, Matthew Burge, MB ChB FRCP, Marion T. Harris, MBBS FRACP, Yu Jo Chua, MBBS FRACP, Jenna Mitchell, MPH, Nick O’Rourke, MBBS FRACS, Howard Chan, MBBS MMed (ClinEpi), Val J. Gebski, MStat, Sivakumar Gananadha, FRACS FACS, Daniel G. Croagh, MBBS PhD FRACS, James G. Kench, MBBS FRCPA, David Goldstein, MBBS FRACP, the Australasian Gastro-Intestinal Trials Group (AGITG) GAP investigators

Erschienen in: Annals of Surgical Oncology | Ausgabe 7/2020

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Abstract

Background

While combination therapy with nab-paclitaxel/gemcitabine (nab-gem) is effective in pancreatic ductal adenocarcinoma (PDAC), its efficacy as perioperative chemotherapy is unknown. The primary objective of this multicenter, prospective, single-arm, phase II study was to determine whether neoadjuvant therapy with nab-gem was associated with higher complete resection rates (R0) in resectable PDAC, while the secondary objectives were to determine the utility of radiological assessment of response to preoperative chemotherapy and the safety and efficacy of nab-gem as perioperative therapy.

Methods

Patients were recruited from eight Australian sites, and 42 patients with radiologically defined resectable PDAC and an Eastern Cooperative Oncology Group performance status of 0–2 were enrolled. Participants received two cycles of preoperative nab-paclitaxel 125 mg/m² and gemcitabine 1000 mg/m² on days 1, 8, and 15 (28-day cycle) presurgery, and four cycles postoperatively. Early response to chemotherapy was measured with fluorodeoxyglucose-positron emission tomography/computed tomography (FDG-PET/CT) scans on day 15.

Results

Preoperative nab-gem was completed by 93% of participants, but only 63% postoperatively. Thirty-six patients had surgery: 6 (17%) were unresectable, 15 (52%) had R0 (≥ 1 mm) resections, 14 (48%) had R1 (< 1 mm) resections, and 1 patient did not have PDAC. Median progression-free survival was 12.3 months and median overall survival (OS) was 23.5 months: R0 patients had an OS of 35 months versus 25.6 months for R1 patients after surgery. Seven patients had not progressed after 43 months.

Conclusions

The GAP trial demonstrated that perioperative nab-gem was tolerable. Although the primary endpoint of an 85% R0 rate was not met, the R0 rate was similar to trials using a > 1 mm R0 resection definition, and survival rates were comparable with recent adjuvant studies.

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Titel: The AGITG GAP Study: A Phase II Study of Perioperative Gemcitabine and Nab-Paclitaxel for Resectable Pancreas Cancer
verfasst von: Andrew P. Barbour, MBBS PhD FRACS FACS
Jaswinder S. Samra, D Phil (Oxon) FRACS
Koroush S. Haghighi, MBBS FRACS FACS
Mark W. Donoghoe, PhD
Matthew Burge, MB ChB FRCP
Marion T. Harris, MBBS FRACP
Yu Jo Chua, MBBS FRACP
Jenna Mitchell, MPH
Nick O’Rourke, MBBS FRACS
Howard Chan, MBBS MMed (ClinEpi)
Val J. Gebski, MStat
Sivakumar Gananadha, FRACS FACS
Daniel G. Croagh, MBBS PhD FRACS
James G. Kench, MBBS FRCPA
David Goldstein, MBBS FRACP
the Australasian Gastro-Intestinal Trials Group (AGITG) GAP investigators
Publikationsdatum: 29.01.2020
Verlag: Springer International Publishing
Erschienen in: Annals of Surgical Oncology / Ausgabe 7/2020
Print ISSN: 1068-9265
Elektronische ISSN: 1534-4681
DOI: https://doi.org/10.1245/s10434-020-08205-2

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