TY - JOUR
T1 - The AGITG GAP Study
T2 - A Phase II Study of Perioperative Gemcitabine and Nab-Paclitaxel for Resectable Pancreas Cancer
AU - the Australasian Gastro-Intestinal Trials Group (AGITG) GAP investigators
AU - Barbour, Andrew P.
AU - Samra, Jaswinder S.
AU - Haghighi, Koroush S.
AU - Donoghoe, Mark W.
AU - Burge, Matthew
AU - Harris, Marion T.
AU - Chua, Yu Jo
AU - Mitchell, Jenna
AU - O’Rourke, Nick
AU - Chan, Howard
AU - Gebski, Val J.
AU - Gananadha, Sivakumar
AU - Croagh, Daniel G.
AU - Kench, James G.
AU - Goldstein, David
AU - Barbour, A.
AU - Goldstein, D.
AU - Samra, J. S.
AU - Harris, M.
AU - Chua, Y. J.
AU - O’Rourke, N.
AU - Yip, S.
AU - Simes, J.
AU - Hicks, R.
AU - Coates, A.
AU - Gurney, H.
AU - Do, V.
AU - Marschner, I.
AU - Mitchell, J.
AU - Donoghoe, M.
AU - Goldstone, S.
AU - Yip, S.
AU - Chua, Y. J.
AU - Pavlakis, N.
AU - Goldstein, D.
AU - Aghmesheh, M.
AU - Joubert, W.
AU - Grimes, D.
AU - Harris, M.
AU - Samra, J. S.
AU - Haghighi, K. S.
AU - Burge, M.
AU - Bagia, S.
AU - Jaber, M.
AU - Gananadha, S.
AU - O’Rourke, N.
AU - Bryant, R.
AU - Nathanson, L.
AU - Cavallucci, D.
AU - Barbour, A.
N1 - Funding Information:
Specialized Therapeutics Australia provided funding support and supplied nab‐paclitaxel; gemcitabine was available on the Pharmaceutical Benefits Scheme (PBS). This study was partly funded by the GAP-T NHMRC Project Grant (APP1026563). Trial management and statistical support was undertaken by the NHMRC-CTC. The AGITG was the legal sponsor and the trial was registered with the Australian and New Zealand Clinical Trial Registry (ACTRN12611000848909). The GAP study was conducted under the auspices of the AGITG, the legal sponsor, independently of the funders. The funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. GAP Investigators
Publisher Copyright:
© 2020, Society of Surgical Oncology.
PY - 2020/7/1
Y1 - 2020/7/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85078794905&partnerID=8YFLogxK
U2 - 10.1245/s10434-020-08205-2
DO - 10.1245/s10434-020-08205-2
M3 - Article
C2 - 31997125
AN - SCOPUS:85078794905
SN - 1068-9265
VL - 27
SP - 2506
EP - 2515
JO - Annals of Surgical Oncology
JF - Annals of Surgical Oncology
IS - 7
ER -