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A single-arm, nonrandomized phase II trial of neoadjuvant gemcitabine and oxaliplatin in patients with resectable pancreas adenocarcinoma.

Publication ,  Journal Article
OʼReilly, EM; Perelshteyn, A; Jarnagin, WR; Schattner, M; Gerdes, H; Capanu, M; Tang, LH; LaValle, J; Winston, C; DeMatteo, RP; DʼAngelica, M ...
Published in: Ann Surg
July 2014

BACKGROUND: The role for neoadjuvant systemic therapy in resectable pancreas adenocarcinoma remains undefined. OBJECTIVE: We evaluated the efficacy of gemcitabine and oxaliplatin administered as preoperative therapy in patients with resectable pancreas adenocarcinoma. METHODS: Eligible patients were screened using computed tomography-pancreas angiography, laparoscopy, endoscopic ultrasonography, and fine-needle aspiration cytology to identify 38 patients who received 4 cycles of neoadjuvant gemcitabine 1000 mg/m intravenously over 100 minutes and oxaliplatin 80 mg/m intravenously over 2 hours, every 2 weeks. Patients whose tumors remained resectable at restaging proceeded to operation and subsequently received 5 cycles of adjuvant gemcitabine (1000 mg/m intravenously over 30 minutes days 1, 8, and 15 every 4 weeks). The primary endpoint was 18-month overall survival and secondary endpoints included radiological, tumor marker and pathological response to neoadjuvant therapy, time to recurrence, patterns of failure, and feasibility of obtaining preoperative core biopsies. RESULTS: Thirty-five of 38 patients (92%) completed neoadjuvant therapy. Twenty-seven patients underwent tumor resection (resectability rate 71%), of which 26 initiated adjuvant therapy for a total of 23 patients (60.5%) who completed all planned therapy. The 18-month survival was 63% (24 patients alive). The median overall survival for all 38 patients was 27.2 months (95% confidence interval: 17-NA) and the median disease-specific survival was 30.6 months (95% confidence interval: 19-NA). CONCLUSIONS: This study met its endpoint and provided a signal suggesting that exploration of neoadjuvant systemic therapy is worthy of further investigation in resectable pancreas adenocarcinoma. Improved patient selection and more active systemic regimens are key. Clinical trials identification: NCT00536874.

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Published In

Ann Surg

DOI

EISSN

1528-1140

Publication Date

July 2014

Volume

260

Issue

1

Start / End Page

142 / 148

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Tomography, X-Ray Computed
  • Surgery
  • Ribonucleotide Reductases
  • Retrospective Studies
  • Pancreatic Neoplasms
  • Pancreatectomy
  • Oxaliplatin
  • Organoplatinum Compounds
  • Neoadjuvant Therapy
 

Citation

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OʼReilly, E. M., Perelshteyn, A., Jarnagin, W. R., Schattner, M., Gerdes, H., Capanu, M., … Allen, P. J. (2014). A single-arm, nonrandomized phase II trial of neoadjuvant gemcitabine and oxaliplatin in patients with resectable pancreas adenocarcinoma. Ann Surg, 260(1), 142–148. https://doi.org/10.1097/SLA.0000000000000251
OʼReilly, Eileen M., Anna Perelshteyn, William R. Jarnagin, Mark Schattner, Hans Gerdes, Marinela Capanu, Laura H. Tang, et al. “A single-arm, nonrandomized phase II trial of neoadjuvant gemcitabine and oxaliplatin in patients with resectable pancreas adenocarcinoma.Ann Surg 260, no. 1 (July 2014): 142–48. https://doi.org/10.1097/SLA.0000000000000251.
OʼReilly EM, Perelshteyn A, Jarnagin WR, Schattner M, Gerdes H, Capanu M, et al. A single-arm, nonrandomized phase II trial of neoadjuvant gemcitabine and oxaliplatin in patients with resectable pancreas adenocarcinoma. Ann Surg. 2014 Jul;260(1):142–8.
OʼReilly, Eileen M., et al. “A single-arm, nonrandomized phase II trial of neoadjuvant gemcitabine and oxaliplatin in patients with resectable pancreas adenocarcinoma.Ann Surg, vol. 260, no. 1, July 2014, pp. 142–48. Pubmed, doi:10.1097/SLA.0000000000000251.
OʼReilly EM, Perelshteyn A, Jarnagin WR, Schattner M, Gerdes H, Capanu M, Tang LH, LaValle J, Winston C, DeMatteo RP, DʼAngelica M, Kurtz RC, Abou-Alfa GK, Klimstra DS, Lowery MA, Brennan MF, Coit DG, Reidy DL, Kingham TP, Allen PJ. A single-arm, nonrandomized phase II trial of neoadjuvant gemcitabine and oxaliplatin in patients with resectable pancreas adenocarcinoma. Ann Surg. 2014 Jul;260(1):142–148.

Published In

Ann Surg

DOI

EISSN

1528-1140

Publication Date

July 2014

Volume

260

Issue

1

Start / End Page

142 / 148

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Tomography, X-Ray Computed
  • Surgery
  • Ribonucleotide Reductases
  • Retrospective Studies
  • Pancreatic Neoplasms
  • Pancreatectomy
  • Oxaliplatin
  • Organoplatinum Compounds
  • Neoadjuvant Therapy