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


Authors: O'Reilly, E. M.; Perelshteyn, A.; Jarnagin, W. R.; Schattner, M.; Gerdes, H.; Capanu, M.; Tang, L. H.; Lavalle, J.; Winston, C.; DeMatteo, R. P.; D'Angelica, M.; Kurtz, R. C.; Abou-Alfa, G. K.; Klimstra, D. S.; Lowery, M. A.; Brennan, M. F.; Coit, D. G.; Reidy, D. L.; Kingham, T. P.; Allen, P. J.
Article Title: A single-arm, nonrandomized phase II trial of neoadjuvant gemcitabine and oxaliplatin in patients with resectable pancreas adenocarcinoma
Abstract: 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.Copyright © 2014 by Lippincott Williams & Wilkins.
Keywords: adult; cancer survival; clinical article; human tissue; cancer surgery; young adult; overall survival; constipation; fatigue; neutropenia; splenectomy; cancer recurrence; ascites; drug efficacy; gastrointestinal hemorrhage; hypertension; gemcitabine; cancer adjuvant therapy; pancreas resection; laparoscopy; computer assisted tomography; infection; multiple cycle treatment; neutrophil count; phase 2 clinical trial; thrombocyte; anemia; gastrointestinal symptom; kidney disease; leukopenia; neuropathy; tumor biopsy; tumor marker; abdominal pain; fever; hyperglycemia; injection site reaction; rash; alanine aminotransferase; alkaline phosphatase; aspartate aminotransferase; hypoalbuminemia; prothrombin time; heart infarction; peripheral edema; anxiety disorder; nausea and vomiting; pancreas adenocarcinoma; hypoglycemia; hyperbilirubinemia; heart arrhythmia; oxaliplatin; blood clotting disorder; lethargy; heart atrium fibrillation; disease specific survival; allergic reaction; amylase; neoadjuvant; endoscopic echography; cerebrovascular accident; electrolyte disturbance; hemorrhoid; partial thromboplastin time; triacylglycerol lipase; abscess; aspiration cytology; erythema multiforme; international normalized ratio; sudden cardiac death; extravasation; fine needle aspiration cytology; thrombocyte anomaly; resectable; cholangitis; body weight disorder; human; male; female; priority journal; article; pancreas angiography; resectable pancreas adenocarcinoma
Journal Title: Annals of Surgery
Volume: 260
Issue: 1
ISSN: 0003-4932
Publisher: Lippincott Williams & Wilkins  
Date Published: 2014-07-01
Start Page: 142
End Page: 148
Language: English
DOI: 10.1097/sla.0000000000000251
PROVIDER: scopus
PUBMED: 24901360
PMCID: PMC4520299
DOI/URL:
Notes: Ann. Surg. -- Export Date: 8 July 2014 -- CODEN: ANSUA -- Source: Scopus
Altmetric Score
MSK Authors
  1. Murray F Brennan
    782 Brennan
  2. Hans Gerdes
    130 Gerdes
  3. Ronald P DeMatteo
    602 DeMatteo
  4. Ghassan Abou-Alfa
    229 Abou-Alfa
  5. Marinela Capanu
    211 Capanu
  6. Diane Lauren Reidy
    153 Reidy
  7. David S Klimstra
    852 Klimstra
  8. Maeve Aine Lowery
    98 Lowery
  9. Peter Allen
    442 Allen
  10. William R Jarnagin
    596 Jarnagin
  11. T Peter Kingham
    293 Kingham
  12. Laura Hong Tang
    328 Tang
  13. Corinne B Winston
    26 Winston
  14. Daniel Coit
    422 Coit
  15. Eileen O'Reilly
    324 O'Reilly
  16. Mark Schattner
    103 Schattner
  17. Robert C Kurtz
    134 Kurtz