Neoadjuvant therapy of high-risk gastric cancer: A phase II trial of preoperative FAMTX and postoperative intraperitoneal fluorouracil-cisplatin plus intravenous fluorouracil Journal Article


Authors: Kelsen, D.; Karpeh, M.; Schwartz, G.; Gerdes, H.; Lightdale, C.; Botet, J.; Lauers, G.; Klimstra, D.; Huang, Y.; Saltz, L.; Quan, V.; Brennan, M.
Article Title: Neoadjuvant therapy of high-risk gastric cancer: A phase II trial of preoperative FAMTX and postoperative intraperitoneal fluorouracil-cisplatin plus intravenous fluorouracil
Abstract: Purpose and Methods: We identified patients with gastric cancer at high risk for recurrence before therapy using endoscopic ultrasonography (EUS). Neoadjuvant therapy using the fluorouracil, doxorubicin, and metrotrexate (FAMTX) regimen was given for three courses before planned laparotomy with the intention to perform curative resection. Postoperatively, intraperitoneal (IP) cisplatin and fluorouracil (FU) and intravenous (IV) FU were administered to patients undergoing resection. Results: Fifty-six assessable patients were treated. Preoperative FAMTX therapy was tolerable, with the major toxicity being neutropenic fever. One treatment-related death was seen. Eighty-nine percent of patients underwent surgical exploration and 61% had potentially curative resections. There were two postoperative deaths. Comparison of pathologic tumor (pT) stage with EUS-predicted tumor stage showed apparent downstaging in 51% of patients. Postoperative IP chemotherapy was delivered to 75% of eligible patients. Toxicity was acceptable. There was no increase in operative morbidity or mortality compared with concurrent nonstudy patients undergoing a similar operative procedure and not receiving preoperative therapy. With a median follow-up time of 29 months, the median survival duration was 15.3 months. For patients who underwent potentially curative resections, the median survival duration was 31 months. Peritoneal failure was seen in 16% of patients. Conclusion: Chemotherapy with the FAMTX regimen is tolerable in patients with locally advanced gastric cancer, without an increase in operative morbidity or mortality. IP therapy can be successfully delivered to most resected patients. The intraabdominal failure pattern appears to be decreased compared with expected. This approach is an appropriate investigational arm to pursue in future studies.
Keywords: adult; cancer survival; human tissue; aged; middle aged; survival rate; human cell; major clinical study; clinical trial; histopathology; neutropenia; cisplatin; doxorubicin; fluorouracil; cancer risk; combined modality therapy; methotrexate; recurrence risk; adenocarcinoma; nephrotoxicity; phase 2 clinical trial; neoplasm recurrence, local; gastrointestinal symptom; mucosa inflammation; antineoplastic combined chemotherapy protocols; risk factors; fever; drug fatality; stomach cancer; infusions, intravenous; stomach neoplasms; infusions, parenteral; intravenous drug administration; intraperitoneal drug administration; humans; human; male; female; priority journal; article
Journal Title: Journal of Clinical Oncology
Volume: 14
Issue: 6
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 1996-06-01
Start Page: 1818
End Page: 1828
Language: English
PUBMED: 8656250
PROVIDER: scopus
DOI: 10.1200/JCO.1996.14.6.1818
DOI/URL:
Notes: Article -- Export Date: 22 November 2017 -- Source: Scopus
Altmetric Score
MSK Authors
  1. Murray F Brennan
    759 Brennan
  2. Hans Gerdes
    126 Gerdes
  3. Leonard B Saltz
    580 Saltz
  4. Gary Schwartz
    358 Schwartz
  5. Ying Huang
    21 Huang
  6. Martin S Karpeh
    93 Karpeh
  7. David S Klimstra
    843 Klimstra
  8. David P Kelsen
    332 Kelsen
  9. Valerie L Quan
    3 Quan