Neoadjuvant chemotherapy without routine use of radiation therapy for patients with locally advanced rectal cancer: a pilot trial Journal Article


Authors: Schrag, D.; Weiser, M. R.; Goodman, K. A.; Gonen, M.; Hollywood, E.; Cercek, A.; Reidy-Lagunes, D. L. ; Gollub, M. J.; Shia, J.; Guillem, J. G.; Temple, L. K.; Paty, P. B.; Saltz, L. B.
Article Title: Neoadjuvant chemotherapy without routine use of radiation therapy for patients with locally advanced rectal cancer: a pilot trial
Abstract: Although neoadjuvant chemoradiotherapy achieves low local recurrence rates in clinical stages II to III rectal cancer, it delays administration of optimal chemotherapy. We evaluated preoperative infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX)/bevacizumab with selective rather than consistent use of chemoradiotherapy. Thirty-two patients with clinical stages II to III rectal cancer participated in this single-center phase II trial. All were candidates for low anterior resection with total mesorectal excision (TME). Patients were to receive six cycles of FOLFOX, with bevacizumab included for cycles 1 to 4. Patients with stable/progressive disease were to have radiation before TME, whereas responders were to have immediate TME. Postoperative radiation was planned if R0 resection was not achieved. Postoperative FOLFOX × 6 was recommended, but adjuvant regimens were left to clinician discretion. The primary outcome was R0 resection rate. Between April 2007 and December 2008, 32 (100%) of 32 study participants had R0 resections. Two did not complete preoperative chemotherapy secondary to cardiovascular toxicity. Both had preoperative chemoradiotherapy and then R0 resections. Of 30 patients completing preoperative chemotherapy, all had tumor regression and TME without preoperative chemoradiotherapy. The pathologic complete response rate to chemotherapy alone was 8 of 32 (25%; 95% CI, 11% to 43%). The 4-year local recurrence rate was 0% (95% CI, 0% to 11%); the 4-year disease-free survival was 84% (95% CI, 67% to 94%). For selected patients with clinical stages II to III rectal cancer, neoadjuvant chemotherapy and selective radiation does not seem to compromise outcomes. Preoperative Radiation or Selective Preoperative Radiation and Evaluation Before Chemotherapy and TME (PROSPECT), a randomized phase III trial to validate this experience, is now open in the US cooperative group network.
Keywords: adult; treatment outcome; aged; disease-free survival; middle aged; survival rate; bevacizumab; fluorouracil; adjuvant therapy; disease free survival; chemotherapy, adjuvant; neoadjuvant therapy; radiotherapy, adjuvant; cancer staging; antineoplastic agent; neoplasm staging; adenocarcinoma; phase 2 clinical trial; antineoplastic combined chemotherapy protocols; pathology; monoclonal antibody; pilot study; pilot projects; folinic acid; adjuvant chemotherapy; platinum complex; rectal neoplasms; rectum tumor; organoplatinum compounds; leucovorin; antibodies, monoclonal, humanized; adjuvant chemoradiotherapy; chemoradiotherapy, adjuvant; humans; human; male; female; article
Journal Title: Journal of Clinical Oncology
Volume: 32
Issue: 6
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2014-02-20
Start Page: 513
End Page: 518
Language: English
DOI: 10.1200/jco.2013.51.7904
PUBMED: 24419115
PROVIDER: scopus
PMCID: PMC5795691
DOI/URL:
Notes: Export Date: 1 May 2014 -- Source: Scopus
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MSK Authors
  1. Leonard B Saltz
    555 Saltz
  2. Philip B Paty
    359 Paty
  3. Marc J Gollub
    103 Gollub
  4. Karyn A Goodman
    240 Goodman
  5. Mithat Gonen
    687 Gonen
  6. Jose Guillem
    361 Guillem
  7. Deborah Schrag
    126 Schrag
  8. Jinru Shia
    445 Shia
  9. Martin R Weiser
    330 Weiser
  10. Larissa Temple
    177 Temple