TY - JOUR
T1 - Neoadjuvant chemotherapy without routine use of radiation therapy for patients with locally advanced rectal cancer
T2 - A pilot trial
AU - Schrag, Deborah
AU - Weiser, Martin R.
AU - Goodman, Karyn A.
AU - Gonën, Mithat
AU - Hollywood, Ellen
AU - Cercek, Andrea
AU - Reidy-Lagunes, Diane L.
AU - Gollub, Marc J.
AU - Shia, Jinru
AU - Guillem, Jose G.
AU - Temple, Larissa K.F.
AU - Paty, Philip B.
AU - Saltz, Leonard B.
PY - 2014/2/20
Y1 - 2014/2/20
N2 - Purpose: 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. Patients and Methods: 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 x 6 was recommended, but adjuvant regimens were left to clinician discretion. The primary outcome was R0 resection rate. Results: 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%). Conclusion: 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.
AB - Purpose: 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. Patients and Methods: 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 x 6 was recommended, but adjuvant regimens were left to clinician discretion. The primary outcome was R0 resection rate. Results: 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%). Conclusion: 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.
UR - https://www.scopus.com/pages/publications/84898684426
UR - https://www.scopus.com/inward/citedby.url?scp=84898684426&partnerID=8YFLogxK
U2 - 10.1200/JCO.2013.51.7904
DO - 10.1200/JCO.2013.51.7904
M3 - Article
C2 - 24419115
AN - SCOPUS:84898684426
SN - 0732-183X
VL - 32
SP - 513
EP - 518
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 6
ER -
