(HealthDay News) — Six weeks of neoadjuvant chemotherapy (NAC) with oxaliplatin and fluoropyrimidine is safe and effective for operable colon cancer, according to phase 3 results published in the Journal of Clinical Oncology.
The phase 3 FOxTROT trial (ClinicalTrials.gov Identifier: NCT00647530) enrolled patients with radiologically staged T3-4, N0-2, M0 colon cancer. The patients were randomly assigned to receive NAC (n=699) or go straight to surgery (n=354).
Patients in the NAC group received 6 weeks of oxaliplatin plus fluoropyrimidine preoperatively and 18 weeks postoperatively. Patients in the control group received oxaliplatin plus fluoropyrimidine for 24 weeks postoperatively. Patients with RAS wild-type tumors could be randomly assigned to receive panitumumab or not during NAC.
Ultimately, 674 patients started NAC, 606 patients completed NAC, and 686 went on to surgery. In the control group, 351 patients underwent surgery. There were fewer serious perioperative complications in the NAC group than in the control group.
The researchers observed “substantial” reductions in T stage, N stage, and extramural venous invasion in the NAC group compared with the control group. More patients in the NAC group than in the control group had histopathologically complete resections — 94% and 89%, respectively (P <.001).
Residual or recurrent disease within 2 years occurred less often in the NAC group than in the control group — 16.9% and 21.5%, respectively (rate ratio [RR], 0.72; 95% CI, 0.54-0.98, P =.037). There were nonsignificant reductions in colon cancer-specific mortality (RR, 0.74; 95% CI, 0.52-1.05, P =.095) and all-cause mortality (RR, 0.76; 95% CI, 0.55-1.06, P =.104) in the NAC group.
There was no additional benefit observed with panitumumab in the patients with RAS wild-type tumors and little benefit from NAC seen in mismatch repair-deficient tumors.
“Six weeks of NAC should be considered as a treatment option for locally advanced colon cancer,” the study authors wrote.
Several authors disclosed financial ties to the pharmaceutical industry.