LARC: neoadjuvant mFOLFOX6 found safe in multicenter study

  • Ichikawa N & al.
  • Surg Today
  • 5 Mar 2019

  • curated by David Reilly
  • Univadis Clinical Summaries
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Takeaway

  • Rectal resection after neoadjuvant chemotherapy (NACT) with modified FOLFOX (leucovorin, 5-fluorouracil, and oxaliplatin; mFOLFOX6) can be performed safely in patients with locally advanced rectal cancer (LARC), and is associated with an acceptable incidence of postoperative complications.

Why this matters

  • FOLFOX in combination with a fluorinated pyrimidine has demonstrated efficacy as postoperative adjuvant therapy for colon cancer.

Study design

  • Multicenter prospective R-NAC-01 study to investigate the safety of rectal surgery after 4 courses of 2-week mFOLFOX6 in 41 patients (36 men, 5 women) with locally advanced rectal cancer.
  • Mean patient age, 60.8 years.
  • BMI, 23.1 kg/m2.
  • Prescribed surgical procedure was total mesorectal resection; D3 surgery involved high ligation of the inferior mesenteric artery and lateral lymph node dissection. 
  • Funding: None disclosed.

Key results

  • In 38 patients who completed therapy per protocol, 10.5% experienced grade ≥3 postoperative complications including anastomotic leakage (7.1%).
  • No patients achieved pathological complete response; 41.5% achieved clinical downstaging; N grade was downstaged in 53.7% of patients.
  • 7.3% of patients experienced grade 2 NACT-related adverse events; 1 patient experienced grade 3 nausea, 1 experienced grade 4 infusion port infection.

Limitations

  • Limited sample size.