Adding oxaliplatin to perioperative fluorouracil and radiotherapy was associated with a higher rate of pathologic complete response (pCR) in advanced rectal cancer patients, compared with single-agent fluorouracil plus radiotherapy, investigators report in the Journal of Clinical Oncology.
For the Neoadjuvant FOLFOX6 Chemotherapy With or Without Radiation in Rectal Cancer (FOWARC) study, 495 patients with locally advanced rectal cancer (LARC) who were undergoing total mesorectal excision were randomly assigned to one of three preoperative treatment arms: neoadjuvant therapy with fluorouracil plus radiotherapy (fluorouracil-radiotherapy group), fluorouracil chemotherapy with perioperative fluorouracil and oxaliplatin plus radiotherapy (mFOLFOX6-radiotherapy group), or fluorouracil chemotherapy with perioperative fluorouracil and oxaliplatin without radiotherapy (mFOLFOX6 group).The rates of pCR were 14.0%, 27.5%, and 6.6% for patients in the fluorouracil-radiotherapy, mFOLFOX6-radiotherapy, and mFOLFOX6 groups, respectively, Dr. Yanhong Deng of the Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou City, China, and her associates reported (J Clin Oncol. 2016. doi: 10.1200/JCO.2016.66.6198).
No patients died during neoadjuvant treatment. Grade 3 or 4 toxicities occurred in 55.5% (n = 86), 88% (n = 139), and 24.5% (n = 40) of patients in the fluorouracil-radiotherapy group, mFOLFOX6-radiotherapy, and mFOLFOX6 groups, respectively. The most common grade 3 to 4 toxicities were leukopenia, radiodermatitis, and radiation proctitis.
Initial analysis of this study showed that “compared with the single-agent fluorouracil, mFOLFOX6 concurrent with radiotherapy preoperatively results in a higher rate of pCR (14.0% vs. 27.5%), a higher good response rate, good compliance, and acceptable toxicity for patients with stage II/III rectal cancer,” the investigators wrote.
“These preliminary results suggest that a strategy of combining full-dose chemotherapy with radiation over chemosensitizing radiation may be a new option for neoadjuvant treatment in LARC,” they added.
Sun Yat-sen University funded this study. Dr. Deng and her associates did not have any disclosures to report.
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