Overall, the toxicity results were encouraging, Dr. Suntharalingam said. All patients received full radiation doses, with only 2 days of delay, and 17 of 24 patients had no delays in radiotherapy. Thirteen of 24 patients received full doses of cetuximab(Drug information on cetuximab), and 8 patients missed only one dose. Eleven of 24 patients received all planned doses of chemotherapy, and 10 patients had only one cycle held or reduced in dose. "We found a significant ability to deliver treatment as planned," Dr. Suntharalingam said.
He reported that 72% of patients achieved a complete response 2 months after completing therapy, and four more were rendered disease-free after neck dissection. "Ultimately, 95% were free of disease after all therapy," he said. One patient died of progressive disease, and two developed metastases without evidence of local failure.
"Longer follow-up is needed to see whether the improved local control translates into improved survival," he said. "In head and neck cancer, we don't get excited until we see 2-year long-term outcomes." Nonetheless, he found the initial evaluation of the toxicity and efficacy of this regimen encouraging. He told ONI that the research team hopes to convince a cooperative group to undertake a phase III trial comparing cetuximab/chemoradiotherapy to standard care (currently cisplatin/radiotherapy in the cooperative group setting, although weekly paclitaxel(Drug information on paclitaxel)/carboplatin/radiotherapy is widely used in the community).