Riddle me this.
The Study: In GORTEC 2007-01, patients with locally advanced H&N cancer were randomized to 70 Gy with concurrent weekly cetuximab +/- carboplatin/5FU x 3 cycles. Don’t confuse this with its sister trial 2007-02. The 01 trial included low volume (N0-N2a) nodal disease while the 02 trial looks at whether induction chemo before cetuximab-radiation improves outcomes for more bulky nodal disease (spoiler: it didn’t). Despite the majority of patients having oropharynx cancer, nearly 80% were p16(-). At 3 years, the addition of carbo/FU to cetuximab-radiation improved progression free survival (PFS) from 40→ 52% by reducing locoregional failure from 39→ 22%. While not powered for overall survival, there was a similar trend from 55→ 60% in favor of adding chemo. In 2014 RTOG 0522 indicated adding cetuximab to cisplatin-radiation didn’t improve any outcomes, while the Canadian HN.6 trial showed panitumumab (another EGFR inhibitor) with radiation wasn't inferior to cisplatin-radiation. Now we're at a cliffhanger as we await the results of RTOG 1016 comparing cetuximab-radiation to cisplatin-radiation for p16(+) tumors.
Bottom Line: Adding chemo to cetuximab-radiation improves local control and PFS in low nodal volume H&N cancer. Put more simply, omitting cytotoxic chemo for these patients results in worse outcomes. | Tao, J Clin Oncol 2018