Formal discussant of the study by Park et al, Nasser H. Hanna, MD, Associate Professor of Medicine at the Indiana University Simon Cancer Center, Indianapolis, said that the trial confirms the difficulty of giving consolidation therapy, since less than two-thirds of patients were able to get the three planned cycles.
“Consolidation therapy did not improve disease-free or overall survival and caused significantly more toxicity. Many studies have tried to demonstrate improved outcomes with additional therapy beyond concurrent chemoradiotherapy [including induction therapy and consolidation therapy], and all studies have failed,” he stated.
I believe that the available evidence does not support additional chemotherapy, induction or consolidation therapy. [Concurrent chemoradiotherapy] should remain the standard of care in the most fit patients, and the [National Comprehensive Cancer Network] guidelines should reflect all the negative studies,” he said.
Most Significant Finding
Turning to the RADIANT trial, Dr. Hanna pointed out that no difference in disease-free or overall survival was observed with erlotinib (Tarceva) in the overall trial and in [fluorescence in situ hybridization]–positive patients.
“The most significant finding was the secondary endpoint showing that patients with EGFR mutations have the most benefit from erlotinib in the advanced-disease setting. There was an 18-month difference in median disease-free survival and few events at this time point,” Dr. Hanna continued.
He said that three additional datasets (from the National Cancer Institute of Canada, Memorial Sloan Kettering Cancer Center, and in the phase II SELECT trial) suggest that adjuvant erlotinib achieves a magnitude of gain in disease-free survival in patients with an activating EGFR mutation that he considers clinically important.
“Do we need phase III trials to use erlotinib? I believe the magnitude of gain in disease-free survival in patients with EGFR mutations is consistent in three datasets; it is persuasive and compelling and appears to be far better than without adjuvant chemotherapy,” Dr. Hanna stated. ■
Disclosure: Dr. Hanna reported no potential conflicts of interest.
