Results from a large, multinational phase III trial showed that consolidation chemotherapy with docetaxel and cisplatin after concurrent chemoradiation with the same agents failed to improve progression-free survival in patients with locally advanced non–small cell lung cancer (NSCLC), according to a report published online in the Journal of Clinical Oncology.
After a median follow up of 50.7 months, progression-free survival (PFS) for the arm that received consolidation chemotherapy (CC) was 8.1 months, compared with 9.1 months for the arm that did not receive CC (hazard ratio, 0.91; 95% confidence interval, 0.73-1.12; P = .36). Median overall survival (OS) was also similar between groups: 20.6 vs. 21.8 months, respectively (P = .44).
Among patients assigned to the CC arm, only 42.1% received all three planned cycles, 54.1% completed at least two cycles, and 31.6% did not receive any CC.
“The major obstacle in this trial was that many patients could not complete the three planned cycles of CC,” wrote Dr. Jin Seok Ahn of the Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea, and colleagues. A large proportion of patients failed to start CC because of disease progression or death, and many patients had incomplete recovery from the adverse effects of concurrent chemoradiation. “A full-dose doublet regimen of CC in our trial might have further reduced the rate of completing the three planned cycles of CC,” the investigators noted (J. Clin. Onc. 2015 July 6 [ doi:10.1200/JCO.2014.60.0130 ]).
The randomized phase III trial included 420 patients with inoperable stage IIIA or IIIB non–small cell lung cancer, enrolled from 31 centers in Korea, China, and Taiwan from 2005 to 2011.
Patients older than 60 years, who had similar baseline characteristics to younger patients, experienced significant benefit from CC (HR 0.72), for reasons that remain unexplained.
An exploratory biomarker study indicated the expression of ERCC1 and class III beta-tubulin was not correlated with PFS or OS.
The study was supported in part by Sanofi-Aventis Korea. Dr. Jin Seok Ahn reported financial ties to Eli Lilly, Pfizer, and Roche. Several of his coauthors reported ties to industry sources.