Five-year data from a study evaluating the use of docetaxel (Taxotere) administered after cisplatin/etoposide chemotherapy plus radiation therapy demonstrate the best long-term survival rates reported in patients with locally advanced (Stage IIIB) non-small cell lung cancer (NSCLC).
The Phase II research findings, along with similar interim results of a follow-up Phase III study, were presented by David Gandara, M.D., of the Southwest Oncology Group (SWOG) at the 41st annual meeting of the American Society of Clinical Oncology (ASCO) in Orlando, Florida.
In the SWOG-9504 study, 29 percent of patients were still alive after five years versus 17 percent of patients from a previous study that did not include docetaxel. The prior study (SWOG-9019), in which patients received the same chemotherapy and radiation without docetaxel as consolidation therapy, showed a median survival of 15 months. By comparison, in SWOG-9504 the median survival was 26 months and progression-free survival was 16 months.
"The long-term survival data are particularly promising because they exceed the results of all other treatment approaches in this group of patients with Stage IIIB disease," said Gandara, chair of the Southwest Oncology Group Lung Cancer Committee. Gandara also is professor of medicine and director of clinical research at the University of California, Davis Cancer Center. "The results of this trial, in combination with the interim results of intergroup trial S0023, which also were presented at the ASCO meeting, confirm that the SWOG-9504 regimen can now be considered a standard of care for patients with unresectable Stage III non-small cell lung cancer," he said.
The follow-up Phase III study S0023 also evaluated concurrent chemoradiation followed by docetaxel, but randomized patients then received either gefitinib (Iressa(TM), ZD1839) as maintenance therapy or a placebo. The study was designed to assess whether maintenance therapy with gefitinib improves overall survival and progression-free survival in patients with unresectable Stage III NSCLC after the completion of combined chemoradiotherapy with cisplatin, etoposide, followed by consolidation docetaxel.