Study shows the longest reported survival rate for patients with locally advanced lung cancer

May 16 2005

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.

In the trial's interim analysis of 573 eligible patients, there was a 19-month median overall survival for all patients. However, the trial was closed last month after review of the data indicated that gefitinib would not improve survival. Patients on the study are being encouraged to complete all of the planned chemotherapy, since results for those patients not receiving gefitinib were similar to those seen in the prior SWOG-9504 study.

"While we found that gefitinib did not improve survival in this patient population, we were pleased to see that consolidation docetaxel following chemoradiation still provided excellent survival for these patients," said

Karen Kelly, MD, lead investigator of the S0023 study. Kelly is professor of medicine at the University of Colorado Health Science Center.

Laurence Baker, D.O., chairman of the Southwest Oncology Group added, "The data safety committee along with the lung committee were able to evaluate, recognize and recommend early closure to us. These results demonstrate that the system works. The results of this preliminary analysis will be provocative and help us to better understand the biology of lung cancer."

The Southwest Oncology Group and the Radiation Therapy Oncology Group (RTOG) recently announced the launch of a Phase III study (R0412/S0332) to determine the optimal induction therapy for patients with operable locally advanced non-small cell lung cancer. The study will integrate docetaxel and cisplatin as induction therapy in both treatment arms and docetaxel as the consolidation therapy after surgery.

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