Docetaxel after cisplatin, etoposide and radiation did not improve OS in lung cancer

In a phase-3 trial that was ended prematurely, researchers found that consolidation docetaxel after treatment with cisplatin, etoposide and concurrent chest radiation did not improve survival and resulted in higher toxicity rates among patients with inoperable stage III non–small-cell lung cancer.

Results from a previous phase-2 study suggested that consolidation docetaxel following standard treatment in this patient population could improve survival. This randomized, phase-3 trial aimed to evaluate whether docetaxel was responsible for the high survival rate in the prior study.

Two-hundred and three patients were evaluated prior to trial termination; 147 did not progress after treatment with cisplatin, etoposide and radiation therapy, and were thus randomly assigned to either IV docetaxel 75 mg/m² every 21 days for three cycles (73 patients) or observation (74 patients).

The median OS time for all patients was 21.7 months. Patients in the docetaxel group had a median OS time of 21.2 months compared with 23.2 months in the observation arm (P=.883). The study was ended early on the basis of evidence of futility.

Toxicities were more frequent in the docetaxel group: 28.8% of patients in the docetaxel arm were hospitalized during the treatment vs. 8.1% of patients in the observation arm. The researchers wrote that 5.5% of patients died as a result of docetaxel.

“It seems that we have reached a plateau in survival using current chemotherapy agents against stage III NSCLC,” the investigators wrote. “Many questions remain unanswered in the treatment of stage III disease, including defining the optimal chemotherapy regimen and the utility of lower dose radiosensitizing chemotherapy; individualizing [radiotherapy] dose and schedule based on pulmonary function, tumor volumes, and newer [radiotherapy] technologies; and defining the role of prophylactic cranial irradiation.”

J Clin Oncol. 2008;10.1200/JCO.2008.17.7840.