Phase III trial of cisplatin (P) plus etoposide (E) plus concurrent chest radiation (XRT) with or without consolidation docetaxel (D) in patients with inoperable stage III non-small cell lung cancer (NSCLC): HOG LUN 01-24/USO-023
Scientific Session: Phase III trial of cisplatin (P) plus etoposide (E) plus concurrent chest radiation (XRT) with or without consolidation docetaxel (D) in patients with inoperable stage III non-small cell lung cancer (NSCLC): HOG LUN 01-24/USO-023
Chemotherapy (containing a platinum drug) combined with chest radiation (RT) has become a standard of care in the treatment of nonoperable non-small cell lung cancer (NSCLC). This treatment is based on studies published in the 1980's that demonstrated a survival benefit in NSCLC with the addition of chemotherapy to RT alone, and further studies from the 1990's demonstrating a 3-4 month improved median survival time with the use of chemotherapy and RT concurrently.
Median survival with platinum-based chemotherapy and concurrent thoracic RT has been demonstrated to be 15-17 months by several groups. A further SWOG study, 9504, added docetaxel maintenance chemotherapy following cisplatin, etoposide, and chest RT for patients with locally advanced NSCLC. This study demonstrated a median survival time of 26 months. Since the publication of this data, taxane-based consolidation chemotherapy has become widely used in treatment of nonoperable NSCLC following chemotherapy and RT.
In this phase III trial patients received cisplatin, etoposide, and thoracic RT. Patients without progressive disease were then randomized to docetaxel maintenance treatment (75 mg/m2 every 3 weeks for 3 doses) versus observation. The study closed early after an analysis of the interim results. These found that the addition of docetaxel did not improve disease progression or survival compared to those who were randomized to observation. In addition, the docetaxel arm had higher rates of infection and death. 28.8% of patients randomized to docetaxel maintenance were hospitalized during their treatment versus 8.1% of patients randomized to observation. This trial showed no overall survival benefit with the addition of docetaxel maintenance to concurrent chemoradiation. Given the significant increase in toxicity described in this study, maintenance taxol-based chemotherapy should likely not be used for patients with unresectable stage III NSCLC after definitive, concurrent, platinum-based chemoradiation outside of a clinical trial.