A study published in the Journal of Clinical Oncology (JCO) reports that nearly 40 percent of patients receiving the anti-cancer drug Taxotere (docetaxel) following standard chemotherapy and radiation for advanced non-small cell lung cancer (NSCLC) were still alive after three-year follow-up. The study, conducted by the Southwest Oncology Group (SWOG) was led by David R. Gandara, of the University of California (Davis), represents the longest survival reported to date in a clinical trial in patients with advanced stage IIIB NSCLC.
This study was identical in design to a prior SWOG study; same patient selection criteria and treatment regimen. The only difference was this current study included Taxotere following chemotherapy and radiotherapy and the predecessor study used cisplatin/etoposide, a widely accepted chemotherapy, instead of Taxotere, which resulted in a dramatic long-term survival improvement.
The Phase II study included 83 patients with newly diagnosed advanced NSCLC, in primary stage IIIB, and was too extensive to be treated by surgery. Stage IIIB NSCLC is an advanced form of NSCLC, typically has invaded surrounding organs and may have resulted in significant lymph node involvement. All patients first received the chemotherapy drugs cisplatin on days one and eight and etoposide every day from the first day to the fifth day of chemotherapy. This regimen was repeated four weeks later. Patients also started concurrent radiotherapy on day one, which continued for five days a week for six weeks. Treatment with Taxotere was started approximately four weeks after the completion of the concurrent cisplatin/etoposide and radiation treatments. The Taxotere treatments were repeated every three weeks for a total of three cycles.
The median survival in this current study was 26 months, and the one-, two-, and three-year survival rates were 76 per cent, 54 per cent and 37 per cent respectively. This compares to a prior study that did not include Taxotere and SWOG investigators had documented one-, two-, and three-year survival rates of 58%, 34%, and 17% respectively, which was the highest survival rate that had ever been reported in pathologically staged IIIB NSCLC. This is a significant improvement on the previous SWOG trial results, in which identical initial cycles of chemotherapy and radiation were followed by two additional cycles of cisplatin/etoposide instead of three cycles of Taxotere. Results of the current study also showed that the median length of survival without disease progression was an impressive 16 months. The regimen in the trial was generally well-tolerated, with neutropenia (a decrease in white blood cells) being the most frequently observed adverse event.