Docetaxel Combination Shows Significant Survival Advantage as First-Line Treatment for Advanced Lung Cancer

August 1, 2001

According to phase III trial data presented at the recent meeting of the American Society of Clinical Oncology (ASCO)

According to phase III trial data presented at therecent meeting of the American Society of Clinical Oncology (ASCO), a regimen of docetaxel (Taxotere) with cisplatin(Platinol) yields a significantly better overall survival rate (P = .0469) thanthe combination of vinorelbine (Navelbine) and cisplatin in patients withadvanced non-small-cell lung cancer who have not received prior chemotherapy.

Significantly Higher Response Rates

The three-arm study, presented by Chandra P. Belani, MD,professor of medicine, University of Pittsburgh School of Medicine andcodirector of the Lung Cancer Program at the University of Pittsburgh CancerInstitute, showed that patients who were treated with docetaxel and cisplatinsurvived significantly longer than those who received the combination ofvinorelbine and cisplatin—a standard regimen for advanced non-small-celllung cancer. The median survival for the docetaxel/cisplatin cohort was 10.9months vs 10 months for the vinorelbine/cisplatin cohort. The 1- and 2-yearsurvival rates were 46% and 20% vs 42% and 14%, respectively.

"While platinum-based chemotherapy is often viewed as afirst-line therapy for patients with advanced non-small-cell lung cancer,there is no established treatment standard for this population," said Dr.Belani. "The improved survival associated with the docetaxel/cisplatincombination means that a superior treatment may be available for this vast groupof patients who are not candidates for surgical resection."

The overall survival for patients treated with docetaxel andcarboplatin was similar to that of patients treated with vinorelbine andcisplatin. Median survival was 9.1 months for the docetaxel/carboplatin regimen.The 1- and 2-year survival rates were also similar in these two arms (37% and16%, respectively, for the docetaxel/carboplatin group).

Study Population and Protocol

The trial, which was conducted at 135 sites in 28 countries,included more than 1,200 men and women 18 years of age or older withpathologically confirmed, unresectable locally advanced and/or recurrent ormetastatic non-small-cell lung cancer and a Karnofsky performance status of atleast 70%. Recurrent disease was defined as evidence of tumor progression aftersurgical or radiation treatment. Patients who received prior treatment with abiological response modifier or chemotherapy agent were ineligible.

The median age of the study population was 60 years, and mostpatients were men. Approximately 67% had stage IV disease, and disease hadspread to at least three other organs in about one-third of patients.

Patients were randomized to one of three treatment groups. Thefirst group received docetaxel at 75 mg/m2 plus cisplatin at 75 mg/m2, with thecycle repeated every 21 days. The second group received the combination ofdocetaxel at 75 mg/m2, and carboplatin at an area under the concentration-timecurve (AUC) of 6, with treatment repeated every 21 days. The third groupreceived a combination of vinorelbine at 25 mg/m2/wk and cisplatin at 100mg/m2,with treatment repeated every 28 days. Patients were treated until there wasevidence of progressive disease or unacceptable adverse events, or until sixcycles had been completed. Treatment response was assessed after every twocycles.

All treatment arms were generally well tolerated. Less than 5%of patients experienced severe sensory neuropathy in both docetaxel treatmentarms. Treatment-related infection, febrile neutropenia, and number of deathswere also similar between the groups. More patients in the vinorelbine/cisplatingroup experienced severe nausea/vomiting and anemia; however, diarrhea was morecommon in patients treated with docetaxel/cisplatin.