Docetaxel Combination Produces 2-Year Survival Advantage in NSCLC Patients

According to a study presented at the 11th AnnualEuropean Cancer Conference, patients with advanced non-small-cell lung cancer(NSCLC) who received docetaxel (Taxotere) in combination with cisplatin (Platinol)achieved better results than those in the control arm, who received vinorelbine(Navelbine)/cisplatin. Most notably, the 2-year survival rate of the docetaxel/cisplatinarm was significantly improved over that reported for the control arm: 21% ofthe patients in the docetaxel/cisplatin arm were alive after 2 years, comparedto 14% of those treated with vinorelbine/cisplatin (P = .044). The1-year survival rate in the docetaxel/cisplatin arm was 46%, compared to 41% inthe control arm (P = .044).

Three Treatment Arms

The study enrolled 1,220 patients with previously untreated advanced NSCLC.Patients were randomized to one of three treatment arms. The first arm receiveddocetaxel followed by cisplatin every 3 weeks. The second group receiveddocetaxel followed by carboplatin every 3 weeks, and the third groupreceived a combination of vinorelbine and cisplatin every 4 weeks. Overallexposure to chemotherapy was equivalent for all three groups.

In both docetaxel combination arms, quality of life and other clinicalbenefit parameters such as body weight, performance status, and pain managementwere improved compared to the control arm. In addition, the response rate wassignificantly higher in the docetaxel/cisplatin arm than in the control arm (32%vs 25%, P = .029). Time to progression was similar in both arms.

"The impressive impact on survival and quality of life demonstrated withthe docetaxel/cisplatin combination could profoundly change the treatmentstandard of patients with NSCLC," said Frank V. Fossella, MD, medicaldirector, Thoracic Oncology Multidisciplinary Care Center at The University ofTexas M. D. Anderson Cancer Center in Houston.

Survival and Adverse Effects

The median survival of patients receiving the docetaxel/cisplatin regimen was11.3 months vs 10.1 months for patients in the control arm (P = .044). Theoverall survival of patients in the docetaxel/carboplatin arm was similar tothat of patients in the control arm. However, patients in the control armexperienced significantly higher rates of nausea and vomiting, while diarrheawas more common among patients in the docetaxel-based arm.

All treatment arms were generally well tolerated. Less than 5% of patients ineither of the docetaxel combination arms developed severe sensory neuropathy.The incidence of treatment-related infection, febrile neutropenia, and death wasalso similar among the groups.

The most common severe side effects associated with the use of docetaxelincluded low blood cell count, fatigue, fluid retention, and mouth sores. Themost common non-severe side effects included hair loss, neurosensory reactions,cutaneous reactions, nail changes, nausea, and diarrhea. These side effects weregenerally reversible and manageable. A premedication regimen withcorticosteroids is recommended before initiating docetaxel therapy in order toprevent or reduce hypersensitivity and fluid retention. Docetaxel is notappropriate for patients with significant liver impairment or a low white bloodcell count.