Combination Chemotherapy Should Be Standard of Care for Lung Cancer

Combination chemotherapy should be thestandard treatment for patients with advanced non-small-cell lung cancer,according to a study presented at the 38th annual meeting of the AmericanSociety of Clinical Oncology (ASCO). The phase III, randomized study comparedthe combination of carboplatin (Paraplatin) and paclitaxel with paclitaxel aloneand showed that patients in the combination arm achieved a statisticallysignificant better response (29%) than patients in the paclitaxel alone arm(17%).

Survival Duration Increased

"Not only did the results of the trial show an increasein response rate, but more importantly, an increase in survival time in patientswho received carboplatin and paclitaxel," said Dr. Rogerio Lilenbaum,director of the Thoracic Oncology Program at the Mount Sinai Cancer Center inMiami Beach and lead investigator of the study for the Cancer and Leukemia GroupB (CALGB). "In addition, the results of the study clearly demonstrate thatelderly patients and the sickest patients may benefit from this regimen."

Patients in the study who received the combination achieved amedian survival of 8.8 months, compared with 6.7 months for patients whoreceived paclitaxel alone. This represents a 24% increase in the duration ofsurvival for those in the combination-therapy arm. In addition, patients in thecombination arm experienced a longer failure-free survival (4.6 vs 2.5 months).

Equivalent Toxicities

"Typically, patients treated with combinationchemotherapy experience more severe toxicity than those treated with singleagents," said Dr. Richard L. Schilsky, associate dean for clinicalresearch, University of Chicago, and chairman, CALGB. "However, thecombination of carboplatin and paclitaxel resulted in only minimal increases intoxicity levels."

Although toxicity levels are slightly higher with combinationtherapy, the quality of life for patients was not compromised. The most commontoxicity for each regimen was a decrease in the absolute neutrophil count (62%for the combination vs 32% for paclitaxel alone). Other side effects includedfebrile neutropenia (8% with the combination vs 5% with paclitaxel alone) andperipheral neuropathy (15% with the combination vs 13% with paclitaxel alone).

Results of the study also indicated that the costs associatedwith treatment with the combination were similar to those with paclitaxel alone."When looking at the results of the study, an unexpected finding was thatthe resource utilization was comparable in both arms," said Dr. Lilenbaum.

Study Design

The trial, sponsored by CALGB, compared the survival rates,quality of life, and cost-effectiveness of carboplatin and paclitaxel vspaclitaxel alone in patients with advanced (stage IIIB/IV) non-small-cell lungcancer. Enrollees included 584 patients with a median age of 63.5 years; 158patients who were over age 70, and 100 patients with a performance status of 2.

Patients in arm 1 received paclitaxel at 225 mg/m² administered over 3 hoursevery 3 weeks for up to six cycles (nearly 4 months). Arm 2 received paclitaxelat 225 mg/m² given over 3 hours plus carboplatin at an area under theconcentration-time curve of 6 using the same schedule as arm 1.