Combination Chemotherapy Should be Standard of Care for Lung Cancer
Carboplatin Plus Paclitaxel Show Promising Results in Treating Patients With Advanced Disease, Including the Elderly
ORLANDO, Fla., May 20 /PRNewswire/ -- Combination chemotherapy should be the standard treatment for patients with advanced non-small cell lung cancer, according to a study being presented today at the 38th Annual Meeting of the American Society of Clinical Oncology (ASCO). The study, which compared carboplatin (C) and paclitaxel (P) with paclitaxel alone, shows a statistically significant advantage in response rate of 29 percent in patients who received C/P versus 17 percent in patients who received P alone.
"Not only did the results of the trial show an increase in response rate, but more importantly an increase in survival time in patients who received carboplatin and paclitaxel," says Dr. Rogerio Lilenbaum, Director of the Thoracic Oncology Program at The Mount Sinai Cancer Center, in Miami Beach, and lead investigator of the study for Cancer and Leukemia Group B (CALGB). "In addition, the results clearly demonstrate that elderly patients and the sickest patients may benefit from this regimen."
The study achieved a median survival of 8.8 months in patients who received C/P versus 6.7 months in patients who received only P. This represents a 24 percent relative increase in the duration of survival for those receiving C/P. In addition, patients who received C/P experienced longer failure-free survival (4.6 months vs. 2.5 months).
"Typically, patients treated with combination chemotherapy experience more severe toxicity than those treated with single agents," explains Dr. Richard L. Schilsky, Associate Dean for Clinical Research, University of Chicago, and Chairman, CALGB. "However, the combination of carboplatin and paclitaxel resulted in only minimal increases in toxicity levels." Patients, regardless of age or performance status, experienced similar toxicities in both arms of the trial.
Although the toxicity levels are slightly higher with combination therapy, the quality of life for patients was not compromised. The most common toxicity for each regimen was a decrease in the absolute neutrophil count (the number of white blood cells a patient has to fight infection (62% with C/P vs. 32% with P). Other side effects include: febrile neutropenia (fevers related to the reduction of white blood cells (8% with C/P vs. 5% with P)) and peripheral neuropathy (damage to the nervous system that can result in such changes as numbness in hands and feet (15% with C/P vs. 13% with P)).
Results of the study also indicate that the resource utilization associated with carboplatin and paclitaxel is similar to that of the single agent paclitaxel. "When looking at the results of the study, an unexpected finding was that the resource utilization were comparable in both arms," explains Dr. Lilenbaum. "The cost-effectiveness analysis is currently underway." Resource utilization refers to the costs associated with the treatment, such as length of time in the hospital and use of supplemental treatments, but not the actual costs of the chemotherapy agents.
Study Design
This randomized phase III clinical trial, sponsored by CALGB, compared the survival rates, quality of life, and cost-effectiveness of using carboplatin and paclitaxel versus paclitaxel alone in patients with advanced (stage IIIB and IV) non-small cell lung cancer. Five hundred and eighty-four patients, with a median age of 63.5 years, participated in the trial; 158 patients were over age 70 and 100 patients were self sufficient, but not able to carry out general work activities (PS-2 on the ECOG scale).
Arm one consisted of up to six cycles of paclitaxel (225mg/m2) administered over three hours every three weeks, for up to six cycles (nearly 4 months). Arm two consisted of paclitaxel (225mg/m2) given over three hours plus carboplatin (AUC (area under the curve) 6), using the same schedule as arm one.
Background
An estimated 169,400 new cases of lung cancer will be diagnosed in 2002, accounting for 13 percent of cancer diagnoses, according to the American Cancer Society. Non-small cell lung cancer accounts for 75 to 80 percent of all lung cancer cases. Lung cancer will claim the lives of more than 154,900 men and women this year, accounting for 28 percent of all cancer deaths. Since 1987, more women have died each year from lung cancer than breast cancer, which, for over 40 years, was the major cause of cancer death in women. It is estimated that approximately 65,700 women will die from lung cancer and 39,600 women will die from breast cancer in 2002.
The CALGB is a national cooperative research group, headquartered in Chicago and sponsored by the National Cancer Institute. The CALGB was founded in 1955 with a goal of bringing together clinical oncologists and laboratory investigators to develop better treatments for cancer. Since then the CALGB has grown into a national network of 30 university medical centers, more than 200 community hospitals and more than 4,000 physicians and research staff who collaborate in clinical studies aimed at reducing the morbidity and mortality from cancer and developing new strategies for early detection and prevention of cancer. CALGB research is focused on seven major disease areas: leukemia, lymphoma, breast cancer, lung cancer, gastrointestinal malignancies, genitourinary cancer and melanoma. |
