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Key Words: non-small cell lung cancer, carboplatin, paclitaxel. (Definitions of many terms related to cancer can be found in the Cancer.gov Dictionary.)

A comparison of two approaches to the treatment of advanced non-small cell lung cancer (NSCLC) found that patients who received a two-drug combination therapy had a median survival that was two months longer than patients who received the single agent paclitaxel (brand name Taxol®), researchers reported at the annual meeting of the American Society of Clinical Oncology in Orlando, Fla., on May 20, 2002.

The study was a phase III randomized trial of 584 patients who had a median age of 63.5 and had either advanced stage IIIB or stage IV tumors. The trial compared the combination therapy of carboplatin plus paclitaxel versus paclitaxel alone, and examined survival, quality of life, and cost-effectiveness.

Patients in this study received treatment every three weeks for a maximum of six treatment cycles. The results showed that, after a median follow-up time of 12.5 months, there was a median survival of 6.5 months for paclitaxel alone versus 8.5 months for the combination therapy. One-year survival rates were similar for the two groups. Patients who could perform their daily activities with ease were more likely than sicker patients to benefit from the combination therapy, while patients in overall poor health did not appear to benefit from either therapy. Researchers found that patients on the combination regimen were also more likely to experience serious side effects, such as anemia and low white blood cell counts.

"Based on our findings, we recommend that treatment be individualized and that a patient's age and overall health be taken into consideration," said lead investigator Rogerio Lilenbaum, M.D., director, Thoracic Oncology Program, Mount Sinai Comprehensive Cancer Center, Fla.

Combination chemotherapy is the standard of care for patients with metastatic or recurrent NSCLC, but previous studies have not demonstrated that it provides a clear survival benefit compared to treatment with a single agent alone. As this study suggests, the survival benefit is still modest, but, according to ASCO President Larry Norton, M.D., it "opens the door a crack. When you look at the curative therapy of all diseases, it starts with a small advance where there is an impact and then that door gets opened a little wider."

This study also demonstrated that combination chemotherapy had no detrimental effect over single-agent chemotherapy on a patient's quality of life, and the cost of the two treatments was similar. "We believe that combination chemotherapy should be the standard of care for patients with non-small cell lung cancer," said Lilenbaum.

Paclitaxel is part of a group of drugs called taxanes, which have a unique way of preventing the growth of cancer cells and was originally isolated from the pacific yew tree. Taxanes affect certain cell structures called microtubules that play an important role in cell function. In normal cell growth, microtubules are formed when a cell starts dividing. Once the cell stops dividing, the microtubules are broken down or destroyed. Taxanes stop the microtubules from breaking down, and cancer cells become so clogged with microtubules that they cannot grow and divide.

Carboplatin belongs to the group of medicines known as alkylating agents. It acts by producing DNA cross-links between strands of DNA, which can lead to the cessation of cancer cell production.

The study was conducted by the NCI-sponsored cooperative group called Cancer and Leukemia Group B (CALGB) between October 1997 and January 2001. CALGB is a national clinical research group sponsored by the National Cancer Institute.

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