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Lung Cancer Guidelines Add Chemotherapy, New Drug: Presented at NCCN

By Ed Susman

HOLLYWOOD, FL – March 12, 2004 – The first new drug therapy for lung cancer in two decades, gefitinib, also know as Iressa, has made its way into the new guidelines suggested for treatment of non-small-cell lung cancer by the National Comprehensive Cancer Network.

Mark Kris, MD, chief of the thoracic oncology service at Memorial Sloan-Kettering Cancer Center, New York, said gefitinib, approved by the U.S. Food and Drug Administration in 2003, is listed as a third-line treatment for non-small-cell lung cancer.

"In clinical trial, gefitinib was very well tolerated, and rarely were dose reductions required," Dr. Kris said in his presentation here March 11th at the NCCN's 9th Annual Conference on Clinical Practice Guidelines and Outcomes Data in Oncology. "Adverse side effects included rash and diarrhea."

Dr. Kris said the drug was inserted into the guideline because data showed the once-daily oral medication was able to exhibit radiographic reductions in tumors in 10% of patients and rapidly improved symptoms in 40% of patients.

He said the drug appeared to get those results even in patients for whom cisplatin or carboplatin and docetaxel were ineffective or not tolerated. He said gefitinib was created to inhibit the tyrosine kinase of the epidermal growth factor receptor that is found in most non-small-cell lung cancers.

In the guideline update, expected to be the pathway of choice for the 19-member hospitals and affiliates of the NCCN, Dr. Kris also said there was a consensus to recommended adjuvant chemotherapy in patients following curative surgery for lung cancer.

"We have seen that adjuvant chemotherapy improves outcomes, although modestly, in other cancers, such as breast cancer," said Dr. Kris. He cited recent studies that suggested a similar and possibly greater improvement in outcomes could be achieved if chemotherapy were offered to lung cancer patients.

He noted that even when lung cancer is found and excised at its earliest manifestation, the T1N0M0 stage, the five-year survival amounted to 67%. In addition, about 70% of non-small-cell lung cancer recurs only outside the chest, and another 10% recurs both locally and distant.

"If we are going to make any impact on non-small-cell lung cancer, it has to b e with systemic therapy," he told the audience of nearly 1,000 clinicians and allied health care professionals.

In the same presentation, David Ettinger, MD, associate director for clinical research at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins School of Medicine, Baltimore, Maryland, suggested that positron emission tomography (PET) imaging appears to outperform computer tomography (CT) scans for the diagnosis of non-small-cell lung cancer.

However, he cautioned that there is enough error even with PET, albeit significantly less than with CT, so that confirmative biopsies must be performed. "It had to fit the data clinically," he said.


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