A New Way To Combat Lung Cancer

In a pivotal clinical study (Study E4599), adding Avastin to carboplatin and paclitaxel improved survival by 25 percent compared to chemotherapy alone, extending survival beyond one year in selected first-line NSCLC patients. Avastin may cut off a tumor's blood supply by targeting and inhibiting a protein called vascular endothelial growth factor (VEGF), which is believed to play an important role in the growth of new blood vessels.

"Avastin, in combination with chemotherapy, is the first therapy in 10 years to improve on standard first-line treatment for advanced lung cancer, and the first FDA-approved therapy ever to extend overall median survival for advanced lung cancer patients beyond one year in a large, randomized clinical study," said Alan Sandler, M.D., Director of Medical Thoracic Oncology at Vanderbilt-Ingram Cancer Center in Nashville, Tenn., and lead investigator on the study. "With this survival benefit, Avastin represents an important step for many advanced lung cancer patients fighting this difficult disease."

Cigarette smoking is the leading risk factor for developing lung cancer-along with secondhand exposure to cigarette smoke. Other risk factors include exposure to certain chemicals and a family history of lung cancer.

"Lung cancer is responsible for more than one-third of all U.S. cancer deaths, killing more people than breast, prostate, colon, liver and kidney cancers combined," said Laurie Fenton, president of the Lung Cancer Alliance in Washington, D.C. "The approval of Avastin is a significant stride in the right direction."

The most common Grade 3-5 (severe) adverse events in Study E4599 seen in Avastin-treated patients were neutropenia (low white blood cell count), fatigue, hypertension (high blood pressure), infection and hemorrhage (bleeding).

In Study E4599, the rate of pulmonary hemorrhage requiring medical intervention (bleeding from the lungs for which medical treatment was needed) for the paclitaxel and carboplatin plus Avastin arm was 2.3 percent (10 of 427), compared to 0.5 percent for the paclitaxel and carboplatin alone arm (2 of 441). There were seven deaths due to pulmonary hemorrhage reported by investigators in the paclitaxel and carboplatin plus Avastin arm, as compared to one in the paclitaxel and carboplatin alone arm.

The most serious adverse events associated with Avastin across all trials were gastrointestinal perforation, slow or incomplete wound healing, severe bleeding problems at the site of a tumor, strokes or heart problems, severe hypertension, nervous system and vision disturbances, neutropenia (a reduced white blood cell count that may increase the chance of infection), infection, severe kidney malfunction and congestive heart failure. The most common adverse events seen in patients receiving Avastin with chemotherapy across all studies were weakness, pain, abdominal pain, headache, hypertension, diarrhea, nausea, vomiting, loss of appetite, constipation, upper respiratory infection, nosebleeds, difficulty breathing, mouth sores, skin irritation and proteinuria (a possible sign of kidney malfunction).

Avastin is covered by most insurers and by Medicare for its approved indications. For full prescribing information, including Boxed WARNINGS for Avastin and information about angiogenesis, visit www.gene.com. For more information on Avastin, visit www.avastin.com.

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