| may have another weapon in their arsenal for | | | | developing lung cancer-along with secondhand |
| fighting lung cancer. The single largest cancer killer | | | | exposure to cigarette smoke. Other risk factors |
| among men and women in the U.S., the disease is | | | | include exposure to certain chemicals and a family |
| expected to take the lives of more than 160,000 | | | | history of lung cancer. |
| Americans this year, often within a short time of | | | | "Lung cancer is responsible for more than |
| diagnosis, according to the American Cancer | | | | one-third of all U.S. cancer deaths, killing more |
| Society. However, for the first time, patients with | | | | people than breast, prostate, colon, liver and |
| the most common type of advanced lung cancer | | | | kidney cancers combined," said Laurie Fenton, |
| have a targeted therapy that, with | | | | president of the Lung Cancer Alliance in |
| chemotherapy, extended overall survival beyond | | | | Washington, D.C. "The approval of Avastin is a |
| one year in a large, randomized clinical study. | | | | significant stride in the right direction." |
| Avastin® (bevacizumab), a targeted therapeutic | | | | The most common Grade 3-5 (severe) adverse |
| antibody (not a chemotherapy), is now approved | | | | events in Study E4599 seen in Avastin-treated |
| by the U.S. Food and Drug Administration (FDA) | | | | patients were neutropenia (low white blood cell |
| to be used in combination with carboplatin and | | | | count), fatigue, hypertension (high blood pressure), |
| paclitaxel for the first-line treatment of patients | | | | infection and hemorrhage (bleeding). |
| with unresectable, locally advanced, recurrent or | | | | In Study E4599, the rate of pulmonary |
| metastatic nonsquamous, non-small cell lung | | | | hemorrhage requiring medical intervention (bleeding |
| cancer (NSCLC). NSCLC is the most common | | | | from the lungs for which medical treatment was |
| type of lung cancer. | | | | needed) for the paclitaxel and carboplatin plus |
| In a pivotal clinical study (Study E4599), adding | | | | Avastin arm was 2.3 percent (10 of 427), |
| Avastin to carboplatin and paclitaxel improved | | | | compared to 0.5 percent for the paclitaxel and |
| survival by 25 percent compared to | | | | carboplatin alone arm (2 of 441). There were |
| chemotherapy alone, extending survival beyond | | | | seven deaths due to pulmonary hemorrhage |
| one year in selected first-line NSCLC patients. | | | | reported by investigators in the paclitaxel and |
| Avastin may cut off a tumor's blood supply by | | | | carboplatin plus Avastin arm, as compared to one |
| targeting and inhibiting a protein called vascular | | | | in the paclitaxel and carboplatin alone arm. |
| endothelial growth factor (VEGF), which is believed | | | | The most serious adverse events associated with |
| to play an important role in the growth of new | | | | Avastin across all trials were gastrointestinal |
| blood vessels. | | | | perforation, slow or incomplete wound healing, |
| "Avastin, in combination with chemotherapy, is the | | | | severe bleeding problems at the site of a tumor, |
| first therapy in 10 years to improve on standard | | | | strokes or heart problems, severe hypertension, |
| first-line treatment for advanced lung cancer, and | | | | nervous system and vision disturbances, |
| the first FDA-approved therapy ever to extend | | | | neutropenia (a reduced white blood cell count that |
| overall median survival for advanced lung cancer | | | | may increase the chance of infection), infection, |
| patients beyond one year in a large, randomized | | | | severe kidney malfunction and congestive heart |
| clinical study," said Alan Sandler, M.D., Director of | | | | failure. The most common adverse events seen |
| Medical Thoracic Oncology at Vanderbilt-Ingram | | | | in patients receiving Avastin with chemotherapy |
| Cancer Center in Nashville, Tenn., and lead | | | | across all studies were weakness, pain, abdominal |
| investigator on the study. "With this survival | | | | pain, headache, hypertension, diarrhea, nausea, |
| benefit, Avastin represents an important step for | | | | vomiting, loss of appetite, constipation, upper |
| many advanced lung cancer patients fighting this | | | | respiratory infection, nosebleeds, difficulty |
| difficult disease." | | | | breathing, mouth sores, skin irritation and |
| Cigarette smoking is the leading risk factor for | | | | proteinuria (a possible sign of kidney malfunction). |