Findings may change the treatment for thousands
Non-small cell lung cancer (NSCLC) - the kind related mostly to smoking - is terribly difficult to treat. Now, researchers at Jefferson Medical College of Thomas Jefferson University have clinical trial results showing that giving advanced lung cancer patients a common chemotherapy drug at the same time they receive daily radiation may help them live longer than by taking one treatment at a time. The new findings promise to change the way thousands of lung cancer patients are treated.
"It's a major step both in patient care and for the future of this particular regimen of chemotherapy and radiation for non-small cell lung cancer," says Walter J. Curran, Jr., M.D., professor and chair of radiation oncology at Jefferson Medical College of Thomas Jefferson University in Philadelphia and clinical director of Jefferson's Kimmel Cancer Center. "With this study, we know that many patients can safely take this regimen.
"This is an important story in drug development because in order for a drug to be used for this stage of the disease, it has to be well tolerated when given with ionizing radiation," he says. "Not all cancer drugs can be combined safely with radiation."
Dr. Curran, who is chairman of the Radiation Therapy Oncology Group, a federally funded cancer clinical trials group which carries out multi-disciplinary research nationwide and which conducted the trial, presents his team's findings Sept. 12 in Tokyo at the Congress of the International Association for the Study of Lung Cancer.
Dr. Curran, along with colleagues at Fox Chase Cancer Center in Philadelphia, M.D. Anderson Cancer Center in Houston and several other centers, examined the results of 597 patients treated with concurrent chemotherapy and daily chest radiation. They found that on average, patients who received the concurrent treatment lived 17.1 months. Those treated sequentially lived an average of 14.6 months.
"Keep in mind that the studies published 10 years ago showed patient survival of 10 months. Now this study is showing a median survival time of 17 months, which is quite an improvement," says Dr. Curran. "The percentage of patients alive at five years or greater increases as well. The median follow up in the study is now over four years. We're seeing substantial numbers of patients five years or later after treatment, which was infrequently seen in a disease that is the most common cause of cancer-related death in this country and worldwide. When you go from 14 to 17 months in median survival time, that's a substantial improvement."
Locally advanced non-small cell lung cancer is diagnosed annually in approximately 50,000 Americans. Nearly all NSCLC cases - which make up approximately 75 percent of lung cancer - are smoking-related. NSCLC tends to spread to adjacent lymph nodes. Surgery offers little to such patients, leaving radiation and chemotherapy.
Patients in the current study were assigned to one of three arms. Patients in arm one received the standard sequential chemotherapy and chest radiation. Those in arm two received daily radiation along with two drugs - cisplatin and vinblastine - at different times in the therapy. In arm three, patients were given a slightly different schedule of the chemotherapy, along with radiation therapy twice daily.
"We conclude that there may be an advantage to concurrent therapy, but there doesn't appear to be an advantage with twice a day radiation," Dr. Curran says. "This study provides strong support for continuing to investigate chemotherapy and radiation delivered concurrently." Patients did experience an increase in side effects, such as difficulty swallowing and bone marrow suppression and anemia.
This is the second major study in the world to look at this issue. A Japanese study also showed 14 months median survival with sequential therapy and 17 months with concurrent treatment, says Dr. Curran.
"Previous studies have shown a five-year survival rate of 5 percent patients with locally advanced NSCLC," he explains. Today, with combining chemotherapy and radiation treatments, 18 percent or more of patients may live five years. "This is a much greater increase in survival rates, percentage-wise, than has been seen in many other major cancers," he says.
He points out that over the last 12 years, researchers have been able to help patients more than double their chance of long-term survival. "When you consider what a common disease this is, doubling the five-year survival rate is a substantial benefit."
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