WEDNESDAY, June 22, 2005 (HealthDay News) -- In one of the first real advances in lung cancer treatment in years, researchers report that chemotherapy after surgery to remove early-stage lung cancer can boost patient survival.
The study found the combination of two drugs, vinorelbine and cisplatin, initiated soon after surgery to remove non-small-cell lung cancer tumors, increased five-year survival rates by 15 percent and overall survival rates by 31 percent.
The findings were first presented at the American Society of Clinical Oncology's annual meeting last year, and have quickly become the standard of care for people with early-stage lung cancer. The full study now appears in the June 23 issue of the New England Journal of Medicine.
"Surgery is not the primary and only care any longer," explained study author Dr. Timothy Winton, an associate professor of surgery and division director of thoracic surgery at the University of Alberta in Edmonton, Canada. "A short course of chemotherapy led to significant improvements in survival and recurrence-free survival. This is extremely good news for lung cancer patients and is a major advance," he added.
Lung cancer is the leading cancer killer, causing more deaths than breast, prostate and colon cancer combined, according to the American Lung Association. More than 160,000 Americans will die of lung cancer this year, and 172,000 will be diagnosed with the disease.
In the past, the only treatment option for early-stage non-small-cell lung cancer -- the most common form of lung malignancy -- was surgical removal of the tumor. According to an accompanying editorial in the same issue of the journal, five-year survival rates after surgery alone range between 23 percent and 67 percent.
The problem with surgery alone is that it can leave traces of malignancy behind. Those hidden cancer cells can then travel and grow in other sites, such as the brain, where they become even more deadly.
Past studies on post-surgery chemotherapy had shown little or no benefit, or the benefit was so small that it didn't outweigh the risks of chemotherapy. But, according to editorial author Dr. Katherine Pisters, of the University of Texas M.D. Anderson Cancer Center in Houston, many of those studies were small and were done with older, less active drugs. Also, she said, diagnostic imaging wasn't as precise as it is today, so many cases in those older studies may not have been properly staged.
To try to correct for those limitations, Winton and his colleagues focused on people diagnosed with early Stage IB or Stage II lung cancer. They also began the chemotherapy regimen within six weeks of surgical tumor removal.
"We wanted to have a significant impact on microscopic, undetectable disease," Winton said.
The study included 482 patients. A total of 242 underwent four cycles of chemotherapy with vinorelbine and cisplatin over a 16-week period, while the remaining 240 patients had no additional treatment after the surgery.
The chemotherapy combination was generally well-tolerated, according to Winton, though two deaths were associated with the medications. The most common side effect, experienced by 88 percent of the treated group -- was neutropenia. Neutropenia is a decrease in the number of neutrophils, a type of white blood cell that helps fight infection. Other side effects included fatigue, nausea, vomiting and constipation.
Overall survival was increased 31 percent for the treated group, the researches report. Those treated lived an average of 94 months vs. 73 months for the surgery-alone group. No one in the surgery-alone group achieved relapse-free survival, while those in the treated group averaged nearly 47 months without a relapse.
Five-year survival rates were also up for those who received chemotherapy: 69 percent compared to 54 percent for the surgery alone group, according to the study.
"Up until now, chemotherapy after surgery was controversial," said Pisters, who noted that several additional studies have since confirmed this study's results. "This is the most encouraging news in lung cancer treatment in a long time."
This encouraging news comes on the heels of last week's disappointing news about the targeted lung cancer drug Iressa. That medication initially looked promising but, according to the FDA, it produced a response in just one in 10 patients. That suggests Iressa may only be effective for a select group of patients with a specific genetic mutation.
Winton said the vinorelbine/cisplatin combination doesn't appear to be that selective and should benefit a wide range of patients. However, he did add that researchers are creating a "biologic tumor bank" to determine whether patients with certain genetic markers benefit more or less from the treatment.
The bottom line, however, is that "we've never had anything in the lung cancer setting with this much benefit," said Pisters. "If you have surgery for lung cancer, you need to find out if you're a candidate for chemotherapy." She recommended that these patients discuss the findings with their physician.
To learn more about lung cancer, visit LungCancer.org.