AN ALTERNATIVE TREATMENT FOR STAGE NSCLC

November 5, 2010 (San Diego, California) — Stereotactic radiation might be an option for patients with operable early-stage nonsmall-cell lung cancer (NSCLC). According to the results of a Japanese study, presented here at the American Society for Radiation Oncology 52nd Annual Meeting, stereotactic radiation is both effective and safe in this population.

"Stereotactic radiation is a standard treatment for patients with inoperable disease," said lead author Yasushi Nagata, MD, professor and radiation oncologist at Hiroshima University in Japan. "But it can be an alternative for operable patients."

The 3-year overall survival, the primary end point of the study, was 76.0% (95% confidence interval [CI], 63.3 - 84.8). According to Dr. Nagata, this survival rate is comparable to historic data of patients with similar stage I NSCLC who underwent surgery.

However, Lynn D. Wilson, MD, MPH, from Yale University School of Medicine, in New Haven, Connecticut, who moderated a press briefing at which highlights of the study by Dr. Nagata and colleagues were presented, explained that surgery is the primary treatment in the United States for patients with early lung cancer.

"Stereotactic radiation is used in the United States," he said, "but generally not as an alternative for a patient who has an operable tumor."

More data are needed in larger populations, he added.

Effective and Safe

Stereotactic body radiation therapy (SBRT) has become an increasingly popular treatment and has shown efficacy in medically inoperable stage I NSCLC. Even though it has been used in patients with operable disease, prospective data are lacking.

When using stereotactic radiation therapy, a much higher dose can be delivered — as much as 6 times the normal radiation dose — when it is localized directly to the tumor, Dr. Nagata pointed out.

Therefore, he explained, the purpose of this study was to evaluate the safety and efficacy of SBRT in patients with operable and with medically inoperable NSCLC. These results are the first ones reported for an operable population.

From 2004 to 2007, Dr. Nagata and colleagues enrolled 65 patients from 15 institutions with operable early-stage NSCLC. The patients were primarily male (45 male, 20 female), with a median age of 79 years (range, 50 to 91 years). The median tumor size was 21 mm (range, 10 to 30 mm); 40 patients had adenocarcinomas, 21 had squamous cell carcinomas, and 4 had other types.

Per protocol, patients received 48 Gy at the isocenter in 4 fractions over a period of 4 to 8 days. All patients in the cohort completed the treatment.

The last follow-up was in November 2009, and the median follow-up of censored cases was 45.4 months. Secondary end points included progression-free survival (54.5%; 95% CI, 41.5 - 65.7), local progression-free survival (68.5%; 95% CI, 55.5 - 78.4), and event-free survival (51.4%; 95% CI, 38.6 - 62.9). A total of 25 progressions have been observed to date.

Overall, SBRT was well tolerated. Grade 3 toxicity included chest pain (n = 1; 1.5%), dyspnea (n = 2; 3.1%), hypoxia (n = 1; 1.5%), and pneumonitis (n = 2; 3.1%). No grade 4 or 5 toxicity was observed.

"Patients in the United States with early lung cancer should consider SBRT as a treatment option," concluded Dr. Nagata.

The authors have disclosed no relevant financial relationships.

American Society for Radiation Oncology (ASTRO) 52nd Annual Meeting: Abstract 59. Presented November 2, 2010.