Aggressive treatment with surgery, radiation therapy, or both following induction chemotherapy for patients with non–small cell lung cancer with three or fewer metastatic lesions (oligometastatic disease) yielded longer progression-free survival times than did standard therapy in a recent phase II clinical trial.
All patients in the trial received induction chemotherapy and then were randomly selected to receive standard treatment or aggressive local consolidative therapy. Standard treatment was determined by the treating physician and consisted of observation only or systemic maintenance therapy without surgery or radiation therapy. Local consolidative therapy was determined by a multidisciplinary team of medical, surgical, and radiation oncologists and consisted of surgery only, radiation therapy only, or both.
For patients who received local consolidative therapy, surgery could be performed on the primary tumor and/or one or more metastases. Radiation therapy could be delivered by three-dimensional conformal radiation therapy, intensity-modulated radiation therapy, stereotactic radiosurgery, or proton therapy.
“With this study, we wanted to be pragmatic and allow the breadth of treatments that are now available to patients in general practice,” said Daniel Gomez, M.D., an associate professor in the Department of Radiation Oncology at The University of Texas MD Anderson Cancer Center. Dr. Gomez was the principal investigator of the multi-institutional trial.
Although local consolidative therapy for non–small cell lung cancer has shown promise in previous studies, patients in those studies were carefully selected for favorable risk factors. “Our research is the first randomized prospective study of oligometastases in lung cancer to look at treating patients aggressively and comparing the results to standard therapy, which typically is maintenance therapy or observation,” Dr. Gomez said.
The prospective phase II trial, which was designed for 94 patients, ceased enrollment at 49 patients because of the benefit seen in the patients who received local consolidative therapy. At a median follow-up of 18.7 months, the median progression-free survival times were 11.9 months for patients who received local consolidative therapy and 3.9 months for patients who received standard treatment. The majority of patients who received standard treatment crossed over to receive local consolidative therapy after disease progression.
“These findings provide evidence and enthusiasm to offer aggressive local treatment and, with validation, could pave the way to treat tens of thousands of lung cancer patients with curative intent,” said Dr. Gomez, who presented the trial’s results at the American Society of Clinical Oncology’s annual meeting in June. Further results from the phase II trial will assess the patients’ overall survival and quality of life, and follow-up trials are being planned.
OncoLog, July 2016, Volume 61, Issue 7