Addition of radiation therapy or surgery to systemic therapy for patients with stage IV lung cancer, a cancer which has spread to a limited number of organs, can significantly increase the total life time, according to the new results of a multicenter randomized controlled trial phase II. The findings were presented last week at the 60th annual meeting of the American Society for Radiation Oncology (ASTRO).
Previously, researchers have reported promising results in disease-free survival, which was published in The Lancet Oncology in 2016. The trial was closed early after accrual and randomization of 49 patients. Initial results, which are also included on the toxicity data were for a median observation period of 12.4 months. These raw data were limited by the lack of an endpoint of overall survival of the short-term observation. These new results include updated data on how long patients lived without their disease worsening, as well as general information on survival and toxicity to 38.8 months follow-up the patient (range 28,3-61,4 months).
"Our hypothesis was that aggressive local therapy - radiation or surgery - to improved progression-free survival, and it happened" - Daniel Gomez said, MD, Associate Medical Director of Radiation Oncology at the University of Texas Cancer Center in Houston . "We found that adding radiation or surgery to cover all disease foci increases the time without relapse, and improves the overall survival time."
Lung cancer is the leading cause of cancer death in the United States. The few existing treatment methods offer long-term survival benefits for patients whose non-small cell lung cancer spread to lungs, partly because of the aggressive nature of lung cancer and its tendency to progression even after treatment. Previous studies of metastatic colorectal cancer and sarcoma, however, suggested that the direct targeting of tumor cells with radiation or surgery may increase the ability of systemic therapies such as chemotherapy, to control the disease and improve survival in patients with oligometastaticheskim cancer patients, which spread to a limited number of bodies . These studies show that the same is true for patients with cancer tumor oligometastaticheskoy stage IV.
The study included patients from three hospitals (MD Anderson Cancer Center, London Health Sciences Centre and the University of Colorado) who had non-small cell lung cancer stage IV of, metastases that have spread no more than three bodies. These patients received systemic therapy consisting of four or more cycles of standard chemotherapy (platinum doublet therapy) or three months or more drugs which target the growth of tumor blood vessels (EGFR or ALK inhibitors for EGFR mutations / ALK-rearrangements). Those whose cancer has progressed after first-line treatment, were then randomly assigned to either an experimental group in which the patients received surgical treatment or radiation therapy on the tumor site (25 patients) or a group which received a standard system maintenance therapy and observation (24 patient).
Conducted advanced data indicate that patients in the experimental group observed no survival without progression of 14.2 months compared with 4.4 months for those who received standard treatment and observation (p = 0,014).
The difference in survival rates between the two groups was even more dramatic: in patients who received radiation / surgery, the median survival was 41.2 months compared with 17.0 months for those who received standard supportive treatment / observation. "This is a very long overall survival time for patients with metastatic disease," - said Dr. Gomez.
For patients receiving radiation / surgery, the time to occurrence of new lesions averaged 14.2 months compared with 6.0 months for those who were in the standard maintenance treatment / control group (p = 0,11).
Recently updated results represent the first randomized data for overall survival local ablation therapy in patients with non-small cell oligometastaticheskim cancer patients, from whom he is not progressed after systemic treatment on the first line. Ongoing research phase II / III will continue to assess the effect of local consolidation therapy (BWL) in larger groups with the addition of targeted immunotherapy and drug therapy.
"In patients with limited metastatic disease, our study shows that there is a role more aggressive treatment," - concluded Dr. Gomez. "In fact, patients who initially were treated with supportive therapy, had an opportunity to get surgery or radiation, if the cancer has spread at the time of the study. Exploratory Analysis shows that the aggressive treatment of all sites of disease progression during improved results for these patients compared to patients who did not receive late local therapy. Thus, it may be useful for later irradiation / surgery for establishing limited metastatic disease. "