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Radiofrequency ablation safe, effective for medically inoperable NSCLC
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Radiofrequency ablation conferred 2-year OS rates comparable to stereotactic body radiotherapy in patients with medically inoperable non–small cell lung cancer, according to study results.
Further, radiofrequency ablation appeared safe and did not adversely affect pulmonary function tests, the study also found.
Stereotactic body radiotherapy or image-guided thermal ablations represent the most common treatment options for patients with lung cancer who refuse surgery, according to study background. However, stereotactic body radiotherapy has been observed to have a deleterious effect on pulmonary function. Radiofrequency ablation (RFA) is the most common image-guided modality used in the treatment of liver, kidney, lung and bone tumors, and early use of RFA as an outpatient treatment for lung cancer exhibited safety and efficacy in select patients.
Damian E. Dupuy, MD, professor of diagnostic imaging at Brown Medical School and director of tumor ablation at Rhode Island Hospital, and colleagues initiated a prospective multicenter trial to evaluate the safety and efficacy of CT-guided RFA in patients with medically inoperable NSCLC.
The analysis included data from 51 patients (median age, 76 years; 54.9% female) with medically inoperable stage IA NSCLC.
Follow-up included contrast-enhanced CT scans at 3, 6, 9, 12, 18 and 24 months following a single, minimally invasive RFA treatment. The researchers also tested pulmonary function 60 days prior to RFA and 3 and 24 months following treatment.
OS at 2 years following RFA served as the primary endpoint. Secondary endpoints included freedom from local recurrence and the effect of RFA on pulmonary function tests.
Overall, 86.3% (95% CI, 77.3-96.3) of the population achieved 1-year OS and 69.8% (95% CI, 58-83.9) achieved 2-year OS. Fifteen patients died during the course of the study, 40% of whom died from lung cancer.
Patients with smaller tumors (< 2 cm) and a performance score of 0 or 1 experienced significantly improved OS after 1 year (83%) and 2 years (78%).
In the total population, 68.9% (95% CI, 57-83.4) of patients achieved 1-year freedom from local recurrence, and 59.8% (95% CI, 47.2-75.7) were local recurrence free at 2 years.
Local recurrences occurred in 19 patients. Eleven patients with local recurrences underwent additional RFA, nine patients underwent radiotherapy and three received chemotherapy.
Twelve patients experienced grade 3 or worse adverse events within 90 days of RFA. These included 21 grade 3 adverse events, two grade 4 adverse events and one grade 5 adverse event. However, no grades 4 or 5 adverse events resulted from RFA treatment.
One death from complications following a myocardial infarction occurred 2 months following RFA.
The researchers did not observe a statistically significant change in pulmonary function test outcomes between 3 and 24 months. However, patients experienced significant improvement in forced vital capacity from baseline to 3 months (P = .02) and 24 months (P < .01).
“RFA can provide safe and effective treatment for patients with medically inoperable early-stage NSCLC in a single outpatient session,” Dupuy and colleagues concluded. “Thermal ablation should continue to play a role in medically inoperable patients with lung cancer and perhaps in high-risk operable patients currently treated with sublobar resection. Further study of newer thermal ablative technologies vs. other treatment options such as sublobar resection and stereotactic body radiotherapy in well-defined patients are needed to better define the role of these therapies for NSCLC."
Despite that local recurrences occurred among patients, RFA should be viewed as a viable treatment option for patients with medically inoperable NSCLC, Jessica S. Donington, MD, MSCr, associate professor of cardiothoracic surgery at New York University School of Medicine, wrote in an accompanying editorial.
“Cancer treatment is always a balance between efficacy and tolerability, and in medically high-risk patients with NSCLC, the precise spot that appropriately balances risk and benefit is incredibly narrow, and small shifts in either direction can dramatically effect OS,” Donington wrote. “There is currently not one treatment that represents the best choice for all patients, but there are several options with varying levels of efficacy and tolerability and clinical indications. The data presented here go a long way toward helping to make educated treatment decisions.” – by Cameron Kelsall
Disclosure: The NHI and Covidien provided funding for the study. Dupuy reports grants from Covidien, Galil Medical and Neurowave Medical, a consultant role with Covidien, royalties from Springer Verlag and UpToDate and a leadership role with Person Medical. Please see the full study for a list of all other researchers’ relevant financial disclosures. Donington reports an advisory role with KCI.
Perspective
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Edward S. Kim, MD
The approach to treating patients with stage I non–small cell lung cancer has traditionally been surgically based. For the majority of patients, lobectomy with lymph node dissection or sampling is adequate to completely treat these tumors. Adjuvant chemotherapy and radiotherapy are used for later-stage tumors. Other modalities are actively being tested for patients with small, early-stage tumors including stereotactic body radiation therapy (SBRT) and radiofrequency ablation (RFA) as described in the small study by Dupuy and colleagues and accompanying editorial by Jessica S. Donington, MD, MSCr. The study data reported are intriguing but need to be tempered in the context that this is a single-arm study with a 2-year efficacy endpoint. The patients eligible for RFA treatment had at least one major or two minor prespecified criteria (eg, FEV1 < 50% predicted, age ≥ 75 years), which meant the patients were deemed high risk for pulmonary surgical resection. The 2-year efficacy data showed some promise, but in a single treatment-arm trial with data from only 54 patients enrolled and 36 patients with 2-year follow-up, the results should be interpreted with caution. As the authors conclude, a randomized comparative study is truly needed to fully evaluate the effectiveness of RFA vs. SBRT or even other local surgical therapies in high-risk, stage I NSCLC patients.The approach to treating high-risk patients has historically been more palliative but may be able to translate into longer survival and improved quality of life with the use of less invasive techniques. Having a dedicated, comprehensive multidisciplinary team focused on thoracic oncology is greatly needed, especially for high-risk patients. The importance of having a multidisciplinary team is even more relevant in community-based oncology centers where patients may not be evaluated by all subspecialties.
As low-dose CT screening adoption and implementation increases, we will hopefully identify more patients with early-stage lung cancers. Although the study by Dupuy and colleagues had some interesting results, it really highlights the need to evaluate newer treatment modalities in a randomized controlled manner. Doing so would allow us to make the best treatment recommendations for our early-stage and high-risk NSCLC patients.
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