American College of Surgeons Oncology Group Z4099/Radiation Therapy Oncology Group 1021: A randomized study of sublobar resection compared with stereotactic body radiotherapy for high-risk stage I non–small cell lung cancer

During the past decade, tremendous interest has arisen in the use of nonoperative therapies for patients with non–small cell lung cancer. Of these therapies, stereotactic body radiotherapy has become established as an effective modality for treating peripheral cancer in medically inoperable patients. Toxicity is low, and the treatment is effective, with excellent local control rates. Several investigators have suggested that stereotactic body radiotherapy could be effective for high-risk operable patients (usually treated with sublobar resection) and even perhaps for standard-risk operable patients (usually treated with lobectomy); however, this is less accepted. A direct comparison of stereotactic body radiotherapy and sublobar resection is difficult for a number of reasons. These include different definitions of recurrence, different populations of patients in these studies (with those undergoing stereotactic body radiotherapy tending to be the medically inoperable group), and different methods of classifying morbidity in the surgical and radiation oncology studies. Imaging follow-up has also not been standardized among the studies. Thus, a randomized study is necessary and timely. Investigators from the American College of Surgeons Oncology Group and the Radiation Therapy and Oncology Group have collaborated to develop a phase III randomized study comparing stereotactic body radiotherapy and sublobar resection (with or without brachytherapy) for high-risk operable patients with non–small cell lung cancer. This study (American College of Surgeons Oncology Group Z4099/Radiation Therapy Oncology Group 1021) has recently opened for accrual. It is hoped that this will help to better define the role of these therapies for patients with non–small cell lung cancer.