Purpose To review treatment outcomes for stereotactic body radiotherapy (SBRT) in medically operable patients with Stage I non–small-cell lung cancer (NSCLC), using a Japanese multi-institutional database. Patients and Methods Between 1995 and 2004, a total of 87 patients with Stage I NSCLC (median age, 74 years; T1N0M0, n = 65; T2N0M0, n = 22) who were medically operable but refused surgery were treated using SBRT alone in 14 institutions. Stereotactic three-dimensional treatment was performed using noncoplanar dynamic arcs or multiple static ports. Total dose was 45–72.5 Gy at the isocenter, administered in 3–10 fractions. Median calculated biological effective dose was 116 Gy (range, 100–141 Gy). Data were collected and analyzed retrospectively. Results During follow-up (median, 55 months), cumulative local control rates for T1 and T2 tumors at 5 years after SBRT were 92% and 73%, respectively. Pulmonary complications above Grade 2 arose in 1 patient (1.1%). Five-year overall survival rates for Stage IA and IB subgroups were 72% and 62%, respectively. One patient who developed local recurrences safely underwent salvage surgery. Conclusion Stereotactic body radiotherapy is safe and promising as a radical treatment for operable Stage I NSCLC. The survival rate for SBRT is potentially comparable to that for surgery.

Stereotactic body radiotherapy (SBRT) for operable Stage i non-small-cell lung cancer: Can SBRT be comparable to surgery?

https://www.jto.org/article/S1556-0864(15)32416-3/pdf

The international association for the study of lung cancer staging project: Prognostic factors and pathologic TNM stage in surgically managed non-small cell lung cancer

https://www.jtcvs.org/article/S0022-5223(19)30776-7/pdf

Comparison of pulmonary segmentectomy and lobectomy: Safety results of a randomized trial

Purpose To evaluate, in Japan Clinical Oncology Group study 0403, the safety and efficacy of stereotactic body radiation therapy (SBRT) in patients with T1N0M0 non-small cell lung cancer (NSCLC). Methods and Materials Eligibility criteria included histologically or cytologically proven NSCLC, clinical T1N0M0. Prescribed dose was 48 Gy at the isocenter in 4 fractions. The primary endpoint was the percent (%) 3-year overall survival. The threshold % 3-year survival to be rejected was set at 35% for inoperable patients, whereas the expected % 3-year survival was 80% for operable patients. Results Between July 2004 and November 2008, 169 patients from 15 institutions were registered. One hundred inoperable and 64 operable patients (total 164) were eligible. Patients' characteristics were 122 male, 47 female; median age 78 years (range, 50-91 years); adenocarcinomas, 90; squamous cell carcinomas, 61; others, 18. Of the 100 inoperable patients, the % 3-year OS was 59.9% (95% confidence interval 49.6%-68.8%). Grade 3 and 4 toxicities were observed in 10 and 2 patients, respectively. No grade 5 toxicity was observed. Of the 64 operable patients, the % 3-year OS was 76.5% (95% confidence interval 64.0%-85.1%). Grade 3 toxicities were observed in 5 patients. No grade 4 and 5 toxicities were observed. Conclusions Stereotactic body radiation therapy for stage I NSCLC is effective, with low incidences of severe toxicity. This treatment can be considered a standard treatment for inoperable stage I NSCLC. This treatment is promising as an alternative to surgery for operable stage I NSCLC.

Prospective Trial of Stereotactic Body Radiation Therapy for Both Operable and Inoperable T1N0M0 Non-Small Cell Lung Cancer: Japan Clinical Oncology Group Study JCOG0403.

https://www.jto.org/article/S1556-0864(15)31039-X/pdf

Japanese Lung Cancer Registry Study of 11,663 Surgical Cases in 2004: Demographic and Prognosis Changes Over Decade

https://www.jto.org/article/S1556-0864(15)31201-6/pdf

Toshihiro Nukiwa

Papers

A Japanese Lung Cancer Registry Study: Prognosis of 13,010 Resected Lung Cancers