A novel neoadjuvant therapy for operable locally-invasive Non-Small Cell Lung Cancer (NSCLC). Phase I study of neo-adjuvant Stereotactic Body RadioTherapy (SBRT). LINNEARRE I (NCT02433574)

• Published in: Clinical lung cancer 2017
• Main Authors: Nguyen, N.-T.A, Isfahanian, N, Pond, G, Hanna, W, Cutz, J.-C, Wright, J, Swaminath, A, Shargall, Y, Chow, T, Wierzbicki, M, Okawara, G, Quan, K, Finley, C, Juergens, R, Tsakiridis, T
• Format: Article
• Language: English
• Subjects: Hematology, Oncology and Palliative Medicine; Pulmonary/Respiratory
• ISSN: 1525-7304
• DOI: 10.1016/j.cllc.2017.01.007

Abstract Background Despite improved staging and operative techniques, the rate of incomplete resection (R1) of non-small cell lung cancer (NSCLC) remains essentially unchanged. Patients with R1 resection have worse survival compared to those with complete resection (R0). Stereotactic body radiotherapy (SBRT) is a rapid and convenient radiotherapy treatment that delivers high dose radiotherapy to tumors with high precision while sparing normal organs. Although its efficacy in treating small lung tumors is documented, its use as neoadjuvant therapy for locally advanced (LA) NSCLC has not been examined. We hypothesized that a short course of pre-operative SBRT is feasible and can be delivered safely as a neoadjuvant therapy in patients at risk for incomplete resection. Methods In this phase I study, twenty patients with cT3-4, N0-1, M0 NSCLC at risk for incomplete resection will be treated with neoadjuvant SBRT followed by surgery and adjuvant chemotherapy. Four groups of 5 patients will be treated with escalating doses (35, 40, 45 and 50Gy) in 10 daily fractions. The primary outcome is feasibility, i.e. the ability to complete SBRT and surgery as planned (within 7 weeks). Secondary outcomes include acute and late adverse events, R0/R1/R2 rates and secondary surrogates of feasibility and safety. Relevance This study is an important first step in introducing a new therapeutic modality to patients with LA-NSCLC that could improve surgical outcomes in the future. If neo-adjuvant SBRT is found to be feasible and safe for LA-NSCLC, its effect in achieving R0 resection could be investigated in randomized trials.