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Published on: February 12, 2017
Low-Dose Stereotactic Body Radiation Therapy-Based Radiation Therapy Followed by Pembrolizumab and Chemotherapy for
Xiangzhi Zhu1, Lijun Zhao1, Shuai Zhang2
1Department of Radiation Oncology, The affiliated Cancer Hospital of Nanjing Medical University, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, Nanjing, China.
Purpose:
Chemoradiation therapy is standard for unresectable stage III non-small cell lung cancer (NSCLC). This phase 1b study assessed the safety and surgical conversion of neoadjuvant low-dose stereotactic body radiation therapy (SBRT)-based radiation therapy followed by pembrolizumab and chemotherapy in patients with potentially resectable stage III NSCLC.
Methods And Materials:
Patients deemed potentially resectable by the multidisciplinary team received neoadjuvant low-dose SBRT-based radiation therapy to the primary tumor (24 Gy for peripheral lesions and 12 Gy for central lesions) delivered in 3 fractions. Selective planning target volumes were applied to spare critical structures and optimize surgical safety. Two cycles of 100-mg pembrolizumab plus platinum-based chemotherapy followed. Surgical feasibility was evaluated by the second multidisciplinary team 4 to 6 weeks after neoadjuvant therapy. The primary endpoint was safety; secondary endpoints included pathological complete response, progression-free survival, and overall survival.
Results:
Seventeen patients received neoadjuvant therapy, with no dose-limiting toxicities observed. Across the overall treatment course, grade 3 to 5 treatment-related adverse events were reported in 5 patients (29.4%), most commonly grade 3 leukopenia (2 patients, 11.8%), and included 1 grade 5 surgical event due to fatal pulmonary artery hemorrhage. Objective responses were noted in 16 patients (94.1%). Surgery was successfully conducted in 11 patients (64.7%), with 10 (90.9%) achieving R0 resection. Six patients (54.5%) achieved pathological complete response. At a median follow-up of 22.8 months (95% CI, 18.9-26.7), the median progression-free survival was 29.0 months (95% CI, 18.1-39.9), and median overall survival was 37.9 months (95%CI, 21.9-53.9).
Conclusions:
Neoadjuvant low-dose SBRT-based radiation therapy followed by pembrolizumab and chemotherapy is tolerable and demonstrates promising rates of surgical conversion and pathological response in patients with potentially resectable stage III NSCLC.
