Dose escalation study of proton beam therapy with concurrent chemotherapy for stage III non-small cell lung cancer

Summary

The purpose of this study is to determine the recommended dose (RD) of proton beam therapy (PBT) for inoperable stage III non-small cell lung cancer (NSCLC). We tested two prescribed doses of PBT;66 Gy (relative biological effectiveness; RBE) in 33 fractions and 74 Gy (RBE) in 37 fractions in arms 1 and 2, respectively. The planning target volume (PTV) included the primary tumor and metastatic lymph nodes with adequate margins. Concurrent chemotherapy included intravenous cisplatin (60 mg/m², day 1) and oral S-1 (80, 100 or 120 mg based on body surface area, days 1-14), repeated as 4 cycles every 4 weeks. Dose-limiting toxicity (DLT) was defined as grade 3 or severe toxicities related to PBT during days 1-90. Each dose level was performed in 3 patients, and then escalated to the next level if no DLT occurred. When 1 patient developed a DLT, 3 additional patients were enrolled. Overall, nine patients (5 men, 4 women; median age, 72 years) were enrolled, including 6 in arm 1 and 3 in arm 2. The median follow-up time was 43 months, and the median progression-free survival was 15 months. In arm 1, grade 3 infection occurred in 1 of 6 patients, but no other DLT was reported. Similarly, no DLT occurred in arm 2. However, 1 patient in arm 2 developed grade 3 esophageal fistula at 9 months after the initiation of PBT. Therefore, we determined that 66 Gy (RBE) is the RD from overall clinical viewpoints. Clinical trial registration no.:UMIN000005585.

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