• Xin Shelley Wang, Qiuling Shi, Tito Mendoza, Steven Lin, Joe Y Chang, Raza H Bokhari, Hui-Kai Lin, Araceli Garcia-Gonzalez, Mona Kamal, Charles S Cleeland, and Zhongxing Liao.
• Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas. Electronic address: xswang@mdanderson.org.
• Int. J. Radiat. Oncol. Biol. Phys. 2020 Jan 1; 106 (1): 100-107.

PurposeIn patients with non-small cell lung cancer (NSCLC), concurrent chemoradiation therapy (CRT) exacerbates a cluster of difficult-to-manage symptoms, especially cancer-related fatigue. Minocycline is a readily available, low-cost antibiotic with antiinflammatory properties. We conducted a phase 2 randomized, double-blinded, placebo-controlled trial to investigate the effect of minocycline in reducing CRT-symptom burden in NSCLC.Methods And MaterialsPatients with NSCLC scheduled to receive CRT provided consent and were randomized to receive either minocycline (100 mg twice daily) or a matching placebo during 6 to 7 weeks of CRT. Patient-reported fatigue and other symptoms were assessed on MD Anderson Symptom Inventory weekly from the start of CRT for 12 weeks. The primary outcome was 12-week (±2 days) area under the curve for symptom burden, which was compared between treatment groups.ResultsForty of 49 enrolled patients (80%) were evaluable (19 on minocycline and 21 on placebo). There were no grade 3 + adverse events related to the study medication. Fatigue was significantly reduced in the minocycline group compared with placebo group during the 12-week trial period (area under the curve = 31.2 ± 14.2 vs 45.0 ± 20.9, P = .011), with a large effect size (Cohen's d = 0.77). Pain (Cohen's d = 0.54) and shortness of breath (Cohen's d = 0.55) were also significantly reduced in the minocycline group (all P < .05).ConclusionsMinocycline during CRT for NSCLC was feasible, had a low toxicity profile, and yielded a clinically and statistically significant positive signal in reducing symptom burden related to NSCLC and CRT. This study is a proof of concept so a larger trial in CRT patients is warranted.Copyright © 2019 Elsevier Inc. All rights reserved.

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