Minocycline Reduces Chemoradiation-Related Symptom Burden in Patients with Non-Small Cell Lung Cancer: A Phase 2 Randomized Trial
| Autor: | Araceli Garcia-Gonzalez, Qiuling Shi, Zhongxing Liao, Charles S. Cleeland, Mona Kamal, Steven H. Lin, Xin Shelley Wang, Tito R. Mendoza, Raza H Bokhari, Joe Y. Chang, H. Lin |
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| Rok vydání: | 2020 |
| Předmět: |
Male
Cancer Research medicine.medical_specialty Lung Neoplasms Minocycline Placebo Proof of Concept Study Article 030218 nuclear medicine & medical imaging law.invention 03 medical and health sciences 0302 clinical medicine Double-Blind Method Randomized controlled trial law Carcinoma Non-Small-Cell Lung Internal medicine medicine Humans Radiology Nuclear Medicine and imaging Prospective Studies Lung cancer Adverse effect Prospective cohort study Fatigue Aged Aged 80 and over Radiation business.industry Anti-Inflammatory Agents Non-Steroidal Area under the curve Chemoradiotherapy Middle Aged medicine.disease Anti-Bacterial Agents Clinical trial Dyspnea Oncology Area Under Curve 030220 oncology & carcinogenesis Quality of Life Female business medicine.drug |
| Zdroj: | Int J Radiat Oncol Biol Phys |
| ISSN: | 0360-3016 |
| Popis: | Purpose In 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 Materials Patients 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. Results Forty 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 Conclusions Minocycline 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. |
| Databáze: | OpenAIRE |
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