Dataset Information

Minocycline Reduces Chemoradiation-Related Symptom Burden in Patients with Non-Small Cell Lung Cancer: A Phase 2 Randomized Trial.

ABSTRACT:

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 < .05).

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.

SUBMITTER: Wang XS

PROVIDER: S-EPMC7043289 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Publications

Minocycline Reduces Chemoradiation-Related Symptom Burden in Patients with Non-Small Cell Lung Cancer: A Phase 2 Randomized Trial.

Wang Xin Shelley XS Shi Qiuling Q Mendoza Tito T Lin Steven S Chang Joe Y JY Bokhari Raza H RH Lin Hui-Kai HK Garcia-Gonzalez Araceli A Kamal Mona M Cleeland Charles S CS Liao Zhongxing Z

International journal of radiation oncology, biology, physics 20191015 1

<h4>Purpose</h4>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.<h4>Methods and materials</h4>Patients with NSCLC sche ...[more]

PMID: 31627177

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Project description:ContextPrevious studies on quality of life (QOL) after lung cancer surgery have identified a long duration of symptoms postoperatively. We first performed a systematic review of QOL in patients undergoing surgery for lung cancer. A subgroup analysis was conducted focusing on symptom burden and its relationship with QOL.ObjectiveTo perform a qualitative review of articles addressing symptom burden in patients undergoing surgical resection for lung cancer.MethodsThe parent systematic review utilized search terms for symptoms, functional status, and well-being as well as instruments commonly used to evaluate global QOL and symptom experiences after lung cancer surgery. The articles examining symptom burden (n = 54) were analyzed through thematic analysis of their findings and graded according to the Oxford Centre for Evidence-based Medicine rating scale.ResultsThe publication rate of studies assessing symptom burden in patients undergoing surgery for lung cancer have increased over time. The level of evidence quality was 2 or 3 for 14 articles (cohort study or case control) and level of 4 in the remaining 40 articles (case series). The most common QOL instruments used were the Short Form 36 and 12, the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, and the Hospital Anxiety and Depression Score. Thematic analysis revealed several key findings: 1) lung cancer surgery patients have a high symptom burden both before and after surgery; 2) pain, dyspnea, cough, fatigue, depression, and anxiety are the most commonly studied symptoms; 3) the presence of symptoms prior to surgery is an important risk factor for higher acuity of symptoms and persistence after surgery; and 4) symptom burden is a predictor of postoperative QOL.ConclusionLung cancer patients undergoing surgery carry a high symptom burden which impacts their QOL. Measurement approaches use myriad and heterogenous instruments. More research is needed to standardize symptom burden measurement and management, with the goal to improve patient experience and overall outcomes.

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Dataset Information

Minocycline Reduces Chemoradiation-Related Symptom Burden in Patients with Non-Small Cell Lung Cancer: A Phase 2 Randomized Trial.

Purpose

Methods and materials

Results

Conclusions

Publications

Minocycline Reduces Chemoradiation-Related Symptom Burden in Patients with Non-Small Cell Lung Cancer: A Phase 2 Randomized Trial.

Similar Datasets

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