International journal of radiation oncology, biology, physics
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Int. J. Radiat. Oncol. Biol. Phys. · Jan 2020
Randomized Controlled TrialMinocycline Reduces Chemoradiation-Related Symptom Burden in Patients with Non-Small Cell Lung Cancer: A Phase 2 Randomized Trial.
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. ⋯ 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.
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Int. J. Radiat. Oncol. Biol. Phys. · Nov 2019
Randomized Controlled Trial Multicenter Study Comparative StudyOne Versus Three Fractions of Stereotactic Body Radiation Therapy for Peripheral Stage I to II Non-Small Cell Lung Cancer: A Randomized, Multi-Institution, Phase 2 Trial.
Stereotactic body radiation therapy for early stage non-small cell lung cancer is a standard of care for medically inoperable patients. Our aim was to compare Common Terminology Criteria for Adverse Events thoracic grade 3 or higher adverse events (AEs) of 30 Gy in 1 fraction (arm 1) versus 60 Gy in 3 fractions (arm 2). ⋯ This randomized phase 2 study demonstrated that 30 Gy in 1 fraction was equivalent to 60 Gy in 3 fractions in terms of toxicity, LC, PFS, and OS. Quality of life measures of social functioning and dyspnea favored single-fraction SBRT.
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Int. J. Radiat. Oncol. Biol. Phys. · Nov 2019
Randomized Controlled Trial Multicenter StudyNet Pain Relief After Palliative Radiation Therapy for Painful Bone Metastases: A Useful Measure to Reflect Response Duration? A Further Analysis of the Dutch Bone Metastasis Study.
Pain response rates are equivalent after single 8 Gy and fractionated palliative radiation therapy for bone metastases. Reirradiation remains more frequent after a single fraction, although this does not simply reflect pain recurrence. Given the possible role of stereotactic radiation therapy in providing durable pain control, measures of durability are required. Net pain relief (NPR), the proportion of remaining life spent with pain response, may provide this. This study assesses the use of NPR as an outcome measure after palliative radiation therapy for bone metastases. ⋯ Patients who responded to conventional radiation therapy experienced improved pain control for approximately half of their remaining life. NPR may provide valuable information in assessing pain response durability. Missing data are, however, inevitable in this population. This must be minimized and the consequences recognized and reported. Additionally, reirradiation protocols and the frequency and duration of trial follow-up may have a significant impact upon this outcome, requiring careful consideration during trial design if NPR is to be used in future studies.
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Int. J. Radiat. Oncol. Biol. Phys. · Apr 2019
Randomized Controlled Trial Multicenter Study Comparative StudyLong-term Follow-up on NRG Oncology RTOG 0915 (NCCTG N0927): A Randomized Phase 2 Study Comparing 2 Stereotactic Body Radiation Therapy Schedules for Medically Inoperable Patients With Stage I Peripheral Non-Small Cell Lung Cancer.
To present long-term results of RTOG 0915/NCCTG N0927, a randomized lung stereotactic body radiation therapy trial of 34 Gy in 1 fraction versus 48 Gy in 4 fractions. ⋯ No excess in late-appearing toxicity was seen in either arm. Primary tumor control rates at 5 years were similar by arm. A median survival time of 4 years for each arm suggests similar efficacy, pending any larger studies appropriately powered to detect survival differences.
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Int. J. Radiat. Oncol. Biol. Phys. · Mar 2019
Randomized Controlled TrialModerate Hypofractionation in Intermediate- and High-Risk, Localized Prostate Cancer: Health-Related Quality of Life From the Randomized, Phase 3 HYPRO Trial.
The phase 3 Hypofractionated Irradiation for Prostate Cancer trial compared hypofractionated radiation therapy with conventionally fractionated radiation therapy in patients with localized prostate cancer. Similar 5-year relapse-free survival rates were achieved in both groups, but noninferiority of hypofractionation was not confirmed for genitourinary and gastrointestinal toxicity. Here, we present the secondary trial endpoint on patient-reported quality of life. ⋯ Noninferiority of the hypofractionated treatment was not demonstrated for genitourinary and gastrointestinal quality of life, and therefore we cannot rule out that relevant differences may exist between both treatments. Noninferiority of hypofractionation was demonstrated for symptoms related to androgen deprivation therapy, sexual activity, and sexual function.