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Single- Versus Multiple-Fraction Radiation Therapy for Painful Bone Metastases: A Systematic Review and Meta-analysis of Nonrandomized Studies.

ABSTRACT: Purpose:Single-fraction radiation therapy (RT) is a convenient and cost-effective regimen for the palliation of painful bone metastases, but is still underused. Randomized controlled trials comparing single- versus multiple-fraction RT are limited by generalizability. We compared the pain response rates after single- versus multiple-fraction RT in nonrandomized studies. Methods and Materials:We searched PubMed and Scopus from the inception of each database through August 2018. We sought to identify nonrandomized studies in which data on pain response rates could be extracted for single- and multiple-fraction RT. Our primary outcomes of interest were the overall and complete pain response rates in evaluable patients. The analysis was performed using a random-effects model with the Mantel-Haenszel method. Results:Of the 3933 articles identified through our search, 9 met our inclusion criteria. Five of 9 included studies did not exclude patients with features of complicated bone metastases. A 1 × 8 Gy radiation schedule was frequently used in single-fraction therapy, and schedules of 5 × 4 Gy and 10 × 3 Gy were frequently used in multiple-fraction therapy. In the 9 studies, the overall response rate was 67% (884 of 1321 patients) for patients in the single-fraction arm and 70% (953 of 1360 patients) for those in the multiple-fraction arm (pooled odds ratio [OR]: 0.85; 95% confidence interval [CI], 0.66-1.08). In 5 studies, the complete response rate was 26% (195 of 753 patients) for patients in the single-fraction arm and 35% (289 of 821 patients) for those in the multiple-fraction arm (pooled OR: 0.89; 95% CI, 0.70-1.13). Conclusions:There were no significant differences in the overall and complete response rates between single- and multiple-fraction RT. The effectiveness of single-fraction regimens was shown in nonrandomized settings, which better reflect daily practice than randomized studies. The CIs for the pooled ORs included clinically meaningful differences, and the study results are inconclusive.

SUBMITTER: Saito T

PROVIDER: S-EPMC6817531 | biostudies-literature | 2019 Oct-Dec

REPOSITORIES: biostudies-literature

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Single- Versus Multiple-Fraction Radiation Therapy for Painful Bone Metastases: A Systematic Review and Meta-analysis of Nonrandomized Studies.

Saito Tetsuo T Yamaguchi Kohsei K Toya Ryo R Oya Natsuo N

Advances in radiation oncology 20190628 4

<h4>Purpose</h4>Single-fraction radiation therapy (RT) is a convenient and cost-effective regimen for the palliation of painful bone metastases, but is still underused. Randomized controlled trials comparing single- versus multiple-fraction RT are limited by generalizability. We compared the pain response rates after single- versus multiple-fraction RT in nonrandomized studies.<h4>Methods and materials</h4>We searched PubMed and Scopus from the inception of each database through August 2018. We ...[more]

PMID: 31673664

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Project description:Introduction:Due to the neurocognitive side effects of whole brain radiation therapy (WBRT), stereotactic radiosurgery (SRS) is being used with increasing frequency. The use of SRS is expanding for patients with multiple (>4) brain metastases (BM). This study summarizes our institutional experience with single-fraction, linear-accelerator-based SRS for multiple BM. Methods and materials:All patients who were treated between January 1, 2013, and September 30, 2015, with single-fraction SRS for ?4 BM were included in this institutional review board-approved, retrospective, single-institution study. Patients were treated with linear accelerator-based image guided SRS. Results:A total of 59 patients with ?4 BM were treated with single-fraction SRS. The median follow-up was 15.2 months, and the median overall survival for the entire cohort was 5.8 months. The median number of treated lesions per patient was 5 (range, 4-23). Per patient, the median planning target volume (PTV) was 4.8?cc (range, 0.7-28.8?cc). The prescribed dose across all 380 BM for the 59 patients ranged from 7 to 20?Gy. The median of the mean dose to the total PTV was 19.5?Gy. Although the number of treated lesions (4-5 vs ?6) did not influence survival, better survival was noted for a total PTV <10?cc versus ?10?cc (7.1 vs 4.2 months, respectively; P?=?.0001). A mean dose of ?19?Gy to the entire PTV was also associated with increased survival (6.6 vs 5.0 months, respectively; P?=?.0172). Patients receiving a dose of >12?Gy to ?10?cc of normal brain had worse survival (5.1 vs 8.6 months, respectively; P?=?.0028). Conclusion:In single-fraction SRS for patients with multiple BM, smaller total tumor volume, higher total dose, and lower volume of normal brain receiving >12?Gy were associated with increased survival. These data suggest that using SRS for the treatment of multiple BM is efficacious and that outcomes may be affected more by total tumor volume than by the number of lesions.

Project description:Background: There is an increasing need for evidence-based efficiency in providing a growing amount of cancer care. One example of a quality gap is the use of multiple-fraction palliative radiation for patients with advanced cancer who have uncomplicated bone metastases; evidence suggests similar pain outcomes for treatment regimens with a lower burden of treatments. Methods: During the first phase of quality improvement work, we used RAND/UCLA appropriateness methodology to understand how radiation oncologists at one academic medical center rate the appropriateness of different treatment regimens for painful uncomplicated bone metastases. We compared radiation oncologist appropriateness ratings for radiation treatments with radiation therapy provided by these oncologists to patients with painful bone metastases between July 2012 and June 2013. Results: Appropriateness ratings showed that single-fraction (8 Gy) treatment (a low burden treatment) was consistently considered an appropriate option to treat a variety of uncomplicated bone metastases. The use of >10 fractions was consistently rated as inappropriate regardless of other factors. Eighty-one patients receiving radiation therapy for painful bone metastases during the study period had an available medical record for chart abstraction. Almost one-third of metastases were considered complicated because of a concern of spinal cord compression, a history of prior irradiation, or an associated pathological fracture. Among uncomplicated bone metastases, 25% were treated with stereotactic body radiation treatment (SBRT). Among the 54 uncomplicated bone metastases treated with conformal radiation, only one was treated with single-fraction treatment and 32% were treated with greater than 10 fractions. Conclusions: Treatment at the study site demonstrates room for improvement in providing low-burden radiation oncology treatments for patients with painful bone metastases. Choosing a radiation treatment schedule for patients with advanced cancer and painful bone metastases requires consideration of many medical and patient-centered factors. Our experience suggests that it will take more than the existence of guidelines to change practice in this area.

Project description:ImportanceTo our knowledge, there have been no clinical trials of ultra-high-dose-rate radiotherapy delivered at more than 40 Gy/sec, known as FLASH therapy, nor first-in-human use of proton FLASH.ObjectivesTo assess the clinical workflow feasibility and treatment-related toxic effects of FLASH and pain relief at the treatment sites.Design, setting, and participantsIn the FAST-01 nonrandomized trial, participants treated at Cincinnati Children's/UC Health Proton Therapy Center underwent palliative FLASH radiotherapy to extremity bone metastases. Patients 18 years and older with 1 to 3 painful extremity bone metastases and life expectancies of 2 months or more were eligible. Patients were excluded if they had foot, hand, and wrist metastases; metastases locally treated in the 2 weeks prior; metal implants in the treatment field; known enhanced tissue radiosensitivity; and implanted devices at risk of malfunction with radiotherapy. One of 11 patients who consented was excluded based on eligibility. The end points were evaluated at 3 months posttreatment, and patients were followed up through death or loss to follow-up for toxic effects and pain assessments. Of the 10 included patients, 2 died after the 2-month follow-up but before the 3-month follow-up; 8 participants completed the 3-month evaluation. Data were collected from November 3, 2020, to January 28, 2022, and analyzed from January 28, 2022, to September 1, 2022.InterventionsBone metastases were treated on a FLASH-enabled (≥40 Gy/sec) proton radiotherapy system using a single-transmission proton beam. This is consistent with standard of care using the same prescription (8 Gy in a single fraction) but on a conventional-dose-rate (approximately 0.03 Gy/sec) photon radiotherapy system.Main outcome and measuresMain outcomes included patient time on the treatment couch, device-related treatment delays, adverse events related to FLASH, patient-reported pain scores, and analgesic use.ResultsA total of 10 patients (age range, 27-81 years [median age, 63 years]; 5 [50%] male) underwent FLASH radiotherapy at 12 metastatic sites. There were no FLASH-related technical issues or delays. The average (range) time on the treatment couch was 18.9 (11-33) minutes per patient and 15.8 (11-22) minutes per treatment site. Median (range) follow-up was 4.8 (2.3-13.0) months. Adverse events were mild and consistent with conventional radiotherapy. Transient pain flares occurred in 4 of the 12 treated sites (33%). In 8 of the 12 sites (67%) patients reported pain relief, and in 6 of the 12 sites (50%) patients reported a complete response (no pain).Conclusions and relevanceIn this nonrandomized trial, clinical workflow metrics, treatment efficacy, and safety data demonstrated that ultra-high-dose-rate proton FLASH radiotherapy was clinically feasible. The treatment efficacy and the profile of adverse events were comparable with those of standard-of-care radiotherapy. These findings support the further exploration of FLASH radiotherapy in patients with cancer.Trial registrationClinicalTrials.gov Identifier: NCT04592887.

Dataset Information

Single- Versus Multiple-Fraction Radiation Therapy for Painful Bone Metastases: A Systematic Review and Meta-analysis of Nonrandomized Studies.

Publications

Single- Versus Multiple-Fraction Radiation Therapy for Painful Bone Metastases: A Systematic Review and Meta-analysis of Nonrandomized Studies.

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