Radiation-induced acute toxicities after image-guided intensity-modulated radiotherapy versus three-dimensional conformal radiotherapy for patients with spinal metastases (IRON-1 trial)

Sprave, Tanja; Verma, Vivek; Forster, R. E.; Schlampp, Ingmar; Brückner, Thomas; Bostel, Tilman; Welte, Stefan; Tonndorf-Martini, Eric; Shafie, Rami A El; Nicolay, Nils H.; Debus, Jürgen; Rief, Harald

doi:10.1007/s00066-018-1333-z

Cited by 25 publications

(17 citation statements)

References 30 publications

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“…Palbociclib might therefore act as a radiosensitizer on normal intestinal tissue, as palliative radiotherapy 36 or palbociclib 2 as single treatments are very unlikely to cause severe gastrointestinal side effects. In vivo data showed conflicting results, as palbociclib exposure resulted both in reduction 37,38 and increase 38 of acute gastrointestinal radiation syndrome in murine models, also depending on irradiation schedule 38 . Consequently, in case of concomitant CDK 4/6 inhibitor administration we advise the use of highly conformal treatment and optimization of the plan to maintain the dose as low as reasonably achievable to the gastrointestinal mucosa, especially in patients with high planning target volumes (PTVs) located in abdominal and pelvic areas and patients that experienced previous gastrointestinal toxicity.…”

Section: Resultsmentioning

confidence: 99%

A single-center retrospective safety analysis of cyclin-dependent kinase 4/6 inhibitors concurrent with radiation therapy in metastatic breast cancer patients

Guerini

Pedretti

Salah

et al. 2020

Sci Rep

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Cyclin dependent kinases 4/6 (CDK4/6) inhibitors gained an essential role in the treatment of metastatic breast cancer. Nevertheless, data regarding their use in combination with radiotherapy are still scarce. We performed a retrospective preliminary analysis of breast cancer patients treated at our Center with palliative radiation therapy and concurrent CDK4/6 inhibitors. Toxicities were measured according to CTCAE 4.0, local response according to RECIST 1.1 or PERCIST 1.0 and pain control using verbal numeric scale. 18 patients (32 treated sites) were identified; 50% received palbociclib, 33.3% ribociclib and 16.7% abemacliclib. Acute non-hematologic toxicity was fair, with the only exception of a patient who developed G3 ileitis. During 3 months following RT, 61.1% of patients developed G 3-4 neutropenia; nevertheless no patient required permanent suspension of treatment. Pain control was complete in 88.2% of patients three months after radiotherapy; 94.4% of patients achieved and maintained local control of disease. Radiotherapy concomitant to CDK4/6 inhibitors is feasible and characterized by a fair toxicity profile, with isolated episodes of high-grade reversible intestinal toxicity. Rate of G 3-4 neutropenia was comparable with that measured for CDK4/6 inhibitors alone. Promising results were reported in terms of pain relief and local control of disease. Selective cyclin dependent kinases 4/6 (CDK4/6) inhibitors block tumor suppressor retinoblastoma protein phosphorylation, preventing the transition of cancer cells from G1 to S phase with consequent inhibition of cell cycle and proliferation 1. To date, three CDK4/6 inhibitors are approved against hormone receptor positive, human epidermal growth factor receptor 2 negative metastatic or advanced breast cancer in combination with aromatase inhibitors or fulvestrant both in first and subsequent lines of therapy. After different phase III trials 2-7 reporting significant improvements in response rate and progression free survival, palbociclib was the

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Section: Resultsmentioning

confidence: 99%

A single-center retrospective safety analysis of cyclin-dependent kinase 4/6 inhibitors concurrent with radiation therapy in metastatic breast cancer patients

Guerini

Pedretti

Salah

et al. 2020

Sci Rep

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“…No patients were excluded post randomization. Baseline characteristics were balanced between the two treatment arms (Table 1 , as previously reported) [ 7 ].…”

Section: Resultsmentioning

confidence: 99%

Bone density and pain response following intensity-modulated radiotherapy versus three-dimensional conformal radiotherapy for vertebral metastases - secondary results of a randomized trial

et al. 2018

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BackgroundThis was a prespecified secondary analysis of a randomized trial that analyzed bone density and pain response following fractionated intensity-modulated radiotherapy (IMRT) versus three-dimensional conformal radiotherapy (3DCRT) for palliative management of spinal metastases.Methods/materialsSixty patients were enrolled in the single-institutional randomized exploratory trial, randomly assigned to receive IMRT or 3DCRT (30 Gy in 10 fractions). Along with pain response (measured by the Visual Analog Scale (VAS) and Chow criteria), quantitative bone density was evaluated at baseline, 3, and 6 months in both irradiated and unirradiated spinal bodies, along with rates of pathologic fractures and vertebral compression fractures.ResultsRelative to baseline, bone density increased at 3 and 6 months following IMRT by a median of 24.8% and 33.8%, respectively (p < 0.01 and p = 0.048). These figures in the 3DCRT cohort were 18.5% and 48.4%, respectively (p < 0.01 for both). There were no statistical differences in bone density between IMRT and 3DCRT at 3 (p = 0.723) or 6 months (p = 0.341). Subgroup analysis of osteolytic and osteoblastic metastases showed no differences between groups; however, mixed metastases showed an increase in bone density over baseline in the IMRT (but not 3DCRT) arm. The 3-month rate of the pathological fractures was 15.0% in the IMRT arm vs. 10.5% in the 3DCRT arm. There were no differences in pathological fractures at 3 (p = 0.676) and 6 (p = 1.000) months. The IMRT arm showed improved VAS scores at 3 (p = 0.037) but not 6 months (p = 0.430). Using Chow criteria, pain response was similar at both 3 (p = 0.395) and 6 (p = 0.732) months.ConclusionsThis the first prospective investigation evaluating the impact of IMRT vs. 3DCRT on bone density. Along with pain response and pathologic fracture rates, significant rises in bone density after 3 and 6 months were similar in both cohorts. Future randomized investigations with larger sample sizes are recommended.Trial registrationNCT, NCT02832830. Registered 14 July 2016

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“…We conducted analyses among different price of WBI and chemotherapy drugs; however, results showed no difference in cost‐effectiveness analyses if the effects were assumed to be equal. Although intensity‐modulated radiotherapy showed no superior to conformal radiotherapy on survival, it might contribute to less side effects 20,21 . There was no sufficient evidence for the difference of efficacy between imported and domestic pemetrexed, thus the utilities and transition probabilities might be different; we did not make a further comparison because of lack of relevant data 22,23…”

Section: Discussionmentioning

confidence: 96%

“…Although intensitymodulated radiotherapy showed no superior to conformal radiotherapy on survival, it might contribute to less side effects. 20,21 There was no sufficient evidence for the difference of efficacy between imported and domestic pemetrexed, thus the utilities and transition probabilities might be different; we did not make a further comparison because of lack of relevant data. 22,23 Sensitivity analyses were performed to minimize the potential bias and uncertainty of the study.…”

Section: Discussionmentioning

confidence: 99%

Cost‐effectiveness of icotinib versus whole‐brain irradiation with or without chemotherapy in EGFR‐mutant NSCLC patients with brain metastases

Bai

Liu

et al. 2020

Asia-Pac J Clncl Oncology

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Purpose: Nonsmall cell lung cancer (NSCLC) patients with brain metastases (BM) have a poor prognosis. Despite the traditional methods including radiotherapy and chemotherapy, epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) might benefit patients on survival and quality of life. We investigated the cost-effectiveness of icotinib compared with whole-brain irradiation (WBI) with or without chemotherapy for NSCLC patients with BM. Materials and methods: A Markov model was conducted based on the data of BRAIN trial. We compared the economic benefit between icotinib and the combination of WBI and WBI plus chemotherapy group. We considered disease progression as intracranial progression and overall progression separately. Sensitivity analyses were performed to observe the stability of the model.

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Radiation-induced acute toxicities after image-guided intensity-modulated radiotherapy versus three-dimensional conformal radiotherapy for patients with spinal metastases (IRON-1 trial)

Cited by 25 publications

References 30 publications

A single-center retrospective safety analysis of cyclin-dependent kinase 4/6 inhibitors concurrent with radiation therapy in metastatic breast cancer patients

A single-center retrospective safety analysis of cyclin-dependent kinase 4/6 inhibitors concurrent with radiation therapy in metastatic breast cancer patients

Bone density and pain response following intensity-modulated radiotherapy versus three-dimensional conformal radiotherapy for vertebral metastases - secondary results of a randomized trial

Cost‐effectiveness of icotinib versus whole‐brain irradiation with or without chemotherapy in EGFR‐mutant NSCLC patients with brain metastases

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