Single fraction radiotherapy is efficacious: a further analysis of the Dutch Bone Metastasis Study controlling for the influence of retreatment

Linden, Yvette M. van der; Lok, Judith J.; Steenland, Elsbeth; Martijn, Hendrik; Houwelingen, Hans C. van; Marijnen, Corrie A.M.; Leer, J.W.H.

doi:10.1016/j.ijrobp.2003.10.006

Cited by 275 publications

(182 citation statements)

References 26 publications

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“…All patients provided informed consent and the Medical Ethics Committees of participating institutions approved the study. Further details of the DBMS and the study protocol were published elsewhere [1,30].…”

Section: Methodsmentioning

confidence: 99%

“…Pain was measured using an 10-point numeric rating scale, ranging from 0 (no pain) to 10 (the worst pain imaginable). A pain score of at least 2 was required to enter the study [1].…”

Section: Questionnairesmentioning

confidence: 99%

“…The pain response rate is above 60%, with the golden standard of a single fraction of 8 Gray (Gy) [1][2][3]. Although reduction of pain is the main treatment goal, it is also important to focus on quality of life (QoL) [4].…”

Section: Introductionmentioning

confidence: 99%

“…We aimed to identify factors predictive for PD. For this purpose, the data from the randomized Dutch Bone Metastasis Study (DBMS) [1] were used.…”

Section: Introductionmentioning

confidence: 99%

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Screening for psychological distress before radiotherapy for painful bone metastases may be useful to identify patients with high levels of distress

et al. 2017

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Background: Psychological distress (PD) has a major impact on quality of life. We studied the incidence of PD before and after radiotherapy for painful bone metastases. Furthermore, we aimed to identify factors predictive for PD. Methods: Between 1996 and 1998, the Dutch Bone Metastasis Study included 1157 patients with painful bone metastases. Patients were randomized between two fractionation schedules. The study showed a pain response of 74% in both groups. Patients filled out weekly questionnaires for 13 weeks, then monthly for two years. The questionnaires included a subscale for PD on the Rotterdam Symptom Checklist. We used generalized estimating equations and multivariable logistic regression analyses. Results: At baseline, 290 patients (27%) had a high level of PD. For the entire group, the level of PD remained constant over time. The majority of patients with a low level of PD at baseline remained at a low level during follow-up. In patients with a high level of PD at baseline, the mean level of PD decreased after treatment and stabilized around the cutoff level. Female patients, higher age, worse performance, lower pain score and worse self-reported QoL were associated with an increased chance of PD, although the model showed moderate discriminative power. Conclusions: A substantial proportion of patients had a high level of PD before and after radiotherapy for painful bone metastases. Most patients who reported high levels of PD when referred for palliative radiotherapy remained at high levels thereafter. Therefore, screening of PD prior to treatment seems appropriate, in order to select patients requiring intervention.

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Section: Methodsmentioning

confidence: 99%

“…Pain was measured using an 10-point numeric rating scale, ranging from 0 (no pain) to 10 (the worst pain imaginable). A pain score of at least 2 was required to enter the study [1].…”

Section: Questionnairesmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

“…We aimed to identify factors predictive for PD. For this purpose, the data from the randomized Dutch Bone Metastasis Study (DBMS) [1] were used.…”

Section: Introductionmentioning

confidence: 99%

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Screening for psychological distress before radiotherapy for painful bone metastases may be useful to identify patients with high levels of distress

et al. 2017

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“…The rationale for SAbR of the spine is demonstrated in excellent pain control, bone marrow sparing in adjacent vertebrae, and a conventional, short treatment course and recovery time 1 , 2 , 3 , 4 , 5 , 6 . With ablative dose delivery, treatment efficacy is balanced with dose‐related toxicity to the spinal cord, requiring a sharp dose gradient outside the target region.…”

Section: Introductionmentioning

confidence: 99%

Dosimetric comparison of Acuros XB with collapsed cone convolution/superposition and anisotropic analytic algorithm for stereotactic ablative radiotherapy of thoracic spinal metastases

Zhen

Hrycushko

Lee

et al. 2015

J Applied Clin Med Phys

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The aim of this study is to compare the recent Eclipse Acuros XB (AXB) dose calculation engine with the Pinnacle collapsed cone convolution/superposition (CCC) dose calculation algorithm and the Eclipse anisotropic analytic algorithm (AAA) for stereotactic ablative radiotherapy (SAbR) treatment planning of thoracic spinal (T‐spine) metastases using IMRT and VMAT delivery techniques. The three commissioned dose engines (CCC, AAA, and AXB) were validated with ion chamber and EBT2 film measurements utilizing a heterogeneous slab‐geometry water phantom and an anthropomorphic phantom. Step‐and‐shoot IMRT and VMAT treatment plans were developed and optimized for eight patients in Pinnacle, following our institutional SAbR protocol for spinal metastases. The CCC algorithm, with heterogeneity corrections, was used for dose calculations. These plans were then exported to Eclipse and recalculated using the AAA and AXB dose calculation algorithms. Various dosimetric parameters calculated with CCC and AAA were compared to that of the AXB calculations. In regions receiving above 50% of prescription dose, the calculated CCC mean dose is 3.1%–4.1% higher than that of AXB calculations for IMRT plans and 2.8%–3.5% higher for VMAT plans, while the calculated AAA mean dose is 1.5%–2.4% lower for IMRT and 1.2%–1.6% lower for VMAT. Statistically significant differences (p<0.05) were observed for most GTV and PTV indices between the CCC and AXB calculations for IMRT and VMAT, while differences between the AAA and AXB calculations were not statistically significant. For T‐spine SAbR treatment planning, the CCC calculations give a statistically significant overestimation of target dose compared to AXB. AAA underestimates target dose with no statistical significance compared to AXB. Further study is needed to determine the clinical impact of these findings.PACS number: 87.55.D‐, 87.53.Ly

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Reanalyses of Randomized Clinical Trial Data

Ebrahim

Sohani

Montoya

et al. 2014

JAMA

161

105

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Well-conducted randomized clinical trials (RCTs) are the gold standard for evaluating the safety and efficacy of medical therapeutics. Yet most often, a single group of individuals who conducted the trial are the only ones who have access to the raw data, conduct the analysis, and publish the study results. This limited access does not typically allow others to replicate the trial findings. Given the time and expense required to conduct an RCT, it is often unlikely that others will independently repeat a similar experiment. Thus, the scientific community and the public often accept the results produced and published by the original research team without an opportunity for reanalysis. Increasingly, however, opinions and empirical data are challenging the assumption that the analysis of a clinical trial is straightforward and that analysis by any other group would obtain the same results. [1][2][3] In this issue of JAMA, Ebrahim et al 4 report their findings based on a rigorous search of previously published reanalyses of RCTs. Their first surprising and discomforting finding was just how infrequently data reanalysis has occurred in medical research. Searching the literature from 1966 to present, the authors found only 37 reports that met their criteria as an RCT reanalysis. Of these few reanalyses performed, the majority (84%) had overlapping authors from the original report. Thus, reanalyses are not only rare, but the majority that were reported were not fully independent of the original research group. Despite this overlap, Ebrahim et al report that about half of the reanalyses differed in statistical or analytic approaches, a third differed in the definitions or measurements of outcomes, and most important, a third led to interpretations and conclusions different than those in the original article. While the definition of what constituted different trial analyses, study end points, findings, and interpretations is subjective, the authors' general conclusions were consistent with an emerging literature that indicates RCT reanalysis can yield different results and conclusions from those originally published. Even when the original investigators are presenting evidence in different venues it is not always consistent. For example, there is evidence from trials that data presented to the US Food and Drug Administration (FDA) may differ in important ways from those originally presented at scientific sessions or published in medical journals. Rising et al 5 assessedclinical trial information provided to the FDA and reported a 9% discordance between the conclusions in the report to the FDA and in the published article. Not unexpectedly, all were in the direction favoring the drug.Another example is discordance between what is reported in ClinicalTrials.gov and what is published in journal articles. Hartung et al 2 showed that in a random sample of phase 3 and 4 trials, in 15% the primary end point in the main article was different from the primary end point the trialists reported in ClinicalTrials.gov. Moreover, 22% re...

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Single fraction radiotherapy is efficacious: a further analysis of the Dutch Bone Metastasis Study controlling for the influence of retreatment

Cited by 275 publications

References 26 publications

Screening for psychological distress before radiotherapy for painful bone metastases may be useful to identify patients with high levels of distress

Screening for psychological distress before radiotherapy for painful bone metastases may be useful to identify patients with high levels of distress

Dosimetric comparison of Acuros XB with collapsed cone convolution/superposition and anisotropic analytic algorithm for stereotactic ablative radiotherapy of thoracic spinal metastases

Reanalyses of Randomized Clinical Trial Data

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