Characteristics of Radiotherapy Trials Compared With Other Oncological Clinical Trials in the Past 10 Years

Liu, Xu; Zhang, Yuan; TANG, Ling; Le, Quynh Thu; Chua, Melvin L.K.; Wee, Joseph; Lee, Nancy Y.; O’Sullivan, Brian; Lee, Anne W.M.; Sun, Ying

doi:10.1001/jamaoncol.2018.0887

Cited by 41 publications

(41 citation statements)

References 24 publications

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“…This was a retrospective study. Given the difficulty of clinical research on radiotherapy in the TKI-targeted era and only few prospective studies on TKI combined with radiotherapy for brain metastasis (14), this retrospective data also had good reference value. Prospective studies can be conducted in the future to further confirm the results of this retrospective study (15).…”

Section: Discussionmentioning

confidence: 89%

Tyrosine Kinase Inhibitor Resistance Increased the Risk of Cerebral Radiation Necrosis After Stereotactic Radiosurgery in Brain Metastases of Non-small-Cell Lung Cancer: A Multi-Institutional Retrospective Case-Control Study

et al. 2020

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This study aimed to investigate the relationship between the timing of stereotactic radiosurgery (SRS) intervention and the complications of cerebral radiation necrosis (CRN) in patients with brain metastases of lung adenocarcinoma who received tyrosine kinase inhibitor (TKI) treatment. Methods: A total of 361 targets from 257 patients with brain oligometastases of lung adenocarcinoma who received CyberKnife treatment between 2010 and 2017 were retrospectively collected from three CyberKnife centers. The difference in brain necrosis between patients with or without TKI application was statistically counted. Logistic regression analysis was used to analyze the effect of applying TKI on the occurrence of CRN in patients and the effect of SRS before and after TKI resistance on CRN. Results: The rate of CRN in the TKI group was significantly higher than that in the non-TKI group. The incidence of brain necrosis in patients undergoing SRS after drug resistance was significantly higher than that in patients undergoing SRS before drug resistance. Regression analysis showed that combination of TKI with SRS, and SRS after TKI resistance were important influencing factors for CRN. Conclusion: Performing the SRS for brain metastases after TKI resistance worsened the occurrence of CRN of patients treated with TKI. Clinical Trial Registration: Chinese clinical trial registry, http://www.chictr.org. cn/edit.aspx?pid=38395&htm=4, Registration number: ChiCTR1900022750.

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Section: Discussionmentioning

confidence: 89%

Tyrosine Kinase Inhibitor Resistance Increased the Risk of Cerebral Radiation Necrosis After Stereotactic Radiosurgery in Brain Metastases of Non-small-Cell Lung Cancer: A Multi-Institutional Retrospective Case-Control Study

et al. 2020

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“…However, similar situations were highly likely to exist in other treatment modalities, including radiotherapy and surgery. For example, our previous study found that the number of radiotherapy trials was very limited, despite that as many as 50% of patients with cancer receive radiotherapy . Second, because the Sunshine Act was aimed at disclosing payments between physicians and the industry, we were unable to collect data on FCOIs among patients’ advocates and the NCCN staff .…”

Section: Discussionmentioning

confidence: 95%

Evidence Underlying Recommendations and Payments from Industry to Authors of the National Comprehensive Cancer Network Guidelines

et al. 2018

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Background. The National Comprehensive Cancer Network (NCCN) guidelines are among the most widely used guidance in oncology. It is critical to understand the extent to which the recommendations in these guidelines are supported by evidence and to investigate whether these recommendations have been influenced by payments from industry to authors. Materials and Methods. We examined the quality and consistency of evidence, as scored by guidelines authors, for systemic treatment incorporated in the NCCN guidelines. Payments data in 2015 were manually abstracted using the Open Payments database, which discloses all payments between the industry and American physicians. Correlations between the percentage of authors who received payments and the proportion of recommendations developed from low-level evidence per guideline were calculated using Spearman rank correlation. Results. In total, 1,782 recommendations were identified in 29 guidelines, of which 1,282 (71.9%) were based on low-quality or low-consistency evidence (low-level evidence), including "case reports or clinical experience only" (18.9%). A substantial proportion (31/143, 21.7%) of category 1 (the highest level) recommendations were based on lowlevel evidence. The majority of authors (87.1%) received payments from industry. However, no association was found between the prevalence of payments among authors and the percentage of recommendations developed from low-level evidence per guideline. Conclusion. The majority of systemic treatment recommendations in the NCCN guidelines are based on low-level evidence, including more than one in five category 1 recommendations. Payments from industry were prevalent among authors. However, industrial payments among authors were not associated with inclusion of regimen/ agent for which there is no conclusive evidence in the guidelines. The Oncologist 2019;24:498-504 Implications for Practice: The authors found that the majority (71.9%) of systemic treatment recommendations issued in the current National Comprehensive Cancer Network guidelines were based on low-level evidence. Physicians should remain cautious when using current guidelines as the sole source guiding patient care decisions.

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“…Of course, that is related to the growing market for pharmaceutical agents in malignancy treatment, and the industrial sponsors strongly supported approximately a third (286/827) of the studies in past years and half of the studies (757/1674) in the contemporary years. On previous report to analyze oncologic trials regardless of the phases of study during recent 10 years, the radiotherapy trials consisted of only 5.3% of whole trials and received a week industrial support of 5.8% [3].…”

Section: Discussionmentioning

confidence: 99%

Where is clinical research for radiotherapy going? Cross-sectional comparison of past and contemporary phase III clinical trials

2020

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Purpose: The features of past and contemporary phase III clinical trials for radiotherapy were reviewed to activate future clinical trials and to advise on actual clinical practice. Methods and materials: The phase III clinical trials for radiotherapy were searched in the database of 'ClinicalTrials. gov' by the U.S. National Institute of Health. Using the staring date, the studies during each period of 4 years were collected for the past (from Jan 2000 to Dec 2003) and contemporary (July 2014 to June 2018) years. For the investigated subjects, the patterns of studies were classified as: Category A, the comparisons of rival radiotherapy protocols; Category B, the comparisons of multidisciplinary approaches; Category C, the investigation of supplementary agents; and Category D, the investigation of optimal partners for concurrent radiotherapy. Results: The number of studies increased, from 96 past to 158 contemporary studies. The patterns of studies were similar with the mild increase of Category A in the contemporary years (22.9% vs. 29.1%). For the study locations and the funding sources, the Chinese studies (2.1% vs. 34.2%, P < 0.001) and the affiliated institutions of researchers (37.5% vs. 72.2%, P < 0.001) markedly increased in the contemporary years from the past Western studies and nonprofit organization, respectively. The robust radiation techniques were more usual in the contemporary years (11.5% vs. 44.9%, P < 0.001). The fractionation schedule and delivery technique were the common issues in both past and contemporary years of Category A. In Category B, the indications of stereotactic radiotherapy was the rising concern, with eight ongoing studies. Except for the studies of palliative or prophylactic goals and stereotactic radiotherapy, the escape from conventional fraction size was 37.9% (36/95) in the contemporary years with the median fraction size of 2.5 Gy (range 2.05-6.6 Gy) in the comparison with 19.0% (15/79) in the past years (P = 0.006). Conclusions: To activate the clinical trials for radiotherapy, the funding sources would be diversified, including industrial support. Hypofractionated schedules using robust techniques could be preemptively considered in actual clinical practice.

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Characteristics of Radiotherapy Trials Compared With Other Oncological Clinical Trials in the Past 10 Years

Abstract: The limited number of and the scarcity of funding for radiotherapy trials is concerning given the integral role of radiotherapy in the clinical management of patients with cancer worldwide. A multidisciplinary collaboration to promote and fund more radiotherapy research is warranted.

Cited by 41 publications

References 24 publications

Tyrosine Kinase Inhibitor Resistance Increased the Risk of Cerebral Radiation Necrosis After Stereotactic Radiosurgery in Brain Metastases of Non-small-Cell Lung Cancer: A Multi-Institutional Retrospective Case-Control Study

Tyrosine Kinase Inhibitor Resistance Increased the Risk of Cerebral Radiation Necrosis After Stereotactic Radiosurgery in Brain Metastases of Non-small-Cell Lung Cancer: A Multi-Institutional Retrospective Case-Control Study

Evidence Underlying Recommendations and Payments from Industry to Authors of the National Comprehensive Cancer Network Guidelines

Where is clinical research for radiotherapy going? Cross-sectional comparison of past and contemporary phase III clinical trials

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