Safety Profile of 5-Aminolevulinic Acid as a Surgical Adjunct in Clinical Practice

Honorato‐Cia, Cristina; Martínez-Simón, Antonio; Cacho‐Asenjo, Elena; Guillén-Grima, Francisco; Tejada-Solís, Sonia; Díez-Valle, Ricardo

doi:10.1097/ana.0000000000000172

Cited by 17 publications

(12 citation statements)

References 19 publications

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“…[ 16 , 24 ] Photosensitivity side effect was probably minimized by protecting the skin and eyes of patients from direct light during 24 hours after 5-ALA was administered, similarly to described in other studies. [ 9 ]…”

Section: Discussionmentioning

confidence: 99%

“…Published studies with similar or bigger sample size to our study are retrospective and/or single centre. [ 9 – 11 ]…”

Section: Discussionmentioning

confidence: 99%

“…The 5-ALA effectiveness in usual clinical practice has been widely assessed in retrospective cohort studies but not in prospective studies. [ 9 – 11 ] We want to point out that in the available systematic reviews and/or metaanalysis studies related to intraoperative 5-ALA in high grade gliomas, the efficacy data assessed were obtained from clinical trials and observational studies together. [ 12 , 13 ] It is widely known that clinical trial conditions are strongly different from clinical practice setting, leading to relevant differences in the obtained results.…”

Section: Introductionmentioning

confidence: 99%

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Safety and Efficacy of 5-Aminolevulinic Acid for High Grade Glioma in Usual Clinical Practice: A Prospective Cohort Study

et al. 2016

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BackgroundDuring the last decade, the use of 5-aminolevulinic acid (5-ALA) has been steadily increasing in neurosurgery. The study's main objectives were to prospectively evaluate the effectiveness and safety of 5-ALA when used in clinical practice setting on high-grade gliomas’ patients.MethodsNational, multicenter and prospective observational study. Inclusion criteria: authorized conditions of use of 5-ALA. Exclusion criteria: contraindication to 5-ALA, inoperable or partial resected tumors, pregnancy and children. Epidemiological, clinical, laboratory, radiological, and safety data were collected. Effectiveness was assessed using complete resection of the tumor, and progression-free and overall survival probabilities.ResultsBetween May 2010 and September 2014, 85 patients treated with 5-ALA were included, and 77 were suitable for the effectiveness analysis. Complete resection was achieved in 41 patients (54%). Surgeons considered suboptimal the fluorescence of 5-ALA in 40% of the patients assessed. The median duration of follow-up was 12.3 months. The progression-free survival probability at 6 months was 58%. The median duration overall survival was 14.2 months. Progression tumor risk factors were grade of glioma, age and resection degree; and death risk factors were grade of glioma and gender. No severe adverse effects were reported. At one month after surgery, new or increased neurological morbidity was 6.5%. Hepatic enzymes were frequently increased within the first month after surgery; however, they subsequently normalized, and this was found to have no clinical significance.ConclusionIn clinical practice, the 5-ALA showed a good safety profile, but the benefits related to 5-ALA have not been yet clearly shown. The improved differentiation expected by fluorescence between normal and tumor cerebral tissue was suboptimal in a relevant number of patients; in addition, the expected higher degree of resection was lower than in clinical trials as well as incomplete resection was not identified as a prognostic factor risk for death. Because optimal fluorescence was correlated to higher complete resection rate, further research is needed to identify patients (or tumors) with more surgery benefits when using the 5-ALA.

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Section: Discussionmentioning

confidence: 99%

“…Published studies with similar or bigger sample size to our study are retrospective and/or single centre. [ 9 – 11 ]…”

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Safety and Efficacy of 5-Aminolevulinic Acid for High Grade Glioma in Usual Clinical Practice: A Prospective Cohort Study

et al. 2016

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“…In most of the subsequently reported studies, no significant toxicities have been reported. [42,44] Even in a recent large review of 207 cases, the safety profile was very favorable with no reported morbidity attributable to the use of ALA. [50] However, one must be cognizant of the potential complications and implement appropriate protocols to ensure minimization of complications (See Practical Tips section). Known cases of porphyrias are an evident contraindication for the use of ALA, although no cases have been reported that have been treated with ALA.…”

Section: Neurology India / March 2015 / Volume 63 / Issuementioning

confidence: 99%

δ-Aminolevulinic acid-induced fluorescence-guided resection of brain tumors

Moiyadi

Stummer²

2015

Neurol India

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Maximal resection of gliomas is the current standard of care. Various technical adjuncts facilitate this. Aminolevulinic acid (ALA)-induced fluorescence guided resection (FGR) is one such strategy. We review the current literature related to ALA FGR. It is based on the selective uptake of ALA into glioma cells and its preferential conversion to protoporphyrin IX. This selectivity provides a high positive predictive value for ALA induced fluorescence. Since the introduction of this technique, clinical experience supports its efficacy in improving resections in malignant gliomas when compared to other contemporary intraoperative imaging strategies such as the magnetic resonance imaging (MRI) or the adjuncts that exhibit passive permeability like fluorescein. Future research into the understanding of the basis of ALA metabolism in glioma cells and advances in visualization technology will potentially improve the scope of application of this technique.

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“…While minor, its route of oral administration can be an issue in patients who are unable to tolerate any oral intake. Additionally, it appears to cause adverse reactions such as photodermatosis (sunburn) needing 24 hour avoidance of sunlight exposure, GI upset, and abnormalities in liver function tests (25,26).…”

Section: -Alamentioning

confidence: 99%

Fluorescence-guided hepatobiliary surgery with long and short wavelength fluorophores

Lwin¹,

Hoffman²,

Bouvet³

2020

Hepatobiliary Surg Nutr

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Importance: Fluorescence-guided surgery (FGS) is a potentially powerful tool for hepatobiliary (HPB) surgery. The high sensitivity of fluorescence navigation is especially useful in settings where tactile feedback is limited.Objective: The present narrative review evaluates literature on the use of FDA-approved fluorophores such as methylene blue (MB), 5-aminolevulinic acid (5-ALA), and indocyanine green (ICG) for clinical intraoperative image-guidance during HPB surgery.Evidence Review: Approaches such as dosing, timing, imaging devices and comparative endpoints are summarized. The feasibility and safety of fluorophores in visualizing the biliary tree, identify biliary leaks, outline anatomic hepatic segments, identify tumors, and evaluate perfusion and graft function in liver transplants are discussed.Findings: Tumor-specific probes are a promising advancement in FGS with a greater degree of specificity.The current status of tumor-specific probes being evaluated in clinical trials are summarized.Conclusions and Relevance for Reviews: Relevant discussion of promising tumor-specific probes in pre-clinical development are discussed. Fluorescence-guidance in HPB surgery is relatively new, but current literature shows that the dyes are reliably able to outline desired structures with a variety of dosing, timing, and imaging devices to provide real-time intra-operative anatomic information to surgeons. Development of tumor-specific probes will further advance the field of HPB surgery especially during oncologic resections.

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Safety Profile of 5-Aminolevulinic Acid as a Surgical Adjunct in Clinical Practice

Abstract: Significant side effects appear to be uncommon. Blood count changes are likely multifactorial; surgical time may account for it partially, whereas 5-ALA role is not clear and may not be significant.

Cited by 17 publications

References 19 publications

Safety and Efficacy of 5-Aminolevulinic Acid for High Grade Glioma in Usual Clinical Practice: A Prospective Cohort Study

Safety and Efficacy of 5-Aminolevulinic Acid for High Grade Glioma in Usual Clinical Practice: A Prospective Cohort Study

δ-Aminolevulinic acid-induced fluorescence-guided resection of brain tumors

Fluorescence-guided hepatobiliary surgery with long and short wavelength fluorophores

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