Temozolomide in aggressive pituitary tumours and pituitary carcinomas

McCormack, Ann

doi:10.1016/j.beem.2022.101713

Cited by 17 publications

(15 citation statements)

References 80 publications

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“…At least one available experienced neuroophthalmologist is required, although in some centers computerized visual eld examination is carried out by the endocrinologist, due to the role of visual eld defects in diagnosis and follow-up of pituitary macroadenomas, particularly when non-secretory [58], but also when secreting in special conditions (e.g., pregnant woman with macroprolactinoma). On the other hand, progressively more frequent use of chemotherapy for invasive refractory pituitary adenomas [59] would require the presence of at least one neuro-oncologist in a PTCOE.…”

Section: Discussionmentioning

confidence: 99%

Validation of criteria for defining Pituitary Tumors Centers of Excellence (PTCOE)

Giustina

Uygur

Frara

et al. 2023

Preprint

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Purpose The Pituitary Society established the concept and mostly qualitative parameters for defining uniform criteria for pituitary tumor centers of excellence (PTCOEs) based on expert consensus. To validate those previously proposed criteria through collection and evaluation of self-reported activity of several internationally-recognized tertiary pituitary centers, thereby transforming the qualitative 2017 definition into a validated quantitative one, which could serve as the basis for future objective PTCOE accreditation. Methods An ad-hoc prepared database protocol was distributed to 9 Pituitary Centers chosen by the project scientific committee and comprising Centers of worldwide repute, which agreed to provide activity information derived from registries related to the years 2018-2020 and completing the database within 60 days. The database, composed of Excel® spreadsheets with requested specific information on leading and supporting teams provided by each Center, was reviewed by two blinded referees and all 9 of 9 candidate centers satisfied the overall PTCOE definition, according to referees’ evaluations. To obtain objective numerical criteria, median values for each activity/parameter were considered as the ideal PTCOE definition target, whereas the low limit of the range was selected as the acceptable target for each respective parameter. Results Three dedicated pituitary neurosurgeons were considered ideal, whereas one dedicated surgeon was acceptable. Moreover, 100 surgical procedures per year is ideal, while the results indicated that 50 surgeries per year is acceptable. Acute post-surgery complications, including mortality and readmission rates, should ideally be negligible or nonexistent, but acceptable criterion was a rate lower than 10% of patients with complications requiring readmission within 30 days after surgery. Four endocrinologists devoted to pituitary diseases are requested in a PTCOE and the total population of patients followed in a PTCOE should not be less than 850. It appears acceptable that at least one dedicated/expert in pituitary diseases is required in neuroradiology, pathology, and ophthalmology groups, whereas at least two expert radiation oncologists are needed. Conclusion This is, to our knowledge, the first study to survey and evaluate the activity of a relevant number of high-volume centers in the pituitary field. This effort, internally validated by ad-hocreviewers, allowed for transformation of previously formulated theoretical criteria for the definition of a PTCOE to precise numerical definitions based on real-life evidence. The application of a derived objective model can be used by external bodies for accreditation of pituitary centers as PTCOEs.

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Section: Discussionmentioning

confidence: 99%

Validation of criteria for defining Pituitary Tumors Centers of Excellence (PTCOE)

Giustina

Uygur

Frara

et al. 2023

Preprint

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“…Since 2006, TMZ has emerged as a therapeutic option for individuals with AgPitNETs/MetPitNETs refractory to conventional therapy with medical management and surgery with or without radiotherapy. Currently, TMZ is now considered a first-line treatment after failure of standard therapy in AgPitNETs/MetPitNETs as it has demonstrated the ability to improve 5-year progression-free and overall survival rates in responding patients [ 3 , 4 , 14 , 30 , 31 ].…”

Section: Therapeutic Managementmentioning

confidence: 99%

Aggressive and Metastatic Pituitary Neuroendocrine Tumors: Therapeutic Management and Off-Label Drug Use

Iglesias

2023

JCM

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Pituitary neuroendocrine tumors (PitNETs) are the most common pituitary tumors and the second most common brain tumors. Although the vast majority (>90%) are benign, a small percentage (<2%) are aggressive. These aggressive PitNETs (AgPitNETs) are defined by the presence of radiological invasion, a high rate of cell proliferation, resistance to conventional treatments, and/or a high propensity for recurrence. Lastly, there are the rare pituitary carcinomas, also known as metastatic PitNETs (MetPitNETs), which account for only 0.2% of cases and are defined by the presence of craniospinal or distant metastases. At present, there are no definitive factors that allow us to predict with certainty the aggressive behavior of PitNETs, making the therapeutic management of AgPitNETs a real challenge. Surgery is considered the first-line treatment for AgPitNETs and MetPitNETs. Radiation therapy can be effective in controlling tumor growth and regulating hormone hypersecretion. Currently, there are no approved non-endocrine medical therapies for the management of AgPitNETs/MetPitNETs, mainly due to the lack of randomized controlled clinical trials. As a result, many of the medical therapies used are off-label drugs, and several are under investigation. Temozolomide (TMZ) is now recognized as the primary medical treatment following the failure of standard therapy (medical treatment, surgery, and radiotherapy) in AgPitNETs/MetPitNETs due to its ability to improve overall and progression-free survival rates in responding patients over 5 years. Other therapeutic options include pituitary-targeted therapies (dopamine agonists and somatostatin analogs), hormonal antisecretory drugs, non-hormonal targeted therapies, radionuclide treatments, and immunotherapy. However, the number of patients who have undergone these treatments is limited, and the results obtained to date have been inconsistent. As a result, it is imperative to expand the cohort of patients undergoing treatment to better determine the therapeutic efficacy and safety of these drugs for individuals with AgPitNETs/MetPitNETs.

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“…[ 12 ] Recently, temozolomide (TMZ) has shown moderate efficacy for the treatment of refractory PAs. [ 13 , 14 ] Moreover, targeted therapies such as antiepidermal growth factor receptor, antivascular endothelial growth factor, and inhibitors of the mammalian target of rapamycin (mTOR) signaling pathway have also been used to treat refractory PAs. Cancer immunotherapy is a promising treatment option for patients with refractory PAs.…”

Section: Introductionmentioning

confidence: 99%

The reporting quality of randomized controlled trials in pharmacotherapy for pituitary adenomas

Yan,

Wang,

Zhao

et al. 2024

Medicine

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Background: Medical therapy has become an increasingly important intervention owing to improvements in the multidisciplinary care for pituitary adenomas (PAs). This study aimed to assess the reporting quality of randomized controlled trials (RCTs) on PAs pharmacotherapy. Methods: RCTs evaluating the efficacy of pharmacotherapy in PAs published in English between January 1, 1974, and December 31, 2022, were searched for and collected from PubMed and MEDLINE. The 2010 Consolidated Standards for Test Reports (CONSORT) statement-based 28 items overall quality score (OQS) was used to evaluate the overall quality of each report. Results: Twenty-seven related RCTs including 1816 patients were retrieved. The median OQS score was 12 (range, 6–19) on a scale of 0 to 28. Important items, such as background, objectives, participants, interventions, and outcomes, were sufficiently reported in 100% (27/27) of the articles. Statistical methods were adequately described in 93% (25/27) of patients. However, RCTs underreported identification as randomized trials in the title (3/27, 11%), sample size, allocation concealment, implementation, ancillary analysis method, and Diagram and Ancillary analyses (1/27, 4%). The OQS of published RCTs has significantly increased since 2010 (P = .012). The multivariate final model showed significant associations between higher OQS and publication since 2010 and enrollment of more than 100 patients. Conclusions: The overall reporting quality of RCTs on pharmacotherapy in PAs was poor, based on the 2010 CONSORT statement. However, we noticed an improvement in the OQS over the years and identified the factors associated with a better report. Increased effort is necessary to raise awareness of these issues among writers, readers, reviewers, and editors.

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Temozolomide in aggressive pituitary tumours and pituitary carcinomas

Cited by 17 publications

References 80 publications

Validation of criteria for defining Pituitary Tumors Centers of Excellence (PTCOE)

Validation of criteria for defining Pituitary Tumors Centers of Excellence (PTCOE)

Aggressive and Metastatic Pituitary Neuroendocrine Tumors: Therapeutic Management and Off-Label Drug Use

The reporting quality of randomized controlled trials in pharmacotherapy for pituitary adenomas

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