Celiac plexus radiosurgery for pain management in advanced cancer: a multicentre, single-arm, phase 2 trial.

BACKGROUND: Refractory upper abdominal pain or lower back pain (retroperitoneal pain syndrome) related to celiac plexus involvement characterises pancreatic and other upper gastrointestinal malignancies and is an unmet need. We hypothesised that ablative radiation delivered to the celiac plexus would decrease pain. METHODS: This multicentre, single-arm, phase 2 study was done at eight hospitals in five countries (Israel, Poland, Canada, the USA, and Portugal). Eligible patients aged 18 years or older with an average pain level of 5-10 on the Brief Pain Inventory short form (BPI-SF), an Eastern Cooperative Oncology Group performance status score of 0-2, and either pancreatic cancer or other tumours involving the celiac axis, received a single fraction of 25 Gy of external-beam photons to the celiac plexus. The primary endpoint was complete or partial pain response based on a reduction of the BPI-SF average pain score of 2 points or more from baseline to 3 weeks after treatment. All evaluable patients with stable pain scores were included in response assessment. The trial is registered with ClinicalTrials.gov, NCT03323489, and is complete. FINDINGS: Between Jan 3, 2018, and Dec 28, 2021, 125 patients were treated, 90 of whom were evaluable. Patients were followed up until death. Median age was 65·5 years (IQR 58·3-71·8), 50 (56%) were female and 40 (44%) were male, 83 (92%) had pancreatic cancer, and 77 (86%) had metastatic disease. Median baseline BPI-SF average pain score was 6 (IQR 5-7). Of the 90 evaluable patients at 3 weeks, 48 (53%; 95% CI 42-64) had at least a partial pain response. The most common grade 3-4 adverse events, irrespective of attribution, were abdominal pain (35 [28%] of 125) and fatigue (23 [18%]). 11 serious adverse events of grade 3 or worse were recorded. Two grade 3 serious adverse events were probably attributed to treatment by the local investigators (abdominal pain [n=1] and nausea [n=1]), and nine were possibly attributed to treatment (seven were grade 3: blood bilirubin increased [n=1], duodenal haemorrhage [n=2], abdominal pain [n=2], and progressive disease [n=2]; and two were grade 5: gastrointestinal bleed from suspected varices 24 days after treatment [n=1] and progressive disease [advanced pancreatic cancer] 89 days after treatment [n=1]). INTERPRETATION: Celiac plexus radiosurgery could potentially be a non-invasive palliative option for patients with retroperitoneal pain syndrome. Further investigation by means of a randomised comparison with conventional celiac block or neurolysis is warranted. FUNDING: Gateway for Cancer Research and the Israel Cancer Association.

Meningioma Presenting With Intratumoral Hemorrhage on Active Surveillance.

Meningiomas are relatively common primary adult brain tumors. They are slow-growing, highly vascular, and graded according to histology, phenotypic and genotypic features. We present a case of a 66-year-old male with a history of tongue squamous cell carcinoma, which presented multiple risk factors for cardiovascular and thromboembolic events. A brain lesion was initially detected on a computed tomography (CT) scan and later characterized by magnetic resonance imaging (MRI). The multidisciplinary team decided to maintain surveillance due to the lack of associated symptoms. Upon expansion in size and acute intralesional hemorrhage seen on follow-up imaging, the patient was submitted to surgical excision. The histopathological testing determined it to be an atypical meningioma. Two months later, the patient received stereotactic radiotherapy, and a post-surgical MRI showed no evidence of tumor recurrence. This case report describes a rare occurrence of intratumoral hemorrhage in a meningioma during surveillance, highlighting the importance of vigilant monitoring and consideration of potential risk factors for hemorrhagic events.

Sclerosing Epithelioid Fibrosarcoma of the Spine: Diagnosis and Treatment of a Rare Entity.

Sclerosing epithelioid fibrosarcoma (SEF) is a rare subtype of sarcoma with high rates of local recurrence and distant metastasis. Morphologically, it resembles other mesenchymal and non-mesenchymal tumors, making it a diagnostic challenge. Treatment relies mostly on surgery with adjuvant chemotherapy or radiotherapy (RT). A 46-year-old woman who presented with lumbar pain and weight loss underwent a computed tomography (CT) scan, magnetic resonance imaging (MRI), and a [18F]-fluorodeoxyglucose positron emission tomography-computed tomography (18F-FDG PET/CT) scan, which showed a lesion involving the L5 vertebra. An incisional biopsy of the lesion established the diagnosis of SEF, with diffuse expression of MUC4 and focal expression of EMA. The patient was treated with neoadjuvant RT followed by surgery. Histology was congruent with the previous diagnosis and demonstrated post-radiation changes. In conclusion, SEF is an aggressive type of sarcoma that is easily misdiagnosed, so it is important to consider it in the differential diagnosis to avoid unbeneficial treatments and a detriment to patient survival.

Malignant Transformation of Retroauricular Hidradenoma in Hidradenocarcinoma in a Nine-Year-Old Patient: A Case Report.

Hidradenocarcinoma, a rare malignant entity that derives from sweat glands, is especially rare in the pediatric population. The treatment of choice is surgery. Radiation therapy is used only in selected patients. Chemotherapy is not used extensively because its effectiveness has not been demonstrated yet. This case report describes a nine-year-old female patient who presented in 2018 with a vegetative lesion in the right parietal region. After excisional surgery, pathology confirmed that the lesion was a benign hidradenoma. However, the lesion recurred six months later, and subsequent surgery revealed nodular hidradenoma with positive margins. In July 2019, a new heterogenous lesion appeared in the right retroauricular region, which was surgically removed. The pathology report found possible malignant characteristics, and the patient was referred to our hospital where she was diagnosed with poorly differentiated right retroauricular carcinoma with infiltrative and perineural permeation, along with homolateral lymph node metastasis. It was histologically compatible with a hidradenocarcinoma. The patient underwent a wide-margin excision and homolateral total cervical lymphadenectomy, followed by adjuvant radiotherapy. The last follow-up MRI was negative for disease recurrence or metastasis; however, a slow-growing node on the left jugular chain (level II) was noted. The patient is on regular follow-ups to monitor disease status and treatment-related adverse events. This case highlights the challenges of diagnosing and treating hidradenocarcinoma, a rare malignancy that requires aggressive management with a multidisciplinary approach. More robust clinical evidence is needed to define the best treatment approach for these aggressive tumors.

Coeliac plexus radiosurgery for pain management in patients with advanced cancer : study protocol for a phase II clinical trial.

INTRODUCTION: Pancreatic cancer is characterised by severe mid-back and epigastric pain caused by tumour invasion of the coeliac nerve plexus. This pain is often poorly managed with standard treatments. This clinical trial investigates a novel approach in which high-dose radiation (radiosurgery) is targeted to the retroperitoneal coeliac plexus nerve bundle. Preliminary results from a single institution pilot trial are promising: pain relief is substantial and side effects minimal. The goals of this study are to validate these findings in an international multisetting, and investigate the impact on quality of life and functional status among patients with terminal cancer. METHODS AND ANALYSIS: A single-arm prospective phase II clinical trial. Eligible patients are required to have severe coeliac pain of at least five on the 11-point BPI average pain scale and Eastern Cooperative Oncology Group performance status of two or better. Non-pancreatic cancers invading the coeliac plexus are also eligible. The intervention involves irradiating the coeliac plexus using a single fraction of 25 Gy. The primary endpoint is the complete or partial pain response at 3 weeks. Secondary endpoints include pain at 6 weeks, analgesic use, hope, qualitative of life, caregiver burden and functional outcomes, all measured using validated instruments. The protocol is expected to open at a number of cancer centres across the globe, and a quality assurance programme is included. The protocol requires that 90 evaluable patients" be accrued, based upon the assumption that a third of patients are non-evaluable (e.g. due to death prior to 3-weeks post-treatment assessment, or spontaneous improvement of pain pre-treatment), it is estimated that a total of 120 patients will need to be accrued. Supported by Gateway for Cancer Research and the Israel Cancer Association. ETHICS AND DISSEMINATION: Ethic approval for this study has been obtained at eight academic medical centres located across the Middle East, North America and Europe. Results will be disseminated through conference presentations and peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT03323489.

Results of the IROCA international clinical audit in prostate cancer radiotherapy at six comprehensive cancer centres.

To assess adherence to standard clinical practice for the diagnosis and treatment of patients undergoing prostate cancer (PCa) radiotherapy in four European countries using clinical audits as part of the international IROCA project. Multi-institutional, retrospective cohort study of 240 randomly-selected patients treated for PCa (n = 40/centre) in the year 2015 at six European hospitals. Clinical indicators applicable to general and PCa-specific radiotherapy processes were evaluated. All data were obtained directly from medical records. The audits were performed in the year 2017. Adherence to clinical protocols and practices was satisfactory, but with substantial inter-centre variability in numerous variables, as follows: staging MRI (range 27.5-87.5% of cases); presentation to multidisciplinary tumour board (2.5-100%); time elapsed between initial visit to the radiation oncology department and treatment initiation (42-102.5 days); number of treatment interruptions ≥ 1 day (7.5-97.5%). The most common deviation from standard clinical practice was inconsistent data registration, mainly failure to report data related to diagnosis, treatment, and/or adverse events. This clinical audit detected substantial inter-centre variability in adherence to standard clinical practice, most notably inconsistent record keeping. These findings confirm the value of performing clinical audits to detect deviations from standard clinical practices and procedures.

Multicentre clinical radiotherapy audit in rectal cancer: results of the IROCA project.

PURPOSE: To perform a clinical audit to assess adherence to standard clinical practice for the diagnosis, treatment, and follow-up of patients undergoing radiotherapy for rectal cancer treatment in four European countries. MATERIALS AND METHODS: Multi-institutional, retrospective cohort study of 221 patients treated for rectal cancer in 2015 at six European cancer centres. Clinical indicators applicable to general radiotherapy processes were evaluated. All data were obtained from electronic medical records. RESULTS: The audits were performed in the year 2017. We found substantial inter-centre variability in adherence to standard clinical practices: 1) presentation of cases at departmental clinical sessions (range, 0-100%) or multidisciplinary tumour board (50-95%); 2) pretreatment MRI (61.5-100%) and thoracoabdominal CT (15.0-100%). Large inter-centre differences were observed in the mean interval between biopsy and first visit to the radiotherapy department (range, 21.6-58.6 days) and between the first visit and start of treatment (15.1-38.8 days). Treatment interruptions ≥ 1 day occurred in 43.9% (2.5-90%) of cases overall. Treatment compensation was performed in 2.1% of cases. Treatment was completed in the prescribed time in 55.7% of cases. CONCLUSIONS: This multi-institutional clinical audit revealed that most centres adhered to standard clinical practices for most of the radiotherapy processes-related variables assessed. However, the audit revealed marked inter-centre variability for certain quality indicators, particularly inconsistent record keeping. Multiple targets for improvement and/or harmonisation were identified, confirming the value of routine clinical audits to detect potential deviations from standard clinical practice.

Improving radiation oncology through clinical audits: Introducing the IROCA project.

As radiotherapy practice and processes become more complex, the need to assure quality control becomes ever greater. At present, no international consensus exists with regards to the optimal quality control indicators for radiotherapy; moreover, few clinical audits have been conducted in the field of radiotherapy. The present article describes the aims and current status of the international IROCA "Improving Radiation Oncology Through Clinical Audits" project. The project has several important aims, including the selection of key quality indicators, the design and implementation of an international audit, and the harmonization of key aspects of radiotherapy processes among participating institutions. The primary aim is to improve the processes that directly impact clinical outcomes for patients. The experience gained from this initiative may serve as the basis for an internationally accepted clinical audit model for radiotherapy.

Locally advanced hypopharyngeal squamous cell carcinoma: single-institution outcomes in a cohort of patients curatively treated either with or without larynx preservation.

OBJECTIVE: The present study was aimed at describing a single-institution experience in the curative treatment of patients diagnosed with locally advanced hypopharyngeal squamous cell carcinoma. MATERIALS AND METHODS: Data concerning all patients treated for locally advanced hypopharyngeal squamous cell carcinoma between January 2006 and June 2012 were reviewed. RESULTS: A total of 144 patients were included in the present study. The median follow-up period was 36.6 months. Median survival was 26 months, and 2-year and 5-year overall survival rates were, 51% and 30.5%, respectively. Median recurrence-free survival was 18 months and 2-year and 5-year recurrence-free survival rates were 42.8% and 28.5%, respectively. CONCLUSION: The outcomes in the present series are in line with the literature.

Locally advanced hypopharyngeal squamous cell carcinoma: single-institution outcomes in a cohort of patients curatively treated either with or without larynx preservation / Carcinoma espinocelular da hipofaringe: resultados de uma instituição numa coorte de doentes tratados com intenção curativa com ou sem preservação da laringe

Abstract Objective: The present study was aimed at describing a single-institution experience in the curative treatment of patients diagnosed with locally advanced hypopharyngeal squamous cell carcinoma. Materials and Methods: Data concerning all patients treated for locally advanced hypopharyngeal squamous cell carcinoma between January 2006 and June 2012 were reviewed. Results: A total of 144 patients were included in the present study. The median follow-up period was 36.6 months. Median survival was 26 months, and 2-year and 5-year overall survival rates were, 51% and 30.5%, respectively. Median recurrence-free survival was 18 months and 2-year and 5-year recurrence-free survival rates were 42.8% and 28.5%, respectively. Conclusion: The outcomes in the present series are in line with the literature.

Resumo Objetivo: O objetivo deste estudo é descrever a experiência de uma instituição no tratamento com intenção curativa de doentes diagnosticados com carcinoma espinocelular da hipofaringe localmente avançado. Materiais e Métodos: Os dados relativos aos doentes portadores de carcinoma espinocelular da hipofaringe localmente avançado tratados entre janeiro de 2006 e junho de 2012 foram revistos. Resultados: Foram incluídos 144 doentes. O tempo mediano de seguimento foi 36,6 meses. A sobrevivência mediana, aos 2 anos e aos 5 anos foi 26 meses, 51% e 30,5%, respectivamente. A sobrevivência livre de recorrência mediana, aos 2 anos e aos 5 anos foi 18 meses, 42,8% e 28,5%, respectivamente. Conclusão: Os resultados encontrados na nossa série estão em acordo com a literatura.

Evaluation of axillary dose coverage following whole breast radiotherapy: variation with the breast volume and shape.

OBJECTIVE: To evaluate the axillary dose coverage in patients treated with tridimensional whole breast radiotherapy (3D-WBRT), according to the breast volume and shape in treatment position. BACKGROUND: Several studies have demonstrated an insufficient dose contribution to the axillary levels, using 3D-WBRT, remaining unclear whether the breast volume and shape can influence it. MATERIALS AND METHODS: We retrospectively delineated the axillary levels on planning CT-images of 100 patients, treated with 3D-WBRT along 2012 in our institution. To estimate the shape we established an anatomic CT-based interval, defined as the Thoracic Extent (TE). The breast volume matched its CTV. Mean dose levels and V95 (volume receiving at least 95% of the prescribed dose) were evaluated. RESULTS: Mean axillary level I (A1), II (A2) and III (A3) volume was 56.1 cc, 16.5 cc and 18.9 cc, respectively, and mean doses were 43.9 Gy, 38.6 Gy and 19.5 Gy. For breast volumes of <800 cc, 800-999 cc, 1000-1199 cc and >1200 cc, mean A1 V95 was 38%, 51%, 61.2% and 57.2% whereas median A2 V95 was 8.3%, 13.4%, 19.4% and 28% respectively. Regarding shape, where the breast relative position to the TE was categorized in intervals between 31% and 40%, 41% and 50%, 51% and 60%, and 61% and 70%, mean A1 V95 was 38.7%, 43.1%, 51.1% and 77.3% whereas mean A2 V95 was 6.1%, 11.2%, 17.1% and 37% respectively. CONCLUSIONS: We observed inadequate dose coverage to all axillary levels, even after applying a sub-analysis accounting for different breast volumes and shapes. Although higher doses were associated with the more voluminous and pendulous breasts, axillary coverage with 3D-WBRT seems to be inefficient, regardless of the breast morphology.