To investigate how treatment complications are related to dosimetric parameters after ruthenium-106 brachytherapy for uveal melanoma, in a large, clinically homogeneous population.
A retrospective ...review was performed to evaluate patients affected by small and medium size uveal melanoma, treated with ruthenium-106 brachytherapy from December 2006 to December 2014. We excluded tumors with posterior margin within 1 mm from the edge of the optic disc and foveola. Main outcome measures were occurrence and time to radiation-related maculopathy, cataract, and optic neuropathy. Secondary end points included local recurrence and distant metastases. Kaplan-Meier analysis with log-rank test and univariate Cox proportional hazards model at 3 years were performed to identify the covariates affecting the outcome of radiation complications.
Two hundred thirty-nine patients, with sufficient data to evaluate the end points, were enrolled. Three years after plaque treatment, radiation maculopathy was found in 61 (25.5%) patients, cataract developed in 10 patients (4.2%) receiving a dose of 27 Gy or higher to the lens, and optic neuropathy was observed in 13 patients (5.4%) with an optic nerve dose exceeding 50 Gy and tumor proximity to optic disc of less than 4 mm. Tumor recurrences and tumor-related metastasis were found respectively in 20 (8.36%) and 14 (5.85%) patients.
Radiation maculopathy occurs within a median time of 31 months in 25% of cases after plaque treatment for uveal melanoma. The most significant risk factors are total dose and distance of tumor margin from the fovea. If the distance is greater than 11.22 mm, no signs of retinal damage are detected.
A prospective phase 1-2 clinical trial aimed at determining the recommended postoperative dose of simultaneous integrated boost volumetric modulated arc therapy (SIB-VMAT) in a large series of ...patients with high-risk and intermediate-risk endometrial cancer (HIR-EC) is presented. The study also evaluated the association between rate and severity of toxicity and comorbidities and the clinical outcomes.
Two SIB-VMAT dose levels were investigated for boost to the vaginal vault, whereas the pelvic lymph nodes were always treated with 45 Gy. The first cohort received a SIB-VMAT dose of 55 Gy in 25 consecutive 2.2-Gy fractions, and the subsequent cohort received higher doses (60 Gy in 2.4-Gy fractions).
Seventy consecutive HIR-EC patients, roughly half of whom were obese (47.1%) or overweight (37.1%), with Charlson Age-Comorbidity Index >2 (48.5%), were enrolled. Thirty-one patients (44.3%) were administered adjuvant chemotherapy before starting radiation therapy. All patients (n=35 per dose level) completed irradiation without any dose-limiting toxicity. Proctitis (any grade) was associated with radiation therapy dose (P=.001); not so enterocolitis. Grade ≥2 gastrointestinal (GI) and genitourinary (GU) toxicity were recorded in 17 (24.3%) and 14 patients (20.0%), respectively, and were not associated with radiation dose. As for late toxicity, none of patients experienced late grade ≥3 GI or grade ≥2 GU toxicity. The 3-year late grade ≥2 GI and GU toxicity-free survival were 92.8% and 100%, respectively, with no difference between the 2 dose levels. With a median follow-up period of 25 months (range, 4-60 months), relapse/progression of disease was observed in 10 of 70 patients (14.2%). The 3-year cumulative incidence of recurrence was 1.5% (95% confidence interval (CI): 0.2-10.7), whereas the 3-year disease-free survival was 81.3% (95% CI: 65.0-90.0).
This clinical study showed the feasibility of this technique and its good profile in terms of acute and late toxicity at the recommended doses even in aged and frail patients.
To determine the recommended dose of endoscopically assisted high-dose-rate intraluminal brachytherapy (HDR-192Ir-ILBT) as a palliative treatment of extrahepatic biliary tract cancer.
Patients with ...non-metastatic extrahepatic biliary cancer with age <80 years, unsuitable for surgical resection or radiochemotherapy for comorbidities or Eastern Cooperative Oncology Group (ECOG) ≥2 or patients with age ≥80 years were included. They were undergone to implantation of metal stents by endoscopic retrograde cholangiopancreatography followed by HDR-192Ir-ILBT. The initial dose of HDR-192-Ir-ILBT was 15 Gy. Three levels of dose were planned. At each dose level almost three patients were treated, and if no Grade 3-4 toxicity (considering as dose-limiting toxicity) was recorded, dose escalation was applied with 5 Gy increments until the maximum tolerated dose was established. A high dose Iridium-192 after loading system was used (Nucletron Microselectron HDR).
From May 2007 to January 2010, 18 patients underwent HDR-192Ir-ILBT, with one catheter in 12 patients and two catheters in six patients. Three levels of dose were planned: 15 Gy in three patients, 20 Gy in nine patients, and 25 Gy in six patients with daily dose of 500 cGy per fraction. One patient at Dose Level II experienced acute toxicity (cholangitis) related to brachytherapy procedure, so the cohort was expanded. No patient of Level III had a dose-limiting toxicity and we stopped at this dose level waiting to assess the late toxicity that has not yet appeared at the time of the analysis. Six months and 1 year overall survival was 77% and 59%, respectively, with a median of 12 months.
The recommended dose was defined as 25 Gy in five fractions. It will be used in a Phase II study to better evaluate tumor and symptom control in patients with extrahepatic biliary tract cancer.
Age is an unfavorable prognostic factor in glioblastoma multiforme (GBM). To assess the possibility and the advantage of radiotherapy (RT) plus concomitant/sequential temozolomide (TMZ) in patients ...over 65 years with GBM, we analyzed 4 prospective trials in terms of compliance and outcomes.
Elderly patients with histologically proven GBM, included in 4 prospective phase II studies with a Karnofsky Performance Status (KPS) >70 and a Charlson Comorbidity Index (CCI) <3, were selected for these analyses. Patients were treated by 3D-conformal RT (60 Gy), fractionated stereotactic conformal-RT (69.4 Gy), or intensity-modulated RT with simultaneous integrated boost (63 Gy). Concomitant (standard modality, first and last week, or from the Monday to Friday) and adjuvant chemotherapy with TMZ was administered. To stratify patients, recursive partitioning analysis was used. Safety and tolerability were measured by the National Cancer Institute Common Criteria. Progression-free survival (PFS) and overall survival (OS) were calculated by Kaplan-Meier method.
From 2001 to 2011, 201 patients were enrolled in 4 trials and 111 elderly patients were recruited for this analysis. Compliance was 96.4%: 4/111 patients discontinued treatment, prevalently for disease progression. During radiochemotherapy, acute toxicity was mild. At a median follow-up of 64 months (range, 9 to 122 mo), median PFS and OS were 10 and 13 months, respectively. Extent of surgery (P=0.009) and radiation dose (P=0.01) significantly improved survival.
Radiochemotherapy is effective and well tolerated by elderly patients when KPS >70 and CCI <3; therefore these criterions should be considered to enroll elderly patients in combined prospective study.
Abstract Background To explore the role of radiotherapy in the extrahepatic bile duct carcinoma, and to understand if and when radiotherapy could be effective for this group of patients. Methods A ...systematic review of recently published literature was completed. Recent studies using radiotherapy with survival data, resection rates and quality of life data have been analyzed. Results There are no randomized trials regarding the treatment of extrahepatic cholangiocarcinoma. The bulk of available studies suggest that in some cases radio-chemotherapy can be used as adjuvant therapy. Radiotherapy could also have a role in unresectable cholangiocarcinoma: external radiotherapy or intraluminal brachytherapy – alone or in combination – could improve the outcome in selected patients. Finally, radiotherapy, and in particular intraluminal brachytherapy, could be used as a palliative treatment to improve the quality of life and in controlling symptoms. Conclusion The role of radiotherapy in extrahepatic cholangiocarcinoma remains undefined due to the lack of randomized trials or otherwise properly controlled studies.
To analyze the outcome of patients with brain oligometastases treated by radiosurgery (SRS) or fractionated stereotactic radiotherapy (FSRT) after whole-brain radiotherapy (WBRT).
Overall survival ...(OS) and local control (LC) were evaluated in patients (patients) with 1-2 brain metastases.
Forty-seven patients were selected. They were submitted to WBRT (median dose=3,750 cGy) followed by SRS (17 patients; median dose=1,500 cGy) or FSRT (30 patients; median dose=2,000 cGy). Median follow-up was 102 months (range=17-151); the median survival was 22 months for the SRS group and 16 months for the FSRT group. One-year and 5-year survival was 56% and 16%, respectively, in SRT and 62.1% and 3%, respectively, in FSRT. Neither treatment proved to significantly impact OS (p=0.4). The 1-year LC rates were 80% and 61.1% in the two groups, respectively (p=0.15).
SRS or FSRT after WBRT could offer the same outcomes in patients with brain oligometasteses. Further investigation is warranted to confirm these data and define the optimal stereotactic modality.
Among biliary tract cancers, intrahepatic cholangiocarcinoma (ICC) has different characteristics compared with those in other sites. Current guidelines suggest several treatment options for ICC, ...including stereotactic body radiation therapy (SBRT). However, the role of SBRT in locally advanced ICC is unclear. The aim of the present study was to present a systematic review on the efficacy and safety of SBRT in ICC. A systematic review based on the PRISMA methodology was performed. Only papers reporting outcomes in terms of overall survival (OS) after SBRT in inoperable patients with ICC were included. Secondary aims were local control (LC), progression-free survival (PFS) and treatment-related toxicity. Six papers (145 patients) were included in the present analysis. SBRT was frequently used as a salvage treatment, since 28.6-66.7% of patients received previous systemic or local treatments. The median SBRT dose was 45 Gy delivered in 3-5 fractions. The median follow-up was 16 months, and median OS time was 14 months (range, 10-48 months). In one of the included studies, SBRT was significantly superior in terms of OS compared with both chemoradiation and trans-arterial-radio-embolization. The 1-year LC rate was 85% in one study, and 1-year PFS rates were 50 and 68% in two studies, respectively. Toxicity was generally not reported in detail or was reported including other sites of biliary cancers. Overall, limited evidence was available on the efficacy of SBRT in ICC, which should be further investigated in prospective studies with a larger number of patients. However, based on the available data, SBRT seems to produce similar results compared with other ICC treatments, with the advantage of being a very short and non-invasive therapy. Therefore, SBRT should be considered in selected patients with ICC.
This review was to focus on breast brachytherapy cosmetic assessment methods state of the art and to define the advantages and disadvantages related to.
We conducted a literature review of the major ...experience on breast brachytherapy cosmetic assessment methods in several databases (PubMed, Scopus, and Google Scholar databases). To identify the relevant works, a task force screened citations at title and abstract level to identify potentially relevant paper. An expert board reviewed and approved the text. The assessment systems were classified into three main groups: (1) the Oncological Toxicity Scales, (2) the Independent Patients Perspective Measures, (3) the Patient-Related Outcome Measures. Each cosmetic assessment method was evaluated following six parameters: (1) anatomical site, (2) advantages, (3) disadvantages, (4) subjective/objective, (5) quantitative/qualitative, (6) computers or pictures needs.
Eleven assessment methods were selected. Three methods were classified as Oncological Toxicity Scale, six in the Independent Patients Perspective Measures classification, and two as Patient-Related Outcome Measures. Six methods are subjective, while eight are objective. Four systems are classified as quantitative, four as qualitative while three both. Five systems need informatics support. Moreover, each method was discussed individually reporting the main characteristics and peculiarities.
Cosmesis is one major end point for the patient who has a malignancy of low lethal potential. In modern personalized medicine, there is a need for standardized cosmetic outcome assessments to analyze and compare the results of treatments. No gold standard methods currently exist. The result of this review is to summarize the various cosmesis methods, defining the strengths and weaknesses of each one and giving a line in research and clinical practice.
To evaluate the preliminary results of perioperative endoscopy-guided brachytherapy (BT) in recurrent sinonasal and nasopharyngeal tumors already treated for their primary tumor with a full course of ...radiotherapy.
Patients with recurrence and already treated with a previous full course of radiotherapy >65 Gy who underwent BT from December 2010 to January 2014 were taken into account for this work. Macroscopic disease was resected by an endoscopic approach, and catheters for BT were endoscopically positioned and fixed at the same time on the surgical bed. Surgery was performed under electromagnetic navigation guidance. The irradiation dose was 30 Gy in 12 fractions, 2.5 Gy each, twice a day, in 6 days.
We performed the endoscopy-guided BT 11 times in 9 patients; in two cases, no previous radiation therapy had been performed; and in one case, followup was too short to be considered. A total of 6 patients were eligible for the analysis. One patient underwent BT three times because of previous target margin recurrences. There were no immediate complications. The median and mean followups were 21 and 19 months, respectively. The median V90 and V85% were 93% and 95%, respectively. In one case, we had a transient deficit of the VI cranial nerve (G3), and in another case, we diagnosed a noncomplicated osteonecrosis (G2). The median disease-free survival is 12 months, and the median overall survival is 23 months.
The combination of endoscopy and BT seems to be a safe option for treating recurrent sinonasal and nasopharyngeal tumors.