Body Radiation Therapy For Patients Research Articles

Stereotactic Body Radiation Therapy for Patients with Early-stage Prostate Cancer.

Stereotactic body radiation therapy (SBRT) is emerging as a new treatment option for early-stage prostate cancer, theoretically providing clinical and economic benefits compared to conventionally fractionated external-beam radiation therapy (CF-EBRT). This review aimed to evaluate available published data to determine if the proposed theoretical benefits translate clinically. A systematic search strategy was employed across three databases using predefined search terms, inclusion and exclusion criteria to identify relevant articles. Sixteen articles were included. Biochemical progression-free survival rates of 77.1-100% were reported in SBRT studies compared to 55-98% in CF-EBRT studies. Incidence of acute grade 1, 2, and 3 genitourinary toxicities were reported in the range of 13.3-71%, 12-25% and 0-3%, respectively, in the SBRT cohort in comparison to 28.7-51.9%, 15.6-41.4%. and 1.1-8.1%, respectively, in the CF-EBRT cohort. Incidence of acute grade 1, 2, and 3 gastrointestinal toxicities were reported in the range of 13-67%, 1-27% and 0-9%, respectively, of the SBRT cohort compared to 16.1- 51.1%, 6.3-20.7% and 0-3%, respectively, of the CF-EBRT cohort. Mean treatment costs estimates associated with SBRT ranged from $22,152 to $24,873 and $33,068 to $35,431 for CF-EBRT. Available data support the hypothesis of lower rates of acute toxicity and reduced economic burden associated with SBRT compared to CF-EBRT, however, randomised data with longer follow-up are needed to determine whether SBRT is clinically more effective than CF-EBRT.

Role of stereotactic body radiation therapy in patients with hepatocellular carcinoma extensively pretreated with transarterial chemoembolization or yttrium-90.

233 Background: Hepatocellular carcinoma (HCC) is an aggressive disease with dismal outcomes. Patients who are not surgical candidates are routinely treated with local therapies such as TACE, Y90, or SRBT among others. The study aimed to assess treatment response and treatment related toxicity to SBRT in patients who received prior TACE or Y90 at our institution, some of whom subsequently underwent orthotopic liver transplantation. Methods: IRB approval was obtained to retrospectively review 26 medical records of patients who received SBRT at the Loyola University Medical Center from 9/9/14-12/28/16. GI toxicities were analyzed using the Common Terminology Criteria for Adverse Events (CTAE) version 4.0 following SBRT. Skin, pharyngeal/esophageal, thorax, lung, GU, and GI toxicities were included in toxicity analysis. Patients received radiation dose from 36 Gy - 50 Gy in 5 fractions using RTOG 1112 dose constraints for dosimetric plan evaluation. Fisher’s exact tests and Wilcoxon Rank Sum tests were used for statistical analysis. Results: Of the 26 patients, 21 patients had prior TACE (median 3 TACE procedures; ranging from 1-5). 6 patients had prior Y90 with or without prior TACE. Median follow up for the cohort was 51 weeks. No patient showed GI toxicities above grade 1 during SBRT, with fatigue and nausea being the most common. One patient who previously received Y90 developed fatal duodenal perforation. Pathology demonstrated this was related to tumor infiltration of the duodenum and was not related to post radiation necrosis. 6 patients went on to undergo OLT with all patients having treatment response on surgical pathology with 4 patients having complete treatment response. Conclusions: SBRT was shown to safely treat patients after prior therapies including Y90 and TACE. Furthermore, SBRT showed favorable outcomes in post-OLT patients. To our knowledge, this is the first study to assess the effects of SBRT following extensive local therapies for HCC including Y90. Prospective data is needed to evaluate these findings further with longer follow up.

A prospective study of the safety and efficacy of liver stereotactic body radiotherapy in patients with and without prior liver-directed therapy

Background and purposeTo evaluate the safety and efficacy of liver stereotactic body radiotherapy (SBRT), and examine potential factors impacting outcomes including prior liver-directed therapy. Materials and methodsPatients with ECOG 0–1, Child-Pugh Class A or B, and primary hepatocellular carcinoma (HCC) or liver metastases unsuitable for surgical resection or ablation were eligible for a prospective single arm trial. SBRT was delivered with a CyberKnife system to 45 Gy in 3 fractions with a predetermined dose de-escalation scheme. Adverse events, local control, and survival were assessed. ResultsA total of 30 patients were enrolled. Eleven patients (37%) had HCC and 19 (63%) patients had liver metastases. Fourteen patients (47%) had prior liver-directed therapies including nine with liver resection, seven with trans-arterial chemoembolization, and six with radiofrequency ablation. Cumulative grade 2 and 3 acute toxicity occurred in 47% and 7% of patients, respectively. Similar rates of ≥grade 2 acute toxicity were observed between patients who had prior liver-directed treatments and those who did not. At a median follow-up of 12.7 months, 1-year local control and overall survival were 81% and 62%, respectively. Prior liver-directed therapy did not affect local control or survival. ConclusionsLiver SBRT is a safe and effective treatment even in the setting of prior liver-directed surgical and ablative therapies.

Clinical outcome of stereotactic body radiotherapy for abdominal lymph node metastases.

Aims and background. To report the clinical outcome of linac-based or robotic, image-guided stereotactic body radiotherapy in patients affected by abdominal lymph node metastases from different primary cancers. Methods and methods. Twenty-six patients with 32 abdominal lymph node metastases were consecutively treated at the University of Florence between April 2011 and May 2012. The mean follow-up was 4.6 months (SD, 3.9; range, 0.3-13). The dose prescription ranged between 24 Gy and 36 Gy delivered in 1-5 fractions. Results. In terms of local control, complete response to stereotactic body radiotherapy was obtained in 18 cases (66.7%), partial response in 7 (25.9%), and stable disease in 2 (7.4%). At the Cox univariate regression analysis, an increased risk of partial response or absence of local response to radiotherapy was found for subjects of the female sex (P = 0.036), age less than 50 years (P = 0.022), primary tumor of the genital tract (P = 0.007), and previous chemotherapy (P = 0.057). An excellent local control rate (90.9%) was obtained in patients affected by abdominal lymph node metastases of prostatic origin. Conclusions. Stereotactic body radiotherapy for abdominal lymph node metastases is a safe and effective treatment in terms of high rates of local control, especially in a subset of patients affected by prostate cancer.

Pretreatment 18F-fluorodeoxyglucose Uptake in the Lung Parenchyma Predicts Poor Survival After Stereotactic Body Radiation Therapy in Patients With Stage I Non-Small Cell Lung Cancer.

Purpose:In this study, we aimed to evaluate the prognostic value of fluorodeoxyglucose uptake in the lung parenchyma and the presence of subclinical interstitial lung disease on computed tomography as predictive factors for survival following stereotactic body radiation therapy in patients with stage I non-small cell lung cancer.Methods:We retrospectively evaluated 125 patients with stage I non-small cell lung cancer who underwent stereotactic body radiation therapy at our institute between December 2005 and March 2013 for various demographic and clinical parameters. The fluorodeoxyglucose uptake in the lung parenchyma corrected with computed tomography value (tissue fraction-corrected standardized uptake value) was quantified using fluorodeoxyglucose-positron emission tomography/computed tomography before the therapy. Additionally, the radiological findings of interstitial lung disease on computed tomography were evaluated. The prognostic analyses were performed using the Kaplan-Meier analysis and Cox proportional hazards regression model for univariate and multivariate analyses.Results:The median follow-up period was 39 months. The 3-year overall survival rate was 67.9%, and the 3-year progression-free survival rate was 52.0%. The multivariate analysis indicated that the tissue fraction-corrected standardized uptake value was correlated with the patients’ overall survival (P = .027, hazard ratio: 2.694, 95% confidence interval: 1.109-8.057). The presence of subclinical interstitial lung disease showed no correlation with the overall survival (P = .535, hazard ratio: 1.256, 95% confidence interval: 0.592-2.473).Conclusion:The results indicated that fluorodeoxyglucose uptake in the lung parenchyma, expressed as the tissue fraction-corrected standardized uptake value, was an independent prognostic factor in patients with stage I non-small cell lung cancer who have received stereotactic body radiation therapy.

P1.13-004 The Role of Lymph Node Staging by EBUS-TBNA in Stereotactic Body Radiation Therapy for patients with Non-Small Cell Lung Cancer.

P1.13-004 The Role of Lymph Node Staging by EBUS-TBNA in Stereotactic Body Radiation Therapy for patients with Non-Small Cell Lung Cancer.

Two Courses of Stereotactic Body Radiation Therapy for Patients With Pancreatic Cancer: Dose and Toxicity

Two Courses of Stereotactic Body Radiation Therapy for Patients With Pancreatic Cancer: Dose and Toxicity

A Prospective Study of the Safety and Efficacy of Liver Stereotactic Body Radiation Therapy in Patients With Prior Liver-Directed Therapy

To determine the toxicities and outcomes after stereotactic body radiotherapy (SBRT) for patients with hepatocellular carcinoma (HCC) and metastatic disease to the liver who had prior liver-directed therapy. Patients with ECOG 0-1, Child-Pugh Class A or B, and primary liver cancer or liver metastases (≤ 3) unsuitable for surgical resection or radiofrequency ablation (RFA) were eligible. SBRT dose goal was 45 Gy in 3 fractions, but was modified based on estimated liver tolerance by a predetermined dose de-escalation scheme. Treatments were delivered with a CyberKnife system that used tracking of liver motion with implanted fiducials. Toxicities were graded by the CTCAE v.3.0 criteria. Local progression was defined as an increase by ≥ 50% in the product of the two perpendicular diameters of a previously irradiated lesion. A total of 30 patients were enrolled from 6/2009 to 3/2014 at two institutions. Eleven patients (37%) had primary HCC and 19 (63%) patients had liver metastases. Almost half of the patients in this cohort (47%) had prior liver-directed therapies including 30% with liver resection, 20% with RFA, and 23% with trans-arterial chemoembolization (TACE). Among the 9 patients with prior liver surgery, 7 underwent resection of ≥ 2 segments, 4 of whom had a hepatic lobectomy. The median dose of SBRT delivered was 45 Gy in 3 fractions (range 27.5-45 Gy) to a median GTV diameter of 3.5 cm (range 1.7-6.5 cm). At a median follow-up of 12.7 months, 1-year local control was 80% in the entire cohort, 82% among those with HCC, and 79% among those with liver metastases. Cumulative grade 2 and grade 3 acute toxicity (≤ 90 days) possibly attributable to SBRT occurred in 47% and 7% of patients, respectively. The two grade 3 toxicities observed were elevated AST and leukopenia. There were no acute grade 4 or 5 toxicities. Four patients (13%) experienced late grade 2 toxicities with no observed grade 3-5 late toxicity. Similar rates of grade 2 or greater acute toxicity rates were observed between patients who had prior liver-directed treatments and those who did not (43% vs 50%, respectively). Liver SBRT is a safe treatment for patients even in the setting of prior liver-directed surgical and ablative therapies as long as standard liver constraints are respected. Preliminary efficacy data suggests good local control of lesions in both primary HCC and liver metastasis settings.

Risk Factors for Radiation-Induced Lung Toxicity after Stereotactic Body Radiation Therapy in Patients with Non-Small Cell Lung Cancer

Radiation-induced lung toxicity (RILT) is a potential fatal toxicity for stereotactic body radiation therapy (SBRT) for medically inoperable non-small cell lung cancer (NSCLC). This study aimed to examine the risk of RILT in a large institutional series of NSCLC patients and identify the dosimetric risk factors that predict RILT in order to help safe SBRT planning. Patients with early-stage or recurrent NSCLC who received lung SBRT between July 2002 and June 2015 formed the study population. The primary endpoint was RILT, including pneumonitis (RP) and fibrosis (RF), which was diagnosed and graded retrospectively according to RTOG1106. Onset time of RILT, either RP or RF, was calculated from the start of SBRT. Lungs were contoured consistently by one radiation oncologist according to RTOG atlas for organs at risk. Dosimetric factors were computed with exclusion of gross tumor volume (GTV) of either ipsilateral lung or total lungs. Risk factors of interest included age, gender, smoking status, pathological type, tumor stage, treatment history, baseline dyspnea, tumor location, prescription dose, history of previous treatment, GTV, planning target volume (PTV) and lung dosimetric parameters. A total of 276 patients with retrievable SBRT plans were eligible. The median follow-up was 47 months(95% CI: 41-53 months). There were 51(18.5%), 81(31.5%) and 110(39.9%) events of RP, RF and RILT, respectively. There were 74(26.8%), 27(9.7%), 8(2.9%) and 1(0.4%) for G1, G2, G3 and G4 RILT, respectively. Of the factors tested, previous radiation of thorax (OR:2.81; 95%CI:1.29-6.16; p=0.01) and V10 of total lungs (OR:1.06; 95%CI:1.01-1.11; p=0.019) were significant for G1+RP. History of lung surgery (OR:3.59; 95%CI:1.59-8.08; p=0.002) and baseline dyspnea (OR:1.99; 95%CI:1.11-3.59; p=0.022) were significant for G1+RF. Older age (OR:1.05; 95% CI:1.01-1.08; p=0.006), lung surgery (OR:3.00; 95%CI:1.27-7.11; p=0.012), baseline dyspnea (OR:2.43; 95% CI:1.35-4.37; p=0.003) and V10 of total lungs (OR:1.05; 95%CI:1.00-1.10; p=0.035) were significant for G1+RILT. Previous radiation of thorax (OR:5.51; 95%CI:2.34-12.96; p<0.001) and baseline dyspnea (OR:3.44; 95%CI:1.45-8.18; p=0.005) were significant for G2+RILT. Analysis of dosimetric parameters of ipsilateral lung demonstrated that none of lung dosimetric factors such as mean lung dose (MLD), V5, V10 and V20 were significantly associated with any grade of RILT(P>0.05). These simple lung dosimetric parameters were not significant for G2+RILT. RILT models will be presented at the meeting. Older age, lung surgery and baseline dyspnea are significant risk factors for RILT. Dosimetrically, V10 but not MLD and V20 of total lungs is a significant risk factor for RILT. This study represents one of the largest series reporting RILT after SBRT with comprehensive analysis of dosimetric risk factors for both ipsilateral lung and total lungs, with the lung organ consistently contoured per RTOG atlas.

Long-Term Results of Stereotactic Body Radiation Therapy for Patients With Small Hepatocellular Carcinoma Ineligible for Resection or Ablation Therapies

To evaluate the long-term outcome of stereotactic body radiotherapy (SBRT) in patients with small hepatocellular carcinoma (HCC) who are ineligible for resection or ablation therapies. We previously published the efficacy and safety of SBRT in 65 patients with 74 HCC who were ineligible for resection or ablation therapies. The following inclusion criteria for curative SBRT were used: (i) age over 20 years; (ii) an Eastern Cooperative Oncology Group Performance Status of 0–2; (iii) Child–Turcotte–Pugh (CTP) class A or B; (iv) less than three HCC nodules, each up to 50 mm in diameter without portal venous thrombosis or extrahepatic metastases; (v) inoperability because of poor general condition or surgery refusal; and (vi) unsuitability for radiofrequency ablation because of tumor location (on the liver surface, particularly high risk of pneumothorax, or near the porta hepatis), tumor invisibility on ultrasonography, or bleeding tendencies (platelet count, ≤50,000/mL; prothrombin activity, ≤50%). Patients were treated with the prescribed dose of 48 Gy in four fractions at the isocenter. CTP scoring was used to classify 56 and 9 patients into classes A and B, respectively. Local progression was defined as irradiated tumor growth on a dynamic computed tomography follow-up. Tumor responses were assessed according to the modified Response Evaluation Criteria in Solid Tumors. Treatment-related toxicities were evaluated according to the Common Terminology Criteria for Adverse Events version 4.0. We also updated the survival and tumor control outcomes for these same patients, with 2 years’ additional follow-up. In previous study, the median follow-up period was 26 months (range, 3–60), and 29 months in survivors (range, 16–60). The 2-year overall survival and local control rates were 76.0% (95% confidence interval [CI], 65.4–86.7%) and 100% (95% CI, 100%), respectively. In this study, the median follow-up period at the time of evaluation was 41 months (range, 3–73), and 58 months in survivors (range, 24–73). The 3-year and 5-year overall survival rates were 56.3% (95% CI, 44.1–68.5%) and 40.9% (95% CI, 28.0–53.8%), respectively. The 3-year and 5-year local control rates were both 100% (95% CI, 100%). Grade 3 or higher toxicities were observed in 15 (23.1%) patients. During the 2 years of additional follow-up period, the proportion of patients who had grade 3 or higher toxicities did not increase. The incidence of grade 3 or higher toxicities was higher in CTP class B than in class A (P = 0.0127). SBRT was effective and relatively safe for patients with small HCC who were ineligible for resection or ablation therapies even during longer follow-up times.

Comprehensive assessment of circulating immune cell populations in response to stereotactic body radiation therapy in patients with liver cancer

Stereotactic body radiation therapy (SBRT) can positively influence an antitumor immune response by inducing necrotic cell death. SBRT also been shown to eliminate tumors outside the radiation therapy field through an immune-mediated process known as the abscopal effect. Recent advances in immunotherapy may provide new therapeutic approaches for patients with liver cancer. Therefore, understanding the immune status of patients with cancer will likely guide how immunotherapy might be used in combination with SBRT. We hypothesized that we would observe changes in circulating blood immune cell populations of patients who received SBRT for liver tumors. Therefore, we assessed 110 immunophenotypes in the peripheral blood of 10 patients with liver cancer or metastases to the liver pretreatment and 2 posttreatment time points. Patients with liver cancer and metastatic patients both exhibited several immunophenotypic abnormalities at baseline compared with a group of healthy volunteer controls. In longitudinal studies, SBRT caused a specific reduction in CD3+ T cell counts and immature CD56brCD16− NK cell counts. The immune profiling and potential identification of circulating biomarkers shown here could lead to the design of combinatorial approaches with SBRT and immunotherapy to optimize the timing of treatment and direct the most effective immunotherapy with SBRT.

Never too old: A single-institution experience of stereotactic body radiation therapy for patients 90 years and older with early stage lung cancer

PurposeTo report on the patient, tumor, and treatment characteristics of patients aged 90 years or older who were treated with lung stereotactic body radiation therapy (SBRT) for early stage lung cancer and the resulting clinical outcomes. Methods and materialsWe surveyed our institutional review board–approved prospective lung SBRT data registry for patients aged 90 years or older who were treated for early stage lung cancer to determine the rates of local failure, progression-free survival, and overall survival as well as treatment-related toxicity. ResultsFor the 2004 to 2016 time period, 19 patients (of a total of 1268 lung SBRT cases) were identified. The median age at treatment was 91.6 years (range, 90-97 years). Most patients were female (52.6%) and former smokers (78.9%). The median tumor size was 2.1 cm (range, 1.5-5.4 cm). Tissue was obtained for diagnosis in 68.4% of patients, with the predominant histology being adenocarcinoma (42.2%). Six patients (31.6%) had central lesions. The median follow-up for all patients was 17.3 months. The median SBRT schedule was 50 Gy in 5 fractions over 5 consecutive days and was used in 9 cases (47.4%). The median pre-SBRT and 6-month post-SBRT pulmonary testing showed that the forced expiratory volume in one second, as the percent predicted, was 81.9 and 84.5 and the diffusing capacity of the lungs for carbon monoxide, as the percent predicted, was 66.5 and 67, respectively. No grade 3 or higher toxicities were observed. The 2-year rates of local failure, progression-free survival, and overall survival were 5.6%, 48.6%, and 47.8%, respectively. ConclusionsLung SBRT appears to be safe and effective in nonagenarians with stage I lung cancer. The absence of high-grade toxicities and mortality warrants its consideration as the primary curative modality in this population.

EP-1226: Stereotactic robotic body radiotherapy for patients with pulmonary oligometastases

EP-1226: Stereotactic robotic body radiotherapy for patients with pulmonary oligometastases

EP-1856: The impact of waiting time on survival of Lung Stereotactic Ablative Body Radiotherapy patients

EP-1856: The impact of waiting time on survival of Lung Stereotactic Ablative Body Radiotherapy patients

Benefits of Using Stereotactic Body Radiotherapy in Patients With Metachronous Oligometastases of Hormone-Sensitive Prostate Cancer Detected by [18F]fluoromethylcholine PET/CT.

For patients with oligometastatic recurrence of prostate cancer (PC), stereotactic body radiation therapy (SBRT) represents an attractive treatment option, as it is safe without major side effects. The aim of this study was to investigate the impact of SBRT in delaying the start of androgen deprivation therapy (ADT). Forty-three patients treated with SBRT for oligometastatic recurrence (< 5 metastases) of hormone-sensitive PC, defined with [18F]fluoromethylcholine positron emission tomography/computed tomography were included. As a control group, 20 patients with oligometastatic disease not treated with SBRT were identified from another hospital. Data were collected retrospectively. A post-SBRT prostate-specific antigen (PSA) response was seen in 29 (67.4%) of 43 patients. Median ADT-free survival (ADT-FS) was 15.6 months (95% confidence interval [CI], 11.7-19.5) for the whole group, and 25.7 months (95% CI, 9.0-42.4) for patients with a PSA response. Seven patients were treated with a second course of SBRT because of oligometastatic disease recurrence; the ADT-FS in this group was 32.1 months (95% CI, 7.8-56.5). Compared with the control group, the ADT-FS from first diagnosis of metastasis was significantly longer, with 17.3 (95% CI, 13.7-20.9) months versus 4.19 months (95% CI, 0.0-9.0), P< .001. Also, time between diagnosis of the metastasis until progression of disease during ADT use (castration resistance) was longer for the SBRT-treated patients (mean 66.6, 95% CI, 53.5-79.8, vs. 36.41, 95% CI, 26.0-46.8 months, P= .020). There were no grade III or IV adverse events reported. SBRT can safely and effectively be used to postpone ADT in appropriately selected patients with oligometastatic recurrence of PC.

Stereotactic body radiotherapy for patients with relapsing prostate cancer with bones or nodes oligometastases.

263 Background: To analyze patients treated by stereotactic body radiotherapy (SBRT) for node or bone oligometastatic recurrence of a prostate cancer previously locally treated, To identify possible pronostic factors of early biochemical failure (BF) after SBRT. Methods: We reviewed patients with a rising PSA treated by SBRT between November 2011 and April 2016 for bone or node oligometastases, diagnosed on a 18F Fluorocholine positron emission tomography-computed tomography (PET-CT) following biochemical failure of a prostate cancer after a local curative treatment. Recurrence-free survival (RFS) was the primary end-point defined as the time interval between SBRT and biochemical failure. Biochemical failure was defined as 2 consecutive elevations of PSA with last dosage superior to PSA dosage before treatment, or clinical failure. PSA value before SBRT, location of metastases, number of lesions treated, concomitant androgen deprivation therapy were analyzed to identify pronostic factors of poor response to SBRT. Results: With a median follow-up from time of SBRT of 12 months, we treated 40 patients and 56 metastatic lesions, with a local-control rate of 85%. 19 patients were treated for 1 to 3 bone lesions and 21 patients for 1 to 3 node lesions. 8 patients with bone oligometastases and 13 patients with node oligometastases had a recurrence (p=0.55). The main sites of failure after SBRT were lymph nodes only (7 ; 33%), bone only (7 ; 33 %), and synchronous node and bone (4 ; 19%). A 2nd and 3rdcourse of radiotherapy was delivered in 8 and 1 patients. Median RFS was 345 days (134-426) in the node SBRT group and 494 days (85-877) in the bone SBRT group (p=0.27). On bivariate analysis, a PSA nadir up to 0.51 ng/mL after SBRT was identified as a pronostic factor of a worse RFS (p=0.0038). This result was not confirmed in multivariate analysis (p=0.87). Conclusions: SBRT for node oligometastases showed a non significant lower rate of RFS when compared to SBRT in bone oligometastases. A larger cohort with a longer follow up is needed to determine whether node and bone oligometastases have similar outcomes after SBRT.

Protocol for an integrated phase II/III randomised controlled trial of transarterial chemotherapy and sorafenib with or without stereotactic body radiation therapy in patients with nonmetastatic unresectable hepatocellular carcinoma

&lt;p class="abstract"&gt;&lt;strong&gt;Background:&lt;/strong&gt; Vast majority of patients with hepatocellular carcinoma (HCC) present with unresectable disease. In the last decade results of randomized trials and subsequent meta-analyses established trans-arterial chemoembolization (TACE) as standard of care in patients with Barcelona clinic liver cancer (BCLC) stage B. However, there is clearly a need to investigate additional therapeutic options that would consolidate the initial response to TACE. A recent meta-analyses concluded that addition of radiation to TACE had 10-35% improvement in two-year overall survival, however as results of meta-analyses were based on small studies, the need for conducting a high quality randomized study was highlighted. The present study is designed to investigate the role of high dose stereotactic radiation as consolidation therapy after TACE in patients with non-metastatic unresectable HCC&lt;span lang="EN-IN"&gt;. &lt;/span&gt;&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Methods:&lt;/strong&gt; Patients diagnosed with non-metastatic unresectable HCC with BCLC stage B/A (medically inoperable) and Child-Pugh’s score A-B7 will be eligible. The trial will randomize patients into TACE alone arm or TACE followed by stereotactic body radiation therapy (SBRT). The primary aim is to compare in-field progression free survival (PFS) in phase II and overall survival in phase III between the control (TACE) and intervention arm (TACE+SBRT). The secondary aim is to compare cause specific survival, imaging response and quality of life in control and intervention arms&lt;span lang="EN-IN"&gt;.&lt;/span&gt;&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Results:&lt;/strong&gt; First analysis of the study has been planned when patient accrued under phase II study have completed 1 year follow up&lt;span lang="EN-IN"&gt;. &lt;/span&gt;&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;&lt;span lang="NL"&gt;&lt;br /&gt;&lt;/span&gt;&lt;/strong&gt;&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;&lt;span lang="NL"&gt;Trail Registration: &lt;/span&gt;&lt;/strong&gt;&lt;span lang="NL"&gt;Clinicaltrials.gov,NCT02794337&lt;/span&gt;&lt;/p&gt;

Stereotactic Body Radiotherapy in Patients with Lung Oligometastases from Colorectal Cancer.

To assess the role of stereotactic body radiotherapy (SBRT) in pulmonary metastases from colorectal cancer (CRC). Thirty-three consecutive patients with pulmonary metastases from CRC who received SBRT were included in the analysis. The primary endpoints were local and systemic progression-free survival, a secondary endpoint was the safety profile of SBRT. A total of 56 lesions were treated with SBRT. A single nodule was treated in 15 patients, two in 13 and three in five. The radiotherapy dose and the adopted fractionations were 24-27 Gy as a single fraction for 40 lesions and 27-42 Gy in three fractions (2-3 times a week) for the other 16 lesions. After a median follow-up of 22.8 months (range=1.3-45.7 months), the median progression-free survival of the irradiated sites was 13.4 months. SBRT can be considered as local therapy in patients with lung metastases from CRC.

Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration in the Nodal Staging of Stereotactic Ablative Body Radiotherapy Patients

Patients with non-small cell lung cancer (NSCLC) being evaluated for stereotactic ablative body radiotherapy (SABR) are typically staged noninvasively with positron emission tomography/computed tomography (PET/CT). Incorporating endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) into the staging workup of these patients has not been evaluated. Our primary objective was to compare the performance of PET/CT with EBUS-TBNA for intrathoracic nodal assessment among SABR-eligible patients. This was a retrospective study consisting of two parts. First, we assessed the concordance for nodal metastasis of PET/CT and EBUS-TBNA. Second, we evaluated clinical outcomes among patients who underwent SABR with and without a prior EBUS-TBNA. We identified 246 eligible patients. Compared with PET/CT, EBUS-TBNA led to a stage shift in 48 of 246 patients (19%). Of 174 N0 patients by PET/CT, 6 (3.4%) had nodal metastasis on EBUS-TBNA. Among 72 clinical N1 patients, 36 (50%) were downstaged to N0 after EBUS-TBNA, therefore becoming eligible for SABR. Concordance between PET/CT and EBUS-TBNA for nodal metastasis was 83% (κ= 0.53). Clinical outcomes of patients who underwent SABR with or without a prior EBUS-TBNA did not differ significantly. Concordance of PET/CT and EBUS-TBNA for nodal disease was only moderate. Incorporating EBUS-TBNA into the staging workup was beneficial in identifying occult nodal metastasis that would otherwise be left untreated with SABR and in expanding the pool of potentially SABR-eligible patients.

Comparing conVEntional RadioTherapy with stereotactIC body radiotherapy in patients with spinAL metastases: study protocol for an randomized controlled trial following the cohort multiple randomized controlled trial design.

BackgroundStandard radiotherapy is the treatment of first choice in patients with symptomatic spinal metastases, but is only moderately effective. Stereotactic body radiation therapy is increasingly used to treat spinal metastases, without randomized evidence of superiority over standard radiotherapy. The VERTICAL study aims to quantify the effect of stereotactic radiation therapy in patients with metastatic spinal disease.Methods/designThis study follows the ‘cohort multiple Randomized Controlled Trial’ design. The VERTICAL study is conducted within the PRESENT cohort. In PRESENT, all patients with bone metastases referred for radiation therapy are enrolled. For each patient, clinical and patient-reported outcomes are captured at baseline and at regular intervals during follow-up. In addition, patients give informed consent to be offered experimental interventions. Within PRESENT, 110 patients are identified as a sub cohort of eligible patients (i.e. patients with unirradiated painful, mechanically stable spinal metastases who are able to undergo stereotactic radiation therapy). After a protocol amendment, also patients with non-spinal bony metastases are eligible. From the sub cohort, a random selection of patients is offered stereotactic radiation therapy (n = 55), which patients may accept or refuse. Only patients accepting stereotactic radiation therapy sign informed consent for the VERTICAL trial. Non-selected patients (n = 55) receive standard radiotherapy, and are not aware of them serving as controls. Primary endpoint is pain response after three months. Data will be analyzed by intention to treat, complemented by instrumental variable analysis in case of substantial refusal of the stereotactic radiation therapy in the intervention arm.DiscussionThis study is designed to quantify the treatment response after (stereotactic) radiation therapy in patients with symptomatic spinal metastases. This is the first randomized study in palliative care following the cohort multiple Randomized Controlled Trial design. This design addresses common difficulties associated with classic pragmatic randomized controlled trials, such as disappointment bias in patients allocated to the control arm, slow recruitment, and poor generalizability.Trial registrationThe Netherlands Trials Register number NL49316.041.14. ClinicalTrials.gov registration number NCT02364115. Date of trial registration February 1, 2015.