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Therapeutic effects and prognostic factors of 125I brachytherapy for pelvic recurrence after early cervical cancer surgery.
Wang, R, Zhu, J, Yang, S, Chen, X, Gu, C, Liang, T, Li, L, Liu, D, Cao, Y
Scientific reports. 2021;(1):11356
Abstract
To investigate the efficacy of 125I seed implantation in the treatment regimen of pelvic recurrence after early cervical cancer surgery and to analyse prognostic factors. To evaluate efficacy and analyse prognostic factors of 125I seed implantation for pelvic recurrence after early cervical cancer surgery. A prospective study was conducted on 62 patients who experienced pelvic recurrence after early cervical cancer surgery between August 2005 and September 2015. The 62 patients were treated and assessed in 2 groups (n = 30). All 62 patients were randomized into two groups that received two different treatment regimens: the treatment group (n = 30), which received 125I particle implantation therapy, and the control group (n = 32), which received whole-pelvic irradiation using the anteroposterior/posteroanterior field and cisplatin-based concurrent chemoradiation therapy. The efficacy/efficiency of 125I seed implantation and prognostic factors were analysed by logistic regression. Overall survival was determined by Kaplan-Meier analysis. Multivariate analysis results were obtained by the Cox proportional hazards regression model. The effective control rates at 1, 3, 6 and 12 months were 76.7%, 80.0%, 83.3%, and 86.7% in the 125I particle implantation group. The total effective control rates at 1, 3, 6 and 12 months were 65.6%, 65.5%, 62.5%, and 71.9% in the chemoradiotherapy group. Significant differences were observed between the two groups. The overall survival rates at 1, 2, 3, 4, and 5 years and the median overall were 96.7%, 93.3%, 86.7%, 71.9%, 65.6% and 4.34 years, respectively, in the 125I seed implantation group and 81.3%, 71.9%, 62.5%, 56.3%, 53.1% and 3.59 years, respectively, in the control group. There were statistically significant differences in survival rates depending on the diameter of the largest recurrent pelvic tumour (χ2 = 6.611, P = 0.010). The multivariate analysis showed that the survival rates were related to the diameter of the largest recurrent pelvic tumour (χ2 = 4.538, P = 0.033). 125I implantation is an effective, safe, and promising method for the treatment of pelvic recurrence after early cervical cancer surgery. The diameter of the recurrent pelvic tumour was identified as a significant independent prognostic factor in patients who received 125I implantation.
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The COMS Randomized Trial of Iodine 125 Brachytherapy for Choroidal Melanoma: IV. Local Treatment Failure and Enucleation in the First 5 Years after Brachytherapy. COMS Report No. 19.
Jampol, LM, Moy, CS, Murray, TG, Reynolds, SM, Albert, DM, Schachat, AP, Diddie, KR, Engstrom, RE, Finger, PT, Hovland, KR, et al
Ophthalmology. 2020;(4S):S148-S157
Abstract
OBJECTIVE To describe the frequency and predictors of local treatment failure and enucleation after iodine 125 (I125) brachytherapy in patients with choroidal melanoma treated and followed up in a large randomized clinical trial. DESIGN Prospective, noncomparative, interventional case series within a randomized, multicenter clinical trial. PARTICIPANTS Patients enrolled in the Collaborative Ocular Melanoma Study (COMS) trial of enucleation versus brachytherapy between February 1987 and July 1998; tumors measured 2.5 to 10.0 mm in apical height and no more than 16.0 mm in longest basal dimension. METHODS I125 brachytherapy was administered via episcleral plaque according to a standard protocol. Follow-up ophthalmic evaluations, including ophthalmic ultrasound and fundus photography, were performed according to a standard protocol at baseline, every 6 months thereafter for 5 years, and subsequently at annual intervals. Survival analysis methods were used to estimate the cumulative risk of postirradiation treatment failure and enucleation. Factors associated with treatment failure and enucleation of plaqued eyes were evaluated using Cox proportional hazards analysis. MAIN OUTCOME MEASURES Reports of enucleation and of local treatment failure, defined as tumor growth, recurrence, or extrascleral extension, derived from clinical reports based on echographic and photographic documentation. RESULTS As of September 30, 2000, 638 of the 650 patients randomized to brachytherapy and so treated had been followed up for 1 year or longer, and 411 had been followed up for at least 5 years. Sixty-nine eyes were enucleated during the first 5 years after brachytherapy, and treatment failure was reported for 57 eyes. The Kaplan-Meier estimate of proportion of patients undergoing enucleation by 5 years was 12.5% (95% confidence interval [CI], 10.0%-15.6%); the risk of treatment failure was 10.3% (95% CI, 8.0%-13.2%). Treatment failure was the most common reason for enucleation within 3 years of treatment; beyond 3 years, ocular pain was most common. Risk factors for enucleation were greater tumor thickness, closer proximity of the posterior tumor border to the foveal avascular zone, and poorer baseline visual acuity in the affected eye. Risk factors for treatment failure were older age, greater tumor thickness, and proximity of the tumor to the foveal avascular zone. Local treatment failure was associated weakly with reduced survival after controlling for baseline tumor and personal characteristics (adjusted risk ratio, 1.5; P = 0.08). CONCLUSIONS Local treatment failure and enucleation were relatively infrequent events after I125 brachytherapy within the COMS. Treatment failure typically occurred early and was associated weakly with poorer survival. The COMS randomized trial documented the absence of a clinically or statistically significant difference in survival for patients randomly assigned to enucleation versus brachytherapy. This analysis documents the efficacy of brachytherapy to achieve sustained local tumor control and to conserve the globe.
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3.
Tumor burden and liver function in HCC patient selection for selective internal radiation therapy: SARAH post-hoc study.
Palmer, DH, Hawkins, NS, Vilgrain, V, Pereira, H, Chatellier, G, Ross, PJ
Future oncology (London, England). 2020;(1):4315-4325
Abstract
Aim: To determine whether a liver tumor burden ≤25% and well-preserved liver function (albumin-bilirubin grade 1) are appropriate criteria for identifying patients with unresectable hepatocellular carcinoma who may benefit from selective internal radiation therapy (SIRT) using 90yttrium resin microspheres versus sorafenib. Patients & methods: Post-hoc analysis of patients in the intention-to-treat population of the SARAH trial (SIRT vs sorafenib) with ≤25% tumor burden and albumin-bilirubin grade 1. Primary end point: overall survival. Results: Median overall survival was 21.9 months (95% CI: 15.2-32.5, n = 37) with SIRT and 17.0 months (11.6-20.8, n = 48) with sorafenib (hazard ratios: 0.73; 95% CI: 0.44-1.21; p = 0.22). Conclusion: A combination of good liver function and low tumor burden may be relevant for selection of hepatocellular carcinoma patients for SIRT.
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Endocrine therapy with or without whole breast irradiation in low-risk breast cancer patients after breast-conserving surgery: 10-year results of the Austrian Breast and Colorectal Cancer Study Group 8A trial.
Fastner, G, Sedlmayer, F, Widder, J, Metz, M, Geinitz, H, Kapp, K, Fesl, C, Sölkner, L, Greil, R, Jakesz, R, et al
European journal of cancer (Oxford, England : 1990). 2020;:12-20
Abstract
PURPOSE To investigate long-term results of patients with hormonal receptor-positive breast cancer treated with breast-conserving surgery (BCS) and consecutive endocrine therapy (ET) with or without whole breast irradiation (WBI). METHODS AND MATERIALS Within the 8 A trial of the Austrian Breast and Colorectal Cancer Study Group, a total of 869 patients received ET after BCS which was randomly followed by WBI (n = 439, group 1) or observation (n = 430, group 2). WBI was applied up to a mean total dosage of 50 Gy (+/- 10 Gy boost) in conventional fractionation. RESULTS After a median follow-up of 9.89 years, 10 in-breast recurrences (IBRs) were observed in group 1 and 31 in group 2, resulting in a 10-year local recurrence-free survival (LRFS) of 97.5% and 92.4%, respectively (p = 0.004). This translated into significantly higher rates for disease-free survival (DFS): 94.5% group 1 vs 88.4% group 2, p = 0.0156. For distant metastases-free survival (DMFS) and overall survival (OS), respective 10-year rates amounted 96.7% and 86.6% for group 1 versus 96.4% and 87.6%, for group 2 (ns). WBI (hazard ratio [HR]: 0.27, p < 0.01) and tumour grading (HR: 3.76, p = 0.03) were found as significant predictors for IBR in multiple cox regression analysis. CONCLUSIONS After a median follow-up of 10 years, WBI resulted in a better local control and DFS compared with ET alone. The omission of WBI and tumour grading, respectively, were the only negative predictors for LRFS.
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Impact of combined selective internal radiation therapy and sorafenib on survival in advanced hepatocellular carcinoma.
Ricke, J, Klümpen, HJ, Amthauer, H, Bargellini, I, Bartenstein, P, de Toni, EN, Gasbarrini, A, Pech, M, Peck-Radosavljevic, M, Popovič, P, et al
Journal of hepatology. 2019;(6):1164-1174
Abstract
BACKGROUND & AIMS Sorafenib is the recommended treatment for patients with advanced hepatocellular carcinoma (HCC). We aimed to compare the efficacy and safety of a combination of sorafenib and selective internal radiation therapy (SIRT) - with yttrium-90 (90Y) resin microspheres - to sorafenib alone in patients with advanced HCC. METHODS SORAMIC is a randomised controlled trial comprising diagnostic, local ablation and palliative cohorts. Based on diagnostic study results, patients were assigned to local ablation or palliative cohorts. In the palliative cohort, patients not eligible for TACE were randomised 11:10 to SIRT plus sorafenib (SIRT + sorafenib) or sorafenib alone. The primary endpoint was overall survival (OS; Kaplan-Meier analysis) in the intention-to-treat (ITT) population. RESULTS In the ITT cohort, 216 patients were randomised to SIRT + sorafenib and 208 to sorafenib alone. Median OS was 12.1 months in the SIRT + sorafenib arm, and 11.4 months in the sorafenib arm (hazard ratio [HR] 1.01; 95% CI 0.81-1.25; p = 0.9529). Median OS in the per protocol population was 14.0 months in the SIRT + sorafenib arm (n = 114), and 11.1 months in the sorafenib arm (n = 174; HR 0.86; p = 0.2515). Subgroup analyses of the per protocol population indicated a survival benefit of SIRT + sorafenib for patients without cirrhosis (HR 0.46; 0.25-0.86; p = 0.02); cirrhosis of non-alcoholic aetiology (HR 0.63; p = 0.012); or patients ≤65 years old (HR 0.65; p = 0.05). Adverse events (AEs) of Common Terminology Criteria for AE Grades 3-4 were reported in 103/159 (64.8%) patients who received SIRT + sorafenib, 106/197 (53.8%) patients who received sorafenib alone (p = 0.04), and 8/24 (33.3%) patients who only received SIRT. CONCLUSION Addition of SIRT to sorafenib did not result in a significant improvement in OS compared with sorafenib alone. Subgroup analyses led to hypothesis-generating results that will support the design of future studies. LAY SUMMARY Sorafenib given orally is the recommended treatment for patients with advanced hepatocellular carcinoma (HCC). In selective internal radiation therapy (SIRT), also known as radioembolisation, microscopic, radioactive resin or glass spheres are introduced into the blood vessels that feed the tumours in the liver. This study found that the addition of SIRT with 90yttrium-loaded resin microspheres to sorafenib treatment in people with advanced HCC did not significantly improve overall survival compared with sorafenib treatment alone. However, the results give an indication of how future studies using this combination therapy in people with advanced HCC could be designed. STUDY REGISTRATION EudraCT 2009-012576-27, NCT0112 6645.
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Dose to the dominant intraprostatic lesion using HDR vs. LDR monotherapy: A Phase II randomized trial.
Tissaverasinghe, S, Crook, J, Bachand, F, Batchelar, D, Hilts, M, Araujo, C, Anderson, D, Bainbridge, T, Farnquist, B
Brachytherapy. 2019;(3):299-305
Abstract
PURPOSE To present the dosimetric results of a Phase II randomized trial comparing dose escalation to the MRI-defined dominant intraprostatic lesion (DIL) using either low-dose-rate (LDR) or high-dose-rate (HDR) prostate brachytherapy. MATERIAL AND METHODS Patients receiving prostate brachytherapy as monotherapy were randomized to LDR or HDR brachytherapy. Prostate and DILs were contoured on preoperative multiparametric MRI. These images were registered with transrectal ultrasound for treatment planning. LDR brachytherapy was preplanned using I-125 seeds. HDR brachytherapy used intraoperative transrectal ultrasound-based planning to deliver 27 Gy/2 fractions in separate implants. DIL location was classified as peripheral, central, or anterior. A student t-test compared DIL D90 between modalities and DIL locations. RESULTS Of 60 patients, 31 underwent LDR and 29 HDR brachytherapy. Up to three DILs were identified per patient (100 total) with 74 peripheral, six central, and 20 anterior DILs. Mean DIL volume was 1.9 cc (SD: 1.7 cc) for LDR and 1.6 cc (SD 1.3 cc) for HDR (p = 0.279). Mean DIL D90 was 151% (SD 30%) for LDR and 132% (SD 13%) for HDR. For LDR, mean peripheral DIL D90 was 159% (SD 27%) and central or anterior 127% (SD 13%). HDR peripheral DILs received 137% (SD 12%) and central or anterior 119% (SD 7%). DIL D90 for peripheral lesions was higher than anterior and central (p < 0.001). CONCLUSIONS DIL location affects dose escalation, particularly because of urethral proximity, such as for anterior and central DILs. HDR brachytherapy may dose escalate better when target DIL is close to critical organs.
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Aflibercept for Radiation Maculopathy Study: A Prospective, Randomized Clinical Study.
Murray, TG, Latiff, A, Villegas, VM, Gold, AS
Ophthalmology. Retina. 2019;(7):561-566
Abstract
PURPOSE To evaluate 2 treatment approaches to intravitreal vascular endothelial growth factor antagonist therapy in radiation maculopathy comparing aflibercept delivered by either a 6-week treatment interval or treat-and-adjust interval. DESIGN Randomized, prospective clinical trial. METHODS Forty consecutive patients were enrolled in an institutional review board-approved clinical trial and randomized to aflibercept treatment via 1 of 2 regimens: (1) fixed, every-6-weeks treatment or (2) variable, treat-and-adjust treatment centered around 6 weeks. All patients had a diagnosis of treated uveal melanoma with documented tumor control. All patients showed visually compromising radiation maculopathy confirmed by a decline in best-corrected visual acuity (BCVA) and spectral-domain (SD) OCT documentation of radiation maculopathy. MAIN OUTCOME MEASURES Best-corrected visual acuity and SD OCT central retinal thickness at 1 year. RESULTS Thirty-nine of 40 patients completed the trial (97.5%) with 1 year of follow-up. Baseline study entry BCVA was 20/63 and was maintained at 20/62 at study conclusion at 60 weeks (1 year). At baseline, SD OCT mean central retinal thickness was 432 μm and improved to 294 μm at 60 weeks (P < 0.02). At the study conclusion, 42.5% of eyes (17/40) showed better than 20/50 BCVA, and only 5% of eyes (2/40) showed a BCVA worse than 20/200. In the every-6-weeks interval treatment arm, patients received 9 injections, whereas in the treat-and-adjust study arm, patients received 8.4 injections (P = 0.88, not significant). One patient experienced an inflammatory response after aflibercept injection, but this did not occur again for this patient, nor for any other study injections (1/400 injections [0.0025%]). No patients demonstrated endophthalmitis or metastatic disease or died during the study window. CONCLUSIONS Aflibercept seems to limit vision loss associated with radiation maculopathy. In this randomized, prospective clinical study, no difference was found between a fixed 6-week treatment interval and a variable treat-and-adjust interval because virtually all patients required treatment every 6 weeks and were not able to extend. Remarkably, almost half of all treated patients maintained BCVA of 20/50 or better throughout 1 year of treatment. Aflibercept is effective in treating radiation maculopathy, but requires an ongoing treatment approach.
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SIRveNIB: Selective Internal Radiation Therapy Versus Sorafenib in Asia-Pacific Patients With Hepatocellular Carcinoma.
Chow, PKH, Gandhi, M, Tan, SB, Khin, MW, Khasbazar, A, Ong, J, Choo, SP, Cheow, PC, Chotipanich, C, Lim, K, et al
Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2018;(19):1913-1921
Abstract
Purpose Selective internal radiation therapy or radioembolization (RE) shows efficacy in unresectable hepatocellular carcinoma (HCC) limited to the liver. This study compared the safety and efficacy of RE and sorafenib in patients with locally advanced HCC. Patients and Methods SIRveNIB (selective internal radiation therapy v sorafenib), an open-label, investigator-initiated, phase III trial, compared yttrium-90 (90Y) resin microspheres RE with sorafenib 800 mg/d in patients with locally advanced HCC in a two-tailed study designed for superiority/detriment. Patients were randomly assigned 1:1 and stratified by center and presence of portal vein thrombosis. Primary end point was overall survival (OS). Efficacy analyses were performed in the intention-to-treat population and safety analyses in the treated population. Results A total of 360 patients were randomly assigned (RE, 182; sorafenib, 178) from 11 countries in the Asia-Pacific region. In the RE and sorafenib groups, 28.6% and 9.0%, respectively, failed to receive assigned therapy without significant cross-over to either group. Median OS was 8.8 and 10.0 months with RE and sorafenib, respectively (hazard ratio, 1.1; 95% CI, 0.9 to 1.4; P = .36). A total of 1,468 treatment-emergent adverse events (AEs) were reported (RE, 437; sorafenib, 1,031). Significantly fewer patients in the RE than sorafenib group had grade ≥ 3 AEs (36 of 130 [27.7%]) v 82 of 162 [50.6%]; P < .001). The most common grade ≥ 3 AEs were ascites (five of 130 [3.8%] v four of 162 [2.5%] patients), abdominal pain (three [2.3%] v two [1.2%] patients), anemia (zero v four [2.5%] patients), and radiation hepatitis (two [1.5%] v zero [0%] patients). Fewer patients in the RE group (27 of 130 [20.8%]) than in the sorafenib group (57 of 162 [35.2%]) had serious AEs. Conclusion In patients with locally advanced HCC, OS did not differ significantly between RE and sorafenib. The improved toxicity profile of RE may inform treatment choice in selected patients.
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Concurrent computed tomography-guided radioactive iodine-125 seeds percutaneous interstitial implantation and chemotherapy for treatment of cervical lymph node metastases.
Li, Z, Wang, X, Fang, K, Shi, J, Qi, X, Sun, R
Journal of cancer research and therapeutics. 2018;(Supplement):S1163-S1169
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Abstract
AIM: The study aimed to evaluate the effect of concurrent computed tomography (CT)-guided percutaneous interstitial implantation of iodine-125 (125I) seeds and chemotherapy on cervical lymph nodes metastasis. METHODS The prospective randomized study included 82 cases with cervical lymph nodes metastasis who were admitted to our hospital from January 2010 to June 2012. All the subjects were randomly divided into the concurrent 125I implantation and chemotherapy group (n = 48) and chemotherapy-only group (n = 34) according to the treatment strategy. The concurrent 125I implantation and chemotherapy group was treated with CT-guided 125I seeds implantation and routine chemotherapy. The routine chemotherapy included paclitaxel and cisplatin. Patients were followed up for 6 months. RESULTS In the concurrent 125I implantation and chemotherapy group, overall response rate (complete response [CR] + partial response [PR]) was 82.61% and 85.51% at 2 and 6 months posttreatment, respectively. The longest diameter of CR and PR lymph nodes was markedly decreased after treatment (P < 0.05). In the chemotherapy-only group, overall response rate was 22.45% and 10.20% at 2 and 6 months posttreatment, respectively. The number of patients with moderate to severe pain was much less in concurrent 125I implantation and chemotherapy group than that of chemotherapy-only group (4.17% vs. 17.64%; P < 0.05) at 6-month posttreatment. No treatment-related death or severe complication was reported in the two groups. CONCLUSION Concurrent CT-guided 125I seeds implantation and chemotherapy is superior to routine chemotherapy in efficacy, safety, and pain relief in patients with cervical lymph nodes metastasis.
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Androgen Suppression Combined with Elective Nodal and Dose Escalated Radiation Therapy (the ASCENDE-RT Trial): An Analysis of Survival Endpoints for a Randomized Trial Comparing a Low-Dose-Rate Brachytherapy Boost to a Dose-Escalated External Beam Boost for High- and Intermediate-risk Prostate Cancer.
Morris, WJ, Tyldesley, S, Rodda, S, Halperin, R, Pai, H, McKenzie, M, Duncan, G, Morton, G, Hamm, J, Murray, N
International journal of radiation oncology, biology, physics. 2017;(2):275-285
Abstract
PURPOSE To report the primary endpoint of biochemical progression-free survival (b-PFS) and secondary survival endpoints from ASCENDE-RT, a randomized trial comparing 2 methods of dose escalation for intermediate- and high-risk prostate cancer. METHODS AND MATERIALS ASCENDE-RT enrolled 398 men, with a median age of 68 years; 69% (n=276) had high-risk disease. After stratification by risk group, the subjects were randomized to a standard arm with 12 months of androgen deprivation therapy, pelvic irradiation to 46 Gy, followed by a dose-escalated external beam radiation therapy (DE-EBRT) boost to 78 Gy, or an experimental arm that substituted a low-dose-rate prostate brachytherapy (LDR-PB) boost. Of the 398 trial subjects, 200 were assigned to DE-EBRT boost and 198 to LDR-PB boost. The median follow-up was 6.5 years. RESULTS In an intent-to-treat analysis, men randomized to DE-EBRT were twice as likely to experience biochemical failure (multivariable analysis [MVA] hazard ratio [HR] 2.04; P=.004). The 5-, 7-, and 9-year Kaplan-Meier b-PFS estimates were 89%, 86%, and 83% for the LDR-PB boost versus 84%, 75%, and 62% for the DE-EBRT boost (log-rank P<.001). The LDR-PB boost benefited both intermediate- and high-risk patients. Because the b-PFS curves for the treatment arms diverge sharply after 4 years, the relative advantage of the LDR-PB should increase with longer follow-up. On MVA, the only variables correlated with reduced overall survival were age (MVA HR 1.06/y; P=.004) and biochemical failure (MVA HR 6.30; P<.001). Although biochemical failure was associated with increased mortality and randomization to DE-EBRT doubled the rate of biochemical failure, no significant overall survival difference was observed between the treatment arms (MVA HR 1.13; P=.62). CONCLUSIONS Compared with 78 Gy EBRT, men randomized to the LDR-PB boost were twice as likely to be free of biochemical failure at a median follow-up of 6.5 years.