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Comparison of Image-Guided Iodine-125 Seed Interstitial Brachytherapy and Local Chemotherapy Perfusion in Treatment of Advanced Pancreatic Cancer.
Zhou, L, Yang, H, Xie, L, Sun, J, Qian, J, Zhu, L
Journal of investigative surgery : the official journal of the Academy of Surgical Research. 2022;(1):1-6
Abstract
OBJECTIVE To compare the efficacy and safety of iodine-125 seed interstitial brachytherapy and local chemotherapy perfusion in treatment of advanced pancreatic cancer. METHODS The present open prospective randomized control study included a total of 165 cases of advanced pancreatic cancer patients who were admitted in our hospital during December 2016 to April 2019. All patients were randomized into two groups with 84 cases in iodine-125 group and 81 cases in chemotherapy perfusion group. Basic clinical characteristics and demographic data were collected. The main outcome was the tumor efficiency. The pain condition was measured by visual analogue scale (VAS) and the Karnofsky score was also measured at different time points, before the treatment, 1 d, 7 d, 14 d, 1 mon, 2 mon and 3 mon after treatment. Serum levels of CEA, CA19-9 and CA50 were measured by immunochemiluminescence. The overall survival was analyzed by K-M curve. RESULTS The ratio of partial remission patients was significantly higher, and the ratio of stable disease (SD)+progressive disease patients was also remarkably lower in iodine-125 group than the chemotherapy perfusion group. The mean VAS scores decreased markedly after treatment and were significantly lower and the mean Karnofsky scores were remarkably higher in iodine-125 group than the chemotherapy perfusion group. The levels of CA19-9 and CA50 were remarkably lower in iodine-125 group, however no significant difference was found for CEA. The survival analysis by K-M curve showed the iodine-125 patients had longer overall survival time than the chemotherapy perfusion group. No infection, pancreatic fistula, biliary fistula, intestinal fistula, gastrointestinal obstruction or radiation enteritis was found in both groups. CONCLUSION Iodine-125 seed interstitial brachytherapy could achieve better efficacy with no increased side complications than chemotherapy perfusion in advanced pancreatic cancer.
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Is surgical resection without radioactive iodine treatment a safe alternative treatment for T1-2N1bM0 papillary thyroid carcinoma?
Fujiwara, T, Yoshizawa, A, Mizuta, M, Tamaki, H
Auris, nasus, larynx. 2021;(1):148-153
Abstract
OBJECTIVE Postoperative radioactive iodine (RAI) adjuvant therapy improves the prognosis in patients with advanced papillary thyroid carcinoma (PTC), although the role of RAI adjuvant therapy remains unclear in intermediate-risk patients, as defined by the American Thyroid Association. The ATA cautiously recommended RAI adjuvant therapy in patients with T1-3N1b, but the Japanese Society of Thyroid Surgery suggests lobectomy without RAI adjuvant therapy in these patients. This study assessed the role and efficacy of RAI adjuvant therapy in patients with T1-3N1b PTC. METHODS A single-center retrospective observational study was performed. We included patients with T1-3N1bM0 PTC who underwent complete resection between January 2003 and December 2017. Patients with bilateral PTC were excluded. We compared recurrence rates after surgery with RAI adjuvant therapy and surgery alone. RESULTS A total of 61 patients (male:female ratio, 18:43; mean age, 57.1 ± 16.7 years) were included, and the median follow-up period was 6.8 years. Of the included patients, 33 were treated with surgery with RAI adjuvant therapy and 28 were treated with surgery alone. The RAI treatment group that underwent surgery had larger tumors, more lymph node metastases, and were younger. There were no disease-specific deaths, and 10 patients experienced local recurrence. The recurrence rate was 24.2% in patients who underwent surgery with RAI adjuvant therapy and 7.1% in patients who underwent surgery alone. Compared to T1-2 stage patients, the T3 stage patients tended to have a higher recurrence rate (odds ratio, 2.38; 95% confidence interval, 0.51-10.7). CONCLUSIONS The recurrence rate was higher in patients who underwent surgery with RAI adjuvant therapy than in patients who underwent surgery alone. Patients in the former group had larger tumors and more lymph node metastases, and this difference in baseline characteristics could explain their higher recurrence rate. The recurrence rate was lower in patients with small tumors, and RAI adjuvant therapy would likely not play a major role in T1-2N1bM0 patients.
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A novel irradiation stent versus conventional irradiation stent for malignant dysphagia: A prospective randomized controlled trial.
Zhu, GY, Lu, J, Wang, C, Guo, JH
Journal of cancer research and therapeutics. 2021;(5):1261-1268
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Abstract
AIM: To evaluate whether a novel irradiation stent (NIS) could decrease the rate of recurrent dysphagia, compared to the conventional irradiation stent (CIS) in patients with malignant dysphagia. MATERIALS AND METHODS We performed an open-label randomized controlled trial of participants with malignant dysphagia. A total of 94 participants were parallelly allocated into the NIS group or the NIS group between April 2019 and April 2020. The primary endpoint was the rate of recurrent dysphagia. The secondary endpoints included technical success, clinical success, overall survival, and adverse events. RESULTS The technical success rate and the clinical success rate was 100.0% (47/47) in both groups. The median follow-up period was 189 days (range 14-422 days). Recurrent dysphagia was observed in 12.8% (6/47) of patients in the NIS group and 31.9% (15/47) in the CIS group (P = 0.026). Tissue/tumor growth occurred in 4 patients (8.5%) after NIS placement and 12 (25.5%) after CIS placement (P = 0.028). Stent migration occurred in 2 patients (4.3%) after NIS placement and 3 (6.4%) after CIS placement (P = 0.646). No food obstruction was found in both groups. The median overall survival was 177 days (95% confidence interval [CI] 139-214) in the NIS group and 168 days (95% CI 153-183) in the CIS group (P = 0.932). The incidence of severe adverse events was comparable between the two groups (21.3% vs. 17.0%, P = 0.600). CONCLUSIONS In patients with malignant dysphagia, compared with CIS, NIS could decrease the rate of tissue/tumor growth without increase the rate of stent migration and therefore decrease the rate of recurrent dysphagia.
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Intermittent versus continuous administration of pazopanib in progressive radioiodine refractory thyroid carcinoma: Final results of the randomised, multicenter, open-label phase II trial PAZOTHYR.
de la Fouchardière, C, Godbert, Y, Dalban, C, Illouz, F, Wassermann, J, Do Cao, C, Bardet, S, Zerdoud, S, Chougnet, CN, Zalzali, M, et al
European journal of cancer (Oxford, England : 1990). 2021;:153-164
Abstract
INTRODUCTION Multikinase inhibitor (MKI) treatments have shown efficacy in progressive radioiodine refractory thyroid cancers (RAIR-TC), but most patients experienced substantial adverse effects. This randomised multicentric study investigated intermittent versus continuous pazopanib administration. PATIENTS AND METHODS The PAZOTHYR study included RAIR-TC patients with progressive disease in the last 12 months, who may have received one prior MKI. RAIR-TC patients received pazopanib for 6 months, and patients with stable disease or tumour response were randomly assigned (1:1) to receive continuous (CP) or intermittent (IP) pazopanib until progression. The primary end-point was time to treatment failure (TTF) defined as the time from randomisation to permanent discontinuation of pazopanib, due to any cause. One hundred randomised patients were needed to demonstrate an increase from 50% (CP) to 70% (IP) (hazard ratio (HR) 0.515, 80% power) in the rate of patients still under treatment 6 months (6m-SuT) post-randomisation. Secondary end-points included the overall response rate (ORR), progression-free survival (PFS) under pazopanib and safety. RESULTS RAIR-TC patients (168) enrolled from June 18, 2013 to January 16, 2018, received 6-month pazopanib treatment and showed 35.6% (95% CI 28.2-43.6) best response rate and 89.4% (83.5-93.7) disease control rate. One hundred patients were randomised (IP:50; CP:50). With a median follow-up of 31.3 months, median TTF was not statistically different between arms (IP:14.7, 95% confidence interval (CI) 9.3-17.4; CP:11.9, 95% CI 7.5-15.6) months (HR 0.79, 0.49-1.27). 6m-SuT rates were similar (IP:80% 66.0-88.7%; CP:78% 63.8-87.2%). Median PFS under pazopanib were not statistically different (IP:5.7 4.8-7.8; CP: 9.2 7.3-11.1) months (HR 1.36, 0.88-2.12). Pazopanib-related adverse events grade 3-4 occurred in 36 (IP: 19, 38%; CP: 17, 34%) randomised patients. Seven pazopanib-related deaths occurred. CONCLUSIONS Intermittent administration of pazopanib did not demonstrate significant superiority in efficacy or tolerance compared with continuous treatment. An intermittent administration scheme cannot be recommended outside clinical trials. This study was registered with ClinicalTrial.gov, number NCT01813136.
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Longer-term recurrence rate after low versus high dose radioiodine ablation for differentiated thyroid Cancer in low and intermediate risk patients: a meta-analysis.
Vardarli, I, Weidemann, F, Aboukoura, M, Herrmann, K, Binse, I, Görges, R
BMC cancer. 2020;(1):550
Abstract
BACKGROUND Regarding the longer-term recurrence rate the optimal activity for the remnant thyroid ablation in patients with differentiated thyroid cancer (DTC) is discussed controversially. For the short-term ablation success rate up to 12 months there are already several meta-analyses. In this study we performed the first meta-analysis regarding the longer-term recurrence rate after radioactive 131-I administration. METHODS We conducted an electronic search using PubMed/MEDLINE, EMBASE and the Cochrane Library. All randomized controlled trials (RCTs) assessed the recurrence rate after radioactive iodine ablation in patients with DTC, with a follow-up of at least two years were selected. Statistics were performed by using Review Manager version 5.3 and Stata software. RESULTS Four RCTs were included in the study, involving 1501 patients. There was no indication for heterogeneity (I2 = 0%) and publication bias. The recurrence rate among patients who had a low dose 131-iodine ablation was not higher than for a high dose activity (odds ratio (OR) 0.93 [95% confidence interval (CI) 0.53-1.63]; P = 0.79). The mean follow-up time was between 4.25 and 10 years. The subgroup analysis regarding the TSH stimulated thyroglobulin values (< 10 ng/mL versus < 2 ng/mL versus ≤1 ng/mL) showed no influence on recurrence rate. CONCLUSIONS For the first time we showed that the longer-term, at least 2-year follow-up, recurrence rate among patients who had 131-iodine ablation with 1.1 GBq was not higher than with 3.7 GBq.
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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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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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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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A Novel Tracheobronchial Stent Loaded with 125I Seeds in Patients with Malignant Airway Obstruction Compared to a Conventional Stent: A Prospective Randomized Controlled Study.
Wang, Y, Lu, J, Guo, JH, Zhu, GY, Zhu, HD, Chen, L, Wang, C, Teng, GJ
EBioMedicine. 2018;:269-275
Abstract
BACKGROUND To evaluate the safety and efficacy of a novel radioactive bare metal stent (RBMS) compared with a conventional bare metal stent (CBMS) in patients with inoperable malignant airway obstruction. METHODS This prospective study was approved by the Institutional Ethics Committee, and informed consent was obtained from each participant. Patients with malignant airway obstruction who had dyspnea were randomly assigned to receive RBMS or CBMS placement. The primary endpoint was stenosis grade, while the secondary endpoints were technical success, overall survival, and complications. A p value of <0·05 was considered statistically significant. RESULTS Between September 2013 and July 2015, 66 patients with inoperable malignant airway obstruction received stent placement fluoroscopically (33 in either group). The median follow-up time was 154 days (range, 15-335 days). The baseline stenosis was immediately relieved in both groups after stent placement, and the stenosis grades in the RBMS group were significantly lower than that in the CBMS group since the second month (p < 0·05). The technical success rates of stent placement were 100% in both groups. The median survival in the RBMS group was significantly longer than that in the CBMS group (170 days vs. 123 days, p < 0·05). There was no significant difference in the incidence of complications between the two groups (p < 0·05). CONCLUSIONS The placement of RBMS in patients with inoperable malignant airway obstruction is feasible and safe, and it significantly reduces restenosis and improves overall survival compared with the placement of CBMS.
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[Toxicity and quality of life comparison of iodine 125 brachytherapy and stereotactic radiotherapy for prostate cancers].
Gnep, K, Lizée, T, Campillo-Gimenez, B, Delpon, G, Droupy, S, Perrier, L, de Crevoisier, R
Cancer radiotherapie : journal de la Societe francaise de radiotherapie oncologique. 2017;(6-7):478-490
Abstract
Quality of life is a major issue for good prognostic prostate cancer, for which brachytherapy is one of the reference treatments. Stereotactic Body Radiotherapy (SBRT) is a recent alternative however not yet validated as a standard treatment. This review of the literature reports and compares the toxicities and the quality of life, either after exclusive brachytherapy with iodine 125 or after SBRT. The comparison is made with the limitations of the absence of randomized trial comparing the two treatment techniques. Acute toxicity appears to be lower after SBRT compared to brachytherapy (from 10 to 40 % versus 30 to 40 %, respectively). Conversely, acute and late gastrointestinal toxicity (from 0 to 21 % and from 0 to 10 % of grade 2, respectively) appears more frequent with SBRT. Late urinary toxicity seems identical between both techniques (from 20 to 30 % of grade 2), with a possible urinary flare syndrome. Both treatments have an impact on erectile dysfunction, although it is not possible to conclude that a technique is superior because of the limited data on SBRT. SBRT has better bowel and urinary (irritation or obstruction) quality of life scores than brachytherapy; while sexual and urinary incontinence remain the same. The absence of randomized trial comparing SBRT with brachytherapy for prostate cancers does not allow to conclude on the superiority of one technique over another, thus justifying a phase III medicoeconomic evaluation.
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Treating cancerous large airway stenosis with staging radioactive particle implantation guided by computed tomography and fiber bronchoscopy: a clinical study.
Mao, Y, Yang, X, Li, M, Guo, W, Zhang, W
World journal of surgical oncology. 2017;(1):149
Abstract
BACKGROUND The purpose of this study is to investigate the clinical effectiveness of staging radioactive particle implantation guided by computed tomography (CT) and fiber-optic bronchoscopy in treating cancerous large airway stenosis. METHODS A total of 102 patients were included; 57 had undergone staging radioactive particle implantation guided by CT and fiber bronchoscopy and 45 did not. Patients were evaluated by CT and fiber-optic bronchoscopy to determine the feasibility of the implantation of radioactive seeds for the treatment of cancerous large airway stenosis. The treatment planning system (TPS) was used to plan the doses. Radioactive seeds were implanted using fiber-optic bronchoscopy. One week later, CT-guided implantation of radioactive seeds was performed. RESULTS The clinical evaluation showed complete, partial, slight, and non-response in 38, 14, 5, and 0 patients, respectively. None of the patients were found with serious complications. The diameter of the affected airway, Karnofsky score, dyspnea index, survival, and quality of life of the patients in both groups was significantly higher and significantly different after the treatment (P < 0.05). The dyspnea index was significantly lower in the treatment group as compared with the control group (P < 0.001). CONCLUSION CT- and fiber bronchoscopy-guided staging radioactive particle implantation has definite treatment effectiveness in treating cancerous large airway stenosis. It should be widely used in clinical practices.