Dataset Information

Adjuvant iodine-125 brachytherapy for hepatocellular carcinoma after complete hepatectomy: a randomized controlled trial.

ABSTRACT:

Background

Tumor recurrence is a major problem after curative resection of hepatocellular carcinoma (HCC). The current study evaluated the effects of adjuvant iodine-125 ((125)I) brachytherapy on postoperative recurrence of HCC.

Methodology/principal findings

From July 2000 to June 2004, 68 HCC patients undergoing curative hepatectomy were randomly assigned into a (125)I adjuvant brachytherapy group (n?=?34) and a group of best care (n?=?34). Patients in the (125)I adjuvant brachytherapy group received (125)I seed implantation on the raw surface of resection. Patients in the best care control group received identical treatments except for the (125)I seed implantation. Time to recurrence (TTR) and 1-, 3- and 5-year overall survival (OS) were compared between the two groups. The follow-up ended in January 2010, and lasted for 7.7-106.4 months with a median of 47.6 months. TTR was significantly longer in the (125)I group (mean of 60.0 months vs. 36.7 months in the control). The 1-, 3- and 5-year recurrence-free rates of the (125)I group were 94.12%, 76.42%, and 73.65% vs. 88.24%, 50.00%, and 29.41% compared with the control group, respectively. The 1-, 3- and 5-year OS rates of the (125)I group were 94.12%, 73.53%, and 55.88% vs. 88.24%, 52.94%, and 29.41% compared with the control group, respectively. The (125)I brachytherapy decreased the risk of recurrence (HR?=?0.310) and the risk of death (HR?=?0.364). Most frequent adverse events in the (125)I group included nausea, vomiting, arrhythmia, decreased white blood cell and/or platelet counts, and were generally mild and manageable.

Conclusions/significance

Adjuvant (125)I brachytherapy significantly prolonged TTR and increased the OS rate after curative resection of HCC.

Trial registration

Australian New Zealand Clinical Trials Registry ACTRN12610000081011.

SUBMITTER: Chen K

PROVIDER: S-EPMC3585398 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

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Publications

Adjuvant iodine-125 brachytherapy for hepatocellular carcinoma after complete hepatectomy: a randomized controlled trial.

Chen Kaiyun K Xia Yong Y Wang Hanning H Xiao Fanglian F Xiang Guoan G Shen Feng F

PloS one 20130228 2

<h4>Background</h4>Tumor recurrence is a major problem after curative resection of hepatocellular carcinoma (HCC). The current study evaluated the effects of adjuvant iodine-125 ((125)I) brachytherapy on postoperative recurrence of HCC.<h4>Methodology/principal findings</h4>From July 2000 to June 2004, 68 HCC patients undergoing curative hepatectomy were randomly assigned into a (125)I adjuvant brachytherapy group (n = 34) and a group of best care (n = 34). Patients in the (125)I adjuvant brachy ...[more]

PMID: 23468980

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Project description:BackgroundThere is currently no widely-accepted consensus for the management of hepatocellular carcinoma with portal vein tumor thrombus. We evaluate the safety and efficacy of ultrasound-guided percutaneous brachytherapy with iodine-125 seeds for the treatment of hepatocellular carcinoma with portal vein-branch tumor thrombus (PVBTT).MethodsSixty-nine hepatocellular carcinoma patients with PVBTT were enrolled; 34 received transarterial chemoembolization (TACE) combined with iodine-125 seeds implanted in the PVBTT; 35 were treated with TACE alone. Adverse events, objective response rate, disease control rate, progression-free survival, and overall survival were compared between the two groups. Tumor responses of PVBTT and intrahepatic tumor were correlated. Multivariate and subgroup analyses were conducted for overall survival.ResultsNo grade 3 or 4 adverse events were recorded, and there was no difference in grade 1 or 2 adverse events between the two groups. Objective response rate and disease control rate for PVBTT were 58.9 and 91.2%, respectively, in the combined treatment group, which were significantly greater than the 5.7 and 54.3% rates, respectively, in the TACE-alone group (both p's ≤ 0.001). Intrahepatic tumor response was positively correlated with the PVBTT response (γ = 0.782, p < 0.01). Survival outcomes were better in the combined treatment group than in the TACE-alone group: the median progression-free survival for PVBTT was 9 months versus 3 months (HR = 0.187 [95% CI: 0.101, 0.345], p < 0.001), and the median overall survival was 11 months versus 7 months (HR = 0.448 [95% CI: 0.265, 0.758], p = 0.003). Multivariate analysis revealed that application of brachytherapy and lower grade PVBTT (Vp1 + Vp2 vs. Vp3) were protective predictors of overall survival. In stratified analysis, the benefit of overall survival was more significant in the subgroup of PVBTT Vp1 + Vp2 rather than in Vp3.ConclusionsThe combination of iodine-125 seed brachytherapy guided by ultrasound and TACE is a convenient, safe, and effective treatment for patients with HCC and PVBTT, conferring a better survival benefit than TACE alone.

Project description:Purpose:To investigate chronological changes in lower urinary tract symptoms (LUTS) in patients who received iodine-125 brachytherapy (BT) for prostate cancer. Methods:We enrolled 706 patients who received BT. Of these, 265 (38%) received BT combined with external beam radiation therapy (EBRT). An International Prostate Symptom Score (IPSS), IPSS quality of life (IPSS-QOL) score, and overactive bladder symptom score (OABSS) were recorded before BT (baseline, BL), and 1, 3, 6, 12, 24, 36, 48, and 60?months after BT. The sum of frequency (2), urgency (4) and nocturia (7) of the IPSS questionnaire was defined as the storage symptoms score, whereas the sum of emptying (1), intermittency (3), weak stream (5), and hesitancy (6) was defined as the voiding symptom score. Results:Total IPSS significantly increased at 3?months following BT compared with BL (mean score: 17.1 vs. 7.99, P?<?0.001) and returned to BL by 36?months. The storage symptom score did not return to BL 36?months after BT. Total OABSS significantly increased 3?months after BT compared with BL (mean score: 6.52 vs. 3.45, P?<?0.001), and returned to BL 48?months after BT. The IPSS-QOL score was the highest score (mean score: 2.46 vs. 3.9, P?<?0.001) 3?months after BT and returned to BL 48?months after BT, however the IPSS-QOL score was lower than BL (mean score: 2.01 vs 2.46, P?<?0.001) at 60?months. The risk factors for LUTS within 1?year after BT were BL IPSS (P?<?0.001) and PV (P?<?0.001). Patients who received combined EBRT experienced transient storage symptoms 24 and 36?months after BT, whereas those who received BT alone did not. However, the storage symptom score of the patients who received combined EBRT was improving 48?months after BT and eventually showed no significant difference compared with those treated with BT alone. Conclusion:Three months after BT, LUTS, including storage symptoms, deteriorated the most but improved with time. The urinary symptom in patients who received combined EBRT can potentially flare again in 24 and 36?months after BT. Knowledge of changes in LUTS associated with BT may influence treatment recommendations and enable patients to make better-informed decisions.

Project description:BackgroundRadiation therapy is the method of choice for subjects with inoperable salivary gland malignancies. I-125 brachytherapy, delivering a high radiation dose to a tumor but sparing surrounding normal tissues, is supposed to be ideal modality for the treatment of salivary gland malignancies. We designed a randomised controlled clinical trial to compare the efficacy of I-125 permanent brachytherapy (PBT) versus intensity-modulated radiation therapy (IMRT) for inoperable salivary gland malignancies.Methods/designIn this study, inclusion criteria are subjects with inoperable salivary gland malignancies, aged 18-80 years, have provided informed consent, with at least one measurable tumor focus, be able to survive ≥3 months, Karnofsky performance status ≥60, have adequate hematopoietic function of bone marrow, have normal liver and kidney function, and are willing to prevent pregnancy. Exclusion criteria include a history of radiation or chemotherapy, a history of other malignant tumors in the past 5 years, receiving other effective treatments, participating in other clinical trials, with circulatory metastasis, cognitive impairment, severe cardiovascular and cerebrovascular diseases, acute infection, uncontrolled systemic disease, history of interstitial lungdisease, and being pregnant or breast feeding. The study will be conducted as a clinical, prospective, randomised controlled trial with balanced randomisation (1:1). The planned sample size is 90 subjects. Subjects with inoperable salivary gland malignancies are randomised to receive either I-125 PBT or IMRT, with stratification by tumor size and neck lymph node metastasis. Participants in both groups will be followed up at 2, 4, 6, 9, 12, 15, 18, 21 and 24 months after randomization. The primary outcome is local control rate of the primary site (based on imaging findings and clinical examination, RECIST criteria) in 1 year. Secondary outcomes are progression-free survival, overall survival, quality of life (QOL) measured with the European Organization for Research and Treatment of Cancer QOL Questionnaire (EORTC QLQ-C30 and QLQ-H&N35) of Chinese version, and safety of treatment. Chi-squared test is used to compare the local control rates in both groups. The survival curves are estimated by the Kaplan-Meier method, and log-rank test is used to test the significant difference.DiscussionOnly few observational studies have investigated the effect of I-125 PBT on inoperable salivary gland malignancies. To our knowledge, this is the first randomised controlled trial to investigate the efficacy of I-125 PBT for subjects with inoperable salivary gland malignancies, and will add to the knowledge base for the treatment of these subjects.Trial registrationThe study is registered to Clinical Trials.gov ( NCT02048254 ) on Jan 29, 2014.

Project description:The optimal protocol for 125I-transperineal prostatic brachytherapy (TPPB) in intermediate-risk prostate cancer (PCa) patients remains controversial. Data on the efficacy of combining androgen-deprivation therapy (ADT) with 125I-TPPB in this group remain limited and consequently the guidelines of the American Brachytherapy Society (ABS) provide no firm recommendations.Seed and Hormone for Intermediate-risk Prostate Cancer (SHIP) 0804 is a phase III, multicenter, randomized, controlled study that will investigate the impact of adjuvant ADT following neoadjuvant ADT and 125I-TPPB. Prior to the end of March, 2011, a total of 420 patients with intermediate-risk, localized PCa will be enrolled and randomized to one of two treatment arms. These patients will be recruited from 20 institutions, all of which have broad experience of 125I-TPPB. Pathological slides will be centrally reviewed to confirm patient eligibility. The patients will initially undergo 3-month ADT prior to 125I-TPPB. Those randomly assigned to adjuvant therapy will subsequently undergo 9 months of adjuvant ADT. All participants will be assessed at baseline and at the following intervals: every 3 months for the first 24 months following 125I-TPPB, every 6 months during the 24- to 60-month post-125I-TPPB interval, annually between 60 and 84 months post-125I-TPPB, and on the 10th anniversary of treatment.The primary endpoint is biochemical progression-free survival (BPFS). Secondary endpoints are overall survival (OS), clinical progression-free survival, disease-specific survival, salvage therapy non-adaptive interval, acceptability (assessed using the international prostate symptom score [IPSS]), quality of life (QOL) evaluation, and adverse events. In the correlative study (SHIP36B), we also evaluate biopsy results at 36 months following treatment to examine the relationship between the results and the eventual recurrence after completion of radiotherapy.These two multicenter trials (SHIP0804 & SHIP36B) are expected to provide crucial data regarding the efficacy, acceptability and safety of adjuvant ADT. SHIP36B will also provide important information about the prognostic implications of PSA levels in intermediate-risk PCa patients treated with 125I-TPPB.NCT00664456, NCT00898326, JUSMH-BRI-GU05-01, JUSMH-TRIGU0709.

Dataset Information

Adjuvant iodine-125 brachytherapy for hepatocellular carcinoma after complete hepatectomy: a randomized controlled trial.

Background

Methodology/principal findings

Conclusions/significance

Trial registration

Publications

Adjuvant iodine-125 brachytherapy for hepatocellular carcinoma after complete hepatectomy: a randomized controlled trial.

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