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A Phase II Multi-Center, Non-Randomized, Parallel Group, Non-Inferiority Study to Compare the Efficacy of No Radioactive Iodine Remnant Ablation to Remnant Ablation Treatment in Low- to Intermediate-Risk of Papillary Thyroid Cancer: The MOREthyroid Trial Protocol.

ABSTRACT: BACKGROUND:Radioactive iodine (RAI) remnant ablation is recommended in patients with papillary thyroid cancer (PTC) and extrathyroidal extension or central lymph node metastasis. However, there exists little evidence about the necessity of remnant ablation in PTC patients with low- to intermediate-risk, those have been increasing in recent decades. METHODS:This multicenter, prospective, non-randomized, parallel group clinical trial will enroll 310 eligible patients with low- to intermediate-risk of thyroid cancer. Inclusion criteria are patients who recently underwent total thyroidectomy for PTC with 3 or less tumors of size 1? to ?2 cm with no microscopic extension and N0/x, or size ?2 cm with microscopic extension and/or N1a (number of lymph node ?3, size of tumor foci ?0.2 cm, and lymph node ratio <0.4). Patients choose to undergo RAI ablation (131I, dose 1.1 GBq) or diagnostic whole-body scan (DxWBS) (131I or 123I, dose 0.074 to 0.222 GBq), followed by subsequent measurement of stimulated thyroglobulin (sTg) within 1 year. Survey for quality of life (QOL) will be performed at baseline and at 1 year after follow-up. The total enrollment period is 5 years, and patients will be followed up for 1 year. The primary endpoint is the non-inferiority of surgery alone to surgery with ablation in terms of biochemical remission (BCR) rate (sTg ?2 ng/mL) without evidence of structural recurrence. The secondary endpoint was the difference of QOL. CONCLUSION:This study will evaluate whether surgery alone achieves similar BCR and improved QOL compared to RAI ablation in patients with low- to intermediate-risk PTC within 1 year.

SUBMITTER: Lee EK

PROVIDER: S-EPMC7520583 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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A Phase II Multi-Center, Non-Randomized, Parallel Group, Non-Inferiority Study to Compare the Efficacy of No Radioactive Iodine Remnant Ablation to Remnant Ablation Treatment in Low- to Intermediate-Risk of Papillary Thyroid Cancer: The MOREthyroid Trial Protocol.

Lee Eun Kyung EK Lee You Jin YJ Park Young Joo YJ Moon Jae Hoon JH Yi Ka Hee KH Kim Koon Soon KS Lee Joo Hee JH Cho Sun Wook SW Joo Jungnam J Hwangbo Yul Y Go Sujeong S Park Do Joon DJ

Endocrinology and metabolism (Seoul, Korea) 20200922 3

<h4>Background</h4>Radioactive iodine (RAI) remnant ablation is recommended in patients with papillary thyroid cancer (PTC) and extrathyroidal extension or central lymph node metastasis. However, there exists little evidence about the necessity of remnant ablation in PTC patients with low- to intermediate-risk, those have been increasing in recent decades.<h4>Methods</h4>This multicenter, prospective, non-randomized, parallel group clinical trial will enroll 310 eligible patients with low- to in ...[more]

PMID: 32981299

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Project description:It remains controversial whether papillary thyroid cancer (PTC) patients with low- to intermediate-risk disease should receive radioactive iodine (RAI) after total thyroidectomy (TT). We aim to identify those who might benefit from RAI treatment in PTC patients with cervical nodal metastasis after TT. Patients were divided into TT and TT+RAI groups from the Surveillance, Epidemiology, and End Results (SEER) database (2004-2018). Overall survival (OS) and cancer-specific survival (CSS) were compared, and propensity score matching (PSM) was performed between groups. A total of 15,179 patients were enrolled, including 3,387 (22.3%) who underwent TT and 11,792 (77.7%) who received TT+RAI. The following characteristics were more likely to present in the TT+RAI group: multifocality, capsular extension, T3, N1b, and more metastatic cervical lymph nodes. RAI was associated with better OS in low- to intermediate-risk PTC patients in the multivariate Cox regression model. The subgroup analysis showed that RAI predicted better OS in patients ≥55 years, American Joint Committee on Cancer (AJCC) stage II, and capsular extension with a hazard ratio (HR) (95% CI) of 0.57 (0.45-0.72), 0.57 (0.45-0.72), and 0.68 (0.51-0.91), respectively. However, RAI failed to improve the prognoses of patients with age <55 years, AJCC stage I, PTC ≤1 cm, and capsular invasion. In the PSM cohort with 3,385 paired patients, TT+RAI treatment predicted better OS compared with TT alone. In addition, TT+RAI predicted better OS in patients with metastatic cervical lymph nodes ≥2, multifocality, extracapsular extension, and American Thyroid Association (ATA) intermediate risk. In conclusion, RAI was associated with better OS in low- to intermediate-risk PTC patients with age ≥55 years, multifocality, extrathyroidal extension, and ATA intermediate risk. However, the survival benefit from RAI may be limited in patients with AJCC stage I, PTC ≤1 cm, unifocality, capsular invasion, and ATA low-risk diseases; these patients even showed pathological cervical lymph node metastasis.

Project description:ImportanceOne-third of patients with papillary thyroid cancer (PTC) develop persistent or recurrent disease after initial therapy. Most patients with persistent or recurrent disease undergo reoperation, but the role of treatment with radioactive iodine (RAI) after reoperation is unclear.ObjectiveTo determine whether receipt of RAI after reoperation for recurrent PTC is associated with improved outcomes.Design, setting, and participantsThis retrospective cohort study included electronic health record data from 102 patients who underwent neck reoperation for persistent or recurrent PTC at a tertiary referral center from April 2006 to January 2016; 50 patients received RAI after reoperation, and 52 did not receive RAI after reoperation. Data analysis was performed from September 1, 2017, to December 1, 2017.Main outcomes and measuresSuppressed thyroglobulin (Tg) levels were compared between patients who underwent reoperation and received RAI and patients who underwent reoperation without receipt of RAI at the following time points: before reoperation (Tg0), after reoperation (Tg1), and after RAI or a comparable time interval among patients whose cases were managed without RAI (Tg2). Outcomes were biochemical response and structural recurrence after reoperation.ResultsThe cohort comprised 102 patients who underwent neck reoperation for persistent or recurrent PTC (median age, 44 years [interquartile range, 33-54 years; SD, 14 years]; 67 [66%] female), 50 of whom received treatment with RAI after reoperation. Clinicopathologic characteristics of the patients at the time of the initial surgical procedure were similar between the reoperation with RAI group and the reoperation without RAI group with the exception of tumor (T) stage (T3 and T4, 28 of 50 [56%] vs 19 of 52 [37%]). Although median Tg levels were similar between the reoperation with RAI group and the reoperation without RAI group (Tg0, 3.3 ng/mL vs 2.4 ng/mL; Tg1, 0.6 ng/mL vs 0.2 ng/mL; and Tg2, 0.5 ng/mL vs 0.2 ng/mL; all differences were nonsignificant), the rate of excellent response at Tg1 was lower in the reoperation with RAI group (4 of 33 [12%] vs 24 of 51 [47%]; P = .007). Structural recurrence after reoperation occurred in 18 of 50 patients (36%) in the reoperation with RAI group and 10 of 52 patients (19%) in the reoperation without RAI group. In multivariable analysis accounting for clinicopathologic characteristics and Tg0, receipt of RAI after reoperation was not associated with the rate of a second structural recurrence. In subset analyses limited to patients with incomplete response to reoperation and patients with T3 or T4 tumors, no association between receipt of RAI and the risk of a second recurrence was found.Conclusions and relevancePatients who received RAI after reoperation had outcomes similar to those in patients who underwent reoperation alone. RAI after reoperation was not associated with a significant clinical benefit in this limited series. Larger multicenter studies are required to determine whether receipt of RAI after reoperation improves outcomes among patients with recurrent PTC.

Project description:About half of patients with papillary thyroid cancer have tumours with activating BRAF(V600E) mutations. Vemurafenib, an oncogenic BRAF kinase inhibitor approved for BRAF-positive melanoma, showed clinical benefit in three patients with BRAF(V600E)-positive papillary thyroid cancer in a phase 1 trial. We aimed to establish the activity of vemurafenib in patients with BRAF(V600E)-positive papillary thyroid cancer.We did an open-label, non-randomised, phase 2 trial at ten academic centres and hospitals worldwide in patients aged 18 years or older with histologically confirmed recurrent or metastatic papillary thyroid cancer refractory to radioactive iodine and positive for the BRAF(V600E) mutation. Participants either had never received a multikinase inhibitor targeting VEGFR (cohort 1) or had been treated previously with a VEGFR multikinase inhibitor (cohort 2). Patients received vemurafenib 960 mg orally twice daily. The primary endpoint was investigator-assessed best overall response in cohort 1 (confirmed on two assessments 4 weeks or longer apart). Analyses were planned to have a minimum median follow-up of 15 months (data cutoff April 18, 2014) and were done in safety, intention-to-treat, and per-protocol populations. This trial is closed and is registered at ClinicalTrials.gov, number NCT01286753.Between June 23, 2011, and Jan 15, 2013, 51 patients were enrolled to the study, 26 in cohort 1 and 25 in cohort 2. Median duration of follow-up was 18·8 months (IQR 14·2-26·0) in cohort 1 and 12·0 months (6·7-20·3) in cohort 2. Partial responses were recorded in ten of 26 patients in cohort 1 (best overall response 38·5%, 95% CI 20·2-59·4). Grade 3 or 4 adverse events were recorded in 17 (65%) of 26 patients in cohort 1 and 17 (68%) of 25 patients in cohort 2; the most common grade 3 and 4 adverse events were squamous cell carcinoma of the skin (seven [27%] in cohort 1, five [20%] in cohort 2), lymphopenia (two [8%] in each cohort), and increased ?-glutamyltransferase (one [4%] in cohort 1, three [12%] in cohort 2). Two individuals in cohort 2 died due to adverse events, one from dyspnoea and one from multiorgan failure, but neither was treatment related. Serious adverse events were reported for 16 (62%) of 26 patients in cohort 1 and 17 (68%) of 25 patients in cohort 2.Vemurafenib showed antitumour activity in patients with progressive, BRAF(V600E)-positive papillary thyroid cancer refractory to radioactive iodine who had never been treated with a multikinase inhibitor. As such, this agent represents a potential new treatment option for these patients.F Hoffmann-La Roche.

Dataset Information

A Phase II Multi-Center, Non-Randomized, Parallel Group, Non-Inferiority Study to Compare the Efficacy of No Radioactive Iodine Remnant Ablation to Remnant Ablation Treatment in Low- to Intermediate-Risk of Papillary Thyroid Cancer: The MOREthyroid Trial Protocol.

Publications

A Phase II Multi-Center, Non-Randomized, Parallel Group, Non-Inferiority Study to Compare the Efficacy of No Radioactive Iodine Remnant Ablation to Remnant Ablation Treatment in Low- to Intermediate-Risk of Papillary Thyroid Cancer: The MOREthyroid Trial Protocol.

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