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1.
N Engl J Med ; 386(10): 923-932, 2022 03 10.
Artigo em Inglês | MEDLINE | ID: mdl-35263518

RESUMO

BACKGROUND: In patients with low-risk differentiated thyroid cancer undergoing thyroidectomy, the postoperative administration of radioiodine (iodine-131) is controversial in the absence of demonstrated benefits. METHODS: In this prospective, randomized, phase 3 trial, we assigned patients with low-risk differentiated thyroid cancer who were undergoing thyroidectomy to receive ablation with postoperative administration of radioiodine (1.1 GBq) after injections of recombinant human thyrotropin (radioiodine group) or to receive no postoperative radioiodine (no-radioiodine group). The primary objective was to assess whether no radioiodine therapy was noninferior to radioiodine therapy with respect to the absence of a composite end point that included functional, structural, and biologic abnormalities at 3 years. Noninferiority was defined as a between-group difference of less than 5 percentage points in the percentage of patients who did not have events that included the presence of abnormal foci of radioiodine uptake on whole-body scanning that required subsequent treatment (in the radioiodine group only), abnormal findings on neck ultrasonography, or elevated levels of thyroglobulin or thyroglobulin antibodies. Secondary end points included prognostic factors for events and molecular characterization. RESULTS: Among 730 patients who could be evaluated 3 years after randomization, the percentage of patients without an event was 95.6% (95% confidence interval [CI], 93.0 to 97.5) in the no-radioiodine group and 95.9% (95% CI, 93.3 to 97.7) in the radioiodine group, a difference of -0.3 percentage points (two-sided 90% CI, -2.7 to 2.2), a result that met the noninferiority criteria. Events consisted of structural or functional abnormalities in 8 patients and biologic abnormalities in 23 patients with 25 events. Events were more frequent in patients with a postoperative serum thyroglobulin level of more than 1 ng per milliliter during thyroid hormone treatment. Molecular alterations were similar in patients with or without an event. No treatment-related adverse events were reported. CONCLUSIONS: In patients with low-risk thyroid cancer undergoing thyroidectomy, a follow-up strategy that did not involve the use of radioiodine was noninferior to an ablation strategy with radioiodine regarding the occurrence of functional, structural, and biologic events at 3 years. (Funded by the French National Cancer Institute; ESTIMABL2 ClinicalTrials.gov number, NCT01837745.).


Assuntos
Radioisótopos do Iodo/uso terapêutico , Neoplasias da Glândula Tireoide/radioterapia , Neoplasias da Glândula Tireoide/cirurgia , Tireoidectomia , Adulto , Terapia Combinada , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Pescoço/diagnóstico por imagem , Prognóstico , Qualidade de Vida , Neoplasias da Glândula Tireoide/diagnóstico por imagem , Ultrassonografia
2.
Oncology ; 100(2): 74-81, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-34788758

RESUMO

The role of radioiodine therapy (RIT) (used as ablation therapy or adjuvant therapy) following total thyroidectomy for differentiated thyroid cancer (DTC) changed. Major revisions of the American Thyroid Association (ATA) Guidelines in 2015 resulted in significant differences in treatment recommendations in comparison to the European Association of Nuclear Medicine (EANM) 2008 guidelines. Recently, we presented the effects on daily practice for RIT among Swiss Nuclear Medicine centres. We now performed a study at the European level and hypothesized that there is also considerable variability among European experts. We performed a decision-tree-based analysis of management strategies from all members of the EANM thyroid committee to map current practice among experts. We collected data on whether or not RIT is administered, on which criteria these decisions are based and collected details on treatment activities and patient preparation. Our study shows discrepancies for low-risk DTC, where "follow-up only" is recommended by some experts, while RIT with significant doses is used by other experts. E.g., for pT1b tumours without evidence of metastases, the level of agreement for the use of RIT is as low as 50%. If RIT is administered, activities of I-131 range from 1.1 GBq to 3.0 GBq. In other constellations (e.g., pT1a), experts diverge from current clinical guidelines as up to 75% administer RIT in certain cases. For intermediate and high-risk patients, RIT is generally recommended. However, dosing and treatment preparation (rhTSH vs. thyroid hormone withdrawal) vary distinctly. In comparison to the Swiss study, the general level of agreement is higher among the European experts. The recently proposed approach on the use of RIT, based on integrated post-surgery assessment (Martinique article) and results of ongoing prospective randomized studies are likely to reduce uncertainty in approaching RIT treatment. In certain constellations, consensus identified among European experts might be helpful in formulating future guidelines.


Assuntos
Radioisótopos do Iodo/uso terapêutico , Neoplasias da Glândula Tireoide/cirurgia , Tireoidectomia/métodos , Tomada de Decisão Clínica , Terapia Combinada , Consenso , Árvores de Decisões , Fracionamento da Dose de Radiação , Europa (Continente) , Humanos , Guias de Prática Clínica como Assunto , Estudos Prospectivos , Neoplasias da Glândula Tireoide/tratamento farmacológico , Neoplasias da Glândula Tireoide/patologia
3.
Eur J Nucl Med Mol Imaging ; 48(10): 3238-3249, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-33619600

RESUMO

PURPOSE: This is the first prospective trial evaluating the efficacy of alpha emitter Radium-223 in patients with bone metastases from radioactive iodine (RAI) refractory (RAIR) differentiated thyroid cancer. METHODS: RADTHYR is a multicenter, single-arm prospective Simon two-stage phase II trial (NCT02390934). The primary objective was to establish the efficacy of three administrations of 55 kBq/kg of Radium-223 by 18F-FDG PET/CT according to PERCIST criteria. Secondary objectives were to establish the efficacy of six administrations of Radium-223 by 18F-FDG PET/CT, 99mTc-HMDP bone scan and 18FNa PET/CT, clinical benefits, changes in serum bone markers, thyroglobulin levels, and safety. RESULTS: Ten patients were enrolled between July 2015 and December 2017 (4 M; median age 74 years). Prior to Radium-223 administration, patients received a median RAI cumulative activity of 15 GBq (7.4-35.6), external radiation therapy (n = 9), bone surgery (n = 8), cimentoplasty (n = 5), and cryoablation (n = 2). 18F-FDG PET/CT showed stable disease (SD) in 4/10 and progressive disease (PD) in 6/10 cases after three administrations and SD in 4/10, PD in 5/10 cases, and 1/10 non-evaluable (NE) case after six administrations. After six injections, 99mTc-HMDP bone scan showed SD in 9 cases and was NE in 1 case; 18FNa PET/CT showed SD in 8 cases, partial response (PR) in 1 case, and was NE in 1 case. No significant clinical benefits were reported during the study. A skeletal event occurred in 6 patients (median time without skeletal event of 12.1 months). Seventy-seven adverse events were reported during treatment (7 of grade 3-4). Three patients developed an acute myeloid, a promyelocytic, and a chronic myeloid leukemia after the last Radium-223 administration considered as drug-related. CONCLUSION: The trial was stopped after interim analysis for lack of response of bone metastases from RAIR thyroid cancer to Radium-223. Severe hematological toxicity was observed in patients heavily pretreated with RAI and external radiation. TRIAL REGISTRATION NUMBER: NCT02390934. Registration date 18.03.2015.


Assuntos
Neoplasias Ósseas , Rádio (Elemento) , Neoplasias da Glândula Tireoide , Idoso , Neoplasias Ósseas/diagnóstico por imagem , Neoplasias Ósseas/radioterapia , Humanos , Radioisótopos do Iodo/efeitos adversos , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada , Estudos Prospectivos , Rádio (Elemento)/efeitos adversos , Neoplasias da Glândula Tireoide/radioterapia , Tomografia Computadorizada por Raios X
4.
Q J Nucl Med Mol Imaging ; 63(3): 284-291, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-28358186

RESUMO

BACKGROUND: 18F-Fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT) plays an important part in the oncological evaluation of the abdomen and pelvis, but the interpretation and quantification is often hampered by intense physiological urinary activity. We evaluate 2 different diuretic imaging protocols by comparing intensity of urinary activity and we look at the impact of multiple variables on the final urinary activity. METHODS: Comparative analysis of 102 patients (median age: 64) having intrapelvic carcinoma. After full body acquisition, 58 patients were administered 20 mg of furosemide 90 min post injection of FDG (P90). For 44 patients, 20 mg of furosemide was administered 30 min post injection of FDG (P30). Comparisons between groups were performed using the Mann-Whitney Test and χ2. The BMI, creatinine, clearance, age, injected activity, diuretic protocol, gender and glycemia were evaluated with multivariate analysis for their impact on the final urinary activity. RESULTS: Concerning the comparison of the urinary activity we observe a significant difference (P=0.0029) between P90 and P30 for the SUVmax (median 4.3 [range 1.6: 17.7] vs. 6.0 [range 2.9: 15.1]), and for the SUVmean (P<0.001) (median 2.4 [range 1.1; 9.9] vs. 3.8 [range 2.0; 10.1]). For 2 patients of P30, the acquisition was interrupted because the patient needed to void. Multivariate analysis shows that creatinine and creatinine clearance do not have a significant independent impact on the final bladder activity. CONCLUSIONS: By comparing the 2 diuretic imaging protocols, we found a significant lower urinary activity for the P90 protocol and the regression decision tree shows that the P90 protocol is mostly superior. The P30 protocol, which seems to be less well tolerated, is adequate in the group of patients with an injected activity of less than 240 MBq and older than 65 years, if P90 is not feasible. For most patients with injected activity ≥240 MBq or BMI of ≥25 and a glycemia >120 mg/dL, a significant amount of residual urinary activity remains for both protocols.


Assuntos
Diuréticos/farmacologia , Fluordesoxiglucose F18 , Neoplasias Pélvicas/diagnóstico por imagem , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Furosemida/farmacologia , Humanos , Masculino , Pessoa de Meia-Idade , Adulto Jovem
5.
N Engl J Med ; 366(18): 1663-73, 2012 May 03.
Artigo em Inglês | MEDLINE | ID: mdl-22551127

RESUMO

BACKGROUND: It is not clear whether the administration of radioiodine provides any benefit to patients with low-risk thyroid cancer after a complete surgical resection. The administration of the smallest possible amount of radioiodine would improve care. METHODS: In our randomized, phase 3 trial, we compared two thyrotropin-stimulation methods (thyroid hormone withdrawal and use of recombinant human thyrotropin) and two radioiodine ((131)I) doses (i.e., administered activities) (1.1 GBq and 3.7 GBq) in a 2-by-2 design. Inclusion criteria were an age of 18 years or older; total thyroidectomy for differentiated thyroid carcinoma; tumor-node-metastasis (TNM) stage, ascertained on pathological examination (p) of a surgical specimen, of pT1 (with tumor diameter ≤1 cm) and N1 or Nx, pT1 (with tumor diameter >1 to 2 cm) and any N stage, or pT2N0; absence of distant metastasis; and no iodine contamination. Thyroid ablation was assessed 8 months after radioiodine administration by neck ultrasonography and measurement of recombinant human thyrotropin-stimulated thyroglobulin. Comparisons were based on an equivalence framework. RESULTS: There were 752 patients enrolled between 2007 and 2010; 92% had papillary cancer. There were no unexpected serious adverse events. In the 684 patients with data that could be evaluated, ultrasonography of the neck was normal in 652 (95%), and the stimulated thyroglobulin level was 1.0 ng per milliliter or less in 621 of the 652 patients (95%) without detectable thyroglobulin antibodies. Thyroid ablation was complete in 631 of the 684 patients (92%). The ablation rate was equivalent between the (131)I doses and between the thyrotropin-stimulation methods. CONCLUSIONS: The use of recombinant human thyrotropin and low-dose (1.1 GBq) postoperative radioiodine ablation may be sufficient for the management of low-risk thyroid cancer. (Funded by the French National Cancer Institute [INCa] and the French Ministry of Health; ClinicalTrials.gov number, NCT00435851; INCa number, RECF0447.).


Assuntos
Radioisótopos do Iodo/uso terapêutico , Neoplasias da Glândula Tireoide/radioterapia , Tireotropina/uso terapêutico , Técnicas de Ablação , Adenocarcinoma Folicular/tratamento farmacológico , Adenocarcinoma Folicular/radioterapia , Adenocarcinoma Folicular/cirurgia , Adulto , Carcinoma Papilar/tratamento farmacológico , Carcinoma Papilar/radioterapia , Carcinoma Papilar/cirurgia , Terapia Combinada , Feminino , Seguimentos , Humanos , Hipotireoidismo/etiologia , Radioisótopos do Iodo/efeitos adversos , Masculino , Pessoa de Meia-Idade , Pescoço/diagnóstico por imagem , Qualidade de Vida , Hormônios Tireóideos/sangue , Hormônios Tireóideos/uso terapêutico , Neoplasias da Glândula Tireoide/tratamento farmacológico , Neoplasias da Glândula Tireoide/cirurgia , Tireoidectomia , Tireotropina/efeitos adversos , Resultado do Tratamento , Ultrassonografia
7.
Eur J Nucl Med Mol Imaging ; 42(3): 397-408, 2015 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-25367748

RESUMO

PURPOSE: To investigate whether MRI (RECIST 1.1, WHO criteria and the volumetric approach) or (18)F-FDG PET/CT (PERCIST 1.0) are able to predict long-term outcome in nonsurgical patients with giant cell tumour of the tendon sheath or of the diffuse type (GCT-TS/DT). METHODS: Fifteen "nonsurgical" patients with a histological diagnosis of GCT-TS/DT were divided into two groups: symptomatic patients receiving targeted therapy and asymptomatic untreated patients. All 15 patients were evaluated by MRI of whom 10 were treated, and a subgroup of 7 patients were evaluated by PET/CT of whom 4 were treated. Early evolution was assessed according to MRI and PET/CT scans at baseline and during follow-up. Cohen's kappa coefficient was used to evaluate the degree of agreement between PERCIST 1.0, RECIST 1.1, WHO criteria, volumetric approaches and the reference standard (long-term outcome, delay 505 ± 457 days). The response rate in symptomatic patients with GCT-TS/DT receiving targeted therapy was also assessed in a larger population that included additional patients obtained from a review of the literature. RESULTS: The kappa coefficients for agreement between RECIST/WHO/volumetric criteria and outcome (15 patients) were respectively: 0.35 (p = 0.06), 0.26 (p = 0.17) and 0.26 (p = 0.17). In the PET/CT subgroup (7 patients), PERCIST was in perfect agreement with the late symptomatic evolution (kappa = 1, p < 0.05). In the treated symptomatic group including the additional patients from the literature the response rates to targeted therapies according to late symptomatic assessment, and PERCIST and RECIST criteria were: 65 % (22/34), 77 % (10/13) and 26 % (10/39). CONCLUSION: (18)F-FDG PET/CT with PERCIST is a promising approach to the prediction of the long-term outcome in GCT-TS/DT and may avoid unnecessary treatments, toxicity and costs. On MRI, WHO and volumetric approaches are not more effective than RECIST using the current thresholds.


Assuntos
Tumores de Células Gigantes/diagnóstico por imagem , Imageamento por Ressonância Magnética , Imagem Multimodal , Tomografia por Emissão de Pósitrons , Tendões/diagnóstico por imagem , Tomografia Computadorizada por Raios X , Adulto , Idoso , Feminino , Fluordesoxiglucose F18 , Tumores de Células Gigantes/patologia , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Compostos Radiofarmacêuticos , Tendões/patologia
10.
Gynecol Oncol ; 137(2): 264-9, 2015 May.
Artigo em Inglês | MEDLINE | ID: mdl-25727652

RESUMO

PURPOSE: To evaluate the contribution of preoperative lymphoscintigraphy to intraoperative lymphatic mapping (ILM) in early cervical cancer METHODS: We conducted an ancillary analysis of the multicenter prospective SENTICOL study in early cervical cancer. Radiocolloid was injected intracervically on the day before (long protocol) or morning of (short protocol) surgery, lymphoscintigraphy was performed, and the results of a centralized image review were communicated to the surgeons. ILM was performed on combined radioactivity/patent blue detection. Sentinel lymph nodes (SLNs) were electively sampled before routine bilateral pelvic lymphadenectomy by laparoscopy. RESULTS: Of 139 patients in the modified intention-to-diagnose analysis, 114 had centrally reviewed lymphoscintigrams, which showed 352 SLNs in 100 patients. Lymphoscintigraphy and ILM detection rates were 87.8% and 97.8%, respectively. Agreement between lymphoscintigraphy and ILM was low for the number of SLNs (κ=0.23; -0.04; 0.49) and bilateral SLNs (κ=0.36; 0.2; 0.52). No patient without SLNs by ILM had SLNs by lymphoscintigraphy. Lymphoscintigraphy identified substantial proportions of unusual drainage pathways. No patients with metastatic nodes had SLNs by lymphoscintigraphy but not by ILM in the relevant territory. In 1 of the 2 patients with false-negative SLN results, SLNs were bilateral by lymphoscintigraphy and unilateral by ILM. CONCLUSION: Although the detection rate was lower by lymphoscintigraphy than by ILM, the substantial proportions of SLNs in unusual territories provided valuable guidance for the surgical exploration. Awareness of the limited agreement between lymphoscintigraphic and surgical detection might help surgeons decrease the false-negative rate.


Assuntos
Linfonodos/patologia , Linfocintigrafia/métodos , Biópsia de Linfonodo Sentinela/métodos , Neoplasias do Colo do Útero/diagnóstico , Adulto , Estudos de Coortes , Detecção Precoce de Câncer , Feminino , Humanos , Cuidados Intraoperatórios/métodos , Linfonodos/cirurgia , Metástase Linfática , Estudos Prospectivos , Neoplasias do Colo do Útero/patologia , Neoplasias do Colo do Útero/cirurgia
11.
Clin Nucl Med ; 49(4): 340-341, 2024 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-38377372

RESUMO

ABSTRACT: A 57-year-old woman with history of chronic lymphocytic leukemia was referred to our center for adjuvant 131 I therapy following complete thyroidectomy for differentiated thyroid cancer. Posttherapeutic scintigraphy revealed atypical diffuse osteomedullar uptake. A major drop in lymphocyte count was observed, from 117.7 g/L to 4.8 g/L 8 weeks after 131 I therapy. Bone marrow uptake is presumed to be related to tracer sequestration in leukemic cells. White blood cell count normalization suggests a high sensitivity of leukemic cells to beta emission. This scintigraphic pattern may act as a pitfall for nuclear medicine physician.


Assuntos
Adenocarcinoma , Leucemia Linfocítica Crônica de Células B , Neoplasias da Glândula Tireoide , Feminino , Humanos , Pessoa de Meia-Idade , Câncer Papilífero da Tireoide/diagnóstico por imagem , Leucemia Linfocítica Crônica de Células B/diagnóstico por imagem , Transporte Biológico , Neoplasias da Glândula Tireoide/diagnóstico por imagem , Neoplasias da Glândula Tireoide/radioterapia , Radioisótopos do Iodo/uso terapêutico
12.
Ann Surg Oncol ; 20(2): 413-22, 2013 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-22911367

RESUMO

BACKGROUND: Sentinel lymph node (SLN) biopsy may improve nodal staging in cervical cancer. The aims of this study are to determine the rate of unusual patterns of cervical lymphatic drainage, to determine the rates of micrometastases and isolated tumor cells (ITCs) in SLNs, and to assess the clinical impact of SLN biopsy. METHODS: Multicenter prospective study conducted between January 2005 and June 2007 in women undergoing laparoscopic surgery for early cervical cancer. Combined technetium/Patent Blue labeling was used. Lymphoscintigraphy was performed before surgery. SLN location was recorded, and factors associated with location were explored. SLNs underwent step sectioning ± immunohistochemistry. RESULTS: 145 patients were enrolled and 139 included in a modified intention-to-diagnose analysis. Although 80.6 % of SLNs were in external iliac and interiliac areas, 38.2 % of patients had at least one SLN in an unexpected area and 5.1 % had SLNs only in unexpected areas. In unexpected areas, the number of SLNs per patient was not significantly different between lymphoscintigraphy and intraoperative detection (0.79 [0.62-1.02] versus 0.50 [0.37-0.68]; P = 0.096). In expected locations, there were significantly more blue and hot SLNs per patient than blue or hot SLNs (1.70 [1.45-1.99], 0.42 [0.30-0.57], 0.52 [0.39-0.69]). Of 28 metastatic SLNs, 17 contained micrometastases or ITCs. SLN involvement was found only by immunohistochemistry in 39.1 % of patients with positive nodes, and involved SLNs were located in unexpected areas in 17 % of those patients. CONCLUSIONS: Sentinel lymph node biopsy detects unusual drainage pathways and micrometastases in a substantial proportion of patients, thus improving nodal staging.


Assuntos
Adenocarcinoma/patologia , Carcinoma Adenoescamoso/patologia , Carcinoma de Células Escamosas/patologia , Drenagem , Linfonodos/patologia , Biópsia de Linfonodo Sentinela , Neoplasias do Colo do Útero/patologia , Adenocarcinoma/diagnóstico por imagem , Adenocarcinoma/cirurgia , Adulto , Idoso , Idoso de 80 Anos ou mais , Carcinoma Adenoescamoso/diagnóstico por imagem , Carcinoma Adenoescamoso/cirurgia , Carcinoma de Células Escamosas/diagnóstico por imagem , Carcinoma de Células Escamosas/cirurgia , Feminino , Seguimentos , Humanos , Laparoscopia , Linfonodos/cirurgia , Metástase Linfática , Linfocintigrafia , Pessoa de Meia-Idade , Micrometástase de Neoplasia , Estadiamento de Neoplasias , Prognóstico , Estudos Prospectivos , Fatores de Risco , Neoplasias do Colo do Útero/diagnóstico por imagem , Neoplasias do Colo do Útero/cirurgia , Adulto Jovem
13.
Breast ; 67: 102-109, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-36709639

RESUMO

PURPOSE: Local ablative treatment (LAT) is increasingly combined with systemic therapy in oligometastatic breast cancer (OMBC), without a high-level evidence to support this strategy. We evaluated the addition of LAT to systemic treatment in terms of progression-free survival (PFS) and overall survival (OS). Secondary endpoints were local control (LC) and toxicity. We sought to identify prognostic factors associated with longer OS and PFS. METHODS AND MATERIALS: We identified consecutive patients treated between 2014 and 2018 for synchronous or metachronous OMBC (defined as ≤ 5 metastases). LAT included stereotactic body radiation therapy (SBRT) and volumetric modulated arc therapy (VMAT), surgery, cryotherapy and percutaneous radiofrequency ablation (PRA). PFS and OS were calculated, and Cox regression models analyzed for potential predictors of survival. RESULTS: One hundred two patients were included (no-LAT, n = 62; LAT, n = 40). Sixty-four metastases received LAT. Median follow-up was 50.4 months (95% CI [44.4; 53.4]). One patient experienced grade 3 toxicity in the LAT group. Five-year PFS and OS were 34.75% (95% CI [24.42-45.26]) and 63.21% (95% CI [50.69-73.37]) respectively. Patients receiving both LAT and systemic therapy had longer PFS and OS than those with no-LAT ([HR 0.39, p = 0.002]) and ([HR 0.31, p = 0.01]). The use of LAT, HER2-positive status and hormone-receptor positivity were associated with longer PFS and OS whereas liver metastases led to worse PFS. CONCLUSIONS: LAT was associated with improved outcomes in OMBC when added to systemic treatment, without significantly increasing toxicity. The prognostic factors identified to extend PFS and OS may help guide clinicians in selecting patients for LAT.


Assuntos
Neoplasias da Mama , Neoplasias Pulmonares , Radiocirurgia , Humanos , Feminino , Resultado do Tratamento , Neoplasias Pulmonares/secundário , Neoplasias da Mama/terapia , Intervalo Livre de Progressão , Modelos de Riscos Proporcionais , Radiocirurgia/métodos , Estudos Retrospectivos
14.
Trials ; 24(1): 298, 2023 Apr 28.
Artigo em Inglês | MEDLINE | ID: mdl-37118818

RESUMO

BACKGROUND: Prophylactic central neck dissection in clinically low-risk cT1bT2N0 papillary thyroid carcinoma is controversial, due to a large number of conflicting retrospective studies, some showing an advantage in terms of locoregional recurrence, others showing no advantage. These previous studies all show high rates of excellent response. We aim to demonstrate the non-inferiority of thyroidectomy alone as compared to total thyroidectomy with prophylactic central neck dissection in conjunction with adjuvant RAI 30 mCi with rTSH stimulation in terms of excellent response at 1 year. TRIAL DESIGN AND METHODS: Prospective randomized open multicenter phase III trial including patients with 11-40-mm papillary thyroid carcinoma (Bethesda VI) or suspicious cytology (Bethesda V) confirmed malignant on intra-operative frozen section analysis, with no suspicious lymph nodes on a specialized preoperative ultrasound examination. Patients will be randomized 1:1 into two groups: the reference group total thyroidectomy with bilateral prophylactic central neck dissection, and the comparator group total thyroidectomy alone. All patients will receive an ablative dose of 30mCi of radioactive iodine (RAI) within 4 months of surgery. The primary outcome is to compare the rate of excellent response at 1 year after surgery between the groups, as defined by an unstimulated serum thyroglobulin (Tg) level ≤ 0.2 ng/mL with no anti-Tg antibodies, an normal neck ultrasound and no ectopic uptake on the post-RAI scintiscan. Non-inferiority will be demonstrated if the rate of patients with excellent response at 1 year after randomization does not differ by more than 5%. Setting the significance level at 0.025 (one-sided) and a power of 80% requires a sample size of 598 patients (299 per group). Secondary outcomes are to compare Tg levels at 8 +/- 2 postoperative weeks, before RAI ablation, the rate of excellent response at 3 and 5 years, the rate of other responses at 1, 3, and 5 years (biochemical incomplete, indeterminate, and structurally incomplete responses), complications, quality of life, and cost-utility. DISCUSSION (POTENTIAL IMPLICATIONS): If non-inferiority is demonstrated with this high-level evidence, prophylactic neck dissection will have been shown to not be necessary in clinically low-risk papillary thyroid carcinoma. TRIAL REGISTRATION: NCT03570021. June 26,2018.


Assuntos
Carcinoma Papilar , Neoplasias da Glândula Tireoide , Humanos , Neoplasias da Glândula Tireoide/diagnóstico por imagem , Neoplasias da Glândula Tireoide/cirurgia , Esvaziamento Cervical/efeitos adversos , Câncer Papilífero da Tireoide/cirurgia , Radioisótopos do Iodo , Estudos Retrospectivos , Estudos Prospectivos , Qualidade de Vida , Carcinoma Papilar/patologia , Carcinoma Papilar/cirurgia , Recidiva Local de Neoplasia/patologia , Tireoidectomia/efeitos adversos
15.
Clin Cancer Res ; 29(13): 2401-2409, 2023 07 05.
Artigo em Inglês | MEDLINE | ID: mdl-37074727

RESUMO

PURPOSE: To evaluate the efficacy and safety of dabrafenib-trametinib-131I for the treatment of radioactive iodine refractory metastatic differentiated thyroid cancer (DTC) with a BRAF p.V600E mutation. PATIENTS AND METHODS: A prospective phase II trial including patients with RECIST progression within 18 months and no lesion > 3 cm. Following a baseline recombinant human (rh)TSH-stimulated diagnostic whole-body scan (dc1-WBS), dabrafenib and trametinib were given for 42 days. A second rhTSH-stimulated dc WBS (dc2-WBS) was done at day 28 and 131I (5.5 GBq-150 mCi after rhTSH) was administered at day 35. Primary endpoint was the 6-month RECIST objective response rate. In case of partial response (PR) at 6 or 12 months, a second treatment course could be given. Among 24 enrolled patients, 21 were evaluable at 6 months. RESULTS: Abnormal 131I uptake was present on 5%, 65%, and 95% of the dc1-WBS, dc2-WBS, and post-therapy scans, respectively. At 6 months, PR was achieved in 38%, stable disease in 52%, and progressive disease (PD) in 10%. Ten patients received a second treatment course: one complete response and 6 PRs were observed at 6 months. The median progression-free survival (PFS) was not reached. The 12- and 24-month PFS were 82% and 68%, respectively. One death due to PD occurred at 24 months. Adverse events (AE) occurred in 96% of the patients, with 10 grade 3-4 AEs in 7 patients. CONCLUSIONS: Dabrafenib-trametinib is effective in BRAF p.V600E-mutated DTC patients for restoring 131I uptake with PR observed 6 months after 131I administration in 38% of the patients.


Assuntos
Adenocarcinoma , Neoplasias da Glândula Tireoide , Tirotropina Alfa , Humanos , Neoplasias da Glândula Tireoide/tratamento farmacológico , Neoplasias da Glândula Tireoide/genética , Radioisótopos do Iodo/efeitos adversos , Proteínas Proto-Oncogênicas B-raf/genética , Estudos Prospectivos , Piridonas/efeitos adversos , Pirimidinonas , Oximas/efeitos adversos , Adenocarcinoma/etiologia , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Mutação
16.
Thyroid ; 33(10): 1190-1200, 2023 10.
Artigo em Inglês | MEDLINE | ID: mdl-37855745

RESUMO

Background: Anaplastic thyroid carcinoma (ATC) is a rare and frequently fatal type of thyroid cancer. The degree of heterogeneity in survival rates for ATC is incompletely studied. This study evaluated the factors associated with overall survival (OS) of patients with ATC using multicenter real-world data from a national tertiary care center network in France. Methods: In this multicenter, retrospective cohort study, all patients with ATC diagnosed between 2010 and 2020 were identified from the national database of the French ENDOCAN-TUTHYREF network. Factors associated with OS were examined in multivariable analyses using Cox proportional hazards models. Results: The study included 360 patients. Of these, 220 (61%) were female and the median age was 72 years (interquartile range: 62-80). The percentages of patients with pure and mixed (synchronously-transformed) ATC (p-ATC and st-ATC) were 62.5% and 26.7%, respectively. The median OS was 6.8 months [confidence interval, CI: 5.5-8.1]: not reached for stage IVa, 11.4 months [8.2-17.8] for IVb, and 4.6 months [3.5-5.7] for IVc. Surgery, radiation therapy to the neck, chemotherapy, and best supportive care were administered to 69 (19.2%), 214 (59.4%), 254 (70.6%), and 66 (18.3%) patients, respectively. In a multivariable analysis, including stage IVb-IVc patients, significantly higher OS was observed in patients with Eastern Cooperative Oncology Group performance-status of 0-1 (hazard ratio [HR], 0.6; [CI, 0.4-0.9], p < 0.02), stage IVb [HR, 0.5; CI, 0.4-0.8, p < 0.001], and multimodal treatment (surgery and chemoradiotherapy) [HR, 0.07; CI, 0.04-0.1, p < 0.001]. Variables associated with significantly worse OS included: p-ATC (vs. st-ATC) [HR, 1.83; CI, 1.33-2.51, p = 0.001] and a neutrophil-to-lymphocyte ratio (NLR) >5.05 [HR, 2.05, CI, 1.39-3.05, p < 0.001]. Conclusions: Factors independently associated with improved OS in ATC included: European Cooperative Oncology Group performance status, disease stage, multimodality treatment, synchronously transformed ATC, and lower NLR. Long-term OS was observed in selected patients with ATC who underwent multimodal treatment.


Assuntos
Carcinoma Anaplásico da Tireoide , Neoplasias da Glândula Tireoide , Humanos , Feminino , Idoso , Masculino , Carcinoma Anaplásico da Tireoide/patologia , Estudos Retrospectivos , Tireoidectomia , Neoplasias da Glândula Tireoide/patologia , Terapia Combinada , Prognóstico
17.
Eur J Nucl Med Mol Imaging ; 39(1): 129-37, 2012 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-21909754

RESUMO

PURPOSE: PET/CT using (18)F-FDG is a well-established diagnostic examination in oncology, cardiology and neurology. The clinical significance of nontumoral testicular uptake of FDG is unknown. Functional testicular imaging may have important clinical applications in the diagnosis and prognosis of male infertility. The aim of this study was to determine the andrological value of a FDG PET/CT in analysing testicular function, by correlating the PET/CT data with the sperm parameters. METHODS: Retrospective analysis of FDG PET/CT in 20 consecutive cancer patients without testicular pathology in whom two semen samples had been obtained for analysis before any chemotherapy. FDG PET/CT parameters were the mean standardized uptake value (SUVmean), used for measuring the intensity of uptake, and the functional testicular volume (FV). For statistical analysis, a Spearman's rank correlation test and a Mann-Whitney test were used. RESULTS: Of 20 patients (mean age 22 years), 18 had provided two sperm samples for cryopreservation. Sperm concentration was above 20 × 10(6)/ml in 55% of the patients. The intensity of uptake and the FV were correlated with the total sperm count, the sperm concentration and motility (p < 0.05). The difference in SUVmean between the two testes showed an inverse correlation with sperm concentration (p = 0.036). Normospermic and oligospermic men had significant differences in: (1) mean SUVmean, (2) mean FV, and (3) the difference in intensity of uptake between the testes (p < 0.05). CONCLUSION: This is the first report on the andrological value of FDG PET/CT in analysing nontumoral testicular function. This pilot study showed a significant correlation between intensity of uptake of FDG and testicular FV with the main sperm parameters. PET/CT with FDG could become a useful new tool in assisted reproductive technologies and other andrological or urological applications.


Assuntos
Fluordesoxiglucose F18 , Imagem Multimodal , Tomografia por Emissão de Pósitrons , Testículo/diagnóstico por imagem , Tomografia Computadorizada por Raios X , Adolescente , Adulto , Andrologia , Transporte Biológico , Fluordesoxiglucose F18/metabolismo , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Contagem de Espermatozoides , Motilidade dos Espermatozoides , Espermatozoides/diagnóstico por imagem , Espermatozoides/metabolismo , Espermatozoides/fisiologia , Neoplasias Testiculares/diagnóstico por imagem , Neoplasias Testiculares/metabolismo , Neoplasias Testiculares/fisiopatologia , Testículo/metabolismo , Testículo/fisiopatologia , Adulto Jovem
18.
Clin Nucl Med ; 46(8): e424-e427, 2021 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-34186543

RESUMO

ABSTRACT: A 52-year-old woman previously treated for a stage IIIc high-grade ovarian serous carcinoma presented right upper quadrant abdominal pain, 3 years after extended surgery and chemotherapy. Abdominal CT, MRI, and 18F-FDG PET/CT showed a right hepatic mass, consistent for lone recurrence nearby the hepatic lateral fissure. Preoperative and histologic examination identified a peritoneal lateral fissure lesion. The patient underwent atypic segment 5 segmentectomy. She has been disease-free for 3 years now. Advanced ovarian cancer can be responsible for perihepatic sulcus lesions, such as this right fissure lesion. They should not be mistaken for inoperable parenchyma metastases.


Assuntos
Neoplasias Hepáticas/secundário , Neoplasias Ovarianas/patologia , Neoplasias Peritoneais/secundário , Diagnóstico Diferencial , Feminino , Fluordesoxiglucose F18 , Humanos , Pessoa de Meia-Idade , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada
19.
Breast ; 59: 144-156, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34252822

RESUMO

Does oligometastatic breast cancer (OMBC) deserve a dedicated treatment? Although some authors recommend multidisciplinary management of OMBC with a curative intent, there is no evidence proving this strategy beneficial in the absence of a randomized trial. The existing literature sheds little light on OMBC. Incidence is unknown; data available are either obsolete or biased; there is no consensus on the definition of OMBC and metastatic sites, nor on necessary imaging techniques. However, certain proposals merit consideration. Knowledge of eventual specific OMBC biological characteristics is limited to circulating tumor cell (CTC) counts. Given the data available for other cancers, studies on microRNAs (miRNAs), circulating tumor DNA (ctDNA) and genomic alterations should be developed Finally, safe and effective therapies do exist, but results of randomized trials will not be available for many years. Prospective observational cohort studies need to be implemented.


Assuntos
Neoplasias da Mama , DNA Tumoral Circulante , MicroRNAs , Células Neoplásicas Circulantes , Biologia , Biomarcadores Tumorais , Neoplasias da Mama/epidemiologia , Neoplasias da Mama/terapia , Feminino , Humanos , Estudos Observacionais como Assunto
20.
Bull Cancer ; 108(11): 1044-1056, 2021 Nov.
Artigo em Francês | MEDLINE | ID: mdl-34593218

RESUMO

Refractory thyroid cancers include radio-iodine-refractory cancers, metastatic or locally advanced unresectable medullary and anaplastic thyroid cancers. Their management has been based for several years on the use of multi-target kinase inhibitors, with anti-angiogenic action, with the exception of anaplastic cancers usually treated with chemo- and radiotherapy. The situation has recently evolved due to the availability of molecular genotyping techniques allowing the discovery of rare but targetable molecular abnormalities. New treatment options have become available, more effective and less toxic than the previously available multi-target kinase inhibitors. The management of refractory thyroid cancers is therefore becoming more complex both at a diagnosis level with the need to know when, how and why to look for these molecular abnormalities but also at a therapeutic level, innovative treatments being hardly accessible. The cost of molecular analyzes and the access to treatments need also to be homogenized because disparities could lead to inequality of care at a national or international level. Finally, the strategy of identifying molecular alterations and treating these rare tumors reinforces the importance of a discussion in a multidisciplinary consultation meeting.


Assuntos
Carcinoma Medular/genética , Genótipo , Mutação , Carcinoma Anaplásico da Tireoide/genética , Neoplasias da Glândula Tireoide/genética , Quinase do Linfoma Anaplásico/genética , Carcinoma Medular/patologia , Carcinoma Medular/terapia , Genes ras , Humanos , Imunoterapia , Terapia de Alvo Molecular , Inibidores de Proteínas Quinases/efeitos adversos , Inibidores de Proteínas Quinases/uso terapêutico , Proteínas Proto-Oncogênicas B-raf/genética , Proteínas Proto-Oncogênicas c-ret/genética , Receptor trkA/genética , Telomerase/genética , Carcinoma Anaplásico da Tireoide/patologia , Carcinoma Anaplásico da Tireoide/terapia , Neoplasias da Glândula Tireoide/patologia , Neoplasias da Glândula Tireoide/terapia
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