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1.
Jpn J Clin Oncol ; 49(4): 354-360, 2019 Apr 01.
Artículo en Inglés | MEDLINE | ID: mdl-30834940

RESUMEN

BACKGROUND: In an interim analysis of a Phase II trial in Japanese patients with pancreatic neuroendocrine tumors (panNETs), sunitinib demonstrated antitumor activity with an objective response rate (ORR) of 50% (95% confidence interval [CI], 21-79) and a median progression-free survival (PFS) of 16.8 months (95% CI, 9.3-26.2). Here, we report the final analyses of efficacy and safety, as well as additional analyses, from this Phase II study. METHODS: This was a multicenter, open-label, Phase II trial (NCT01121562) of sunitinib in Japanese patients with panNETs. Patients received oral sunitinib 37.5 mg/day on a continuous daily dosing schedule. Dose modifications were permitted. The primary endpoint was clinical benefit rate (CBR). Secondary endpoints included ORR, PFS, overall survival (OS), safety and pharmacokinetics. RESULTS: Of 12 patients enrolled and treated, all discontinued treatment-the majority (n = 8) owing to disease progression. Most patients were male (n = 8), <65 years of age (n = 11) and had a non-functional tumor (n = 10). The median (range) number of days on drug was 323.5 (22-727). The CBR (95% CI) was 75.0% (42.8-94.5). ORR (95% CI) was 50.0% (21.1-78.9). Median (95% CI) PFS was 16.8 (9.3-26.2) months; however, median (95% CI) OS was not reached (22.0-not estimable). Most common adverse events (AEs; all-causality) were diarrhea (n = 10; 83.3%), hand-foot syndrome (n = 8; 66.7%) and hypertension (n = 8; 66.7%). CONCLUSIONS: These results support the efficacy and safety of sunitinib in Japanese patients with panNETs. Appropriate AE management through dose reduction and interruption may prolong sunitinib treatment and maximize its efficacy.


Asunto(s)
Antineoplásicos/uso terapéutico , Tumores Neuroendocrinos/tratamiento farmacológico , Neoplasias Pancreáticas/tratamiento farmacológico , Sunitinib/uso terapéutico , Adulto , Anciano , Supervivencia sin Enfermedad , Femenino , Humanos , Japón , Masculino , Persona de Mediana Edad , Tumores Neuroendocrinos/mortalidad , Tumores Neuroendocrinos/patología , Neoplasias Pancreáticas/mortalidad , Neoplasias Pancreáticas/patología , Supervivencia sin Progresión
2.
BMC Cancer ; 18(1): 698, 2018 Jun 28.
Artículo en Inglés | MEDLINE | ID: mdl-29954369

RESUMEN

BACKGROUND: The advent of tyrosine kinase inhibitors (TKIs) has changed the treatment of RAI refractory, unresectable recurrent differentiated thyroid cancer (DTC), which was formerly treated with multidisciplinary remedies. CASE PRESENTATION: Here we describe the case of a 64-year-old woman who underwent total thyroidectomy with tracheal resection and suffered from a recurrent tumor in the neck and multiple lung and bone metastases 3 and 11 months, respectively, after the operation. Multimodal therapies, RI (I-131), EBRT, and taxane-based chemotherapy were ineffective, and sorafenib was started as a TKI. However, because of disease progression, sorafenib was replaced by lenvatinib after 9 months. The effect of lenvatinib has continued for more than 1 year and 9 months, and the patient has well survived. During the treatment period, a tracheal pin-hole fistula suddenly emerged, which was naturally cured by the temporary cessation of lenvatinib. Adverse events such as hypertension, proteinuria, and diabetes as innate complications have been successfully managed until the present according to our institute regulations. CONCLUSIONS: Even where multimodal treatment was ineffective, lenvatinib was suggested to be an alternative treatment option for RAI refractory recurrent DTC and patient could have a chance to be controlled successfully.


Asunto(s)
Antineoplásicos/uso terapéutico , Recurrencia Local de Neoplasia/tratamiento farmacológico , Compuestos de Fenilurea/uso terapéutico , Inhibidores de Proteínas Quinasas/uso terapéutico , Quinolinas/uso terapéutico , Cáncer Papilar Tiroideo/tratamiento farmacológico , Neoplasias de la Tiroides/tratamiento farmacológico , Terapia Combinada , Femenino , Humanos , Persona de Mediana Edad , Compuestos de Fenilurea/efectos adversos , Quinolinas/efectos adversos
3.
Pathol Int ; 68(4): 246-250, 2018 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-29451347

RESUMEN

A rare case of a metastatic ectopic papillary thyroid carcinoma (PTC) of the lung that transformed into a squamous cell carcinoma (SCC) that resembles pulmonary SCC is reported. A subcutaneous ectopic PTC in the left anterior neck area, together with a normal thyroid gland, were excised. The ectopic PTC showed thyroglobulin, TTF-1 and PAX-8 immunoreactivity and a BRAF V600E mutation. During the post-operative follow-up period, a rapidly growing 2 cm nodular lesion in the lower left lobe of the lung was detected. The lung tumor consisted of solid sheets and nests of squamous cells but without the nuclear features of PTC. Neither papillary nor follicular structures of cancer cells were identified. Carcinoma cells were positive for TTF-1, PAX-8, p40, CK14, and p63, while showing a high Ki-67 labeling index and a BRAF V600E mutation. These results support our interpretation of a PTC that originated from ectopic thyroid tissue in the left anterior neck and that developed a lung metastasis showing squamous cell differentiation.


Asunto(s)
Carcinoma Papilar/patología , Carcinoma de Células Escamosas/secundario , Neoplasias Pulmonares/secundario , Neoplasias de la Tiroides/patología , Anciano , Carcinoma Papilar/genética , Carcinoma de Células Escamosas/genética , Transformación Celular Neoplásica/patología , Humanos , Neoplasias Pulmonares/genética , Masculino , Mutación , Proteínas Proto-Oncogénicas B-raf/genética , Cáncer Papilar Tiroideo , Neoplasias de la Tiroides/genética
4.
BMC Clin Pathol ; 17: 9, 2017.
Artículo en Inglés | MEDLINE | ID: mdl-28588422

RESUMEN

BACKGROUND: Some poorly differentiated thyroid carcinomas (PDTC) arise from pre-existing, well-differentiated carcinomas of follicular cell origin; however, others most likely arise de novo. The case of a PDTC adjacent to a pre-existing nodular goiter is very rare. CASE PRESENTATION: A patient had a PDTC, a widely invasive, cellular tumor with cells that lacked the nuclear features of a papillary thyroid carcinoma. Carcinoma cells were arranged in trabecular, solid, and microfollicular histological patterns and displayed high mitotic activity. A nodule partially encapsulated in a thick fibrous capsule was found adjacent to the PDTC. The nodule was composed of small or dilated follicles, without papillary carcinoma-like nuclear features, that were consistent with a nodular goiter. The PDTC showed a high Ki-67 labeling index and an NRAS gene mutation (codon 61, Q61K). CONCLUSION: These results support our diagnosis of a PDTC, probably arising from a nodular goiter.

5.
Surg Today ; 45(5): 606-10, 2015 May.
Artículo en Inglés | MEDLINE | ID: mdl-24973058

RESUMEN

PURPOSE: To compare the outcomes of single-incision laparoscopic surgery for totally extraperitoneal inguinal hernia repair (SILS-TEP) and conventional three-port totally extraperitoneal (TEP) repair. METHODS: We performed a retrospective analysis of 137 patients (SILS-TEP, 100; conventional TEP, 37) scheduled to undergo elective inguinal hernia from January 2011 to July 2013 at Osaka Police Hospital. RESULTS: There were no significant differences in the patient demographics. There were no significant differences in the length of the operation between the two groups (SILS-TEP group, 93 min vs. conventional TEP group, 92 min for unilateral hernias, p = 0.8; SILS-TEP group, 142 min vs. conventional TEP, 128 min for bilateral hernias, p = 0.4). The postoperative hospital stay, total medical charge for the hospital stay and the numerical rating scale before and 3 months after surgery were comparable in both groups. Two cases treated by SILS-TEP repair were converted to conventional three-port TEP repair (one case) and mesh-plug method (one case). The postoperative complications were comparable in both groups, and these were managed conservatively. One recurrence (2 %, 1/37) developed in the conventional TEP group, compared with 0 recurrences (0/100) in the SILS-TEP group. CONCLUSIONS: SILS-TEP repair seems to be safe and feasible, with no significant differences in the total medical charges for the hospital stay or the postoperative pain score 3 months after surgery compared with conventional three-port TEP repair.


Asunto(s)
Hernia Inguinal/cirugía , Herniorrafia/métodos , Laparoscopía/métodos , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del Tratamiento
6.
Surg Endosc ; 28(3): 902-9, 2014 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-24263457

RESUMEN

BACKGROUND: Endoscopic thyroidectomy (ET) or robotic thyroidectomy is yet to be applied to thyroid carcinoma invasive to the trachea and to wide lymph node node metastasis. On the other hand, small-incision thyroidectomy lacks sufficient working space and clear vision. The author has newly developed hybrid-type endoscopic thyroidectomy (HET) to overcome these problems. METHODS: From March 2011 to February 2012, HET was performed for 85 patients. Clinicopathologic characteristics were analyzed. To evaluate the superiority of HET for malignancy representatively, conventional lobectomy with central compartment node dissection (CCND) performed 1 year previously was compared with HET. In lobectomy and node dissection, a single skin incision (1.5 cm) is made above the clavicle, with a port incision (5 mm) made 3 cm below the clavicle. Then CCND is performed directly through the incision by lifting up the isthmus. To obtain sufficient working space for the lobectomy, the strap muscles are taped and pulled toward the head, then hung by the cradle. The thyroid lobe is retracted to the midline with a retractor, followed by isolation of the inferior laryngeal nerve and transection of the inferior thyroid vessels with the monitor of the scope. Lateral lymph nodes dissection can be performed at the same time, if necessary. In total thyroidectomy, the same procedure is performed at the opposite side. The scalpel can be used to shave through each incision in case of tracheal invasion. RESULTS: Of the 85 cases, 62 were malignant, involving papillary thyroid carcinoma (PTC), and 23 were benign. Total thyroidectomy was performed for 22 of the PTC cases and CCND for 49 of the cases. Shaving for tracheal invasion was performed for eight patients. No mortality, complications, recurrence, or metastasis was found 1-2 years after the operation. Compared with conventional thyroidectomy, HET was superior in blood loss, visual analog scale, and postoperative hospital stay. CONCLUSION: The author's method (Tori's method) might be less invasive, cosmetically excellent, and moreover, safe and feasible for differentiated thyroid carcinoma including invasion to the trachea.


Asunto(s)
Carcinoma/cirugía , Endoscopía/métodos , Robótica/métodos , Neoplasias de la Tiroides/cirugía , Tiroidectomía/métodos , Neoplasias de la Tráquea/cirugía , Adulto , Anciano , Anciano de 80 o más Años , Axila , Carcinoma/diagnóstico , Carcinoma/secundario , Carcinoma Papilar , Femenino , Estudios de Seguimiento , Humanos , Escisión del Ganglio Linfático , Ganglios Linfáticos/patología , Metástasis Linfática , Masculino , Persona de Mediana Edad , Invasividad Neoplásica , Estudios Retrospectivos , Cáncer Papilar Tiroideo , Neoplasias de la Tiroides/diagnóstico , Neoplasias de la Tiroides/secundario , Neoplasias de la Tráquea/patología , Resultado del Tratamiento
7.
JOP ; 14(6): 636-41, 2013 Nov 10.
Artículo en Inglés | MEDLINE | ID: mdl-24216550

RESUMEN

CONTEXT: Accessory spleen is a congenital abnormality consisting of normal splenic tissue in ectopic sites that is found in approximately 10-15% of the general population. However, an intrapancreatic accessory spleen has seldom been reported and multiple epithelial cysts in the intrapancreatic accessory spleen are extremely rare. CASE REPORT: A 37-year-old woman with no clinical manifestations presented with two cystic lesions in the tail of the pancreas. The tumor markers CA 19-9 (251 U/mL) and SPAN-1 (38 U/mL) were increased. Computed tomography showed a multilocular cyst, 40 mm in size, and a unilocular cyst, 20 mm in size, in the tail of the pancreas and gallstones. The cystic component was hypointense on T1-weighted magnetic resonance images and hyperintense on T2-weighted magnetic resonance images. A laparoscopic distal pancreatectomy was performed with the presumptive diagnosis of a mucinous cystic neoplasm or an intraductal papillary mucinous neoplasm with gallstones. The pathological examination showed that the walls of the two cysts were covered with non-keratinized stratified squamous epithelium, surrounded by normal splenic tissue. The final pathological diagnosis was two epithelial cysts originating from an intrapancreatic accessory spleen. CONCLUSIONS: Even though multiple masses were detected in the pancreatic tail, the possibility of epithelial cysts originating from an accessory spleen should be considered. Laparoscopic distal pancreatectomy might be a safe and effective procedure and provide good cosmetic result for a benign or low-grade malignant tumor in the pancreas.


Asunto(s)
Coristoma/cirugía , Quistes/cirugía , Pancreatectomía/métodos , Enfermedades Pancreáticas/cirugía , Bazo , Enfermedades del Bazo/cirugía , Adulto , Antígenos de Neoplasias/metabolismo , Antígeno CA-19-9/metabolismo , Quistes/diagnóstico , Quistes/metabolismo , Diagnóstico Diferencial , Epitelio/patología , Femenino , Humanos , Laparoscopía , Imagen por Resonancia Magnética , Enfermedades del Bazo/diagnóstico , Enfermedades del Bazo/metabolismo , Tomografía Computarizada por Rayos X
8.
Surg Today ; 43(8): 942-5, 2013 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-23543099

RESUMEN

This report addresses whether it is safe to perform totally extraperitoneal (TEP) inguinal hernia repair for patients taking antithrombotic agents. Between January 2011 and June 2012, 77 patients (70 men, 7 women) underwent TEP repair at Osaka Police Hospital, 22 (28.6 %) of whom had been treated with antithrombotic drugs preoperatively. Warfarin was stopped at least 3 days preoperatively and antiplatelet drugs were stopped at least 7 days preoperatively. Standard bridging intravenous heparin therapy was used according to the operative risk of each patient. The mean operative time, intraoperative bleeding, postoperative complications, and length of hospital stay did not differ significantly between these patients and a control group, although the patients on antithrombotic therapy were significantly older with higher surgical risk. No major complications or recurrence developed in either group. Our TEP repair method and bridging heparin therapy seem to be safe and feasible for minimizing postoperative complications.


Asunto(s)
Fibrinolíticos/efectos adversos , Hernia Inguinal/cirugía , Cuidados Preoperatorios , Warfarina/efectos adversos , Factores de Edad , Anciano , Anciano de 80 o más Años , Anticoagulantes/administración & dosificación , Estudios de Factibilidad , Femenino , Heparina/administración & dosificación , Humanos , Masculino , Persona de Mediana Edad , Inhibidores de Agregación Plaquetaria/efectos adversos , Complicaciones Posoperatorias/prevención & control , Estudios Retrospectivos , Riesgo , Prevención Secundaria , Resultado del Tratamiento
9.
Surg Endosc ; 26(5): 1490-4, 2012 May.
Artículo en Inglés | MEDLINE | ID: mdl-22044985

RESUMEN

PURPOSE: The intracorporeal anastomotic procedure is one of the most difficult components in single-incision laparoscopic gastrectomy. We describe a simple surgical technique for intracorporeal circular-stapled Billroth I gastroduodenostomy with transumbilical introduction of the instrument. SURGICAL TECHNIQUE: After standard laparoscopic mobilization of the distal stomach using a mini-loop retractor (diameter, 2 mm), a semi-circumference duodenotomy was made just distal to the pyloric ring. The anvil of a circular stapling device, secured with a Prolene suture with a needle, was introduced via the duodenotomy. The suture was advanced anteriorly such that an anvil shaft transfixed the anterior duodenal wall. The duodenum was staple-transected at this point, and the anvil shaft was removed from the duodenum by pulling the thread. The anvil shaft was advanced against the posterior wall of the stomach and tightly grasped by the mini-loop retractor to avoid slippage. After the cartridge-carrying instrument was introduced transumbilically with the pneumoperitoneum maintained using a surgical glove, the anvil shaft was connected with the center rod of the instrument under fine laparoscopic view. The instrument was fired to complete the circular-stapled gastroduodenostomy. RESULTS: We employed this technique in 20 patients. Neither postoperative complications, including anastomotic leakage and stricture, nor postoperative mortality were observed. CONCLUSIONS: Our modified technique for intracorporeal Billroth I reconstruction in single-incision laparoscopic distal gastrectomy is safe and feasible. This technique could be an attractive surgical option for all laparoscopic reconstructive procedures using circular stapling devices.


Asunto(s)
Duodenostomía/métodos , Gastrectomía/métodos , Gastroenterostomía/métodos , Laparoscopía/métodos , Neoplasias Gástricas/cirugía , Humanos , Tiempo de Internación , Ilustración Médica , Grapado Quirúrgico/métodos , Técnicas de Sutura
10.
Pathol Int ; 62(5): 339-43, 2012 May.
Artículo en Inglés | MEDLINE | ID: mdl-22524663

RESUMEN

Recently, a surgically resected case of intraductal tubulopapillary neoplasm (ITPN) with stromal osseous and cartilaginous metaplasia was encountered. A CT scan showed calcification at the tail of the pancreas two years before the operation. In the resected specimen, macroscopically, the main pancreatic duct was dilated and filled with a whitish solid mass without mucinous material. The tumor showed mainly a solid and papillary growth pattern. The tumor cells had no evidence of acinar differentiation. The tumor cells, at the tail of the pancreas, invaded focally to surrounding pancreatic parenchyma with stromal desmoplastic and fibrosclerotic reaction and also formed nodular stromal osseous and cartilaginous metaplasia. The tumor did not invade extrapancreatic tissue and showed no lymph node metastasis. As there were no signs of chronic calcifying pancreatitis, it is hypothesized that the metaplastic stroma was formed by a stromal reaction due to the tumor growth. It is thought, therefore, that the intraducal component of the tumor had existed at least for two years. This case suggests that ITPN is a relatively indolent tumor with a better prognosis than that of other types of invasive ductal adenocarcinoma of the pancreas.


Asunto(s)
Adenocarcinoma Papilar/patología , Carcinoma Ductal Pancreático/patología , Osificación Heterotópica/patología , Neoplasias Pancreáticas/patología , Células del Estroma/patología , Adenocarcinoma Papilar/metabolismo , Adenocarcinoma Papilar/cirugía , Anciano , Biomarcadores de Tumor/metabolismo , Carcinoma Ductal Pancreático/metabolismo , Carcinoma Ductal Pancreático/cirugía , Cartílago/patología , Desmosomas/ultraestructura , Humanos , Masculino , Metaplasia , Microvellosidades/ultraestructura , Osificación Heterotópica/metabolismo , Neoplasias Pancreáticas/metabolismo , Neoplasias Pancreáticas/cirugía , Proteínas S100/metabolismo , Células del Estroma/metabolismo , Tomografía Computarizada por Rayos X , Resultado del Tratamiento
11.
Surg Today ; 42(6): 583-8, 2012 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-22218871

RESUMEN

Acute pancreatitis occurring in an aberrant pancreas (acute aberrant pancreatitis) is a rare clinical condition. A 67-year-old male was referred to the emergency department complaining of severe epigastralgia. He was evaluated by computed tomography, and the findings suggested jejunal penetration into the mesentery and abscess formation. We performed emergency surgery and found a mass located in the jejunal mesentery. Intraoperatively, we diagnosed it to be a malignant tumor complicated by penetration, and we performed a partial resection of the jejunum to remove the mass. Based on the pathological results, it was evident that this was a case of acute aberrant pancreatitis occurring on a background of chronic pancreatitis. The patient had an uneventful postoperative course. This report is the first presentation describing the possible mechanism that contributes to the process of infected pancreatic necrosis in an aberrant pancreas.


Asunto(s)
Coristoma/diagnóstico , Coristoma/cirugía , Enfermedades del Yeyuno/diagnóstico , Enfermedades del Yeyuno/cirugía , Páncreas/patología , Pancreatitis/etiología , Anciano , Coristoma/complicaciones , Enfermedad Crónica , Humanos , Masculino , Necrosis/patología , Pancreatitis/diagnóstico
12.
Surg Today ; 42(11): 1119-24, 2012 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-22674289

RESUMEN

Melanoma with metastasis to the common bile duct is relatively rare. This report presents the case of a 56-year-old Japanese male that showed an abnormal laboratory profile 18 months after resection of a skin melanoma occurring on the left fifth finger. The cytology of bile obtained by endoscopic retrograde cholangiopancreatography yielded a diagnosis of melanoma with metastasis to the common bile duct. Surgery revealed melanoma within the distal common bile duct. There were no other secondary metastases in the abdomen and a radical pancreatoduodenectomy was performed. The patient survived for 13 months without any signs of recurrence and died of progressive systemic metastatic melanoma 34 months after surgery. Therefore, radical surgical resection appears to be effective for the prolongation of survival in cases of melanoma with metastasis to the common bile duct.


Asunto(s)
Neoplasias del Conducto Colédoco/secundario , Neoplasias del Conducto Colédoco/cirugía , Melanoma/secundario , Pancreaticoduodenectomía/métodos , Neoplasias Cutáneas/patología , Colangiopancreatografia Retrógrada Endoscópica/métodos , Neoplasias del Conducto Colédoco/patología , Progresión de la Enfermedad , Resultado Fatal , Humanos , Imagen por Resonancia Magnética/métodos , Masculino , Melanoma/cirugía , Persona de Mediana Edad , Estadificación de Neoplasias , Neoplasias Cutáneas/cirugía
13.
Eur J Cancer ; 173: 210-218, 2022 09.
Artículo en Inglés | MEDLINE | ID: mdl-35932627

RESUMEN

PURPOSE: Anaplastic thyroid cancer (ATC) is a rare and highly aggressive cancer for which effective systemic therapy has long been sought. Here, we assessed the efficacy and safety of lenvatinib in patients with unresectable ATC. PATIENTS AND METHODS: The study was investigator-initiated and conducted under a multicenter, open-label, nonrandomized, phase II design. Eligibility criteria included pathologically proven ATC; unresectable measurable lesion as defined by RECIST 1.1; age 20 years or older; ECOG PS 0-2; and adequate organ function. The primary end-point was overall survival. Secondary end-points were progression-free survival, objective response rate, disease control rate, clinical benefit rate, and safety. RESULTS: Of 52 patients enrolled from 17 institutions, 42 patients who were confirmed to have ATC were included for efficacy analysis, and 50 patients were included for safety analysis. The estimated 1-year overall survival rate was 11.9% (95% CI, 4.4%-23.6%). One patient (2.4%) achieved complete response, four patients (9.5%) partial response, and 26 patients (61.9%) stable disease, including nine patients (21.4%) who demonstrated durable stable disease, giving an objective response rate of 11.9%, disease control rate of 73.8%, and clinical benefit rate of 33.3%. Adverse events of any grade were observed in 45 patients (90.0%), the most common of which of any grade included loss of appetite (48.0%), fatigue (48.0%), hypertension (44.0%), and palmar-plantar erythrodysesthesia syndrome (26.0%). CONCLUSION: Lenvatinib treatment resulted in disappointing survival for unresectable ATC patients. Although the number of responders was small, responses were durable, indicating that lenvatinib may be beneficial for selected patients. Further investigation to identify suitable candidates for lenvatinib monotherapy is needed.


Asunto(s)
Antineoplásicos , Quinolinas , Carcinoma Anaplásico de Tiroides , Neoplasias de la Tiroides , Adulto , Antineoplásicos/efectos adversos , Humanos , Compuestos de Fenilurea/efectos adversos , Inhibidores de Proteínas Quinasas/efectos adversos , Quinolinas/efectos adversos , Carcinoma Anaplásico de Tiroides/tratamiento farmacológico , Carcinoma Anaplásico de Tiroides/patología , Neoplasias de la Tiroides/tratamiento farmacológico , Neoplasias de la Tiroides/patología , Adulto Joven
14.
Thyroid ; 32(9): 1059-1068, 2022 09.
Artículo en Inglés | MEDLINE | ID: mdl-35950621

RESUMEN

Background: Sorafenib and lenvatinib are multikinase inhibitors (MKIs) approved for patients with radioactive iodine-refractory (RAI-R) differentiated thyroid cancer (DTC). There is no consensus on when to initiate MKI treatment. The objective of this study was to evaluate time to symptomatic progression (TTSP) in patients with RAI-R DTC for whom the decision to treat with an MKI was made at study entry. Methods: International, prospective, open-label, noninterventional cohort study (NCT02303444). Eligible patients had asymptomatic progressive RAI-R DTC, with ≥1 lesion ≥1 cm in diameter and life expectancy ≥6 months. The decision to treat with an MKI was at the treating physician's discretion. Primary endpoint was TTSP from study entry. Two cohorts were evaluated: patients for whom a decision to initiate an MKI was made at study entry (Cohort 1) and patients for whom there was a decision not to initiate an MKI at study entry (Cohort 2). Cohorts were compared descriptively. Results: The full analysis set (FAS) comprised 647 patients. The median duration of observation was 35.5 months (range <1-59.4). Of 344 MKI-treated patients, 209 received sorafenib, 191 received lenvatinib, and 19 received another MKI at some point. Median TTSP was 55.4 months (interquartile range [IQR] 18.6-not estimable [NE]) overall, 55.4 months (IQR 15.2-NE) in Cohort 1 (n = 169), and 51.4 months (IQR 20.0-NE) in Cohort 2 (n = 478). TTSP ≥36 months was achieved in 64.5% of patients overall, 59.5% of patients in Cohort 1, and 66.4% of patients in Cohort 2. Median overall survival from classification as RAI-R was 167 months and median progression-free survival from start of MKI therapy was 19.2 months and from start of sorafenib therapy 16.7 months. Among sorafenib-treated patients, 70% had dose modifications, 35% had a dose reduction, 89% experienced ≥1 treatment-emergent adverse event (TEAE), and 82% experienced ≥1 drug-related TEAE. Conclusions: This real-world study provides valuable insight into outcomes in patients with asymptomatic, progressive RAI-R DTC under observation or receiving MKI treatment. TTSP in the FAS provides insight into the current prognosis for patients with RAI-R DTC in the era of MKIs. Registration: NCT02303444.


Asunto(s)
Adenocarcinoma , Antineoplásicos , Neoplasias de la Tiroides , Antineoplásicos/uso terapéutico , Estudios de Cohortes , Humanos , Radioisótopos de Yodo/uso terapéutico , Compuestos de Fenilurea/uso terapéutico , Estudios Prospectivos , Inhibidores de Proteínas Quinasas/efectos adversos , Quinolinas , Sorafenib/uso terapéutico , Neoplasias de la Tiroides/tratamiento farmacológico , Neoplasias de la Tiroides/patología , Neoplasias de la Tiroides/radioterapia
15.
Surg Endosc ; 25(7): 2400-4, 2011 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-21298524

RESUMEN

BACKGROUND: Laparoscopic gastrectomy is a widely accepted procedure for treating early gastric cancers. This procedure is less invasive than conventional open approaches, and the oncologic outcomes are comparable. Single-incision laparoscopic surgery, developed to reduce the invasiveness of traditional laparoscopy, is applied to various abdominal surgical procedures. However, its application to laparoscopic gastrectomy for the treatment of gastric cancer has not been reported, mainly because of difficulties achieving adequate lymphadenectomy and reconstruction. The authors report their initial clinical experience with single-incision laparoscopic gastrectomy for early gastric cancer. METHODS: A single vertical 2.5-cm intraumbilical incision was made, and three laparoscopic trocars were placed within the umbilicus. A 2-mm mini-loop retractor was inserted in the left upper and middle abdomen, and a roll of gauze was attached to its tip. This instrument is an atraumatic and useful tool for retracting various organs. Gastric mobilization and adequate dissection of lymph nodes were performed. The stomach and duodenum then were transected intracorporeally using linear staplers. Intracorporeal anastomosis was performed for reconstruction. RESULTS: All seven single-incision laparoscopic distal gastrectomies with lymphadenectomy were performed without the use of additional trocars or conversion to laparotomy. The median time for gastric mobilization with lymphadenectomy was 155 min (range, 130-183 min). The median operative time was 344 min (range, 282-385 min), and the median estimated blood loss was 25 ml (range, 0-100 ml). A median total of 67 lymph nodes were retrieved. No serious perioperative complications occurred, and no mortalities were observed in this case series. CONCLUSIONS: The authors' initial experience with single-incision laparoscopic distal gastrectomy showed that it is a feasible and safe procedure for early gastric cancer and gives a favorable cosmetic result. To the authors' knowledge, this is the first report describing successful single-incision laparoscopic gastrectomy for gastric cancer.


Asunto(s)
Gastrectomía/métodos , Laparoscopía/métodos , Neoplasias Gástricas/cirugía , Anciano , Anastomosis Quirúrgica , Femenino , Humanos , Metástasis Linfática , Masculino , Persona de Mediana Edad , Neumoperitoneo Artificial , Grapado Quirúrgico , Resultado del Tratamiento , Ombligo
16.
Adv Ther ; 37(9): 3850-3862, 2020 09.
Artículo en Inglés | MEDLINE | ID: mdl-32676927

RESUMEN

INTRODUCTION: Lenvatinib is approved in Japan for treating patients with all histological subtypes of unresectable thyroid cancer, including differentiated thyroid cancer (DTC), medullary thyroid cancer (MTC), and anaplastic thyroid cancer (ATC). However, safety and effectiveness data are limited in Japanese patients. Therefore, this prospective, post-marketing observational study evaluated, in daily clinical practice, the safety and effectiveness of lenvatinib in Japanese patients with unresectable thyroid cancer. METHODS: All patients with unresectable thyroid cancer first treated with lenvatinib between May and November 2015 were registered. Patients were orally administered lenvatinib and followed up for 12 months. The endpoints included adverse drug reactions (ADRs), overall survival (OS), overall response rate (ORR), and time-to-treatment failure. Post hoc Cox multivariate analyses were performed to assess prognostic factors associated with the 12-month OS rate. RESULTS: Of 629 registered patients, 594 were included in the analysis. A total of 442 patients (74.4%) had DTC, 28 (4.7%) had MTC, and 124 (20.9%) had ATC. Hypertension, proteinuria, and palmar-plantar erythrodysesthesia syndrome were the most frequently reported ADRs across all histological subtypes. The median OS was 101.0 days in patients with ATC which was not reached in patients with DTC and patients with MTC, with 12-month OS rates of 15.6%, 75.7%, and 83.0%, respectively. The ORRs were 59.2%, 45.0%, and 43.8% among 368 patients with DTC, 20 with MTC, and 105 with ATC, respectively. Multivariate analyses revealed that Eastern Cooperative Oncology Group performance status (ECOG PS), tumor size, the presence of tumor invasion, and body weight were baseline prognostic factors affecting OS in patients with DTC, while ECOG PS and the presence of liver metastasis were prognostic factors in patients with ATC. CONCLUSION: Lenvatinib demonstrated an acceptable safety profile for patients with thyroid cancer in a real-world setting in Japan. The safety profile and effectiveness findings for lenvatinib in this study were consistent with those from previous clinical trials, irrespective of histological subtype.


Asunto(s)
Antineoplásicos/uso terapéutico , Carcinoma Neuroendocrino/tratamiento farmacológico , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Compuestos de Fenilurea/uso terapéutico , Quinolinas/uso terapéutico , Carcinoma Anaplásico de Tiroides/tratamiento farmacológico , Neoplasias de la Tiroides/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Japón/epidemiología , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Tasa de Supervivencia , Adulto Joven
17.
Surg Endosc ; 23(11): 2605-9, 2009 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-19266229

RESUMEN

BACKGROUND: Current techniques of laparoscopic colectomy require an abdominal incision for extraction of the specimen. Although this incision is smaller than that for open laparotomy incision, it may reduce the advantages of laparoscopic surgery. In totally laparoscopic sigmoid colectomy, intracorporeal anastomosis is technically difficult. A safe and simple technique for circularly stapled intracorporeal anastomosis is described. METHODS: After mobilization of the colon and division of the mesentery, a semicircumferential colotomy is made at the anterior colonic wall just proximal to the transection site. The anvil of a circular stapling device, secured with a Prolene suture, is introduced via the colotomy. The suture is advanced anteriorly so that the center rod of the circular stapling device penetrates the colonic wall. The colon is staple-transected at this point to secure the anvil on the proximal colon. A grasping forceps is brought through the rectum, and the specimen is extracted through the colotomy made at the distal staple line. After the colotomy is reclosed with a linear stapler, anastomosis is established using a hemidouble stapling technique. RESULTS: Totally laparoscopic sigmoid colectomies were performed for 16 patients with colon cancers. All the patients were treated laparoscopically without any complications. The average operation time was 180 min. Although one patient experienced wound infection, no major complications occurred. There was no mortality in this series. CONCLUSIONS: The procedure of totally intracorporeal anastomosis combined with transanal extraction of the specimen can be performed easily, enabling surgeons to achieve minimal invasiveness comparable with that of hybrid natural orifice translumenal endoscopic surgery (NOTES).


Asunto(s)
Colectomía/métodos , Laparoscopía/métodos , Neoplasias del Colon Sigmoide/patología , Neoplasias del Colon Sigmoide/cirugía , Anastomosis Quirúrgica/métodos , Femenino , Estudios de Seguimiento , Humanos , Tiempo de Internación , Masculino , Estadificación de Neoplasias , Dolor Postoperatorio/fisiopatología , Satisfacción del Paciente , Medición de Riesgo , Administración de la Seguridad , Muestreo , Resultado del Tratamiento
18.
Dig Surg ; 26(6): 441-5, 2009 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-20068314

RESUMEN

AIM: To describe a simple technique for intracorporeal circular-stapled gastrojejunostomy in laparoscopic distal gastrectomy with Roux-en-Y reconstruction. METHODS: After the stomach and duodenum were mobilized, gastrotomy was established in the anterior gastric wall. An anvil, which was secured with a suture needle, was inserted completely through the gastrotomy. The needle was advanced to the greater curvature of the gastric wall to enable penetration of the central rod into the gastric wall. Subsequently, the stomach was cut using a linear stapler to secure the anvil on the stomach and was sequentially transected using another linear stapler to achieve distal gastrectomy. Circular-stapled gastrojejunostomy was then performed intracorporeally using the hemidouble-stapling technique, while handling the shaft of the instrument via the umbilical incision. The jejunal stump was closed using a linear stapler. RESULTS: Gastrojejunostomies were successfully performed in 20 gastric cancer patients using this technique. None of the patients showed anastomotic leakage and/or stenosis. There were no mortalities in this series. CONCLUSIONS: Gastrojejunostomy performed using the above-mentioned technique was safe and simple. The most important feature of the technique was the elimination of the need for purse-string suture placement, as well as the achievement of better cosmesis using the transumbilical approach.


Asunto(s)
Gastrectomía/métodos , Derivación Gástrica/métodos , Laparoscopía , Neoplasias Gástricas/cirugía , Grapado Quirúrgico/métodos , Ombligo , Anciano , Anastomosis en-Y de Roux/métodos , Femenino , Humanos , Laparoscopía/métodos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Técnicas de Sutura , Resultado del Tratamiento
19.
Dig Surg ; 26(6): 446-50, 2009 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-20068315

RESUMEN

BACKGROUND: Laparoscopically assisted low anterior resection is difficult even for experienced surgeons because of difficulties in selecting the appropriate transection line and completing anastomosis in the narrow pelvic space. The prolapsing technique resolves these problems. We combined our new technique for intracorporeal anastomosis with this prolapsing technique and achieved a totally laparoscopic low anterior resection. METHODS: After the total mesorectal excision, a semi-circumferential colotomy is made at the anterior colonic wall just proximal to the proximal transection site. The anvil of a circular stapling device, secured with a Prolene suture, is introduced via the colotomy. The suture is advanced anteriorly so that the center rod of the anvil penetrates the colonic wall. The colon is staple-transected at this point to secure the anvil on the proximal colon. The distal rectum is everted and pulled transanally outside the body using a grasping forceps inserted from the anus. Staple-closure and transection of the distal rectum is performed under direct vision. Anastomosis is established using the double-stapling technique. RESULTS: Totally laparoscopic low anterior resections using this technique were performed for 7 patients with rectal cancer. There was no anastomotic leakage/stenosis. CONCLUSIONS: Our procedure can be performed easily, which enables surgeons to achieve minimal invasiveness compared with hybrid NOTES.


Asunto(s)
Colectomía/métodos , Laparoscopía , Neoplasias del Recto/cirugía , Anastomosis Quirúrgica/métodos , Colectomía/instrumentación , Procedimientos Quirúrgicos del Sistema Digestivo/métodos , Humanos , Laparoscopía/métodos , Estudios Retrospectivos , Grapado Quirúrgico/instrumentación , Grapado Quirúrgico/métodos , Resultado del Tratamiento
20.
Gan To Kagaku Ryoho ; 36(1): 123-5, 2009 Jan.
Artículo en Japonés | MEDLINE | ID: mdl-19151577

RESUMEN

A 58-year-old man who complained of an abdominal tumor was admitted to our hospital. Abdominal CT scan showed that a 15-cm tumor occupied the entire right upper abdomen and that there were ascites and liver metastases. A liver biopsy was performed. The liver biopsy showed a small cell carcinoma pattern, but no definitive origin of the tumor was determined. Considering the extensive peritoneal invasion and multiple liver metastases, he received 2 / courses of cisplatin/etoposide chemotherapy, but his tumor became larger with concomitant abdominal pain and nausea. The patient suddenly died due to multiple organ failure caused by tumor necrosis. The autopsy revealed a pathological diagnosis of primary small cell carcinoma of the pancreas.


Asunto(s)
Carcinoma de Células Gigantes/patología , Carcinoma de Células Pequeñas/patología , Neoplasias Pancreáticas/patología , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Autopsia , Carcinoma de Células Gigantes/diagnóstico por imagen , Carcinoma de Células Gigantes/tratamiento farmacológico , Carcinoma de Células Pequeñas/diagnóstico por imagen , Carcinoma de Células Pequeñas/tratamiento farmacológico , Resultado Fatal , Humanos , Masculino , Persona de Mediana Edad , Metástasis de la Neoplasia/diagnóstico por imagen , Metástasis de la Neoplasia/patología , Neoplasias Pancreáticas/diagnóstico por imagen , Neoplasias Pancreáticas/tratamiento farmacológico , Radiografía
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