Publications by authors named "Hiroki Mitani"

47 Publications

Clinicopathological and genomic features in patients with head and neck neuroendocrine carcinoma.

Mod Pathol 2021 Jul 10. Epub 2021 Jul 10.

Division of Medical Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.

Neuroendocrine carcinoma (NEC) of the head and neck is a rare type of malignancy, accounting for only 0.3% of all head and neck cancers, and its clinicopathological and genomic features have not been fully characterized. We conducted a retrospective analysis of 27 patients with poorly differentiated NEC of the head and neck seen at our institution over a period of 15 years. Patient characteristics, adopted therapies, and clinical outcomes were reviewed based on the medical records. Pathological analysis and targeted sequencing of 523 cancer-related genes were performed using evaluable biopsied/resected specimens based on the clinical data. The most common tumor locations were the paranasal sinus (33%) and the oropharynx (19%). Eighty-one percent of the patients had locally advanced disease. The 3-year overall survival rates in all patients and in the 17 patients with locally advanced disease who received multimodal curative treatments were 39% and 53%, respectively. Histologically, large cell neuroendocrine carcinoma was the predominant subtype (58% of evaluable cases), and the Ki-67 labeling index ranged from 59 to 99% (median: 85%). Next-generation sequencing in 14 patients identified pathogenic/likely pathogenic variants in TP53, RB1, PIK3CA-related genes (PREX2, PIK3CA, and PTEN), NOTCH1, and SMARCA4 in six (43%), three (21%), two (14%), two (14%), and one (7%) patients, respectively. Sequencing also detected the FGFR3-TACC3 fusion gene in one patient. The median value of the total mutational burden (TMB) was 7.1/Mb, and three patients had TMB ≥ 10. Regardless of the aggressive pathological features, our data revealed favorable clinical characteristics in the patients with locally advanced disease who received curative treatment. The lower TP53 and RB1 mutation prevalence rates compared to those described for small cell lung cancer suggests the biological heterogeneity of NEC in different parts of the body. Furthermore, the FGFR3-TACC3 fusion gene and mutations in genes encoding the components of the NOTCH and PI3K/AKT/mTOR pathways found in our study may be promising targets for NEC of the head and neck.
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http://dx.doi.org/10.1038/s41379-021-00869-9DOI Listing
July 2021

Sites of invasion of cancer of the external auditory canal predicting oncologic outcomes.

Head Neck 2021 Jul 9. Epub 2021 Jul 9.

Department of Head and Neck Surgery, National Cancer Center Hospital East, Kashiwa, Japan.

Background: This study aimed to reveal the influence of the invasion site of external auditory canal (EAC) cancer by analyzing the outcome of patients with advanced tumor.

Methods: A total of 111 patients with T4 EAC cancer were enrolled in this study. Of these patients, 79 underwent chemoradiotherapy and 32 underwent surgery under curative intent. Univariate and multivariate analyses and the Kaplan-Meier method were used to focus on the tumor invasion sites and overall survival of the patients.

Results: The 3-year overall survival rate of all patients was 55.0%. In multivariate analysis, the only significant invasion site for overall survival was the facial nerve, with the dura mater being the next most influential site. When Kaplan-Meier survival curve was calculated, facial nerve and dura mater were the significant factors resulting in poor patient outcomes.

Conclusion: The facial nerve and dura mater are crucial sites of EAC cancer for patient outcomes.
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http://dx.doi.org/10.1002/hed.26800DOI Listing
July 2021

Multifocality and Progression of Papillary Thyroid Microcarcinoma During Active Surveillance.

World J Surg 2021 Sep 7;45(9):2769-2776. Epub 2021 Jun 7.

Department of Endocrine Surgery, Nippon Medical School Graduate School of Medicine, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan.

Background: Prospective trials of active surveillance (AS) have shown low rates of progression in low-risk papillary thyroid microcarcinoma (PTMC; T1aN0M0). However, the significance of multifocality as a prognostic factor remains controversial.

Methods: Data from 571 patients (mean age, 53.1 years; 495 females) who underwent AS were reviewed. PTMC was unifocal in 457 patients (80.0%) and multifocal in 114 patients (20.0%), with 2-5 lesions each (261 tumors in total). Tumor progression was defined as tumor size enlargement ≥ 3 mm and/or development of clinically evident lymph node metastasis (LNM).

Results: After a mean duration of AS of 7.6 years, 53 patients (9.3%) showed tumor enlargement and 8 patients (1.4%) developed LNM. The 10-year progression rate was 13.1%. Age, sex, and calcification pattern did not differ significantly between uni- and multifocal diseases. However, anti-thyroglobulin antibody and/or anti-thyroid peroxidase antibody was more frequently positive with multifocal PTMCs (46.7%) than with unifocal disease (34.4%, p = 0.024). Patients with uni- and multifocal disease showed no significant differences in 10-year rate of tumor enlargement (11.4% vs. 14.8%), LNM development (1.1% vs. 2.4%), or progression (12.4% vs 15.9%). Multivariate analysis of predictors for progression showed multifocality was not a significant risk factor (odds ratio, 1.45; 95% confidence interval, 0.79-2.54; p = 0.22). Eventually, 9 patients (7.9%) with multifocal PTMCs underwent surgery and 7 needed total thyroidectomy, although 7 still showed T1N0M0 low-risk cancer.

Conclusions: Even patients with multiple PTMCs (T1amN0M0) are good candidates for AS. Many patients can avoid total thyroidectomy and subsequent surgical complications.
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http://dx.doi.org/10.1007/s00268-021-06185-2DOI Listing
September 2021

Transoral surgery for superficial head and neck cancer: National Multi-Center Survey in Japan.

Cancer Med 2021 Jun 15;10(12):3848-3861. Epub 2021 May 15.

Department of Gastroenterology, Kobe City Medical Center General Hospital, Kobe, Japan.

Head and neck cancers, especially in hypopharynx and oropharynx, are often detected at advanced stage with poor prognosis. Narrow band imaging enables detection of superficial cancers and transoral surgery is performed with curative intent. However, pathological evaluation and real-world safety and clinical outcomes have not been clearly understood. The aim of this nationwide multicenter study was to investigate the safety and efficacy of transoral surgery for superficial head and neck cancer. We collected the patients with superficial head and neck squamous cell carcinoma who were treated by transoral surgery from 27 hospitals in Japan. Central pathology review was undertaken on all of the resected specimens. The primary objective was effectiveness of transoral surgery, and the secondary objective was safety including incidence and severity of adverse events. Among the 568 patients, a total of 662 lesions were primarily treated by 575 sessions of transoral surgery. The median tumor diameter was 12 mm (range 1-75) endoscopically. Among the lesions, 57.4% were diagnosed as squamous cell carcinoma in situ. The median procedure time was 48 minutes (range 2-357). Adverse events occurred in 12.7%. Life-threatening complications occurred in 0.5%, but there were no treatment-related deaths. During a median follow-up period of 46.1 months (range 1-113), the 3-year overall survival rate, relapse-free survival rate, cause-specific survival rate, and larynx-preservation survival rate were 88.1%, 84.4%, 99.6%, and 87.5%, respectively. Transoral surgery for superficial head and neck cancer offers effective minimally invasive treatment. Clinical trials registry number: UMIN000008276.
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http://dx.doi.org/10.1002/cam4.3927DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8209601PMC
June 2021

Baseline Tumour Size as a Prognostic Factor for Radioiodine-refractory Differentiated Thyroid Cancer Treated With Lenvatinib.

Anticancer Res 2021 Mar;41(3):1683-1691

Department of Medical Oncology, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.

Background/aim: Lenvatinib is standard therapy for radioiodine-refractory differentiated thyroid cancer (RR-DTC), although the optimal timing for starting treatment is still controversial. The aim of this study was to evaluate the prognostic impact of baseline tumour size (BTS) in patients with RR-DTC treated with lenvatinib.

Patients And Methods: Fifty-one RR-DTC patients who had at least one measurable lesion and treated with lenvatinib were retrospectively analysed. BTS was defined as the sum of the longest dimensions of all measurable target lesions.

Results: Median progression-free survival (PFS) and overall survival (OS) in the larger BTS (≥42 mm) group were shorter than those in the smaller (<42 mm) group. This result was more significant in patients with fast-growing tumours. BTS was an independent prognostic factor for both PFS and OS.

Conclusion: Starting lenvatinib at BTS <42 mm should be recommended to achieve good treatment outcomes in patients with RR-DTC.
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http://dx.doi.org/10.21873/anticanres.14932DOI Listing
March 2021

Efficacy of Paclitaxel-based Chemotherapy After Progression on Nivolumab for Head and Neck Cancer.

In Vivo 2021 Mar-Apr;35(2):1211-1215

Department of Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.

Background/aim: In the CheckMate-141 trial regarding head and neck cancer (HNC), nivolumab conferred a survival benefit to patients. However, the best treatment sequence of chemotherapy and anti-PD-1/PD-L1 therapy in these cancers is unclear.

Patients And Methods: This was an observational study using data collected prospectively from 97 HNC patients treated with nivolumab at our institutions. Twenty-two HNC patients who received paclitaxel-based chemotherapy before (pre-PTX, n=12) and after (post-PTX, n=10) nivolumab were evaluated.

Results: The median follow-up time was 15.9 months (range=6.9-35.9 months). There was a significant difference in the overall response rate (ORR) between pre-PTX (17%) and post-PTX (70%) (p=0.027). Similarly, time to progression (TTP) was significantly longer after nivolumab than before nivolumab (post-PTX, 7.4 months; pre-PTX, 4.9 months, p=0.020).

Conclusion: Paclitaxel-based chemotherapy had a better ORR and TTP after nivolumab than before nivolumab for HNC. The sequential administration of anti-PD-1 therapy followed by paclitaxel-based chemotherapy could be a better strategy for HNC.
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http://dx.doi.org/10.21873/invivo.12371DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8045096PMC
June 2021

Prognostic significance of 8 weeks' relative dose intensity of lenvatinib in treatment of radioiodine-refractory differentiated thyroid cancer patients.

Endocr J 2021 Jun 28;68(6):639-647. Epub 2021 Jan 28.

Department of Medical Oncology, The Cancer Institute Hospital of The Japanese Foundation for Cancer Research, Tokyo, Japan.

Lenvatinib is a standard therapy for radioiodine-refractory differentiated thyroid cancer (RR-DTC). However, because of the high incidence of adverse events resulting from this treatment, it is not easy to maintain the dose intensity of lenvatinib, especially in Japanese patients. Although the prognostic impact of lenvatinib dose interruption has been reported, the target dose intensity of lenvatinib to optimize survival benefits remains unknown. We therefore propose a target dose intensity of lenvatinib during the first 8 weeks of treatment. We retrospectively analyzed 42 RR-DTC patients who were treated with lenvatinib for more than 8 weeks. We performed receiver operating characteristic curve analysis to determine the cut-off value of 8 weeks' relative dose intensity (8w-RDI) to predict treatment response, and identified that the optimal cut-off value of 8w-RDI was 60% (sensitivity: 81.8%; specificity: 80.6%). Median progression-free survival (PFS) (not reached [NR] vs. 11.0 months; hazard ratio [HR] 0.29; 95% confidence interval [CI] 0.11-0.72; p < 0.01) and overall survival (NR vs. 27.6 months; HR 0.44; 95% CI 0.11-0.91; p = 0.03) were longer in the higher 8w-RDI (≥60%) patients than in the lower 8w-RDI (<60%) patients. Multivariate analysis revealed that 8w-RDI at ≥60% was an independent prognostic factor for PFS (HR 0.29; 95% CI 0.09-0.96; p = 0.04). Targeting for ≥60% of the relative dose intensity during the first 8 weeks of lenvatinib treatment can be sufficient to achieve significant tumor shrinkage and prolong PFS in RR-DTC patients.
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http://dx.doi.org/10.1507/endocrj.EJ20-0754DOI Listing
June 2021

Comparison of the efficacy and safety of the EXTREME regimen for treating recurrent or metastatic head and neck squamous cell carcinoma in older and younger adult patients.

Cancer Rep (Hoboken) 2021 04 9;4(2):e1322. Epub 2020 Dec 9.

Department of Medical Oncology, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.

Background: Head and neck squamous cell carcinoma (HNSCC) is a geriatric cancer. However, older adult patients are frequently underrepresented in large clinical trials.

Aims: The aim of this study is to assess the efficacy and safety of the EXTREME regimen (platinum + fluorouracil + cetuximab) in older and younger adult patients with HNSCC.

Methods And Results: Patients with recurrent or metastatic HNSCC treated with the EXTREME regimen were retrospectively analyzed. We compare the efficacy and safety in older (aged ≥70 years) younger (aged <70 years) adult patients. Of the 86 patients examined in this study, 21 (24.4%) were older adults. There was no difference in overall response rate (46.9% vs 38.5%, P = .76), median progression-free survival [5.7 months vs 5.8 months, hazard ratio (HR) 0.88, 95% confidence interval (CI) = 0.52-1.51, P = .66] and overall survival (OS) (14.6 months vs 15.2 months, HR 0.79, 95% CI 0.43-1.43, P = .44) in younger vs older patients. There was also no difference in the incidence of grade 3/4 adverse events between groups. The exploratory analysis for geriatric nutritional risk index (GNRI) showed the association with lower GNRI (≤98) and poor OS in older adult patients (37.7 months vs 7.0 months, HR 0.53, 95% CI 0.31-0.89, P = .002).

Conclusions: The EXTREME regimen with optimal dose modification is safe and effective for both older and younger adult patients with HNSCC. The GNRI can be an indicator to select the older adult patients who can get benefit from the EXTREME regimen.
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http://dx.doi.org/10.1002/cnr2.1322DOI Listing
April 2021

Multi-institutional Survey of Squamous Cell Carcinoma of the External Auditory Canal in Japan.

Laryngoscope 2021 03 30;131(3):E870-E874. Epub 2020 Jul 30.

Department of Head and Neck Surgery, National Cancer Center Hospital East, Kashiwa, Japan.

Objectives: This study aimed to evaluate the efficacy of chemoradiotherapy (CRT) for patients with advanced cancer of the external auditory canal (EAC) by analyzing the outcome of the patients.

Methods: This is a multi-institutional retrospective survey, and we reviewed the medical records of the subjects. A total of 181 patients with tumor (T)3 or T4 tumor in 17 institutions were enrolled. Further analysis was performed for 74 patients who underwent CRT under curative intent.

Results: Overall 5-year survival rates of the patients who underwent CRT (n = 74) were 54.6%. Those of the patients who underwent CRT with modified TPF (docetaxel, cisplatin [CDDP], and 5-fluorouracil) regimen (n = 50) and CRT with CDDP regimens (n = 24) were 64.4% and 36.7%, respectively. Significant differences were observed between these two groups.

Conclusion: Given the tendency that head and neck surgeons prefer CRT for advanced larger cancer of the EAC, CRT for advanced EAC cancer using the modified TPF regimen showed good clinical outcomes.

Level Of Evidence: 4 Laryngoscope, 131:E870-E874, 2021.
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http://dx.doi.org/10.1002/lary.28936DOI Listing
March 2021

Neutrophil-to-Lymphocyte Ratio as a Prognostic Marker for Anaplastic Thyroid Cancer Treated With Lenvatinib.

In Vivo 2020 Sep-Oct;34(5):2859-2864

Department of Medical Oncology, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.

Background/aim: Lenvatinib is one of the few options for patients with anaplastic thyroid cancer (ATC). However, tumor markers for ATC treated with lenvatinib is lacking. The aim of this study was to explore whether the neutrophil-to-lymphocyte ratio (NLR) can be a tumor marker for ATC treated with lenvatinib.

Patients And Methods: We retrospectively analyzed the prognostic significance of the NLR in 13 ATC patients treated with lenvatinib.

Results: The disease control rate was better in patients with lower NLR (<8; 89%) than higher NLR (≥8; 25%) (p=0.05). Median progression-free survival and overall survival were longer in patients with lower NLR than higher NLR (4.0 vs. 1.6 months, p<0.05; and 10.2 vs. 3.8 months, p<0.05, respectively). Patients whose NLR on day 14 decreased compared to baseline had a slightly higher overall response rate than patients without NLR decrease (42.9% vs. 0%, p=0.19).

Conclusion: The baseline NLR is a potential prognostic marker, and the change of NLR can be an early indicator of response for ATC patients treated with lenvatinib.
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http://dx.doi.org/10.21873/invivo.12113DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7652499PMC
June 2021

Promoter Mutation and Extent of Thyroidectomy in Patients with 1-4 cm Intrathyroidal Papillary Carcinoma.

Cancers (Basel) 2020 Jul 30;12(8). Epub 2020 Jul 30.

Department of Endocrine Surgery, Nippon Medical School, Tokyo 113-8603, Japan.

There are concerns regarding overtreatment in papillary thyroid carcinoma (PTC). and promoter mutations play important roles in the development of PTC. However, initial surgical approaches for PTC based on genetic characteristics remain unclear. The present study aimed to identify genetic mutations as predictors of prognosis and to establish proper indications for lobectomy (LT) in patients with 1-4 cm intrathyroidal PTC. Prospectively accumulated data from 685 consecutive patients with PTC who underwent primary thyroid surgery at the Cancer Institute Hospital, Tokyo, Japan, between 2001 and 2012 were retrospectively reviewed. Of the 685 patients examined, 538 (78.5%) had mutation and 133 (19.4%) had promoter mutations. Patients with promoter mutations displayed significantly worse outcomes than those without mutations (10-year cause-specific survival (CSS): 73.7% vs. 98.1%, < 0.001; 10-year disease-free survival (DFS): 53.7% vs. 93.3%, < 0.001). As for extent of thyroidectomy among mutation-negative patients with 1-4 cm intrathyroidal PTC, patients who underwent LT showed no significant differences in 10-year CSS and 10-year DFS compared to patients who had total thyroidectomy (TT) under propensity score-matching. Avoiding TT for those patients indicates a possible pathway to prevent overtreatment and reduce postoperative complications.
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http://dx.doi.org/10.3390/cancers12082115DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7464551PMC
July 2020

ASO Author Reflections: What is the Optimal Method of Digestive Reconstruction Following Pharyngolaryngectomy with Total Esophagectomy?

Ann Surg Oncol 2020 Dec 8;27(Suppl 3):824-825. Epub 2020 Jul 8.

Department of Head and Neck Surgery, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.

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http://dx.doi.org/10.1245/s10434-020-08837-4DOI Listing
December 2020

Digestive Reconstruction After Pharyngolaryngectomy with Total Esophagectomy.

Ann Surg Oncol 2021 Feb 7;28(2):695-701. Epub 2020 Jul 7.

Department of Head and Neck Surgery, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.

Background: Pharyngolaryngectomy with total esophagectomy (PLTE) is often indicated for patients with synchronous head and neck cancer and thoracic esophageal cancer or those with head and neck cancer extending to the upper mediastinum. A long conduit is required for the reconstruction, and the blood flow at the tip of the conduit is not always sufficient. Thus, reconstructive surgery after PLTE remains challenging, and optimal reconstruction methods have not been elucidated to date.

Methods: This analysis investigated 65 patients who underwent PLTE. The short-term outcomes among the procedures were compared to explore the optimal digestive reconstruction methods.

Results: We used a simple gastric conduit for 7 patients, a gastric conduit with microvascular anastomosis (MVA) for 10 patients, an elongated gastric conduit with an MVA for 20 patients, a gastric conduit combined with a free jejunum transfer (FJT) for 25 patients, and other procedures for 3 patients. Postoperatively, 17 (26.2%) of the patients experienced severe complications, classified as Clavien-Dindo grade 3b or higher, including graft failure for 3 patients (6.2%). Anastomotic leakage was found in six patients (9.2%), and all leakages occurred at the pharyngogastric anastomosis. The reoperation rate was 15.4% (n = 10), and three patients (4.6%) died of massive bleeding from major vessels. The patients who underwent simple gastric conduit more frequently had graft failure (P = 0.04), anastomotic leakage (P < 0.01), and reoperation (P = 0.04) than the patients treated with the other reconstructive methods.

Conclusion: Additional procedures such as MVA, gastric tube elongation, and FJT contribute to improving the outcomes of reconstruction after PLTE.
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http://dx.doi.org/10.1245/s10434-020-08830-xDOI Listing
February 2021

Efficacy of Nivolumab for Head and Neck Cancer Patients with Primary Sites and Histological Subtypes Excluded from the CheckMate-141 Trial.

Cancer Manag Res 2020 3;12:4161-4168. Epub 2020 Jun 3.

Department of Medical Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo 135-8550, Japan.

Background: In the CheckMate-141 trial, nivolumab conferred a survival benefit in patients with recurrent or metastatic refractory squamous cell carcinoma (SCC) head and neck cancer (HNC). Here, we examined the efficacy of nivolumab in patients with histological subtypes or primary sites of HNC not included in the CheckMate-141 trial.

Methods: This was a retrospective analysis of data collected prospectively from 97 patients who were treated with nivolumab for recurrent or metastatic HNC at our institution. The patients were assigned to three groups based on HNC primary site: 1) oral cavity, pharynx, and larynx, which were included in CheckMate-141 (n = 68), 2) nasopharynx (excluded in CheckMate-141, n = 7) and 3) other primary sites excluded in CheckMate-141 (n = 22) and assigned to two groups according to histological subtype: 1) SCC (included in CheckMate-141, n = 83) and 2) non-SCC (all sites excluded in CheckMate-141, n = 14). Survival outcomes and nivolumab treatment response were compared between the primary site and histological subgroups.

Results: The median number of nivolumab treatments was 7 cycles (range, 1-53 cycles) and the median follow-up time was 9.1 months (range, 0.66-33.0 months). There were no significant differences in response rates between the three primary site subgroups (CheckMate-141 sites 22%, nasopharynx 43%, others 18%; p=0) or the two histological subtype subgroups (SCC 25%, non-SCC 7%, p=0). Similarly, overall survival and progression-free survival were comparable for patients stratified by primary site or histological subtype.

Conclusion: No significant difference in response rates or survival outcomes was detected between nivolumab-treated HNC patients with primary sites and histological subtypes that were included versus excluded in the CheckMate-141 trial. These data provide a potential rationale for nivolumab therapy for all HNC patients in clinical practice.
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http://dx.doi.org/10.2147/CMAR.S249393DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7280058PMC
June 2020

Mycophenolate mofetil as a successful treatment of corticosteroid-resistant immune checkpoint inhibitor-induced hepatitis.

Oxf Med Case Reports 2020 Apr 23;2020(4):omaa027. Epub 2020 May 23.

Department of Medical Oncology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.

Immune checkpoint inhibitors (ICIs) are now widely used to many malignant diseases, but some patients suffer from immune-related adverse events during or after ICI treatments. The monoclonal antibody infliximab is usually chosen as a salvage treatment to combat corticosteroid-resistant adverse events, but infliximab is not recommended as a response to hepatitis because of the potential risk of liver failure. An alternative treatment option has not been established. We treated a head and neck cancer patient (a 50-year-old Japanese male) who suffered from corticosteroid-resistant hepatitis during treatment with nivolumab, an anti-PD-1 ICI, and that was recovered by mycophenolate mofetil salvage therapy.
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http://dx.doi.org/10.1093/omcr/omaa027DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7243717PMC
April 2020

Fatal invasive pulmonary aspergillosis caused by voriconazole-resistant Aspergillus tubingensis in a patient with solid tumor.

J Infect Chemother 2020 Mar 29;26(3):301-304. Epub 2019 Nov 29.

Department of Infectious Diseases, Cancer Institute Hospital, Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan.

We report a fatal case of invasive pulmonary aspergillosis caused by voriconazole-resistant Aspergillus tubingensis in a patient with solid tumor but without severe immunosuppression. A high index of suspicion for invasive pulmonary aspergillosis, coupled with molecular identification of species and resistance genes, may facilitate early initiation of appropriate treatment.
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http://dx.doi.org/10.1016/j.jiac.2019.10.022DOI Listing
March 2020

Predictive Factors for Completion of TPF Induction Chemotherapy in Patients With Locally Advanced Head and Neck Cancer.

Anticancer Res 2019 Aug;39(8):4337-4342

Department of Medical Oncology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.

Background: Induction therapy with docetaxel, cisplatin and fluorouracil (TPF) is a treatment option for locally advanced head and neck cancer (LAHNC), but it is not known which patients are appropriate for TPF.

Patients And Methods: We retrospectively reviewed the records of patients with LAHNC who underwent induction TPF, and evaluated factors predictive of the completion of TPF treatment (defined as ≥3 cycles administered).

Results: Of the total 93 enrolled patients, 73 (78.5%) achieved therapy completion. In a multivariate analysis, hypolaryngeal/ laryngeal primary tumor site was a negative predictive factor (hazard ratio(HR)=0.32, 95% confidence interval(CI)=0.11-0.96, p=0.041) and body mass index ≥22 kg/m was a positive predictive factor (hazard ratio=3.51, 95% confidence intervaI=1.04-11.83, p=0.043) of TPF completion.

Conclusion: For patients with LAHNC, oropharyngeal primary tumor site and high body mass index can be used to predict TPF completion and may contribute to decisions on the indications for TPF in terms of safety and tolerability.
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http://dx.doi.org/10.21873/anticanres.13601DOI Listing
August 2019

Incidence and risk factors of interstitial lung disease of patients with head and neck cancer treated with cetuximab.

Head Neck 2019 08 4;41(8):2574-2580. Epub 2019 Mar 4.

Department of Medical Oncology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.

Background: Interstitial lung disease (ILD) is known as a potentially severe adverse event associated with epidermal growth factor receptor (EGFR)-targeted therapy. The incidence and risk factors of ILD in patients with head and neck squamous cancer (HNSCC) treated with cetuximab, an anti-EGFR monoclonal antibody, have not been established.

Methods: We retrospectively reviewed patients with HNSCC who received cetuximab from December 2012 to December 2016 at our institute and evaluated the incidence and risk factors of ILD.

Results: Of the 201 patients with HNSCC, ILD was observed in 9 patients (4.5%), 8 of whom had grade 3 or higher. High Krebs von den Lungen-6 (KL-6) and ≥50 pack-years of smoking were significantly predictive of associated with ILD (P = 0.00011 and 0.05, respectively).

Conclusion: The incidence of ILD in patients with HNSCC treated with cetuximab was <5%, but most of the ILD cases were severe. High KL-6 and smoking histories might be predictive for ILD among patients with HNSCC.
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http://dx.doi.org/10.1002/hed.25727DOI Listing
August 2019

Active Surveillance for T1bN0M0 Papillary Thyroid Carcinoma.

Thyroid 2019 01 8;29(1):59-63. Epub 2019 Jan 8.

4 Department of Ultrasonography, Cancer Institute Hospital, Tokyo, Japan.

Background: Prospective trials of active surveillance for asymptomatic papillary microcarcinoma (T1aN0M0) since the 1990s have shown progression rates of only 5-10%. Late rescue surgery after progression had no deleterious effects on mortality and morbidity. The 2015 American Thyroid Association guidelines approved active surveillance for very low-risk papillary thyroid carcinoma (PTC) as an alternative method to immediate surgery. However, there is no study that evaluates long-term active surveillance for T1b tumors.

Methods: A prospective trial of active surveillance with 360 very low-risk PTC (T1aN0M0) patients has been conducted since 1995. Of the 392 T1bN0M0 patients, 61 selected active surveillance over surgery and eventually participated in this trial, while the remaining 331 patients underwent surgery. To find an appropriate management strategy for patients with T1bN0M0 PTC, the outcomes of active surveillance for T1bN0M0 to T1aN0M0 PTC were investigated and compared, and the outcomes of surgery for T1bN0M0 PTC were studied.

Results: After a mean of 7.4 years of active surveillance, 29 (8%) T1aN0M0 tumors and four (7%) T1bN0M0 tumors had increased in size (p = 0.69). Development of lymph node metastasis was seen in three (0.8%) patients and two (3%) patients, respectively (p = 0.10). No significant difference in progression rate was seen between groups. Among T1bN0M0 tumors, weak calcification and rich vascularity were risk factors for tumor-size increase, and younger age was a predictor for the development of lymph node metastasis. Mean initial tumor size was significantly greater in T1bN0M0 patients who underwent immediate surgery (14.5 ± 2.8 mm) than it was in patients who chose observation (11.7 ± 1.1 mm; p < 0.0001). No postoperative recurrence was seen in patients with tumor <15 mm in diameter.

Conclusions: Active surveillance is an option for selected patients with T1bN0M0 PTC.
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http://dx.doi.org/10.1089/thy.2018.0462DOI Listing
January 2019

MYB and MYBL1 in adenoid cystic carcinoma: diversity in the mode of genomic rearrangement and transcripts.

Mod Pathol 2018 06 6;31(6):934-946. Epub 2018 Feb 6.

Pathology Project for Molecular Targets, The Cancer Institute, Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto, Tokyo, 135-8550, Japan.

MYB-NFIB and MYBL1-NFIB have been reported in ~60% of adenoid cystic carcinoma cases, but driver alterations in the remaining ~40% of adenoid cystic carcinoma remain unclear. We examined 100 adenoid cystic carcinoma cases for MYB and MYBL1 locus rearrangements by fluorescence in situ hybridization (FISH) with originally designed probe sets using formalin-fixed paraffin-embedded materials. Approximately one-third of samples were also analyzed by fusion transcript-specific RT-PCR and capture RNA sequencing. In the 27 cases with frozen materials, MYB-NFIB and MYBL1-NFIB fusion transcripts were detected in 9 (33%) and 6 cases (22%) by RT-PCR, respectively. Meanwhile, high expression of MYB (18 cases, 67%) or MYBL1 (9 cases, 33%) was detected in all 27 cases in a mutually exclusive manner, regardless of its form (full-length, truncation, or fusion transcript). Interestingly, genomic rearrangements around the corresponding highly-expressed gene were observed in all 27 cases by FISH, suggesting a causative relationship between genomic rearrangements and gene expression. Among the 100 cases, including additional 73 cases, 97 harbored genomic rearrangements in the MYB (73 cases) or MYBL1 locus (24 cases) including 10 cases with atypical FISH patterns undetectable through ordinary split FISH approaches: breakpoints far distant from MYB (5 cases) and a small NFIB locus insertion into the MYB (3 cases) or MYBL1 locus (2 cases). In clinicopathological analyses, histological grade, primary tumor size, and lymph node metastasis were identified as prognostic factors, whereas MYB/MYBL1 rearrangements were not, but were associated with histological grade. In the present study, MYB or MYBL1 locus rearrangement was detected in nearly all adenoid cystic carcinoma cases, and therefore it would be a good diagnostic marker for adenoid cystic carcinoma. However, fusion transcript-specific RT-PCR for MYB-NFIB and MYBL1-NFIB and ordinary split FISH assays for MYB and MYBL1 were less sensitive, and thus detection methods should be judiciously designed because of the diversity of rearrangement modes in adenoid cystic carcinoma.
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http://dx.doi.org/10.1038/s41379-018-0008-8DOI Listing
June 2018

A comparison of weekly paclitaxel and cetuximab with the EXTREME regimen in the treatment of recurrent/metastatic squamous cell head and neck carcinoma.

Oral Oncol 2017 10 5;73:21-26. Epub 2017 Aug 5.

Departments of Medical Oncology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan. Electronic address:

Background: The effectiveness of the combination chemotherapy of weekly paclitaxel and cetuximab has not yet been compared to that of the current standard regimen, EXTREME (combination of 5-fluorouracil, cisplatin and cetuximab).

Methods: We retrospectively reviewed the clinical records of R/M SCCHN patients who received cetuximab-containing chemotherapy as a first-line therapy; from these, patients receiving a weekly paclitaxel and cetuximab regimen (cohort A) and the EXTREME regimen (cohort B) were extracted. The responses, prognoses and adverse events of these two cohorts were evaluated.

Results: A total of 86 patients were included (cohort A, 49; cohort B, 36). Patients with histories of platinum-based chemotherapy were more frequently given the cohort A treatment. Though the response rates were similar in the two cohorts (45% in cohort A and 51% in cohort B; p=0.83), the progression-free survival (PFS) was significantly more favorable in cohort A by the log-rank test (6.0monthsvs 5.0months; p=0.027). In the Cox-regression hazard analyses, male gender (hazard ratio [HR]=2.1, p=0.010), older age (≥ 70 yo) (HR=5.0, p=0.018), PS 0 (HR=2.2, p=0.027), no history of platinum chemotherapy (HR=3.2, p=0.003) and the presence of a tracheostomy (HR=2.3, p=0.039) were favorable factors within cohort A.

Conclusion: In selected R/M SCCHN patients, the combination of weekly paclitaxel and cetuximab could be the better treatment option than the EXTREME regimen.
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http://dx.doi.org/10.1016/j.oraloncology.2017.07.022DOI Listing
October 2017

Indwelling voice prosthesis insertion after total pharyngolaryngectomy with free jejunal reconstruction.

Laryngoscope Investig Otolaryngol 2017 02 24;2(1):30-35. Epub 2017 Jan 24.

Department of Head and Neck Surgery.

Objectives: Total pharyngolaryngectomy with free jejunal reconstruction is often performed in patients with hypopharyngeal carcinoma. However, postoperative speechlessness significantly decreases patient quality of life. We investigated whether Provox® insertion could preserve speech after total pharyngolaryngectomy with free jejunal reconstruction.

Study Design: Retrospective chart review.

Methods: A total of 130 cases of secondary Provox® insertions after total pharyngolaryngectomy with free jejunal reconstruction were analyzed. Communication outcomes were compared using the Head and Neck Cancer Understandability of Speech Subscale. Outcomes and complications associated with insertion site (jejunal insertion vs. esophageal insertion) and adjuvant irradiation therapy were also evaluated.

Results: Provox® insertion had favorable communication outcomes in 102 cases (78.4%). Neither the insertion site nor irradiation affected the communication outcome. Complications were observed in 20 cases (15.4%). Local infection was the most common complication. Free jejunal insertion, in which the resection range was enlarged, had a lower complication rate than did esophageal insertion, and its complication rate was unaffected by previous irradiation. For all patients, the hospitalization duration and duration of speechlessness were 13.4 days and 14.6 months, respectively. Patients receiving jejunal insertions had a significantly shorter hospitalization duration than did those receiving esophageal insertions. Unlike Provox®2, Provox®Vega significantly reduced the complication rate to zero.

Conclusion: For jejunal inserson of a Provox® prosthetic, a sufficient margin can be maintained during total pharyngolaryngectomy and irradiation can be performed, and satisfactory communication outcomes were observed. Provox® insertion after total pharyngolaryngectomy with free jejunal reconstruction should be considered the standard therapy for voice restoration.

Level Of Evidence: 4.
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http://dx.doi.org/10.1002/lio2.63DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5510280PMC
February 2017

Thick tumor capsule is a valuable risk factor for distant metastasis in follicular thyroid carcinoma.

Auris Nasus Larynx 2018 Feb 12;45(1):147-155. Epub 2017 May 12.

Department of Pathology, Cancer Institute Hospital, Japan.

Objective: While the biological behavior of follicular thyroid carcinoma (FTC) has been studied in great detail using clinical experience, few studies have investigated pre- or intraoperative factors related to the risk of distant metastasis (DM) among patients with FTC. The aim of this study was to analyze the characteristics of FTC with DM.

Methods: This study retrospectively investigated 102 patients with FTC who underwent surgery between 1988 and 2013. We compared clinicopathological characteristics between FTC with and without DM.

Results: Univariate analysis revealed nodal metastasis (p=0.045), serum thyroglobulin (Tg) at initial operation (≥1000ng/ml; p<0.0001), widely invasive appearance according to macroscopic findings (p<0.0001), thick tumor capsule (≥1mm; p<0.0001), vascular invasion (p=0.0003), extrathyroidal invasion (p=0.047), and venous tumor embolism (p=0.045) as significant risk factors for DM. Multivariate analysis conducted using pre- and intraoperative factors identified thick tumor capsule (≥1mm), serum Tg at initial operation (≥1000ng/ml), and macroscopically widely invasive appearance as risk factors independently associated with development of DM.

Conclusion: Patients with these risk factors should undergo total thyroidectomy and radioactive iodine ablation.
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http://dx.doi.org/10.1016/j.anl.2017.05.002DOI Listing
February 2018

Two Cases of Ectopic Hamartomatous Thymoma Masquerading as Sarcoma.

Case Rep Otolaryngol 2017 10;2017:1672919. Epub 2017 Jan 10.

Department of Head and Neck Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koutou-ku, Tokyo 135-8550, Japan.

Ectopic hamartomatous thymoma (EHT) is an extremely rare benign tumor. EHTs are difficult to differentiate from sarcomas, especially synovial sarcomas. We encountered two cases of EHT that were referred from other hospitals because sarcoma was suspected. In these cases, fusion gene detection via polymerase chain reaction or fluorescence in situ hybridization was useful for differentiating EHT from synovial sarcoma. EHT requires accurate diagnosis before surgery to avoid excessive treatment. Both tumor location and the presence of fat inside the tumor are important imaging findings for EHT, and confirmation of spindle cells, epithelial cells, and mature adipose cells in the tumor is an important pathological finding. It is important to exclude synovial sarcoma from the differential diagnosis via fusion gene analysis.
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http://dx.doi.org/10.1155/2017/1672919DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5259666PMC
January 2017

Combination chemotherapy of carboplatin and paclitaxel for advanced/metastatic salivary gland carcinoma patients: differences in responses by different pathological diagnoses.

Acta Otolaryngol 2016 Sep 20;136(9):948-51. Epub 2016 Apr 20.

a Department of Medical Oncology , Cancer Institute Hospital of the Japanese Foundation for Cancer Research , Tokyo , Japan ;

Background: A standard chemotherapy for recurrent/metastatic salivary gland cancers has not been established. Combination chemotherapy of carboplatin and paclitaxel should be evaluated as a treatment option.

Methods: This study retrospectively reviewed salivary gland cancer patients who received combination chemotherapy of carboplatin and paclitaxel. The differences in objective responses and in the prognoses according to the different pathological diagnoses were evaluated.

Results: A total of 38 patients were enrolled in the study; of them, 18 had salivary duct carcinomas (SDCs), nine had adenoid cystic carcinomas (ACCs), and 11 had other pathological diagnoses. Objective responses were observed in 15 (39%) patients. The median progression-free survival (PFS) was 6.5 months, and the median overall survival (OS) was 26.5 months. ACC patients had relatively low response rates (9%), but there were no significant differences in PFS or OS compared to other sub-types. The treatment was well tolerated, with few adverse events.

Conclusion: Salivary gland cancer patients showed a moderate clinical response to the combination chemotherapy of carboplatin and paclitaxel. The objective response rates differed according to the pathological diagnoses, but there were no significant differences in prognoses.
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http://dx.doi.org/10.3109/00016489.2016.1170876DOI Listing
September 2016

Predictive factors of head and neck squamous cell carcinoma patient tolerance to high-dose cisplatin in concurrent chemoradiotherapy.

Mol Clin Oncol 2016 Feb 25;4(2):303-309. Epub 2015 Nov 25.

Department of Medical Oncology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo 135-8550, Japan.

Although high-dose cisplatin is the standard regimen of concurrent chemoradiotherapy (CCRT) for locally advanced head and neck squamous cell carcinoma (HNSCC), varying levels of patient tolerance towards cisplatin have been reported, and the predictive factors of cisplatin tolerance remain to be elucidated. The present study retrospectively reviewed newly diagnosed HNSCC patients who received CCRT. Cisplatin (80 mg/m) was administered every 3 weeks. The proportion of high-dose cisplatin-tolerant patients (cumulative cisplatin dose, ≥200 mg/m) was determined, and the predictive factors of cisplatin tolerance were analyzed in a logistic regression analysis. Between June 2006 and March 2013, a total of 159 patients were treated with CCRT. The median follow-up time was 36.7 months. A total of 73 patients (46%) tolerated a cumulative cisplatin dose ≥200 mg/m; male gender [odds ratio (OR), 25.00; P=0.005] and high body surface area (BSA) (>1.80 m; OR, 2.21; P=0.032) were significantly predictive of high-dose cisplatin tolerance. The high-dose cisplatin-tolerant patients had a significantly higher complete response (CR) rate (82 vs. 67%, P=0.045); however, there were no significant between-group differences in the 3-year OS (79.5 vs. 81.2%, P=0.59) or PFS (70.4 vs. 44.6%, P=0.076) by cisplatin tolerance. In clinical practice, approximately one-half of the patients tolerated high-dose cisplatin in CCRT. Male gender and high BSA could be predictive of cisplatin tolerance.
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http://dx.doi.org/10.3892/mco.2015.687DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4734196PMC
February 2016

[Total Glossolaryngectomy of an Advanced Oropharyngeal and Tongue Squamous-Cell Carcinoma: A 29-Case Series Study].

Nihon Jibiinkoka Gakkai Kaiho 2015 Jun;118(6):745-50

We report herein on 29 patients with advanced oropharyngeal and tongue squamous-cell carcinoma who underwent a total glossolaryngectomy at the Cancer Institute Hospital of the JFCR between July 2005 and June 2013. In this study, we tried to evaluate associations between several variables of the primary tumor and prognosis in these 29 patients. The cause-specific 5-year survival rate with the Kaplan-Meier method was 45% in all patients. Tumor recurrence occurred in 15 patients. Four patients had recurrence in the primary site, 11 patients in neck lymph nodes or in the lungs or bone. The multivariate analysis revealed that the number of neck lymph node metastases, age and alcohol drinking were poor prognostic markers for patients undergoing a total glossolaryngectomy. Cause-specific survival was compared between patients with salvage surgery and initial surgery using Kaplan-Meier survival curves with log-rank tests. There was no significant association with survival (log-rank test: p = 0.13). The overall local control rate was 69% in all patients. Regarding salvage surgery, 9 of 16 patients had no recurrence in the primary site or neck lymph nodes. The limitations of this study include the small number of patients especially regarding the prognosis study and may have included a selection bias regarding undergoing a total glossolaryngectomy.
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http://dx.doi.org/10.3950/jibiinkoka.118.745DOI Listing
June 2015

A Clinical Study of Pharyngolaryngectomy with Total Esophagectomy: Postoperative Complications, Countermeasures, and Prognoses.

Otolaryngol Head Neck Surg 2015 Sep 26;153(3):392-9. Epub 2015 Jun 26.

Department of Head and Neck Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.

Objective: Patients with advanced hypopharyngeal or cervical esophageal cancer have a comparatively high risk of also developing thoracic esophageal cancer. Pharyngolaryngectomy with total esophagectomy is highly invasive, and few reports about it exist. We examined the postoperative complications and respective countermeasures and prognoses of patients who underwent pharyngolaryngectomy with total esophagectomy.

Study Design: Case series with chart review.

Setting: Department of Head and Neck Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Japan.

Subjects And Methods: We examined the postoperative complications and respective countermeasures and prognoses of 40 patients who underwent pharyngolaryngectomy with total esophagectomy in our hospital.

Results: Postoperative complications were observed in 23 patients (57.5%) and consisted of 8 groups: tracheal region necrosis in 5 patients; neck abscess formation/wound infection in 5; fistula in 4; tracheostomy suture leakage in 2; ileus in 2; lymphorrhea in 2; pulmonary complications in 2; and other complications, including hemothorax, tracheoinnominate artery fistula, temporary cardiac arrest due to intraoperative mediastinum operation, methicillin-resistant Staphylococcus aureus enteritis, and sepsis, in 1 patient each. A lethal complication-brachiocephalic vein hemorrhage due to tracheostomy suture leakage and hemorrhagic shock due to tracheoinnominate artery fistula-occurred in 2 (5%) patients. The crude 5-year survival rate was 48.6%.

Conclusions: Serious postoperative complications were related to tracheostomaplasty. Although pharyngolaryngectomy with total esophagectomy is highly invasive, we believe that our outlined treatment method is the most appropriate for cases of advanced hypopharyngeal or cervical esophageal cancer that also requires concurrent surgery for esophageal cancer.
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http://dx.doi.org/10.1177/0194599815591965DOI Listing
September 2015

Recurrence pattern after conservative surgery for papillary thyroid carcinoma.

Auris Nasus Larynx 2014 Dec 26;41(6):548-51. Epub 2014 Jun 26.

Department of Otolaryngology, Head and Neck Surgery, Takeda General Hospital, Japan.

Objective: Risk-based treatment represents the optimal management strategy for papillary thyroid carcinoma; however, the optimal extent of thyroidectomy and neck dissection remains controversial. This study aims to clarify the pattern of recurrence after conservative surgery in patients with papillary thyroid carcinoma.

Methods: We retrospectively reviewed 93 patients with papillary thyroid carcinoma treated with conservative surgery. We analyzed recurrence rate, recurrence pattern, risk factors for recurrence, salvage treatment, and disease-free survival (DFS) in patients stratified according to risk.

Results: The recurrence rate was significantly lower in the low-risk group compared with the high-risk group (14% vs 34%; p<0.01). The recurrence pattern also differed between the two groups, with ipsilateral lateral neck recurrence being more common in the low-risk group (9%), while contralateral lateral neck recurrence was more common in the high-risk group (18%). Patients with contralateral thyroid lobe metastasis and/or direct contralateral thyroid lobe invasion showed a significantly higher rate of contralateral lateral neck metastasis than patients negative for both these features. The overall 5-year DFS was 81% in all patients. Advanced T and N classification, large primary tumor (≥4cm), extrathyroidal invasion, and high-risk group were significantly associated with poorer 5-year DFS in univariate analysis.

Conclusion: Conservative surgery may represent a good treatment option for patients with low-risk papillary thyroid carcinoma. Tumor recurrence patterns differ between risk groups, with contralateral thyroid lobe lesions and direct contralateral lobe invasion being risk factors for contralateral lateral neck recurrence.
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http://dx.doi.org/10.1016/j.anl.2014.05.012DOI Listing
December 2014

Occult functioning vagal paraganglioma in the infrahyoid carotid sheath.

Auris Nasus Larynx 2013 Jun 23;40(3):330-3. Epub 2012 May 23.

Division of Head and Neck, Cancer Institute Hospital, Tokyo, Japan.

Paragangliomas are highly vascular tumors that arise from chief cells in extra-adrenal paraganglia of the autonomic nervous system. Vagal paragangliomas occur along the vagal nerve, usually located in the rostral portion of the vagus nerve in the vicinity of the gangliom nodosum. Actively functional vagal paragangliomas are rare. We report a patient with functioning vagal paraganglioma located in the infrahyoid carotid sheath. The patient had no history of hypertension and catecholamines were not measured before surgery. The findings of diagnostic imaging workup, including computed tomography, ultrasonography and magnetic resonance, were suggestive of paraganglioma. The blood pressure and pulse rates increased sharply intraoperatively during tumor manipulation, together with spikes in noradrenaline and dopamine. The tumor was removed with successful preservation of the vagus nerve trunk. The blood catecholamine levels returned to normal immediately after surgery. Head and neck surgeons should be aware of occult functioning paragangliomas and patients with such tumors should undergo full hormonal assessment.
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http://dx.doi.org/10.1016/j.anl.2012.05.007DOI Listing
June 2013
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