Publications by authors named "Kiyoaki Tsukahara"

105 Publications

Neck Dissections Based on Sentinel Lymph Node Navigation Versus Elective Neck Dissections in Early Oral Cancers: A Randomized, Multicenter, and Noninferiority Trial.

J Clin Oncol 2021 Apr 20:JCO2003637. Epub 2021 Apr 20.

National Cancer Center Hospital, Tokyo, Japan.

Purpose: This study aimed to compare patients with early oral cavity squamous cell carcinoma (OCSCC) (tumor category [T] 1-2, node-negative, and no distant metastasis) treated with traditional elective neck dissection (ND) with those managed by sentinel lymph node biopsy (SLNB) using survival and neck function and complications as end points.

Methods: Sixteen institutions in Japan participated in the study (trial registration number: UMIN000006510). Patients of age ≥ 18 years with histologically confirmed, previously untreated OCSCC (Union for International Cancer Control TNM Classification of Malignant Tumors 7th edition T1-2, node-negative no distant metastasis), with ≥ 4 mm (T1) depth of invasion, were randomly assigned to undergo standard selective ND (ND group; n = 137) or SLNB-navigated ND (SLNB group; n = 134). The primary end point was the 3-year overall survival rate, with a 12% noninferiority margin; secondary end points included postoperative neck functionality and complications and 3-year disease-free survival. Sentinel lymph nodes underwent intraoperative multislice frozen section analyses for the diagnosis. Patients with positive sentinel lymph nodes underwent either one-stage or second-look ND.

Results: Pathologic metastasis-positive nodes were observed in 24.8% (34 of 137) and 33.6% (46 of 134) of patients in the ND and SLNB groups, respectively ( = .190). The 3-year overall survival in the SLNB group (87.9%; lower limit of one-sided 95% CI, 82.4) was noninferior to that in the ND group (86.6%; lower limit 95% CI, 80.9; for noninferiority < .001). The 3-year disease-free survival rate was 78.7% (lower limit 95% CI, 72.1) and 81.3% (75.0) in the SLNB and ND groups, respectively ( for noninferiority < .001). The scores of neck functionality in the SLNB group were significantly better than those in the ND group.

Conclusion: SLNB-navigated ND may replace elective ND without a survival disadvantage and reduce postoperative neck disability in patients with early-stage OCSCC.
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http://dx.doi.org/10.1200/JCO.20.03637DOI Listing
April 2021

Effectiveness of nivolumab affected by prior cetuximab use and neck dissection in Japanese patients with recurrent or metastatic head and neck cancer: results from a retrospective observational study in a real-world setting.

Int J Clin Oncol 2021 Jun 8;26(6):1049-1056. Epub 2021 Apr 8.

Department of Otolaryngology, Head and Neck Surgery, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Kita15 Nishi7, Kita-Ku, Sapporo, Hokkaido, 060-8638, Japan.

Background: To examine the effect of prior use of cetuximab and neck dissection on the effectiveness of nivolumab, we conducted a large-scale subgroup analysis in Japanese patients with recurrent/metastatic head and neck cancer.

Methods: Data on the effectiveness of nivolumab were extracted from patient medical records. All patients were analyzed for effectiveness by prior cetuximab use. In the analyses for prior neck dissection, only patients with locally advanced disease were included.

Results: Of 256 patients analyzed, 155 had received prior cetuximab. Nineteen of 50 patients with local recurrence underwent neck dissection. The objective response rate was 14.7 vs 17.2% (p = 0.6116), median progression-free survival was 2.0 vs 3.1 months (p = 0.0261), and median overall survival was 8.4 vs 12 months (p = 0.0548) with vs without prior cetuximab use, respectively. The objective response rate was 23.1 vs 25.9% (p = 0.8455), median progression-free survival was 1.8 vs 3.0 months (p = 0.6650), and median overall survival was 9.1 vs 9.9 months (p = 0.5289) with vs without neck dissection, respectively.

Conclusions: These findings support the use of nivolumab for patients with recurrent/metastatic head and neck cancer regardless of prior cetuximab use or neck dissection history.

Trial Registration Number: UMIN-CTR (UMIN000032600), Clinicaltrials.gov (NCT03569436).
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http://dx.doi.org/10.1007/s10147-021-01900-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8134300PMC
June 2021

Pericardial metastasis of parotid mucoepidermoid carcinoma diagnosed by pericardial biopsy.

Auris Nasus Larynx 2021 Mar 6. Epub 2021 Mar 6.

Department of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University, 6-7-1, Shinjuku-ku, Tokyo, Nishishinjuku 160-0023, Japan.

A 30-year-old man presented with swelling in the lower left ear. Close examination led to a diagnosis of parotid gland cancer, T4N0M0 Stage IVA, so total resection of the left parotid gland and left neck dissection were performed. Pathological examination led to a diagnosis of high-grade malignant-type mucoepidermoid, and chemoradiotherapy was performed as postoperative treatment. Fourteen days after completion of chemoradiotherapy, the patient was admitted to the hospital with headache and lack of appetite. Echocardiography showed a pericardial effusion and complete collapse of the right ventricle; cardiac tamponade was diagnosed, and pericardiocentesis was performed. The pericardial effusion was bloody, and a metastatic lesion was suspected, but cytological examination showed class IIIa. On day 33 of the illness, respiratory distress and hypotension were observed. A clot was seen covering the lower wall of the heart, and dilatation of the lower wall was significantly impaired. Pericardiotomy was performed on day 36. Pathological examination diagnosed cardiac metastasis of mucoepidermoid carcinoma of the parotid gland. Although only 4 cases of parotid cancer have been reported as primary lesions of metastatic heart tumors, this case represents the world's first description of isolated parenchymal metastasis of mucoepidermoid carcinoma of the parotid gland diagnosed by pericardial biopsy.
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http://dx.doi.org/10.1016/j.anl.2021.02.016DOI Listing
March 2021

Refractory pharyngeal ulceration due to cytomegalovirus in a patient with HIV infection: a case report and literature review.

BMC Infect Dis 2021 Mar 10;21(1):252. Epub 2021 Mar 10.

Department of Infectious Disease, Tokyo Medical University Hospital, 6-7-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan.

Background: Cytomegalovirus (CMV) is an important pathogen among immunocompromised hosts. Typically, CMV in human immunodeficiency virus (HIV) infection causes diseases of the retina, digestive tract, lungs and liver, but there are few cases of CMV infection of the pharynx and larynx.

Case Presentation: A 57-year-old man with HIV infection was admitted because of pharyngeal pain. Before and after admission, pharyngeal biopsies guided by laryngeal endoscopy were performed four times, but pathological examination showed nonspecific inflammation, and the cause of pharyngeal ulceration was unclear. Additionally, the ulceration deteriorated after initiation of retroviral therapy. Laryngomicrosurgery was conducted under general anesthesia to remove tissue, and pathological diagnosis confirmed CMV infection. Pathological features included enlargement of the cytoplasm and nucleus in infected cells, and intranuclear bodies called owl's eye inclusions. Ganciclovir dramatically improved the symptoms and laryngoscopic findings.

Conclusions: This case was diagnosed as pharyngitis and pharyngeal ulceration caused by CMV infection, related to immune reconstitution inflammatory syndrome. In previous reports of CMV-induced pharyngeal or laryngeal ulceration in HIV infection, we found six cases similar to our present case. All cases were diagnosed by biopsy. The present case indicates the importance of biopsy for definitive diagnosis. CMV infection should be considered as a differential diagnosis of pharyngeal ulceration in patients with HIV infection.
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http://dx.doi.org/10.1186/s12879-021-05943-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7944882PMC
March 2021

Treatment outcomes of transoral robotic and non-robotic surgeries to treat oropharyngeal, hypopharyngeal, and supraglottic squamous cell carcinoma: A multi-center retrospective observational study in Japan.

Auris Nasus Larynx 2021 Jun 22;48(3):502-510. Epub 2021 Feb 22.

Department of Otorhinolaryngology-Head and Neck Surgery, Yokohama City University, School of Medicine, Yokohama, Japan.

Objectives: The aim of this multicenter retrospective cohort study was to compare efficacy and subsequent postoperative treatment between transoral robotic surgery (TORS) and any non-robotic transoral surgery in Japanese patients with early oropharyngeal squamous cell carcinoma (OPSCC), hypopharyngeal SCC (HPSCC), or supraglottic SCC (SGSCC).

Materials And Methods: Clinical information and surgical outcomes were compared between patients with early-stage OPSCC, HPSCC, and SGSCC who underwent TORS (TORS cohort) and those who underwent non-robotic transoral surgery, including transoral videolaryngoscopic surgery (TOVS), endoscopic laryngopharyngeal surgery (ELPS), and transoral laser microsurgery (TLM) (non-robotic cohort). The data of the Head and Neck Cancer Registry of Japan (registry cohort) were used to validate the comparison. The main outcomes were the presence of positive margins under pathology and the requirement for postoperative therapy, including radiotherapy or chemoradiotherapy.

Results: Sixty-eight patients in the TORS cohort, 236 patients in the non-robotic cohort, and 1,228 patients in the registry cohort were eligible for this study. Patients in the TORS cohort were more likely to have oropharyngeal tumor disease and T2/3 disease than those in the other cohorts (P<0.001 and P=0.052, respectively). The TORS cohort had significantly fewer patients with positive surgical margins than the non-robotic cohort (P=0.018), as well as fewer patients who underwent postoperative treatment, although the difference was not significant (P=0.069). In the subgroup analysis of patients with OPSCC, a total of 57 patients in the TORS cohort, 73 in the non-robotic cohort, and 171 in the registry cohort were eligible for the present study. Patients with OPSCC who underwent TORS were more likely to have lateral wall lesions than those in the other cohorts (P=0.003). The TORS cohort also had significantly fewer patients with positive surgical margins than the non-robotic cohort (P=0.026), and no patients in the TORS cohort underwent any postoperative treatment for OPSCC, although the difference was not significant (P=0.177).

Conclusions: Our results suggest that TORS leads to fewer positive surgical margins than non-robotic transoral surgeries. The clinical significance of TORS may be further validated through the results of all-case surveillance for patients who underwent TORS running in Japan in the future.
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http://dx.doi.org/10.1016/j.anl.2021.01.024DOI Listing
June 2021

Efficacy and Safety of Paclitaxel Combined With Cetuximab for Head and Neck Squamous Cell Carcinoma.

In Vivo 2021 Mar-Apr;35(2):1253-1259

Department of Otorhinolaryngology and Head and Neck Surgery, Tokyo Medical University, Tokyo, Japan.

Background/aim: For recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN), popular regimens containing platinum-based anticancer agents and immune checkpoint inhibitors are impractical for platinum-intolerant patients. Herein, the efficacy and safety of paclitaxel and cetuximab combination therapy in R/M SCCHN were evaluated.

Patients And Methods: In this retrospective study, paclitaxel (80 mg/m) and cetuximab (400 mg/m loading dose followed by 250 mg/m weekly) were administered in 28-day cycles on days 1, 8, and 15.

Results: Thirty-eight patients were treated. The overall response and disease control rates of first-line therapy were 43% and 79%, respectively, while those of second-line and later therapies were 20% and 90%, respectively. The median progression-free and overall survival were 5.3 and 12.5 months, respectively. All adverse events were manageable, including grade 3/4 neutropenia and anaemia affecting 8-13% of patients.

Conclusion: Paclitaxel and cetuximab combination therapy may be suitable for treating R/M SCCHN.
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http://dx.doi.org/10.21873/invivo.12376DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8045122PMC
January 2021

Nivolumab for recurrent/metastatic hypopharyngeal squamous cell carcinoma in a liver transplant recipient.

Auris Nasus Larynx 2021 Feb 18. Epub 2021 Feb 18.

Department of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023, Japan.

Nivolumab administration to patients with organ transplantation history requires careful management. Herein, we report the case of a living-donor liver-transplant recipient, a 52-year-old man, with recurrent and metastatic hypopharyngeal cancer treated with nivolumab. He was diagnosed with T2N2bM0 stage IVA hypopharyngeal squamous cell carcinoma. While using oral immunosuppressants (cyclosporine and mycophenolate mofetil), the patient underwent right neck dissection followed by radiotherapy as an initial treatment. Three months after radiotherapy, positron emission tomography scans revealed multiple bone metastases. We administered two courses of the EXTREME regimen, comprising cisplatin, 5-fluorouracil, and cetuximab, as the first-line treatment for distal metastasis, but the patient presented with progressive disease. The patient was administered nivolumab as the second-line treatment. The programmed death-ligand 1 (PD-L1) expression level in a biopsy specimen of the primary hypopharyngeal tumor and resected specimen of the cervical lymph node metastasis was 40% and 10%, respectively. PD-L1 expression was not detected in hepatocytes of the liver biopsy sample obtained before nivolumab introduction. The patient received four courses of nivolumab 240 mg. Although liver dysfunction was alleviated by adjusting the dose of the hepatoprotective agent and cyclosporine, the progressive disease status persisted after completing nivolumab courses. The patient died of hypopharyngeal cancer progression.
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http://dx.doi.org/10.1016/j.anl.2021.02.002DOI Listing
February 2021

Cochlear implantation in a patient with a mutation.

Clin Case Rep 2021 Jan 11;9(1):298-303. Epub 2020 Nov 11.

Department of Otolaryngology, Head and Neck Surgery Tokyo Medical University Shinjuku-ku Japan.

Cochlear implants (CIs) are generally considered useful in the treatment of hereditary hearing loss with progressive deafness. Early CI can be beneficial for maintaining social activities in mutation patients.
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http://dx.doi.org/10.1002/ccr3.3520DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7813023PMC
January 2021

The Diagnostic Utility of RAS Q61R Mutation-specific Immunohistochemistry in Epithelial-Myoepithelial Carcinoma.

Am J Surg Pathol 2021 Jul;45(7):885-894

Departments of Anatomic Pathology.

Epithelial-myoepithelial carcinoma (EMC) is a rare salivary gland cancer characterized by biphasic tubular structures composed of inner ductal and outer clear myoepithelial cells. Because of its histologic variety and overlap of histologic features with other salivary gland tumors, there are broad differential diagnoses. The HRAS Q61R mutation has been reported to be frequent in and specific to EMC. We evaluated the usefulness of RAS Q61R mutant-specific immunohistochemical (IHC) staining for detecting this genetic alteration in EMC. We investigated 83 EMC cases and 66 cases of salivary gland tumors with an EMC-like component, including pleomorphic adenoma, adenoid cystic carcinoma, basal cell adenoma/adenocarcinoma, and myoepithelial carcinoma. Sanger sequencing was performed for HRAS, KRAS, and NRAS. The diffuse and membranous/cytoplasmic RAS Q61R IHC expression was observed in 65% of EMC cases, in which all cases harbored the HRAS Q61R mutation. IHC-positive cases were present only in de novo EMCs (54/76 cases, 71%) but not in EMCs ex pleomorphic adenoma. The immunoreactivity was almost always restricted to the myoepithelial cells. Conversely, all EMC cases lacking the HRAS Q61R mutation were negative on IHC. In addition, only 3% of EMC-like tumors showed the abovementioned immunopositivity. None of the cases examined carried KRAS or NRAS mutations. IHC for RAS Q61R is highly sensitive and specific for detecting the HRAS Q61R mutation in EMC. Since significant immunopositivity was almost exclusively identified in nearly two thirds of EMCs but seldom in the histologic mimics, the IHC of RAS Q61R is a useful tool for diagnosing EMC in general pathology laboratories.
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http://dx.doi.org/10.1097/PAS.0000000000001673DOI Listing
July 2021

Predicting the efficacy of chemoradiotherapy for locally advanced human papilloma virus-related oropharyngeal squamous cell carcinoma using one course of TPF chemotherapy.

Eur Arch Otorhinolaryngol 2021 Jan 2. Epub 2021 Jan 2.

Department of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University Hachioji Medical Center, 1163 Tatemachi, Hachioji-shi, Tokyo, 193-0998, Japan.

Purpose: The standard induction chemotherapy for head and neck cancer is TPF [cisplatin (CDDP), docetaxel (DOC), and 5-fluorouracil (5-FU)]. We assessed whether one course of TPF could predict the efficacy of chemoradiotherapy for human papilloma virus (HPV)-related oropharyngeal squamous cell carcinoma.

Methods: We retrospectively reviewed 51 patients with stage III-IV HPV-related oropharyngeal squamous cell carcinoma who received one course of TPF with CDDP 60 mg/m, DOC 60 mg/m, and 5-FU 600 mg/m. We recommended chemoradiotherapy for patients with complete or partial response (CR/PR), and surgery for those with stable or progressive disease (SD/PD). The endpoints were TPF-related adverse events and efficacy, chemoradiotherapy efficacy, and 2-year survival.

Results: Neutropenia was the most common grade ≥ 3 adverse event (88%). No grade 5 adverse events occurred. TPF achieved CR in 4% of patients (2/51), PR in 73% (37/51), SD in 20% (10/51), and PD in 4% (2/51). Concurrent cetuximab and radiotherapy (bio-radiotherapy, BRT) were administered to 61% of patients (31/51), concurrent CDDP and radiotherapy (CDDP-RT) to 16% (8/51), RT alone to 2% (1/51), and surgery was performed for 22% (11/51). CR was achieved in 85% of the chemoradiotherapy group, and the rate tended to increase with TPF efficacy. CR was achieved in 84% (26/31) of patients receiving BRT, 88% (7/8) receiving CDDP-RT, and 100% (1/1) receiving RT. The 2-year survival rates were 92% overall, and 97% and 79% in the chemoradiotherapy and surgery groups, respectively.

Conclusions: When facing difficulty in deciding between chemoradiotherapy and surgery, one course of TPF may be an effective option.
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http://dx.doi.org/10.1007/s00405-020-06549-9DOI Listing
January 2021

Pathological evaluation of tumor grade for salivary adenoid cystic carcinoma: A proposal of an objective grading system.

Cancer Sci 2021 Mar 2;112(3):1184-1195. Epub 2021 Feb 2.

Department of Pathology and Molecular Diagnostics, Graduate School of Medical Sciences, Nagoya City University, Nagoya, Japan.

Three pathological grading systems advocated by Perzin/Szanto, Spiro, and van Weert are currently used for adenoid cystic carcinoma (AdCC). In these systems, the amount or presence of the solid tumor component in AdCC specimens is an important index. However, the "solid tumor component" has not been well defined. Salivary AdCC cases (N = 195) were collected after a central pathology review. We introduced a novel criterion for solid tumor component, minAmax (minor axis maximum). The largest solid tumor nest in each AdCC case was histologically screened, the maximum oval fitting the solid nest was estimated, and the length of the minor axis of the oval (minAmax) was measured. The prognostic cutoff for the minAmax was determined using training and validation cohorts. All cases were evaluated for the four grading systems, and their prognostic impact and interobserver variability were examined. The cutoff value for the minAmax was set at 0.20 mm. Multivariate prognostic analyses showed the minAmax and van Weert systems to be independent prognostic tools for overall, disease-free, and distant metastasis-free survival while the Perzin/Szanto and Spiro systems were selected for overall survival but not for disease-free or distant metastasis-free survival. The highest hazard ratio for overall survival (11.9) was obtained with the minAmax system. The reproducibility of the minAmax system (kappa coefficient of 0.81) was scored as very good while those of the other three systems were scored as moderate. In conclusion, the minAmax is a simple, objective, and highly reproducible grading system useful for prognostic stratification for salivary AdCC.
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http://dx.doi.org/10.1111/cas.14790DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7935776PMC
March 2021

Attempting to define sentinel node micrometastasis in oral squamous cell carcinoma.

Fukushima J Med Sci 2020 Dec 2;66(3):143-147. Epub 2020 Dec 2.

Department of Head and Neck Surgery and Otolaryngology, Asahi University Hospital.

Objective: The aim of this supplemental study of a sentinel node (SN) biopsy (SNB) trial for oral squamous cell carcinoma (OSCC) was to assess the effectiveness in identifying micrometastasis and determining whether elective neck dissection (END) is necessary.

Materials And Methods: Twenty-three patients with pathologically positive SNs were included. The sizes of the metastatic lesions in positive SNs (SMSNs) were classified and the rates of occult metastasis of non-SNs were compared.

Results: The patients were divided according to the SMSN:<0.2 mm (group A, n=3);0.2 mm to <2.0 mm (group B, n=7);and ≥2.0 mm (group C, n=13). The rates of occult metastasis in groups A, B, and C were 0% (0/3), 14% (1/7) and 23% (3/13), respectively.

Conclusion: Rare cancer cell distribution to nodes other than SNs was observed in the patients with SN metastatic lesions of at least smaller than 0.2 mm in size, suggesting the possibility of defining SN micrometastasis in N0 OSCC.
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http://dx.doi.org/10.5387/fms.2020-17DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7790463PMC
December 2020

Effectiveness and safety of nivolumab in patients with head and neck cancer in Japanese real-world clinical practice: a multicenter retrospective clinical study.

Int J Clin Oncol 2021 Mar 21;26(3):494-506. Epub 2020 Nov 21.

Department of Otolaryngology, Head and Neck Surgery, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Kita15 Nishi7, Kita-Ku, Sapporo, Hokkaido, 060-8638, Japan.

Background: To fill the data gap between clinical trials and real-world settings, this study assessed the overall effectiveness and safety of nivolumab in patients with head and neck cancer (HNC) during Japanese real-world clinical practice.

Methods: This was a multicenter, retrospective study in Japanese patients with recurrent or metastatic HNC who received nivolumab for the first time between July and December 2017. Data on the clinical use, effectiveness, and safety of nivolumab were extracted from patient medical records.

Results: Overall, 256 patients were enrolled in this study. The median duration of nivolumab treatment was 72.5 days, with patients receiving a median of 6.0 (range 1-27) doses. Median overall survival (OS) was 9.5 (95% confidence interval [CI] 8.2-12.0) months and the estimated 12-month OS rate was 43.2%. The objective response rate (ORR) was 15.7% overall and 21.1%, 7.1%, and 13.6% in patients with primary nasopharynx, maxillary sinus, and salivary gland tumors, respectively, who had been excluded from CheckMate 141. Grade ≥ 3 immune-related adverse events occurred in 5.9% of patients. No new safety signals were identified compared with adverse events noted in CheckMate 141.

Conclusions: The effectiveness and safety of nivolumab in real-world clinical practice are consistent with data from the CheckMate 141 clinical trial. Therapeutic response was also observed in the groups of patients excluded from CheckMate 141.

Trial Registration Number: UMIN-CTR (UMIN000032600), Clinicaltrials.gov (NCT03569436).
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http://dx.doi.org/10.1007/s10147-020-01829-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7895797PMC
March 2021

Real-World, Long-Term Outcomes of Nivolumab Therapy for Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck and Impact of the Magnitude of Best Overall Response: A Retrospective Multicenter Study of 88 Patients.

Cancers (Basel) 2020 Nov 18;12(11). Epub 2020 Nov 18.

Department of Otorhinolaryngology, Head and Neck Surgery, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0374, Japan.

No real-world, long-term outcomes of immunotherapy with nivolumab for recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) have yet been reported. Furthermore, the prognostic impact of the best overall response (BOR) of this therapy remains unclear. We conducted a multi-institutional cohort study of the long-term efficacy and safety of this therapy and investigated prognostic factors associated with survival. Further, we evaluated the relationship between BOR and survival. Median follow-up time was 25.9 months. Median overall survival (OS) was 9.6 months, and two-year survival rate was 25.0%. Median progression-free survival (PFS) was 3.7 months, and two-year PFS rate was 19.6%. BOR was assessed as complete response (CR) in 6%, partial response (PR) in 13%, stable disease (SD) in 30%, and progressive disease (PD) in 52% of the patients. Overall response rate was 18%, and disease control rate was 48%. For immune-related adverse events (irAEs), 38 irAEs were detected in 29 patients. On multivariate analysis, the development of irAEs was significantly associated with better OS and PFS. Better BOR was significantly associated with longer OS and PFS. These findings demonstrate the long-term efficacy and safety of nivolumab therapy for R/M SCCHN in a real-world setting. The magnitude of BOR and the development of irAEs might be useful surrogate markers of survival.
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http://dx.doi.org/10.3390/cancers12113427DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7699139PMC
November 2020

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

Macrolide antibiotics enhance the antitumor effect of lansoprazole resulting in lysosomal membrane permeabilization‑associated cell death.

Int J Oncol 2020 Dec 21;57(6):1280-1292. Epub 2020 Oct 21.

Department of Biochemistry, Tokyo Medical University, Tokyo 160‑8402, Japan.

The proton pump inhibitor lansoprazole (LPZ) inhibits the growth of several cancer cell lines, including A549 and CAL 27. We previously reported that macrolide antibiotics such as azithromycin (AZM) and clarithromycin (CAM) potently inhibit autophagic flux and that combining AZM or CAM with the epidermal growth factor receptor inhibitors enhanced their antitumor effect against various cancer cells. In the present study, we conducted the combination treatment with LPZ and macrolide antibiotics against A549 and CAL 27 cells and evaluated cytotoxicity and morphological changes using cell proliferation and viability assays, flow cytometric analysis, immunoblotting, and morphological assessment. Combination therapy with LPZ and AZM greatly enhanced LPZ‑induced cell death, whereas treatment with AZM alone exhibited negligible cytotoxicity. The observed cytotoxic effect was not mediated through apoptosis or necroptosis. Transmission electron microscopy of A549 cells treated with the LPZ + AZM combination revealed morphological changes associated with necrosis and accumulated autolysosomes with undigested contents. Furthermore, the A549 cell line with ATG5 knockout exhibited complete inhibition of autophagosome formation, which did not affect LPZ + AZM treatment‑induced cytotoxicity, thus excluding the involvement of autophagy‑dependent cell death in LPZ + AZM treatment‑induced cell death. A549 cells treated with LPZ + AZM combination therapy retained the endosomal Alexa‑dextran for extended duration as compared to untreated control cells, thus indicating impairment of lysosomal digestion. Notably, lysosomal galectin‑3 puncta expression induced due to lysosomal membrane permeabilization was increased in cells treated with LPZ + AZM combination as compared to the treatment by either agent alone. Collectively, the present results revealed AZM‑induced autolysosome accumulation, potentiated LPZ‑mediated necrosis, and lysosomal membrane permeabilization, thus suggesting the potential clinical application of LPZ + AZM combination therapy for cancer treatment.
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http://dx.doi.org/10.3892/ijo.2020.5138DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7646592PMC
December 2020

[A Rebleeding Case of Carotid Blowout Syndrome after Endovascular Treatment with Covered Stent].

No Shinkei Geka 2020 Oct;48(10):935-940

Department of Neurosurgery, Tokyo Medical University Hospital.

We present a case of a patient who survived carotid blowout syndrome(CBS)due to covered stent placement, but bled again 34 days later. A 67-year-old man with laryngeal cancer experienced cardiac arrest due to carotid blowout a day after he underwent the balloon occlusion test and abnormal feeder embolization of the tumor. After quick resuscitation, he was treated with endovascular therapy using a covered stent, since he had insufficient cerebral ischemic tolerance. We succeeded in stent placement and the bleeding stopped without any procedural complications. The patient survived after the procedure. However, bleeding recurred when a nasal endoscope was inserted 34 days later. The rupture point was immediately distal of the stent. We performed carotid artery occlusion with coils and n-butyl-cyanoacrylate. The patient survived, but his condition gradually weakened and died 97 days after stenting. Emergency hemostasis for carotid blowout using a covered stent is the only available treatment for patients who do not have sufficient cerebral ischemic tolerance. However, this procedure has a higher rate of re-bleeding than carotid artery occlusion. Moreover, it is an off-label treatment in Japan. Therefore, possible treatments for CBS including use of covered stent or treatments for non-ruptured CBS should be analyzed in the future.
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http://dx.doi.org/10.11477/mf.1436204299DOI Listing
October 2020

Co-treatment with endoscopic laryngopharyngeal surgery and endoscopic submucosal dissection.

Auris Nasus Larynx 2021 Jun 14;48(3):457-463. Epub 2020 Oct 14.

Department of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan.

Objective: Endoscopic laryngopharyngeal surgery (ELPS) is an effective and minimally invasive treatment for pharyngeal cancers. However, the disadvantages of ELPS are the interference of instruments in the operative field and the difficulty in approaching certain areas. To overcome these drawbacks, we began to perform combination treatment of ELPS and endoscopic submucosal dissection (ESD). The aim of the present study was to compare the efficacies of treatment with ELPS alone and ELPS combined with ESD.

Methods: A total of 103 lesions in 73 patients who underwent pharyngeal ELPS for superficial pharyngeal cancer between August 2014 and January 2020 at our hospital were analyzed. Lesions were divided into the ELPS alone group and ELPS combined with ESD group. Lesion characteristics, technical results, adverse events, and long-term outcomes were analyzed.

Results: In the ELPS combined with ESD group, procedure speed was shorter than the ELPS alone group (20.2 ± 10.0 mm/min vs 13.0 ± 6.6 mm/min, p < 0.001), and R0 resection rate was higher (67.4% vs 45.6%, p = 0.027). There were no significant differences in tumor size, depth of tumor invasion, and adverse events among the 2 groups. These results remained unchanged after propensity score matching. The overall and cause-specific survival rates at 3 years were 96.7% and 100% for the ELPS combined with ESD group and ELPS alone group, respectively.

Conclusions: Combination treatment of ESD and ELPS enabled more efficient resection than ELPS alone. Cooperative treatment of pharyngeal cancer patients involving gastroenterologists and head and neck surgeons is effective and beneficial, and results in favorable long-term outcomes.
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http://dx.doi.org/10.1016/j.anl.2020.10.003DOI Listing
June 2021

Multicentre, retrospective study of the efficacy and safety of nivolumab for recurrent and metastatic salivary gland carcinoma.

Sci Rep 2020 10 12;10(1):16988. Epub 2020 Oct 12.

Department of Head and Neck Oncology and Surgery, International University of Health and Welfare, Mita Hospital, Tokyo, 108-8329, Japan.

Although immune-checkpoint inhibitors (ICIs) are effective against various cancers, little is known regarding their role in salivary gland carcinoma (SGC) treatment. Therefore, we evaluated the efficacy and safety of nivolumab monotherapy in patients with recurrent and/or metastatic SGC. In this multicentre retrospective study, nivolumab (240 mg) was administered every 2 weeks. The overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety were examined; the correlation between treatment outcomes and clinicopathological factors was analysed. Twenty-four patients were enrolled; the most common histopathology was salivary duct carcinoma. Eleven tumours were PD-L1-positive; no tumour was microsatellite instability-high. The ORR was 4.2%, and the median PFS and OS were 1.6 and 10.7 months, respectively. One patient continued nivolumab for 28 months without disease progression. One patient showed grade 4 increase in creatine phosphokinase levels and grade 3 myositis. Biomarker analysis revealed significantly increased OS in patients with performance status of 0; modified Glasgow prognostic score of 0; low neutrophil-to-lymphocyte ratio, lactate dehydrogenase, and C-reactive protein; and high lymphocyte-to-monocyte ratio and in patients who received systemic therapy following nivolumab. Although nivolumab's efficacy against SGC was limited, some patients achieved long-term disease control. Further studies are warranted on ICI use for SGC.
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http://dx.doi.org/10.1038/s41598-020-73965-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7552420PMC
October 2020

Second postoperative hemorrhage five weeks after transoral robotic surgery.

Auris Nasus Larynx 2020 Sep 16. Epub 2020 Sep 16.

Department of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University, 6-7-1 Nishishinjyuku, Shinjyuku-ku, Tokyo, Japan.

Transoral robotic surgery (TORS) is becoming widely used in Japan, and information on postoperative hemorrhage is needed. We treated a patient who developed a second massive postoperative hemorrhage on Day 35 post-TORS. The 69-year-old man was diagnosed with p16-positive, T1N1M0 stage I cancer of the anterior wall of the oropharynx. Curative treatment began with right neck dissection. The external carotid artery and its branches were not ligated. One month after right neck dissection, TORS was conducted. On Day 23 post-TORS, the patient was brought to the emergency room due to pharyngeal bleeding. Hemorrhage was stopped by reclosing the site with Z-shaped silk sutures. Severe hemorrhage recurred on Day 35 post-TORS. The patient went into hemorrhagic shock. Tracheostomy was immediately performed. The neck dissection wound was then opened and the external carotid artery clamped. Hemostasis was confirmed transorally, but the hemorrhage site was again sutured with Z-shaped silk sutures to stop the bleeding. The patient was discharged on Day 58 post-TORS. Even in hindsight, this hemorrhage would have been difficult to prevent with better local treatment. This means that using transcervical arterial ligation together with TORS is appropriate from the perspective of making every effort to prevent potentially fatal postoperative hemorrhage.
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http://dx.doi.org/10.1016/j.anl.2020.09.002DOI Listing
September 2020

Minocycline-induced black thyroid with black pigmentation of the thyroid cartilage, cricoid cartilage, and trachea found during reconstructive surgery for hypopharyngeal cancer.

Auris Nasus Larynx 2020 Sep 7. Epub 2020 Sep 7.

Department of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023, Japan.

Black thyroid is characterized by a rare pigment change observed almost exclusively in patients taking minocycline. We present the case of a 72-year-old man diagnosed with T3N3bM0 stage IVB hypopharyngeal squamous cell carcinoma who had been taking minocycline for approximately 18 months as a treatment for prurigo chronica multiformis. Initial treatment consisted of total pharyngolaryngoesophagectomy, bilateral neck dissection, total thyroidectomy, pharyngeal reconstruction using a free jejunal autograft, and creation of a permanent tracheostoma. During surgery, black discoloration of the thyroid and trachea was observed. Postoperative histological findings confirmed the black discoloration, with deposits of dark-brown, melanin-like granules observed in the thyroid, trachea, thyroid cartilage, and cricoid cartilage. Therefore, the black discoloration of the thyroid associated with the use of minocycline can extend to the thyroid cartilage, cricoid cartilage, and trachea. This information is important for surgeons to recognize in order to prevent unnecessary resection due to misdiagnosis.
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http://dx.doi.org/10.1016/j.anl.2020.08.028DOI Listing
September 2020

Salvage Chemotherapy After Nivolumab for Recurrent or Metastatic Head and Neck Carcinoma.

Anticancer Res 2020 Sep;40(9):5277-5283

Department of Head and Neck Oncology and Surgery, International University of Health and Welfare Mita Hospital, Tokyo, Japan.

Background/aim: The treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) has remained challenging. The effect of salvage chemotherapy (SCT) after nivolumab has been identified recently in other cancer types. The aim of this study was to examine the efficacy of SCT after nivolumab treatment in patients with R/M HNSCC.

Patients And Methods: A retrospective study was conducted at four institutions in Japan. Fifty-six patients were enrolled in the study.

Results: The overall survival (OS) in SCT patients was significantly longer than that in best supportive care (BSC) patients. In the SCT patients, the median OS, median progression-free survival (PFS) and objective response rate (ORR) were 7.3 months, 2.3 months and 36%, respectively. Prognostic factor for OS and ORR was performance score (PS) and previous radiation, respectively.

Conclusion: SCT after nivolumab is associated with better clinical outcomes in patients with R/M HNSCC compared to those receiving BSC.
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http://dx.doi.org/10.21873/anticanres.14532DOI Listing
September 2020

Investigation of the Efficacy and Safety of Nivolumab in Recurrent and Metastatic Nasopharyngeal Carcinoma.

In Vivo 2020 Sep-Oct;34(5):2967-2972

Department of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University, Tokyo, Japan.

Background/aim: Nivolumab, an anti-PD-1 inhibitor, has demonstrated efficacy in patients with several types of recurrent and metastatic (R/M) squamous cell carcinoma of the head and neck. We evaluated patients with R/M-NPC receiving nivolumab.

Patients And Methods: Twelve patients with R/M-NPC were enrolled at 4 institutions. The primary endpoint was overall survival, and secondary endpoints were i) progression-free survival (PFS), ii) overall response rate (ORR), iii) disease control rate (DCR), and iv) treatment-related toxicity.

Results: The 1-year survival rate was 75.8%, the median PFS was 2.8 months, and the 1-year PFS rate was 33.3%. The best therapeutic response was complete response in 2, stable disease in 3 and progressive disease in 7 patients. The ORR of all patients was 16.7% and the DCR was 41.7%.

Conclusion: Nivolumab is a useful and relatively safe second-line systemic therapy in patients with R/M-NPC, and even patients who do not respond to nivolumab may survive for a long time.
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http://dx.doi.org/10.21873/invivo.12127DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7652473PMC
June 2020

Prediction of Therapeutic Effects from One Course of TPF Chemotherapy for Advanced Hypopharyngeal Laryngeal Cancer.

In Vivo 2020 Sep-Oct;34(5):2891-2896

Department of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University, Tokyo, Japan.

Background: In head and neck cancer, docetaxel, cisplatin and 5-fluorouracil (TPF) is often given in two or three cycles. The purpose of this study was to perform single-cycle TPF for chemoselection in patients with advanced hypopharyngeal laryngeal cancer.

Patients And Methods: The study included 56 patients with stage III/IV advanced hypopharyngeal/laryngeal squamous cell carcinoma. The primary endpoint was progression-free survival (PFS), and secondary endpoints were overall survival (OS), TPF response rate, laryngeal sparing, and grade 3 or more adverse events.

Results: The median PFS was 34.8 months. The median OS was not evaluable. The response rate was 71%. The median laryngeal preservation period was not estimable. Grade 3 or 4 adverse events were reported in 46 patients.

Conclusion: PFS rate in this study may have been improved by selecting surgical treatment for patients for whom chemoradiotherapy seemed less effective. One cycle of TPF in induction chemotherapy appeared effective for chemoselection.
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http://dx.doi.org/10.21873/invivo.12117DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7652482PMC
June 2020

Prognostic impact of CRTC1/3-MAML2 fusions in salivary gland mucoepidermoid carcinoma: A multiinstitutional retrospective study.

Cancer Sci 2020 Nov 14;111(11):4195-4204. Epub 2020 Sep 14.

Department of Pathology and Molecular Diagnostics, Graduate School of Medical Sciences, Nagoya City University, Nagoya, Japan.

Mucoepidermoid carcinoma (MEC) is rare, but the most common primary malignancy of the salivary gland and not infrequent in young individuals. CRTC1/3-MAML2 fusions are frequently detected in MEC and are useful as a diagnostic biomarker. However, there has been debate as to whether the fusions have prognostic significance. In this study, we retrospectively collected 153 salivary gland MEC cases from 11 tertiary hospitals in Japan. As inclusion criteria, the MEC patients in this study had curative surgery as the initial treatment, received no preoperative treatment, and had no distant metastasis at the time of the initial surgery. The MEC diagnosis was validated by a central pathology review by five expert salivary gland pathologists. The CRTC1/3-MAML2 fusions were detected using FISH and RT-PCR. In 153 MEC cases, 90 (58.8%) were positive for CRTC1/3-MAML2 fusions. During the follow-up period, 28 (18.3%) patients showed tumor recurrence and 12 (7.8%) patients died. The presence of the fusions was associated with favorable tumor features. Of note, none of the fusion-positive patients died during the follow-up period. Statistical analysis showed that the presence of the fusions was a prognostic indicator of a better overall survival in the total and advanced-stage MEC cohorts, but not in the early-stage MEC cohort. In conclusion, CRTC1/3-MAML2 fusions are an excellent biomarker for favorable overall survival of patients with salivary gland MEC.
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http://dx.doi.org/10.1111/cas.14632DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7648036PMC
November 2020

Long-term prognosis of preserved useful hearing after surgery in patients with vestibular schwannoma: a study of 91 cases.

Acta Neurochir (Wien) 2020 11 15;162(11):2619-2628. Epub 2020 Aug 15.

Department of Anesthesiology, Center Hospital of National Center for Global Health and Medicine, Tokyo, Japan.

Background: In patients with a vestibular schwannoma, some studies have reported that useful hearing preserved initially after surgery deteriorates gradually in the long term. Studies with more patients are needed to clarify the maintenance rate of postoperative hearing function and to identify prognostic of hearing function.

Method: Ninety-one patients (mean age, 39.5 years; mean tumor size, 18.9 mm) with preserved useful hearing immediately after surgery were retrospectively analyzed. The useful hearing was defined as the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) classes A and B. Hearing tests, including auditory brainstem responses (ABR) and distortion product otoacoustic emissions (DPOAE), were evaluated preoperatively, immediately after surgery, and at outpatient follow-up.

Results: At the final follow-up (mean, 63.0 months), the useful hearing was maintained in 79 patients (87%), and the hearing class remained unchanged during the follow-up period in 40 patients (44%). Significant predictors of useful hearing maintenance were AAO-HNS class A immediately after surgery, improvement of ABR, and the absence of postoperative DPOAE deterioration. Postoperative DPOAE deterioration correlated with hearing class deterioration.

Conclusions: Despite hearing being preserved in vestibular schwannoma patients immediately after surgery, Thirteen percent lost their useful hearing during the long follow-up period, and hearing class worsened in 55% of the patients. This study, which analyzed one of the largest series of vestibular schwannoma patients, demonstrated that retrocochlear condition is a key factor for useful hearing maintenance. In patients with vestibular schwannoma who have preserved hearing function, regular postoperative monitoring of hearing function is as important as regular MRI.
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http://dx.doi.org/10.1007/s00701-020-04523-2DOI Listing
November 2020

The impact of clinicopathological factors on clinical outcomes in patients with salivary gland adenoid cystic carcinoma: a multi-institutional analysis in Japan.

Int J Clin Oncol 2020 Oct 1;25(10):1774-1785. Epub 2020 Jul 1.

Department of Pathology and Molecular Diagnostics, Nagoya City University Graduate School of Medical Sciences, 1-Kawasumi, Mizuho-ku, Nagoya, 467-8601, Japan.

Background: Owing to the low incidence of adenoid cystic carcinoma (AdCC), reliable survival estimates and prognostic factors remained unclarified.

Methods: In this multi-institutional retrospective analysis, we collected 192 AdCC cases, and investigated the impact of clinicopathological factors on clinical outcomes of the patients. All AdCC cases were of salivary gland origin and were surgically treated with curative intent. Diagnoses of AdCC were validated by a central pathology review by expert pathologists.

Results: The 5-year overall survival (OS) and disease-free survival (DFS) rates were 92.5 and 50.0%, respectively. Treatment failure occurred in 89 patients (46%) with the distant failures in 65 (34%). Multivariate analysis indicated that pN2 and a pathologically positive surgical margin were independent prognostic factors for both OS and DFS. Histological grade III was an independent prognostic factor for OS. A primary site in the submandibular gland, pT3/4, pN1, and histological grade II were independent prognostic factors for DFS. Postoperative radiation therapy (PORT) improved the locoregional control (LRC) rate. Prophylactic neck dissection was not associated with a better OS or better LRC among patients with cN0. Facial nerve dissection did not improve clinical outcomes in parotid AdCC cases without facial nerve palsy.

Conclusions: A higher TN classification, a pathologically positive surgical margin, and a higher histological grade were associated with a lower OS. PORT improved LRC rates but neck dissection failed to improve clinical outcomes in patients with cN0. As the distant metastasis was frequent, effective systemic therapy is imperative to improve the survival of AdCC patients.
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http://dx.doi.org/10.1007/s10147-020-01731-9DOI Listing
October 2020

Age-based efficacy and safety of nivolumab for recurrent or metastatic head and neck squamous cell carcinoma: A multicenter retrospective study.

Asia Pac J Clin Oncol 2020 Dec 23;16(6):340-347. Epub 2020 Jun 23.

Department of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University, Tokyo, Japan.

Aim: This study retrospectively investigated the efficacy and safety of nivolumab for patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) classified using age <65 years as the cutoff.

Methods: Overall, 88 patients with R/M HNSCC treated with nivolumab were classified into the young group (<65 years; n = 39) and elderly group (≥65 years; n = 49). Efficacy was evaluated using overall survival (OS), progression-free survival (PFS), overall response rate (ORR) and disease control rate (DCR). Safety was evaluated considering immune-related adverse events (irAEs).

Results: The median OS was 9.7 and 8.6 months in the young and elderly groups, respectively. The 1-year OS rate was 42.0% and 29.4% in the young and elderly groups, respectively. The median PFS was 3.0 and 4.2 months in the young and elderly groups, respectively. The 1-year PFS rate was 30.0% and 27.9% in the young and elderly groups, respectively. In the young group, the ORR was 10.3% and DCR was 33.3%. In the elderly group, the ORR was 18.4% and DCR was 53.1%. There were no significant differences in OS, PFS, ORR, and DCR (P = 0.36, 0.53, 0.29 and 0.06, respectively). Interstitial lung disease (ILD) as an irAE occurred in the young group at a significantly higher rate (20.5% vs 4.1%; P = 0.02).

Conclusions: There were no significant differences in OS, PFS, ORR, and DCR between the young and elderly groups. DCR tended to be better in the elderly group (P = 0.06). ILD occurred at a significantly higher rate in the young group.
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http://dx.doi.org/10.1111/ajco.13374DOI Listing
December 2020

DUPLICATE: Overall survival and PD-L1 expression in patients with recurrent or metastatic head and neck cancer treated with nivolumab.

Auris Nasus Larynx 2020 Jun 4. Epub 2020 Jun 4.

Department of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University, Tokyo, Japan.

The Publisher regrets that this article is an accidental duplication of an article that has already been published, https://doi.org/10.1016/j.anl.2020.02.018. The duplicate article has therefore been withdrawn. The full Elsevier Policy on Article Withdrawal can be found at https://www.elsevier.com/about/our-business/policies/article-withdrawal.
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http://dx.doi.org/10.1016/j.anl.2020.02.018DOI Listing
June 2020