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BACKGROUND: Salivary duct carcinoma (SDC) is a high-grade adenocarcinoma with a 5-year survival rate of 40%. Although drug therapy has improved patients' prognosis, the impact of brain metastasis (BM) remains poorly understood. We aimed to retrospectively examine the incidence of BM in patients with SDC (n = 464) and develop a tool to estimate their prognoses. METHODS: We retrospectively examined 464 patients with SDC enrolled in a multicenter study. We investigated the incidence of BM, overall survival (OS) rates, and factors affecting prognosis in patients with BM. We also developed an SDC-graded prognostic assessment (GPA) score for disease prognostication. RESULTS: Sixty-five (14%) patients had BM. The median OS (mOS) was 13.1 months. On univariate and multivariate analyses, factors such as Eastern Cooperative Oncology Group Performance Status >1, human epidermal growth factor receptor 2-negative status, and locoregional uncontrolled disease were associated with poor OS. SDC-GPA scores according to the prognostic factors were 0, 1, 2, and 3 points, and mOS estimates were 50.5, 16.1, 3.9, and 1.2 months, respectively (p < 0.001). CONCLUSION: The SDC-GPA score emerged as a useful prognostication tool for patients with BM.
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Neoplasias Encefálicas , Carcinoma Ductal , Neoplasias das Glândulas Salivares , Humanos , Estudos Retrospectivos , Ductos Salivares/patologia , Prognóstico , Neoplasias das Glândulas Salivares/patologia , Carcinoma Ductal/patologia , Neoplasias Encefálicas/patologiaRESUMO
Salivary duct carcinoma (SDC) is an aggressive type of salivary gland carcinoma. Recently, immunotherapies targeting immune checkpoints, including PD1, PD-L1, CTLA4, and LAG3, have had a considerable prognostic impact on various malignant tumors. The implementation of such immune checkpoint inhibitor (ICI) therapies has also been attempted in cases of salivary gland carcinoma. The tumor immune microenvironment (TIME) is implicated in tumorigenesis and tumor progression and is closely associated with the response to ICI therapies. However, the TIME in SDC has not been fully explored. We examined the immunohistochemical expression of CD8, FOXP3, PD1, PD-L1, CTLA4, LAG3, and mismatch repair (MMR) proteins, tumor-infiltrating lymphocytes (TILs), and microsatellite instability (MSI) status in 175 cases of SDC. The associations between these TIME-related markers and the clinicopathological factors and prognosis were evaluated. An elevated expression of CD8, FOXP3, PD1, CTLA4, and LAG3 was associated with more aggressive histological features and an advanced N and/or M classification, elevated Ki-67 index, and poor prognosis. Furthermore, cases with a high PD-L1 expression exhibited more aggressive histological features and adverse clinical outcomes than those with a low expression. Alternatively, there was no significant correlation between TILs and clinicopathological factors. No SDC cases with an MSI-high status or MMR deficiency were found. The coexistence of both an immunostimulatory and immunosuppressive TIME in aggressive SDC might play a role in the presence of T-cell exhaustion. The contribution of multiple immune escape pathways, including regulatory T cells and immune checkpoints, may provide a rationale for ICI therapy, including combined PD1/CTLA4 blockade therapy.
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Carcinoma , Neoplasias das Glândulas Salivares , Humanos , Antígeno B7-H1/metabolismo , Antígeno CTLA-4 , Prognóstico , Ductos Salivares/metabolismo , Linfócitos do Interstício Tumoral , Neoplasias das Glândulas Salivares/patologia , Instabilidade de Microssatélites , Carcinoma/patologia , Fatores de Transcrição Forkhead/metabolismo , Microambiente TumoralRESUMO
There is no standardized technique for lip reconstruction because the structure and functions of the lip are diverse. We developed a new lip reconstructive approach using a bilateral oblique mucosal V-Y advancement flap. We present the case of a 76-year-old woman with severe dementia, referred to our institute for a tumor on her lower lip. She was diagnosed with lip squamous cell carcinoma (cT2N0M0). The tumor measured 25 × 20 mm. It was resected with a surgical safety margin of 6 mm. Bilateral triangular flaps were fashioned obliquely on the rear lateral side of the defect extending from the labial to the buccal mucosa and used to repair the defect. The operation time was 66 min. She was discharged on the fourth postoperative day without any complications. Speech and food intake functions have been preserved and she has been followed up for 26 months with no recurrence. The lip closing and color match has been adequate despite a slight thinning of the lip. This technique offered a major benefit of short operation and hospitalization time because it was a simple, less-invasive, one-step procedure. This is a practical procedure, suitable for vulnerable patients of advanced age or with comorbidities.
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Carcinoma de Células Escamosas , Neoplasias de Cabeça e Pescoço , Neoplasias Labiais , Procedimentos de Cirurgia Plástica , Humanos , Feminino , Idoso , Neoplasias Labiais/cirurgia , Retalhos Cirúrgicos , Carcinoma de Células Escamosas/cirurgia , Neoplasias de Cabeça e Pescoço/cirurgiaRESUMO
BACKGROUND/AIM: Pembrolizumab exhibits anticancer efficacy in platinum-sensitive or platinum-unfit patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). However, no large-scale retrospective real-world data are available. This retrospective study aimed to examine the efficacy and safety of pembrolizumab in multiple facilities. PATIENTS AND METHODS: Data of 167 patients with R/M SCCHN treated with pembrolizumab between December 2019 and February 2022 were analyzed. The endpoint was overall survival (OS), progression-free survival (PFS), and immune-related adverse events (irAEs). OS and PFS were analyzed comparatively with and without irAEs, and complete response (CR) or partial response (PR), and stable disease (SD) or progressive disease (PD) were compared. RESULTS: One hundred thirty-five patients received pembrolizumab alone, whereas the others received pembrolizumab with chemotherapy. For the pembrolizumab only group, the median OS and PFS were 22.7 and 5.1 months, respectively. There were significant differences in OS and PFS between CR or PR and SD or PD (p<0.01, p<0.01, respectively). For pembrolizumab with chemotherapy, the OS was not reached and median PFS was 7.0 months. There was a significant difference in PFS between CR or PR and SD or PD (p<0.01). There was a significant difference in PFS between patients with and without irAEs (p=0.02). CONCLUSION: The real-world therapeutic effect of pembrolizumab for R/M SCCHN was comparable to that observed in the KEYNOTE048 trial. In addition, irAEs and best overall response were considered as prognostic factors.
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Neoplasias de Cabeça e Pescoço , Humanos , Estudos Retrospectivos , Neoplasias de Cabeça e Pescoço/tratamento farmacológico , Carcinoma de Células Escamosas de Cabeça e Pescoço/tratamento farmacológico , Células EpiteliaisRESUMO
PURPOSE: Due to difficulties in breath holding, patients who undergo total laryngectomy may be prone to the development of chronic constipation. However, few reports have described chronic constipation in laryngectomized patients, and no report has described prevalence in patients who have undergone total pharyngolaryngectomy. METHODS: We conducted a cross-sectional study to investigate the prevalence of chronic constipation after laryngectomy and evaluated the relationship between patient characteristics and chronic constipation. Information on patient characteristics and the details of surgery were obtained from medical records and an original questionnaire survey in 50 patients. RESULTS: The prevalence of chronic constipation after laryngectomy was high, at 36%, with 18 cases. Patients who received total laryngectomy were significantly more likely to have chronic constipation than those who received total pharyngolaryngectomy (47.1% vs 12.5%, P = 0.026), who had a similar prevalence to the general public. Furthermore, the period from surgery to survey was significantly shorter in the constipation group than in the no constipation group (P = 0.043). CONCLUSIONS: The prevalence of chronic constipation in patients who had undergone laryngectomy for head and neck cancer was high, particularly in patients who received total laryngectomy and in those with only a short period since surgery.
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Neoplasias de Cabeça e Pescoço , Laringectomia , Humanos , Laringectomia/efeitos adversos , Estudos TransversaisRESUMO
AIM: Fluorescence imaging (FI) using indocyanine green (ICG) is a noteworthy alternative technique for sentinel lymph node (SLN) detection without radiation exposure in oral cavity and oropharynx cancer. However, conventional FI is monochrome, so the visibility is limited. This study assessed whether color FI using the HyperEye Medical System (HEMS) is feasible as an alternative for SLN detection. METHODS: Patients with previously untreated cT1-2N0 oral or oropharyngeal cancer who were to undergo primary tumor resection and elective neck dissection (END) in our hospital were enrolled from November 2012 to March 2016. The patients underwent SLN detection for biopsy via the HEMS following the injection of ICG solution around the primary lesion before neck dissection. The visibility and the diagnostic accuracy of the imaging were evaluated. RESULTS: SLNs were visualized in all eight cases; however, transcutaneous fluorescence detection was not observed in all cases. Utilizing color mode imaging simplified harvest by clearly discriminating SLNs from surrounding structures, while the monochrome mode proved to be more sensitive for detection. Two cases showed occult metastases on both sentinel and regional nodes. The identification and false negative rates were 100% and 0%, respectively. There were no complications incurred due to this method. CONCLUSION: Our results suggest that color FI with the HEMS allows for the accurate and safe harvest of SLNs with a preparatory skin incision. Although there is room for improvement of sensitivity, this easy-to-handle procedure might provide the potential to expand the role of the ICG method for SLN detection in head and neck cancer.
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Neoplasias Orofaríngeas , Linfonodo Sentinela , Humanos , Linfonodo Sentinela/diagnóstico por imagem , Linfonodo Sentinela/cirurgia , Linfonodo Sentinela/patologia , Biópsia de Linfonodo Sentinela/métodos , Corantes , Verde de Indocianina , Neoplasias Orofaríngeas/diagnóstico por imagem , Neoplasias Orofaríngeas/cirurgia , Neoplasias Orofaríngeas/patologia , Imagem Óptica/métodos , Linfonodos/diagnóstico por imagem , Linfonodos/cirurgia , Linfonodos/patologiaRESUMO
BACKGROUND/AIM: Nivolumab has antitumor efficacy in patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) who relapse within 6 months after platinum-based therapy; however, the efficacy of nivolumab for platinum-sensitive R/M HNSCC has not been shown. Therefore, this study compared the efficacy and safety of nivolumab for platinum-refractory and platinum-sensitive R/M HNSCC. PATIENTS AND METHODS: This was a retrospective study of patients who received nivolumab for R/M HNSCC who had been previously treated with platinum-based anticancer drugs. Patients were divided into a platinum-sensitive and a platinum-refractory group, and progression-free survival (PFS), overall survival (OS), the overall response rate (ORR) [complete response (CR) + partial response (PR)], the disease control rate (DCR) (CR + PR + stable disease), and the incidence of immune-related adverse events (irAEs) were compared between the two groups. RESULTS: We included 88 patients with squamous cell carcinoma: 60 with platinum-refractory disease and 28 with platinum-sensitive disease. The median PFS in the platinum-refractory and platinum-sensitive groups were 2.7 months and 5.3 months, respectively (p=0.03), and the median OS were 8.8 months and 17.1 months, respectively (p=0.06). There were no significant differences in the ORR, DCR, or incidence of irAEs between the two groups (p>0.99, p=0.11, and p>0.99, respectively). CONCLUSION: Nivolumab is a safe and effective treatment for platinum-sensitive R/M HNSCC.
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Antineoplásicos , Carcinoma de Células Escamosas , Neoplasias de Cabeça e Pescoço , Antineoplásicos/uso terapêutico , Carcinoma de Células Escamosas/secundário , Neoplasias de Cabeça e Pescoço/tratamento farmacológico , Humanos , Recidiva Local de Neoplasia/patologia , Nivolumabe/efeitos adversos , Platina/uso terapêutico , Estudos Retrospectivos , Carcinoma de Células Escamosas de Cabeça e Pescoço/tratamento farmacológicoRESUMO
Background: The efficacy and safety of human epidermal growth factor receptor 2 (HER2)-targeted therapy and androgen deprivation therapy (ADT) for locally advanced or recurrent or metastatic (LA/RM) salivary duct carcinoma (SDC) have been reported in prospective studies. However, the survival benefit of these therapies to conventional therapy remains controversial, and whether HER2-targeted therapy or ADT should be chosen in HER2- and androgen receptor (AR)-positive SDC patients remains unknown. Methods: Overall, 323 LA/RM SDC patients treated at seven institutions between August 1992 and June 2020 were retrospectively enrolled. The primary aim was to analyze the effect of HER2-targeted therapy and ADT on overall survival from the diagnosis of LA/RM disease to death from any cause (OS1). The secondary indicators included the overall response rate (ORR), clinical benefit rate (CBR), overall survival from therapy initiation for LA/RM disease (OS2), progression-free survival (PFS), time to second progression (PFS2), duration of response (DoR), and duration of clinical benefit (DoCB) of HER2-targeted therapy or ADT as first-line therapy for HER2-positive/AR-positive SDC. Results: Patients treated with HER2-targeted therapy or ADT had longer OS1 than those treated without these therapies (Median OS1: historical control, 21.6 months; HER2-targeted therapy, 50.6 months; ADT, 32.8 months; HER2-targeted therapy followed by ADT, 42.4 months; and ADT followed by HER2-targeted therapy, 45.2 months, p < 0.001). Among HER2-positive/AR-positive SDC patients, although HER2-targeted therapy had better ORR, CBR, and PFS than those of ADT as first-line therapy, we found no significant differences between HER2-targeted therapy and ADT regarding OS2, PFS2, DoR, and DoCB. Conclusion: Patients treated with HER2-targeted therapy and ADT showed longer survival in LA/RM SDC. HER2-targeted therapy can be recommended prior to ADT for HER2-positive/AR-positive SDC. It is warranted to establish a biomarker that could predict the efficacy of clinical benefit or better response in ADT.
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BACKGROUND/AIM: In patients with squamous cell carcinoma of the head and neck (SCCHN), delayed surgery can result in poorer postoperative function and prognosis due to the growth of the tumor and extended surgery. Further, delay may even make the tumor unresectable. To prevent tumor growth during the waiting period before surgery, S-1 has been administrated preoperatively at several facilities in Japan. To date, however, the safety and efficacy of preoperative S-1 remain unclear. PATIENTS AND METHODS: We conducted a retrospective cohort study of 118 patients with SCCHN treated with S-1 before radical surgery at 2 institutions in Japan. We evaluated the safety of S-1 therapy, which was evaluated by the incidence of grade 3 or greater adverse events (AEs). The rate of achievement of non-growth of tumors was also calculated. RESULTS: Regarding safety, 125 AEs of all grades were recorded in 71 patients (60%). Of these, grade 3 AEs were detected in 3 patients (3%), and no grade 4 or 5 AEs occurred. The nongrowth rate of primary lesions and lymph node metastases was 89% and 85%, respectively. CONCLUSION: Preoperative S-1 therapy might be useful, with acceptable toxicity, on an outpatient basis in patients with SCCHN.
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Carcinoma de Células Escamosas , Neoplasias de Cabeça e Pescoço , Carcinoma de Células Escamosas/tratamento farmacológico , Carcinoma de Células Escamosas/patologia , Carcinoma de Células Escamosas/cirurgia , Neoplasias de Cabeça e Pescoço/tratamento farmacológico , Neoplasias de Cabeça e Pescoço/cirurgia , Humanos , Metástase Linfática , Terapia Neoadjuvante , Estudos Retrospectivos , Carcinoma de Células Escamosas de Cabeça e Pescoço/tratamento farmacológico , Carcinoma de Células Escamosas de Cabeça e Pescoço/cirurgiaRESUMO
This study compared the incidence of perioperative complications and swallowing function between free jejunal flap reconstruction and cutaneous free tissue flap construction. We included 223 patients who underwent hypopharyngeal reconstruction using free flap. At discharge, +the free jejunal flap was associated with a Functional Oral Intake Scale (FOIS) score of 1-6 in 132 cases (70%) and a score of 7 in 56 cases (30%). Regarding the cutaneous free tissue flaps, FOIS scores of 1-6 were observed in 18 cases (51%), and a score of 7 was noted in 17 cases (49%). Donor site complications occurred in 12% of the patients who underwent free jejunal flap procedures and in none of the patients who underwent cutaneous free tissue flap procedures. We found that the free jejunal flap had a regular dietary intake rate in 56 patients (30%), whereas cutaneous free tissue flaps had a regular dietary intake rate in 17 patients (49%). Cutaneous free tissue flaps had a significantly higher regular dietary intake rate at discharge and a significantly lower incidence of donor site complications than free jejunal flaps. In conclusion, free-flap reconstruction may be a better method than free jejunal flap reconstruction for the treatment of hypopharyngeal cancer.
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BACKGROUND/AIM: There are no real-world comparative data of nivolumab doses of 3 mg/kg and 240 mg/body for recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). We investigated the efficacy and safety of nivolumab in treating recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) at different doses using real-world data. PATIENTS AND METHODS: R/M SCCHN patients who received nivolumab were divided into the 3 mg/kg and 240 mg/body groups and retrospectively examined for efficacy and safety. RESULTS: A total of 199 patients (3 mg/kg and 240 mg/body, 88 and 111 patients, respectively) were included. The 3 mg/kg vs. 240 mg/body groups had similar overall response rates (15% vs. 25, p=0.15), disease control rates (46% vs. 57%, p=0.15), overall survival (9.5 months vs. 10.9 months), and progression-free survival (3.7 months vs. 3.8 months, p=0.95). The incidence of immune-related adverse events was also similar in both groups. CONCLUSION: In R/M SCCHN patients, nivolumab showed similar efficacy and safety at doses of 3 mg/kg and 240 mg/body.
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Neoplasias de Cabeça e Pescoço/tratamento farmacológico , Inibidores de Checkpoint Imunológico/administração & dosagem , Recidiva Local de Neoplasia , Nivolumabe/administração & dosagem , Carcinoma de Células Escamosas de Cabeça e Pescoço/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Neoplasias de Cabeça e Pescoço/imunologia , Neoplasias de Cabeça e Pescoço/mortalidade , Neoplasias de Cabeça e Pescoço/patologia , Humanos , Inibidores de Checkpoint Imunológico/efeitos adversos , Masculino , Pessoa de Meia-Idade , Nivolumabe/efeitos adversos , Intervalo Livre de Progressão , Estudos Retrospectivos , Carcinoma de Células Escamosas de Cabeça e Pescoço/imunologia , Carcinoma de Células Escamosas de Cabeça e Pescoço/mortalidade , Carcinoma de Células Escamosas de Cabeça e Pescoço/secundário , Fatores de Tempo , Tóquio , Adulto JovemRESUMO
Oncocytoma arising from the parotid gland and extending into the parapharyngeal space (PPS) has not been previously reported. A 64-year-old woman presented with a large slowly growing mass extending from the parotid to the submandibular area, expanding medially to displace the pharynx across the midline. Core-needle biopsy revealed an oncocytoma in the PPS measuring 120 × 88 × 60 mm in size. Although the tumor was of an unprecedentedly large size and extended into multiple spaces, it could be removed via a cervical-parotid approach without osteotomy. The resected tumor was again diagnosed as oncocytoma. A postoperative complication was weakness of the ipsilateral facial nerve, which almost completely resolved in 6 months. No recurrence has been noted on 1 y follow-up. We were able to resect an extremely large oncocytoma arising from the parotid gland without osteotomy.
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OBJECTIVE: Salivary duct carcinoma (SDC) is a highly aggressive and uncommon tumor arising not only de novo but also in pleomorphic adenoma. Androgen receptor (AR)- and HER2-targeted therapy have recently been introduced for SDC as promising treatment options; however, no predictive biomarkers have yet been established. EZH2 and H3K27me3 are closely linked to the development and progression of various cancers, and EZH2 is also expected to be a desirable therapeutic target. We therefore explored the clinicopathological and prognostic implications of EZH2 and H3K27me3 in a large cohort of SDC patients, focusing on their impact on the therapeutic efficacy of AR- or HER2-targeted therapy. MATERIALS AND METHODS: The EZH2 and H3K27me3 immunohistochemical expression and EZH2 Y646 gain-of-function mutation status were examined in 226 SDCs, and the relationship with the clinicopathological factors as well as clinical outcomes were evaluated within the three groups depending on the treatment: AR-targeted (combined androgen blockade with leuprorelin acetate and bicalutamide; 89 cases), HER2-targeted (trastuzumab and docetaxel; 42 cases), and conventional therapy (112 cases). RESULTS: EZH2 and H3K27me3 were variably immunoreactive in most SDCs. A positive correlation was found between the expression of EZH2 and H3K27me3. The EZH2 expression in the SDC component was significantly higher than that in the pre-existing pleomorphic adenoma component. EZH2 Y646 was not identified in any cases. EZH2-high cases more frequently had an advanced clinical stage and aggressive histological features than EZH2-low cases. An EZH2-high status in patients treated with AR-targeted therapy was associated with a significantly shorter progression-free and overall survival as well as a lower objective response rate and clinical benefit rate. In addition, a H3K27me3-high status in patients treated with AR-targeted therapy was related to a shorter overall survival. Conversely, there was no association between the EZH2 and H3K27me3 expression and the clinical outcomes in the conventional or HER2-targeted therapy groups. CONCLUSIONS: A high expression of EZH2 and H3K27me3 in SDC might be a predictor of a poor efficacy of AR-targeted therapy. Our data provide new insights into the role of EZH2 and H3K27me3 in therapeutic strategies for SDC.
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BACKGROUND: Parapharyngeal space tumors are rare. Among them, tumors in the prestyloid compartment are particularly suitable for surgery; however, there are no detailed reports of such surgery and their features remain unknown. METHODS: We conducted a retrospective cohort study. For 67 surgical cases of benign tumors in this compartment, we examined the patient and tumor characteristics, fine-needle aspiration cytology (FNAC), and intraoperative details such as surgical approach, use of complete excision, and postoperative complications. RESULTS: Pleomorphic adenomas (PAs) comprised 73.1% of the lesions. The diagnostic accuracy of FNAC to differentiate benign and malignant tumors was 97.7%. Of the treated lesions, 94.0% were removed via the cervical approach alone, including all PAs. The remaining 6.0% were resected via the cervical-parotid approach. The median operative time and bleeding volume were 89 min and 50 mL, respectively. Operative time using the cervical approach was significantly shorter (p = 0.021). All cases could be treated via complete surgical excision. Postoperative complications occurred in 32.8% of patients, with transient slight facial palsy being the most common. No fatal complications occurred and 92.5% of patients had no sequelae. There was no significant association between complications and surgical approach. CONCLUSION: Based on diagnosis by FNAC, with a high accuracy rate, most benign prestyloid tumors, especially PAs, were resected using the cervical approach alone, with a shorter operative time and without severe complications.
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Adenoma Pleomorfo , Espaço Parafaríngeo , Adenoma Pleomorfo/cirurgia , Biópsia por Agulha Fina , Humanos , Glândula Parótida , Estudos RetrospectivosRESUMO
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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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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Antineoplásicos Imunológicos/uso terapêutico , Carcinoma Ductal/tratamento farmacológico , Inibidores de Checkpoint Imunológico/uso terapêutico , Nivolumabe/uso terapêutico , Neoplasias das Glândulas Salivares/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Antígeno B7-H1/metabolismo , Carcinoma Ductal/mortalidade , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Metástase Neoplásica , Estudos Retrospectivos , Neoplasias das Glândulas Salivares/mortalidade , Análise de Sobrevida , Resultado do TratamentoRESUMO
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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Antineoplásicos Imunológicos , Neoplasias Nasofaríngeas , Antineoplásicos Imunológicos/efeitos adversos , Humanos , Carcinoma Nasofaríngeo/tratamento farmacológico , Recidiva Local de Neoplasia/tratamento farmacológico , Nivolumabe/efeitos adversos , Resultado do TratamentoRESUMO
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.
Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carcinoma de Células Escamosas de Cabeça e Pescoço/tratamento farmacológico , Idoso , Idoso de 80 Anos ou mais , Antineoplásicos Imunológicos/administração & dosagem , Antineoplásicos Imunológicos/efeitos adversos , Antineoplásicos Imunológicos/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Metástase Neoplásica , Recidiva Local de Neoplasia , Estadiamento de Neoplasias , Nivolumabe/administração & dosagem , Nivolumabe/efeitos adversos , Nivolumabe/uso terapêutico , Recidiva , Retratamento , Terapia de Salvação , Carcinoma de Células Escamosas de Cabeça e Pescoço/diagnóstico , Carcinoma de Células Escamosas de Cabeça e Pescoço/mortalidade , Resultado do TratamentoRESUMO
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.