This work was supported by the JSPS Grant-in-Aid for Scientific Research (C) to Dr

This work was supported by the JSPS Grant-in-Aid for Scientific Research (C) to Dr. for 28?months without disease progression. One individual showed grade 4 increase in creatine phosphokinase levels and grade 3 myositis. Biomarker analysis revealed significantly increased OS in patients with overall performance status of 0; altered Glasgow prognostic score MC180295 of 0; low neutrophil-to-lymphocyte ratio, lactate dehydrogenase, and C-reactive protein; and high lymphocyte-to-monocyte ratio and in patients who MC180295 received systemic therapy following nivolumab. Although nivolumabs efficacy against SGC was limited, some patients achieved long-term disease control. Further studies are warranted on ICI use for SGC. androgen receptor, combined androgen blockade, human epidermal growth factor receptor 2, altered Glasgow prognostic score, high-frequency microsatellite instability, programmed death-ligand 1, recurrent/metastatic, salivary duct carcinoma, docetaxel/cisplatin/5-fluorouracil. aThe HER2 status was defined according to the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines for breast malignancy54. bA case was considered to be AR-positive when??20% of the tumour cell nuclei showed strong staining55. cAbiraterone, 3; bicalutamide, 2; enzalutamide, 2; docetaxel, cisplatin?+?docetaxel, carboplatin?+?pemetrexed, cisplatin?+?5-fluorouracil, cisplatin?+?5-fluorouracil?+?cetuximab and trastuzumab?+?docetaxel?+?pertuzumab, 1 each. The median quantity of cycles of nivolumab administered was 8 (range 1C57). As of the cut-off date, 30 January 2020, two patients (8%) continued to receive nivolumab for 28 and 6?months, whereas 22 patients (92%) discontinued treatment due to PD (n?=?19, 79%) and AEs (n?=?3, 13%). Six patients (25%) received one or more of the following systemic therapy regimens after nivolumab treatment: cetuximab plus paclitaxel (n?=?5, 21%), carboplatin plus docetaxel, trastuzumab plus docetaxel, abiraterone, and S-1 (n?=?1, 4%, respectively). Response and survival outcomes The therapeutic efficacy MC180295 of nivolumab are shown in Table ?Table2.2. None of the patients achieved CR; 1 (4%), 2 (8%), and 21 (88%) patients showed PR, SD, and PD, respectively. The ORR was 4.2% (95% CI 0.1C21.1%). Two patients with SD managed the status for more than 24?weeks. Thus, both CBR and DCR were 12.5% (95% CI 2.7C32.4%). The KaplanCMeier survival curves of PFS and OS of all patients are shown in Fig.?1; the median PFS was 1.6 (95% CI 1.2C4.4) months and the median OS was 10.7 (95% CI 5.1C19.8) months. The therapeutic effects observed in 20 patients with SDC were as follows: ORR, 5.0% (95% CI 2.7C24.9%); median PFS, 1.5 (95% CI 1.1C2.7) months; and median OS, 11.3 (95% CI 3.8C19.8) months. Figure?2 shows the waterfall, spider, and swimmer plots of all patients based on the histopathological diagnosis. Figure?3 shows MC180295 the representative images of tumour before and during nivolumab monotherapy in two patients. Table 2 Treatment efficacy. confidence interval, not reached. aConfirmed total and partial responses. bComplete response, partial response, and stable disease. cComplete response, partial response, and stable disease??24?weeks. Open in a separate windows Physique 1 KaplanCMeier curves of progression-free and overall survival. KaplanCMeier curves of (A) MC180295 progression-free survival and (B) overall survival. The vertical lines indicate censored events. Open in a separate window Physique 2 Characteristics of responses Rabbit polyclonal to PCSK5 in patients with salivary gland carcinoma treated with nivolumab according to Response Evaluation Criteria in Solid Tumours (version 1.1) based on histopathological diagnosis. (A) The highest reduction from your baseline in target lesions. Tumour shrinkage relative to the baseline was observed in four patients (16.7%). The upper dotted lines represent the threshold for progressive disease (a 20% increase in the sum of the longest diameter of the target lesions) and the lower dotted lines represent the threshold for any partial response (a 30% decrease in the sum of the longest diameter of the target lesions). (B) Change from the baseline (%) in the sum of the target lesions over time to progressive disease. The upper dotted lines represent the threshold for progressive disease (a 20% increase in the sum of the longest diameter of the target lesions) and the lower dotted lines show the threshold for any partial response (a 30% decrease in the sum of the longest diameter of.