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71.
Ruxandra Ulmeanu Ileana Antohe Ecaterina Anisie 《Expert review of anticancer therapy》2016,16(2):165-167
Lung cancer still remains associated with a high mortality rate and more efficacious therapies are needed in order to improve the disease outcome. Nivolumab is a monoclonal antibody which blocks the programmed death-1 receptor which is currently evaluated in phase III clinical trials in advanced lung cancer. Here, we evaluate the results of a phase III study in which nivolumab efficacy and safety were compared to those of docetaxel. Nivolumab was able to improve survival and progression-free survival and exhibited a very good safety profile. Further clinical data are needed in order to better position this therapy among the existing methods. The promising results support the use of this therapy as a stand-alone approach. 相似文献
72.
目的：分析纳武利尤单抗致免疫相关性肺炎发生情况、临床特点、治疗与转归以及再给药后肺炎复发情况,为临床治疗过程中免疫相关性肺炎的鉴别及处置提供参考。方法：检索Web of Science、PubMed、中国知网、维普数据库和万方数据库关于纳武利尤单抗致免疫相关性肺炎的文献并进行分析。结果：纳武利尤单抗致免疫相关性肺炎的个案报道共57例,中位发生时间为（2.6±2.3）个月,其影像学特征主要表现为GGO、实变和网格状影,肺炎类型主要表现为隐源性机化性肺炎和非特异性间质性肺炎。49例经停药和（或）对症治疗后好转或痊愈,1例出现呼吸衰竭,7例死亡。好转后,10例患者再次给予纳武利尤单抗治疗,4例复发。结论：纳武利尤单抗治疗过程中需关注患者的临床症状及肺部影像学特征,鉴别其可能导致的免疫相关性肺炎,发生免疫相关性肺炎的患者需根据其严重程度不同予以相应的治疗手段,同时应警惕再次给药后的肺炎复发风险。 相似文献
74.
Yasuhiro Fujisawa Koji Yoshino Atsushi Otsuka Takeru Funakoshi Hiroshi Uchi Taku Fujimura Shigeto Matsushita Hiroo Hata Hisako Okuhira Ryota Tanaka Kojiro Nagai Yoshihiro Ishida Yoshio Nakamura Sadanori Furudate Kentaro Yamamura Keisuke Imafuku Yuki Yamamoto 《Journal of dermatological science》2018,89(1):60-66
Background
Due to resistance and immune-related adverse events (irAE) some melanoma patients require ipilimumab after nivolumab therapy. However, little is known about the result of this switching.Objective
Investigate the outcome of ipilimumab switching in Japanese patients.Methods
We retrospectively collected 60 patients who were treated with ipilimumab after nivolumab from 9 institutes in Japan. Information of the primary tumor, treatment, response, irAE), and survival was collected.Results
In our cohort, acral lentiginous and mucosal melanoma accounted for 53% of the cases. The most common reason for initiating ipilimumab was disease progression (93%). Median interval from the last nivolumab administration to first ipilimumab administration was 29 days. Only 38% of patients completed 4 injections of ipilimumab. The best overall response was 3.6%. IrAE occurred in 78% of patients and 70% of those were of grade 3/4 (G3/4) and 31% of patients experienced 2 or more irAEs. An within interval of 28 days or less between the last nivolumab administration and ipilimumab administration was correlated with the development of G3/4 pyrexia and 3 or more irAEs, but irAE occurrence did not affect survival. Multivariate analysis showed that endocrine irAE (relative risk = 0.22, P = 0.015) and skin irAE (relative risk = 2.78, P = 0.048) were significant factors associated with survival.Conclusion
In our study, the response ratio to ipilimumab after nivolumab was unsatisfactory and associated with a high frequency of severe irAEs. As there are few second-line treatment options for patients with BRAF wild-type advanced melanoma after nivolumab failure, patients should be closely monitored if ipilimumab is initiated. 相似文献75.
BackgroundAnti-programmed cell death receptor-1 (PD-1) antibodies represent an effective treatment option for metastatic melanoma as well as for other cancer entities. They act via blockade of the PD-1 receptor, an inhibitor of the T-cell effector mechanisms that limit immune responses against tumours. As reported for ipilimumab, the anti-PD-1 antibodies pembrolizumab and nivolumab can induce immune-related adverse events (irAEs). These side-effects affect skin, gastrointestinal tract, liver, endocrine system and other organ systems. Since life-threatening and fatal irAEs have been reported, adequate diagnosis and management are essential.Methods and findingsIn total, 496 patients with metastatic melanoma from 15 skin cancer centers were treated with pembrolizumab or nivolumab; 242 side-effects were described in 138 patients. In 116 of the 138 patients, side-effects affected the skin, gastrointestinal tract, liver, endocrine, and renal system. Rare side-effects included diabetes mellitus, lichen planus, and pancreas insufficiency due to pancreatitis.ConclusionAnti-PD1 antibodies can induce a plethora of irAEs. The knowledge of them will allow prompt diagnosis and improve the management resulting in decreased morbidity. 相似文献
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Lorraine Pelosof May Tun Saung Martha Donoghue Sandra Casak Sirisha Mushti Joyce Cheng Xiling Jiang Jiang Liu Hong Zhao Maryam Khazraee Kirsten B. Goldberg Marc Theoret Steven Lemery Richard Pazdur Lola Fashoyin-Aje 《The oncologist》2021,26(4):318-324
On June 10, 2020, the U.S. Food and Drug Administration (FDA) approved nivolumab (OPDIVO; Bristol Myers Squibb, New York, NY) for the treatment of patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine‐ and platinum‐based chemotherapy. Approval was based on the results of a single, randomized, active‐control study (ATTRACTION‐3) that randomized patients to receive nivolumab or investigator''s choice of taxane chemotherapy (docetaxel or paclitaxel). The study demonstrated a significant improvement in overall survival (OS; hazard ratio = 0.77; 95% confidence interval: 0.62–0.96; p = .0189) with an estimated median OS of 10.9 months in the nivolumab arm compared with 8.4 months in the chemotherapy arm. Overall, fewer patients in the nivolumab arm experienced treatment‐emergent adverse events (TEAEs) of any grade, grade 3–4 TEAEs, and serious adverse events compared with the control arm. The safety profile of nivolumab in patients with ESCC was generally similar to the known safety profile of nivolumab in other cancer types with the following exception: esophageal fistula was identified as a new, clinically significant risk in patients with ESCC treated with nivolumab. Additionally, the incidence of pneumonitis was higher in the ESCC population than in patients with other cancer types who are treated with nivolumab. This article summarizes the FDA review of the data supporting the approval of nivolumab for the treatment of ESCC.Implications for PracticeThe approval of nivolumab for the treatment of adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine‐ and platinum‐based chemotherapy was based on an overall survival (OS) benefit from a randomized, open‐label, active‐controlled study called ATTRACTION‐3. Prior to this study, no drug or combination regimen had demonstrated an OS benefit in a randomized study for patients with ESCC after prior fluoropyrimidine‐ and platinum‐based chemotherapy. 相似文献
78.
Merav Lidar Eitan Giat Daniela Garelick Yuval Horowitz Howard Amital Yael Steinberg-Silman Jacob Schachter Ronnie Shapira-Frommer Gal Markel 《Autoimmunity reviews》2018,17(3):284-289
Background
The use of immune checkpoint inhibitors (ICI) has grown incessantly since they were first approved in 2014. These monoclonal antibodies inhibit T cell activation, yielding a dramatic tumor response with improved survival. However, immunotherapy is frequently hampered by immune adverse events (iAE) such as hypophysitis, colitis, hepatitis, pneumonitis and rash. Until recently, rheumatic side effects were only infrequently reported.Aim
To describe the rheumatic manifestations encountered among patients treated with ICIs in a large tertiary cancer center in IsraelMethods
The cancer center's patient registry was screened for patients who had ever been treated with ipilimumab, pembrolizumab and/or nivolumab with relevant data gathered from clinical charts.Results
Rheumatic manifestations were encountered in 14 of 400 patients (3.5%) who had received immunotherapy between January 1st 2013 and April 30th, 2017. The most common rheumatic manifestation was inflammatory arthritis (85%) for which a third (4/11) had a clear cut predisposing factor such as a personal or family history of psoriasis, a prior episode of uveitis or ACPA positivity. Pulmonary sarcoidosis and biopsy-proven eosinophilic fasciitis were diagnosed in two additional patients. Treatment with NSAIDS was mostly unsuccessful while steroid therapy was beneficial in doses ≥20?mg/d. Methotrexate enabled steroid tapering without an excess of side effects or tumor progression in the short follow-up available. Overall, rheumatic manifestations tended to occur later in the course of immunotherapy as compared to other iAE.Conclusions
Our findings underscore that rheumatic iAE are part of the side effect profile of ICIs and require heightened awareness as these therapies are becoming the standard of care for various malignancies. We show that these appear later in the course of iAEs and respond preferentially to high dose steroids. MTX appears effective as a steroid sparing agent. 相似文献79.
Thomas Powles Laurence Albiges Michael Staehler Karim Bensalah Saeed Dabestani Rachel H. Giles Fabian Hofmann Milan Hora Markus A. Kuczyk Thomas B. Lam Lorenzo Marconi Axel S. Merseburger Sergio Fernández-Pello Rana Tahbaz Alessandro Volpe Börje Ljungberg Axel Bex 《European urology》2018,73(3):311-315
The randomised phase III clinical trial Checkmate-214 showed a survival superiority for the combination of ipilimumab and nivolumab when compared with the previous standard of care in first-line metastatic/advanced clear cell renal cell carcinoma (RCC) (Escudier B, Tannir NM, McDermott DF, et al. CheckMate 214: efficacy and safety of nivolumab plus ipilimumab vs sunitinib for treatment-naïve advanced or metastatic renal cell carcinoma, including IMDC risk and PD-L1 expression subgroups. LBA5, ESMO 2017, 2017). These results change the frontline standard of care for this disease and have implications for the selection of subsequent therapies. For this reason the European Association of Urology RCC guidelines have been updated.
Patient summary
The European Association of Urology guidelines will be updated based on the results of the phase III Checkmate-214 clinical trial. The trial showed superior survival for a combination of ipilimumab and nivolumab (IN), compared with the previous standard of care, in intermediate- and poor-risk patients with metastatic clear cell renal cell carcinoma. When IN is not safe or feasible, alternative agents such as sunitinib, pazopanib, and cabozantinib should be considered. Furthermore, at present, the data from the trial are immature in favourable-risk patients. Therefore, sunitinib or pazopanib remains the favoured agent for this subgroup of patients. 相似文献80.
Naoto Okada Hitoshi Kawazoe Kenshi Takechi Yoshihiro Matsudate Ryo Utsunomiya Yoshito Zamami Mitsuhiro Goda Masaki Imanishi Masayuki Chuma Noriaki Hidaka Koji Sayama Yoshiaki Kubo Akihiro Tanaka Keisuke Ishizawa 《Clinical therapeutics》2019,41(1):59-67