Low-Dose Nivolumab in Renal Cell Carcinoma: A Real-World Experience

Zhao, Joseph J; Kumarakulasinghe, Nesaretnam Barr; Muthu, Vaishnavi; Lee, Matilda; Walsh, Robert J.; Low, Jia Li; Choo, Joan R.E.; Tan, Hon Lyn; Chong, Wan Qin; Ang, Yvonne; Chan, Gloria; Yong, Wei Peng; Huang, Yiqing; Ngoi, Natalie; Wong, Alvin Seng Cheong

doi:10.1159/000512000

Cited by 13 publications

(13 citation statements)

References 42 publications

(55 reference statements)

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“…The development of generic or bio-similar molecules and innovative studies on low-dose regimens or longer duration treatment schedules would help bring down the cost of treatment and improve accessibility in these regions. There are multiple retrospective analyses that suggest that such schedules might be helpful [26][27][28]. However, there is need for performing dose response, minimum effective dose finding studies and these need to be backed up by phase 2 and phase 3 randomised studies.…”

Section: Discussionmentioning

confidence: 99%

Retrospective analysis: checkpoint inhibitor accessibility for thoracic and head and neck cancers and factors influencing it in a tertiary centre in India

Patil¹,

Abraham²,

Ravikrishna³

et al. 2022

ecancer

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Background: Access to cancer care is an issue in low and low middle-income countries. The problem is worse with respect to access to new therapies like checkpoint inhibitors. Hence, we decided to audit our practice in the head and neck and thoracic medical oncology unit from 2015 to 2019 to study the accessibility of checkpoint inhibitors and factors influencing it.Methods: All patients who were registered in the head and neck and thoracic medical oncology unit between 2015 and 2019 were included in the study. Patients who received immunotherapy were identified from the prospective database of immunotherapy maintained by the department. We made a list of patients who were eligible for immunotherapy per year and identified how many of them received recommended immunotherapy. The indication for eligibility of immunotherapy was based on published pivotal data and it was applicable from the date of publication of the study online. Descriptive statistics were performed. For nominal and ordinal variable percentage with 95% confidence intervals (95% CI) was provided. Factors impacting the accessibility of immunotherapy were identified.Findings: A total of 15,674 patients were identified who required immunotherapy; out of them only 444 (2.83%, 95% CI: 2.58-3.1) received it. Among head and neck cancer patients, 4.5% (156 out of 3,435) received immunotherapy versus 2.35% (288 out of 12,239) among thoracic cancer patients (p < 0.001). Among the general category (low socioeconomic), 0.29% (28 out of 9,405 ) versus 6.6% (416 out of 6,269) among the private category (high socioeconomic) received immunotherapy (p < 0.001). While 3.7% (361 out of 9,737) among males versus 1.39% (83 out of 5,937) females received immunotherapy (p < 0.001). There was also a temporal trend seen in the accessibility of immunotherapy (p < 0.001). Conclusion:The accessibility of immunotherapy is below 3% in India. Patients with head and neck cancers, those registered as private category and male patients had higher access to this therapy. There was also a temporal trend observed suggesting increased accessibility over the years.

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Section: Discussionmentioning

confidence: 99%

Retrospective analysis: checkpoint inhibitor accessibility for thoracic and head and neck cancers and factors influencing it in a tertiary centre in India

Patil¹,

Abraham²,

Ravikrishna³

et al. 2022

ecancer

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“…In contrast, another study confirmed similar efficacy and safety between a flat dose of 240 mg nivolumab and a dose of 3 mg/kg nivolumab based on pharmacokinetic and dose efficacy analyses, indicating that a lower flat dose nivolumab (20 or 100 mg) might be comparably effective to a higher dose [28]. Therefore, growing evidence has confirmed the efficacy and safety of low-dose ICIs to reduce the financial toxicity and improve clinical outcome in several cancer types, such as NSCLC, RCC, and Hodgkin lymphoma [15][16][17]. In NSCLC, Yoo et al reported 47 patient who received low-dose nivolumab (20 or 100 mg) or standard dose (3 mg/kg) for cancer treatment; there was no statistical difference of ORR (13.8% versus 16.7%), PFS (3.0 month versus 1.0 month) and OS (12.5 month versus 8.2 month) between low-dose group and standard dose groups [16].…”

Section: Discussionmentioning

confidence: 99%

“…Therefore, lowdose ICIs may be a viable option for the management of cancer. Growing evidence has demonstrated the efficacy of low-dose nivolumab in some cancer types, such as NSCLC, recall cell carcinoma (RCC), and Hodgkin lymphoma [15][16][17]. The major rationale is that no correlation between dose and response has been observed for anti-PD-1 ICIs, whether nivolumab or pembrolizumab.…”

Section: Introductionmentioning

confidence: 99%

“…A low-dose regimen may be an alternative option to reduce the financial toxicity incurred by ICIs. The efficacy and safety of low-dose nivolumab have been demonstrated in patients with NSCLC, RCC, and Hodgkin lymphoma in real-world practice [ 15 – 17 ]. However, to our knowledge, the clinical impact of low-dose nivolumab in patients with advanced HCC is unclear.…”

Section: Introductionmentioning

confidence: 99%

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Low-dose nivolumab in advanced hepatocellular carcinoma

et al. 2022

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Background The approved dose of nivolumab is 3 mg/kg or a flat dose of 240 mg for indications. There is no dose-response relationship for nivolumab; therefore, a low-dose regimen may be an option to reduce financial toxicity. This study was designed to investigate the efficacy and safety of low-dose nivolumab in the management of hepatocellular carcinoma (HCC). Methods We retrospectively reviewed patients with HCC who received 20 or 100 mg of nivolumab intravenously every 2 weeks. The objective response rate was determined in accordance with the Response Evaluation Criteria in Solid Tumors criteria version 1.1. The Cox regression model and Kaplan–Meier method were used to analyze hazard factors, progression-free survival (PFS), and overall survival (OS). Adverse events (AEs) were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Results In total, 78 patients were enrolled, including 49 with hepatitis B virus (HBV) and 23 with hepatitis C virus (HCV). All patients were staged as Barcelona Clinic Liver Cancer stage C, and 20 patients were classified as having Child–Pugh classification B (7). Nivolumab 20 mg was an independent prognostic factor for better PFS, and albumin-bilirubin grade 1 was the independent prognostic factor for superior OS in the multivariate analyses. Patients with better HBV (HBV DNA < 500 IU/ml) and HCV (HCV RNA undetectable) controls had superior OS. All AEs were grade 1–2 in severity, and all patients tolerated nivolumab without treatment interruption or dose adjustment. Additionally, 31 patients underwent subsequent therapy after nivolumab treatment. Conclusion Low-dose nivolumab may be effective with manageable toxicity and can be an alternative option to reduce financial toxicity in patients with advanced HCC who cannot afford the high cost of immune checkpoint inhibitors in real-world practice.

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“…A retrospective study from Korea compared the low-dose nivolumab group (20 mg/100 mg Q3W) with the standard-dose group (3 mg/kg Q2W) in nonsmall cell lung cancer (NSCLC) with no significant difference in ORR, progression-free survival (PFS), and overall survival (OS) (34). Results from another retrospective studies in Singapore also showed that low-dose (100 mg/140 mg) nivolumab did not reduce efficacy in renal cancers (35). In a single-arm, open-label phase II study conducted in Russia, the ORR for 40 mg Q2W nivolumab in relapsed/refractory Hodgkin lymphoma was 70%, with 13/30 (43.3%) achieving complete remission (CR) (36).…”

Section: Nivolumabmentioning

confidence: 99%

Dosing Regimens of Immune Checkpoint Inhibitors: Attempts at Lower Dose, Less Frequency, Shorter Course

Jiang

Liu

et al. 2022

Front. Oncol.

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Immune checkpoint inhibitors (ICIs) are a revolutionary breakthrough in the field of cancer by modulating patient’s own immune system to exert anti-tumor effects. The clinical application of ICIs is still in its infancy, and their dosing regimens need to be continuously adjusted. Pharmacokinetic/pharmacodynamic studies showed a significant plateau in the exposure-response curve, with high receptor occupancy and plasma concentrations achieved at low dose levels. Coupled with concerns about drug toxicity and heavy economic costs, there has been an ongoing quest to reevaluate the current ICI dosing regimens while preserving maximum clinical efficacy. Many clinical data showed remarkable anticancer effects with ICIs at the doses far below the approved regimens, indicating the possibility of dose reduction. Our review attempts to summarize the clinical evidence for ICIs regimens with lower-dose, less-frequency, shorter-course, and provide clues for further ICIs regimen optimization.

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Low-Dose Nivolumab in Renal Cell Carcinoma: A Real-World Experience

Cited by 13 publications

References 42 publications

Retrospective analysis: checkpoint inhibitor accessibility for thoracic and head and neck cancers and factors influencing it in a tertiary centre in India

Retrospective analysis: checkpoint inhibitor accessibility for thoracic and head and neck cancers and factors influencing it in a tertiary centre in India

Low-dose nivolumab in advanced hepatocellular carcinoma

Dosing Regimens of Immune Checkpoint Inhibitors: Attempts at Lower Dose, Less Frequency, Shorter Course

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