Real-world effectiveness and safety of nivolumab in patients with non-small cell lung cancer: A multicenter retrospective observational study in Japan

Morita, Ryo; Okishio, Kyoichi; Shimizu, Junichi; Saito, Haruhiro; Sakai, Hiroshi; Kim, Young Hak; Hataji, Osamu; Yomota, Makiko; Nishio, Makoto; Aoe, Keisuke; Kanai, Osamu; Kumagai, Toru; Kibata, Kayoko; Tsukamoto, Hiroaki; Oizumi, Satoshi; Fujimoto, Daichi; Tanaka, Hiroshi; Mizuno, Keiko; Masuda, Takeshi; Kozuki, Toshiyuki; Haku, Takashi; Suzuki, Hiroyuki; Okamoto, Isamu; Hoshiyama, Hirotoshi; Ueda, Junya; Ohe, Yuichiro

doi:10.1016/j.lungcan.2019.11.014

Cited by 59 publications

(64 citation statements)

References 23 publications

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“…In line with these reports, differential responses to nivolumab among multiple tumors in a patient with HCC can be understood. Heterogeneous responses to nivolumab among multiple metastatic tumors were also demonstrated in melanoma ( 30 ) and non-small cell lung cancer patients ( 31 ). This heterogeneity can be explained by innate or acquired resistance of tumor cells when a considerable tumor burden exists.…”

Section: Discussionmentioning

confidence: 99%

Real-World Outcomes of Nivolumab in Patients With Unresectable Hepatocellular Carcinoma in an Endemic Area of Hepatitis B Virus Infection

et al. 2020

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Real-world results of nivolumab monotherapy against HCC are lacking in the hepatitis B virus (HBV)-endemic, Asia-Pacific regions. Moreover, heterogeneous responses to immune checkpoint inhibitors have rarely been described in advanced HCC. The aim of this study is to evaluate the efficacy and safety of nivolumab monotherapy in a real-world setting in 33 Korean patients with unresectable HCC. In our cohort, twenty-nine patients (88%) showed HBsAg positivity. At the time of nivolumab initiation, 4 among 33 patients (12%) were classified as Barcelona Clinic Liver Cancer (BCLC)-B stage and 29 (88%) as BCLC-C stage, respectively. Prior sorafenib treatment was given to 31 (94%) patients, and 13 (39%) received prior regorafenib treatment. For the liver reserve, patients were classified as Child–Pugh class A (79%) and B (21%), respectively. Grade 3 toxicities occurred in one patient, who developed pneumonitis after 5 cycles of nivolumab treatment. Best overall responses were complete response in 2 patients out of the 33 enrolled patients (6%), partial response in 4 patients (12%) and stable disease in 4 patients (12%). With 29 patients having images for the response evaluation, the objective response rate was 21.4%. The median overall survival (OS) of the cohort was 26.4 weeks (range 2.3–175.1). Achieving objective responses, pre-treatment small tumors (maximal diameter <5 cm) and favorable liver function as assessed by Albumin–Bilirubin grade were significant factors for the favorable OS. Interestingly, differential responses to nivolumab among multiple tumors in a single patient were noted in 6 patients (18%). In these patients, small metastatic tumors were regressed, although their larger tumors did not respond to nivolumab monotherapy. In summary, nivolumab treatment seems clinically efficacious in treating unresectable HCC in an endemic area of HBV infection. Further prospective evaluation is required to overcome the heterogeneous efficacy of nivolumab monotherapy according to the baseline tumor burden.

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Section: Discussionmentioning

confidence: 99%

Real-World Outcomes of Nivolumab in Patients With Unresectable Hepatocellular Carcinoma in an Endemic Area of Hepatitis B Virus Infection

et al. 2020

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“…Also, subgroup analysis based on the treatment line was not performed due to insufficient included studies in this meta-analysis. However, we should notice that patients receiving ICIs can be heavily pretreated in real-world clinical practice, and efficacy of immunotherapy is dependent on the line of treatment (10,60). Second, all the included studies are post-hoc exploratory analyses with risk of bias to some extent, as inevitable imbalance of confounding factors presenting between treatment and control arms.…”

Section: Discussionmentioning

confidence: 99%

Efficacy of Immune Checkpoint Inhibitors in Non-small-cell Lung Cancer Patients With Different Metastatic Sites: A Systematic Review and Meta-Analysis

Yang

Bai

et al. 2020

Front. Oncol.

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Background: Organ-specific response patterns reported in previous studies indicate different response toward immune checkpoint inhibitors (ICIs) in non-small-cell lung cancer (NSCLC) patients with different metastatic sites. This study aims to compare the efficacy of ICIs with conventional therapy in NSCLC patients with bone, brain or liver metastases. Materials and Methods: MEDLINE, Embase, and CENTRAL were searched for studies comparing ICIs with conventional therapy in NSCLC patients with bone, brain or liver metastases. The pooled hazard ratio (HR) of overall survival (OS) and progression-free survival (PFS) among included studies was analyzed using the random effects model. Results: Eight studies consisting of 988 NSCLC patients were included, 259 with brain metastases and 729 with liver metastases. No available study with bone metastases information was identified. For patients with brain metastases, ICIs significantly improved their OS (HR, 0.57; P = 0.007). For patients with liver metastases, both OS (HR, 0.72; P = 0.006), and PFS (HR, 0.72; P = 0.004) improvements were observed in the ICI treatment arm. Subgroup analysis was conducted based on target of ICIs and treatment regimen. PD-1 inhibitors could benefit patients with liver or brain metastases on OS and PFS (brain metastases: OS, HR, 0.43; P < 0.001; liver metastases: PFS, HR, 0.52; P = 0.003; OS, HR, 0.66; P = 0.001), while PD-L1 inhibitors could not. Patients with brain metastases could only gain OS improvement from ICIs combined with chemotherapy (HR, 0.41; P = 0.001), but for patients with liver metastases, the benefit was detected using ICIs single agent (HR, 0.68; P = 0.012) or ICIs combined with chemotherapy plus anti-VEGF therapy (HR, 0.52; P = 0.005). Conclusion: ICIs could significantly improve OS in NSCLC patients with brain or liver metastases compared with conventional therapy. Patients with brain metastases could only gain OS benefit from ICIs combined with chemotherapy, while those with liver metastases obtained superior OS from ICIs single agent or ICIs combined with chemotherapy plus anti-VEGF therapy.

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“…The full details of the study design were recently reported. 19 This was a multicentre, non-interventional, retrospective medical chart review study (trial registration NCT03273790) in which medical record data (collected by participating investigators using electronic data capture; Mebix, Inc, Tokyo, Japan) from 23 cancer hospitals in Japan were analysed.…”

Section: Methodsmentioning

confidence: 99%

“…The study population has been described. 19 Previously treated advanced/metastatic patients with NSCLC who initiated nivolumab treatment between April 2016 and December 2016 were included, with the exception of patients who participated in the postmarketing surveillance of nivolumab and patients who participated in any clinical studies prior to or after nivolumab treatment.…”

Section: Methodsmentioning

confidence: 99%

“…Study calculations have been reported. 19 All eligible patients enrolled in the study were included in the analyses. For this subanalysis, the effectiveness and safety of nivolumab were assessed in patients aged ≥75 years and compared with patients aged <75 years; for the supplementary analysis, effectiveness outcomes were assessed in patients aged <75 years, 75 to <80 years and ≥80 years.…”

Section: Methodsmentioning

confidence: 99%

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Nivolumab treatment of elderly Japanese patients with non-small cell lung cancer: subanalysis of a real-world retrospective observational study (CA209-9CR)

et al. 2020

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ObjectivesWe conducted a subanalysis of data from the multicentre, retrospective observational Nivolumab Japan Real World (CA209-9CR) study to evaluate nivolumab effectiveness and safety in elderly patients (aged ≥75 years) with advanced/metastatic non-small cell lung cancer.Materials and methodsMedical record data of patients initiating nivolumab treatment between April 2016 and December 2016 were collected using electronic data capture from 23 cancer hospitals in Japan between March 2017 and August 2018. Nivolumab treatment data were collected to investigate the treatment patterns by age group (<75 and ≥75 years), and the effectiveness and safety of nivolumab treatment.ResultsOf the 901 patients evaluated, 178 (19.8%) were aged ≥75 years. Overall, patients received a median of five nivolumab treatments regardless of age group. Comparable progression-free survival was observed, with a median of 2.1 months in patients aged <75 years and 2.1 months in patients aged ≥75 years (p=0.5441). No significant differences were found in duration of response, overall response rate or disease control rate between the two age groups. Median overall survival in patients aged <75 and ≥75 years was 14.7 months and 12.3 months, respectively. Grade ≥3 adverse events (AEs) occurred in 29.2% and 28.1% of patients aged <75 and ≥75 years, respectively. Immune-related AEs decreased slightly with increasing age; time to onset and rates of improvement were similar for patients aged <75 and ≥75 years. The most common grade 3–4 AEs were interstitial lung disease in both age groups (4.0% in patients aged <75 years and 2.8% in those aged ≥75 years). Poor performance status was associated with worse outcomes in both age groups.ConclusionBased on Japanese real-world data, the effectiveness and safety of nivolumab were confirmed regardless of age.

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Real-world effectiveness and safety of nivolumab in patients with non-small cell lung cancer: A multicenter retrospective observational study in Japan

Cited by 59 publications

References 23 publications

Real-World Outcomes of Nivolumab in Patients With Unresectable Hepatocellular Carcinoma in an Endemic Area of Hepatitis B Virus Infection

Real-World Outcomes of Nivolumab in Patients With Unresectable Hepatocellular Carcinoma in an Endemic Area of Hepatitis B Virus Infection

Efficacy of Immune Checkpoint Inhibitors in Non-small-cell Lung Cancer Patients With Different Metastatic Sites: A Systematic Review and Meta-Analysis

Nivolumab treatment of elderly Japanese patients with non-small cell lung cancer: subanalysis of a real-world retrospective observational study (CA209-9CR)

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