Efficacy and Safety of Nivolumab in Previously Treated Patients With Non–Small-cell Lung Cancer: Real World Experience in Argentina

Martín, Claudio; Lupinacci, L.; Perazzo, Florencia; Bas, Carlos; Carranza, Omar; Puparelli, Carmen; Kowalyszyn, Rubén Dario; Magrí, Ignacio; Varela, Mirta; Richardet, Eduardo; Vera, Karina; Foglia, Silvia; Jerez, Ignacio; Aman, E.; Martinengo, Gaston Lucas; Batagelj, Emilio; Dri, Alejandro; Pilnik, N.; Mandó, Pablo; Tsou, Florencia; Recondo, Gonzálo; Cayol, Federico; Flores, M Cathy; Sena, S.; Bagnes, Claudia; Waisberg, Federico; Minatta, J.N.; Rizzo, Manglio

doi:10.1016/j.cllc.2020.02.014

Cited by 21 publications

(18 citation statements)

References 29 publications

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“…However, a high level of heterogeneity should be also noted. The vast majority of studies reported insignificant differences in severe AE rates between the groups, however, studies with a significantly lower [7] or higher [32,65] rates of treatment-related toxicity were present. This analysis might be biased by toxicity underreporting which is well-described in retrospective studies where toxicity is reported by clinicians [99].…”

Section: Discussionmentioning

confidence: 97%

Effectiveness and safety of immunotherapy in NSCLC patients with ECOG PS score ≥2 – Systematic review and meta-analysis

et al. 2021

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Background: Immune checkpoint inhibitors (ICIs) are standard of care in advanced non-small cell lung cancer (NSCLC), however their status in patients with poor performance status (PS) is poorly defined. We aimed to evaluate the efficacy and safety of ICIs in NSCLC patients with PS ≥ 2. Methods: We conducted a systematic review and meta-analysis of interventional and observational studies, which reported efficacy and safety data on ICIs in PS ≥ 2 comparing to PS ≤ 1 NSCLC patients. Efficacy endpoints included: Objective Response Rate (ORR), Disease-Control Rate (DCR), Overall Survival (OS), Progression-Free Survival (PFS). Safety endpoint was the incidence of severe (grade≥3) Adverse Events (AE). Random-effects model was applied for meta-analysis. Heterogeneity was assessed using I 2 . The review is registered on PROS-PERO (CRD42020162668). Findings: Sixty-seven studies (n = 26,442 patients) were included. In PS ≥ 2 vs. PS ≤ 1 patients, the pooled odds ratios were: for ORR 0.46 (95 %CI: 0.39− 0.54, I 2 :0 %); for DCR 0.39 (95 %CI: 0.33− 0.48, I 2 :50 %) and for AEs 1.12 (95 %CI: 0.84-1.48, I 2 :39 %). The pooled hazard ratio for PFS was 2.17 (95 %CI: 1.96-2.39, I 2 :65 %) and for OS was 2.76 (95 %CI: 2.43-3.14, I 2 :76 %). The safety profile was comparable regardless of the PS status. Interpretation: Patients with impaired PS status are, on average, twice less likely to achieve a response when exposed to ICIs when compared with representative PS ≤ 1 population. For lung cancer patients treated with ICIs, the impaired PS is not only prognostic, but also predictive for response, while the safety profile is not affected. Prospective randomized studies are indispensable to determine whether poor PS patients derive benefit from ICIs.

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Section: Discussionmentioning

confidence: 97%

Effectiveness and safety of immunotherapy in NSCLC patients with ECOG PS score ≥2 – Systematic review and meta-analysis

et al. 2021

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“…In a large-scale, real-world analysis of patients with NSCLC who received docetaxel as second-line therapy, atypical pneumonia was the third most common AE, recorded in 18% of patients, and 10-12% of patients needed emergency visits or treatment [23]. The frequency of pneumonitis previously observed with nivolumab monotherapy ranged from 1 to 10.8% in clinical trials and realworld studies [9,10,14,15,24,25]. The age, ECOG status, and pre-existing pulmonary conditions of patients included in the studies affected the frequency of treatment-related pneumonitis.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of efficacy and toxicity of nivolumab combined with or without docetaxel in patients with advanced NSCLC

Wang

Nie

Dai

et al. 2021

Cancer Immunol Immunother

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Background The combination of PD-1/PD-L1 inhibitor and chemotherapy has been clinically confirmed to be beneficial as the first-line treatment of patients with advanced NSCLC. This study aimed to assess the effect of nivolumab + docetaxel versus nivolumab monotherapy in patients with NSCLC after the failure of platinum doublet chemotherapy. Materials and methods The efficacy and toxicity of nivolumab + docetaxel combination therapy versus nivolumab monotherapy were compared in this retrospective study. Primary endpoint of the study was progression-free survival (PFS), and the secondary endpoints were objective response rate (ORR), overall survival (OS), and toxicity. Results Between November 2017 and December 2019, 77 patients were included in this study, with 58 patients in the nivolumab group and 19 in the nivolumab + docetaxel group. The median follow-up was 18 months, and the PFS was 8 months for patients receiving nivolumab + docetaxel and 2 months for those receiving nivolumab alone (p = 0.001), respectively. Nivolumab + docetaxel showed superior OS compared with nivolumab, with the median OS unreached versus 7 months (p = 0.011). Among patients without EGFR/ALK variation, compared to nivolumab monotherapy, nivolumab + docetaxel showed better PFS (p = 0.04) and OS (p = 0.05). There was no significant difference in grade 3–4 adverse events (AEs) between the two groups (p = 0.253). Conclusions The combination of nivolumab and docetaxel demonstrated a meaningful improvement in progression-free survival and overall survival compared to nivolumab monotherapy, in patients with NSCLC after the failure of platinum doublet chemotherapy, irrespective of EGFR/ALK variation status.

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“…Another Argentinian study was conducted to explore the efficacy and safety of nivolumab in previously treated patients with advanced NSCLC; the results showed that nivolumab was well tolerated, with promising prognostic outcomes in patients with NSCLC who had undergone previous treatment. 75 respectively. 78 The KEYNOTE-025 trial assessed the safety and efficacy of pembrolizumab in patients with NSCLC who had been previously treated in Japan.…”

Section: Pd-1/pd-l1 Inhibitors As Second-line Treatment In Advanced Nsclcmentioning

confidence: 98%

The progress and challenge of anti-PD-1/PD-L1 immunotherapy in treating non-small cell lung cancer

Mei

Liu

et al. 2021

Ther Adv Med Oncol

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The use of programmed cell-death protein 1 (PD-1)/programmed cell-death ligand 1 (PD-L1) inhibitors is the standard therapy for the first-line or second-line treatment of patients with non-small-cell lung cancer (NSCLC). In contrast to current traditional treatments such as chemotherapy or radiotherapy, anti-PD-1 and anti-PD-L1 treatments can directly attenuate tumour-mediated exhaustion and effectively modulate the host anti-tumour immune response in vivo. In addition, compared with traditional therapy, PD-1/PD-L1 inhibitor monotherapy can significantly prolong survival without obvious side effects in the treatment of advanced NSCLC. Ideally, several biomarkers could be used to monitor the safety and effectiveness of anti-PD-1 and anti-PD-L1 treatments; however, the current lack of optimal prognostic markers remains a widespread limitation and challenge for further clinical applications, as does the possibility of immune-related adverse events and drug resistance. In this review, we aimed to summarise the latest progress in anti-PD-1/anti-PD-L1 treatment of advanced NSCLC, worldwide, including in China. An exploration of underlying biomarker identification and future challenges will be discussed in this article to facilitate translational studies in cancer immunotherapy.

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Efficacy and Safety of Nivolumab in Previously Treated Patients With Non–Small-cell Lung Cancer: Real World Experience in Argentina

Cited by 21 publications

References 29 publications

Effectiveness and safety of immunotherapy in NSCLC patients with ECOG PS score ≥2 – Systematic review and meta-analysis

Effectiveness and safety of immunotherapy in NSCLC patients with ECOG PS score ≥2 – Systematic review and meta-analysis

Evaluation of efficacy and toxicity of nivolumab combined with or without docetaxel in patients with advanced NSCLC

The progress and challenge of anti-PD-1/PD-L1 immunotherapy in treating non-small cell lung cancer

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