Real-world data from the Portuguese Nivolumab Expanded Access Program (EAP) in previously treated Non Small Cell Lung Cancer (NSCLC)

Figueiredo, Ana; Almeida, Maria Amélia; Almodovar, Teresa; Alves, Paula M.; Araújo, António; Araújo, David; Barata, Fernando; Barradas, Lourdes; Barroso, Ana; Brito, Ulisses; Camacho, Eduard Cadavid; Canário, Dolores; Cardoso, Teresa; Chaves, A.; Costa, Luís; Cunha, J.; Duarte, José; Estevinho, F.; Felizardo, M.; Fernandes, João Paulo S.; Ferreira, L.; Fidalgo, Paula; Freitas, Cláudia; Garrido, Pilar; Gil, Nuno; Hasmucrai, Direndra; Jesus, Eduarda Eugenia Dias de; Lopes, José António; Macedo, Joana Espiga de; Meleiro, A.; Neveda, R; Nogueira, Fábio César Sousa; Pantorotto, M.; Parente, Bárbara; Pêgo, Alice; Rocha, Mário de Seixas; Roque, Juliano Miguel Amado; Santos, Cristina; Saraiva, J.; Silva, E.; Silva, Stephany Caroline Menezes da; Simões, Sérgio; Soares, Marta; Teixeira, E.; Timóteo, Teresa; Hespanhol, Venceslau

doi:10.1016/j.pulmoe.2019.06.001

Cited by 18 publications

(18 citation statements)

References 14 publications

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“…Similarly, compared with nivolumab alone, the OS of nivolumab + docetaxel was significantly longer (unreached vs. 7 months, p = 0.011). The ORR of nivolumab in this study (15.5%) was slightly lower than previous reports (17.6-22.3%) [17][18][19], perhaps because in this study almost 57% of the patients were receiving nivolumab as a third or fourth line of therapy. Furthermore, it caused the median OS of nivolumab in this study was lower than it was reported in Checkmate 017 and Checkmate 057 [8,9].…”

Section: Discussioncontrasting

confidence: 90%

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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Section: Discussioncontrasting

confidence: 90%

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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“…Performance status is the most important prognostic factor. Several multivariate analyses showed ECOG 0–1 to be the most significant predictor of clinical benefit [ 6 , 7 , 13 , 30 , 31 ]. An analysis that focused on negative prognostic factors in response to nivolumab therapy clearly identified the following risk factors of early death: ECOG ≥ 2 (OR 5.66, 95% CI 2.01–15.61; p < 0.001), C-reactive protein to albumin ratio >0.3 (OR 10.56, 95% CI 3.61–3086; p < 0.001), and poor response to first-line chemotherapy (OR 2.06, 95% CI 1.03–4.14; p < 0.001) [ 31 ].…”

Section: Discussionmentioning

confidence: 99%

“…ECOG 0–1 is required in clinical trials, but the patient population is much more diverse in clinical practice. According to the real-world data, the prevalence of patients with ECOG ≥ 2 who are treated with nivolumab ranges from 3% to 46% [ 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 ]. The prognostic value of performance status has been well documented.…”

Section: Nivolumab In Daily Practicementioning

confidence: 99%

“…Poor performance status was also a risk factor for short PFS (HR 0.64, 95% CI 0.51–0.8; p < 0.0001) [ 8 ]. Multivariate analysis of the Portuguese EAP data identified performance status as the only independent prognostic factor ( p < 0.0006) [ 13 ]. In a univariate analysis, the risk of death was much lower in patients with ECOG 0–1 than in patients with ECOG 2 (HR 3.8, 95% CI 2.3–6.07; p < 0.0001) [ 13 ].…”

Section: Nivolumab In Daily Practicementioning

confidence: 99%

“…Multivariate analysis of the Portuguese EAP data identified performance status as the only independent prognostic factor ( p < 0.0006) [ 13 ]. In a univariate analysis, the risk of death was much lower in patients with ECOG 0–1 than in patients with ECOG 2 (HR 3.8, 95% CI 2.3–6.07; p < 0.0001) [ 13 ]. Another univariate analysis reported an OS of 3.4 months (95% CI 2.3–4.4) in patients with ECOG 2 versus 11.79 months (95% CI 8.5–15.07) in patients with ECOG 1.…”

Section: Nivolumab In Daily Practicementioning

confidence: 99%

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Nivolumab for Previously Treated Patients with Non-Small-Cell Lung Cancer—Daily Practice versus Clinical Trials

Knetki-Wróblewska

Kowalski

Krzakowski

2020

JCM

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Based on the results of the CheckMate 017 and CheckMate 057 studies, nivolumab therapy has become a new standard treatment for both squamous and non-squamous non-small-cell lung cancer (NSCLC). However, due to the specific inclusion criteria of these clinical trials, the efficacy and safety of nivolumab in real-world practice were not certain. In general, the real-world results of nivolumab treatment have been consistent with those obtained in clinical trials. Additional analyses of the real-world data have made the identification of prognostic factors possible. Good performance status is the most significant predictor of clinical benefit. Brain metastases, liver metastases, EGFR mutation, malignant pleural effusion, and a high number of metastatic sites were identified as negative prognostic factors. By contrast, a longer time to disease progression (>6 months) from the beginning of prior chemotherapy and an objective response to chemotherapy seem to have positive prognostic value in the case of nivolumab treatment. In terms of patient age, the data are inconclusive. Some blood biomarkers can also be considered significant prognostic factors.

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Predictive factors for progression‐free survival in non‐small cell lung cancer patients receiving nivolumab based on performance status

et al. 2019

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Background Nivolumab has promising efficacy for the treatment of non‐small cell lung cancer (NSCLC). Various predictive factors for nivolumab response in those with NSCLC have been reported, including performance status (PS). The objective of this retrospective study was to determine the predictive factors for nivolumab response in those with NSCLC with good PS and those with poor PS. Methods We retrospectively collected pretreatment clinical data of 296 consecutive patients with NSCLC treated with nivolumab. We investigated the relationship between progression‐free survival (PFS) and patient characteristics and analyzed predictive factors associated with good PS (PS 0‐1) or poor PS (PS 2‐4). Results The median age of patients was 70 years; 206 patients were male, and 224 were classified as having good PS (PS 0‐1). The median PFS was 3.0 months, 3.7 months, and 1.2 months for all patients, patients with good PS, and patients with poor PS respectively. Multivariate analysis showed that never smoking (hazard ratio [HR], 1.77; 95% confidence interval [CI], 1.15‐2.75), high C‐reactive protein (CRP) (HR, 1.39; 95% CI, 1.00‐1.93), liver metastasis (HR, 1.95; 95% CI, 1.24‐3.07), pleural effusion (HR, 1.45; 95% CI, 1.06‐2.00), and steroid use (HR, 2.85; 95% CI, 1.65‐4.94) were associated with significantly shorter PFS in patients with good PS. A high advanced lung cancer inflammation index (ALI) was significantly associated with longer PFS in patients with poor PS (HR, 0.24; 95% CI, 0.08‐0.79). Conclusions In patients with NSCLC treated with nivolumab, the factors found to be predictive of shorter PFS in patients with good PS were never smoking, high CRP, liver metastasis, pleural effusion, and steroid administration, whereas high ALI was predictive of longer PFS in patients with poor PS.

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Real-world data from the Portuguese Nivolumab Expanded Access Program (EAP) in previously treated Non Small Cell Lung Cancer (NSCLC)

Cited by 18 publications

References 14 publications

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

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

Nivolumab for Previously Treated Patients with Non-Small-Cell Lung Cancer—Daily Practice versus Clinical Trials

Predictive factors for progression‐free survival in non‐small cell lung cancer patients receiving nivolumab based on performance status

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