Use of nivolumab in elderly patients with advanced squamous non–small-cell lung cancer: results from the Italian cohort of an expanded access programme

Grossi, Francesco; Crinò, Lucio; Logroscino, Antonio; Canova, Stefania; Delmonte, Angelo; Melotti, Barbara; Proto, Claudia; Gelibter, Alain; Cappuzzo, Federico; Turci, D.; Gamucci, Teresa; Antonelli, Paola; Marchetti, Paolo; Santoro, Armando; Giusti, S.; Costanzo, Francesco Di; Giustini, Lucio; Conte, Alessandro Del; Livi, Lorenzo; Giannarelli, Diana; Marinis, Filippo de

doi:10.1016/j.ejca.2018.05.015

Cited by 86 publications

(60 citation statements)

References 29 publications

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“…In comparison, the HR did not favour nivolumab over docetaxel in patients !75 years of age in CheckMate 017, although these results should be interpreted with caution due to the small number of elderly patients included [16]. In addition, median OS was lower (5.8 months) in patients !75 years of age compared with the overall population in the Italian expanded access program, potentially due to the high proportion of elderly patients with comorbidities in this study [21]. Response rates in elderly patients were similar to the overall population of this trial and to earlier reports of nivolumab in previously treated patients with squamous NSCLC [19].…”

Section: Discussionsupporting

confidence: 74%

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CheckMate 171: A phase 2 trial of nivolumab in patients with previously treated advanced squamous non-small cell lung cancer, including ECOG PS 2 and elderly populations

Felip

Ardizzoni

Ciuleanu

et al. 2020

European Journal of Cancer

119

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Background: CheckMate 171 (NCT02409368) is an open-label, multicentre, phase 2 trial of nivolumab in previously treated advanced squamous non-small cell lung cancer (NSCLC), conducted as part of a post-approval commitment to the European Medicines Agency (EMA). We report outcomes from this trial. Methods: Patients with Eastern Cooperative Oncology Group performance status (ECOG PS) 0e2 and disease progression during/after !1 systemic treatment (!1 being platinum-based chemotherapy) for advanced or metastatic disease were treated with nivolumab 3 mg/kg every 2 weeks until progression or unacceptable toxicity. The primary end-point was incidence of grade 3e4 treatment-related select adverse events (AEs). Other end-points included overall survival (OS) and safety. Results: Of 811 patients treated, 103 had ECOG PS 2; 278 were aged !70 years and 125 were !75 years of age. Minimum follow-up was~18 months. Safety was similar across populations; the most frequent grade 3e4 treatment-related select AEs in all treated patients were diarrhoea (1%), increased alanine aminotransferase (ALT, 1%), pneumonitis (0.7%), colitis (0.6%) and increased aspartate aminotransferase (AST, 0.5%). Median OS was similar in all treated patients and those aged !70 and !75: 10.0 months, 10.0 months and 11.2 months, respectively. Median OS was 5.2 months in patients with ECOG PS 2. Conclusion: These results suggest that nivolumab is well tolerated and active in patients with advanced, relapsed squamous NSCLC, including the elderly, with OS outcomes consistent with phase 3 data. In patients with ECOG PS 2, nivolumab had similar tolerability, but outcomes were worse, as expected in this difficult-to-treat, poor prognosis population. Clinical trial registration: NCT02409368.

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Section: Discussionsupporting

confidence: 74%

“…However, these pivotal trials provided limited data on patients with squamous NSCLC and poor prognostic factors. More recently, real-world studies have shown that nivolumab is effective and well tolerated in elderly patients and those with poor performance status [7,21,22].…”

Section: Introductionmentioning

confidence: 99%

CheckMate 171: A phase 2 trial of nivolumab in patients with previously treated advanced squamous non-small cell lung cancer, including ECOG PS 2 and elderly populations

Felip

Ardizzoni

Ciuleanu

et al. 2020

European Journal of Cancer

119

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“…Importantly, our work is consistent with the findings of a recent study demonstrating that patients age 75 years or older who had squamous NSCLC and were receiving immunotherapy had shorter OS compared with younger patients, yet comparable toxicity profiles. 13 Our work also provides insight into the specific toxicities experienced by older patients with NSCLC treated with PD-1 and PD-L1 blockade. In our cohort, thyroiditis, dermatitis, and pneumonitis were the most common irAEs, which is consistent with the findings of other studies.…”

Section: Discussionmentioning

confidence: 91%

Impact of Age on Outcomes with Immunotherapy in Patients with Non–Small Cell Lung Cancer

Lichtenstein

Nipp

Muzikansky

et al. 2019

Journal of Thoracic Oncology

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Introduction: Immunotherapy has revolutionized the treatment of NSCLC, but little is known about the activity of programmed cell death 1 and programmed death ligand 1 blockade across age groups. Methods: We retrospectively evaluated patients with NSCLC who initiated programmed cell death 1 and programmed death ligand 1 inhibitors from January 2013 through July 2017. Medical records and radiographic imaging were reviewed to determine progression-free survival (PFS) and overall survival (OS). We also compared immunotherapy-related toxicities, steroid use, and hospitalizations by age. Results: Of the 245 patients, 26.1% were younger than 60 years, 31.4% were age 60 to 69 years, 31.0% were age 70 to 79 years, and 11.4% were age 80 years or older. The median PFS times by age group were as follows: younger than 60 years, 1.81 months; age 60 to 69 years, 2.53 months; age 70 to 79 years, 3.75 months; and age 80 years or older, 1.64 months (log-rank p value ¼ 0.055). The median OS times by age group were as follows: younger than 60 years, 13.01 months; age 60 to 69 years, 14.56 months; age 70 to 79 years, 12.92 months; and age 80 years or older, 3.62 months (log-rank p value ¼ 0.011). Rates of immunotherapy-related toxicities, steroid use, and hospitalizations did not differ by age. Conclusions: Although the OS and PFS benefits of immunotherapy differ by age, the rates of toxicity are similar regardless of age.

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“…Despite broader inclusion criteria used in EVIDENS, these effectiveness results are in line with those of the CheckMate 017 7 and 057 6 phase III trials and other real-world studies of nivolumab conducted in Europe ( Table 5). [15][16][17][18][19][20][21][22][23][24][25][26][27] Examination of the influence of baseline characteristics on OS did not reveal any significant effect of PD-L1 expression, although the analysis may have been underpowered to detect an association given that the sample size of patients in whom PD-L1 expression data were available was small. ECOG PS, smoking status, corticosteroids at baseline, EGFR mutation status, symptomatic brain metastasis and TRAEs significantly influenced OS in nivolumab recipients as seen in our multivariate analysis, even though some of these factors are also well-known prognostic factors in NSCLC.…”

Section: Discussionmentioning

confidence: 99%

“…13 Instead, data have been reported from small patient cohorts, retrospective studies and early access programs, for which inclusion/exclusion enrollment criteria may be restrictive. [13][14][15][16][17][18][19][20][21][22][23][24][25][26][27] Due to known variation in cancer survival rates across Europe, 28 country-specific data may be more appropriate to describe the real-world experience with nivolumab in the treatment of NSCLC. Furthermore, data collected in the context of a real-world study can also help to address important clinical evidence gaps such as the outcomes in patients who were underrepresented in, or excluded from, pivotal clinical trials of nivolumab due to more severe comorbidities or poor prognostic factors.…”

Section: Introductionmentioning

confidence: 99%

Effectiveness and safety of nivolumab in the treatment of lung cancer patients in France: preliminary results from the real-world EVIDENS study

et al. 2020

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EVIDENS is an ongoing, prospective, non-interventional study evaluating the effectiveness and safety of nivolumab in lung cancer patients in France (ClinicalTrials.gov NCT03382496).Adults with a pathologically confirmed diagnosis of lung cancer and initiating treatment with nivolumab were recruited from 146 sites in France. This analysis included only patients with non-small cell lung cancer (NSCLC) who received ≥1 nivolumab infusion, and evaluated patient characteristics at the time of nivolumab initiation and its effectiveness and safety after a median follow-up of 18 months.A total of 1,420 patients with NSCLC were included, most of whom had an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1 (82.9%), non-squamous histology (69.2%) and stage IV disease (91.4%). Brain metastases were present in 19.9% of patients. Nivolumab was a secondline or ≥third-line regimen in 73.6% and 26.1% of patients, respectively. Almost all patients had prior chemotherapy (99.7%). Median overall survival was 11.2 months (95% confidence interval [CI]: 10.0--12.4). ECOG PS, smoking status, corticosteroids at baseline, epidermal growth factor receptor mutation status, presence of symptomatic brain metastases and treatment-related adverse events (TRAEs) were independent predictors of survival. Grade 3 and 4 TRAEs were reported in 105 (7.4%) and 12 (0.8%) patients, respectively; no treatment-related deaths were reported.Preliminary results of the EVIDENS study confirm the effectiveness and safety of nivolumab, mostly in pre-treated advanced NSCLC patients, with similar benefits to those observed in the phase III randomized clinical trials, despite a broader study population. ARTICLE HISTORY

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Use of nivolumab in elderly patients with advanced squamous non–small-cell lung cancer: results from the Italian cohort of an expanded access programme

Cited by 86 publications

References 29 publications

CheckMate 171: A phase 2 trial of nivolumab in patients with previously treated advanced squamous non-small cell lung cancer, including ECOG PS 2 and elderly populations

CheckMate 171: A phase 2 trial of nivolumab in patients with previously treated advanced squamous non-small cell lung cancer, including ECOG PS 2 and elderly populations

Impact of Age on Outcomes with Immunotherapy in Patients with Non–Small Cell Lung Cancer

Effectiveness and safety of nivolumab in the treatment of lung cancer patients in France: preliminary results from the real-world EVIDENS study

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