Durvalumab in frail and elderly patients with stage four non-small cell lung cancer: Study protocol of the randomized phase II DURATION trial

Kuon, Jonas; Hommertgen, Adriane; Krisam, Johannes; Lasitschka, Felix; Blasi, Miriam; Bozorgmehr, Farastuk; Maenz, Martin; Kieser, Meinhard; Schneider, Marc A.; Thomas, Michael

doi:10.1186/s13063-020-04280-8

Cited by 7 publications

(3 citation statements)

References 46 publications

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“…Our data, according with those from similar experiences in melanoma ( 37 ), clearly disproves the mistake that age-related impairment of the immune system hampers the effectiveness of PD-1 blockade. This evidence could explain the efficacy of cemiplimab also in the frail subgroup and add data to a poorly investigated issue on which trials are being planned ( 32 ). Of note is that we found an equivalent rate of response also in the subgroup of immunosuppressed patients.…”

Section: Discussionmentioning

confidence: 90%

“…Medical data were reviewed to categorize the comorbidity of a patient by the modified Charlson Comorbidity Index (CCI) (29). A frailty index adopted in studies on a similar population (30)(31)(32) was set up by adding scores assigned to age, ECOG performance status, and CCI as defined in Supplementary Table S1. A score ≥2 defined the frail population.…”

Section: Methodsmentioning

confidence: 99%

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Cemiplimab in an Elderly Frail Population of Patients With Locally Advanced or Metastatic Cutaneous Squamous Cell Carcinoma: A Single-Center Real-Life Experience From Italy

et al. 2021

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BackgroundCutaneous squamous cell carcinoma (CSCC) is the second most common skin cancer whose incidence is growing parallel to the lengthening of the average lifespan. Cemiplimab, an antiPD-1 monoclonal antibody, is the first approved immunotherapy for patients with locally advanced CSCC (laCSCC) or metastatic CSCC (mCSCC) thanks to phase I and II studies showing high antitumor activity and good tolerability. Nevertheless, at present, very few data are available regarding cemiplimab in real-life experience and in frail, elderly, and immunosuppressed patients as well as regarding biomarkers able to predict response so as to guide therapeutic choices.Patients and MethodsWe built a retroprospective cohort study including 30 non-selected patients with laCSCC (25) and mCSCC (five) treated with cemiplimab from August 2019 to November 2020. Clinical outcomes, toxicity profile, and correlations with disease, patients, and peripheral blood parameters are explored.ResultsThe median age was 81 years (range, 36–95), with 24 males and five patients having an immunosuppressive condition, while the frailty prevalence was 83% based on index derived from age, Eastern Cooperative Oncology Group performance status, and Charlson Comorbidity Index. We reported 23 responses (76.7%) with nine complete responses (30%). A statistically significant higher response rate was observed in head and neck primary tumors and in patients with hemoglobin level >12 g/dl. No difference was observed with respect to frailty, median age, sex, and body mass index. The baseline low neuthophil/lymphocyte ratio and low platelet/lymphocyte ratio resulted to be also correlated with a better response. Moreover, lymphocyte, neutrophil, and monocyte behaviors had an opposite trend in responders and non-responders. An overall response was reported in four of five immunosuppressed patients. Seventeen patients (57.6%) have an ongoing response and are still alive. Six responders had interrupted treatment (two for toxicity and four for personal choice) but maintained their response. The treatment was well tolerated by the majority of patients. The most common adverse events were fatigue in seven patients (23.3%) and skin toxicity in 10 patients (33.3%), including pruritus in six patients, rash in three patients, and bullous erythema in one patient.ConclusionsIn our real-life experience, cemiplimab showed a high antitumor activity with acceptable safety profile similar to those in trials with selected patients. Moreover, its antitumor activity resulted to be not impaired in very elderly patients and in those with immunocompromised status.

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Section: Discussionmentioning

confidence: 90%

Section: Methodsmentioning

confidence: 99%

Cemiplimab in an Elderly Frail Population of Patients With Locally Advanced or Metastatic Cutaneous Squamous Cell Carcinoma: A Single-Center Real-Life Experience From Italy

et al. 2021

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“…More research is needed in the elderly population to better understand the role of immunotherapy in this particular patient subset. The DURATION study is a Phase II trial comparing doublet chemotherapy for four cycles versus single-agent chemotherapy for two cycles followed by two cycles of durvalumab and subsequent durvalumab maintenance treatment every 4 weeks in patients ≥70 years of age, with primary end point including treatment-related grade III/IV adverse events and secondary end point PFS, RR and OS analyzed by PD-L1 expression (NCT03345810) [ 34 ].…”

Section: Selection Of Patientsmentioning

confidence: 99%

Choosing the best first-line therapy: NSCLC with no actionable oncogenic driver

Kim

Halmos

2020

Lung Cancer Manag.

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Combination platinum-based therapy has been the standard of care for the treatment of advanced non-small-cell lung cancer (NSCLC). Immunotherapy has emerged and demonstrated to show benefit in the treatment of patients with advanced NSCLC. In this review, we discuss the pivotal trials that led to the US FDA approval of specific immunotherapy regimens in particular patient populations. We discuss the optimal use of immunotherapy as monotherapy based on the KEYNOTE-024, KEYNOTE-042 and IMpower110 trials, chemo-immunotherapy based on KEYNOTE-189, KEYNOTE-407, IMpower150 and IMpower130 trials, and as doublet immunotherapy based on CheckMate-227. We also discuss the role and limitations of PD-L1 expression and tumor mutational burden as predictive biomarkers in response to single-agent immunotherapy and combination chemoimmunotherapy. Furthermore, we discuss emerging resistance markers such as STK11 and KEAP1 mutations in immunotherapy response and briefly discuss the role of immunotherapy in elderly patients and in patients with actionable mutations.

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Tolérance et efficacité des inhibiteurs de points de contrôle immunitaire en monothérapie chez les patients âgés

Mailly-Giacchetti,

Lopez-Trabada,

Feldman

et al. 2023

Bulletin du Cancer

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Durvalumab in frail and elderly patients with stage four non-small cell lung cancer: Study protocol of the randomized phase II DURATION trial

Cited by 7 publications

References 46 publications

Cemiplimab in an Elderly Frail Population of Patients With Locally Advanced or Metastatic Cutaneous Squamous Cell Carcinoma: A Single-Center Real-Life Experience From Italy

Cemiplimab in an Elderly Frail Population of Patients With Locally Advanced or Metastatic Cutaneous Squamous Cell Carcinoma: A Single-Center Real-Life Experience From Italy

Choosing the best first-line therapy: NSCLC with no actionable oncogenic driver

Tolérance et efficacité des inhibiteurs de points de contrôle immunitaire en monothérapie chez les patients âgés

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