Publications by authors named "Aurelia Alexandru"

Background: We report 5-year efficacy and safety outcomes from CheckMate 9LA in patients with metastatic non-small cell lung cancer (mNSCLC) and exploratory analyses in key patient subgroups.

Methods: Adults with stage IV/recurrent NSCLC and no sensitizing EGFR/ALK alterations were randomized to receive nivolumab plus ipilimumab with chemotherapy (n = 361) or chemotherapy (n = 358). Outcomes were assessed in all randomized patients and subgroups.

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Article Synopsis
  • A phase 3 trial found that neoadjuvant treatment with nivolumab plus chemotherapy improved event-free survival in patients with resectable non-small-cell lung cancer (NSCLC) compared to chemotherapy alone, with 70.2% of the nivolumab group remaining event-free at 18 months, versus 50.0% in the chemotherapy group.!* -
  • Patients receiving nivolumab also had a significantly higher rate of pathological complete response (25.3%) compared to those on chemotherapy (4.7%), indicating better treatment efficacy.!* -
  • The safety profile was similar between both groups, with 32.5% of nivolumab patients experiencing grade 3 or 4 treatment-related adverse events
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Background: In CheckMate 9LA, nivolumab plus ipilimumab with chemotherapy prolonged overall survival (OS) versus chemotherapy regardless of tumor PD-L1 expression or histology. We report updated efficacy and safety in all randomized patients with a minimum 4-year follow-up and an exploratory treatment-switching adjustment analysis in all treated patients who received chemotherapy and subsequent immunotherapy.

Methods: Adults with stage IV/recurrent non-small cell lung cancer (NSCLC), no sensitizing alterations, and ECOG performance status ≤1 were randomized 1:1 to nivolumab 360 mg every 3 weeks plus ipilimumab 1 mg/kg every 6 weeks with chemotherapy (two cycles) or chemotherapy (four cycles, with optional maintenance pemetrexed for the nonsquamous population).

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Introduction: In CheckMate 227 Part 1, nivolumab plus ipilimumab prolonged overall survival (OS) versus chemotherapy in patients with metastatic NSCLC, regardless of tumor programmed death-ligand 1 (PD-L1) expression. Here, we report post hoc exploratory systemic and intracranial efficacy outcomes and safety by baseline brain metastasis status at 5 years' minimum follow-up.

Methods: Treatment-naive adults with stage IV or recurrent NSCLC without EGFR or ALK alterations, including asymptomatic patients with treated brain metastases, were enrolled.

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Background: In CheckMate 9LA (NCT03215706), first-line nivolumab plus ipilimumab with chemotherapy (2 cycles) significantly improved overall survival versus chemotherapy (4 cycles) in patients with metastatic non-small cell lung cancer and no known sensitising epidermal growth factor receptor/anaplastic lymphoma kinase alterations. We present exploratory patient-reported outcomes (PROs; minimum follow-up, 2 years).

Methods: In patients (N = 719) randomised 1:1 to nivolumab plus ipilimumab with chemotherapy or chemotherapy alone, disease-related symptom burden and health-related quality of life were assessed using the Lung Cancer Symptom Scale (LCSS) and 3-level EQ-5D (EQ-5D-3L).

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Introduction: In CheckMate 227, nivolumab plus ipilimumab prolonged overall survival (OS) versus chemotherapy in patients with tumor programmed death-ligand 1 (PD-L1) greater than or equal to 1% (primary end point) or less than 1% (prespecified descriptive analysis). We report results with minimum 4 years' follow-up.

Methods: Adults with previously untreated stage IV or recurrent NSCLC were randomized (1:1:1) to nivolumab plus ipilimumab, nivolumab, or chemotherapy (PD-L1 ≥1%); or to nivolumab plus ipilimumab, nivolumab plus chemotherapy, or chemotherapy (PD-L1 <1%).

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Article Synopsis
  • This study examines the effectiveness of combining nivolumab and ipilimumab with two cycles of chemotherapy in treating advanced non-small-cell lung cancer (NSCLC), aiming to improve patient survival.* -
  • Conducted across 103 hospitals in 19 countries, the trial randomly assigned 1150 patients to either the experimental group (nivolumab + ipilimumab + chemotherapy) or a control group (chemotherapy alone), assessing overall survival as the primary outcome.* -
  • Results from an interim analysis showed that patients in the experimental group had a significantly longer overall survival (median 14.1 months) compared to those receiving chemotherapy alone.*
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Aim: The current study evaluated the efficacy and tolerability of second-line afatinib in patients with mutation-positive (m+) non-small-cell lung cancer (NSCLC) following chemotherapy.

Patients & Methods: In this open-label, single-arm Phase IV study, patients with m+ (Del19/L858R) NSCLC who had progressed following platinum-based chemotherapy received afatinib (starting dose 40 mg/day). The primary end point was confirmed objective response.

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Background: In an early-phase study involving patients with advanced non-small-cell lung cancer (NSCLC), the response rate was better with nivolumab plus ipilimumab than with nivolumab monotherapy, particularly among patients with tumors that expressed programmed death ligand 1 (PD-L1). Data are needed to assess the long-term benefit of nivolumab plus ipilimumab in patients with NSCLC.

Methods: In this open-label, phase 3 trial, we randomly assigned patients with stage IV or recurrent NSCLC and a PD-L1 expression level of 1% or more in a 1:1:1 ratio to receive nivolumab plus ipilimumab, nivolumab alone, or chemotherapy.

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We report a rare case of testicular teratoma combined with a neuroendocrine tumour, emphasizing the difficulty of the following aspects: the clinical and laboratory diagnosis, the treatment options and the evolution of patients suffering from this disease. Case presentation: The patients with testicular neuroendocrine tumours represent a rarity, considering that as of 2017, only 22 cases had been reported in the literature. The case operated on in our clinic presents an association between a testicular teratoma and a neuroendocrine tumour.

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Purpose: For lung cancer, the TNM staging system included atelectasis (At) as a negative prognostic factor, within the T category. However, according to our clinical experience, we observed the opposite. The aim of the study was to evaluate the influence of At on patient outcome for unresectable stage III and IV non-small cell lung cancer (NSCLC).

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During the last years, molecular targeted agents generated a small revolution within the various treatment options for malignant tumors. Preclinical data showed that activation of the epidermal growth factor receptor (EGFR)-depending downstream pathways, plays a major role in tumor growth and development. Small molecules, like the tyrosine kinase inhibitors (TKIs), proved their capacity to inhibit the trigger event of this oncogenic activation.

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Background: The impact of adjuvant chemotherapy (CT) in the management of resectable non-small cell lung cancer (NSCLC) is highly debated. The aim of the study was to evaluate the outcome of this category of patients, treated at the Military Hospital Bucharest (surgery) and Institute of Oncology Bucharest (CT).

Patients And Methods: We retrospectively analyzed the survival data according to various patients' characteristics, the corresponding pattern of relapses, along with the data concerning the CT program.

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