Oral Metronomic Vinorelbine in Advanced Non-small Cell Lung Cancer Patients Unfit for Chemotherapy
Why this work is in the frame
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Bibliographic record
Abstract
Aim: To explore the feasibility and activity of oral metronomic vinorelbine patients with advanced NSCLC not eligible to standard chemotherapy because of old age (70 years), and/or poor Eastern Cooperative Oncology Group performance status (2), and/or extensive brain or bone disease, and/or active comorbidities (2) requiring for pharmacological treatment. Patients and Methods: In a prospective phase II not randomized study, patients with stage IV NSCLC unfit to chemotherapy were treated with oral metronomic vinorelbine at 30 mg fixed dose three times a week until disease progression. Results: Fifty patients were treated, 19 (38%) in the first-line setting. Five patients (11%) experienced a grade 3 toxicity; no grade 4 toxicity occurred. Overall disease control rate was 32%, 44% and 26% in first and subsequent lines, respectively (p=0.39). Median OS and PFS were 7.3 months (95% confidence interval [CI]=4.7-10.0) and 2.7 months (95%CI=2.0-3.4), respectively. Conclusion: These data support the activity and safety of metronomic vinorelbine in a relevant proportion of patients usually excluded from any specific treatment. Lung cancer is the most common cancer in males and the most frequent cause of cancer-related death in both sexes. The incidence of lung cancer is steadily increasing, with 1,824,701 million new cases per year and 1,589,925 million of deaths estimated worldwide in 2012 (1). About 70% of patients present with metastatic or locally advanced disease (2, 3). Non-small cell lung cancer (NSCLC) accounts for approximately 85% of all newly-diagnosed lung cancer (4). Patients with advanced lung cancer have an expected median survival of 6 months and a 5-year survival of 2% (5). In this palliative setting, chemotherapy has proven to be a significant improvement of survival, although it is associated with even relevant toxicity (6, 7). A doublet platinum-based chemotherapy in those patients not harbouring an epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) molecular alteration or with low or negative PDL1 expression is the preferred chemotherapy regimen Approximately 16% of adenocarcinoma patients with EGFR-mutated and 4% with ALK will benefit more from tyrosine kinase inhibitors (TKIs) (10-13). More recently, immuno-oncology has been changing this scenario leading to an increasing proportion of patients surviving both in the locally advanced or advanced NSCLC (14-18). In the firstline treatment, immune-oncology has replaced chemotherapy in those patients with a high expression of PDL1, representing in clinical trials approximately the 25% of all advanced NSCLC patients (19).
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Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it