ABSTRACT
BACKGROUND: There is limited literature on the prevalence of EGFR mutations in early-stage non-small cell lung cancer (NSCLC). EARLY-EGFR (NCT04742192), a cross-sectional study, determined the prevalence of EGFR mutations in early-stage NSCLC. METHODS: This non-interventional, real-world study enrolled consecutive patients with resected stage IA-IIIB (American Joint Committee on Cancer 8th edition) NSCLC from 14 countries across Asia, Latin America, and Middle East and Africa. The primary endpoint was prevalence of EGFR mutations and secondary endpoints included prevalence of EGFR mutation subtypes and treatment patterns. RESULTS: Of 601 patients (median [range] age: 62.0 [30.0-86.0] years) enrolled, 52.7% were females and 64.2% were non-smokers. The majority had stage IA-IB NSCLC (64.1%) and adenocarcinoma histology (98.7%). Overall prevalence of EGFR mutations was 51.0%; majority reported exon-19 deletions (48.5%) followed by exon-21 L858R mutations (34.0%). Women had a higher EGFR mutation rate than men (64.0% versus 36.4%). Compared with no EGFR mutations, patients with EGFR mutations were more likely to be non-smokers (35.1% versus 60.9%) and have stage I NSCLC compared to stage II and III NSCLC (54.8% versus 47.3% and 35.6%). Systemic adjuvant therapy was planned in 33.8% patients with stage IB to IIIB disease and adjuvant chemoradiotherapy in 6.8% patients. Age ≥60 years, females, and Asians were found to have a significantly (p < 0.05) higher odds of EGFR mutations, while smoking history and stage III disease had lower odds of EGFR mutations. CONCLUSION: The EARLY-EGFR study provides an overview of EGFR mutations and subtype prevalence in patients with early-stage NSCLC. The study highlights the limited adherence to treatment guidelines suggesting an unmet need for improved adjuvant therapy.
ABSTRACT
Ovarian cancer (OC) is the leading cause of death from gynaecological cancer. It is extremely hard to diagnose in the early stages and around 70% of patients present with advanced disease. Metronomic chemotherapy (MCT) is described as the chronic administration of, generally low, equally spaced, doses of chemotherapeutic drugs with therapeutic efficacy and low toxicity. This is an effective and low-cost way to treat several types of tumours, including ovarian cancer. Here, we present six cases of advanced ovarian cancer treated with MCT with low doses of cyclophosphamide, which showed clinical response and stable disease.
ABSTRACT
BACKGROUND: Preclinical results showing therapeutic effect and low toxicity of metronomic chemotherapy with cyclophosphamide (Cy) + celecoxib (Cel) for mammary tumors encouraged its translation to the clinic for treating advanced breast cancer patients (ABCP). PATIENTS AND METHODS: A single-arm, mono-institutional, non-randomized, phase II, two-step clinical trial (approved by Bioethics Committee and Argentine Regulatory Authority) was designed. Patients received Cy (50 mg po.d) + Cel (200 mg p.o.bid). Patient eligibility criteria included: ABCP who progressed to anthracyclines, taxanes and capecitabine, ≤4 chemotherapy schemes, with good performance status. Several pro- and anti-angiogenic molecules and cells were determined as biomarkers. Informed consent was signed by all patients. Primary endpoint was clinical benefit (CB). RESULTS: Twenty patients were enrolled. Main clinical outcomes were prolonged disease stabilization and partial remission in 10/20 and 1/20 patients, respectively. CB was 55 %, and time to progression (TTP) was 21.1 weeks. Median TTP in patients who achieved CB was 35.6 weeks, and mean overall survival was 44.20 weeks. There were no grade 3/4 toxicities associated with treatment. Circulating endothelial cells (CECs) increased at the time of progression in patients who showed CB (P = 0.014). Baseline CECs and circulating endothelial progenitor cells showed marginal associations with TTP. Serum VEGF decreased (P = 0.050), sVEGFR-2 increased (P = 0.005) and VEGF/sVEGFR-2 ratio decreased during treatment (P = 0.041); baseline VEGF and VEGF/sVEGFR-2 were associated with TTP (P = 0.035 and P = 0.030, respectively), while sVEGFR-2 did not. CONCLUSIONS: Treatment was effective, showing low toxicity profile and excellent tolerability. The combination had anti-angiogenic effect. Increased levels of CEC could be useful for detecting progression. Baseline VEGF and VEGF/sVEGFR-2 values could be useful as early predictors of response. TRIAL REGISTRATION: ANMAT#4596/09.
