| Popis: |
Background and importance According to the PARAMOUNT trial, induction chemotherapy with a platin/pemetrexed combination and pemetrexed maintenance therapy reduced the risk of progression free survival (PFS) and overall survival (OS) in patients with non-cell lung cancer (NSCLC). Aim and objectives The aim of the study was to assess the effectiveness and safety of this drug combination in NSCLC and to evaluate the degree of agreement with the PARAMOUNT results. Material and methods A descriptive retrospective study was conducted. All patients that initiated treatment with platin/pemetrexed from January 2018 to September 2019 were included. Clinical data were obtained from digital clinical history and the prescription software Farmis Oncofarm: sex, age, stage, performance status (PS), periodicity of chemotherapy, dose received and number of cycles. PFS and OS were used as efficacy end points, and were obtained by the Kaplan–Meier method (SPSS Statistics programme). In terms of safety, adverse events (AE) of any grade were recorded for assessment of the safety profile. Effectiveness data and safety were compared with the PARAMOUNT results. Results Forty-two patients were enrolled, 36 men and 6 women, with an average age of 67 years (range 42–80). Cancer stage was as follows: stage IV (90%), stage IIB (7%) and stage IIIA (3%). Baseline PS was 0–1 in 60% of cases and in the remainder, 2–3. All patients received as induction therapy on day 1, 21 day cycles of pemetrexed (500 mg/m2) in combination with cisplatin 75 mg/m2 (n=16) or carboplatin AUC=5 (n=26). Pemetrexed maintenance therapy (500 mg/m2) was administrated until progression or death. The median number of cycles was 4 (1–16). Median PFS was 4 months (95% CI 3 to 5) and median OS was 17 months (95% CI 11 to 21). In the PARAMOUNT study, median PFS was 4 months and median OS was 14 months. Sixty per cent of patients (n=25) had AE. The most common AE were mucositis (n=7), asthenia (n=6), diarrhoea (n=3), dermatitis (n=3), vomiting (n=3), anaemia (n=2) and neutropenia (n=2). In the clinical trial, the most common AE of any grade were anaemia, neutropenia, fatigue and nausea. Conclusion and relevance PFS and OS showed a clinical benefit. The safety profile for the use of this combination showed it was tolerated. The effectiveness and AE were similar compared with the published clinical trial. References and/or acknowledgements No conflict of interest. |
