Pemetrexed in Advanced Non-Small-Cell Lung Cancer: at Progression vs Maintenance Therapy After Induction Chemotherapy
Status:
Terminated
Trial end date:
2018-03-01
Target enrollment:
Participant gender:
Summary
Non-small-cell lung cancer (NSCLC) accounts for a majority (approximately 85%) of lung cancer
cases. Patients with localized disease can be cured through surgery, but only 20 % are
operable.For the majority of patients with advanced disease, palliative cytotoxic
chemotherapy remains the recommended therapy. Chemotherapy prolongs survival and improves
quality of life.
The recommended first-line therapy is 4-6 courses of a platinum in combination with a third
generation compound (e.g. gemcitabine, vinorelbine, docetaxel, pemetrexed, paclitaxel). After
first-line therapy, it has been recommended to observe the patients and offer second-line
chemotherapy at disease progression.
Regimens for second-line therapy include docetaxel or pemetrexed monotherapy. Pemetrexed is
less toxic and superior to gemcitabine in non-squamous NSCLC, whereas docetaxel is the
recommended second-line therapy in squamous cell carcinoma.
The results of the studies of maintenance pemetrexed therapy are encouraging; the observed
survival benefit is clinically relevant and relatively large considering the poor survival in
patients with advanced NSCLC. Furthermore, pemetrexed appears to be well tolerated. There
are, however, several limitations to the studies that have been conducted: Relatively few
elderly patients and no PS 2 patients were enrolled - and not all patients on the
control-arms received pemetrexed at progression.
The overall aim of this study is to investigate whether immediate maintenance pemetrexed
therapy prolongs survival compared to observation and pemetrexed therapy at progression in
patients with advanced NSCLC. Furthermore, it will be explored whether patients with
'performance status' 2 and elderly ≥ 70 years tolerate and benefit from maintenance therapy;
and what characteristics and blood biomarkers are associated with sensitivity and
tolerability of such therapy.