Maintenance Gemcitabine in the Chinese Advanced Lung Cancer
Status:
Unknown status
Trial end date:
2013-04-01
Target enrollment:
Participant gender:
Summary
Lung cancer, the most common cancer worldwide, remains the leading cause of cancer death.
Approximately two-thirds of all patients with newly diagnosed non-small-cell lung cancer
(NSCLC) present with advanced stage that palliative chemotherapy is the only appropriate
measure. The standard treatment for this patient population consists of third generation
platinum-based doublet regimen for no more than 6 cycles followed by watch and wait until
disease progression (PD) before the administration of second-line and third-line systemic
anticancer therapeutic agents. Patients who go on to receive second-line therapy represent a
selected subgroup with an improved overall prognosis.
Switch maintenance therapy with pemetrexed or erlotinib in patients with advanced NSCLC
without PD after first-line chemotherapy has been confirmed to improve progression free
survival (PFS) and overall survival (OS) significantly compared with placebo in two large
randomized controlled studies. However, continuation gemcitabine maintenance therapy in this
setting yields conflicting results in the west, i.e.showing a prolongation of PFS without OS
improvement. Thus, we investigate the efficacy and safety of continuation of gemcitabine
maintenance therapy for patients with metastatic NSCLC with ECOG performance status of 0-1
and without PD after four cycles of first-line chemotherapy with gemcitabine and cisplatin in
China.