Abstract
Chemotherapy with pemetrexed plus carboplatin followed by pemetrexed maintenance therapy is a first-line regimen for patients with advanced non-squamous non-small-cell lung cancer. This phase II clinical study investigated the efficacy and safety of this regimen in older patients (aged ≥65 years) with advanced non-squamous non-small-cell lung cancer. All patients received 4 courses of induction therapy with pemetrexed (500 mg/m2) combined with carboplatin once every 3 weeks. If patients had stable disease or achieved a complete or partial tumor response after 4 courses of pemetrexed + carboplatin therapy, maintenance treatment with pemetrexed monotherapy was administered until either disease progression or intolerable toxicity occurred. The primary endpoint was progression-free survival, while secondary endpoints were the objective response rate, overall survival, and tolerability. A total of 105 elderly patients (median age, 71 years) with advanced lung adenocarcinoma were enrolled in the trial. The ORR with induction therapy was 36.2% and the disease control rate was 70.5%. Sixty-two patients (59.0%) subsequently received pemetrexed maintenance therapy. The median progression-free survival for all patients was 8.23 months (95% CI 5.85-10.62 months) and the median overall survival was 22.6 months (95% CI 20.09-25.11 months). Grade 3 or greater toxicities included neutropenia (15.3%), thrombocytopenia (9.5%), anemia (8.6%), leukopenia (4.8%), nausea (1.0%), vomiting (1.0%), and fatigue (1.0%). No treatment-related deaths occurred. These results indicate that pemetrexed combined with carboplatin therapy maintained by single-agent pemetrexed treatment of elderly patients with advanced non-squamous non-small-cell lung cancer was effective and tolerable.ClinicalTrials.gov identifier: NCT01860508.
Highlights
Lung cancer is the most common malignancy, and in 2015 it was the most common cause of cancerrelated deaths in both men and women
The median progression-free survival (PFS) for all patients was 8.23 months, and the median overall survival (OS) was 22.60 months (Figures 2A and 2B)
There were no treatment-related deaths. This single-arm, open-label clinical study evaluated the efficacy and safety of pemetrexed in combination www.impactjournals.com/oncotarget with carboplatin as first-line therapy followed by singleagent pemetrexed maintenance therapy in elderly Chinese patients (≥65 years of age) with non-squamous non-small-cell lung cancer (NSCLC)
Summary
Lung cancer is the most common malignancy, and in 2015 it was the most common cause of cancerrelated deaths in both men and women. About 85% of lung cancers are non-small-cell lung cancer (NSCLC), and in 80% of patients, the initial diagnosis is made late [1]. Non-squamous NSCLC, first-line chemotherapy with pemetrexed plus a platinum agent followed by pemetrexed maintenance therapy has www.impactjournals.com/oncotarget become the standard chemotherapy regimen. This regimen has been found to improve overall survival (OS) by 2.9 months versus placebo, and reduce the risk of disease progression by 38% and death by 22% [2, 3]. In the elderly (the WHO definition of which is age ≥65 years), NSCLC occurrence and death rates are increased relative to younger patients [4]. Elderly patients require more medication and are more prone to water and electrolyte disturbances
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