Efficacy and safety of first-line pemetrexed plus carboplatin followed by single-agent pemetrexed maintenance in elderly Chinese patients with non-squamous non-small-cell lung cancer

Xinmin Zhao, Hui Yu, Jing Zhao, Xianghua Wu, Si Sun, Zhiguo Luo, Huijie Wang, Jie Qiao, Jianhua Chang, Jialei Wang, Xinmin Zhao, Hui Yu, Jing Zhao, Xianghua Wu, Si Sun, Zhiguo Luo, Huijie Wang, Jie Qiao, Jianhua Chang, Jialei Wang

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.

Keywords: carboplatin; elderly; maintenance therapy; non-small-cell lung cancer; pemetrexed.

Conflict of interest statement

CONFLICTS OF INTEREST The authors declare no conflicts of interest.

Figures

Figure 1. Study profile showing patient registration…
Figure 1. Study profile showing patient registration and numbers of patients who received induction treatment and maintenance therapy
Figure 2
Figure 2
(A) Progression-free survival (PFS) of all patients (median, 8.23 months; 95% CI 5.85-10.62 months). (B) Overall survival (OS) of all patients (median, 22.60 months; 95% CI 20.09-25.11 months).

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Source: PubMed

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