Nedaplatin/Gemcitabine Versus Carboplatin/Gemcitabine in Treatment of Advanced Non-small Cell Lung Cancer: A Randomized Clinical Trial

Abstract

Objective: To evaluate the efficacy and safety of nedaplatin/gemcitabine (NG) and carboplatin/gemcitabine (CG) in the management of untreated advanced non-small cell lung cancer (NSCLC).

Methods: Sixty-two patients with previously untreated advanced NSCLC were recruited between June 2006 and November 2007. Subjects were randomly assigned to the NG arm (n=30) and the CG arm (n=32). Only patients (24 and 25 in the NG and CG arms, respectively) who completed ≥2 chemotherapy cycles were included in the data analysis. The primary outcome measure was the objective response rate (ORR). The secondary outcome measures included progression-free survival (PFS), overall survival (OS) and adverse events.

Results: There were no statistically significant differences in the efficacy measures (ORR, P=0.305; median PFS, P=0.198; median OS, P=0.961) or in the major adverse events (grade 3/4 neutropenia, P=0.666; grade 3/4 anemia, P=0.263; grade 3/4 thrombocytopenia, P=0.212) between the two treatment arms. However, there was a trend towards higher ORR (37.5% vs. 24.0%), longer PFS (6.0 vs. 5.0 months), and less adverse events in the NG arm.

Conclusion: NG regimen seems to be superior over CG regimen for advance NSCLS, but further investigation is needed to validate this superiority.

Keywords: Carboplatin; Chemotherapy; Gemcitabine; Nedaplatin; Non-small cell lung cancer; Squamous cell carcinoma.

Conflict of interest statement

Disclosure of Potential Conflicts of Interest: No potential conflicts of interest were disclosed.

Figures

Figure 1

PR (target lesions reduction by 32%) achieved by the patient diagnosed with cT4N3M0 stage III B squamous cell carcinoma (SCC) of the right lower lung lobe after completing first-line NG. A: CT-guided biopsy of the primary lesion showed SCC (HE ×200); B: Baseline primary lesion in the right lower lung lobe and malignant pleural and pericardial effusion; C: Tumor shrinkage and disappearance of malignant pleural and pericardial effusion after 4 cycles of NG.

Figure 2

PR (target lesions reduction by 45%) attained by the patient diagnosed with cT4N2M1 (liver) stage IV squamous cell carcinoma (SCC) of the right middle lung lobe after completing first-line NG. A: Bronchoscopy revealed SCC (HE ×200); B: Baseline primary lesion in the right middle lung lobe; C: Tumor shrinkage after 2 cycles of NG.

Figure 3

Kaplan-Meier survival curves of PFS and OS. A: Survival curves of PFS between NG and CG arms; B: Survival curves of OS between NG and CG arms.