TORNA ALL’ELENCO

Pemetrexed versus pemetrexed plus carboplatin in pretreated patients with advanced non-small cell lung cancer: A pooled analysis of two randomized trials in Journal of Thoracic Oncology

2011
AO Cuneo

Tipo pubblicazione

Conference Abstract

Autori/Collaboratori (20)Vedi tutti...

Tiseo M

Ardizzoni A

Boni L


et alii...

Abstract

Background: To evaluate the benefit of adding carboplatin to single-agent pemetrexed chemotherapy in 2nd-line treatment of advanced NSCLC, by pooling the results of two identical phase II randomized trials (GOIRC 02.2006 and NVALT-7 trials) carried out in Italy and The Netherlands, respectively. Methods: Main eligibility criteria in both trials were: diagnosis of advanced NSCLC, disease progression after 1st-platinum-based chemotherapy, normal organ function and ECOG performance status 0-2. Patients were randomized to receive pemetrexed 500 mg/m2 alone or combined with carboplatin (AUC5). Cycles were repeated every 3 weeks for a maximum of 4 courses. Both studies were designed to detect a 33% decrease in the hazard of disease progression in the combination arm. The pooled analysis was pre-planned and designed to assess the impact of adding carboplatin to pemetrexed in terms of overall survival (OS) in the overall population and in certain subgroups. Results: A total of 479 patients were randomized in the two trials. Main patients characteristics were: male gender 68%, median age 62 (range 36-84), PS 0/1 45/49%, squamous cell histology 19%, stage IV 79%, interval from last 1st-line chemotherapy course and randomization ? 3 months in 71% of patients (42% ? 6 months), prior response to 1st-line chemotherapy 50%. Despite identical eligibility criteria in the two studies, there was heterogeneity for some clinical characteristics (more squamous tumors, more advanced PS, longer treatment-free interval in the Dutch study). In the overall population, survival was not improved by the addition of carboplatin to pemetrexed; the HR for death was 0.88 (95%CI: 0.71-1.07; p = 0.202; p for heterogeneity = 0.693). Objective response rate was increased in the carboplatin-containing arm with an OR of 1.78 (95%CI: 1.01-3.12; p = 0.046; p for heterogeneity = 0.060). A non-statistically significant increase in PFS favouring combined chemotherapy was observed with a HR of 0.85 (

Keywords

pemetrexed; carboplatin; platinum; non small cell lung cancer; patient; lung cancer; human; chemotherapy; population; arm; disease course; gender; hazard; overall survival; lung tumor; squamous cell; histology; randomization; male; diagnosis; health care quality; death; Netherlands; survival; neoplasm; Italy; electrocorticography;