Publications (2)3.64 Total impact
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ABSTRACT: The MUNICON trial confirmed prospectively the usefulness of early response evaluation by 2-deoxy-2-[F-18]fluoro-D-glucose-positron emission tomography (FDG-PET) . Metabolic responders (R) showed initially a higher FDG uptake compared with nonresponders (p = 0.018). An association of the vascular endothelial growth factor (VEGF) 936C>T polymorphism and FDG uptake was reported for breast cancer. Therefore, we investigated the VEGF 936C>T polymorphism for an association with response and survival. The study was based on 110 patients included in the MUNCON trial (103 male, seven female; 75 AEG I, 35 AEG II, event-free survival (EFS) median 21.1 ± 4.6 months). Response was significantly associated with EFS. The VEGF 936C>T polymorphism was determined by PCR and restriction fragment length polymorphism analysis. For analysis, the T-variants were combined. One hundred two patients were evaluable. Seventy-two patients showed the CC, 24 the CT, and six the TT genotype. Median EFS was 29.3 months for CC and 11.7 months for CT/TT (p = 0.04). No association of the genotypes (CC or CT/TT) with the SUV or response was found. Multivariate analysis revealed histopathological regression (p = 0.003) and genotype (p = 0.04) as independent prognostic factors. A combination of genotype and PET response (Gen-PET) defines three prognostic groups early in the course of treatment (p = 0.002). Cox regression analysis including clinical and histopathological response and Gen-PET reveals Gen-PET as independent prognostic factor (p = 0.003). The VEGF 936C>T polymorphism is a prognostic factor in patients undergoing neoadjuvant chemotherapy, although it is not associated with FDG uptake and response. The combination of metabolic response and VEGF 936C>T polymorphism defines three different prognostic groups. These findings need to be confirmed prospectively. This study has been registered in the European Clinical Trials Database as trial 2007-003356-11.
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ABSTRACT: We report a comparative analysis of 2 sequential, prospective phase II trials on the efficacy of platinum/leucovorin/5-fluorouracil (PLF) +/- paclitaxel (T-PLF) in the neoadjuvant treatment of adenocarcinoma of the esophagus (AEG I). Inclusion criteria were histologically proven, locally advanced AEG I stage uT3/4 anyN cM0/M1a. 67 patients were treated with either PLF (n = 32) or T-PLF (n = 35). Paclitaxel (80 mg/m(2)) was added to PLF on days 1, 15, and 29. Primary endpoint was the response. Additionally, 5-year survival was analyzed. The study population was well balanced, apart from an imbalance in clinical cM1a (33.3% PLF vs. 8.6% T-PLF; p = 0.01). Histopathological response rates (23.3% PLF vs. 25.0% T-PLF) showed no significant difference. Clinical response rates were improved for T-PLF (21.9 vs. 45.7%; p = 0.04). Median overall survival for clinical and histopathological responders was significantly improved for T-PLF (p = 0.005, p = 0.01), but not for PLF (p = 0.08, p = 0.25). Median overall survival was better with T-PLF without reaching statistical significance (18.9 months PLF vs. 43.1 months T-PLF; p = 0.27). Toxicity was slightly increased by paclitaxel. No treatment-related deaths occurred. Our data failed to demonstrate statistically significant superiority of the T-PLF regimen except for clinical response. However, there was a trend towards improved survival.