Showing papers by "Nils Homann published in 2014"

HER-FLOT: Trastuzumab in combination with FLOT as perioperative treatment for patients with HER2-positive locally advanced esophagogastric adenocarcinoma: A phase II trial of the AIO Gastric Cancer Study Group.

Abstract: 4073^ Background: Perioperative chemotherapy is a mainstay in the treatment of locally advanced esophagogastric adenocarcinomas (EGA). Trastuzumab improved survival when added to chemotherapy in pts with HER-2-positive metastatic EGA. We investigated the combination of trastuzumab and FLOT as perioperative treatment in pts with locally advanced EGA. Methods: A multicenter phase II study evaluated the efficacy & toxicity of perioperative HER-FLOT (24-h 5-FU 2,600 mg/m², leucovorin 200mg/m², oxaliplatin 85mg/mg², docetaxel 50 mg/m², trastuzumab 6mg/kg then 4 mg/kg d1, repeated d15 for four cycles pre- and postoperatively followed by 9 cycles of trastuzumab monotherapy 6mg/kg 3-weekly) in pts with HER-2 positive EGA (IHC 3+ or IHC 2+/ ISH+). Pts had to have ≥cT2, any N, M0 EGA. The primary endpoint was the rate of centrally tested pathological complete remissions (pCR). Secondary endpoints comprised disease-free and overall survival, R0 resection rate, toxicity and surgical morbidity. Here we report data of ...

Quality of life of older adult patients receiving docetaxel-based chemotherapy triplets for esophagogastric adenocarcinoma: a randomized study of the Arbeitsgemeinschaft Internistische Onkologie (AIO).

Abstract: Background Treatment of patients with advanced or metastatic esophagogastric adenocarcinoma should not only prolong life but also provide relief of symptoms and improve quality of life (QOL). Esophagogastric adenocarcinoma mainly occurs in elderly patients, but they are underrepresented in most clinical trials and often do not receive effective combination chemotherapy, most probably for fear of intolerance. Using validated instruments, we prospectively assessed QOL within the randomized FLOT65+ phase II trial.

VEGFR-3 and CXCR4 as predictive markers for treatment with fluorouracil, leucovorin plus either oxaliplatin or cisplatin in patients with advanced esophagogastric cancer: a comparative study of the Arbeitsgemeinschaft Internistische Onkologie (AIO)

Abstract: Combination of fluoropyrimidines and a platinum derivative are currently standards for systemic chemotherapy in advanced adenocarcinoma of the stomach and gastroesophageal junction (GEJ). Nevertheless, individual likelihood for response to these therapeutic regimes remains uncertain. Even more, no predictive markers are available to determine which patients may benefit more from oxaliplatin versus cisplatin or vice versa. The new invasion and stem cell markers VEGFR-3 and CXCR4 have been linked prognostically with more aggressive esophagogastric cancer types. Thus, we aimed to assess correlations of VEGFR-3 and CXCR4 expression levels with clinical outcome in a randomized phase III study of patients with oxaliplatin/leucovorin/5-FU (FLO) versus cisplatin/leucovorin/5-FU (FLP). The patients data examined in this study (n = 72) were from the collective of the FLO vs. FLP phase III AIO trial. Tumour tissues were stained via immunohistochemistry for VEGFR-3 and CXCR4 expression and results were evaluated by two independent, blinded investigators. Outcome parameter: Survival analysis was calculated for patients receiving FLO vs. FLP in relation to VEGFR-3 and CXCR4 expression. 54% and 36% of the examined tumour tissues showed strong positive expression of VEGFR-3 and CXCR4 respectively. No superiority of each regime was detected in terms of overall survival (OS) in the whole population. Patients with strong expression of CXCR4 on their tumour tissues profited more in terms of OS under the treatment of FLP (mOS: 28 vs 15 months, p = 0.05 respectively). Patients with negative VEGFR-3 and CXCR4 expression had a trend to live longer when FLO regime was applied (mOS: 22 vs. 9 months, p = 0.099 and 20 vs. 10 months, p = 0.073 respectively). In an exploratory analysis of patients older than 60 years at diagnosis, we observed a significant benefit in overall survival for VEGFR-3 and CXCR4-positive patients when treated with FLP (p = 0.002, p = 0.021 respectively). CXCR4 positive patients profited in terms of OS from FLP, whereas FLO proved to be more effective in CXCR4 and VEGFR-3 negative patients. Our results suggest, despite the limited size of the study, a predictive value of these biomarkers concerning chemotherapy with FLP or FLO in advanced esophagogastric cancer.

LEOPARD-II: A randomized phase II study of radiochemotherapy (RCT) with 5FU and cisplatin plus/minus cetuximab (Cet) in unresectable locally advanced esophageal cancer (LAEC).

Abstract: 4081 Background: Patients (pts) with LAEC have a poor prognosis; new therapies are required. A study showed the addition of Cet to RCT to be safe and effective for resectable EC [Ruhstaller et al, ...