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    Keywords: ELDERLY-PATIENTS ; SUPPORTIVE CARE ; COOPERATIVE-ONCOLOGY-GROUP ; PHASE-III TRIAL ; ADVANCED GASTRIC-CANCER ; 1ST-LINE THERAPY ; ARBEITSGEMEINSCHAFT INTERNISTISCHE ONKOLOGIE ; COMPREHENSIVE GERIATRIC ASSESSMENT ; ESOPHAGOGASTRIC CANCER ; YOUNGER PATIENTS
    Abstract: AIM: To investigate the outcome of palliative chemotherapy in old patients with gastroesophageal cancer at the National Center for Tumor Diseases, Heidelberg. METHODS: Using a prospectively generated database, we retrospectively analyzed 55 patients 〉= 70 years under palliative chemotherapy for advanced gastroesophageal cancer at the outpatient clinic of the National Center for Tumor Diseases Heidelberg, Germany between January 2006 and December 2013. Further requirements for inclusion were (1) histologically proven diagnosis of gastroesophageal cancer; (2) advanced (metastatic or inoperable) disease; and (3) no history of radiation or radiochemotherapy. The clinical information included Eastern Cooperative Oncology Group performance status (ECOG PS), presence and site of metastases at diagnosis, date of previous surgery and perioperative chemotherapy, start and stop date of first-line treatment, toxicities and consecutive dosage reductions of first- line treatment, response to first- line therapy, date of progression, usage of second- line therapies and date and cause of death. Survival times [progression- free survival (PFS), overall survival (OS) and residual survival (RS)] were calculated. Toxicity and safety were examined. Prognostic factors including ECOG PS, age and previous perioperative treatment were analyzed. RESULTS: Median age of our cohort was 76 years. 86% of patients received a combination of two cytotoxic drugs. 76 percent of patients had an oxaliplatin-based first-line therapy with the oxaliplatin and 5-fluorouracil regimen being the predominantely chosen regimen (69%). Drug modifications due to toxicity were necessary in 56% of patients, and 11% of patients stopped treatment due to toxicities. Survival times of our cohort are in good accordance with the major phase. trials that included mostly younger patients: PFS and OS were 5.8 and 9.5 mo, respectively. Survival differed significantly between patient groups with low (〈= 1) and high (〉= 2) ECOG PS (12.7 mo vs 3.8 mo, P 〈 0.001). Very old patients (〉= 75 years) did not show a worse outcome in terms of survival. Patients receiving second-ine treatment (51%) had a significantly longer RS than patients with best supportive care (6.8 vs 1.4 mo, P = 0.001). Initial ECOG PS was a strong prognostic factor for PFS, OS and RS. CONCLUSION: Old patients with non-curable gastroesophageal cancer should be offered chemotherapy, and ECOG PS is a tool for balancing benefit and harm upfront. Second-line treatment is reasonable.
    Type of Publication: Journal article published
    PubMed ID: 25945004
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    Keywords: CANCER ; Germany ; IN-VIVO ; VIVO ; PROTEIN ; METABOLISM ; TUMORS ; MECHANISM ; mechanisms ; colorectal cancer ; metastases ; chemotherapy ; adenocarcinoma ; PET ; neoadjuvant treatment ; K-RAS MUTATIONS ; cetuximab ; ESOPHAGOGASTRIC JUNCTION ; metabolic imaging ; F-18-FDG PET CT
    Abstract: BACKGROUND: The epidermal growth factor receptor monoclonal antibody cetuximab has proven activity in metastatic colorectal cancer. To date, the mechanisms of action are not completely understood. Especially the impact on tumor glucose metabolism, or tumor vascularization remains largely unclear. The understanding of mechanisms such as early changes in tumor metabolism is of clinical importance since there may be a substantial influence on choice and sequence of drug combinations. Early signals of response to cetuximab may prove useful to identify patients having a relevant clinical treatment benefit. The objective of this trial is to evaluate the predictive relevance of the relative change in 18 F-Fluorodeoxyglucose tumor uptake for early clinical response during short-term single agent treatment with cetuximab. Early clinical response will be routinely measured according to the response evaluation criteria in solid tumors. Accompanying research includes cytokine immune monitoring and analysis of tumor proteins and tumor genes. Methods/design The REMOTUX trial is an investigator-initiated, prospective, open-label, single-arm, single-center early exploratory predictive study. The first 18 F-FDG PET-CT is conducted at baseline followed by the run-in phase with cetuximab at days 1 and 8. At day 14, the second 18 F-FDG PET-CT is performed. Subsequently, patients are treated according to the Folfiri-cetuximab regimen as an active and approved first-line regimen for metastatic colorectal carcinoma. At day 56, clinical response is evaluated with a CT-scan compared to the baseline analysis. Tracer uptake is assessed using standardized uptake values (SUVs). The main hypothesis to be tested in the primary analysis is whether or not the relative change in the SUV from baseline to day 14 has any predictive relevance for early clinical response determined at day 56. Patients are followed until death from any cause or until 24 months after the last patient has ended trial treatment. DISCUSSION: The aim of this trial is to evaluate metabolic changes in metastatic colorectal cancer during short-term single agent treatment with cetuximab and to analyse their potential of predicting early clinical response. This could be helpful to answer the question if early identification of patients not responding to cetuximab is possible. Trial registration ClinicalTrials.gov NCT200811021020; EudraCT 200901327923.
    Type of Publication: Journal article published
    PubMed ID: 22439666
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    Keywords: SURVIVAL ; SURGERY ; CISPLATIN ; chemoradiation ; PHASE-II TRIAL ; ESOPHAGEAL-CARCINOMA ; docetaxel ; GASTRIC-CARCINOMA ; GASTROESOPHAGEAL JUNCTION
    Abstract: 18-Fluorodeoxyglucose-PET (18F-FDG-PET) can be used for early response assessment in patients with locally advanced adenocarcinomas of the oesophagogastric junction (AEG) undergoing neoadjuvant chemotherapy. It has been recently shown in the MUNICON trials that response-guided treatment algorithms based on early changes of the FDG tumor uptake detected by PET are feasible and that they can be implemented into clinical practice. Only 40%-50% of the patients respond metabolically to therapy. As metabolic non-response is known to be associated with a dismal prognosis, metabolic non-responders are increasingly treated with alternative neoadjuvant chemotherapies or chemoradiation in order to improve their clinical outcome. We plan to investigate whether PET can be used as response assessment during radiochemotherapy given as salvage treatment in early metabolic non-responders to standard chemotherapy. Methods/Design: The HICON trial is a prospective, non-randomized, explorative imaging study evaluating the value of PET as a predictor of histopathological response in metabolic non-responders. Patients with resectable AEG type I and II according to Siewerts classification, staged cT3/4 and/or cN+ and cM0 by endoscopic ultrasound, spiral CT or MRI and FDG-PET are eligible. Tumors must be potentially R0 resectable and must have a sufficient FDG-baseline uptake. Only metabolic non-responders, showing a 〈35% decrease of SUV two weeks after the start of neoadjuvant chemotherapy are eligible for the study and are taken to intensified taxane-based RCT (chemoradiotherapy (45 Gy) before surgery. 18FDG-PET scans will be performed before (=Baseline) and after 14 days of standard neoadjuvant therapy as well as after the first cycle of salvage docetaxel/cisplatin chemotherapy (PET 1) and at the end of radiochemotherapy (PET2). Tracer uptake will be assessed semiquantitatively using standardized uptake values (SUV). The percentage difference [increment]SUV = 100 (SUVBaseline - SUV PET1)/SUVBaseline will be calculated and assessed as an early predictor of histopathological response. In a secondary analysis, the association between the difference SUVPET1 - SUVPET2 and histopathological response will be evaluated. Discussion: The aim of this study is to investigate the potential of sequential 18FDG-PET in predicting histopathological response in AEG tumors to salvage neoadjuvant radiochemotherapy in patients who do not show metabolic response to standard neoadjuvant chemotherapy. Trial Registration: Clinical trial identifier NCT01271322
    Type of Publication: Journal article published
    PubMed ID: 21702914
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