Showing papers by "Günther G. Steger published in 2017"
TL;DR: Five-year OS and IDFS rates suggest that the prognosis for patients with TNBC is better than previously thought, and final OS results showed no significant benefit from bevacizumab therapy for early TNBC.
77 citations
TL;DR: This is the first validation with high level of evidence (IIB) of the prognostic value of a LI test in colon cancers, and it still needs to be confirmed in independent series of colon cancer patients.
37 citations
TL;DR: Decreased serum BChE and albumin levels are associated with increased all-cause mortality in treatment-naïve cancer patients without a manifest malignant hepatic involvement irrespective of tumor entity or stage.
Abstract: // Noemi Pavo 1 , Markus Raderer 2 , Georg Goliasch 1 , Raphael Wurm 1 , Guido Strunk 3 , Anna Cho 1 , Johannes F. Novak 1 , Heinz Gisslinger 2 , Gunther G. Steger 2 , Michael Hejna 2 , Wolfgang Kostler 2 , Sabine Zochbauer-Muller 2 , Christine Marosi 2 , Gabriela Kornek 2 , Leo Auerbach 4 , Sven Thorben Schneider 5 , Bernhard Parschalk 5 , Werner Scheithauer 2 , Robert Pirker 2 , Barbara Kiesewetter 2 , Richard Pacher 1 , Christoph Zielinski 2 and Martin Hulsmann 1 1 Department of Internal Medicine II, Division of Cardiology, Medical University of Vienna, Vienna, Austria 2 Department of Internal Medicine I, Division of Oncology and Hematology, Medical University of Vienna, Vienna, Austria 3 Complexity Research, Vienna, Austria 4 Department of Gynaecology, Medical University of Vienna, Vienna, Austria 5 Department of Otorhinolaryngology - Head and Neck Surgery, Medical University of Vienna, Vienna, Austria Correspondence to: Martin Hulsmann, email: // Keywords : cancer, liver, biomarker, inflammation, prognosis Received : December 29, 2016 Accepted :April 04, 2017 Published : April 16, 2017 Abstract Background. Routinely tested liver biomarkers as alanine aminotransferase (ALT), aspartate aminotransferase (AST), γ-glutamyltransferase (GGT), butyryl-cholinesterase (BChE), albumin and bilirubin are altered in distinct malignancies and hepatic metastases. This study aimed to investigate whether all liver parameters have the ability to predict long-term mortality in treatment naive cancer patients but without a malignant hepatic involvement. Methods. We prospectively enrolled 555 consecutive patients with primary diagnosis of cancer without prior anticancer therapy. BChE, albumin, AST, ALT, GGT and bilirubin as well as the inflammatory makers C-reactive protein (CRP), serum amyloid A (SAA) and interleukin-6 (IL-6) were determined. All-cause mortality was defined as primary endpoint. Results. During a median follow-up of 25 (IQR16-31) months 186 (34%) patients died. All liver parameters were significantly associated with all-cause mortality (p < 0.001 for all). However, for patients without a malignant primary or secondary hepatic involvement (82%) only the functional parameters BChE and albumin remained significantly associated with the primary endpoint (crude HR per 1-IQR increase 0.61, 95%CI:0.49-0.77; p < 0.001 for BChE and 0.58, 95%CI:0.47-0.70; p < 0.001 for albumin). This e ect was persistent after multivariate adjustment (adj.HR per 1-IQR increase 0.65, 95%CI:0.50-0.86; p = 0.002 for BChE and 0.63, 95%CI:0.50-0.79; p < 0.001 for albumin). BChE and albumin correlated inversely with CRP ( r = -0.21, p < 0.001 and r = -0.36, p < 0.001), SAA ( r = -0.19, p < 0.001 and r = -0.33, p < 0.001) and IL-6 ( r = -0.13, p = 0.009 and r = -0.17, p = 0.001). Conclusions. Decreased serum BChE and albumin levels are associated with increased all-cause mortality in treatment-naive cancer patients without a manifest malignant hepatic involvement irrespective of tumor entity or stage. This association may reflect progressing systemic inflammation and metabolic derangement with subclinical involvement of the liver.
15 citations
TL;DR: Real world data from STEPAUT support EVE+EXE as a suitable treatment option for HR+, HER2− ABC recurring or progressing on/after prior nonsteroidal aromatase inhibitors (NSAIs) in routine clinical practice.
Abstract: Background STEPAUT, an Austrian non-interventional study evaluated the safety and efficacy of everolimus (EVE) + exemestane (EXE) in patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor receptor-2 negative (HER2–) advanced breast cancer (ABC) recurring/progressing on/after prior nonsteroidal aromatase inhibitors (NSAIs) in routine clinical practice. Results of the 1st interim analysis (IA) were consistent with BOLERO-2 data. Here we present results from the 2nd pre-planned IA. Materials and Methods STEPAUT, with a planned enrolment of 300 pts, included postmenopausal pts, aged ≥ 18 yrs with HR+, HER2– ABC treated with EVE+EXE, progressing on/after NSAIs. Primary endpoint was progression-free survival (PFS); secondary endpoints included response per RECIST v1.1 and safety. Results The 2nd IA included 225 pts with a median age of 65 yrs. At the time of data cut-off: 9 May, 2016, 147 pts had discontinued study treatment, mainly due to disease progression and adverse events (AEs). Median duration of follow-up was 6.5 months (range 0−26.3 months), 172 pts (95%) had ECOG PS 0-1 and 52% of pts had visceral metastasis. A majority of pts (n=109, 54%) received the approved EVE dose of 10mg as the start dose, while 91 pts (45%) received half of the approved EVE dose i.e. 5mg. Median PFS values for different subgroups are shown in table 1 below. Overall, 57 pts (28%) required therapy interruption while 37 pts (18%) had EVE dose reduction from 10 to 5mg. A decreasing trend in AE frequency irrespective of EVE dose was observed during treatment period. The majority of AEs were of mild to moderate severity; most frequent AEs (all grades) were stomatitis, mucositis (48.0%), exanthema, rash (22.2%), and dyspnea, cough (22.2%). Frequent grade 3 or 4 AEs were stomatitis, mucositis (4.4%), weight loss, reduced general condition (2.7%), and inappetence, nausea (2.2%). Median time to first occurrence of stomatitis was 0.5 months; 8 pts (5%) discontinued therapy due to stomatitis and/or rash. Serious AEs constituted 10% of all AEs. Conclusions Real world data from STEPAUT support EVE+EXE as a suitable treatment option for HR+, HER2− ABC recurring or progressing on/after prior NSAIs. Overall safety profile was also consistent with previous reports. Of note, occurrence of stomatitis and/or rash did not negatively influence PFS. Furthermore, a lower start dose of EVE 5mg did not seem to affect PFS negatively as long as the dose was adjusted to 10mg after a short period of time, thus supporting the administration of the approved EVE 10mg/day dose in the routine clinical setting. Citation Format: Steger GG, Bartsch R, Pfeiler G, Petru E, Greil R, Helfgott R, Egle D, Ohler L, Lang A, Tinchon C, Haslbauer F, Redl A, Hennebelle M, Mraz B, Winiger-Candolfi I, Gnant M. Efficacy and safety of everolimus plus exemestane in HR+, HER2– advanced breast cancer progressing on/after prior endocrine therapy, in routine clinical practice: 2nd interim analysis from STEPAUT [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P4-22-20.
8 citations
TL;DR: A HER2/CEP17 ratio of >6 in the pre-therapeutic tumor biopsy is associated with a significantly higher pCR rate particularly in HER2 / HR co-positive tumors, and can be used to predict outcome before neoadjuvant trastuzumab is initiated.
Abstract: Purpose To evaluate whether pathological complete response to neoadjuvant trastuzumab is dependent on the level of HER2 amplification. Patients and Methods 114 women with HER2-overexpressing early breast cancer who had received neo-adjuvant trastuzumab in the prospective ABCSG-24 and ABCSG-32 trials, and for whom the HER2/CEP17 ratio was available, were included in this analysis. The ratio was correlated with tumor response as measured by the three most commonly used definitions of pathological complete response: ypT0 ypN0, ypT0/is ypN0, and ypT0/is. Results In trastuzumab-treated patients, ypT0 pN0 was achieved in 69.0% of patients with a HER2/CEP17 ratio of >6, but only in 30.4% of tumors with a ratio of ≤6 (p=0.001, Chi Square test). When pCR was defined by ypT0/is pN0 or by ypTis, 75.9% and 82.8% of tumors with a high ratio had a complete remission, while only 39.1%, and 38.3% with a low ratio achieved a pCR (p=0.002 and p Conclusion A HER2/CEP17 ratio of >6 in the pre-therapeutic tumor biopsy is associated with a significantly higher pCR rate particularly in HER2 / HR co-positive tumors, and can be used to predict outcome before neoadjuvant trastuzumab is initiated. Citation Format: Singer CF, Tan YY, Fitzal F, Steger GG, Egle D, Reiner A, Rudas M, Gruber C, Bartsch R, Fridrik M, Seifert M, Exner R, Balic M, Bago-Horvath Z, Filipits M, Gnant M, For the Austrian Breast and Colorectal Cancer Study Group. Pathological complete response to neoadjuvant trastuzumab is dependent on HER2/CEP17 ratio in HER2-amplified early breast cancer [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P1-09-10.
2 citations