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BACKGROUND: Depatuxizumab mafodotin (Depatux-M) is a tumor-specific antibody-drug conjugate consisting of an antibody (ABT-806) directed against activated epidermal growth factor receptor (EGFR) and the toxin monomethylauristatin-F. We investigated Depatux-M in combination with temozolomide or as a single agent in a randomized controlled phase II trial in recurrent EGFR amplified glioblastoma. METHODS: Eligible were patients with centrally confirmed EGFR amplified glioblastoma at first recurrence after chemo-irradiation with temozolomide. Patients were randomized to either Depatux-M 1.25 mg/kg every 2 weeks intravenously, or this treatment combined with temozolomide 150-200 mg/m2 day 1-5 every 4 weeks, or either lomustine or temozolomide. The primary endpoint of the study was overall survival. RESULTS: Two hundred sixty patients were randomized. In the primary efficacy analysis with 199 events (median follow-up 15.0 mo), the hazard ratio (HR) for the combination arm compared with the control arm was 0.71 (95% CI = 0.50, 1.02; P = 0.062). The efficacy of Depatux-M monotherapy was comparable to that of the control arm (HR = 1.04, 95% CI = 0.73, 1.48; P = 0.83). The most frequent toxicity in Depatux-M treated patients was a reversible corneal epitheliopathy, occurring as grades 3-4 adverse events in 25-30% of patients. In the long-term follow-up analysis with median follow-up of 28.7 months, the HR for the comparison of the combination arm versus the control arm was 0.66 (95% CI = 0.48, 0.93). CONCLUSION: This trial suggests a possible role for the use of Depatux-M in combination with temozolomide in EGFR amplified recurrent glioblastoma, especially in patients relapsing well after the end of first-line adjuvant temozolomide treatment. (NCT02343406).

In spite of the prevailing myth, neither the political self-conception of West Berlin that emerged soon after the war nor the city’s international image were mere by-products of the Cold War. They resulted, rather, from a binational campaign that was based on strategic considerations. Returned Social Democratic émigrés, sympathetic American officials, and certain journalists convinced the German and the American public of West Berlin’s heroic defence of democratic ideals with remarkable speed and success. They could rely on both tangible and intangible resources for their campaign of erecting an ›Outpost of Freedom‹ in what was left of the former Reichshauptstadt. While the heady Weimar days of pre-war Berlin provided countless images that appeared to authenticate this new narrative, the transatlantic network was also able to draw on considerable financial resources and media outlets to promote it. This article seeks to outline the historical actors behind the project and the narratives on which they drew., Trotz des noch immer vorherrschenden Mythos waren weder das städtische Selbstverständnis noch das internationale Image West-Berlins nach 1945 zufällige Nebenprodukte des Kalten Krieges; sie waren vielmehr das Ergebnis einer transnationalen Kampagne. Aus dem Exil zurückgekehrte Sozialdemokraten schafften es in Zusammenarbeit mit wohlwollenden Vertretern der USA und einigen Journalisten erstaunlich rasch, die deutsche und amerikanische Öffentlichkeit von der heldenhaften Verteidigung demokratischer Werte durch die West-Berliner Bevölkerung zu überzeugen. Bei dem Versuch, auf den Trümmern der einstigen Reichshauptstadt einen »Vorposten der Freiheit« zu errichten, konnten diese Protagonisten auf materielle wie immaterielle Ressourcen zurückgreifen. Einerseits stützte sich das deutsch-amerikanische Netzwerk auf bestehende Vorstellungen und Erzählungen von Berlin, die den neu entstandenen Mythos glaubhaft erscheinen ließen. Andererseits verfügte es über beachtliche finanzielle Mittel und verschiedenste Medien, um die Deutungen nach außen zu kommunizieren. Der Aufsatz stellt die Akteure hinter diesem Projekt vor und skizziert die Narrative, auf denen der Mythos West-Berlins aufbaute.

My Road to Berlin, or Mein Weg nach Berlin, presents a Willy Brandt that confounds a present-day reader’s expectations. While the 1960 autobiography of the then-mayor of West Berlin links his career with the familiar story of democracy’s development in Germany, this work nevertheless retains an unexpected edge. In one surprising scene, the mayor denounces his East Berlin SED counterparts as a ›Communist foreign legion‹ whom ›the citizens of my city had decisively defeated‹ during the Second Berlin Crisis of 1958 (p. 17). In the book, Brandt comes off as a Cold Warrior of steely determination rather than a Brückenbauer bridging ideological divides. Far from being out of character, however, My Road to Berlin captures Brandt at a pivotal moment in his career, when he sought to offer himself to both West German voters and a global public as a viable alternative to Konrad Adenauer.

William Insull Jr1, Peter P Toth2, H Robert Superko3, Roopal B Thakkar4, Scott Krause4, Ping Jiang4, Rhea A Parreno4, Robert J Padley41Baylor College of Medicine and Methodist Hospital, Houston, Texas; 2University of Illinois College of Medicine, Peoria, Illinois; 3Celera, Alameda, California, Mercer University, Atlanta, Georgia; 4Abbott, Abbott Park, Illinois, USAObjective: To compare the effects of combination niacin extended-release + simvastatin (NER/S) versus atorvastatin alone on apolipoproteins and lipid fractions in a post hoc analysis from SUPREME, a study which compared the lipid effects of niacin extended-release + simvastatin and atorvastatin in patients with hyperlipidemia or mixed dyslipidemia.Patients and methods: Patients (n = 137) with dyslipidemia (not previously receiving statin therapy or having discontinued any lipid-altering treatment 4–5 weeks prior to the study) received NER/S (1000/40 mg/day for four weeks, then 2000/40 mg/day for eight weeks) or atorvastatin 40 mg/day for 12 weeks. Median percent changes in apolipoprotein (apo) A-1, apo B, and the apo B:A-I ratio, and nuclear magnetic resonance lipoprotein subclasses from baseline to week 12 were compared using the Wilcoxon rank-sum test and Fisher’s exact test.Results: NER/S treatment produced significantly greater percent changes in apo A-I and apo B:A-I, and, at the final visit, apo B <80 mg/dL was attained by 59% versus 33% of patients, compared with atorvastatin treatment (P = 0.003). NER/S treatment resulted in greater percent reductions in calculated particle numbers for low-density lipoprotein (LDL, 52% versus 43%; P = 0.022), small LDL (55% versus 45%; P = 0.011), very low-density lipoprotein (VLDL) and total chylomicrons (63% versus 39%; P < 0.001), and greater increases in particle size for LDL (2.7% versus 1.0%; P = 0.007) and VLDL (9.3% versus 0.1%; P < 0.001), compared with atorvastatin.Conclusion: NER/S treatment significantly improved