Annual Meeting Proceedings II - Newly Released Abstracts for

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2 Plenary Session, Sun, 1:00 PM-4:00 PM Long-term follow-up results of EORTC 26951: A randomized phase III study on adjuvant PCV chemotherapy in anaplastic oligodendroglial tumors (AOD). Martin J. Van Den Bent, Khê Hoang-Xuan, Alba Ariela Brandes, Johan M Kros, Mathilde C.M. Kouwenhoven, Martin J. B. Taphoorn, Jean-Yves Delattre, Hans J.J.B. Bernsen, Marc Frenay, Cees Tijssen, Wolfgang Grisold, Laszlo Sipos, Roelien H. Enting, Winand N.M. Dinjens, Pim French, Charles J Vecht, Anouk Allgeier, Denis A. Lacombe, Thierry Gorlia; Erasmus University Medical Center, Daniel den Hoed Cancer Center, Rotterdam, Netherlands; Groupe Hospitalier Pitié- Salpêtrière, Paris, France; Medical Oncology Department, Bellaria-Maggiore Hospital, Azienda USL of Bologna, Bologna, Italy; Erasmus Medical Center, Rotterdam, Netherlands; Erasmus University Medical Center, Rotterdam, Netherlands; Medical Center Haaglanden/VU Medical Center, The Hague/Amsterdam, Netherlands; Pitie-Salpetriere Hospital-Pierre et Marie Curie Paris VI University, Paris, France; Canisius Wilhelmina Ziekenhuis, Nijmegen, Netherlands; Anticancer Center, Centre Antoine-Lacassagne, Nice, France; Elisabeth Gasthuis, Tilburg, Netherlands; Kaiser Franz Josef Hospital, Vienna, Austria; Neurooncologist National Institute of Neurosciences, Budapest, Hungary; Universitair Medisch Centrum Groningen, Groningen, Netherlands; Erasmus MC, Rotterdam, Netherlands; Medical Center The Hague, The Hague, Netherlands; European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium Background: AOD are chemotherapy-sensitive tumors especially if 1p/19q co-deleted. Between 1995 and 2002 the EORTC Brain Tumor Group conducted a prospective phase III study on adjuvant procarbazine, CCNU and vincristine chemotherapy (PCV) in AOD. We now present long-term follow-up. Methods: Patients (pts) with locally diagnosed newly diagnosed AOD were randomized between radiotherapy (RT, 33 x 1.8 Gy) and the same RT followed by 6 cycles of standard PCV (RT/PCV). Primary endpoints were overall survival (OS) and progression-free survival (PFS). 1p/19q status, IDH status and MGMT promoter methylation were determined in 300, 167, and 186 pts respectively. Results: Between 1996 and 2002, 368 pts were included. At the time of analysis 281 pts (76.4%) had died. Median PFS after RT/PCV was significantly longer compared to RT alone (24.3 months versus 13.21 months, hazard ratio [HR] 0.66, [95% confidence interval (95% CI) 0.52, 0.83]). More RT arm patients received chemotherapy at progression (75% vs 53%). Median OS was also significantly prolonged in the RT/PCV arm (42.3 months vs 30.6 months for the RT arm, HR 0.75 [95% CI 0.60, 0.95]). 1p/19q co-deleted patients (n � 76) treated with RT/PCV had improved OS compared to RT arm pts (median OS not reached vs 113 months; HR 0.54, p � 0.0487). In the 224 patients without 1p/19q co-deletion the difference in OS was non-significant (OS RT/PCV arm 25 months vs 22 months in the RT arm, HR 0.82, p � 0.18; test for interaction p � 0.22). There was a slight trend towards improved OS in MGMT methylated and IDH mutated tumors versus unmethylated and IDH wild type tumors (Table). Conclusions: The addition of PCV to RT increases PFS and OS in AOD. Pts with 1p/19q co-deletion appear to benefit most from the addition of PCV, with a trend for improved OS in pts with MGMT methylation and IDH mutations. Molecular features and the HR reduction for OS in the RT/PCV arm. Feature Status N HR 95% CI Status N HR 95% CI P 1p/19q Co-deleted 76 0.54 0.29, 1.01 Intact 224 0.82 0.61, 1.10 0.22 MGMT Methylated 132 0.67 0.44, 1.01 Unmethylated 54 0.80 0.46, 1.42 0.6 IDH Mutated 77 0.59 0.33, 1.07 Wild type 90 0.72 0.46, 1.11 0.58 Abbreviations: n: number of pts; p: p value interaction test. CENTRAL NERVOUS SYSTEM TUMORS © 2012 American Society of Clinical Oncology. Reprinted with permission.
LYMPHOMA AND PLASMA CELL DISORDERS 3 Plenary Session, Sun, 1:00 PM-4:00 PM Bendamustine plus rituximab (B-R) versus CHOP plus rituximab (CHOP-R) as first-line treatment in patients with indolent and mantle cell lymphomas (MCL): Updated results from the StiL NHL1 study. Mathias J. Rummel, Norbert Niederle, Georg Maschmeyer, Andre G. Banat, Ulrich von Gruenhagen, Christoph Losem, Dorothea Kofahl-Krause, Gerhard Heil, Manfred Welslau, Christina Balser, Ulrich Kaiser, Eckhart Weidmann, Heinz A. Duerk, Harald Ballo, Martina Stauch, Juergen Barth, Axel Hinke, Wolfram Brugger, Study Group Indolent Lymphomas (StiL); Universitaetsklinik, Giessen, Germany; Klinikum Leverkusen, Leverkusen, Germany; Potsdam Klinikum, Potsdam, Germany; Outpatient Clinic, Cottbus, Germany; Onkologische Praxis, Neuss, Germany; Medizinische Hochschule Hannover, Hannover, Germany; Kreiskrankenhaus Lüdenscheid, Luedenscheid, Germany; Praxis Aschaffenburg, Aschaffenburg, Germany; Onkologische Praxis, Marburg, Germany; St. Bernward Krankenhaus, Hildesheim, Germany; Krankenhaus Nordwest, Frankfurt, Germany; St. Marien-Hospital Hamm, Hamm, Germany; Onkologische Praxis, Offenbach, Germany; Outpatient Department, Kronach, Germany; WisP Clinical Research Organisation, Langenfeld, Germany; Schwarzwald-Baar Clinic, Villingen- Schwenningen, Germany Background: This multicenter, randomized, phase III study compared B-R and CHOP-R as first-line treatment in indolent lymphoma and MCL and was presented at ASH 2009 including a comprehensive safety analysis. Here we present an updated analysis with a cut-off date for 31 Oct 2011. Methods: 549 patients (pts) with indolent or MCL were randomized to receive B-R or CHOP-R for a max of 6 cycles. The primary endpoint was PFS. Results: 514 pts randomized pts were evaluable (261 B-R; 253 CHOP-R). Patient characteristics were well balanced between arms; median age was 64 years. At a median follow-up of 45 months, PFS was significantly prolonged with B-R compared with CHOP-R (HR 0.58, 95% CI 0.44–0.74; P�0.001). Median PFS was 69.5 versus 31.2 months, respectively. The PFS benefit with B-R was maintained in all histological subtypes except marginal zone lymphoma. The PFS benefit with B-R was independent of age; HR 0.52 (P�0.002) in pts �60 years (n�199), and HR 0.62 (P�0.002) in pts �60 years (n�315). In pts with normal LDH (62%), PFS was significantly prolonged with B-R compared with CHOP-R (P�0.001), while in the elevated LDH group (38%) PFS was numerically, but not significantly increased with B-R compared with CHOP-R (P�0.118). In patients with follicular lymphoma, FLIPI subgroups defined by 0–2 factors (favorable) and 3–5 factors (unfavorable) had a longer PFS with B-R than with CHOP-R (P�0.043 and P�0.068 for the favorable and unfavorable FLIPI subgroups, respectively). Seventy four salvage treatments had been initiated in the B-R group; compared with 116 in the CHOP-R group, of those in the CHOP-R group 52 pts received B-R as salvage regimen. Overall survival did not differ between the treatment arms, with 43 and 45 deaths in the B-R and CHOP-R arms, respectively. Twenty secondary malignancies were observed in the B-R group compared with 23 in the CHOP-R group, with 1 hematological malignancy in each group (1 MDS in B-R, 1 AML in CHOP-R). Conclusions: In patients with previously untreated indolent lymphoma, and elderly patients with MCL, B-R demonstrates a PFS benefit and improved tolerability compared with CHOP-R. © 2012 American Society of Clinical Oncology. Reprinted with permission.
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