Publications 2005

Clinical role of multidrug resistance protein 1 expression in chemotherapy resistance in early-stage breast cancer: the Austrian Breast and Colorectal Cancer Study Group

Filipits M, Pohl G, Rudas M, Dietze O, Lax S, Grill R, Pirker R, Zielinski C, Hausmaninger H, Kubista E, Samonigg H, Jakesz R

Journal of Clinical Oncology 2005, 23:1161-1168

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A prospective randomised trial to study the role of levamisole and interferon alfa in an adjuvant therapy with 5-FU for stage III colon cancer (Study 90)

W Schippinger, M Jagoditsch, C Sorré, M Gnant, G Steger, H Hausmaninger, B Mlineritsch, R Schaberl-Moser, HJ Mischinger, F Hofbauer, P Holzberger, M Mittlböck and R Jakesz for the Austrian Breast and Colorectal Cancer Study Group

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Abstract

The purpose of this trial was to examine the efficacy of the addition of levamisole (LEV) or interferon alfa (IFN) to an adjuvant chemotherapy with 5-fluorouracil (5-FU) in patients with stage III colon cancer. According to a 2 × 2 factorial study design, 598 patients were randomly assigned to one of four adjuvant treatment arms. Patients in arm one received 5-FU weekly for 1 year, patients in arm two 5-FU plus LEV, in arm three 5-FU plus IFN and patients in arm four 5-FU, LEV and IFN. The relative risk of relapse and the relative risk of death were significantly higher for patients treated with LEV compared with those without LEV treatment (HR 1.452, 95% CI 1.135–1.856, P=0.0028; HR 1.506, 95% CI 1.150–1.973, P=0.0027, respectively). No significant impact on survival was observed for therapy with IFN in the univariate analysis. The addition of LEV to adjuvant 5-FU significantly worsened the prognosis of patients with stage III colon cancer. Interferon alfa had no significant influence on survival when combined with adjuvant 5-FU, but increased the toxicity of therapy substantially.

British Journal of Cancer (2005) 92, 1655 – 1662

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Switching of postmenopausal women with endocrine-responsive early breast cancer to anastrozole after 2 years? adjuvant tamoxifen: combined results of ABCSG trial 8 and ARNO 95 trial

Raimund Jakesz, Walter Jonat, Michael Gnant, Martina Mittlboeck, Richard Greil, Christoph Tausch, Joern Hilfrich, Werner Kwasny, Christian Menzel, Hellmut Samonigg, Michael Seifert, Guenther Gademann, Manfred Kaufmann, on behalf of the ABCSG and the GABG.

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Abstract

BACKGROUND: Tamoxifen has been the standard adjuvant treatment for postmenopausal women with hormone-responsive early breast cancer for more than 20 years. However, the third-generation aromatase inhibitor anastrozole has proven efficacy and tolerability benefits compared with tamoxifen when used as initial adjuvant therapy. We investigate whether women who have received a period of adjuvant tamoxifen would benefit from being switched to anastrozole.

METHODS: We present a combined analysis of data from two prospective, multicentre, randomised, open-label trials with nearly identical inclusion criteria. Postmenopausal women with hormone-sensitive early breast cancer who had completed 2 years’ adjuvant oral tamoxifen (20 or 30 mg daily) were randomised to receive 1 mg oral anastrozole (n=1618) or 20 or 30 mg tamoxifen (n=1606) daily for the remainder of their adjuvant therapy. The primary endpoint was event-free survival, with an event defined as local or distant metastasis, or contralateral breast cancer. Analysis was by intention to treat.

FINDINGS: 3224 patients were included in analyses. At a median follow-up of 28 months, we noted a 40% decrease in the risk for an event in the anastrozole group as compared with the tamoxifen group (67 events with anastrozole vs 110 with tamoxifen, hazard ratio 0.60, 95% CI 0.44-0.81, p=0.0009). Both study treatments were well tolerated. There were significantly more fractures (p=0.015) and significantly fewer thromboses (p=0.034) in patients treated with anastrozole than in those on tamoxifen.

INTERPRETATION: These data lend support to a switch from tamoxifen to anastrozole in patients who have completed 2 years’ adjuvant tamoxifen.

Lancet 2005; 366: 455–62

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Trastuzumab after Adjuvant Chemotherapy in HER2-positive Breast Cancer

Piccart-Gebhart M, Procter M, Leyland-Jones B, Goldhirsch A, Untch M, Smith I, Gianni L, Baselga J, Bell R, Jackisch C, Cameron D, Dowsett M, Barrios C, Steger G, Huang C, Andersson M, Inbar M, Lichinitser M, Láng I, Nitz U, Iwata H, Thomssen C, Lorisch C, Suter T, Rüschoff J, Süt´ö, Greatorex V, Ward C, Straehle C, McFadden E, Dolci S, Gelber S

The New England Journal of Medicine 2005 Oct 20;353(16):1659-72.

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