Search results for "Axel"

Sorafenib (SOR) plus docetaxel (DOC) as first-line therapy in patients with HER2-negative metastatic breast cancer (MBC): A randomized, placebo-contr…

2014

1072 Background: Anti-angiogenic therapy with the monoclonal anti-VEGF antibody Bevacizumab (Bev) in combination with chemotherapy increases overall response rates (ORR) and progression free surviv...

Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (Neo…

2011

Summary Background Studies with pertuzumab, a novel anti-HER2 antibody, show improved efficacy when combined with the established HER2-directed antibody trastuzumab in breast cancer therapy. We investigated the combination of pertuzumab or trastuzumab, or both, with docetaxel and the combination of pertuzumab and trastuzumab without chemotherapy in the neoadjuvant setting. Methods In this multicentre, open-label, phase 2 study, treatment-naive women with HER2-positive breast cancer were randomly assigned (1:1:1:1) centrally and stratified by operable, locally advanced, and inflammatory breast cancer, and by hormone receptor expression to receive four neoadjuvant cycles of: trastuzumab (8 mg…

Secondary acute leukemia following mitoxantrone-based high-dose chemotherapy for primary breast cancer patients.

2003

The incidence of secondary myelodysplasia/acute myeloid leukemia (AML) was retrospectively assessed in an international joint study in 305 node-positive breast cancer patients, who received mitoxantrone-based high-dose chemotherapy (HDCT) followed by autologous stem cell support as adjuvant therapy. The median age of the patients was 57 years (range 22-67). In all, 268 patients received peripheral blood stem cells, and 47 patients received autologous bone marrow. After a median follow-up of 57 months (range 10-125), three cases of secondary AML (sAML) were observed, resulting in a cumulative incidence of 0.94%. One case of sAML developed 18 months after HDCT (FAB M3) The karyotype was trans…

Carboplatin and pegylated liposomal doxorubicin for advanced ovarian cancer. Preliminary activity results of the MITO-2 phase III trial

2008

<i>Background:</i> Based on the efficacy of pegylated liposomal doxorubicin (PLD) in relapsed ovarian cancer, we are conducting a phase III study comparing carboplatin plus either paclitaxel or PLD as first-line therapy in advanced ovarian cancer. Because of limited phase I and II data on PLD plus carboplatin in this setting, we conducted an interim activity analysis. <i>Patients and Methods:</i> Patients with stage 1c-IV epithelial ovarian cancer were randomized to carboplatin AUC 5 plus either paclitaxel 175 mg/m<sup>2</sup> or PLD 30 mg/m<sup>2</sup> every 3 weeks for 6 cycles. The interim activity analysis was planned according to a single…

Safety and efficacy of the treatment with Nab-paclitaxel in mEtastatic bREast cancer In elDerly patiEnts: NEREIDE study

2017

Ten-Year Safety and Efficacy Analyses of the Big 02-98 Phase III Trial with an Exploratory Analysis on the Role of Ki67 in Predicting Benefit of Adju…

2014

ABSTRACT Aim: The BIG 2-98 is a randomized phase III trial that tested the effect of adding docetaxel with anthracycline-based adjuvant chemotherapy (CT) in women with node-positive breast cancer (BC). here we present the 10 year safety and efficacy analyses and report an exploratory analysis of the predictive value of Ki67 for docetaxel efficacy. Methods: In total, 2,887 patients with node positive BC were randomly assigned to one of four treatments: (I) sequential control: doxorubicin (A, 75 mg/m2) × 4 → CMF; (II) concurrent control: AC × 4 → CMF; (III) A × 3 → docetaxel (T, 100 mg/m2) × 3 → CMF and (IV) : AT (50/75 mg/m2) × 4 → CMF. The primary objective was to evaluate the efficacy of d…

How to Develop Molecular Targeted Drugs in Gastric Cancer: First or Second Line?

2013

The inclusion of new targeted drugs into treatment strategies of advanced or metastatic esophagogastric cancers (AGC) shows great promise, particularly with validated predictive biomarkers. The majority of agents already tested or in current phase III trials are targeting the epidermal growth factor receptor family (EGFR1/ HER2) or angiogenesis inhibitors. Against HER2, only trastuzumab (T) combined with first-line chemotherapy significantly improved overall survival (OS) in patients with HER2-overexpressing (HER+) tumors (ToGA). Despite first positive signals, the dual tyrosine kinase inhibitor (TKI) of HER2 and EGFR1 lapatinib did not reach primary endpoints in HER2+ tumors in first- and …

Multimodal treatment of gastric cancer

2007

Although radical surgical R0 resections are the basis of cure for gastric cancer, surgery alone only provides long-term survival in 20-30% of patients with advanced-stage disease. Thus, in Western and European countries, advanced gastric cancer has a high risk of recurrence and metachronous metastases. Very recently, multimodal strategies combining different neoadjuvant and/or adjuvant protocols have improved the prognosis of gastric cancer when combined with surgery with curative intent. As used in palliative regimens, the combination of cisplatin with intravenous or oral fluoropyrimidines has been the integral component of such (neo)adjuvant strategies. However, the cytotoxic agents docet…

A Phase 3 Trial of Bevacizumab in Ovarian Cancer

2011

Angiogenesis plays a role in the biology of ovarian cancer. We examined the effect of bevacizumab, the vascular endothelial growth factor inhibitor, on survival in women with this disease.We randomly assigned women with ovarian cancer to carboplatin (area under the curve, 5 or 6) and paclitaxel (175 mg per square meter of body-surface area), given every 3 weeks for 6 cycles, or to this regimen plus bevacizumab (7.5 mg per kilogram of body weight), given concurrently every 3 weeks for 5 or 6 cycles and continued for 12 additional cycles or until progression of disease. Outcome measures included progression-free survival, first analyzed per protocol and then updated, and interim overall survi…

CD1a: a novel biomarker for Barrett's metaplasia?

2003

educational book. Alexandria: American Society for Clinical Oncology, 2001: 226–44. 49 Hussain M, Smith DC, Al-Sukhun S, et al. Preliminary results of HER-2/neu screening and treatment with trastuzumab (Herceptin) (T), paclitaxel (P), carboplatin (C) and gemcitabine (G) in patients with advanced urothelial cancer. Proc Am Soc Clin Oncol 2002; 21: 800a. 50 Al-Sukhun S, Hussain M. Current understanding of the biology of advanced bladder cancer. Cancer 2003; 97 (8 suppl): 2064–75. 51 Hussain SA, Ganesan R, Hiller L, et al. Pro-apoptotic genes BAX and CD40L are predictors of survival in transitional cell carcinoma of the bladder. Br J Cancer 2003; 88: 586–92. 52 Stein JP, Ginsberg DA, Grossfiel…