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De Boer R.H.,Royal Melbourne Hospital | Kotasek D.,Ashford Cancer Center | White S.,Austin Health | Koczwara B.,Flinders University | And 7 more authors.
Breast Cancer Research and Treatment | Year: 2012

The purpose of this study was to investigate the safety, tolerability, and pharmacokinetics of motesanib when combined with docetaxel or paclitaxel in patients with metastatic breast cancer. In this open-label, dose-finding, phase 1b study, patients received motesanib 50 or 125-mg orally once daily (QD), beginning day 3 of cycle 1 of chemotherapy, continuously in combination with either paclitaxel 90 mg/m2 on days 1, 8, and 15 every 28-day cycle (Arm A) or docetaxel 100 mg/m2 on day 1 every 21-day cycle (Arm B). Dose escalation to motesanib 125 mg QD occurred if the incidence of dose-limiting toxicities (DLTs, primary endpoint) was 33 %. If the maximum tolerated dose (MTD) of motesanib was established in Arm B, additional patients could receive motesanib at the MTD plus docetaxel 75 mg/m2. Forty-six patients were enrolled and 45 received ≥1 dose of motesanib. The incidence of DLTs was <33 % in all cohorts; thus, motesanib 125 mg QD was established as the MTD. Seven patients (16 %) had grade 3 motesanib-related adverse events including cholecystitis (2 patients) and hypertension (2 patients). Pharmacokinetic parameters of motesanib were similar to those reported in previous studies. The objective response rate was 56 % among patients with measurable disease at baseline who received motesanib in combination with taxane-based chemotherapy. The addition of motesanib to either paclitaxel or docetaxel was generally tolerable up to the 125-mg QD dose of motesanib. The objective response rate of 56 % suggests a potential benefit of motesanib in combination with taxane-based chemotherapy. © 2012 The Author(s).

Stockler M.R.,University of Sydney | Harvey V.J.,Auckland Hospital | Francis P.A.,Peter MacCallum Cancer Center | Byrne M.J.,Sir Charles Gairdner Hospital | And 15 more authors.
Journal of Clinical Oncology | Year: 2011

Purpose: We compared oral capecitabine, administered intermittently or continuously, versus classical cyclophosphamide, methotrexate, and fluorouracil (CMF) as first-line chemotherapy for women with advanced breast cancer unsuited to more intensive regimens. Patients and Methods: Three hundred twenty-three eligible women were randomly assigned to capecitabine administered intermittently (1,000 mg/m 2 twice daily for 14 of every 21 days; n = 107) or continuously (650 mg/m 2 twice daily for 21 of every 21 days; n = 107), or to classical CMF (oral cyclophosphamide 100 mg/m 2 days 1 to 14 with intravenous methotrexate 40 mg/m 2 and fluorouracil 600 mg/m 2 on days 1 and 8 every 28 days; n = 109). The primary end point was quality-adjusted progression-free survival (PFS); secondary end points included PFS, overall survival (OS), objective tumor response, and adverse events. Intermittent and continuous capecitabine were to be compared first and, if similar (P > .05), combined for definitive comparisons versus CMF. Results: Quality-adjusted PFS (P = .2), objective tumor response rate (20%; P = .8), and PFS (median, 6 months; hazard ratio [HR], 0.86; 95% CI, 0.67 to 1.10; P = .2) were similar in women assigned capecitabine versus CMF.OSwas longer in women assigned capecitabine rather thanCMF(median, 22 v 18 months; HR, 0.72; 95% CI, 0.55 to 0.94; P=.02). Febrile neutropenia, infection, stomatitis, and serious adverse events were more common with CMF; hand-foot syndrome was more common with capecitabine. Conclusion: Capecitabine improved OS by being similarly active, less toxic, and more tolerable than CMF. Capecitabine is a good first-line chemotherapy option for women with advanced breast cancer who are unsuited to more intensive regimens. © 2011 by American Society of Clinical Oncology.

This feasibility study represents the first report of a new carbon dioxide-based tissue expander designed to allow gradual controlled expansion and to eliminate the need for percutaneous injections. Seven patients underwent implantation with a total of 10 (three bilateral) tissue expanders. After intraoperative filling by the surgeon and wound healing, small doses of carbon dioxide were administered on a daily basis by the patient by means of a hand-held dosage controller leading to gradual, incremental expansion. Rapid expansion during the active dosing phase and flexibility to meet individual patient needs during expansion were demonstrated with all subjects. These patients achieved full expansion in an average of 15 days. All seven patients were able to use the device safely and with ease at home, leading to successful tissue expansion and permanent breast reconstruction. Copyright © 2011 by the American Society of Plastic Surgeons.

Blakeney W.G.,Fremantle Hospital | Zilko S.R.,Fremantle Hospital | Edmonston S.J.,Shenton Park Physiotherapy Clinic | Schupp N.E.,Sir Charles Gairdner Hospital | Annear P.T.,Mount Hospital
Knee Surgery, Sports Traumatology, Arthroscopy | Year: 2016

Purpose: The purpose of the present study was to validate a new scoring system for proximal hamstring injury—the Perth Hamstring Assessment Tool (PHAT). Methods: This is a prospective series of 74 consecutive proximal hamstring surgical repairs in 72 patients, with a median age of 50.5 years (range 16–74). Patients completed the PHAT, SF12 Health Survey and Lower Extremity Functional Scale (LEFS). The scoring system was validated by calculating its internal consistency, reproducibility, reliability and sensitivity to change. Construct validity was evaluated using Pearson’s correlation analysis to examine the strength of association between the PHAT, LEFS and SF-12 scores. Results: The PHAT showed high completion rate (100 %), high internal consistency (Cronbach’s alpha 0.80), high reproducibility (ICC 0.84) and high sensitivity to change. There was moderate correlation with the LEFS and low correlation with the Physical Component Score of the SF-12. Conclusion: This study has validated the PHAT as an assessment tool for proximal hamstring tendon injuries. The new questionnaire provides a measure of outcome that is reliable and sensitive to clinically important change. This simple questionnaire provides the clinician with a quick and practical tool for assessing patients with proximal hamstring injuries: to assess pre-operative disability and monitor recovery post-operatively. Level of evidence: II. © 2016 European Society of Sports Traumatology, Knee Surgery, Arthroscopy (ESSKA)

Vogel C.,University of Miami | Chan A.,Mount Hospital | Gril B.,U.S. National Institutes of Health | Kim S.-B.,University of Ulsan | And 4 more authors.
Japanese Journal of Clinical Oncology | Year: 2010

The management of human epidermal growth factor receptor 2-positive (ErbB2+) breast cancer is challenging; patients with ErbB2+ breast tumors have more aggressive disease and a poor prognosis. The increasing incidence of breast cancer in Asia and the limitations of existing treatments pose additional challenges. In this review, we summarize the preclinical and clinical evidence that indicates how lapatinib, a novel inhibitor that targets the human epidermal growth factor receptor (ErbB1) and ErbB2 may help clinicians address four particularly challenging issues in the management of ErbB2+ breast cancer. These issues are: (i) trastuzumab therapy failure, (ii) development of central nervous system metastases, (iii) minimizing toxicity and (iv) selecting the most appropriate partners (chemotherapy and non-chemotherapy) for combination therapy with lapatinib. Lapatinib, in combination with chemotherapeutic agents, such as capecitabine, provides clinical benefits to patients with ErbB2+ breast cancer, including patients who develop progressive disease on trastuzumab. Lapatinib, in combination with non-chemotherapeutic agents, such as letrozole, may also provide a chemotherapy-free treatment option for postmenopausal patients with estrogen receptor-positive/ErbB2+ metastatic breast cancer. Encouraging results have also emerged regarding the synergistic effects of lapatinib in combination with other agents for the treatment of ErbB2+ breast cancer. Promising findings have also been reported for the use of lapatinib to prevent and treat central nervous system metastases. Collectively, these results indicate that the judicious use of lapatinib, an effective oral therapy with a manageable toxicity profile, can enhance the management of patients with ErbB2+ breast cancer. © The Author (2010). Published by Oxford University Press. All rights reserved.

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