Monash Cancer Center

Bentleigh East, Australia

Monash Cancer Center

Bentleigh East, Australia
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NASHUA, N.H. and MELBOURNE, Australia, May 01, 2017 (GLOBE NEWSWIRE) -- iCAD, Inc. (Nasdaq:ICAD), an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early identification and treatment of cancer, today announced the first early-stage breast cancer patient was treated in Australia with intraoperative radiation therapy (IORT) using the Xoft® Axxent® Electronic Brachytherapy (eBx®) System®. The patient was treated at Monash Cancer Centre, a partnership between Peter MacCallum Cancer Centre and Monash Health, in Melbourne, Australia. “In recent years, healthcare facilities around the world have increasingly adopted the Xoft System, recognizing the unique benefits this revolutionary technology offers to both patients and clinicians in treating a range of different cancers,” said Ken Ferry, CEO of iCAD. “We are pleased to join with Monash Cancer Centre to provide unprecedented access to this advanced treatment option to patients in Australia.” In March 2017, Monash Cancer Centre became the first medical center in Australia to adopt the Xoft System through iCAD’s local distribution partner, Regional Health Care Group Pty Ltd. The system is FDA cleared, CE marked, entered in the Australian Register of Therapeutic Goods (ARTG), and licensed in a growing number of countries for the treatment of cancer anywhere in the body, including early-stage breast cancer, non-melanoma skin cancer, and gynecological cancer. For the treatment of early-stage breast cancer, IORT with the Xoft System allows radiation oncologists and breast surgeons to work together to administer one precise, concentrated dose of radiation to a tumor site at the time of lumpectomy. IORT with the Xoft System can be completed in as little as eight minutes, making it possible to replace six to eight weeks of traditional radiation therapy with a single treatment. The Xoft System’s miniaturized x-ray source can be inserted into a variety of applicators that are specifically designed for certain clinical indications. Monash Cancer Centre will offer the complete suite of Xoft System applicators used to deliver IORT, skin eBx, endometrial and cervical cancer radiation treatment. “Our adoption of the Xoft System underscores our commitment to providing optimal quality of care to our patients and we are proud to be the first to offer this technology to patients in Australia in the context of an international clinical trial,” said Dr. Steven David, MBBS, FRANZCR, Radiation Oncologist, Moorabbin Campus Director, Peter MacCallum Cancer Centre. “In our detailed review of the range of available radiation therapy solutions, the Xoft System’s distinguished versatility across a variety of clinical applications, mobility, and unique patient benefits made it the preeminent solution for our practice.” Monash Cancer Centre is the second international site to participate in iCAD’s clinical trial evaluating the Xoft System for the treatment of early-stage breast cancer, called the ExBRT trial (“A Safety and Efficacy Study of Intra-Operative Radiation Therapy [IORT] Using the Xoft® Axxent® Electronic Brachytherapy [eBx®] System at the Time of Breast Conservation Surgery for Early-Stage Breast Cancer”). “Intraoperative radiotherapy will offer women with early-stage breast cancer another therapeutic option, and, we believe, a better patient experience with less treatment morbidity, and a more rapid return to normal activity. As well as our current commitment to the study, we hope the breast service and other Monash Cancer Centre tumor services, will be able to contribute to understanding the use of this technology in other disease types and stages,” said Dr. Jane Fox, Director, Breast Services, Monash Health. “We are encouraged by the research to date as the global community of treatment centers continues to provide appropriate patients with the unique option to complete a full dose of radiation therapy in a single treatment.” “Monash Cancer Centre’s participation in the ExBRT trial offers important growth of the body of international clinical data demonstrating the safety and efficacy of the Xoft System for appropriate patients,” added Mr. Ferry. “We remain committed to continuing to expand research to identify additional treatment areas like IORT that have the potential to transform the treatment of cancer for patients worldwide.” Monash Cancer Centre at Moorabbin Hospital is a key service of Monash Health – Victoria’s largest health service. The Monash Cancer Centre provides the more than 1.5 million residents of southern Melbourne with access to world leading cancer treatment integrated in one convenient location through this key collaboration between Monash Health and the Peter MacCallum Cancer Centre. Cancer patients receive all care, from diagnosis to treatment and follow-up support, at the one place. Peter MacCallum Cancer Centre is one of the world’s leading cancer research, education and treatment centres and is Australia’s only public hospital solely dedicated to caring for people affected by cancer. Peter MacCallum Cancer Centre has over 2,500 staff, including more than 580 laboratory and clinical researchers, all focused on providing better treatments, better care and potential cures for cancer. For more information on Peter MacCallum Cancer Centre, please visit the website at www.petermac.org. Regional Health Care Group (RHCG) is 100% Australian-owned and one of Australia’s most successful privately-owned groups of companies in the Healthcare / Research & Development sector.  RHCG is highly regarded in all clinical settings as a provider of premium quality capital equipment & medical consumables, with business extending across the Australian continent & New Zealand.  RHCG are specialists in successfully introducing innovative technology & devices to the Australian & NZ healthcare market. For more information on RHCG, please visit the company’s website at www.rhcg.com.au. The Xoft System is an isotope-free radiation treatment that is FDA cleared, CE marked, and licensed in a growing number of countries for the treatment of cancer anywhere in the body, including treatment of early-stage breast cancer, gynecological cancers and non-melanoma skin cancer. It utilizes a proprietary miniaturized x-ray as the radiation source that delivers precise treatment directly to cancerous areas while sparing healthy tissue and organs. The Xoft System requires only minimal shielding and therefore does not require room redesign or construction investment. Minimal shielding also allows medical personnel to remain in the room with the patient during treatment. The mobility of the Xoft System makes it easy to treat patients at multiple locations and to easily store the system when not in use. The Axxent Hub is a cloud-based oncology collaboration software solution that enables centers to monitor treatment workflow and enhance communication between clinical specialists. Xoft is a wholly owned subsidiary of iCAD, Inc. For more information about Xoft visit www.xoftinc.com, like us on Facebook or follow us on Twitter at @xofticad. iCAD delivers innovative cancer detection and radiation therapy solutions and services that enable clinicians to find and treat cancers earlier and faster while improving patient outcomes. iCAD offers a comprehensive range of upgradeable computer aided detection (CAD) and workflow solutions to support rapid and accurate detection of breast, prostate and colorectal cancers. iCAD’s Xoft® Axxent® Electronic Brachytherapy (eBx®) System® delivers high dose rate, low energy radiation, which targets cancer while minimizing exposure to surrounding healthy tissue. The Xoft System is FDA cleared and CE marked for use anywhere in the body, including treatment of non-melanoma skin cancer, early-stage breast cancer and gynecological cancers. The comprehensive iCAD technology platforms include advanced hardware and software as well as management services designed to support cancer detection and radiation therapy treatments. For more information, visit or www.icadmed.com or www.xoftinc.com. "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995 Certain statements contained in this News Release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve a number of known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, but are not limited to the Company’s ability to defend itself in litigation matters, to achieve business and strategic objectives, the risks of uncertainty of patent protection, the impact of supply and manufacturing constraints or difficulties, uncertainty of future sales levels, protection of patents and other proprietary rights, the impact of supply and manufacturing constraints or difficulties, product market acceptance, possible technological obsolescence of products, increased competition, litigation and/or government regulation, changes in Medicare or other reimbursement policies, risks relating to our existing and future debt obligations, competitive factors, the effects of a decline in the economy or markets served by the Company; and other risks detailed in the Company’s filings with the Securities and Exchange Commission. The words “believe”, “demonstrate”, “intend”, “expect”, “would”, “could”, “consider”, “project”, “estimate”, “will”, “continue”, “anticipate”, “likely”, “seek”, and similar expressions identify forward-looking statements. Readers are cautioned not to place undue reliance on those forward-looking statements, which speak only as of the date the statement was made. The Company is under no obligation to provide any updates to any information contained in this release. For additional disclosure regarding these and other risks faced by iCAD, please see the disclosure contained in our public filings with the Securities and Exchange Commission, including the 10-K for the year ended December 31, 2016, available on the Investors section of our website at http://www.icadmed.com and on the SEC’s website at http://www.sec.gov.


Patel G.S.,Flinders University | Jain K.,Flinders University | Kumar R.,Flinders University | Strickland A.H.,Monash Cancer Center | And 11 more authors.
Supportive Care in Cancer | Year: 2014

Purpose: Indwelling central venous catheters (CVCs) have been increasingly used to enable delivery of intravenous chemotherapy. We aimed to compare the safety and cost of two commonly used CVCs, peripherally inserted central venous catheter (PICCs) and ports, in the delivery of chemotherapy in patients with non-haematological malignancies. Methods: Seventy patients were randomly assigned to receive either a PICC or a port. The primary endpoint was occurrence of major complications, which required removal of the CVC and secondary endpoints included occurrence of any complications. Results: Port devices were associated with fewer complications compared with PICC lines (hazard ratio of 0.25, CI, 0.09-0.86, P = 0.038). Major complication rate was lower in the port arm compared to the PICC arm (0.047 versus 0.193 major complications/100 catheter days, P = 0.034) with 6 versus 20 % of patients experiencing major complications, respectively. Thrombosis, the most common complication, was significantly higher in the PICC arm compared to the port arm (25 versus 0 %, P = 0.013). Quality of life and cost estimates did not differ significantly between the two arms. Conclusions: Port devices are associated with a lower risk of complications, with no difference in cost, compared to PICC lines in patients with non-haematological malignancies receiving intravenous chemotherapy. © 2013 Springer-Verlag Berlin Heidelberg.


Azad A.A.,Joint Austin Ludwig Oncology Unit | Siow S.-F.,Joint Austin Ludwig Oncology Unit | Tafreshi A.,Joint Austin Ludwig Oncology Unit | Moran J.,Austin Health | And 2 more authors.
Journal of Palliative Medicine | Year: 2014

Background: Do-not-resuscitate (DNR) orders prevent medically futile attempts at resuscitation but are not always instituted in hospitalized patients with advanced cancer. One explanation for this underuse is the perception that DNR orders are inevitably associated with withdrawal of all medical interventions and inpatient death. Objectives: To audit discharge and survival outcomes and changes in clinical management in hospitalized adult oncology patients with a DNR order, allowing an assessment of whether such orders lead to cessation of acute interventions and high rates of in-hospital death. Methods: Retrospective data were collected from 270 oncology inpatients at Austin Health, Melbourne, Australia, between February 1, 2012 and November 30, 2012. Results: Mean and median time to institution of DNR orders after admission were 2.1 and 1.0 days, respectively (interquartile range, 0-2 days). Medical interventions continued in 80% or more of cases after DNR orders were placed included blood draws, intravenous antimicrobials, imaging, blood products, and radiotherapy. Two-thirds of patients survived hospitalization and were discharged alive. Survival at 30 days and 90 days after DNR orders were implemented was 63% and 33%, respectively. Baseline Charlson Comorbidity Index score of 5 or less and Eastern Cooperative Oncology Group performance status of 2 or less were associated with a higher probability of being discharged alive and longer overall survival. Conclusions: Most medical interventions were continued with high frequency in adult oncology inpatients after placement of DNR orders. A majority of patients survived hospitalization and remained alive at 30 days after DNR orders were documented. This study offers some reassurance that DNR orders do not inevitably lead to cessation of appropriate medical treatment. © 2014, Mary Ann Liebert, Inc..


PubMed | Jules Bordet Institute, Karolinska Institutet, Institute of Oncology, University of Houston and 76 more.
Type: Review | Journal: ESMO open | Year: 2016

The European Society for Medical Oncology (ESMO) and the American Society of Clinical Oncology (ASCO) are publishing a new edition of the ESMO/ASCO Global Curriculum (GC) thanks to contribution of 64 ESMO-appointed and 32 ASCO-appointed authors. First published in 2004 and updated in 2010, the GC edition 2016 answers to the need for updated recommendations for the training of physicians in medical oncology by defining the standard to be fulfilled to qualify as medical oncologists. At times of internationalisation of healthcare and increased mobility of patients and physicians, the GC aims to provide state-of-the-art cancer care to all patients wherever they live. Recent progress in the field of cancer research has indeed resulted in diagnostic and therapeutic innovations such as targeted therapies as a standard therapeutic approach or personalised cancer medicine apart from the revival of immunotherapy, requiring specialised training for medical oncology trainees. Thus, several new chapters on technical contents such as molecular pathology, translational research or molecular imaging and on conceptual attitudes towards human principles like genetic counselling or survivorship have been integrated in the GC. The GC edition 2016 consists of 12 sections with 17 subsections, 44 chapters and 35 subchapters, respectively. Besides renewal in its contents, the GC underwent a principal formal change taking into consideration modern didactic principles. It is presented in a template-based format that subcategorises the detailed outcome requirements into learning objectives, awareness, knowledge and skills. Consecutive steps will be those of harmonising and implementing teaching and assessment strategies.


Milat F.,Monash Medical Center | Milat F.,Prince Henrys Institute | Milat F.,Monash University | Goh S.,Monash Medical Center | And 12 more authors.
Bone | Year: 2013

Prostate cancer is a leading cause of cancer death, frequently associated with widespread bone metastases. We report two cases of hypocalcemia following the first dose of denosumab in metastatic hormone refractory prostate cancer, the first case requiring 26. days of intravenous calcium therapy. This is the first report of prolonged hypocalcemia following denosumab in a patient with normal renal function. © 2013 .


Whittle J.R.,Royal Melbourne Hospital | Lickliter J.D.,Monash Cancer Center | Gan H.K.,Austin Hospital | Gan H.K.,Ludwig Institute for Cancer Research | And 7 more authors.
Journal of Clinical Neuroscience | Year: 2015

There are limited treatment options for patients with recurrent glioblastoma (GBM). The EnGeneIC delivery vehicle (EDV) is a novel nanocellular (minicell) compound which packages theoretically effective concentrations of chemotherapeutic drugs that are designed to target tumors via minicell-surface attached bispecific proteins (EnGeneIC, Lane Cove West, NSW, Australia). Epidermal growth factor receptor (EGFR) is overexpressed in 40-50% of patients with GBM and is a promising target for new therapeutics. VEDVDox contains doxorubicin (Dox) within the minicells and targets EGFR through Vectibix (V; Amgen Biologicals, Thousand Oaks, CA, USA). We conducted a first in human Phase I study of VEDVDox in adults with recurrent GBM expressing EGFR on immunohistochemistry, following standard therapy including radiation and temozolomide, to establish a safe maximum tolerated dose and determine a recommended Phase II dose (RPTD). VEDVDox was administered weekly in an 8 week cycle, with dose escalation in successive cohorts of patients using a standard 3 + 3 design. In total, 14 patients were treated at three dose levels, and the RPTD was identified as 5 × 109 VEDVDox. Overall VEDVDox was well tolerated, with no dose limiting toxicity and no withdrawals from the study due to adverse events. The most common adverse events were nausea, fever, and chills or rigors, experienced in seven, five and five patients, respectively. Transient uncomplicated hypophosphatemia was seen in seven patients and was not dose-related. Our results demonstrate that VEDVDox, up to a dose of 5 × 109 VEDVDox weekly, is well tolerated in patients with recurrent GBM. © 2015 Elsevier Ltd. All rights reserved.


Lawrence M.G.,Monash University | Pook D.W.,Monash University | Pook D.W.,Monash Cancer Center | Wang H.,Monash University | And 13 more authors.
Prostate | Year: 2015

BACKGROUND Fresh patient specimens of castrate-resistant prostate cancer (CRPC) are invaluable for studying tumor heterogeneity and responses to current treatments. They can be used for primary patient-derived xenografts (PDXs) or serially transplantable PDXs, but only a small proportion of samples grow successfully. To improve the efficiency and quality of PDXs, we investigated the factors that determine the initial engraftment of patient tissues derived from TURP specimens. METHODS Fresh tissue was collected from castrate patients who required a TURP for urinary symptoms. Tissue was grafted under the renal capsule of immune-compromised mice for up to 14 weeks. The abundance of cancer in ungrafted and grafted specimens was compared using histopathology. Mice were castrated or implanted with testosterone pellets to determine the androgen-responsiveness of CRPC PDXs from TURP tissue. RESULTS Primary PDXs were successfully established from 7 of 10 patients that underwent grafting. Of the 112 grafts generated from these 10 patients, 21% contained cancer at harvest. Grafts were most successful when the original patient specimens contained high amounts of viable cancer, defined as samples with (i) at least 50% cancer cells, (ii) no physical damage, and (iii) detectable Ki67 expression. PDX grafts survived in castrated hosts and proliferated in response to testosterone, confirming that they were castrate resistant but androgen-responsive. CONCLUSIONS Primary PDXs of CRPC can be established from TURP specimens with modest success. The take rate can be increased if the original tissues contain sufficient numbers of actively proliferating cancer cells. Selecting specimens with abundant viable cancer will maximize the rate of engraftment and increase the efficiency of establishing PDXs that can be serially transplanted. © 2015 Wiley Periodicals, Inc.


PubMed | Royal Prince Alfred Hospital, Monash Cancer Center, Royal Melbourne Hospital, Peter MacCallum Cancer Center and 2 more.
Type: Clinical Trial, Phase I | Journal: Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia | Year: 2015

There are limited treatment options for patients with recurrent glioblastoma (GBM). The EnGeneIC delivery vehicle (EDV) is a novel nanocellular (minicell) compound which packages theoretically effective concentrations of chemotherapeutic drugs that are designed to target tumors via minicell-surface attached bispecific proteins (EnGeneIC, Lane Cove West, NSW, Australia). Epidermal growth factor receptor (EGFR) is overexpressed in 40-50% of patients with GBM and is a promising target for new therapeutics. (V)EDVDox contains doxorubicin (Dox) within the minicells and targets EGFR through Vectibix (V; Amgen Biologicals, Thousand Oaks, CA, USA). We conducted a first in human Phase I study of (V)EDVDox in adults with recurrent GBM expressing EGFR on immunohistochemistry, following standard therapy including radiation and temozolomide, to establish a safe maximum tolerated dose and determine a recommended Phase II dose (RPTD). (V)EDVDox was administered weekly in an 8week cycle, with dose escalation in successive cohorts of patients using a standard 3+3 design. In total, 14 patients were treated at three dose levels, and the RPTD was identified as 510(9)(V)EDVDox. Overall (V)EDVDox was well tolerated, with no dose limiting toxicity and no withdrawals from the study due to adverse events. The most common adverse events were nausea, fever, and chills or rigors, experienced in seven, five and five patients, respectively. Transient uncomplicated hypophosphatemia was seen in seven patients and was not dose-related. Our results demonstrate that (V)EDVDox, up to a dose of 510(9)(V)EDVDox weekly, is well tolerated in patients with recurrent GBM.


Ng S.P.,Peter MacCallum Cancer Center | David S.,Peter MacCallum Cancer Center | Alamgeer M.,Monash Cancer Center | Ganju V.,Monash Cancer Center
International Journal of Radiation Oncology Biology Physics | Year: 2015

Purpose To assess the diagnostic performance of pretreatment 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG PET/CT) and its impact on radiation therapy treatment decisions in patients with locally advanced breast cancer (LABC). Methods and Materials Patients with LABC with Eastern Cooperative Oncology Group performance status <2 and no contraindication to neoadjuvant chemotherapy, surgery, and adjuvant radiation therapy were enrolled on a prospective trial. All patients had pretreatment conventional imaging (CI) performed, including bilateral breast mammography and ultrasound, bone scan, and CT chest, abdomen, and pelvis scans performed. Informed consent was obtained before enrolment. Pretreatment whole-body 18F-FDG PET/CT scans were performed on all patients, and results were compared with CI findings. Results A total of 154 patients with LABC with no clinical or radiologic evidence of distant metastases on CI were enrolled. Median age was 49 years (range, 26-70 years). Imaging with PET/CT detected distant metastatic disease and/or locoregional disease not visualized on CI in 32 patients (20.8%). Distant metastatic disease was detected in 17 patients (11.0%): 6 had bony metastases, 5 had intrathoracic metastases (pulmonary/mediastinal), 2 had distant nodal metastases, 2 had liver metastases, 1 had pulmonary and bony metastases, and 1 had mediastinal and distant nodal metastases. Of the remaining 139 patients, nodal disease outside conventional radiation therapy fields was detected on PET/CT in 15 patients (10.8%), with involvement of ipsilateral internal mammary nodes in 13 and ipsilateral level 5 cervical nodes in 2. Conclusions Imaging with PET/CT provides superior diagnostic and staging information in patients with LABC compared with CI, which has significant therapeutic implications with respect to radiation therapy management. Imaging with PET/CT should be considered in all patients undergoing primary staging for LABC. © 2015 Elsevier Inc.


PubMed | Monash Cancer Center and Peter MacCallum Cancer Center
Type: Evaluation Studies | Journal: International journal of radiation oncology, biology, physics | Year: 2015

To assess the diagnostic performance of pretreatment (18)F-fluorodeoxyglucose positron emission tomography/computed tomography ((18)F-FDG PET/CT) and its impact on radiation therapy treatment decisions in patients with locally advanced breast cancer (LABC).Patients with LABC with Eastern Cooperative Oncology Group performance status <2 and no contraindication to neoadjuvant chemotherapy, surgery, and adjuvant radiation therapy were enrolled on a prospective trial. All patients had pretreatment conventional imaging (CI) performed, including bilateral breast mammography and ultrasound, bone scan, and CT chest, abdomen, and pelvis scans performed. Informed consent was obtained before enrolment. Pretreatment whole-body (18)F-FDG PET/CT scans were performed on all patients, and results were compared with CI findings.A total of 154 patients with LABC with no clinical or radiologic evidence of distant metastases on CI were enrolled. Median age was 49 years (range, 26-70 years). Imaging with PET/CT detected distant metastatic disease and/or locoregional disease not visualized on CI in 32 patients (20.8%). Distant metastatic disease was detected in 17 patients (11.0%): 6 had bony metastases, 5 had intrathoracic metastases (pulmonary/mediastinal), 2 had distant nodal metastases, 2 had liver metastases, 1 had pulmonary and bony metastases, and 1 had mediastinal and distant nodal metastases. Of the remaining 139 patients, nodal disease outside conventional radiation therapy fields was detected on PET/CT in 15 patients (10.8%), with involvement of ipsilateral internal mammary nodes in 13 and ipsilateral level 5 cervical nodes in 2.Imaging with PET/CT provides superior diagnostic and staging information in patients with LABC compared with CI, which has significant therapeutic implications with respect to radiation therapy management. Imaging with PET/CT should be considered in all patients undergoing primary staging for LABC.

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