Saturday, March 06, 2010
Gynecologic Oncology Group (GOG) Notifies CTI That Continuation of GOG-212 Pivotal Trial of OPAXIO Maintenance Therapy... -- SEATTLE, March 4 /PRNewswire-FirstCall/ --
Gynecologic Oncology Group (GOG) Notifies CTI That Continuation of GOG-212 Pivotal Trial of OPAXIO Maintenance Therapy in Front Line Ovarian Cancer Remains High Priority
GOG-218 Bevacizumab Results Do Not Influence Importance of GOG-212
SEATTLE, March 4 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that CTI received a statement on March 1, 2010 from the Gynecologic Oncology Group (GOG) leadership that the phase III GOG-212 clinical trial of CTI's OPAXIO™ used as maintenance therapy for ovarian cancer remains a high priority and enrollment will continue. The GOG made the statement to clarify that the recent results of the GOG-218 clinical trial bevacizumab in maintenance therapy for ovarian cancer has not influenced the importance of completing the GOG-212 clinical trial. The Gynecologic Oncology Group (GOG) is one of the National Cancer Institute's (NCI) funded cooperative cancer research groups. The GOG is a multidisciplinary cooperative clinical trial research group focused on the study of gynecologic malignancies. The GOG is conducting phase III trials in ovarian cancer and other gynecologic cancers and has established standard treatments for these diseases in the U.S.
GOG leadership noted that, "GOG-218 and GOG-212 differ in the type of patients under study. It is important to note that some of the patients who completed the initial 6 cycles of chemotherapy in GOG-218 had clinical evidence of persistent tumor and where randomized to either placebo (no treatment) or bevacizumab. Thus a subset of GOG-218 patients received no therapy, despite the presence of persistent tumor. This is not the typical setting of using maintenance or consolidation therapy and it is not the setting for patients enrolled in GOG-212. In GOG-212, only patients who have achieved a complete clinical response are considered candidates for enrollment in the trial."
"Reliance upon the data from GOG-218 to establish the "standard of care" must take into consideration the actual treatment effect (i.e. duration of benefit), the cost of the treatment, and the associated toxicity... [in GOG-212] the toxicity of the intervention may have less associated mortality and the incremental cost-effectiveness ratio may be more acceptable to patients and the health care economists. Thus the GOG has no intention to discontinue enrollment in GOG 212 as they feel that the study is addressing a different scientific question and the primary outcome study goal is survival, not progression free survival, an outcome of greater importance to both physicians and patients," the statement added.
The Data Monitoring Committee is scheduled to conduct an interim analysis of overall survival when 130 events are recorded among patients in the no maintenance treatment arm. The statistical analysis plan utilizes pre-specified boundaries for early stopping for success. Based on current enrollment and study duration, the interim analysis could be conducted as early as 2011. If successful, the Company could utilize those results to form the basis of its New Drug Application for OPAXIO.
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit www.celltherapeutics.com.
This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the trading price of the securities of CTI. Specifically, the risks and uncertainties that could affect the development of pixantrone include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general, and with pixantrone in particular, including, without limitation, the potential failure of OPAXIO to prove safe and effective for the use as maintenance therapy in ovarian cancer as determined by the FDA, the risk that the GOG could decide to discontinue enrollment in the future, CTI's ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling pixantrone, and the risk factors listed or described from time to time in CTI's filings with the Securities and Exchange Commission including, without limitation, CTI's most recent filings on Forms 10-K, 10-Q and 8-K. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.
"Full data are expected to be reported at the American Society of Clinical Oncology meeting in Chicago in June."
Note: early trial closure
Rapid Development of Hypertension and Proteinuria with Cediranib, an Oral Vascular Endothelial Growth Factor Receptor Inhibitor -- Robinson et al. 5 (3): 477 -- Clinical Journal of the American Society of Nephrology
Conclusions: Cediranib induced a rapid but variable rise in BP within 3 days of initiation in most patients. Proteinuria was common and also developed rapidly. The rapid development of hypertension suggests that acute inhibition of VEGF-dependent vasodilation might explain the BP rise with VEGF inhibitors. Clinicians must be vigilant in early detection and management of toxicities of this expanding drug class, especially in older patients.
Note: obtain copies of all reports including blood work (CA125...) surgical and pathology reports You may want to ask your doctor these questions before your treatment begins: * What is the stage of my disease? Has the cancer spread from the ovaries? If so, to where? * What are my treatment choices? Do you recommend intraperitoneal chemotherapy for me? Why? * Would a clinical trial be appropriate for me? * Will I need more than one kind of treatment? * What are the expected benefits of each kind of treatment? * What are the risks and possible side effects of each treatment? What can we do to control side effects? Will they go away after treatment ends? * What can I do to prepare for treatment? * Will I need to stay in the hospital? If so, for how long? * What is the treatment likely to cost? Will my insurance cover the cost? * How will treatment affect my normal activities? * Will treatment cause me to go through an early menopause? * Will I be able to get pregnant and have children after treatment? * How often should I have checkups after treatment?
Impact of F-18 fluorodeoxyglucose positron emission tomography-computed tomography on oncologic patient management: British Columbia (abstract)
"..The results of the PET-CT study resulted in a change in treatment decision in 49.8% of the studies and resulted in improved decision making in 83.2% of the studies."
The Cross Cancer Institute (Alberta) Multidisciplinary Summer Studentship in Palliative and Supportive Care in Oncology: Teaching students to see through patients eyes
The Cross Cancer Institute Multidisciplinary Summer Studentship in Palliative and Supportive Care in Oncology: Teaching students to see through patients' eyes.
Association between frequency and intensity of recreational physical activity and epithelial ovarian cancer risk by age period-abstract
"In conclusion, strenuous recreational activity early in life may increase the risk of ovarian cancer, whereas more recent recreational activity may reduce the risk."
About Lynch Syndrome Lynch syndrome refers to individuals with hereditary predisposition to colorectal cancer (CRC) and other malignancies as a result of an inherited mutation in a specific type of gene known as a mismatch repair (MMR) gene. Lynch syndrome includes those with an existing cancer as well as those who have not developed cancer. * Also referred to as hereditary nonpolyposis colorectal cancer (HNPCC) * Autosomal dominant inheritance pattern (50% risk to offspring to inherit the gene mutation) * The lifetime risk for CRC in individuals with Lynch syndrome reported in the literature ranges from approximately 20-80%, dependent upon: o Gene involved o Sex of the individual o Population studied * Mean age of onset of CRC is approximately 45 years * Increased risk for other malignancies including: endometrial, ovarian, urinary tract, gastric, small bowel, pancreatic, and sebaceous skin tumors
abstract: College of Physicians & Surgeons (NY, USA): Views of Discrimination among Individuals Confronting Genetic Disease
"Discrimination can be subjective, and take various forms. Searches for only objective evidence of it may be inherently difficult. Providers need to be aware of, and prepared to address, subtle and indirect discrimination; ambiguities, confusion and potential limitations concerning current legislation; and needs for education about these laws. Policies are needed to prevent discrimination in life, long-term care, and disability insurance, not covered by GINA."
Perceptions of High-Risk Care and Barriers to Care Among Women at Risk for Hereditary Breast and Ovarian Cancer following Genetic Counseling....
Perceptions of High-Risk Care and Barriers to Care Among Women at Risk for Hereditary Breast and Ovarian Cancer following Genetic Counseling in the Community Setting
english translation: more women had a hard time deciding on surgery for breast cancer than for ovarian cancer
"...Close to a quarter of participants reported difficulty deciding whether or not to undergo risk-reducing mastectomy while 10% noted difficulty deciding for or against bilateral salpingo-oophorectomy...."