Ferriss J.S.,Temple University |
Java J.J.,Gynecologic Oncology Group Statistical |
Bookman M.A.,Arizona Oncology |
Fleming G.F.,University of Chicago |
And 7 more authors.
Gynecologic Oncology | Year: 2015
Objectives Predictive factors for efficacy of bevacizumab in advanced ovarian cancer have remained elusive. We investigated ascites both as a prognostic factor and as a predictor of efficacy for bevacizumab. Methods Using data from GOG 0218, patients receiving cytotoxic therapy plus concurrent and maintenance bevacizumab were compared to those receiving cytotoxic therapy plus placebo. The presence of ascites was determined prospectively. Chi-square and Wilcoxon-Mann-Whitney tests compared baseline variables between subgroups. Survival was estimated by Kaplan-Meier method, and Cox proportional hazard models were used to evaluate independent prognostic factors and estimate their covariate-adjusted effects on survival. Results Treatment arms were balanced with respect to ascites and other prognostic factors. Overall, 886 (80%) women had ascites, 221 (20%) did not. Those with ascites were more likely to have: poorer performance status (p < 0.001); serous histology (p = 0.012); higher baseline CA125 (p < 0.001); and suboptimal cytoreduction (p = 0.004). In multivariate survival analysis, ascites was prognostic of poor OS (Adjusted HR 1.22, 95% CI 1.00-1.48, p = 0.045), but not PFS. In predictive analysis, patients without ascites treated with bevacizumab had no significant improvement in either PFS (AHR 0.81, 95% CI 0.59-1.10, p = 0.18) or OS (AHR 0.94, 95% CI 0.65-1.36, p = 0.76). Patients with ascites treated with bevacizumab had significantly improved PFS (AHR 0.71, 95% CI 0.62-0.81, p < 0.001) and OS (AHR 0.82, 95% CI 0.70-0.96, p = 0.014). Conclusions Ascites in women with advanced ovarian cancer is prognostic of poor overall survival. Ascites may predict the population of women more likely to derive long-term benefit from bevacizumab. © 2015 Elsevier Inc. All rights reserved.
News Article | December 12, 2016
Patients with advanced non-small-cell lung cancer survive four months longer with fewer side effects on an immunotherapy drug called atezolizumab compared to chemotherapy, according to a phase 3 clinical trial published in The Lancet. The trial enrolled 1225 advanced non-small-cell lung cancer patients who have no more treatment options, but this study used an early analysis of the first 850 patients from the trial. Half of the group were given atezolizumab and the other half were given docetaxel chemotherapy, which is the standard treatment for advanced non-small-cell lung cancer. Patients given atezolizumab - a drug that blocks the programmed death ligand 1 (PD-L1) protein - survived for an average of 13.8 months, compared with 9.6 months for those on chemotherapy. As well as the benefits in survival, atezolizumab also had fewer side effects than chemotherapy with 14.8% (90 of 609) of those given the drug having grade three or four side effects compared with 42.7% (247 of 578) of those given chemotherapy. However, 46 (of 609, 7.6%) of the patients given atezolizumab still gave up treatment due to side effects, as well as 108 (of 578 patients, 18.7%) of those on chemotherapy. "Lung cancer is the most common cancer affecting 1.8 million people each year worldwide. It is also the leading cause of cancer death worldwide and survival remains stubbornly low. Recently, important advances in the treatment of the disease have come from immunotherapies that target the PD-L1 and PD-1 pathway," said Dr Achim Rittmeyer, lead author, University Goettingen, Germany. "Atezolizumab reinvigorates patients' immune systems against cancer, and our trial has shown that this has significant results for their survival."  In the trial the researchers also studied the amount of PD-L1 protein on the patients' cancer and immune cells and how long patients survived for on each treatment. They found that the drug worked best for patients with the highest levels of the PD-L1 protein on their cells - more than doubling survival compared with those given chemotherapy (20.5 months compared with 8.9 months overall survival) - but still increased survival for those with little to no levels of the protein by three and a half months (12.6 compared with 8.9 months overall survival). "This is the first phase 3 trial of a PD-L1-directed immunotherapy in lung cancer. The fact that it improves survival in patients with all categories of PD-L1 expression is highly encouraging and adds to the already known benefits of immunotherapy in lung cancer." said Dr David Gandara, senior author, UC Davis Comprehensive Cancer Center, USA.  Other immunotherapies for non-small-cell lung cancer, such as nivolumab and pembrolizumab, are designed to block PD-L1's counterpart, the programmed cell death protein 1 (PD-1) which is located on the immune cell surface. Normally the PD-L1 and PD-1 proteins signal to one another to activate the immune system to attack tumours. It's thought that the extra PD-L1 protein on some cancer cells' surfaces helps them hide from the immune system, meaning it cannot find and kill cancer cells as usual. But by blocking the extra PD-L1 protein, atezolizumab may unveil the cells to the immune system so they can be attacked and destroyed. The study is the first phase 3 trial of a PD-L1 inhibitor drug and has shown longer survival than trials of PD-1 inhibitors. The authors note that the trial was 'open label', meaning that patients and doctors knew whether or not they were being given immunotherapy. In addition, after the study treatment finished some (17%) of those given chemotherapy on the trial were prescribed another immunotherapy drug (mostly nivolumab) by their own doctor. This could have increased survival in the chemotherapy group, meaning that the difference between two groups may be greater than shown in this study. Writing in a linked Comment, Professor Elisabeth Quoix, Hôpitaux Universitaires de Strasbourg, France, said: "After decades of disappointments with non-specific vaccines or more recently tumor associated antigen specific vaccines, immunotherapy with antibodies that target the PD-L1 and PD-1 pathway have emerged as a major therapeutic breakthrough. This treatment improves the prognosis of patients with non-small-cell lung cancer that cannot benefit from targeted therapies... The time in which chemotherapy will no more be the mainstay of treatment of metastatic non-small-cell lung cancer is perhaps not so far away. Nevertheless... Several points need to be clarified, such as the optimum therapeutic schedule and the optimum duration of treatment, to limit treatment costs. Additionally combinations of different immunotherapies might be of interest." The study was funded by F. Hoffman-La Roche Ltd and Genentech Ltd.. It was conducted by scientists from Lungenfachklinik Immenhausen, Aix Marseille Universite, Sungkyunkwan University School of Medicine, Seconda Università degli Studi di Napoli, Asklepios Fachkliniken München-Gauting, Karmanos Cancer Institute/Wayne State University, Aichi Cancer Center Hospital, Institute M. Sklodowska-Curie, Hospital Regional Universitario Carlos Haya, AOU San Gerardo, Minnesota Oncology, Southern California Permanente Medical Group, PUCRS School of Medicine, University of California, Centro Internacional de Estudios Clinicos, European Institute of Oncology, Istanbul University Cerrahpasa Medical Faculty Hospital, Seoul National University Bundang Hospital, Genentech Inc. and UC Davis Comprehensive Cancer Center. A declaration of interests is available in the Article. [ 1] Quote direct from author and cannot be found in the text of the Article. IF YOU WISH TO PROVIDE A LINK FOR YOUR READERS, PLEASE USE THE FOLLOWING, WHICH WILL GO LIVE AT THE TIME THE EMBARGO LIFTS: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)32517-X/fulltext
O'Brien M.,Minnesota Oncology |
Stricker C.T.,University of Pennsylvania
Clinical Journal of Oncology Nursing | Year: 2014
Nurses have an important role in the development, implementation, and evaluation of cancer survivorship programs. Growing numbers of cancer survivors challenge community oncology practices to incorporate survivorship care according to new standards and guidelines. In response, one community-based oncology clinic created an advanced practice nurse (APN)-led survivorship program using the concept of Seasons of Survival as a guide. Survivorship care, when based on a more expansive definition of survivorship as beginning at the time of diagnosis, encompasses holistic nursing and multidisciplinary care. The APN assesses each patient's concerns and quality of life using a validated measure to tailor survivorship and supportive care. This article reviews the foundation and structure of the program in detail, describes program implementation using case studies, and outlines the program evaluation process and results. © Oncology Nursing Society.
Stricker C.T.,University of Pennsylvania |
O'Brien M.,Minnesota Oncology
Clinical Journal of Oncology Nursing | Year: 2014
The number of adult cancer survivors in the United States has exceeded 13 million and continues to rise, yet care for these survivors continues to be poorly coordinated and their needs remain inadequately addressed. As one solution to this growing problem, the Institute of Medicine in 2006 recommended the delivery of a survivorship care plan (SCP) to each patient completing active treatment. The American College of Surgeons Commission on Cancer subsequently published its Program Standard 3.3, requiring accredited programs to implement treatment summaries and SCPs by 2015, to help improve communication, quality, and coordination of care for cancer survivors. As practices and cancer centers around the country have undertaken SCP implementation efforts, myriad barriers to their preparation and delivery have emerged, with time and human resource burden top among these, in addition to a lack of proven outcomes. Fortunately, a growing number of publications document practical and feasible delivery models, and an increasingly robust body of research on stakeholder preferences is available to focus SCP implementation efforts. © Oncology Nursing Society.
Gesme B.D.H.,Minnesota Oncology |
Wiseman M.,Wiseman Communications
Journal of Oncology Practice | Year: 2011
Pathway users say that pathways reduce errors, reduce costs, and increase efficiency. Hennessy notes that KCCC regularly monitors patient satisfaction and has also found that since implementing pathways, patient satisfaction has increased. "It's clear that you can have pathways and high patient satisfaction at the same time." Michigan's Neumann says the big issue for the future is who will drive the process of cancer care: the payer, the providers, or a commercial third party. He comments, "We realize there are savings to be made in managing chemotherapy better and in efficient management of disease, including such things as diagnostic approach, end-of-life care, and emergency department visits. Better management of all of these areas is in the sights of\ these pathway programs. We need to figure out how to do that in a way that aligns physician incentives with cost-efficient medicine. Copyright © 2011 by American Society of Clinical Oncology.
Cohen S.A.,St Vincent Health |
Leininger A.,Minnesota Oncology
Application of Clinical Genetics | Year: 2014
Lynch syndrome is the most common cause of hereditary colon cancer, and accounts for as much as 3% of all colon and endometrial cancers. The identification and management of individuals with Lynch syndrome have evolved over the past 20 years, yet the syndrome remains vastly underdiagnosed. It is important for clinicians to recognize individuals and families who are at risk in order to be able to manage them appropriately and reduce their morbidity and mortality from this condition. This review will touch on the history of Lynch syndrome, the current knowledge of genotype-phenotype correlations, the cancers associated with Lynch syndrome, and management of individuals who are gene carriers. © 2014 Cohen and Leininger.
Cutaneous head and neck melanoma in OPTiM, a randomized phase 3 trial of talimogene laherparepvec versus granulocyte-macrophage colony-stimulating factor for the treatment of unresected stage IIIB/IIIC/IV melanoma
PubMed | Temple University, University of Houston, Rutgers Cancer Institute of New Jersey, Amgen and 7 more.
Type: Journal Article | Journal: Head & neck | Year: 2016
Cutaneous head and neck melanoma has poor outcomes and limited treatment options. In OPTiM, a phase 3 study in patients with unresectable stage IIIB/IIIC/IV melanoma, intralesional administration of the oncolytic virus talimogene laherparepvec improved durable response rate (DRR; continuous response 6 months) compared with subcutaneous granulocyte-macrophage colony-stimulating factor (GM-CSF).Retrospective review of OPTiM identified patients with cutaneous head and neck melanoma given talimogene laherparepvec (n=61) or GM-CSF (n=26). Outcomes were compared between talimogene laherparepvec and GM-CSF treated patients with cutaneous head and neck melanoma.DRR was higher for talimogene laherparepvec-treated patients than for GM-CSF treated patients (36.1% vs 3.8%; p=.001). A total of 29.5% of patients had a complete response with talimogene laherparepvec versus 0% with GM-CSF. Among talimogene laherparepvec-treated patients with a response, the probability of still being in response after 12 months was 73%. Median overall survival (OS) was 25.2 months for GM-CSF and had not been reached with talimogene laherparepvec.Treatment with talimogene laherparepvec was associated with improved response and survival compared with GM-CSF in patients with cutaneous head and neck melanoma. 2016 Wiley Periodicals, Inc. Head Neck 38: 1752-1758, 2016.
PubMed | Red Cross, University of Washington, Penn State Hershey Cancer Institute, Pfizer and 5 more.
Type: Journal Article | Journal: British journal of haematology | Year: 2016
This phase 2 study evaluated the efficacy and safety of inotuzumab ozogamicin (InO) in patients with indolent B-cell non-Hodgkin lymphoma (NHL) refractory to rituximab alone, rituximab plus chemotherapy or anti-CD20 radioimmunotherapy. Patients received InO 18mg/m(2) intravenously on a 28-d cycle for a planned 4-8 cycles. The initial InO dose and schedule could be adjusted for tolerability and patients were allowed to receive 2 additional cycles (up to 8 total) after achieving a complete response (CR). The primary endpoint was overall response. Eighty-one patients were enrolled, among whom 48 (59%) received 3 InO cycles and 13 (16%) completed the treatment phase. The overall response rate was 67% (CR, 31%). Median (95% confidence interval) progression-free survival was 127 (89-269) months; median overall survival was not reached. Haematological adverse events (AEs) were common, particularly thrombocytopenia (74%) and neutropenia (56%). These were also the most common AEs leading to treatment discontinuation (37% and 11%, respectively); 58% of patients reported AEs leading to treatment discontinuation. InO demonstrated robust activity in these heavily pretreated patients, although treatment duration was limited by haematological toxicities. Additional studies may determine dosing regimens that allow for reduced toxicity.
Chen C.-C.,IMS Health |
Hess G.P.,IMS Health |
Hess G.P.,Philadelphia University |
Liu Z.,Novartis |
And 5 more authors.
Clinical Genitourinary Cancer | Year: 2012
This study was conducted to evaluate the treatment outcomes associated with common second-line targeted therapies given after first-line sunitinib for metastatic renal cell carcinoma (mRCC). The sample comprised patients with mRCC (n = 257) who were receiving second-line everolimus, sorafenib, or temsirolimus between April 1, 2008, and February 29, 2011, after first-line sunitinib treatment. The patients were followed-up from the start of second-line treatment until treatment failure (defined as advancement to a third-line therapy or to mortality) or the last observation in the medical and pharmacy databases. Treatment failure was observed in 38.5% (n = 99) of cases: 20.2% of patients (n = 52) advanced a line of treatment; and 18.3% of patients (n = 47) died. Kaplan-Meier analysis indicated a statistical difference in time to treatment failure among the 3 second-line targeted therapies (log-rank test, P =.045). The estimated 1-year cumulative probabilities of treatment failure were 49.9% for everolimus, 68.4% for sorafenib, and 71.4% for temsirolimus. In a multivariate Cox proportional hazards model, a higher adjusted risk of treatment failure vs. everolimus was observed for both temsirolimus (hazard ratio [HR] 2.05 [95% CI, 1.26-3.35]; P =.004) and sorafenib (HR 1.77 [95% CI, 1.02-3.07]; P =.043). The results of this real-world data analysis suggest that the risk of second-line treatment failure after first-line sunitinib was significantly higher with temsirolimus and sorafenib compared with everolimus. © 2012 Elsevier Inc. All rights reserved.
News Article | December 9, 2016
Portland, Oregon - A drug typically used to treat depression and anxiety can significantly reduce joint pain in postmenopausal women being treated for early stage breast cancer, according to new SWOG research to be presented Friday at a special plenary presentation at the San Antonio Breast Cancer Symposium. Investigators from SWOG, the international cancer clinical trials network funded by the National Cancer Institute (NCI), conducted a randomized, placebo-controlled trial to test whether duloxetine, a depression and anxiety drug, could alleviate pain caused by aromatase inhibitors, a common breast cancer treatment that's particularly effective with postmenopausal women. Dr. N. Lynn Henry led the clinical trial, called S1202. A SWOG investigator from Huntsman Cancer Institute at the University of Utah and co-chair of SWOG's symptom control and quality of life committee, Henry wanted to conduct the study because it addressed a common problem for women with breast cancer. Tens of thousands of postmenopausal women each year are treated with aromatase inhibitors (AIs), pills that stop the production of estrogen and essentially starve hormone receptor-positive breast cancer cells. Many women - as many as 50 percent -- experience joint pain and stiffness as a side effect of AI therapy. About 20 percent experience significant pain. This can affect knees, hips, hands, and wrists, and make it difficult for women to walk, climb stairs, do simple tasks like type, or sit for an extended period of time. Henry said some women stop taking their medication to get relief. The pain is so common it has a name: AI-Associated Musculoskeletal Syndrome (AIMSS). "A lot of 60-year-old women report feeling like they're 80," Henry said. "The pain can really interfere with daily life. And this is a big problem. The length of treatment with AIs can be five to 10 years, so we're asking a lot of women to manage significant discomfort for a very long period of time." While clinical trials have shown that acupuncture and exercise can reduce symptoms of AIMSS, there is no evidence for an effective solution for all women. Henry and her team chose to test duloxetine, a drug commonly sold as Cymbalta by original maker Eli Lilly and Company. Duloxetine is primarily used to treat depression and anxiety, and also fibromyalgia and nerve pain caused by diabetes. SWOG researchers enrolled 299 adult patients to S1202 at 43 institutions throughout the NCI's National Cancer Trials Network (NCTN) and the NCI Community Oncology Research Program (NCORP). Those 299 patients were randomly assigned to either receive duloxetine or a placebo for 12 weeks. They filled out a questionnaire upon enrolling, and again at two, six, 12 and 24 weeks into the study. Questions focused on pain, rated on a 0-10 scale, and also on depression and quality of life. Results showed that patients taking duloxetine saw their average pain drop on the scale from 5.5 to about 3. Improvement was rapid, and relief persisted through the end of the 12-week trial. Improvement in pain was also seen in the placebo arm of the trial, suggesting a robust placebo effect. Henry will present her findings at one of six plenary sessions at the San Antonio Breast Cancer Symposium, a leading cancer research conference with an international audience. "We've shown that this treatment is a potential option for women," Dr. Henry said. "Taking this drug may help them tolerate their breast cancer treatment. And it's important for their health that they stick with their treatment." Her work was supported in part by NCI grants CA189974, CA37429, CA189821, CA189816, CA189823, CA180868, CA189867, CA15488, CA21115, CA180820; Damon Runyon Cancer Research Foundation; and Eli Lilly and Company, which provided the study drug and matching placebo. A national team of SWOG researchers took part in S1202. Along with Dr. Henry, they include: Joe Unger, Ph.D, of Fred Hutchinson Cancer Research Center; Anne Schott, M.D. of University of Michigan Comprehensive Cancer Center; Louis Fehrenbacher, M.D. of Kaiser Permanente, Northern California; Patrick J. Flynn, M.D., Metro Minnesota CCOP/Minnesota Oncology; Debra Prow, M.D., McFarland Clinic; Carl W. Sharer, D.O., Phoenixville Cancer Center; Danika L. Lew, M.A., Fred Hutchinson Cancer Research Center; Anna Moseley, M.S., Fred Hutchinson Cancer Research Center; Michael J. Fisch, M.D., AIM Specialty Health; Carol Moinpour, Ph.D., Fred Hutchinson Cancer Research Center; Dawn L. Hershman, M.D., Columbia University Medical Center; James L. Wade, III, M.D., Cancer Care Specialists of Illinois/Heartland NCORP. SWOG is a global network of researchers that design and conduct cancer clinical trials, and, as part of the Nation Cancer Institute's National Clinical Trials Network, is a major part of the cancer research infrastructure in the U.S. and the world. The group's goal is to change medical practice so it improves the lives of people with cancer. Founded in 1956, SWOG's over 1,300 trials have led to the approval of 14 cancer drugs, changed the standard of cancer care more than 100 times, and saved more than 2 million years of human life. Learn more at swog.org.