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  • Lumpie
    Lumpie Member Posts: 1,553
    edited February 2019

    Cancer Drug Has Money-Back Guarantee — in China

    Palbociclib Refund Not Available in US

    In China, Pfizer will reimburse up to 33% of the cost of its breast cancer drug palbociclib (Ibrance) if a patient's disease progresses within 4 months...

    https://www.medscape.com/viewarticle/909138?src=wn...


  • Lumpie
    Lumpie Member Posts: 1,553
    edited February 2019

    Celecoxib With Neoadjuvant Chemotherapy for Breast Cancer and Outcomes Based on COX-2 Expression and ER Status

    Celecoxib use during chemotherapy adversely affected survival in patients with breast cancer, and the effect was more marked in PTGS2-low and/or estrogen receptor-negative tumors. COX-2 inhibitors should preferably be avoided during docetaxel use in patients with breast cancer who are undergoing neoadjuvant chemotherapy (NAC).

    Journal of Clinical Oncology

    https://www.practiceupdate.com/C/79231/56?elsca1=e...

    DOI: 10.1200/JCO.18.00636 Journal of Clinical Oncology


  • Lumpie
    Lumpie Member Posts: 1,553
    edited February 2019

    Correlating Standardized Uptake Value With Pathologic Complete Response to Pertuzumab and Trastuzumab in Breast Cancer

    • Patients with stage II/III, ER-negative, HER2-positive breast cancer treated with four cycles of neoadjuvant pertuzumab and trastuzumab were followed to evaluate the correlation between early measurements of tumor maximum standardized uptake values corrected for lean body mass (SULmax) on PET/CT and pathologic complete response (pCR). Compared with patients who did not obtain pCR, those who did had a greater reduction in SULmax by day 15, a higher prevalence of SULmax reduction ≥40%, and a higher proportion of day 15 SULmax ≤3.
    • Early changes in SULmax predict the response to adjuvant pertuzumab/trastuzumab among patients with ER-negative, HER2-positive breast cancer. The use of this imaging strategy may eventually facilitate the use of targeted therapy.

    Early changes in SULmax predict response to four cycles of PT in estrogen receptor-negative, HER2-positive breast cancer. Once optimized, this quantitative imaging strategy may facilitate a more tailored approach to therapy in this setting.

    Journal of Clinical Oncology

    https://www.practiceupdate.com/C/79480/56?elsca1=e...

    DOI: 10.1200/JCO.2018.78.7986 Journal of Clinical Oncology

  • Lumpie
    Lumpie Member Posts: 1,553
    edited February 2019

    Immunogenicity and Safety of the Adjuvanted Recombinant Zoster Vaccine in Patients With Solid Tumors Receiving Chemotherapy

    • The authors of this phase II/III observer-blind, multicenter study report the immunogenicity and safety of the recombinant zoster vaccine (RZV) given to 232 patients with solid tumors before or at the initiation of a chemotherapy cycle. Patients given the RZV vaccine had higher postvaccination anti-gE antibody concentrations, gE-specific CD4+ T-cell frequencies, and vaccine response rates compared with patients given placebo. Adverse events occurred more frequently in the RZV group compared with the placebo group.
    • The use of RZV in patients with solid tumors receiving immunosuppressive chemotherapies was associated with a durable humoral and cell-mediated immune response without the development of any new safety concerns.
    • RZV was immunogenic in patients with STs receiving immunosuppressive chemotherapies. Humoral and cell-mediated immune responses persisted 1 year after vaccination. No safety concerns were identified.
    • data are emerging that RZV is both immunogenic and safe in solid tumor patients vaccinated before or during chemotherapy. If validated in other groups of immunocompromised patients, this would represent a significant advance in cancer care.
    • https://www.practiceupdate.com/content/immunogenic...
    • https://onlinelibrary.wiley.com/doi/full/10.1002/c...
    • https://doi.org/10.1002/cncr.31909
  • Lumpie
    Lumpie Member Posts: 1,553
    edited February 2019

    Tucatinib With T-DM1 for HER2-Positive Metastatic Breast Cancer

    Interview with Alison K Conlin MD Interview by Farzanna S Haffizulla MD, FACP, FAMWA

    https://www.practiceupdate.com/content/tucatinib-w...

    Re: a recent study looking at tucatinib in combination with T-DM1 for patients with HER2-positive breast cancer. Results were quite promising "both in the body and in central nervous system metastases."

  • Lumpie
    Lumpie Member Posts: 1,553
    edited February 2019

    Impact of Metastatic Pattern on the Prognosis in Stage IV Breast Cancer at Initial Diagnosis

    • Using data from the SEER program from 2010 to 2013, this study evaluated 9143 women with stage IV breast cancer at initial diagnosis to determine factors associated with specific sites of metastases. Of these patients, 37.5% had bone metastases and a median overall survival of 38 months; 21.9% had visceral metastases and a median overall survival of 21 months; 28.8% had bone and visceral metastases and a median overall survival of 19 months; and 11.9% had other metastases and a median overall survival of 33 months. Older age, black race, grade 3/4 tumors, triple-negative disease, bone and visceral metastases, and an unmarried status were associated with significantly shorter overall survival. Patients with triple-negative and ER−/HER2+ disease were more likely to have brain, liver, lung, and other metastases, while patients with ER+/HER2+ disease were more likely to have liver metastases.
    • These findings demonstrate significant differences in survival based on specific sites of metastases that are influenced by tumor subtypes, which may be used to guide therapeutic choices for these patients.
    • https://www.practiceupdate.com/content/impact-of-m...
    • https://link.springer.com/article/10.1007%2Fs10549...
    • Leone, B.A., Vallejo, C.T., Romero, A.O. et al. Breast Cancer Res Treat (2017) 161: 537. https://doi.org/10.1007/s10549-016-4066-7
  • Lumpie
    Lumpie Member Posts: 1,553
    edited February 2019

    Everolimus/Lapatinib/Capecitabine Is Effective and Safe for HER2+ Breast Cancer With Brain Metastases

    • Results of this study demonstrate the tolerability of the combination of everolimus, lapatinib, and capecitabine in heavily pretreated patients with HER2-positive disease and brain metastasis.
  • marijen
    marijen Member Posts: 2,181
    edited February 2019

    New cell-tracking technique sheds light on breast cancer spread

    Barcoding reveals complex clonal behavior in patient-derived xenografts of metastatic triple negative breast cancer | Nature Communications


    https://www.medicalnewstoday.com/articles/324477.p...


    https://www.nature.com/articles/s41467-019-08595-2

  • marijen
    marijen Member Posts: 2,181
    edited February 2019

    Christina Bennett, MS

    November 28, 2018

    Statins Repurposed to Slow Proliferation in Metastatic Breast Cancer Cells



    The findings suggest the consideration of long-term use of statins for patients with breast cancer.

    Statins were shown to slow proliferation in metastatic breast cancer cells but not primary tumor cells, suggesting the long-term use of statins in the adjuvant setting should be considered for patients with breast cancer.1 Statins have been found to reduce mortality in patients with breast cancer, but the mechanism by which statins influence mortality without affecting the growth of the primary tumor has been unclear. The study results were recently published in the British Journal of Cancer.

    To elucidate the effect of statins on metastatic cell proliferation, study researchers created several models to mimic breast cancer metastasis. In vitro and ex vivo models were created to mimic breast cancer metastasis to the liver. The in vitro model was a 2-dimensional coculture, and the ex vivo model was a 3-dimensional microphysiological system. Two independent mouse models were created to mimic spontaneous breast cancer metastasis to the lung and liver.

    Statins were shown in each model to "directly affect the proliferation of breast cancer cells, specifically at the metastatic site," the study authors wrote. In the in vitro model, atorvastatin slowed proliferation of mesenchymal but not epithelial breast cancer cells. When dormant breast cancer cells were stimulated in the 3-dimensional ex vivo microphysiological system, atorvastatin inhibited their emergence. In both mouse models, statins slowed proliferation of metastatic cells but not primary tumor cells.

    RELATED ARTICLES

    "As statins can block metastatic tumor outgrowth, they should be considered for use as long-term adjuvant drugs to delay clinical emergence and decrease mortality in breast cancer patients," the study authors concluded.

    Reference

    1. Beckwitt CH, Clark AM, Ma B, Whaley D, Oltvai ZN, Wells A. Statins attenuate outgrowth of breast cancer metastases. Br J Cancer. 2018;119(9):1094-1105. doi: 10.1038/s41416-018-0267-7
  • Lumpie
    Lumpie Member Posts: 1,553
    edited February 2019

    p, p'-DDT Exposure Linked to Breast Cancer Through Age 54

    Risk for breast cancer varies based on timing of first exposure, age at diagnosis

    "Considering the patterns we observed, working backward to determine when a woman first came into contact with the chemical could help inform early detection and treatment of DDT-associated breast cancer,"

    study published online Feb. 13 {2019} in the Journal of the National Cancer Institute.

  • Lumpie
    Lumpie Member Posts: 1,553
    edited February 2019

    Researchers Develop Therapy to Fight Blood Clots and Cancer Metastasis

    A preclinical study of deactivated platelets promises new approach to treating diseases.

    https://gwtoday.gwu.edu/researchers-develop-therap...

    A new reversible, drug-free antiplatelet therapy could reduce the risk of blood clots and potentially prevent the spread of cancer cells from a primary site to different parts of the body—or cancer metastasis, according to a study published Wednesday in Science Translational Medicine.

    "our results suggest that platelet decoys might represent an effective strategy for obtaining antithrombotic and antimetastatic effects."

    http://stm.sciencemag.org/content/11/479/eaau5898

    DOI: 10.1126/scitranslmed.aau5898

  • Lumpie
    Lumpie Member Posts: 1,553
    edited February 2019

    Influence of Adjuvant Systemic Regimens on Contralateral Breast Cancer Risk and Receptor Subtype

    • This population-based cohort study was designed to evaluate the influence of various systemic treatment regimens on the subtype-specific risk of contralateral breast cancer (CBC). The 10-year cumulative incidence of CBC was 3.8%. Endocrine therapy, adjuvant chemotherapy, and trastuzumab with chemotherapy were associated with a reduced risk of CBC. Taxane-containing chemotherapy and aromatase inhibitors were associated with the largest reduction in CBC risk.
    • The risk of CBC is reduced in association with endocrine therapy, chemotherapy, and trastuzumab with chemotherapy, and each regimen has varying effects on CBC subtypes. The biggest reduction in risk is seen following treatment with taxane-containing chemotherapy and aromatase inhibitors.
    • Of 83,144 BC patients, 2,816 developed a CBC; the 10-year cumulative incidence was 3.8%

  • Lumpie
    Lumpie Member Posts: 1,553
    edited February 2019

    Broad Institute targets blood-draw diagnostics

    FEBRUARY 19, 2019

    With pledges of $25 million, the nonprofit Broad Institute of MIT and Harvard plans to announce Tuesday that it's creating a new center to develop a diagnostic test to pinpoint how well cancer patients respond to treatment through a simple blood draw.

    Louis V. Gerstner Jr., the former CEO of IBM who chairs the institute's board of directors, has committed $15 million to the Gerstner Center for Cancer Diagnostics at the Broad. The center will receive an additional $10 million from the Eli and Edythe Broad Foundation.

    The center is pursuing a goal that some other biotech companies in the United States are also chasing: developing a sensitive blood-based biopsy to speed cancer detection.

    Although many aspects of cancer treatment have improved dramatically in recent years, diagnostic tests have lagged, according to Broad officials. Today, doctors still rely on a biopsy of a tumor obtained through surgery or have the patient undergo a CT or MRI scan. Surgical biopsies are invasive, of course, and the other tests provide no molecular insights.

    The Gerstner Center will focus on developing a blood biopsy that would monitor a patient's response to chemotherapy, radiation, or immunotherapy with molecular precision. Broad scientists hope the test would identify small numbers of cancer cells that remain in patients who have been treated and may cause a relapse years or even decades later.

    "Not long ago, I thought that blood biopsy was more science fiction than reality," said Dr. Todd Golub, a cancer specialist who works as Broad's chief scientific officer and will head the Gerstner Center. "In fact, Broad scientists have demonstrated that it's possible to look at an entire cancer genome from a blood biopsy. That is spectacular."

    The new center will work with technology experts, cancer biologists, computational scientists, and clinicians.

    By Jonathan Saltzman

    https://www.bostonglobe.com/business/2019/02/19/br...

  • Lumpie
    Lumpie Member Posts: 1,553
    edited February 2019

    Cancer treatment at home is safe, effective, and closer to happening than you think

    Imagine having cancer and being told that most of your treatment will happen in your home instead of a high-tech cancer center. That may sound preposterous, but it's closer to happening than you might think.

    The cancer care at home model could become a reality...

    It's time to reimagine the role of hospitals and outpatient clinics in cancer care. Rather than being the routine site of care, hospitals and outpatient clinics should be reserved for the minority of cancer patients who require treatments that only hospitals and clinics can give. People with cancer will thank us for this change, from the comfort of their homes.

    https://www.statnews.com/2019/02/06/cancer-treatme...


  • Lumpie
    Lumpie Member Posts: 1,553
    edited February 2019

    People diagnosed with cancer often don't embrace the term 'survivor'


    "Cancer survivor" has become a catch-all phrase to refer to living individuals diagnosed with cancer at some point in their lives. Cancer clinics and clinicians, patient advocacy organizations and media reportscommonly use the term.

    Should the same term be used for the entire spectrum of living people who have experienced cancer, which represents more than 100 distinct diseases affecting approximately 14 million people in the United States?

    An analysis of 23 studies of how people diagnosed with cancer view the term "cancer survivor" shows that although many embrace it, others see it as inappropriate.

    Language used with and about patients is important and can cause needless distress when used without care.

    Conclusions: Using the blanket term "survivor" to label a diverse group is problematic; although the term offers a positive identity for some, others reject it or find it offensive, at least for patients like those represented in this study. If cancer patients are going to be labeled, they should choose the one that is most empowering and reflective of their experience.

    https://theconversation.com/people-diagnosed-with-...

    https://www.tandfonline.com/doi/abs/10.1080/073473...

  • Lumpie
    Lumpie Member Posts: 1,553
    edited February 2019

    Increasing the Dose Intensity of Chemotherapy by More Frequent Administration or Sequential Scheduling

    The Lancet
    This meta-analysis was designed to compare the impact of dose-intense versus standard-schedule chemotherapy for patients with early breast cancer. The risk of recurrence at 10 years was lower in the dose-intense group compared with the standard-schedule group (28.0% vs 31.4%; P<.0001). Both 10-year breast cancer mortality and all-cause mortality were also significantly lower in the dose-intense group compared with the standard-schedule group.The use of dose-intense chemotherapy for patients with breast cancer appears to reduce the risk of recurrence and cancer death.Increasing the dose intensity of adjuvant chemotherapy by shortening the interval between treatment cycles, or by giving individual drugs sequentially rather than giving the same drugs concurrently, moderately reduces the 10-year risk of recurrence and death from breast cancer without increasing mortality from other causes.https://www.practiceupdate.com/C/79928/56?elsca1=e...https://linkinghub.elsevier.com/retrieve/pii/S0140...DOI:https://doi.org/10.1016/S0140-6736(18)33137-4
  • Lumpie
    Lumpie Member Posts: 1,553
    edited February 2019

    Pembrolizumab Plus Trastuzumab in Trastuzumab-Resistant, Advanced HER2-Positive Breast Cancer

    PANACEA: a single-arm, multicentre, phase 1b–2 trial

    The Lancet Oncology
    TAKE-HOME MESSAGEThis phase Ib/II trial was designed to evaluate the activity of pembrolizumab plus trastuzumab among patients with trastuzumab-resistant advanced HER2-positive breast cancer. In the phase II cohort, there was an objective response rate of 15% among PD-L1–positive patients but no responses in PD-L1–negative patients.Pembrolizumab plus trastuzumab appears to have some activity against PD-L1–positive, HER2-positive breast cancer, and further studies are needed to confirm these findings.HER2-positive breast cancers usually contain large amounts of T-cell infiltrate. We hypothesised that trastuzumab resistance in HER2-positive breast cancer could be mediated by immune mechanisms. We assessed the safety and anti-tumour activity of pembrolizumab, a programmed cell death protein 1 (PD-1) inhibitor, added to trastuzumab in trastuzumab-resistant, advanced HER2-positive breast cancer.Pembrolizumab plus trastuzumab was safe and showed activity and durable clinical benefit in patients with PD-L1-positive, trastuzumab-resistant, advanced, HER2-positive breast cancer. Further studies in this breast cancer subtype should focus on a PD-L1-positive population and be done in less heavily pretreated patients.https://www.practiceupdate.com/C/79904/56?elsca1=e...https://www.thelancet.com/journals/lanonc/article/...(18)30812-X/fulltextDOI:https://doi.org/10.1016/S1470-2045(18)30812-X
  • traveltext
    traveltext Member Posts: 1,055
    edited February 2019

    CONCLUSION

    “Compared with women, men with HR+/HER2+ tumors had twice the risk of death.

    https://journals.lww.com/amjclinicaloncology/Abstract/2019/02000/Overall_Survival_of_Men_and_Women_With_Breast.18.aspx

    Objectives: To analyze differences in overall survival(OS) between male breast cancer (MBC) and female breast cancer (FBC) according to tumor subtype compared with other factors.

    Materials and Methods: We evaluated men and women with breast cancer between 2010 and 2013 with known hormone receptor (HR) status and human epidermal growth factor receptor 2 (HER2) status reported to the National Cancer Institute's Surveillance, Epidemiology, and End Results program. Patient characteristics were compared between groups. Univariate and multivariate analyses were performed to determine the effect of each variable on OS. Breast cancer–specific survival was a secondary endpoint.

    Results: We included 1187 MBC and 166,054 FBC. Median follow-up was 21 months (range, 1 to 48) for both groups. OS at 3 years for MBC and FBC was 85.6% and 90.4%, respectively (P=0.0002). MBC were more ductal, had higher grade, presented with more advanced stage and were often HR+/HER2− (each P<0.0001). MBC had worse OS than FBC in HR+/HER2− (Hazard ratio [HaR], 1.5; P=0.0005), HR+/HER2+ (HaR, 2.8; P<0.0001) and triple negative (HaR, 4.3; P<0.0001) (P interaction<0.02). MBC had significantly worse OS than FBC in stages I and II, but similar OS in stages III and IV (P interaction<0.01). In multivariate analysis, HR+/HER2+ was the only subtype with significant differences in OS between MBC and FBC (HaR, 2.0; P=0.002).

    Conclusions: OS was significantly different in both groups. Men had worse OS in early stages while similar OS in stages III and IV. There were significant differences in OS according to tumor subtype; compared with women, men with HR+/HER2+ tumors had twice the risk of death.

  • Lumpie
    Lumpie Member Posts: 1,553
    edited February 2019

    Oncotype DX Not Cost-Effective for Low-Risk Breast Cancer

    Incremental cost-effectiveness ratio varies across clinical risk groups, sensitive to patient age

    The multigene expression test Oncotype DX (ODX) is not cost-effective for women with breast cancer who are at low risk for recurrence, according to research published online Jan. 22 in the Journal of the National Comprehensive Cancer Network.

    "ODX is not cost-effective for women with clinical low-risk breast cancer, which constitutes most patients with ER-positive disease," the authors write.

    https://www.practiceupdate.com/C/80064/56?elsca1=e...

    http://www.jnccn.org/content/17/1/39.full?sid=4a3a...

    doi:10.6004/jnccn.2018.7077

  • Lumpie
    Lumpie Member Posts: 1,553
    edited February 2019

    Hepatic Arterial Therapy With Oxaliplatin and Systemic Capecitabine for Liver Metastases From Breast Cancer

    • The authors report the results of two phase II trials investigating the combination of capecitabine and oxaliplatin in patients with breast cancer and liver metastases. Among the 52 patients, the response rate was 42.3%, including 7.7% complete responses and 34.6% partial responses. The median progression-free survival was 10.8 months. The most frequently reported grade 3 adverse events were hand–foot syndrome, neuropathy, fatigue, and abdominal pain.
    • The results demonstrate that the combination of capecitabine and oxaliplatin is effective and well-tolerated in patients with breast cancer liver metastases.

    One challenge of a patient who has liver metastasis is that she needs her liver to be metabolizing properly in order for chemotherapy—really any systemic treatments—to work as intended. The approach reported here appears to bypass the usual method of administration, and the drug is placed directly in the liver itself. The numbers are small, but the results are promising. The treatment schedule can be tricky and will require close monitoring, follow-up, and specific points of contact throughout the treatment process.

    These women are paving the ways for future women diagnosed after them. {Gratuitous comment by poster: Many of us are grateful!}


  • Lumpie
    Lumpie Member Posts: 1,553
    edited February 2019

    The role of histone deacetylase inhibitors in metastatic breast cancer

    {This sounds fairly cutting edge and technical, but for those who like to be ahead of the curve/keep up with the latest research, I thought I would put this early report out there....}

    Histone deacetylase inhibitors (HDACi) are a relatively new class of drug that plays an important role in the epigenetic and non-epigenetic regulation in cancer, inducing death, apoptosis and cell cycle arrest in cancer cells. Although HDACi are approved only for hematologic malignancies, there are several trials in the breast cancer setting with promising results. In this review, we summarize the latest studies with HDACi in breast cancer from the emerging data in the translational research until its possible applicability in the clinical practice.

    https://www.practiceupdate.com/c/77977/67/13/?elsc...

    https://www.thebreastonline.com/article/S0960-9776(18)30330-8/fulltext

    DOI: https://doi.org/10.1016/j.breast.2018.12.001

    {This is a pay-per-article unless you have access to a research database.}

  • Lumpie
    Lumpie Member Posts: 1,553
    edited February 2019

    The role of histone deacetylase inhibitors in metastatic breast cancer

    {This sounds fairly cutting edge and technical, but for those who like to be ahead of the curve/keep up with the latest research, I thought I would put this early report out there....}

    Histone deacetylase inhibitors (HDACi) are a relatively new class of drug that plays an important role in the epigenetic and non-epigenetic regulation in cancer, inducing death, apoptosis and cell cycle arrest in cancer cells. Although HDACi are approved only for hematologic malignancies, there are several trials in the breast cancer setting with promising results. In this review, we summarize the latest studies with HDACi in breast cancer from the emerging data in the translational research until its possible applicability in the clinical practice.

    https://www.practiceupdate.com/c/77977/67/13/?elsc...

    https://www.thebreastonline.com/article/S0960-9776(18)30330-8/fulltext

    DOI: https://doi.org/10.1016/j.breast.2018.12.001

    {This is a pay-per-article unless you have access to a research database.}

  • Lumpie
    Lumpie Member Posts: 1,553
    edited February 2019

    'Not Letting It Define Us' — Walking The Runway With Metastatic Breast Cancer

    https://www.npr.org/sections/health-shots/2019/02/...

    {This isn't technically research news but I thought some people might be interested in this news coverage of MBC....}

    ....This was the third annual #Cancerland fashion show, put on by METAvivor, a nonprofit organization that supports research and awareness of metastatic breast cancer, along with lingerie company, AnaOno. The goal: Raise funds for research to improve treatment for metastatic disease, while changing public perception of the condition.

  • marijen
    marijen Member Posts: 2,181
    edited February 2019

    New recommendations say not all women need genetic testing for cancer. Critics say it could cost lives
    CNN

    Primary care providers should screen women for personal, family and/or ethnic history of breast, ovarian, tubal or peritoneal cancer to decide who should undergo genetic counseling for BRCA1 and BRCA2 mutations, the US Preventive Services Task Force recommended Tuesday. The mutations increase a woman's cancer risk. Read the full story

    Shared from Apple News

  • marijen
    marijen Member Posts: 2,181
    edited February 2019


    How chronic stress boosts cancer cell growth

    https://www.medicalnewstoday.com/articles/324540.php


  • Lumpie
    Lumpie Member Posts: 1,553
    edited March 2019

    FDA Approves Herceptin Hylecta for Subcutaneous Injection in Certain HER2-Positive Breast Cancers

    South San Francisco, CA -- February 28, 2019 --

    Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the U.S. Food and Drug Administration (FDA) has approved Herceptin Hylecta™ (trastuzumab and hyaluronidase-oysk) for subcutaneous (under the skin) injection for the treatment of certain people with HER2-positive early breast cancer (node-positive, or node-negative and ER/PR-negative or with one high-risk feature) in combination with chemotherapy and HER2-positive metastatic breast cancer in combination with paclitaxel or alone in people who have received one or more chemotherapy regimens for metastatic disease. This new treatment includes the same monoclonal antibody as intravenous Herceptin® (trastuzumab) in combination with recombinant human hyaluronidase PH20, an enzyme that helps to deliver trastuzumab under the skin. Herceptin Hylecta is a ready-to-use formulation that can be administered in two to five minutes, compared to 30 to 90 minutes for intravenous Herceptin.

    "Over the past 20 years, Herceptin has significantly advanced treatment of HER2-positive breast cancer," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "The approval of Herceptin Hylecta gives physicians and patients in the United States a new option to select treatment based on individual needs and preferences."

    The FDA approval is based on results from three clinical studies in HER2-positive early breast cancer:

    • The Phase III HannaH study compared neoadjuvant (before surgery) and adjuvant (after surgery) Herceptin Hylecta to intravenous Herceptin, both in combination with chemotherapy. Subcutaneous administration of Herceptin Hylecta resulted in non-inferior levels of trastuzumab in the blood (pharmacokinetics) and non-inferior clinical efficacy (pathological complete response rate; pCR) compared to intravenous Herceptin.
    • The Phase III SafeHER study of adjuvant Herceptin Hylecta identified no new safety signals, with safety and tolerability consistent with the known safety profiles of intravenous Herceptin and Herceptin Hylecta.
    • The PrefHER patient preference study of adjuvant Herceptin Hylecta followed by intravenous Herceptin, or the reverse sequence, found the majority (86 percent) of people preferred Herceptin Hylecta over intravenous Herceptin.

    The most common side effects in people receiving Herceptin Hylecta for early breast cancer were feeling tired, joint pain, diarrhea, injection site reaction, upper respiratory tract infection, rash, muscle pain, nausea, headache, swelling, flushing, fever, cough and pain in extremity.

    For those who qualify, Genentech offers patient assistance programs for people prescribed Herceptin Hylecta by their doctor through Genentech Access Solutions. Please contact Genentech Access Solutions at (866) 422-2377 or visit http://www.Genentech-Access.com for more information.

    https://www.gene.com/media/press-releases/14779/20...

    {wow. That's big. It was my understanding that they had no intention of launching the sub-q product in the U.S.}

  • Lumpie
    Lumpie Member Posts: 1,553
    edited March 2019

    Pharmacy benefit manager (PBM) Delays for Cancer Drugs May Risk Lives, Warn Oncologists

    The Community Oncology Alliance (COA) has been collecting ... stories from oncologists for several years, as it has become increasingly apparent that PBMs — who generally act as middlemen between insurers and healthcare providers — are having a major impact on cancer patients' lives and on how oncologists deliver care.

    ...the PBM "made a medical decision without having seen the patient," ... The PBM does not have the same liability as the physician on record. "They have no repercussions on their end — and yet they're making medical decisions," he noted. ...in oncology, the delays can mean the difference between life or death. Turnaround times for authorizations are increasing, and the process has become more complicated...

    https://www.medscape.com/viewarticle/909623?src=wn...

    February 27, 2019

  • Lumpie
    Lumpie Member Posts: 1,553
    edited March 2019

    A Simple Blood Test Is as Effective as a Biopsy in Detecting Lung Cancer Mutations

    http://time.com/5540396/cancer-blood-test-liquid-b...

    February 27, 2019

    Biopsies are a necessary burden for people with cancer. Taking a small sample of tissue and sending it through genetic and molecular analysis can help doctors not just diagnose cancer, but also learn more about its inner workings to find the best treatments based on which mutations are feeding the disease.

    But tissue biopsies are invasive, and depending on where the tumors are in the body, they can be painful to obtain. For some people, there may not even be enough cancer tissue for doctors to get the answers they need.

    In a press briefing previewing the upcoming American Association for Cancer Research annual meeting in Atlanta, researchers reported that a commercial blood test, called a liquid biopsy, was at least as effective as a tissue sample at identifying important mutations in non-small cell lung cancers.

    {It's not breast cancer but this development is encouraging news for non-invasive testing.}

  • Lumpie
    Lumpie Member Posts: 1,553
    edited March 2019

    How Breast Cancer Avoids Immune System Detection

    Decision trees help identify which therapy combinations may work best based on the cluster-specific evasion mechanisms found

    The identification of biomarkers to cluster breast cancer patients into subgroups based on their immune evasion mechanisms may help guide the choice of immunotherapy, according to new research. The findings provide a better understanding of the response to immunotherapies and shed light on the rational design of novel combination therapies...

    This will require more preclinical investigations and clinical trials to determine if the combination immunotherapies should be administrated at the same time or sequentially, and if sequentially, in which order, using what dosage, to maximize patient response rate and minimize the adverse effects.

    https://www.medpagetoday.com/reading-room/asco/imm...

  • Lumpie
    Lumpie Member Posts: 1,553
    edited March 2019

    3D Mammo Better for Breast Ca Screening in Younger Women?

    Better detection, lower recall, particularly among controversial age group

    Breast cancers detected with 3D mammography were smaller and more likely to not have spread to local lymph nodes than those detected by screening with standard digital mammography, a retrospective found.

    Specifically, 73.7% of screening-detected breast cancers were 1 cm or smaller and node negative with 3D mammography examination compared with 65.4% with standard mammography, and this improved specificity was most evident in women ages 40 to 49...

    February 28, 2019

    https://www.medpagetoday.com/radiology/diagnosticr...

    doi:10.1001/jamaoncol.2018.7078