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Hormone injections scale back danger for early menopause from breast most cancers chemotherapy

Posted in News on 7th November 2018

Ultimate outcomes of SWOG Most cancers Analysis Community’s groundbreaking worldwide Prevention of Early Menopause Research (POEMS) medical trial are in, they usually present continued proof that girls who get injections of the hormone drug goserelin together with normal breast most cancers chemotherapy usually tend to turn out to be pregnant – with out creating detrimental unintended effects or shortening their lives.

“These five-year follow-up outcomes affirm our preliminary findings,” stated SWOG investigator Halle Moore, MD, lead researcher on the POEMS research and affiliate professor of medication at Cleveland Clinic. “Goserelin protects the ovaries from the consequences of chemotherapy, lowering the danger for early menopause. By getting these injections, extra girls grew to become pregnant with out negatively affecting their well being or their possibilities of surviving their most cancers.”

The outcomes are revealed within the present challenge of the Journal of the Nationwide Most cancers Institute. When the POEMS workforce introduced preliminary research outcomes on the 2014 American Society for Medical Oncology (ASCO) annual assembly, they gained worldwide consideration. POEMS is a singular collaboration, managed by SWOG, one in all 5 teams within the Nationwide Most cancers Institute’s Nationwide Medical Trials Community (NCTN), with assist from two different NCTN teams – ECOG-ACRIN Most cancers Analysis Group and the Alliance for Medical Trials in Oncology. The Worldwide Breast Most cancers Research Group, which incorporates the Australia New Zealand Breast Most cancers Trials Group, offered trial entry to sufferers around the globe.

The randomized, section III trial additionally obtained consideration for focusing not on the effectiveness of a most cancers remedy, however the affect that remedy has on the lives of most cancers survivors. In the US, virtually 49,000 girls beneath the age of 50 are recognized annually with invasive breast most cancers. Hormone-receptor detrimental breast most cancers is a much less frequent kind, which does not feed on estrogen or progesterone, and would not usually reply to medication that focus on these hormones.

Ovarian failure is one aspect impact of chemotherapy, one which carries a heavy burden for ladies, together with infertility, sexual dysfunction, and unsightly signs. To find out if ovarian failure might be prevented, the POEMS workforce launched their trial. Between 2004 and 2011, investigators randomized 218 premenopausal girls with hormone-receptor detrimental breast most cancers, putting them into two research teams. One group obtained normal chemotherapy remedy, and the opposite obtained normal chemotherapy plus goserelin.

Preliminary outcomes confirmed that 22 p.c of sufferers on normal remedy skilled ovarian failure whereas solely eight p.c who obtained goserelin did. As well as, these 2014 outcomes additionally confirmed that 12 p.c of sufferers on the usual arm obtained pregnant, whereas 22 p.c who obtained goserelin did.

The brand new outcomes, which embody 5 years of follow-up, present comparable results. On common, 23 p.c of girls who took goserelin grew to become pregnant in contrast with 12 p.c on the usual remedy. Importantly, girls who took goserelin skilled comparable, and even higher, survival charges in contrast with girls who obtained normal chemo. 5 years after remedy, 88 p.c of girls who took goserelin had been alive and disease-free in contrast with 79 p.c of girls who obtained normal chemo. Whereas variations in survival weren’t statistically important, 92 p.c of girls who took goserelin had been alive at 5 years in comparison with 83 p.c of management sufferers.

When the POEMS outcomes had been first issued, SWOG senior investigator Kathy Albain, MD, FACP, FASCO, of the Cardinal Bernardin Most cancers Middle of Loyola College Chicago, predicted they’d change the usual of look after breast most cancers. They usually have. The Nationwide Complete Most cancers Community Medical Apply Tips for Oncology and the St. Gallen Consensus Convention pointers already replicate the usage of goserelin for young women who hope to guard ovarian perform throughout chemotherapy for breast most cancers.

“Most cancers researchers got down to change the usual of care to be able to enhance, or lengthen, folks’s lives,” Moore stated. “Our remaining outcomes present a method to enhance high quality of life for younger girls with hormone-receptor detrimental breast most cancers. In the event that they wish to be moms, they’ll enhance their probabilities safely and successfully. I am pleased with this end result, and our worldwide workforce.”



Dermatologic Antagonistic Occasions Widespread With Focused Therapies, Immunotherapies

Posted in News on 7th November 2018

November 06, 2018

Dermatologic toxicities may diminish a patient's quality of life

Dermatologic toxicities may diminish a patient’s quality of life

Dermatologic adverse events (dAEs) are common among cancer patients treated with targeted therapies and immunotherapies and “often profoundly diminish patients’ quality of life,” according to a review published in the American Journal of Clinical Dermatology.

For patients treated with epidermal growth factor receptor inhibitors (EGFRI) and mitogen-activated protein (MAP) kinase kinase inhibitors (MEKI), acneiform rash is the most common dermatologic toxicity (25-85% of patients) and typically appears within 2 to 4 weeks. The pathophysiology of this rash is poorly understood, but studies suggest that inflammation, immunosuppression, and superinfection play a key role. A Phase 2 study (Lacouture ME et al. 2010) found that administration of the antibiotic doxycycline in combination with topical corticosteroids resulted in a reduction in the incidence of dAEs for patients receiving EGFRI panitumumab. Topical dapsone gel was also found to be promising. 

Monotherapy with a BRAF inhibitor can cause the activation of secondary skin tumors and other hyperproliferative lesions (~20% of patients). However, “metastatic spread has not been reported from these secondary cancers,” write the authors. Hand-foot skin reactions and maculopapular hypersensitivity-like rash have also been associated with BRAF inhibitor therapy.

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Dermatologic toxicities with immune checkpoint inhibitors (ICIs) occur in about 40% of patients and are typically observed within the first 4-8 weeks of treatment. These reactions include non-specific maculopapular rash (most commonly reported), eczema-like or psoriatic lesions, and lichenoid dermatitis.

As for oral mucosal toxicities, oral mucositis is frequently reported with mammalian target of rapamycin (mTOR) inhibitors (around 30% of patients treated with monotherapy), while stomatitis has been linked to multikinase angiogenesis inhibitors (25% of patients) and EGFRIs (15% of patients); oral lichenoid reactions and xerostomia typically occur with ICI therapy.

With regard to hair toxicities, alopecia is commonly induced by BRAF inhibitors, MEKIs, and endocrine therapy. Targeted therapies are also associated with nail toxicities such as paronychia, periungual granulomas, onycholysis, brittle nails, and a slower nail growth rate.

“Dermatologic toxicities related to targeted therapies and immune checkpoint inhibitors profoundly diminish patients’ quality of life, which impacts adherence to the treatment, jeopardizing its success and thus patient progression-free survival,” concluded the authors. “Closer collaboration between dermatologists and oncologists is essential.”

For more information visit Springer.com.

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AEGEA Medical begins PACE II medical research in ladies who underwent endometrial ablation

Posted in News on 6th November 2018

AEGEA Medical, Inc. has introduced the graduation of the Submit-Ablation Cavity Entry (PACE II) medical research in ladies who beforehand underwent endometrial ablation as a part of AEGEA’s pivotal trial of the corporate’s patented Adaptive Vapor Ablation expertise. The multi-center observational research, which is being carried out at seven websites throughout the U.S. in as much as 50 ladies, is designed to evaluate uterine cavity entry in addition to the feasibility of diagnostic and therapeutic interventions three to 4 years following remedy.

AEGEA Medical is conducting the PACE II research primarily based on outcomes from the AEGEA PACE pilot research, which discovered that post-procedure entry to the mid-uterine cavity or past was attainable in 82 % of the research’s 11 sufferers who beforehand participated in a Part II research of vapor ablation in The Netherlands. The first observational endpoint of PACE II is the power to entry the uterine cavity and carry out a diagnostic hysteroscopic examination, with different observational endpoints together with feasibility of endometrial biopsy and IUD placement, the power to visualise the uterine cornua/ostia, and presence and traits of adhesions throughout the uterine cavity. The corporate expects PACE II to be accomplished inside six months.

“Whereas endometrial ablation applied sciences have served physicians and their sufferers effectively for a while, the difficulty of post-procedure uterine cavity entry has by no means actually been addressed,” mentioned Maria Sainz, president and CEO of AEGEA Medical. “We consider it is a crucial success metric for the remedy, because it speaks to the opportunity of future uterine-related interventions. The PACE Pilot knowledge on 11 sufferers handled with Adaptive Vapor Ablation expertise could be very promising in how Vapor Ablation can tackle this unmet want, preserving doctor and affected person choices sooner or later.”

Endometrial ablation is a secure, efficient and fast-growing process for the remedy of heavy menstrual bleeding (menorrhagia), with the variety of U.S. circumstances estimated to have elevated from 430,000 in 2014 to 490,000 in 2017 alone. Because the variety of procedures continues to rise per yr, research have proven that scar tissue and re-access to the cavity could be difficult publish remedy, limiting the power to seek for suspected most cancers by way of ultrasound or biopsy, and ruling out the usage of IUDs for therapeutic intervention. In these situations, the dearth of post-procedure uterine cavity entry typically leaves ladies with hysterectomy as the one viable possibility.

“Submit-procedure uterine cavity entry is the following massive subject in endometrial ablation,” mentioned the research’s Nationwide Principal Investigator, Alan Johns, MD, Medical Director, Medical Analysis Baylor Analysis Institute, Fort Value. “Given the early efficiency of AEGEA’s Adaptive Vapor Ablation expertise on this space, I consider it has the potential to deal with this concern, offering physicians and sufferers with a extra considerate method to endometrial ablation that permits for future uterine interventions as needed. Importantly, this multi-center research has been designed with goal standards to keep away from affected person choice bias. Moreover, the research consists of unbiased knowledgeable evaluation of the hysteroscopy imagery to additional improve the information’s scientific rigor.”


Lorbrena Accredited for Beforehand-Handled ALK-Constructive Metastatic NSCLC

Posted in News on 6th November 2018

November 05, 2018

Lorbrena is a third generation ALK tyrosine kinase inhibitor

Lorbrena is a third generation ALK tyrosine kinase inhibitor

Pfizer announced that the Food and Drug Administration (FDA) has approved Lorbrena (lorlatinib) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on: crizotinib and at least 1 other ALK inhibitor for metastatic disease; or alectinib as the first ALK inhibitor therapy for metastatic disease; or ceritinib as the first ALK inhibitor therapy for metastatic disease. 

Lorbrena, a third generation ALK tyrosine kinase inhibitor (TKI), has been approved under the accelerated pathway based on tumor response rate and duration of response. Continued approval may be based on verification and description of clinical benefit in a confirmatory trial. 

The FDA approval was supported by data from a non-randomized, dose-ranging and activity-estimating, multi-cohort, multicenter Phase 1/2 study that evaluated Lorbrena in patients with ALK-positive metastatic NSCLC who were previously treated with 1 or more ALK TKIs (N=215) . 

Results showed an overall response rate (ORR) of 48% (95% CI, 42%, 55%) among treated patients (4% complete response; 44% partial response); 57% of patients had previous treatment with >1 ALK TKI. The median duration of response was 12.5 months (95% CI, 8.4, 23.7). In addition, an assessment of intracranial ORR showed a 60% response rate (95% CI, 49%, 70%) among patients with measurable intracranial lesions; 69% of patients had a history of brain metastases. The median duration of response in these patients was 19.5 months (95% CI, 12.4, not reached [NR]). 

The most frequent adverse reactions reported with treatment included edema, peripheral neuropathy, cognitive effects, dyspnea, fatigue, weight gain, arthralgia, mood effects, and diarrhea. 

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“Lorbrena’s approval is an important milestone for patients, having demonstrated marked activity in a study that included a broad range of individuals with ALK-positive non-small cell lung cancer. This includes patients who were heavily pretreated and facing limited options after receiving first- and second-generation ALK tyrosine kinase inhibitors,” stated Mace Rothenberg, MD, Chief Development Officer, Oncology, Pfizer Global Product Development.

Lorbrena will be available as 25mg and 100mg strength tablets in 30-count bottles.

For more information call (800) 438-1985 or visit Lorbrena.com.

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Section III CLL14 examine evaluating Venclexta plus Gazyva to deal with CLL meets its major endpoint

Posted in News on 5th November 2018

Genentech, a member of the Roche Group , introduced as we speak that the randomized Section III CLL14 examine, which evaluated fixed-duration Venclexta® (venetoclax) together with Gazyva® (obinutuzumab) in folks with beforehand untreated power lymphocytic leukemia (CLL) and co-existing medical circumstances, met its major endpoint and confirmed a statistically vital discount within the danger of illness worsening or dying (progression-free survival [PFS] as assessed by investigator) in comparison with standard-of-care Gazyva plus chlorambucil. The outcomes confirmed that no new security alerts or enhance in identified toxicities of Venclexta or Gazyva have been noticed with the remedy mixture.

“Individuals with power lymphocytic leukemia proceed to want extra remedy choices as a result of some sufferers are unable to tolerate chemotherapy regimens as a result of their underlying well being,” mentioned Sandra Horning, M.D., chief medical officer and head of International Product Growth. “CLL14 is the primary examine to point out superior progression-free survival for Venclexta plus Gazyva in comparison with a standard-of-care routine. We are going to work with well being authorities to deliver this potential chemotherapy-free remedy choice to individuals who want it as shortly as doable.”

Knowledge from the CLL14 examine shall be submitted to world well being authorities. Venclexta together with Rituxan® (rituximab) has been permitted by the U.S. Meals and Drug Administration (FDA) for the remedy of individuals with CLL or small lymphocytic lymphoma, with or with out 17p deletion, who’ve obtained at the very least one prior remedy. A supplemental New Drug Software (sNDA) is at the moment underneath assessment by the FDA for Venclexta together with a hypomethylating agent or together with low dose cytarabine for the remedy of individuals with beforehand untreated acute myeloid leukemia (AML) who’re ineligible for intensive chemotherapy, with a call anticipated by finish of 12 months.

A strong medical growth program for Venclexta is ongoing in a number of kinds of blood most cancers, together with AML and a number of myeloma. Gazyva continues to be investigated together with permitted and investigational molecules in CLL and follicular lymphoma.

Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It’s collectively commercialized by the businesses in the USA and commercialized by AbbVie outdoors of the USA.



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