Randomized, Double-Blind Study of Denosumab Versus Zoledronic Acid in the Treatment of Bone Metastases in Patients With Advanced Cancer (Excluding Breast and Prostate Cancer) or Multiple Myeloma.

Henry DH, Costa L, Goldwasser F, Hirsh V, Hungria V, Prausova J, Scagliotti GV, Sleeboom H, Spencer A, Vadhan-Raj S, von Moos R, Willenbacher W, Woll PJ, Wang J, Jiang Q, Jun S, Dansey R, Yeh H.

Joan Karnell Cancer Center, Philadelphia, PA; Hospital de Santa Maria and Instituto de Medicina Molecular, Lisboa, Portugal; Teaching Hospital Cochin, Paris, France; McGill University Health Centre, Montreal, Canada; Irmandade da Santa Casa de Misericordia de Sao Paulo, Sao Paulo, Brazil; University Hospital Motol, Prague, Czech Republic; University of Torino, Orbassano, Italy; HagaZiekenhuis-Leyenburg, Den Haag, the Netherlands; The Alfred Hospital, Melbourne, Australia; MD Anderson Cancer Center, Houston, TX; Kantonsspital Graubünden, Chur, Switzerland; Medical University of Innsbruck, Innsbruck, Austria; Weston Park Hospital, University of Sheffield, Sheffield, United Kingdom; and Amgen, Thousand Oaks, CA.

Abstract

PURPOSE This study compared denosumab, a fully human monoclonal anti-receptor activator of nuclear factor kappa-B ligand antibody, with zoledronic acid (ZA) for delaying or preventing skeletal-related events (SRE) in patients with advanced cancer and bone metastases (excluding breast and prostate) or myeloma. PATIENTS AND METHODS Eligible patients were randomly assigned in a double-blind, double-dummy design to receive monthly subcutaneous denosumab 120 mg (n = 886) or intravenous ZA 4 mg (dose adjusted for renal impairment; n = 890). Daily supplemental calcium and vitamin D were strongly recommended. The primary end point was time to first on-study SRE (pathologic fracture, radiation or surgery to bone, or spinal cord compression). Results Denosumab was noninferior to ZA in delaying time to first on-study SRE (hazard ratio, 0.84; 95% CI, 0.71 to 0.98; P = .0007). Although directionally favorable, denosumab was not statistically superior to ZA in delaying time to first on-study SRE (P = .03 unadjusted; P = .06 adjusted for multiplicity) or time to first-and-subsequent (multiple) SRE (rate ratio, 0.90; 95% CI, 0.77 to 1.04; P = .14). Overall survival and disease progression were similar between groups. Hypocalcemia occurred more frequently with denosumab. Osteonecrosis of the jaw occurred at similarly low rates in both groups. Acute-phase reactions after the first dose occurred more frequently with ZA, as did renal adverse events and elevations in serum creatinine based on National Cancer Institute Common Toxicity Criteria for Adverse Events grading. CONCLUSION Denosumab was noninferior (trending to superiority) to ZA in preventing or delaying first on-study SRE in patients with advanced cancer metastatic to bone or myeloma. Denosumab represents a potential novel treatment option with the convenience of subcutaneous administration and no requirement for renal monitoring or dose adjustment.

First aid

First aid is a complicated subject and it is situation-specific. First aid is the help and medical assistance that someone gives, not only to an injured person, but to a person who is sick. Preparedness is a key element of first aid, like having basic medical emergency kits in your home, car, boat, or RV. It is also advised to be prepared for illness while traveling locally or to a foreign country. Cuts, puncture wounds, sprains, strains, nosebleeds are one type of injury that may require first aid; heart attacks, strokes, seizures, and heat stroke are examples of more critical first aid emergencies.

Making Decisions About Cancer Treatment

fter a diagnosis of cancer, patients and their families must make a number of decisions about cancer treatment, some of which are more difficult than others. These decisions are complicated by unfamiliar words, various statistics, and a sense of urgency. However, it is important to allow time to research your options and ask questions. Decisions about cancer treatment are personal, and it is important that you feel comfortable about your decisions.

Learn about your cancer. Try to understand as much as you can about your cancer, such as its stage (a way of describing a cancer, such as where it is located and if it has spread to other parts of the body). The Cancer.Net Guides to Cancer are a good place to begin. If you are unfamiliar with certain words, ask your doctor or nurse or use a medical dictionary. Some people find it helpful to take notes during a doctor’s visit or bring a friend along to help keep track of all the information.

Know your options. Talk with your doctor about treatment options for your type and stage of cancer. Some of these options may include surgery, radiation therapy, chemotherapy, hormone therapy, active surveillance (watchful waiting), enrolling in a clinical trial, and not receiving treatment. People are often surprised to learn that they may have different treatment options.

Understand the goals of treatment. Often, cancer can be cured with treatment, called curative treatment. However, there are times when treatment is only used to relieve side effects, such as pain, and this is called palliative treatment. Knowing the goals of treatment helps people evaluate which risks are acceptable. For example, people who know their treatment is curative may be more willing to face potentially unpleasant side effects.

Learn about the risks and benefits of each treatment option. Different treatments have different risks, as well as potential side effects. An important part of making a decision is weighing the positives and negatives of each treatment option, including your ability to manage the side effects that are more common for the specific type of treatment. Factors to consider include the likelihood that the cancer will recur (come back) after treatment, the chances of living longer with or without treatment, the possibility of side effects, and your personal and family preferences.

Obtain a second opinion. Many people find that it helps to get a second or even third opinion from another oncologist and many doctors encourage it. Different oncologists may have different experiences with various treatments, and seeking multiple opinions may help you make a decision. Read more about types of oncologists. Also, learn more about seeking a second opinion.

Consult guidelines or other decision-making tools. Many cancer organizations, such as the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN), publish guidelines and treatment decision-making tools to help doctors and people with cancer understand various treatment options. One example is a decision aid tool developed by ASCO and Cancer Care Ontario for people with non-small cell lung cancer. Some cancer centers offer sophisticated statistical tools you can use with your doctor to help determine the best treatment option based on your personal medical information. Always use treatment guidelines and other programs with the help and interpretation of your doctor. Learn more about ASCO’s Patient Guides.

Talk about your decision with people you trust. Talk to your family, friends, a member of the clergy or spiritual advisor, an oncology social worker, and other people with cancer. What you decide is ultimately up to you, but some people find it helpful to talk through their concerns with other people. Many patient support organizations bring together people who have coped with similar experiences.

The role of statistics

Your doctor will probably mention many statistics when describing treatment options, including relative survival rates, disease-free survival rates, and progression-free survival rates. These numbers may be a good way to learn about how the treatment options differ, but they can’t predict how well the treatment will work in an individual. Your doctor can help you understand how these statistics relate to your treatment. Learn more about cancer statistics.

Doctor Healthy

Doctor Healthy Search

DENOSUMAB FOR BONE METASTASES

Randomized, Double-Blind Study of Denosumab Versus Zoledronic Acid in the Treatment of Bone Metastases in Patients With Advanced Cancer (Excluding Breast and Prostate Cancer) or Multiple Myeloma.

Abstract

0 comments:

Post a Comment

Doctor Healthy

First aid

When the Doctor Says Cancer

Seeking support

Archive

The online Doctor

Get organized

Consider a second opinion

Making Decisions About Cancer Treatment

Doctor Healthy Search