Authorized User and Radiation Safety Officer for Xofigo (Radium 223) at UCPA to treat bone mets for patients diagnosed with Castrate Resistant Prostate Cancer and bone metastasis at our Prostate Cancer Center.
Education: BS from Gannon University
MD from Penn State University College of Medicine
Residency: The Reading Hospital and Medical Center
Dr. Gouldy has been Board Certified by the American College of Radiology since May of 1999.
Dr. Gouldy has been with Quantum since 1-1-01. Her special Interests are in Ultrasound and Nuclear Medicine.
Xofigo(r) is the first and only alpha particle-emitting radioactive therapeutic agent approved by the United States Food and Drug Administration (FDA) for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease. Urology of Central PA proudly adds this therapy to its roster of treatment options, underscoring its commitment to bringing the latest medicines to patients.
According to the American Cancer Society, prostate cancer is the most common type of cancer found in American men, other than skin cancer. This year alone, it is estimated that more than 230,000 men will be diagnosed with the cancer and nearly 29,500 men will die from the disease in the United States.2 If prostate cancer starts to spread to other areas of the body (metastasize), it most commonly goes to the bones.3 Once the cancer has reached the bone, interactions between tumors cells and the bone cells responsible for breaking down and rebuilding bone result in excessive bone rebuilding and rapid tumor growth.4 Ninety percent of all men with CRPC have radiological evidence of bone metastases5, which are shown to be one of the main causes of death in patients with CRPC. 6
ABOUT XOFIGO(r) (RADIUM RA 223 DICHLORIDE) INJECTION
Xofigo(r) is indicated in the United States for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.1
Xofigo is an alpha particle-emitting radioactive therapeutic agent with an anti-tumor effect on bone metastases. The active ingredient in Xofigo is the alpha particle-emitting isotope radium-223, which mimics calcium and forms complexes with the bone mineral hydroxyapatite at areas of increased bone turnover, such as bone metastases. The high linear energy transfer of Xofigo may cause double-strand DNA breaks in adjacent cells, resulting in an anti-tumor effect on bone metastases. The alpha particle range from radium-223 dichloride is less than 100 micrometers which may limit the damage to the surrounding normal tissue.1
IMPORTANT SAFETY INFORMATION
*Contraindications: Xofigo is contraindicated in women who are or may become pregnant. Xofigo can cause fetal harm when administered to a pregnant woman
*Bone Marrow Suppression: In the randomized trial, 2% of patients in the Xofigo arm experienced bone marrow failure or ongoing pancytopenia, compared to no patients treated with placebo. There were two deaths due to bone marrow failure. For 7 of 13 patients treated with Xofigo bone marrow failure was ongoing at the time of death. Among the 13 patients who experienced bone marrow failure, 54% required blood transfusions. Four percent (4%) of patients in the Xofigo arm and 2% in the placebo arm permanently discontinued therapy due to bone marrow suppression. In the randomized trial, deaths related to vascular hemorrhage in association with myelosuppression were observed in 1% of Xofigo-treated patients compared to 0.3% of patients treated with placebo. The incidence of infection-related deaths (2%), serious infections (10%), and febrile neutropenia (<1%) was similar for patients treated with Xofigo and placebo. Myelosuppression –notably thrombocytopenia, neutropenia, pancytopenia, and leukopenia– has been reported in patients treated with Xofigo.
Please see additional important safety information on following page and full Prescribing Information.
IMPORTANT SAFETY INFORMATION (continued)
Monitor patients with evidence of compromised bone marrow reserve closely and provide supportive care measures when clinically indicated. Discontinue Xofigo in patients who experience life-threatening complications despite supportive care for bone marrow failure
*Hematological Evaluation: Monitor blood counts at baseline and prior to every dose of Xofigo. Prior to first administering Xofigo, the absolute neutrophil count (ANC) should be ≥1.5 × 109/L, the platelet count ≥100 × 109/L, and hemoglobin ≥10 g/dL. Prior to subsequent administrations, the ANC should be ≥1 × 109/L and the platelet count ≥50 × 109/L. Discontinue Xofigo if hematologic values do not recover within 6 to 8 weeks after the last administration despite receiving supportive care
*Concomitant Use With Chemotherapy: Safety and efficacy of concomitant chemotherapy with Xofigo have not been established. Outside of a clinical trial, concomitant use of Xofigo in patients on chemotherapy is not recommended due to the potential for additive myelosuppression. If chemotherapy, other systemic radioisotopes, or hemibody external radiotherapy are administered during the treatment period, Xofigo should be discontinued
*Administration and Radiation Protection: Xofigo should be received, used, and administered only by authorized persons in designated clinical settings. The administration of Xofigo is associated with potential risks to other persons from radiation or contamination from spills of bodily fluids such as urine, feces, or vomit. Therefore, radiation protection precautions must be taken in accordance with national and local regulations
*Fluid Status: Dehydration occurred in 3% of patients on Xofigo and 1% of patients on placebo. Xofigo increases adverse reactions such as diarrhea, nausea, and vomiting, which may result in dehydration. Monitor patients’ oral intake and fluid status carefully and promptly treat patients who display signs or symptoms of dehydration or hypovolemia
*Injection Site Reactions: Erythema, pain, and edema at the injection site were reported in 1% of patients on Xofigo
*Secondary Malignant Neoplasms: Xofigo contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure may be associated with an increased risk of cancer and hereditary defects. Due to its mechanism of action and neoplastic changes, including osteosarcomas, in rats following administration of radium -223 dichloride, Xofigo may increase the risk of osteosarcoma or other secondary malignant neoplasms. However, the overall incidence of new malignancies in the randomized trial was lower on the Xofigo arm compared to placebo (<1% vs 2%; respectively), but the expected latency period for the development of secondary malignancies exceeds the duration of follow up for patients on the trial
*Subsequent Treatment with Cytotoxic Chemotherapy: In the randomized clinical trial, 16% patients in the Xofigo group and 18% patients in the placebo group received cytotoxic chemotherapy after completion of study treatments. Adequate safety monitoring and laboratory testing was not performed to assess how patients treated with Xofigo will tolerate subsequent cytotoxic chemotherapy
*Adverse Reactions: The most common adverse reactions (≥10%) in the Xofigo arm vs the placebo arm, respectively, were nausea (36% vs 35%), diarrhea (25% vs 15%), vomiting (19% vs 14%), and peripheral edema (13% vs 10%). Grade 3 and 4 adverse events were reported in 57% of Xofigo-treated patients and 63% of placebo-treated patients. The most common hematologic laboratory abnormalities in the Xofigo arm (≥10%) vs the placebo arm, respectively, were anemia (93% vs 88%), lymphocytopenia (72% vs 53%), leukopenia (35% vs 10%), thrombocytopenia (31% vs 22%), and neutropenia (18% vs 5%)
For important risk and use information about Xofigo, please see the full Prescribing Information available at www.xofigo-us.com.
Xofigo is a registered trademark of Bayer.
1.XOFIGO(r) (radium Ra 223 dichloride) [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, May 2013.
2.American Cancer Society. How many men get prostate cancer? Available at: http://www.cancer.org/cancer/prostatecancer/overviewguide/prostate-cancer-overview-key-statistics. Accessed April 28, 2014.
3.Goh et al. New Multidisciplinary Prostate Bone Metastates Clinic: First of Its Kind in Canada. Current Oncology. Volume 14, Number 1.
4.Jin, Dayyani, and Gallick. Steps in Prostate
5.Saad, MD, et. al. “Guidelines for the management of castration-resistant prostate cancer.” Can Urol Assoc J 2010;4(6):380-4.
6.Lange PH, Vasella RL. “Mechanisms, hypotheses and questions regarding prostate cancer metastatic to bone.” Cancer & Metastasis Reviews.1999;17:331-336