Treating Bone Metastases with Local Therapy in a Breast Cancer Patient Resulted in Decreased Pain and Prevented Fracture

Abstract

Lytic lesions from bone metastases from breast, lung and prostate carcinomas, are associated with a poor prognosis and significant morbidities that include fracture and debilitating pain. Chemotherapeutics, palliative radiation therapy and surgical intervention are routinely used to treat these lesions. The ZetaMet™ Bone Graft is a novel antitumorigenic and osteoinductive graft that offers a potential alternative treatment option. ZetaMet is composed of calcium phosphate salts, type-I collagen and the small molecule N-allyl noroxymorphone dihydrate. Here, we report the case of a stage IV breast cancer patient with multiple lytic metastatic lesions to the spine that were successfully treated, which led to a significant reduction in pain and increased quality of life. This outcome demonstrates that a locally administered therapeutic intervention may represent an important alternative for patients with bone metastases that warrants further study.

Plain language summary

What questions did we seek to answer?

Pain from bone cancer is debilitating, uncurable and often treated with opioid drugs that reduce a person’s quality of life. A recently discovered drug might help patients by preventing bone pain by making new bone while stopping bone destruction caused by the tumor. A patient with stage IV breast cancer, who was in immense pain and could no longer be active, underwent treatment. She had widely distributed metastases from the breast cancer in her liver, lungs, brain and bones. The tumors had traveled to her spine causing immense pain, and she requested treatment with the experimental drug/device ZetaMet™. Via special permission from the US FDA, the patient received the experimental treatment, which has not been approved for use. After FDA approval for the experimental use of ZetaMet, tumors in three bones of the patient’s spine were treated.

What were the results?

2 years after treatments with ZetaMet for the tumors located in three different spinal bones, the patient is alive, and her pain has become manageable, leading to quality-of-life improvements and resumption of many routine daily activities, such as walking and spending time with family, despite the typical prognosis for this type of cancer (survival <6 months). Further, the treatment led the patient to electively reduce pain medication use by over fourfold, which decreases the serious risks and many complications posed by overuse.

What do the results suggest?

The experimental treatment, ZetaMet, has a great deal of promise in treating very sick patients with breast cancer that has spread to bone, improving quality of life and reducing pain medication.

Keywords::

• breast cancer
• lytic tumor
• spinal metastasis

Editorial assistance to prepare this manuscript for publication was provided by S Bublitz of MedVal Scientific Information Services, LLC, and was funded by Zetagen Therapeutics, Inc. Research reported in this publication was supported, in part, by the National Cancer Institute (NCI) of the National Institutes of Health (NIH) under awards R43CA221553 (BS Margulies) and R44CA221553 (BS Margulies). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Competing interests disclosure

The Authors declare no Competing Non-Financial Interests but declare the following Competing Financial Interests: N.T., J.C.L., and B.S.M. are employed by and have stock options in Zetagen Therapeutics. D.P. declares no competing financial interests. The authors have no other competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript apart from those disclosed.

Writing disclosure

Writing assistance was provided by Stephen Bublitz, ELS, of MedValScientific Information services, LLC, and funded by Zetagen therapeutics, Inc.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board (IRB) approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved. Further, studies were conducted consistent with the principles outlined in the National Institutes of Health (NIH) guidelines on the ethical conduct of research.

Data availability

All the data generated or analyzed during this study are included in this published article.

Ethics approval

Both procedures were reviewed and approved by Western IRB (Seattle WA; IRB# 20214825).

Additional information

Funding

Editorial assistance to prepare this manuscript for publication was provided by S Bublitz of MedVal Scientific Information Services, LLC, and was funded by Zetagen Therapeutics, Inc. Research reported in this publication was supported, in part, by the National Cancer Institute (NCI) of the National Institutes of Health (NIH) under awards R43CA221553 (BS Margulies) and R44CA221553 (BS Margulies). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.