BlueCross BlueShield of Tennessee Medical Policy Manual

Hematopoietic Stem Cell Transplant for Breast Cancer

DESCRIPTION

Hematopoietic stem cell transplantation (HSCT) refers to a procedure in which hematopoietic stem cells are infused to restore bone marrow function in cancer patients who receive bone marrow-toxic doses of cytotoxic drugs with or without whole body radiation therapy. Hematopoietic stem cells may be obtained from the transplant recipient (autologous HSCT) or from a donor (allogeneic HSCT). They can be harvested from bone marrow, peripheral blood, or umbilical cord blood shortly after delivery of neonates.

The success of autologous HSCT is predicated on the ability of cytotoxic chemotherapy with or without radiation to eradicate cancerous cells from the blood and bone marrow. This permits subsequent engraftment and repopulation of bone marrow space with presumably normal hematopoietic stem cells obtained from the patient prior to undergoing bone marrow ablation. As a consequence, autologous HSCT is typically performed as consolidation therapy when the patient’s disease is in complete remission.

Breast cancer forms in tissues of the breast, usually the ducts and lobules and occurs in both men and women. For individuals with stage I and II disease, breast conservation and modified radical mastectomy are the therapeutic options. Adjuvant therapy with cytotoxic drugs or endocrine treatment, or both, is recommended for individuals with node-positive disease. Multimodality therapy (chemotherapy, surgery, and radiation) is recommended for virtually all individuals with locally advanced disease. Although a small percentage of patients with metastatic breast cancer achieve long-term disease-free survival, this stage of disease essentially is not curable, and therapy is largely palliative. A wide range of systemic, local, and supportive therapies are available for the palliation of metastatic breast cancer.

POLICY

• Single or tandem autologous hematopoietic stem-cell transplantation to treat any stage of breast cancer is considered not medically necessary.

• Allogeneic hematopoietic stem-cell transplantation to treat any stage of breast cancer is considered investigational.

See also:

• Autologous Hematopoietic Stem-Cell Transplantation for Malignant Astrocytomas and Gliomas

• Donor Lymphocyte Infusion for Hematologic Malignancies Treated with an Allogeneic Hematopoietic Stem-Cell Transplant

• Hematopoietic Stem Cell Transplantation for Central Nervous System Embryonal and Ependymoma Tumors

• Hematopoietic Stem-Cell Transplantation for Miscellaneous Solid Tumors in Adults

• Hematopoietic Stem Cell Transplantation in the Treatment of Germ Cell Tumors

• High Dose Chemotherapy with Autologous Stem-Cell Transplant for Primary Amyloid Light-Chain (AL) Amyloidosis

• High Dose (Myeloablative) Chemotherapy with Bone Marrow, Peripheral Stem Cell, or Cord Blood Transplant for Hematopoietic Stem Cell Support

• Nonmyeloablative Allogeneic Stem Cell Transplantation (Reduced Intensity Stem Cell Transplant) for Treatment of Malignancy

• Pancreas / Pancreas-Kidney / Pancreatic Islet Cell Transplantation

• Tandem High Dose Chemotherapy with Hematopoietic Stem Cell Support

IMPORTANT REMINDERS

• Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.

• We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION

In the late 1980s/early 1990s, initial results of phase II trials for breast cancer and autologous hematopoietic stem-cell transplant (HSCT) were promising, showing high response rates in patients with metastatic disease who underwent high-dose consolidation. In the early 1990s, larger prospective comparisons of conventional-dose chemotherapy to high-dose therapy with SCT were initiated but accrued slowly, with up to a decade from initiation to the reporting of results. In the interim the treatment became almost standard of care, with many individuals receiving high-dose therapy off protocol, further reducing accrual to ongoing randomized trials. The results of the randomized trials were presented beginning in 1999, and showed little survival benefit; subsequently, this treatment modality has been abandoned as an approach to breast cancer.

HSCT in the treatment of solid tumors continues to be largely experimental with the realization that dose intensification fails to improve survival. With the advent of reduced-intensity allogeneic transplant there is interest in exploring alloreactivity to metastatic solid tumors via the graft versus donor effect. of donor derived T-cells.

SOURCES

Blue Cross BlueShield Association. Medical Policy Reference Manual. (1:2012). Hematopoietic stem cell transplantation for the treatment of breast cancer (8.01.27) Retrieved January 11, 2013 from Blue Web. (22 articles and/or guidelines reviewed)

Cancer Care Ontario. Program in Evidence-based Care. (2009, January) Stem cell transplantation in adults: Recommendations. Retrieved March 3, 2011 from http://www.guideline.gov/content.aspx?id=14435&search=stem+cell.

Mayer E., Burstein, H. (2007) Chemotherapy for breast cancer. Hematology/Oncology Clinics of North America. 21 (2), 257-272. (Level 1 Evidence)

Zander, A., Schmoor, C., Kroger, N., Mobus, V., Frickhofen, N., Metzner, B. et al. (2008) Randomized trial of high-dose adjuvant chemotherapy with autologous hematopoietic stem-cell support versus standard-dose chemotherapy in breast cancer patients with 10 or more positive lymph nodes: Overall survival after 6 years of follow-up. Annals of Oncology.19 (6), 1082-1089. (Level 1 Evidence)

ORIGINAL EFFECTIVE DATE: 7/9/2011

MOST RECENT REVIEW DATE:  2/14/2013

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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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