Doxorubicin Hydrochloride and Caffeine

• Generic Name: doxorubicin
• Dosage Forms: n.a.
• Other Brand Names: Adriamycin, Adriamycin RDF, Rubex, Adriamycin PFS

Conventional doxorubicin: Treatment (in combination with other antineoplastic agents) of breast cancer.

Combination chemotherapy, as adjunct to surgery, increases disease-free (i.e., decreased recurrence) and overall survival in premenopausal and postmenopausal women with node-negative or -positive early (TNM stage I or II) breast cancer.

Adjuvant combination chemotherapy that includes cyclophosphamide, methotrexate, and fluorouracil has been used most extensively and is considered a regimen of choice for early breast cancer, but doxorubicin-containing regimens (e.g., combined cyclophosphamide and doxorubicin with or without fluorouracil; combined cyclophosphamide and doxorubicin with or without tamoxifen) appear to be comparably effective and also are considered regimens of choice; differences in toxicity profiles may influence choice of regimen.

In stage III (locally advanced) breast cancer, commonly employed effective regimens (with or without hormonal therapy) used sequentially after surgery and radiation therapy for operable disease and after biopsy and radiation therapy for inoperable disease include cyclophosphamide, methotrexate, and fluorouracil; cyclophosphamide, doxorubicin, and fluorouracil; and cyclophosphamide, methotrexate, fluorouracil, and prednisone; combined cyclophosphamide and doxorubicin therapy also has been used. These and other regimens have been used in treatment of more advanced (stage IV) and recurrent disease.

Conventional doxorubicin: Has been used alone or in combination chemotherapy for the palliative treatment of AIDS-related Kaposi’s sarcoma.

Liposomal doxorubicin: Palliative treatment of AIDS-related Kaposi’s sarcoma in adults intolerant to combination chemotherapy or whose disease has progressed while receiving such therapy.

Combination chemotherapy that includes conventional doxorubicin (with bleomycin and vincristine) has been a preferred regimen, but many clinicians currently consider a liposomal anthracycline (doxorubicin or daunorubicin) the first-line therapy of choice for advanced AIDS-related Kaposi’s sarcoma.

Conventional doxorubicin: Has been used in treatment (in combination chemotherapy regimens) of ovarian carcinoma, but other agents currently are preferred.

Liposomal doxorubicin: Palliative treatment of metastatic ovarian carcinoma that is refractory to both paclitaxel- and platinum-based chemotherapy regimens (designated an orphan drug by FDA for this use).

Further study is needed to establish role of liposomal doxorubicin in the treatment of advanced epithelial ovarian cancer.

Conventional doxorubicin: Treatment (in combination regimens with cisplatin, methotrexate, and vinblastine) of invasive and advanced bladder carcinoma.

Has been used intravesically for treatment of residual tumor and/or as adjuvant therapy for prophylaxis of superficial bladder carcinoma.

Evidence is limited, but other agents (e.g. mitomycin, epirubicin) appear to be similar in efficacy but less toxic than doxorubicin and generally are preferred for prophylaxis or treatment of superficial bladder cancer.

Conventional doxorubicin: Treatment (in combination chemotherapy regimens) of extensive-stage small cell lung cancer.

Conventional or liposomal doxorubicin: Use with bortezomib and dexamethasone may be considered a reasonable choice (accepted, with possible conditions) as induction therapy for newly diagnosed multiple myeloma in transplant-eligible patients (see Dosage under Dosage and Administration); however, in the absence of longer follow-up data, use of a modified bortezomib-liposomal doxorubicin-dexamethasone regimen using reduced liposomal doxorubicin and bortezomib dosages is not fully established because of unclear risk/benefit and/or inadequate experience. Consider performance status and preexisting conditions (e.g., peripheral neuropathy) when selecting a combination chemotherapy regimen.

Conventional doxorubicin: Used in combination therapy (with vincristine and high-dose dexamethasone) for refractory multiple myeloma.

Conventional doxorubicin: Treatment of solid tumors including thyroid carcinoma, gastric carcinoma, soft-tissue and osteogenic sarcomas, neuroblastoma, and Wilms' tumor; malignant lymphomas of both Hodgkin and non-Hodgkin type; and acute lymphocytic (lymphoblastic) leukemia.

Conventional doxorubicin: Treatment of carcinoid tumors, hepatoblastoma, and retinoblastoma.

Conventional doxorubicin: Treatment of Ewing’s sarcoma, squamous cell carcinoma of the cervix and prostate, and uterine cancer.

Although conventional doxorubicin is labeled for use in the treatment of AML, other agents are preferred.