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Metastatic Breast Cancer GEMZAR in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. About Breast Cancer Breast cancer is the leading cause of cancer death in women, second only to lung cancer. In 2009, more than 40,000 women will die from breast cancer in the United States.¹ According to the American Cancer Society (ACS), breast cancer is the second leading cause of cancer death in women, second only to lung cancer. In 2009, more than 40,000 women will die from breast cancer in the United States. The chance that breast cancer will be responsible for a woman's death is about 1 in 35 (about 3%).¹ The ACS also estimates that in 2009, more than 192,000 new cases of invasive breast cancer will be diagnosed among women in the United States. The chance of developing invasive breast cancer at some time in a woman’s life is about 1 in 8 or 12%.¹ Metastatic breast cancer ultimately develops in 35% to 40% of all patients with breast cancer. Anthracyclines are now used earlier in the course of therapy, and are usually a part of adjuvant therapy. Disease resistance to or disease progression after anthracycline therapy may necessitate subsequent therapy.² First Chance for Response In the treatment of metastatic breast cancer, the likelihood of response decreases with each subsequent line of therapy. In general, response rates diminish by half for use of the agents as second and third-line treatment, although there is great variability among trials. This graphic is provided to illustrate the likelihood of response by extent of prior treatment and assumes an initial response of 60%. Myelosuppression is usually the dose-limiting toxicity with GEMZAR therapy. For safety and dosing guidelines, see complete Warnings, Precautions, Adverse Reactions, and Dosage and Administration sections in the full Prescribing Information.
Indications and Important Safety Information for GEMZAR Indications GEMZAR in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. GEMZAR is indicated in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (stage IIIA or IIIB), or metastatic (stage IV) non-small cell lung cancer. GEMZAR in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. GEMZAR is indicated as first-line treatment for patients with locally advanced (nonresectable stage II or stage III) or metastatic (stage IV) adenocarcinoma of the pancreas. GEMZAR is indicated for patients previously treated with 5-FU. Important Safety Information Myelosuppression is usually the dose-limiting toxicity with GEMZAR therapy. Contraindication Known hypersensitivity to GEMZAR. Warnings Infusion times of GEMZAR longer than 60 minutes and more frequent than weekly dosing have been shown to increase toxicity. Pulmonary toxicity has been reported. In cases of severe lung toxicity, GEMZAR therapy should be discontinued immediately and appropriate supportive care measures instituted. Hemolytic Uremic Syndrome (HUS) and/or renal failure have been reported following one or more doses of GEMZAR. Renal failure leading to death or requiring dialysis, despite discontinuation of therapy, has been rarely reported. The majority of the cases of renal failure leading to death were due to HUS. Serious hepatotoxicity, including liver failure and death, has been reported very rarely in patients receiving GEMZAR alone or in combination with other potentially hepatotoxic drugs. GEMZAR is Pregnancy Category D. GEMZAR can cause fetal harm when administered to a pregnant woman. Precautions Use caution in patients with pre-existing renal impairment or hepatic insufficiency. Administration of GEMZAR may exacerbate underlying hepatic insufficiency. The optimum regimen for safe administration of GEMZAR with therapeutic doses of radiation has not yet been determined in all tumor types. GEMZAR has radiosensitizing activity and radiation recall reactions have been reported. It is not known whether GEMZAR or its metabolites are excreted in human milk. The effectiveness of GEMZAR in pediatric patients has not been demonstrated. The toxicities of GEMZAR observed in pediatric patients were similar to those reported in adults. GEMZAR clearance is affected by age as well as gender. Patients receiving therapy with GEMZAR should be monitored closely by a physician experienced in the use of cancer chemotherapeutic agents. Monitoring and Dosage Modifications Dosage adjustments for hematologic toxicity may be required. Serum creatinine, potassium, calcium, and magnesium should be monitored during combination therapy with cisplatin. Patients should be assessed with a CBC, including differential and platelet count, prior to each dose of GEMZAR. Modify or suspend therapy according to the Dosage Reduction Guidelines in the full Prescribing Information. Hepatic and renal function (including transaminases and serum creatinine) should be evaluated prior to therapy with GEMZAR and periodically thereafter. Abbreviated Adverse Events (% incidence) for GEMZAR in Advanced Recurrent Ovarian Cancer The most severe adverse events (grades 3/4) with GEMZAR plus carboplatin versus carboplatin alone, respectively, for the treatment of patients with advanced ovarian cancer were neutropenia (71 vs 12); thrombocytopenia (35 vs 11); leukopenia (53 vs 7); anemia (28 vs 11); nausea (6 vs 3); vomiting (6 vs 3); and constipation (7 vs 3). The most common adverse events (all grades) were neutropenia (90 vs 58); leukopenia (86 vs 70); anemia (86 vs 75); thrombocytopenia (78 vs 57); RBC transfusion (38 vs 15); alopecia (49 vs 17); neuropathy/sensory (29 vs 27); nausea (69 vs 61); fatigue (40 vs 32); vomiting (46 vs 36); diarrhea (25 vs 14); and constipation (42 vs 37). Abbreviated Adverse Events (% incidence) for GEMZAR in 1st-line Advanced NSCLC The most severe adverse events (grades 3/4) with GEMZAR plus cisplatin for the first-line treatment of patients with NSCLC in comparative trials of a 28-day regimen (GEMZAR plus cisplatin versus cisplatin alone) and a 21-day regimen (GEMZAR plus cisplatin versus etoposide plus cisplatin), respectively, were neutropenia (57 vs 4, 64 vs 76); thrombocytopenia (50 vs 4, 55 vs 13); leukopenia (46 vs 3, 29 vs 43); anemia (25 vs 7, 22 vs 15); nausea 28d (27 vs 21); vomiting 28d (23 vs 19); nausea/vomiting 21d (39 vs 26); neuromotor 28d (12 vs 3); hypomagnesemia 28d (7 vs 2); neurohearing 28d (6 vs 6); creatinine elevation 28d (5 vs 3); and dyspnea (7 vs 5, 1 vs 0). The most common adverse events (all grades) of the 28-day regimen (GEMZAR plus cisplatin versus cisplatin alone) and the 21-day regimen (GEMZAR plus cisplatin versus etoposide plus cisplatin), respectively, were anemia (89 vs 67, 88 vs 77); leukopenia (82 vs 25, 86 vs 87); neutropenia (79 vs 20, 88 vs 87); thrombocytopenia (85 vs 13, 81 vs 45); lymphocytopenia 28d (75 vs 51); hematuria (15 vs 13, 22 vs 10); creatinine 28d (38 vs 31); hyperglycemia 28d (30 vs 23); hypomagnesemia 28d (30 vs 17); nausea 28d (93 vs 87); vomiting 28d (78 vs 71); nausea and vomiting 21d (96 vs 86); alopecia (53 vs 33, 77 vs 92); neuromotor 28d (35 vs 15); constipation (28 vs 21, 17 vs 15); neurohearing 28d (25 vs 21); paresthesias 21d (38 vs 16); and infection (18 vs 12, 28 vs 21). Abbreviated Adverse Events (% incidence) for GEMZAR in 1st-line Metastatic Breast Cancer The most severe adverse events (grades 3/4) with GEMZAR plus paclitaxel versus paclitaxel alone, respectively, for the treatment of patients with metastatic breast cancer were neutropenia (48 vs 11); alopecia (18 vs 22); leukopenia (11 vs 2); anemia (7 vs 4); fatigue (7 vs 2); thrombocytopenia (6 vs 2); ALT elevation (6 vs 1); and neuropathy-sensory (6 vs 3). The most common adverse events (all grades) were alopecia (90 vs 92); anemia (69 vs 51); neutropenia (69 vs 31); neuropathy-sensory (64 vs 58); nausea (50 vs 31); fatigue (40 vs 28); myalgia (33 vs 33); vomiting (29 vs 15); and thrombocytopenia (26 vs 7). Abbreviated Adverse Events (% incidence) for GEMZAR in 1st-line Advanced Pancreatic Cancer The most severe adverse events (grades 3/4) with GEMZAR versus 5-FU for the first-line treatment of patients with pancreatic cancer and data reported from a single-agent safety database, respectively, were neutropenia (26 vs 5, 24); alkaline phosphatase elevation (16 vs 17, 20); AST elevation (12 vs 2, 17); nausea/vomiting (13 vs 5, 12); ALT elevation (10 vs 0, 11); anemia (10 vs 0, 10); leukopenia (10 vs 2, 9); thrombocytopenia (10 vs 2, 8); bilirubin elevation (4 vs 9, 8); and pain (2 vs 0, 7). The most common adverse events (all grades) were AST elevation (72 vs 52, 78); alkaline phosphatase elevation (71 vs 64, 77); anemia (65 vs 45, 73); ALT elevation (72 vs 38, 72); leukopenia (71 vs 15, 64); nausea and vomiting (64 vs 58, 71); neutropenia (62 vs 18, 61); thrombocytopenia (47 vs 15, 36); pain (10 vs 7, 42); fever (30 vs 16, 38); proteinuria (10 vs 2, 32); constipation (10 vs 11, 31); diarrhea (24 vs 31, 30); rash (24 vs 13, 28); and bilirubin elevation (16 vs 25, 26). For safety and dosing guidelines, see complete Warnings, Precautions, Adverse Reactions, and Dosage and Administration sections in the full Prescribing Information. SG24 References: American Cancer Society. What are the Key Statistics for Breast Cancer? Available at: http://www.cancer.org/docroot/CRI/content/CRI_2_4_1X_What_are_the_key_statistics_for_breast_cancer_5.asp. Accessed August 6, 2009. The Oncologist. 2002;7(suppl 6):4-12. Cancer: Principles and Practice of Oncology. 7th ed. Lippincott Williams & Wilkins; 2005:1459.

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