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Pancreatic Cancer

A cornerstone of therapy

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.

GEMZAR has shown:

  • Efficacy for first-line locally advanced (nonresectable) or metastatic pancreatic cancer
  • Improvement in clinical benefit response*1
  • Improved survival1
  • Consistent, proven efficacy across a large body of randomized trials2-20

* Clinical benefit response was the primary endpoint of this pivotal study and is defined as a measure of clinical improvement based on analgesic consumption, pain intensity, performance status, and weight change.

About Pancreatic Cancer

According to the American Cancer Society (ACS), more than 42,000 Americans will be diagnosed with pancreatic cancer during 2009. Approximately 35,000 Americans died of pancreatic cancer in 2008, making pancreatic cancer the fourth leading cause of cancer death overall.21

Pancreatic cancer is the fourth leading cause of cancer death overall in the United States.21

The ACS also estimates that the lifetime risk of developing pancreatic cancer is about 1 in 76 and is about the same for both men and
women. 21 A person's risk may be altered by certain risk factors, including age, smoking, and diet.22

More than half of pancreatic cancers have metastasized at the time of diagnosis, with only 8% localized. Almost all pancreatic cancers are adenocarcinomas of the ductal epithelium, symptoms primarily caused by mass effect rather than disruption of exocrine or endocrine function.23

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:

  1. GEMZAR (gemcitabine HCl for injection) [package insert]. Indianapolis, IN: Eli Lilly and Company; 2007.
  2. Br J Cancer. 2002;87(2):161-167.
  3. Cancer. 2002;94(4):902-910.
  4. J Chemotherapy. 2004;16(6):589-594.
  5. Proc Am Soc Clin Oncol. 2004;22(14 suppl). Abstract 4006.
  6. J Clin Oncol. 2004;22(18):3776-3783.
  7. J Clin Oncol. 2004;22(8):1430-1438.
  8. Proc Am Soc Clin Oncol. 2005;23(16 suppl). Abstract 4010.
  9. J Clin Oncol. 2005;23(15):3509-3516.
  10. Proc Am Soc Clin Oncol. 2005;23(16 suppl). Abstract 1.
  11. Lancet Oncol. 2005;6:369-376.
  12. J Clin Oncol. 1997;15(6):2403-2413.
  13. J Clin Oncol. 2001;19(15):3447-3455.
  14. J Clin Oncol. 2003;21(17):3296-3302.
  15. Eur J Cancer. 2003;39:1377-1383.
  16. Proc Am Soc Clin Oncol. 2004;22(14 suppl). Abstract 4005.
  17. Proc Am Soc Clin Oncol. 2004;22(14 suppl). Abstract 4118.
  18. Proc Am Soc Clin Oncol. 2005;23(16 suppl). Abstract 4009.
  19. Br J Cancer. 2006;95(5):587-592.
  20. J Clin Oncol. 2006;24(27):4441-4447.
  21. American Cancer Society. What are the Key Statistics About Cancer of the Pancreas? Available at:
    http://www.cancer.org/docroot/CRI/content/CRI_2_4_1X_What_are_the_key_statistics_for_pancreatic_cancer_34.asp. Accessed August 6, 2009.
  22. American Cancer Society. What are the Risk Factors for Cancer of the Pancreas? Available at:
    http://www.cancer.org/docroot/CRI/content/CRI_2_4_2X_What_are_the_risk_factors_for_pancreatic_cancer_34.asp?rnav=cri. Accessed August 6, 2009.
  23. American Family Physician. 2006:75(3):485-492.
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