Addition of Tarceva® to Gemzar® Improves Survival in Pancreatic Cancer

Addition of Tarceva® to Gemzar® Improves Survival in Pancreatic Cancer.

According to an early online publication in the Journal of Clinical Oncology, the addition of the targeted agent Tarceva® (erlotinib) to Gemzar® (gemcitabine) improves survival in patients with advanced pancreatic cancer.

The pancreas is an organ surrounded by the stomach, small intestine, bile ducts (tubes that connect the liver to the small intestine), gallbladder, liver, and spleen. The pancreas helps the body break down food and also produces hormones, such as insulin, to regulate the bodys storage and use of food.

Pancreatic cancer has one of the highest mortality rates of all cancers. Pancreatic cancer is often called a silent killer because its symptoms are usually not recognizable until it has advanced and spread outside the pancreas. As a result, the majority of pancreatic cancers are not diagnosed until they have reached advanced stages and are considered incurable. Researchers continue to evaluate novel ways to treat pancreatic cancer in order to improve overall survival duration for these patients.

Tarceva is an agent that is targeted against the human epidermal growth factor receptor pathway 1 (HER1), which is involved in cellular growth and replication. In various types of cancers, the HER1 pathway is mutated (abnormal) or overexpressed, resulting in uncontrolled cellular growth. Tarceva targets the HER1 pathway and reduces or prevents the uncontrolled growth and replication of these cancer cells through this pathway.

Researchers from medical institutions around the world recently conducted a Phase III (phase of trial prior to FDA review) clinical trial evaluating Tarceva in the treatment of pancreatic cancer. This trial included 569 patients with advanced pancreatic cancer who were not eligible to have their cancer surgically removed. Patients were treated with either Tarceva plus Gemzar (the standard chemotherapy agent for the treatment of pancreatic cancer) or Gemzar plus placebo (inactive substitute).

  • At one year survival was 23% for patients treated with Tarceva/Gemzar compared with only 17% for patients treated with Gemzar alone.
  • More patients treated with Tarceva/Gemzar achieved stabilization of their disease compared with those treated with Gemzar alone.
  • Patients treated with Tarceva/Gemzar had a higher incidence of side effects; however, most of the side effects were mild.

The researchers concluded that the addition of Tarceva to Gemzar improves survival compared to Gemzar alone among patients with advanced pancreatic cancer. The authors state, To our knowledge, this randomized Phase III trial is the first to demonstrate statistically significantly improved survival in advanced pancreatic cancer by adding any agent to gemcitabine.

Reference: Moore M, Goldstein D, Hamm J, et al. Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a Phase III trial of the National Cancer Institute of Canada Clinical Trials Group. Journal of Clinical Oncology [early online publication]. April 23, 2007. DOI: 10.1200/JCO.2006.07.9525.

Related News:FDA Approves Tarceva® in Combination with Gemzar® for Pancreatic Cancer(11/03/2005)

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Addition of Tarceva to Gemzar® Improves Survival in Pancreatic Cancer

Addition of Tarceva to Gemzar® Improves Survival in Pancreatic Cancer

According to results recently presented at the 2005 annual meeting of the American Society of Clinical Oncology, researchers have found that the combination of the drugs Tarceva and Gemzar improves survival among patients with inoperable pancreatic cancer.

The pancreas is gland located in the abdomen and is responsible for producing juices that help digest foods, as well as the hormones glucagon and insulin, both of which help regulate blood sugar levels. Pancreatic cancer is a malignancy associated with the tissues of the pancreas. Pancreatic cancer is the fourth leading cause of cancer deaths in the United States. Unfortunately in most cases pancreatic cancer is not curable and in only some cases is pancreatic cancer operable. Current treatment options for pancreatic cancer include surgery, radiation and chemotherapy. Although single-agent chemotherapy with Gemzar® remains the standard treatment for pancreatic cancer, research has increasingly focused on combination chemotherapy regimens compared to treatment with Gemzar alone. Epidermal growth factor receptor (EGFR) is a protein commonly found in pancreatic cancer cells. Tarceva is a different type of chemotherapy that is taken orally and acts to disrupt cell growth by targeting EGFR.

Canadian researchers conducted this recent phase III, randomized trial to evaluate the effectiveness of Tarceva in the treatment of pancreatic cancer. This study included 569 patients diagnosed with inoperable pancreatic cancer that had not received prior chemotherapy other than that received during concurrent radiation therapy. The presence of epidermal growth factor receptors was not a factor in eligibility for the study. Patients were randomized to receive either Gemzar (1000mg/m2 IV weekly for 7 of 8 weeks, followed by weekly for 3 of 4 weeks) along with Tarceva 100 mg daily (521 patients) or placebo. Initially, patients were treated with Tarceva 100 mg daily, which was extremely well tolerated, so researchers increased the dose to 150mg daily for patients who enrolled at a later date (48 patients).

Overall survival and progression-free survival was significantly improved among the patients who received the combination of Gemzar and Tarceva. One-year survival rates for the Tarceva treatment group was 24%, compared to 17% in the placebo group. Extensive analysis revealed that Tarceva was also associated with an increased progression-free survival. Tumor control rates (complete response/partial response/stable disease) were 57% for the Tarceva group and 49% for the control group. There were no differences in the complete plus partial response rates between the two groups (9%) but there were more patients with stable disease in the Tarceva group. Side effects associated with Tarceva included a mild rash, diarrhea, and alteration of blood counts. However, patients treated with Tarceva who developed a mild to moderate rash had an increased average survival rate, as well as an increased one-year survival rate compared to patients who had no rash or minimal rash symptoms.

Researchers concluded that the addition of Tarceva to Gemzar significantly improved survival outcomes for patients with inoperable pancreatic cancer when compared to treatment with Gemzar alone. Further studies to evaluate the association between EGFR status and response to Tarceva are underway.

Reference: Moore M, Goldstein D, Hamm J, et al. Ertlotinib plus gemcitabine compared to gemcitabine alone in patients with advanced pancreatic cancer. A phase III trial of the National Cancer Institute of Canada Clinical Trials Group (NCIC-CTG). Proceedings from the 2005 annual meeting of the American Society of Clinical Oncology. Presented at the plenary session May 14, 2005. Abstract #1.

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