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Study: Erlotinib (Tarceva) May Prolong Survival in Women With Cervical Cancer

Treatment is indicated for NSCLC and pancreatic cancer in U.S.

A new clinical study has found that erlotinib (Tarceva, Genentech/Astellas Oncology), a targeted antitumor agent, has the potential to improve treatment for cervical cancer. Published online in Cancer, a journal of the American Cancer Society, the results indicate that larger trials are warranted to determine whether the drug should become part of standard therapy for women with this disease.

Nearly half a million new cases of cervical cancer are reported worldwide each year, making it the third most common cancer among women. Despite the widespread use of screening programs and the recent advent of vaccines against human papilloma virus, cervical cancer continues to be a significant public health problem.

Cisplatin-based chemoradiation is the standard therapy for locally advanced cervical cancer. Unfortunately, treatment responses are unpredictable and often brief. A potentially promising new treatment strategy involves targeting the epithelial growth factor receptor (EGFR), which is often over-expressed in cervical cancer. Inhibiting this receptor is known to have antitumor effects against a variety of cancers.

Angélica Nogueira-Rodrigues, MD, PhD, of the Brazilian National Cancer Institute, and her colleagues designed a phase II clinical trial to test the potential of the EFGR inhibitor erlotinib combined with chemoradiation therapy in 36 women with cervical cancer. The median duration of therapy was 77 days, and the median follow-up period was 59.3 months.

Overall, the therapy was well tolerated, and 34 patients (94.4%) achieved a complete response (i.e., the disappearance of all cancerous lesions). After 2 years, 91.7% of the women were alive, and 80.6% percent experienced no progression of their disease. After 3 years, 80% of the women were alive, and 73.8% experienced no disease progression.

“While cervical cancer is a neglected disease, and very few clinical trials have been reported in the last 10 years, some groups, including ours, have reported that its biology might be prone to targeted therapy,” said Nogueira-Rodrigues. “To the best of our knowledge, this is the first study to present that a targeted agent has promising activity in the management of locally advanced cervical disease.”

She also remarked that targeted therapy may be added to the standard treatment for locally advanced cervical cancer if randomized trials confirm the new study’s results.

Epidermal growth factor receptors (EGFRs) are expressed on the cell surface of both normal and cancer cells. In some tumor cells, signaling through this receptor plays a role in tumor cell survival and proliferation irrespective of the EGFR gene mutation status. Erlotinib reversibly inhibits the kinase activity of EGFRs, preventing autophosphorylation of tyrosine residue associated with the receptor and thereby inhibiting further downstream signaling.

In the U.S., Tarceva (erlotinib) is approved for first-fine therapy, maintenance therapy, and second- or third-line therapy of advanced non–small-cell lung cancer (NSCLC):

  • Tarceva is prescribed as first-line treatment for patients with metastatic NSCLC that has certain types of EGFR mutations.
  • Tarceva is prescribed as maintenance treatment for patients with advanced-stage NSCLC whose cancer has not spread or grown after initial treatment with certain types of chemotherapy.
  • Tarceva is prescribed as second- or third-line treatment for patients with advanced-stage NSCLC whose cancer has spread or grown after receiving at least one chemotherapy regimen.

Tarceva, in combination with gemcitabine, is also prescribed for patients with advanced-stage pancreatic cancer whose cancer has spread, grown, or cannot be surgically removed and who have not received previous chemotherapy.

Sources: Wiley; March 10, 2014; and Tarceva Package Insert; October, 2013.

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