(RxWiki News) It’s always exciting when clinical trials show positive results for a new cancer treatment. An international phase lll trial did just that.
This trial demonstrated that a new therapy helps stomach (gastric) cancer patients live longer.
Ramucirumab works as a second-line therapy after initial chemotherapy to slow the growth of this aggressive cancer by attacking molecules that feeds the tumor.
"See a doctor if you have consistent stomach pain."
Josep Tabernero, MD, head of the Medical Oncology Department at the Vall d´Hebron University Hospital, and director of the Vall d´Hebron Institute of Oncology (VHIO) in Barcelona, Spain, and colleagues from around the world, conducted the study.
“Gastric cancer is a common cancer worldwide, and in the United States, most patients unfortunately present with metastatic disease," Alok A. Khorana, MD, director of the Gastrointestinal Malignancies Program at Taussig Cancer Institute of the Cleveland Clinic and vice-chair for Clinical Services at Taussig Cancer Institute, told dailyRx News.
"There have been few new drugs or regimens developed for this cancer in the past decade," Dr. Khorana added.
Ramucirumab is an antibody that was developed to treat solid tumors. It targets vascular endothelial growth factor receptor-2 (VEGFR-2). VEGFR-2 plays a key role in angiogenesis, which is the formation of blood vessels that nourish tumors and help them grow.
This trial involved 355 advanced gastric cancer patients from 119 centers in 29 countries in North America, Central and South America, Europe, Asia, Australia and Africa.
The patients in the groups were randomly assigned - 238 were treated with ramucirumab and 117 were given a placebo (sugar pill).
All of the patients had previously been treated with chemotherapy, which is the standard first-line therapy for gastric cancer. Patients typically live 8-10 months after undergoing chemotherapy, and there is currently no second-line therapy for this cancer. The patients also received supportive care to treat disease symptoms.
Ramucirumab treatment in these patients had the following results:
- Median survival was 5.2 months compared to 3.8 months for those who received a placebo.
- Six-month overall survival was 41.8 percent in the treated group and 31.6 percent in the untreated group.
- After 12 months, 17.8 percent of individuals given ramucirumab were still alive, in contrast to 11.8 percent of the patients who were given a placebo.
Participants who received ramucirumab had higher rates of high blood pressure than did those who were on placebo – 16 percent compared to 8 percent. Other adverse side effects were similar among the groups.
"The results of this novel compound demonstrate that targeted therapeutics can be effective in this cancer as well; previously, such studies targeting the angiogenesis pathway had failed in this setting," Dr. Khorana said.
"Ramucirumab represents an important new option for patients suffering from this difficult disease,” said Dr. Khorana, who was not involved in the study.
Gastric cancer will be diagnosed in an estimated 21,500 Americans this year, and the disease will cause some 11,000 deaths. It's the fourth most common cancer worldwide.
This study was published October 2 in The Lancet.
ImClone Systems funded the research. A number of the authors disclosed financial relationships with pharmaceutical companies and other commercial enterprises.