Source: Lancet  |  Posted 11 years ago

NEW ORLEANS, LA -- May 23, 2000 -- Camptosar? (CAMP-to-sar) (irinotecan hydrochloride injection) (CPT-11) in combination with cisplatin increased survival compared with the current standard treatment for patients with extensive small-cell lung cancer, according to data from a Phase III study presented at the annual meeting of the American Society of Clinical Oncology (ASCO).
This randomized, multi-center Japanese trial, enrolled 154 patients and was designed with survival as the primary endpoint. Sixty percent of patients receiving Camptosar and cisplatin lived one year or longer compared with 40 percent of patients receiving standard treatment with etoposide and cisplatin. The study was stopped at a pre-planned interim analysis point due to the survival benefit in the Camptosar treatment group. Patients receiving the Camptosar regimen had a median survival of 390 days vs. 287 days for the comparator arm (p=0.0021). The two-year survival rate for patients receiving Camptosar and cisplatin was 19 percent compared with 6.5 percent for patients receiving the standard treatment.
"Treatment advances in small-cell lung cancer have been few and far between," said Nagahiro Saijo, M.D., Chairman of Medical Oncology at the National Cancer Center Hospital in Japan and of the Lung Cancer Study Group of the Japanese Clinical Oncology Group (JCOG). Dr. Saijo is the lead investigator of the lung cancer trial for Camptosar in Japan. "Significantly increased survival rates among patients being treated with Camptosar and cisplatin led us to halt the study early."
Lung cancer is the deadliest form of cancer and is the second most common type of cancer overall, accounting for 14 percent of all cancer diagnoses and 28 percent of all cancer deaths. It is estimated that 164,100 new cases of lung cancer will be diagnosed and that 156,900 people will die from the disease in the United States this year. Approximately 15 to 25 percent of all lung cancer is classified as small-cell.
Safety data from the Phase III study showed that patients receiving Camptosar and cisplatin experienced a 5 percent incidence of severe thrombocytopenia (reduction in blood platelets), a 27 percent incidence of severe leukopenia (reduction in white blood cells) and a 66 percent incidence of severe neutropenia (reduction in specialized white blood cells), all of which are serious side effects often associated with chemotherapy. Comparatively, patients receiving standard therapy of etoposide and cisplatin experienced a 19 percent incidence of severe thrombocytopenia, a 52 percent incidence of severe leukopenia and a 92 percent incidence of severe neutropenia. For the patients receiving Camptosar and cisplatin, this represents a 74 percent reduction in the incidence of thrombocytopenia, a 48 percent reduction in the incidence of leukopenia, and a 28 percent reduction in the incidence of severe neutropenia compared with patients receiving etoposide/cisplatin. Sixteen percent of patients receiving Camptosar experienced severe diarrhea compared with no patients in the standard therapy group. Other non-hematologic side effects did not differ between treatment arms.
"Camptosar was recently approved by the FDA for the first-line treatment of metastatic colorectal cancer based on its ability to improve survival," said Alan Sandler, M.D., Medical Director, Thoracic Oncology Program at Indiana University School of Medicine. "The results from this trial showed a significant survival benefit from Camptosar in extensive small-cell lung cancer. It's exciting to explore the spectrum of activity of this drug, especially in small-cell lung cancer where there are currently limited front- line chemotherapy options."
Camptosar, manufactured and marketed by Pharmacia Corporation, is currently being investigated for treatment of a wide variety of cancers including non-small-cell lung cancer, pancreatic cancer, brain tumors and ovarian cancer. The agent was recently approved by the United States Food and Drug Administration (FDA) as first-line therapy for the treatment of patients with advanced colorectal cancer (cancer that has spread beyond the colon or rectum) in combination with 5-FU and leucovorin (5-FU/LV). Camptosar is also marketed by Pharmacia in Canada, New Zealand, Australia and Latin America. The product is marketed in Japan by Yakult as Campto and by Daiichi as Topotecin.
Pharmacia Oncology is bringing discovery to life for every person touched by cancer. The current oncology portfolio includes Camptosar (irinotecan hydrochloride injection), Aromasin (exemestane tablets); Ellence/ Farmorubicin (epirubicin hydrochloride injection); Idamycin (idarubicin hydrochloride injection); and Zinecard (dexrazoxane injection). Products in development include signaling inhibitors SU5416 and SU6668 and other compounds for the treatment of patients with cancer occurring in various forms. Celecoxib, a COX-2 specific inhibitor, is currently in clinical trials to investigate its role in inhibiting the formation of colorectal cancer cells. Celebrex (celecoxib capsules), has been approved to reduce the number of adenomatous colorectal polyps in patients with familial adenomatous polyposis (FAP) as an adjunct to usual care (endoscopic surveillance and surgery). Celecoxib is also being investigated across a variety of human tumors.
Pharmacia Corporation is a leading global pharmaceutical company created through the merger of Pharmacia & Upjohn and Monsanto Company with its G.D. Searle & Co. unit. Pharmacia has a broad product portfolio, a robust pipeline of new drugs, and an annual investment of more than $2 billion in pharmaceutical research and development.
Related Links: [Camptosar (irinotecan hydrochloride injection)], [cisplatin] and [Pharmacia Corporation]
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