Phase II Study Results of Celecoxib Combined with Standard Chemotherapy Presented at ASCO
May 21, 2002
Researchers at NewYork-Presbyterian Hospital's Weill Cornell Medical Center today announced initial phase II study results that suggest the addition of celecoxib (CELEBREX®) to paclitaxel/carboplatin, a common chemotherapy regimen, contributed to a clinical response in non-small cell lung cancer patients prior to surgery. These data were presented today at the American Society of Clinical Oncology Meeting in Orlando, FL.
The study was designed to evaluate the preoperative tumor response of 25 enrolled patients. Seventeen patients showed a clinical response and eight patients demonstrated stable disease. Overall, these response rates were significant when compared to those reported in previous studies of paclitaxel/carboplatin alone for the treatment of non-small-cell lung cancer (56 percent and six percent, respectively). The findings also showed that this combination therapy resulted in > 95 percent tumor cell death in 28 percent of patients' tumors. No unexpected side effects were seen. Events related to celecoxib included three allergic skin reactions and eight cases of dyspepsia.
"We're encouraged by these findings that support our continued study of celecoxib to complement lung-cancer treatments given to shrink tumor size prior to surgery," said Nasser K. Altorki, M.D., Director, Division of Thoracic Surgery, at NewYork-Presbyterian Hospital's Weill Cornell Medical Center.
Studies have shown that elevated levels of the cyclooxygenase-2 (COX-2) enzyme are present in more than 80 percent of lung tumors, leading scientists to believe that the COX-2 enzyme is a notable molecular target for new cancer treatment approaches. Celecoxib specifically blocks the COX-2 enzyme. Researchers are exploring how celecoxib stimulates the death of cancer cells while generally not harming healthy cells. Laboratory studies show that celecoxib inhibits angiogenesis—the process by which tumors create new blood vessels needed to obtain nutrients for their growth and spread.
This year, an estimated 170,000 Americans will be diagnosed with lung cancer—155,000 of whom will die during 2002.1 In fact more Americans die each year from lung cancer than from breast, prostate, and colorectal cancers combined. Non-small-cell lung cancer is the most aggressive type of lung cancer, and results of standard treatment are poor in all but the most localized cases. In fact, according to the National Cancer Institute, all newly diagnosed patients with non-small-cell lung cancer are potential candidates for studies evaluating new forms of treatment.2
Celecoxib is the COX-2 specific inhibitor approved in the U.S. for the treatment of osteoarthritis (OA), adult rheumatoid arthritis (RA), and the management of acute pain and primary dysmenorrhea in adults. In addition, celecoxib is approved to reduce the number of adenomatous colorectal polyps in familial adenomatous polyposis (FAP), a rare and devastating genetic disease that may result in colorectal cancer as an adjunct to usual care.
Celecoxib should not be taken by patients who have aspirin-sensitive asthma or allergic reactions to aspirin or other arthritis medicines or certain sulfa drugs called sulfonamides, or who are in their third trimester of pregnancy. As with all NSAIDs, serious GI tract ulcerations can occur without warning symptoms. Physicians and patients should remain alert to the signs and symptoms of GI bleeding. Celecoxib does not affect platelet function and therefore should not be used for cardiovascular prophylaxis. As with all NSAIDs, celecoxib should be used with caution in patients with fluid retention, hypertension, or heart failure. In overall clinical studies the most common side effects of celecoxib were dyspepsia, diarrhea and abdominal pain, which were generally mild to moderate.
About NewYork-Presbyterian Hospital's Weill Cornell Medical Center
NewYork-Presbyterian Hospital's Weill Cornell Medical Center is a 2,369-bed academic medical center created from the merger between The New York Hospital and The Presbyterian Hospital. It provides state-of-the-art inpatient, ambulatory, and preventive care in all areas of medicine at five major centers: New York Weill Cornell Medical Center, Columbia Presbyterian Medical Center, Children's Hospital of New York, The Allen Pavilion, and the Westchester Division. One of the largest and most comprehensive health-care institutions in the world, the Hospital is committed to excellence in patient care, research, education, and community service.