If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Thalidomide Investigated For Various Types Of Cancer NEW YORK, N.Y. -- November 5, 1999 -- Leading oncology teams from around the world presented data this week from several studies on the use of thalidomide (Thalidomid®), in combination with various chemotherapeutic agents, or as a stand-alone therapy, in a number of solid and hematologic cancers. Researchers from the University College London, National Cancer Institute, New York University Medical Center, and New York’s Saint Vincents Medical Center presented data on the use of the drug in advanced cancers, prostate cancer, glioblastoma multiforme, and multiple myeloma at the New York Chemotherapy Foundation Symposium XVII. Thalidomide has been commercially available since October 1998. As part of the four-day session, Dr. Tim Eisen, of University College, in London, reported on a group of 66 patients with advanced cancers, including ovarian, renal, melanoma and breast cancer. The patients were treated with 100 mg of thalidomide daily until disease progression or unacceptable toxicity occurred. Dr. Eisen reported that three of 18 patients with renal cancer showed partial responses and an additional three patients experienced stabilization of their disease for up to six months. In addition, four of 17 melanoma patients experienced stable disease for periods of up to five months. No other objective responses were observed in this trial. Side effects observed were lethargy and constipation, with no grade 3 or 4 toxicities reported. Trial results were also presented on the use of thalidomide for androgen independent prostate cancer (AIPC). Dr. William Figg, of the National Cancer Institute, reported trial results in which 63 patients were treated with either a low dose (200 mg/day, n=50) or a high dose (up to 1,200 mg/day, n=13) thalidomide. Fifty-three percent of the LD and 68 percent of the HD patients had declines in prostate specific antigen (PSA). The study’s most common side effects were constipation, dizziness, edema, fatigue, neurocortical, neurosensory and xerostomia. Dr. Michael Gruber, of New York University Medical Center, presented phase I/II data on thalidomide used in combination with carboplatin to assess the safety and efficacy of this combination therapy in treating patients with recurrent glioblastoma multiforme (GBM). The study involved 71 patients who were administered the maximum tolerated dose (MTD) of thalidomide, 300 mg/m2, until recurrence. At the MTD, 53 of the patients were evaluated for efficacy, with 70 percent (37) experiencing responses (two with partial responses, 35 with disease stabilization). The trial’s most commonly reported side effects were constipation and drowsiness. Dr. Sundar Jagannath, of Saint Vincents Medical Center, observed a 67 percent overall response rate among a group of 15 refractory multiple myeloma patients treated with thalidomide alone (n=10), or with a combination of chemotherapy and thalidomide (n=5). Seven (7) of the 10 patients treated with thalidomide alone responded (5 PR and 2 CR) while three of the five patients treated with chemotherapy and thalidomide showed responses (2 PR and 1 CR). The chemotherapeutic agents administered in this study include dexamethasone, cyclophosphamide, etoposide with doxorubicin and cisplatin. These results were similar to those reported by a team of Arkansas Cancer Research Center (ACRC) physicians, led by Dr. Bart Barlogie, during the 1998 Chemotherapy Foundation Symposium and the 1998 American Society of Hematology meeting. An update of the ACRC trial was also presented at this meeting.
Safety Notice Thalidomide is contraindicated in pregnant women and women capable of becoming pregnant. Even a single capsule taken by a pregnant woman can cause severe birth defects or death to an unborn baby. To minimize this risk, only prescribers and pharmacies registered with the System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.) distribution program may prescribe or dispense Thalidomid®. Other adverse drug reactions known to be associated with thalidomide therapy include: peripheral neuropathy; a common, potentially severe side effect that may be irreversible; drowsiness/ somnolence; dizziness/orthostatic hypotension; neutropenia; hypersensitivity reactions; and increased HIV-viral load. Physicians should consult full prescribing information about these and other adverse reactions prior to initiating treatment with Thalidomid® (thalidomide). Thalidomid® (thalidomide), manufactured by Celgene Corporation (Nasdaq: CELG), received U.S. Food and Drug Administration (FDA) clearance on July 16, 1998 for the acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and as maintenance therapy for prevention and suppression of cutaneous manifestation recurrences. Thalidomid® is not indicated as monotherapy for ENL treatment in the presence of moderate to severe neuritis.
Related Links: Thalidomid® (thalidomide) and Celgene Corporation.
|
