s lymphoma (NHL), in which early signs of anti-tumor activity were observed
were announced at the 45th Annual Meeting of the American Society of
Hematology (ASH) taking place in San Diego.
In a study led by Andre Goy, M.D. of the University of Texas M.D. Anderson
Cancer Center, 40 patients were evaluated with various types of NHL.
Patients were treated with VELCADE and results from this ongoing study
include:
-- Overall response rate of 50 percent for 20 of the 22 evaluable patients in
the mantle cell lymphoma group. Specifically: Four had complete responses;
Six had partial responses (including two with major partial responses); and
Two experienced stable disease. -- These patients are still being followed to
determine the duration of their response. To date, the median duration of
response has been 5.6 months with a range of 1 to 14 months. -- This patient
population was heavily pre-treated, and had received an average of four prior
therapies (with a range of 1 to 12). -- In six out of nine evaluable patients
with diffuse large cell lymphoma, one had a partial response. These patients
all had relapsed lymphoma who had failed multiple prior therapies. -- One
patient who had also failed four prior therapies for Waldenstrom룑s
Macroglobulinemia (a B-cell malignancy) achieved a partial response after two
cycles. -- The most common side effects observed in this trial were fatigue,
dehydration, and hypotension, which were generally manageable.
룕In early studies, VELCADE demonstrated promising activity against both
indolent and aggressive types of NHL among patients that failed multiple prior
therapies; additional studies will be conducted to determine the safety and
efficacy of VELCADE against NHL either alone or in combination with other
therapies,룖 said Dr. Goy.
In a separate study sponsored by the National Cancer Institute led by Owen
A. O룑Connor, M.D., Ph.D., Head, Laboratory of Experimental Therapeutics for
the Lymphoproliferative Malignancies, Memorial Sloan-Kettering Cancer Center,
New York, N.Y., 24 patients with indolent NHL were evaluated. Preliminary
results of this ongoing study included:
-- Six out of eight evaluable patients with follicular lymphoma experienced
major responses: One patient with a durable complete response; Five partial
responses; and The median duration of response was six months. -- In nine
out of 10 evaluable patients with mantle cell lymphoma: Five achieved partial
responses; Three experienced stable disease; and Duration of response has
ranged from 1 to 19 months. One patient who relapsed 19 months after
treatment with VELCADE™ (bortezomib) for Injection was retreated and
achieved a second partial response and at three months is still durable. --
Both patients with nodal marginal zone lymphoma achieved a partial response
with a duration of response of more than five months; -- All three patients
with small lymphocytic lymphoma experienced stable disease with durations
observed from between four and six months; and -- Side effects observed
were generally manageable and included thrombocytopenia, sensory
neuropathy, small vessel necrotizing vasculitis, and lymphopenia.
룕VELCADE, with its new and unique mechanism of action, proteasome
inhibition, is different from traditional chemotherapies,룖 said David Schenkein,
M.D., vice president, clinical oncology development, Millennium.
룕We are encouraged by these study findings for various subtypes of difficult-
to-treat relapsed and refractory lymphomas. We are continuing to study
VELCADE alone and in combination against solid and hematologic cancers in
multiple ongoing clinical trials.룖
VELCADE™ (bortezomib)
for Injection
VELCADE, the first of a new class of medicines called proteasome inhibitors,
is the first treatment in more than a decade to be approved for patients with
multiple myeloma - a cancer of the blood.
Millennium received approval from the U.S. Food and Drug Administration
(FDA) on May 13, 2003 to market VELCADE for the treatment of multiple
myeloma patients who have received at least two prior therapies and have
demonstrated disease progression on the last therapy.
The effectiveness of VELCADE is based on response rates. There are no
controlled trials demonstrating a clinical benefit such as an improvement in
survival.
VELCADE has a generally predictable, manageable safety profile (with
appropriate monitoring and, if necessary, dose modification). VELCADE is
contraindicated in patients with hypersensitivity to bortezomib, boron, or
mannitol.
In 228 patients who were treated with VELCADE in two phase II studies of
multiple myeloma, the most commonly reported adverse events were asthenic
conditions (including fatigue, malaise and weakness) (65 percent), nausea(64
percent), diarrhea (51 percent), appetite decreased(including anorexia)(43
percent), constipation(43 percent), thrombocytopenia (43 percent), peripheral
neuropathy (including peripheral sensory neuropathy and peripheral
neuropathy aggravated)(37 percent), pyrexia(36 percent), vomiting(36
percent), and anemia(32 percent).
Fourteen percent of patients experienced at least one episode of grade four
toxicity, with the most common toxicity being thrombocytopenia(3 percent) and
neutropenia(3 percent). A total of 113(50 percent) of the 228 patients
experienced serious adverse events(SAEs).
The most commonly reported SAEs included pyrexia(7 percent), pneumonia(7
percent), diarrhea(6 percent), vomiting(5 percent), dehydration(5 percent) and
nausea(4 percent).
Non-Hodgkin룑s Lymphoma
Non-Hodgkin룑s Lymphoma is the most common hematological cancer and
the fifth leading cause of cancer death in U.S. There are approximately 63,000
new cases diagnosed per year, it is attributed to 27,000 deaths and is the
second fastest growing form of cancer in the U.S. According to the American
Cancer Society, the incidence of non-Hodgkin룑s lymphoma has more than
doubled since the 1970룑s. The average age of diagnosis is between 55 and
60.
■ 기사 요지
메디메디아 USA 발간 `P&T(Pharmacy and Therapeutics)` 12월 8일자에 게재된 내용
으로 Bortezomib의 비호지킨성림프종(NHL) 치료효과에 관한 2가지 임상시험 결과를 소개
하고 있다.
美 앰디앤더슨암센터의 안드레 고이 박사팀 연구에서는 다양한 형태의 NHL 환자 40명을
대상으로 조사한 결과, 측정가능한 환자 22명중 20명에게서 50%의 약물반응이 나타났다.
환자들은 평균 4차례의 전치료를 받았으며, 현재까지 조사된 약물반응 기간은 평균 5.6개
월이었다. 미국암연구소가 후원한 또 다른 연구에서는 무통증NHL 환자 24명을 대상으로 시
험을 진행, 측정 가능한 여포림프종 환자 8명중 6명에게서 유의한 약물반응이 나타났으며 약
물반응 기간은 6개월(median)로 조사됐다. 정리·이상돈 기자
sdlee@kimsonline.co.kr