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Patients received another initial regimen two patients received carmustine BCNU one patient, CCNU; two patients, aziridinylbenzoquinone AZQ two patients, melphalan; and one patient, fludarabine these patients were designated "Group B." Three of these patients received their initial chemotherapy as adjuvant treatment and five received it after radiotherapy for recurrent tumor. With respect to the initial chemotherapy, in Group A three patients had exhibited a complete response; eight, a partial response; one, stable disease; and three could not be evaluated. Thus 11 92% ; of the 12 assessable patients had initially exhibited a response to chemotherapy. The times to progression of disease after initial chemotherapy for the patients in Group A ranged from 6 to 54 months median 15 months ; . In Group B one patient had shown a complete response to CCNU; three, a partial response one to administration of BCNU and two to melphalan and one patient, stable disease after receiving fludarabine. Two patients could not be evaluated one had received BCNU and the other AZQ ; and one patient displayed progressive disease after receiving AZQ. Thus four 67% ; of six assessable patients had shown a response to the initial chemotherapy. The times to progression of disease after.
26 Brugiatelli M, Claisse JF, Lenormand B, Marabiro F, Callea V, Malloum K, Chevret S, Binet JL, Dighiero G, Travade P. Long term clinical outcome of B-cell chronic lymphocytic leukaemia patients in clinical remission phase evaluated at phenotypic level. Br J Haematol 1997; 97: 113118. Miller AB, Hoogstraten B, Staquet M, Winkler A. Reporting results of cancer treatment. Cancer 1981; 47: 207214. Duffy DR, Santner TJ. Confidence intervals for binomial parameter based on multistage tests. Biometrics 1987; 43: 8193. Rummel MJ, Kafer G, Pfreundschuh M, Jager E, Reinhardt U, Mitrou PS, Hoelzer D, Bergmann L. Fludarabine and epirubicin in the treatment of chronic lymphocytic leukaemia: a German multicenter phase II study. Ann Oncol 1999; 10: 183188. Zinzani PL, Magagnoli M, Moretti L, De Renzo A, Battista R, Zaccaria A, Guardigni L, Mazza P, Marra R, Ronconi F, Lauta VM, Bendandi M, Gherlinzoni F, Gentilini P, Ciccone F, Cellini C, Stefoni V, Ricciuti F, Gobbi M, Tura S. Randomized trial of fludarabine versus fludarabine and idarubicin as front line treatment in patients with indolent or mantle-cell lymphoma. J Clin Oncol 2000; 18: 773779. O'Brien S, Kantarjian H, Beran M, Freireich E, Kornblau S, Koller C, Lerner S, Gilbreath J, Keating M. Fludarabine FAMP ; and cyclophosphamide CTX ; therapy in chronic lymphocytic leukemia CLL ; . Blood 1996; 88 Suppl. 1 ; : 480a Abstr. 1910. ; 32 Flinn IW, Byrd JC, Morrison C, Janison J, Diehl LF, Murphy T, Piantadosi S, Seifter C, Ambinder RF, Vogelsang G, Grever MR. Fludarabine and cyclophosphamide with filgrastim support in patients with previously untreated indolent lymphoid malignancies. Blood 2000; 96: 7175. Cazin B, Binet JL, Divine M, Lepretre S, Lederlin P, Travade P, Lemaire G, Guibon O. Oral fludarabine and cyclophosphamide in previously untreated chronic lymphocytic leukemia. Blood 2000; 96 Suppl. 1 ; : 515a Abstr. 2218 ; . 34 O'Brien S, Kantarjian H, Beran M, Robertson LE, Freilich E, Kornblau S, Koller C, Estey E, Lerner S, Keating M. Fludarabine and mitoxantrone therapy in chronic lymphocytic leukemia. Blood 1996; 88 Suppl. 1 ; : 588a Abstr. 2341 ; . 35 Rummel MJ, Stilgenbauer S, Gamm H, Karakas T, Mitrou PS, Doelmer H, Hoelzer D, Bergmann L. Fludarabine versus fludarabine plus epirubicin in the treatment of chronic lymphocytic leukemia preliminary results of a randomized phase III multicenter study. Blood 2000; 96 Suppl. 1 ; : 2946 Abstr. 5013.
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The study involved 395 patients with chronic lymphocytic leukemia and consisted of a randomized comparison of fludarabine with chlorambucil, currently considered the standard therapy.
Are calculated, not measured ; . WBC is the number of white cells, and PLT the number of platelets. Questions to Drs. Stark and Kyle produced the following comments: 1 - While high levels of IgM can be reduced by plasmapheresis, the decision for this ought not be based on the IgM count by itself. Look for "sausage capillaries" among the blood vessels of the eye for evidence of hyperviscosity, or for other symptoms of damage. 2 Immunoglobulins are part of the liquid portion of the blood. 3 CD20 is the name of a protein molecule that appears on the lymphocyte's surface. It shows up in most WM patients but also in others ; . 4 There is no level of serum viscosity that automatically produces symptoms. We usually look for a level of 4 as danger sign, but patients have measured as high as 15 and shown no symptoms. 5 IgA and IgG, generally low in WM patients, do not usually return to normal levels after treatment. But oftentimes that does not indicate poor resistance to infection. Don't take gamma globulin shots just because of that low measurement. Save them for when and if lowered resistance becomes a problem. 6 2CdA and fludarabine are known to cause reduced platelet levels, but there is usually a recovery over time. A sudden drop months or years later is probably due to something else. "ask the sPeakers" Panel roBert kYle, Moderator Aileen Ardizon, Annamarie Fidel-Rice and Drs. Morie Gertz and Gwen Nichols all participated in a panel on Sunday morning to answer questions on wide-ranging topics from the audience. Here is a recap: 1 In WM, do individual B cells overproduce IgM, or do the cells themselves divide uncontrollably, giving large numbers of cells each producing the normal quantity of IgM? There are more B cells than normal, but not so much because cells divide as because they just don't die. Sometimes they overproduce, sometimes they don't. Symptoms can be caused by high IgM, or by low but potent IgM. And the large numbers crowd out normal cells, so blood counts fall and lymph nodes enlarge. 2 Is there a particular antigen that stimulates the malignant cell?.
To determine whether the inhibitory effect of estradiol on PRL secretion was a specific action of estradiol or rather a strain-specific pharmacological effect because of the high dose, we evaluated the lactotroph response to estradiol in another strain of mice. Using the same amount of estradiol and length of exposure, we found that estradiol increased both serum PRL levels and pituitary weights in 129S6 SvEv mice, consistent with a published report by Wynick et al. 17 ; indicating the strain-specific nature of estradiol responses. There are many discrepancies as to the nature and extent of estrogen's action in several animal models and in humans. In humans PRL levels coincide with hormonal status and lactotrophs proliferate before lactation to maintain elevated PRL levels. However, exogenous estradiol administration in humans has little effect on lactotroph function except in highly susceptible persons and when very high doses are administered 1, 23 ; . In contrast, exogenous estradiol is a potent stimulator of PRL secretion and lactotroph proliferation in certain strains of rodents. Fischer 344 rats are the most widely studied and most sensitive rat strain to estrogen-induced pituitary growth. Other strains are also sensitive to estradiol including ACI, Wistar-Furth, and Copenhagen 24 27 ; , whereas some strains are relatively insensitive to estrogen-induced pituitary tumorigenesis including Brown-Norway, Holtzman, and Sprague Dawley 28 30 ; . addition to differences in estradiol sensitivity among strains of rat, there are likely varied responses between rats and mice. Caution must be used when comparing data from these two species. However, genetic regulation of estrogen-induced pituitary growth has been less well characterized in mice than rats. In one study, Gardner and Strong 31 ; presented a comparison of pituitary responses in seven different mouse strains A, C3H, CBA, C12I, JK, N, and C57 ; . These authors found that only C57 mice displayed significant hyperplasia 15 of 106 mice ; after approximately 250 450 d of estrogen treatment and that higher doses of estradiol did not increase the initiation or severity of tumorigenesis, although this was difficult to interpret because high doses were associated with earlier mortality from nonpituitary causes. More recently other investigators have reported that C57 mice are relatively refractory to estradiol-induced pituitary tumorigenesis.
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1. Pinsky SM. 1986 Current status of thyroid imaging. In: Freeman LM, ed. Current concepts in diagnostic nuclear medicine, vol 3, no. 1. Chicago: MacMillan Professional Journals; 4 12. 2. Belfiore A, La Rosa GL, Giuffrida D, et al. 1995 The management of thyroid nodules. J Endocrinol Invest. 18: 155158. 3. Fabbro D, Di Loreto C, Beltrami CA, Belfiore A, Di Lauro R, Damante G. 1994 Expression of thyroid specific transcription factors TTF-1 and PAX-8 in human thyroid neoplasm. Cancer Res. 54: 4744 4749. Rubenfeld S, Wheeler TM. 1988 Thyroid cancer presenting as a hot thyroid nodule: report of a case and review of the literature. Thyroidology. 1: 63 68. Russo D, Arturi F, Filetti S. 1996 Thyroid-stimulating hormone receptor gene mutations and polymorphism in thyroid diseases. Curr Opin Endocrinol Diabetes. 3: 428 432. Russo D, Arturi F, Wicker R, et al. 1995 Genetic alterations in thyroid hyperfunctioning adenomas. J Clin Endocrinol Metab. 80: 13471351. 7. Nagayama Y, Kaufman KD, Seto P, Rapoport B. 1989 Molecular cloning, sequence and functional expression of the cDNA for the human thyrotropin receptor. Biochem Biophys Res Commun. 165: 1184 1190. Sanger F, Nicklen S, Coulson AR. 1977 DNA sequencing with chain terminating inhibition. Proc Natl Acad Sci USA. 82: 488 492. Filetti S, Belfiore A, Amir S, et al. 1988 Thyrotoxicosis due to thyroid cancer: role of thyroid stimulating antibodies. N Engl J Med. 318: 753759. 10. Gross JL, Vasques Moraes I. 1996 Thyroid hormone-producing metastases in differentiated thyroid cancer. J Endocrinol Invest. 19: 2124. 11. Ehrenheim Ch. Heintz P, Schober O, Schicha H, Hundeshagen H. 1986 Jodinduzierte T3-Hyprthyreose beim metastasierenden follikularen Schilddrusenkarzinom. Nuklearmedizin. 25: 201204. 12. Kosugi S, Shenker A, Mori T. 1994 Constitutive activation of cyclic AMP but not phosphatidylinositol signaling caused by four mutations in the 6th transmembrane helix of the human thyrotropin receptor. FEBS Lett. 356: 291294 and flumist.
MRC Working party on Leukaemia in Adults Chronic Lymphocytic Leukaemia trial 4: A Randomised Comparison of Chlorambucil, Fludarabine and Fludarabine plus Cyclophosphamide. Study Objectives To compare conventional therapy with Chlorambucil versus the new agent fludarabine, used alone or in combination with cyclophosphamide in terms of survival, response to treatment, duration of response, toxicity and quality of life. Study Treatment.
See further in subsection 4.2.3.2 under ii ; . Tomas, Nin 1994 ; Implementing Kaitiakitanga under the RMA, p. 40. Binney, Judith 1999 ; Songlines from Aotearoa in Neumann, Thomas & Ericksen eds ; Foundational histories in Australia and Aotearoa New Zealand, p. 218. The Maori perception of time and the past is not the same held by western society, as it cannot impose a chronological order. For Maori the world was and still is ordered and understood by whakapapa genealogy ; . All things, from emotions to flora and fauna, are part of an organic net and system of relationships. See further in Tau, Te Maire 2001 ; Matauranga Maori as an Epistemology in Sharp & McHugh eds. ; Histories, Power and Loss. Uses of the Past, pp. 63 & 65-67. 85 Miller, J. R. 2002 ; Introduction in Magocsi, Paul Robert ed. ; Aboriginal Peoples of Canada, pp. 14, 17, 19 & 22. See further also in World Directory on Minorities 1997 ; , pp. 12-17 and fluoride.
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4. Change for the right reasons. It's broadly true that long-running campaigns-- kept fresh and relevant--are great brand-builders. And it's sadly true that new people, wanting to make their mark, change things for change's sake. But once in a while, wholesale change is right. Molson Canadian Cassies I ; was a niche player when it launched "What Beer's all About" in the late 80s. Canadian became mainstream, and displaced Labatt Blue as market leader. You'd think they'd keep going with "What Beer's all About." And they did for a few years. But tastes were shifting. To stay ahead of this, they launched "I AM" in the mid 90s Cassies III ; . This was successful, but eventually it too ran out of steam. Canadian then re-incarnated again with "Joe's Rant." Cassies 2001. ; More recently, though this time the need for change more obvious, Juicy Fruit almost literally ; destroyed its former image with the guitar-smashing campaign. Cassies 2005. ; 31. Transcending Advertising. A number of Cassies campaigns have moved into popular culture--at least for a while. Generally, advertisers and agencies are pleased when this happen, though there are always nay-sayers asking "Is it on strategy? Is it relevant? Is it building the business?" "Where's the Beef?" had a lot more than 15 minutes of fame. But did it build the Wendy's business? I've seen arguments on both sides. Budweiser and "Whassup" faced similar questions. Cassies cases that mention the effect--and they all do it positively--include Richmond Savings Cassies III Molson Canadian, Tourism New Brunswick, Manitoba Telecom Cassies 2001 Bank of Montreal and ED Cassies 2002 Familiprix, Irving Mainway Coffee and Motrin Cassies 2003 Desjardins and Qubec Milk Cassies 2004 ; . Crescendo Pizza, Familiprix, Pepsi Qubec and Qubec Milk Cassies 2005 ; . Viral marketing is the latest incarnation of effort that transcends advertising. There has not yet been a Cassies winner based on this, but it would be good to see one
A well-established in vitro assay was used to test the efficacy of these inhibitors against C. parvum.14 Briefly, human ileocaecal epithelial cells HCT-8; ATCC CCL 244 ; were cultured in 75 cm2 tissue culture flasks in a maintenance medium consisting of RPMI 1640 supplemented with 10% Opti-MEM Gibco-BRL ; , 2% fetal bovine serum FBS ; and 2 mM L-glutamine at 37C in a humidified, 5% CO2-enriched atmosphere.1517 Ninety-six-well flat-bottomed microtitre plates were seeded with 5.0 104 HCT-8 cells well and incubated for 1424 h. For infection, the maintenance medium was replaced by 100 L well parasite growth medium17 containing 3.0 104 sterilized oocysts. Non-viable, negative controls consisted of the same number of oocysts that had been frozen and thawed using liquid nitrogen and a 37C water bath. Parasites were allowed to invade host cells for 90 min at 37C, and any non-invading parasites were removed by rinsing once with warm PBS. After rinsing, 150 L of fresh growth medium containing drugs at appropriate concentrations was added to each well. Negative controls contained drug diluent and growth medium only. Four to eight replicate wells were used for each experimental condition. All compounds were tested at least twice in separate experiments. Infected HTC-8 monolayers were incubated for 48 h, then fixed with 8% formalin in PBS pH 7.3 ; for 2 h at room temperature. After fixation, plates were blocked for 1 h with 1% bovine serum albumin BSA ; containing 0.002% Tween-20 in PBS, and they were then labelled for 30 min with and fluphenazine.
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By the local ethics committee. Written informed consent was received from each patient. Patients with advanced MM stage II III, aged 18 to 65 years, with response or refractory to induction or salvage chemotherapy were eligible for the study protocol. Nine patients were treated in a sequential autologous-allogeneic tandem approach and 12 patients received an allograft after relapse or no change following an autologous transplantation. To be included patients were required to have sufficient cardiac function ejection fraction 30% ; , a creatinine clearance greater than 30 mL h, a lung diffusion capacity of at least 50%, and liver transaminase values not more than 3 times the upper limit of normal. HLA-A and HLA-B antigens were typed by serologic methods; HLA-DRB1 and DQB1 alleles were typed with sequence-specific oligonucleotide probes. One antigen mismatch in class I or II was allowed. Unrelated donors gave informed consent according to the national protocol and stem cell mobilization collection or bone marrow harvesting was performed according to the accepted international and national standards and procedures. Patient characteristics Patient characteristics are shown in detail in Table 1. Twenty-one patients were enrolled in the study between January 2000 and January 2002. Preliminary results in 7 patients who were treated in an autologousallogeneic tandem protocol have been reported in a previous report and are now included with an extended follow-up.22 The median age of the 13 men and 8 women was 50 years range, 32-61 years ; . Ten donors were men and 11 were women. The median 2microglobulin level at diagnosis was 2.9 mg dL range, 1.0-7.0 mg dL ; . Cytogenetic fluorescence in situ hybridization FISH ; analysis was available in 6 patients and showed a deletion 13 in one patient. Nine patients had received prior radiation therapy and the median number of previous chemotherapy cycles was 6 range, 4-15 ; . All patients had received at least one previous cycle of high-dose chemotherapy followed by autologous SCT. Seven patients had received 2 cycles of previous high-dose chemotherapy. Eleven patients experienced relapse after autologous transplantation, whereas 10 patients received an allogeneic transplant as consolidation therapy after an autograft, either as a planned autologous-allogeneic protocol n 9 ; or after no change to an autograft n 1 ; . The disease status prior to allogeneic transplantation was complete remission CR; n 1 ; , partial remission PR; n 8 ; , minor response MR; n 1 ; , no change NC; n 3 ; , and progressive disease PD; n 8 ; . Nineteen and flurazepam.
One 1 ; point for sixth. Should ties remain after applying Rule 167, Rule 180.16 or Rule 181.10, the points to be awarded for the tied places shall be totaled and points equal to this total divided by the number of tied competitors shall be scored for the team of each individual so tied. When two or more teams have the same number of points, the teams shall be cochampions and any trophies shall be awarded in multiple copies. RULE 13 OTHER CHAMPIONSHIPS 1. In addition to the USA Open and Junior Outdoor, the USA Indoor Championships, and the National Track & Field Club Championships, as above, the following Championships may be conducted at the discretion of the National Track and Field Committees: Men a ; USA Junior Indoor Track and Field Championships. b ; Club Relay Championships 400 Meters Relay 4x100 ; 800 Meters Relay 4x200 ; 1600 Meters Relay 4x400 ; 3200 Meters Relay 4x800 ; 6000 Meters Relay 4x1500 ; 440 Meters Shuttle High Hurdles Relay 4x110 ; 1600 Meters Sprint Medley Relay 400-200-200-800 ; 4000 Meters Distance Medley Relay 1200-400-800-1600 ; All relays may be run in the equivalent yard distances. ; c ; Decathlon see Rule 200 ; d ; Pentathlon see Rule 200 ; e ; Indoor Pentathlon see Rule 200 ; f ; Indoor Heptathlon see Rule 200 ; g ; 56 lb. Weight Throw see Rule 195 ; . This event shall be held independently of the USA Track and Field Championships. Women a ; Heptathlon see Rule 200 ; b ; Indoor Pentathlon see Rule 200 ; c ; Club Relay Championships. all events listed under Men, above ; 2. Regional and Association, Open and Junior Outdoor Track and Field Championships may be held. Rule 10 shall apply to such Championships except.
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A. Acute Promyelocytic Leukemia: cytogenetic feature: t 15; 17 ; : ATRA + Arsenic Trioxide ID01-014 ; B. Cytogenetic feature: Inv16 or t 8: Fludarabine + Ara-C ID02-266 ; C. Age 50 DCTER ID01-591 ; Age 49 Ida + Ara-C + - IL-11 ID02-020 ; D. Post remission therapy: Minitransplant in Worse Prognosis CG DM00-117 ; E. Patients not considered appropriate for AML treatment: Bevacizumab ID01-152 ; SCH66336 DM01-260 ; PTK 787 ZK DM02-203 ; FLT-3 mutation: CEP-701 ID02-274 and flurbiprofen.
All 349 patients who took at least one dose of treatment were evaluated for safety. Seventy-seven patients 22.1% ; had at least one adverse event, 46 26% ; in the clarithromycin group and 31 18% ; in the penicillin V group. There was no statistically significant difference between the two treatment groups P 0.073 ; . The most frequently reported events in the clarithromycin group were gastrointestinal. A relationship between adverse events and treatment was excluded in 55.9% of patients in the clarithromycin group and in 52.4% in the penicillin V group. Only one serious adverse event was reported, in a 19-year-old patient.
ASISH K. SAHA, 1 D. ROSS LAYBUTT, 2 DAVID DEAN, 1 DEMETRIOS VAVVAS, 1 ELENA SEBOKOVA, 3 BRONWYN ELLIS, 2 IWAR KLIMES, 3 EDWARD W. KRAEGEN, 2 ELEAZAR SHAFRIR, 4 AND NEIL B. RUDERMAN1 1Diabetes and Metabolism Unit, Evans Department of Medicine and Department of Physiology, Boston University Medical Center, Boston, Massachusetts 02118; 2Garvan Institute of Medical Research, St. Vincent's Hospital, Sydney, New South Wales 2010, Australia; 3Diabetes and Nutrition Research Group, Institute of Experimental Endocrinology, Slovak Academy of Sciences, 83306 Bratislava, Slovak Republic; and 4Department of Biochemistry, Hebrew University, Hadassah Medical School, Jerusalem 91120, Israel and fluvastatin.
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INDICATIONS AND USAGE Campath is indicated for the treatment of B-cell chronic lymphocytic leukemia B-CLL ; in patients who have been treated with alkylating agents and who have failed fludarabine therapy. Determination of the effectiveness of Campath is based on overall response rates. See CLINICAL STUDIES. ; Comparative, randomized trials demonstrating increased survival or clinical benefits such as improvement in disease-related symptoms have not yet been conducted. CONTRAINDICATIONS Campath is contraindicated in patients who have active systemic infections, underlying immunodeficiency e.g., seropositive for HIV ; , or known Type I hypersensitivity or anaphylactic reactions to Campath or to any one of its components. WARNINGS See BOXED WARNING and focalin.
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Primary CLL cells from 20 different patients were plated with or without NLCs, and cell viability was assessed overtime. Co-culture of CLL cells with NLC protected the CLL cells from undergoing spontaneous apoptosis. After 48 hours the average viability of CLL cells with NLC was 75% whereas the mean viability of CLL cultured alone was significantly lower at 59% p 0.017 ; . In addition, coculture of CLL cells with NLC protected the leukemia cells from the cytotoxic effects of fludarabine. Following treatment with 10 M Fludarabine the mean viability of the CLL cells was 28% whereas the viability of CLL cells cultured with NLC was 51% p 0.001 ; . In contrast, NLC did not significantly protect CLL cells from AT-101 mediated apoptosis. Treatment of CLL cells with AT-101 at 5 M, with or without NLC, resulted in CLL cell viability at 48 hours of only 40% + -7%. ; or 30% + -7%. ; , respectively, a difference that was not statistically significant.
Cal recurrence in melanoma in situ: influence of sex, age, site of involvement and therapeutic modalities. Br J Dermatol 2003; 148: 703-8. Suter L. Long-term chronic, late ; radiation reactions of the skin. In: Panizzon RG, Cooper JS, eds. Radiation treatment and radiation reactions in dermatology. Berlin: Springer-Verlag, 2004: 143-57. 3. Hengge UR, Schaller J. Successful treatment of invasive squamous cell carcinoma using topical imiquimod. Arch Dermatol 2004; 140: 404-6. [Erratum, Arch Dermatol 2005; 141: 764.] and follistim.
Analysis, data were collected for 70 patients 60 years of age median 69 years, range 61-82 years ; with low-grade 60% ; or transformed low-grade 34% ; NHL treated in phase I-III trials from 1990-1999 [34]. In this cohort, 31% patients had bulky disease 500 g ; . Treatment with Bexxar resulted in ORs in 60% of patients, with a median duration of 9 months, and 20% of patients had CRs, with a median duration not reached after a median of 15 months follow-up. A similar analysis of phase I-III clinical trials showed that therapy with Bexxar is efficacious in patients with a number of poor prognostic factors, including age 60 years, bulky disease, elevated LDH levels, and four or more prior chemotherapies Table 2 ; [35]. Treatment of Newly Diagnosed Patients Seventy-six patients with newly diagnosed advancedstage follicular lymphoma were treated with Bexxar in a phase II single-institution study at the University of Michigan. Confirmed responses occurred in 72 patients 95% ; , and 56 patients 74% ; achieved confirmed CRs [36]. Among patients with CRs, 45 remained in continuous complete remission from 30-66 months, and the median duration of response and median progression-free survival had not been reached at a median follow-up of 43 months. At 5 years, 62% of patients remained free of progression. Treatment with Bexxar is also currently being investigated as first-line therapy in combination with fludarabine in newly diagnosed patients with NHL [37]. Of 35 patients treated, all achieved investigator-assessed responses, and 27 77% ; achieved CRs. The median duration of response had not been reached after a median follow-up of 23 months. The Southwest Oncology Group SWOG ; has also investigated the combination of Bexxar therapy with CHOP chemotherapy in newly diagnosed patients trial S9911 ; . Durability of Responses An analysis of the duration of responses to Bexxar therapy has demonstrated the excellent durability of CRs in 269 evaluable patients with low-grade or transformed low-grade NHL treated with Bexxar from 1990-1999, who have been and flumist.
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1 keating mj, o’ brien s, lerner s, et al chemoimmunotherapy with fludarabine f ; , cyclophosphamide c ; , and rituximab r ; improves complete response cr ; , remission duration and survival as initial therapy of chronic lymphocytic leukemia cll and formoterol.
Alemtuzumab Campath ; Genzyme Corporation, Cambridge, MA ; is a recombinant DNA-derived humanized IgG1 kappa monoclonal antibody specific for the cell surface glycoprotein CD52 expressed on normal and malignant human peripheral blood B and T lymphocytes as well as natural killer cells, monocytes, macrophages, and other tissues. The mechanism of action is not completely understood, but involves a number of effects, including complement-mediated cell lysis, antibody-dependent cellular toxicity, and the induction of apoptosis. Because of its immunosuppressive properties, alemtuzumab was investigated initially for the treatment of autoimmune diseases and in transplant [1, 2]. Clinical activity was then demonstrated in a number of malignancies, including chronic lymphocytic leukemia CLL ; and T-cell prolymphocytic leukemia [35], which led to further investigation in these settings. The U.S. Food and Drug Administration FDA ; granted accelerated approval for alemtuzumab on May 7, 2001, for the treatment of patients with B-cell chronic lymphocytic leukemia B-CLL ; who had been treated with alkylating agents and failed fludarabine therapy based on evidence of durable objective response rates in the range of 21%33% across three single-arm studies. U.S. regulatory approval was contingent upon completion of a postmarketing commitment to confirm clinical benefit in the CAM 307 trial. CAM 307 was an open-label, international, multicenter, randomized trial designed to demonstrate a longer progression-free survival PFS ; duration with single-agent alemtuzumab than with single-agent chlorambucil in patients with previously untreated, Rai stage IIV B-CLL experiencing progression of their disease requiring initiation of antileukemia treatment. The analyses of the primary PFS ; and key secondary endpoints were performed on an intent-to-treat ITT ; population of 297 patients. Conversion from accelerated to regular approval for alemtuzumab and a new labeling claim for the initial treatment of B-CLL on September 19, 2007, were supported by evidence of a significant and clinically meaningful longer PFS time, supported by higher overall and complete response rates.
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