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A multinational, prospective evaluation. Citation factors are not reflecting the. Radiotherapy and concurrent weekly docetaxel. Topotecan T ; cisplatin DDP ; 3 days versus. Correlation between complete response. Total resource use in treating advanced. Preliminary data of a phase II. Neo-adjuvant chemotherapy with docetaxel. Efficacy and safety of a two-drug chemotherapy. Randomized phase 3 study of gemcitabine. The gemcitabine G ; plus cisplatin. A phase II study, multicenter, randomized. A randomized phase III trial in inoperable. Final results from a randomized phase II. Weekly versus three-weekly docetaxel. Three-weekly docetaxel 75mg m2 versus. Does paclitaxel Ptx ; dose & infusion. A bias in comparison of time to. Induction chemotherapy CTX ; . Fotemustine F ; versus Dacarbazine. The health-related quality-of-life impact. Phase III randomized multicenter trial. Prophylaxis with GM-CSF mouthwashes. Oral daily ibandronate: An effective and. Early intervention with epoetin alfa in breast. Darbepoetin alfa is effective in. Once per cycle dosing of darbepoetin. Loading maintenance regimen of darbepoetin. Zoledronic acid 4 mg ; is more effective. Transdermal fentanyl shows a similar. Implantable Drug Delivery System IDDS ; . Feasibility of a double-blind placebo. The efficacy of fixed doses of. Preliminary results on efficacy of. Effect of posttransplant + 7th day. A single dose of pegfilgrastim. Meropenem + - granulocyte colony stimulating. Exploratory analysis of the effect. A prospective randomised comparative-group. Early intervention with Epoetin alfa. Effect of epoetin alfa on hemoglobin and. Quality of life QoL ; in clinical. Supportive care SC ; in patients with. Use of analgesics in patients with advanced. Comparison of three intracavitary regimens. Effect of darbepoetin alfa and. Prospective, randomized trial to test the. An individual patient data meta-analysis. Bi-weekly 24-hour infusion of high dose. Phase I study of a weekly schedule. Phase I study of gemcitabine GEM ; . Rapamycin Combination of rapamycin with cyclosporin. Ras Current status of signal transduction. Combined adm. of vinorelbine, fostriecin. Phase I study of a 3-drug combination. Investigation of novel genes associated with. Recombinant human erythropoietin Loading maintenance regimen of darbepoetin. Pharmacologic modeling of recombinant . Exploratory analysis of the effect. Effect of epoetin alfa on hemoglobin and. Effect of darbepoetin alfa and. Rectal cancer Capecitabine-oxaliplatin combination. Observed toxicities in a phase I. High sphincter preservation rate. Impact of new drugs NDs ; CPT11, IOHP ; . Phase I study of 24hr continuous hepatic. advanced metastatic Preoperative hyperfractionated accelerated. locally advanced Preoperative chemoradiotherapy. Observed toxicities in a phase I. Early experience of long-term radiotherapy. Red blood cell transfusion A randomized phase II-B trial with amifostine. Pegfilgrastim minimizes hematologic. Gemcitabine two hours infusion ; with. Once per cycle dosing of darbepoetin. Exploratory analysis of the effect. Regional metastases Vascular invasion findings of oral. The influence of the mode of regional. 134 489PD ; 134 490PD ; 134 491PD ; 137 500P ; 137 501P ; 138 504P ; 139 509P ; 140 510P ; 141 517P ; 142 518P ; 142 519P ; 143 523P ; 144 526P ; 145 529P ; 145 531P ; 145 532P ; 147 539P ; 149 547P ; 155 571P ; 157 578O ; 159 586P ; 166 614P ; 167 617O ; 168 619O ; 168 620O ; 169 625PD ; 170 626PD ; 170 627PD ; 171 629PD ; 171 630PD ; 171 631PD ; 172 633P ; 172 634P ; 174 641P ; 174 642P ; 175 645P ; 176 648P ; 177 651P ; 177 652P ; 177 653P ; 178 656P ; 178 657P ; 180 664P ; 181 666P ; 182 671P ; 184 682 ; 186 688O ; 188 697PD ; 188 698PD ; 189 700PD ; 195 722P ; 117 427P ; 6 18IN ; 19 67P ; 25 89P ; 116 422O ; 170 627PD ; 176 650P ; 177 651P ; 178 656P ; 184 682 ; 80 288P ; 82 296P ; 82 297P ; 84 305 ; 197 729P ; 90 324 ; 81 295P ; 82 296P ; 89 323 ; 106 386P ; 122 446P ; 143 522P ; 170 626PD ; 177 651P ; 152 557P ; 156 574.
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Indirect estimate of treatment effect In the same way in which the baseline is estimated in Analysis 1, the absolute hazards are calculated using median weeks' survival and an exponential approximation. The log absolute hazard is assumed to be normally distributed around a true underlying absolute effect which is given a vague prior, N 0, 0.001 ; . Relative treatment effects for paclitaxel combination compared with topotecan can then be estimated as the difference between the respective log absolute hazards.
A thorough physical therapy evaluation and an individually designed program of activities can be invaluable for maintaining and increasing strength, range of motion, and mobility. For patients with sclerodermatous chronic GVHD, range-of-motion exercises may preserve joint mobility and decrease the pain associated with joint contractures. Although detailed literature on its efficacy is lacking, it is our practice to have all patients evaluated by a physical therapist familiar with the disease. Patients receive a personal prescription for activities and exercises with the initial evaluation, and their progress is monitored approximately every 3 months. Occupational therapy may be instrumental for maximizing functional capabilities in activities of daily living, employment opportunities, and sexual satisfaction. Support groups or individual therapy may benefit patients as they learn to cope with this chronic illness.
Treatment schedule 9-AC CD NSC 603071 ; was supplied by the Division of Cancer Treatment, NCI, in vials that contained 1 mg or 2 mg of 9-AC, with dimyristoylphosphatidylcholine, dimyristoylphosphatidylglycerol and mannitol. A special diluent that contained 20% dextrose, 0.9% sodium chloride, and sterile water was used to reconstitute 9-AC CD. Ten milliliters of special diluent was added to the 1 mg vial product or 20 ml the 2 mg vial product, such as the resulting mixture contained 100 ul ml of 9-AC CD. The appropriate dose of the reconstituted 9-AC CD was then transferred into a 50 or 100 ml medication cassette reservoir Pharmacia Deltec, Inc, St. Paul, MN ; . An additional amount of special diluent was used to obtain the volume necessary to administer the dose. 9-AC CD was infused through a central venous access device using CADD-1 pumps Pharmacia Deltec, Inc. ; without any in-line filters. The drug was administered as a 24-hour continuous intravenous infusion over seven days every three to four weeks. The starting dose was 0.2 mg m2 d for seven days i.e., 1.4 mg m2 per course ; . This dose was 50% of the MTD identified in phase I solid tumor studies using a three-day continuous infusion [12]. It was selected because longer exposure schedules of topo I inhibitors are associated with more significant toxicities e.g., mucositis with topotecan ; . Subsequent dose escalations were in 50% increments until grade 1 toxicity other than nausea and myelosuppression ; was observed, then in 30% to 35% increments until the MTD was reached. Cohorts of three patients were entered on each dose level, and additional patients could be entered according to usual '3 + 3' design [16]. During neutropenia, all patient received oral prophylactic antibiotic therapy with antibacterial agents trimethoprim-sulfamethoxazole 1 tablet twice daily, ciprofloxacin 500 to 750 mg twice daily, or levofloxin 500 mg daily ; , anti-fungal agents fluconazole 100 to 200 mg daily ; , and anti-viral agents acyclovir 200 mg twice daily or valocy.
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Glucose uptake, the difference being most pronounced from 120 minutes after ingestion of a mixed meal 21 ; . The present data demonstrate that although the rate of glucose delivery to muscle may be moderately impaired, under everyday conditions postprandial storage of glucose as glycogen in muscle is markedly impaired in type 2 diabetes. This observation is consistent with the demonstration of subnormal insulin stimulated rate of incorporation of C-glucose into muscle glycogen in type 2 diabetic subjects 32.
Note-Alcohol was included only when combined with other drugs. Several patients ingested more than one drug. * Upjohn, Kalamazoo, Mich. t Lilly, Indianapolis. t Sandoz, East Hanover, NJ. Smith Klein & French, Philadelphia. I Parke-Davis, Morris Plains, NJ. # Merck Sharpe & Dohme, West Point, Pa. * Roerig, New York. tt Abbott, North Chicago, Ill and toradol.
DNA topoisomerases catalyze changes in the linkage of DNA strands, playing critical roles in DNA replication, transcription and recombination, as well as chromosome condensation and segregation [reviewed in 1-3 ; ]. Alterations in DNA topology are catalyzed in reactions characterized by the formation of a covalent enzyme-DNA intermediate. Eukaryotic DNA topoisomerase I Top1p ; is a type IB enzyme that transiently cleaves a single strand of duplex DNA, while forming a tyrosyl linkage with the 3' phosphoryl end of the cleaved DNA 1-3 ; . Rotation of the non-covalently held DNA around the nonscissile DNA strand allows for the relaxation of positive or negative supercoils. In a second transesterification reaction, the 5'OH nucleophile attacks the phosphotyrosyl linkage to religate the DNA. In eukaryotes, the nuclear type IB enzyme, encoded by the TOP1 gene, is highly conserved in terms of amino acid sequence and catalytic mechanism 1-5 ; . The nuclear enzyme is also the cellular target of several antitumor agents, such as camptothecin CPT ; and indolocarbazole analogs [reviewed in 6-9 ; ]. The CPT analogs, Topotecan and SN-38 the active metabolite of CPT-11 ; , have shown remarkable antitumor activity against a broad range of pediatric and adult malignancies 10 ; . These drugs target Top1p by reversibly stabilizing the covalent enzyme-DNA intermediate. During S-phase of the cell cycle, the collision of advancing replication forks with the ternary drug-Top1p-DNA complexes produces irreversible DNA lesions that trigger S-phase checkpoint activation, cell cycle arrest and cell death 1, 5-8 ; . Consistent with this cytotoxic mechanism, cells treated with aphidicolin to inhibit DNA replication are resistant to CPT 11 ; . In the yeast Saccharomyces cerevisiae, strains deleted for specific DNA damage and replication checkpoint genes, such as RAD53, MEC1, TEL1, RAD9, RAD17, RAD24 and TOF1, exhibit enhanced sensitivity to CPT and other Top1p poisons 1217 ; . Moreover, cells defective in processive DNA replication due to alterations in Cdc45p or.
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Fig. 7. BN 80915 has strong antiproliferative effects on HT-29 human colon carcinoma cells growing in three dimensions as multicellular spheroids. Exponentially growing cells were exposed to the indicated concentrations of BN 80915 E ; , topotecan ; , or SN-38 , ; , and the growth inhibitory effects were determined after 72 h of continuous drug exposure. Each point is the average of two independent experiments, each done in duplicate. Bars, SD and toremifene.
As daunorubicin, doxorubicin, epirubicin and idarubicin ; , worked by affecting topoisomerase activity.11 In the 1990s, the topoisomerase inhibitors irinotecan and topotecan were introduced. Although these agents have demonstrated antitumour effects in many cancers, the side effects are often quite severe. Several new agents inhibiting topoisomerase are undergoing clinical trials.
Patients sustained a higher CR rate 71% versus 40% ; . Median survival has not yet been observed at 15 months. The incidence of grade 3 or 4 leukopenia rose from 22% to 38%, but was still acceptable. This effort has lead to a phase III trial at Sarah Cannon and affiliates evaluating PET versus PE, with accrual 50% completed. Gatzemeier and colleagues have evaluated the combination of carboplatin and oral etoposide with paclitaxel [92]. Twenty-six patients have been accrued since April 1996. Etoposide was administered at 100 mg daily, days 2 through 8, with carboplatin at an AUC of 5 day 1; paclitaxel was given at 175 mg m2 over one h day 1. The overall response rate was 81%, with 39% CR. Myelosuppression was relatively mild. There were no episodes of grade 3 nonhematologic toxicity. Progression and survival data have not been reported. Non-Etoposide Combinations Finally, other investigators have evaluated the role of paclitaxel in non-etoposide combinations. Jett and colleagues from the University of Pittsburgh examined combination topotecan 1 mg m2 for 30 min daily for five days and paclitaxel 135 mg m2 i.v. over 24 h on day 5 with G-CSF support [93]. Eligibility was restricted to ED SCLC. Eighteen patients were enrolled. Median age was 65. The patient-specific incidence of grade 3 and 4 neutropenia was 89%, over 78% of treatment courses. Ninety-two percent of patients experienced grade 4 thrombocytopenia. The overall response rate was 66%, and the median survival was promising at 59 weeks. Nair and Marschke from the North Central Treatment Group have evaluated cisplatin 75 mg m2 combined with paclitaxel at either 135 mg m2 or 175 mg m2 [94]. Twentythree patients were treated at the lower dose, 48 patients at the higher dose. Seventy-one percent of evaluable patients in the low-dose group, and 89% of evaluable patients at the higher dose had major responses to treatment. The median times to progression in these two groups were 145 days and 167 days, respectively, and the median survivals were 239 days and 267 days, respectively. The estimated one-year survival rates were 24% in the low-dose group and 38% in the high-dose group. Current efforts of the RTOG in limited SCLC focus on combining standard hyperfractionated RT beginning day 1 with etoposide, cisplatin, and paclitaxel RTOG 9609 ; . As of October 1997, this trial has accrued 33 of 52 targeted patients. The ECOG will be assessing the same chemotherapy combination, but XRT will be delayed until day 43 after two cycles of chemotherapy have been given and will be administered on a once-daily basis and torsemide.
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Fig. 3. Effect of treatment with TNBS on muscle contractility in the permeabilized rat colon. A: pCa2 -absolute force. B: the pCa2 -relative force relationship. One hundred percent represents the maximum force induced by 30 M Ca2 with 1 M calyculin-A. Results are expressed as means SE n 12 ; AJP-Gastrointest Liver Physiol VOL.
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With recurrent acute leukemia [31]. Dose escalations were designed to achieve specified incremental increases in the steady-state concentration of the lactone form of topotecan. The investigators measured the steady-state topotecan concentration, then modified the dose as necessary to obtain a concentration within 20% of the target exposure. The maximum tolerated systemic exposure MTSE ; defined in this study was a steady-state concentration of 4.0 ng ml. The topotecan dosage required to achieve this MTSE ranged from 1.6-2.1 mg m2 day. Toxicity Myelosuppression, predominantly neutropenia, was the DLT associated with topotecan in pediatric solid tumor patients regardless of schedule or route of drug administration. Therefore, in some studies a maximum tolerated topotecan dose following the addition of G-CSF was also defined [26, 27]. In general, the addition of G-CSF allowed only one additional dose level increase before thrombocytopenia became dose limiting. Mucositis was the DLT in leukemia patients. Nondose-limiting nonhematologic toxicities associated with topotecan administration in children are similar to those reported in adults. Nonhematologic toxicities included: nausea and vomiting, alopecia, mucositis, elevated liver transaminases, and skin rash pruritus [25, 26, 31, 33]. As in adults, diarrhea was increasingly problematic with protracted dosing schedules as well as after oral drug administration [29, 34]. Phase I Studies of Topotecan in Combination with Other Agents Phase I studies of topotecan in combination with other anticancer agents or treatment modalities were initiated at an.
Conditions.2627 These findings suggest that alterations of cyclic stretching of smooth muscle may influence cellular and extracellular components in the vessel wall and affect vascular growth. The results presented by Christensen1 support the hypothesis that pulse pressure may be a determinant of vascular structure. His findings provide an important step forward in our efforts to understand factors that influence vascular structure. In addition, the findings serve to emphasize the need for further work in this new exciting area to elucidate the mechanism by which pulse pressure influences vascular growth and to clarify the extent to which it acts as a stimulus of altered vascular structure during chronic hypertension. References and trandolapril.
2002; 29: 30-39. Frankel AE, Baer MR, Hogge DE, Stuart RK. Immunotherapy of acute myeloid leukemia. Curr Pharm Biotechnol. 2001; 2: 209-215. Hamblin TJ. Disappointments in treating acute leukemia in the elderly. N Engl J Med. 1995; 332: 1712-1713. Parmar S, Rundhaugen LM, Boehlke L, Riley M, Nabhan C, Raji A, Frater JL, Tallman MS. Phase II trial of arsenic trioxide in relapsed and refractory acute myeloid leukemia, secondary leukemia and or newly diagnosed patients at least 65 years old. Leuk Res. 2004; 28: 909-919. Sun SY, Hail N Jr, Lotan R. Apoptosis as a novel target for cancer chemoprevention. J Natl Cancer Inst. 2004; 96: 662-672. Bomgaars L, Berg SL, Blaney SM. The Development of Camptothecin Analogs in Childhood Cancers. Oncologist. 2001; 6: 506-516. Pizzolato JF, Saltz LB. The camptothecins. Lancet 2003; 361: 2235-2242. Rowinsky EK, Kaufmann SH, Baker SD, Miller CB, Sartorius SE, Bowling MK, Chen TL, Donehower RC, Gore SD. A phase I pharmacological study of topotecan infused over 30 mins for five days in patients with refractory acute leukemia. Clin Cancer Res. 1996; 2: 1921-1930. Weihrauch MR, Staib P, Seiberlich B, Hoffmann M, Diehl V, Tesch H. Phase I II clinical study of topotecan and cytarabine in patients with myelodysplastic syndrome, chronic myelomonocytic leukemia and acute myeloid leukemia. Leuk Lymphoma. 2004; 45: 699-704. Bolanos-Meade J, Guo C, Gojo I, Karp JE. A phase II study of timed sequential therapy of acute myelogenous leukemia AML ; for patients over the age of 60: two cycle timed sequential therapy with topotecan, ara-C and mitoxantrone in adults.
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Formation with 21-day topotecan infusion: A Phase 1 pharmaco-dynamic study. Proc Soc Clin Onc. 14: 1496, 1995 and topotecan.
Fig. 1. Exposure of retinoblastoma cells to topotecan, vincristine, carboplatin, and etoposide in culture. A, Y79 and Weri1 retinoblastoma cell growth properties in RPMI were monitored to determine their optimum growth density. B, cell number, cell viability [calcein ethidium bromide EthBr ; ], and apoptosis TUNEL ; was used to calculate see Materials and Methods ; the viable cell number at each time point. The proportion of BrdU BrdU ; labeled cells representative of the percentage of proliferating cells was determined separately red bars ; . Bars, 10 Am. C, Y79 cells were exposed to different concentrations of topotecan TPT ; , vincristine VCR ; , or carboplatin CBP ; for 8 hours. Seventy-two hours later, the cell number and proportion of metabolically active cells calcein ethidium bromide ; , apoptotic cells TUNEL ; , and dividing cells BrdUrd ; were scored and plotted. The concentration required to reduce cell viability by 50% LC50 ; is indicated by a dashed line. D, vincristine 0.005 Amol L; VCR ; and carboplatin 4 Amol L ; were combined with a broad range of etoposide ETO ; concentrations dashed line ; , and viability was determined forY79 shown ; and Weri1cells. For comparison, a parallel experiment was carried out with etoposide alone solid line ; . Topotecan 0.03 Amol L ; was combined with different concentrations of carboplatin or vincristine concentrations dashed line ; , and viability was determined. For comparison, a parallel experiment was carried out with carboplatin or vincristine treatment alone solid line ; . Points represent duplicate experiments done in triplicate and treprostinil!
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