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H8 COMBINATION OF IDARUBICIN, ETOPOSIDE, CITARABINE AND DESAMETASONE IVAD ; IN RELAPSED OR REFRACTORY NONHODGKIN'S LYMPHOMA NHL ; M. Vinci, A. Romanelli, L. Tedeschi, A. Miedico, D. Tabiadon, G. Luporini Oncology Dept, San Carlo Borromeo Hospital, Milan, Italy Introduction: Different therapies can be used to treat relapsed or refractory NHL and these should be based on drugs not included in front-line chemotherapy. For patients who are not transplant candidates and for those who the treatments generally have a palliative intent, the optimal salvage therapy remains to be defined. We evaluated the toxicity and efficacy of the combination of idarubicin, etoposide, citarabine and desametasone in unfavorable lymphoma-relapsed or -resistant to prior doxorubicin- or mitoxantrone-based regimens. Patients and methods: Ten patients pts ; with refractory or relapsed NHL 7 large B cell; 3 follicular ; were assessed. All pts had relapsed after or failed to respond to anthracycline-based regimen and six of them had received 2 or more regimens of chemotherapy. Median age was 62 years range 5672 ; and PS 12. Treatment was given on an outpatient basis: idarubicin 12 mg m2 e.v. day 1, etoposide 150 mg m2 ev 2 h c.i day 1, citarabine 500 mg m2 e.v. 3 h c.i. day 1 and desametasone 20 mg m2 o.s. days 15. All pts received preventive treatment with fluconazole, ciprofloxacine and ranitidine during treatment. Response was assessed after 3 cycles and responders continued for up 6 cycles. Results: A total of 43 cycles were delivered. The overall response rate to IVAD was 60% after 3 cycles and three of these pts 50% ; achieved a complete remission after 6 cycles.The duration of CRs was 10 + , 20 and 21 + months. One of the 3 pts in PR died of causes unrelated to lymphoma.The OS rate for all pts was 13 + months range 1 + 43 .The main toxicity was hematological: afebrile neutropenia grade 3 occurred in 4 pts and grade 4 in 3 pts; no thrombocytopenias grade 34 were observed. Extra-hematologic toxicities were insignificant and no pts died from causes related to therapy. Conclusions: IVAD appears to be a feasible treatment with acceptable toxicity. It has an interesting rate and duration of response in the salvage and palliative setting of heavly pretreated pts with relapsed or refractory NHL. A larger number of pts should be treated to confirm these prelimirary suggestions.
ABSTRACT The role of all-trans retinoic acid ATRA ; in pediatric acute promyelocytic leukemia APL ; is the topic of several ongoing studies. The results of the Italian pediatric experience with the multicentric GIMEMA-AIEOP "AIDA" trial are presented. Of the 983 patients with APL enrolled in this protocol between January 1993 and June 2000, 124 13% ; had less than 18 years. Treatment consisted of ATRA and Idarubicin induction followed by 3 polychemotherapy consolidation courses. Molecular response by RT-PCR was assessed after consolidation and patients who were PCR-negative were randomized for different maintenances. One hundred and seven children were eligible and evaluable for induction: 103 96% ; achieved an hematological complete remission. Overt ATRA syndrome was observed in 2 patients and pseudotumor cerebri in 10. Ninety four patients were evaluable for RT-PCR analysis at the end of consolidation: 91 97% ; proved PCRnegative and 3 PCR-positive. The overall survival and event-free-survival EFS ; are 89% 95% c.i: 83-95% ; and 76% c.i: 65-85% ; , respectively, at more than 10 years. The WBC count at diagnosis 10 x 109 l had a significant impact on EFS 59% vs 83%, at 10 years ; . These results highlight the efficacy and feasibility of the AIDA protocol in the pediatric APL population.
Objective: Primary objectives are: to estimate the median and 2 year overall survival; to estimate the risk of late neurotoxicity relative to results achieved in TROG 92.01. Secondary objectives are: assess acute toxicity; assess functional indices of living in patients with PCNSL. Accrual: 14 patients accrued from 8 centres. Another 4 centres have ethics approval with 3 centres pending. Acute Toxicity: A 21% grade 3 and 64% grade 4 neutropenia rate has been observed. Febrile neutropenia: 14% grade 3 and 14% grade 4. Thrombocytopenia: 28% grade 3 and 7% grade 4. The recommended action is the routine use of Filgrastim following Idarubicin D1 and D22 and a dose reduction of Idarubicin 25% following febrile neutropenia cycle 1. The trial was suspended in order to review the neutropenia rate with a likely dose reduction of 20-25% Idarubicin. Outcomes: Of the 14 patients accrued 5 have died 1 disease progression, 2 disease related, 1 CVA, 1 treatment related ; . Eight of the nine patients alive have completed the full protocol. Funding: Central data management and institutional support from Pfizer.
Induction therapy consisted of ara-c 200 mg m 2 , continuous infusion, days 1– 7 ; with either zorubicin zrb ; 200 mg m 2 days 1– 4 ; or idarubicin idr ; 8 mg m 2 days 1– 5.
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The level of RS in the diet. An undigested protein, containing the essential amino acids, seems to be present in the intestine of chicks fed RS. The eleetrophoretic pat tern of soluble intestinal protein is in AA mg 100 mg protein agreement with the above assumption. The protein presence of this protein fraction becomes obvious by increasing the dietary level of RS protein from 15 to 22% . The results in dicate the inhibition of protein digestion by factors present in the RS meal. The amino acid composition obtained by hydrolysis of the intestinal contents of chicks fed the different meals at different levels was very similar for the four groups. This intestinal amino acid composition was compared with that of soybean meal as reported by Rackis et al. 8 ; and found to be very similar. These findings agree with the conclusion of Crompton and Nesheim 9 ; that "the dilution of dietary pro tein by endogenous protein was insufficient to mask the AA pattern of ingested pro tein." Our experiments with chicks can be compared with the above experiment of 4The Crompton and Nesheim with ducks, as in the 10 in HS RSvein ofthe both experiments the conditions were of sample ; HS RS heartHS steady state, without fasting. RS The FAA pattern of the intestinal con " tents reflects more clearly the digestion of dietary protein than does the pattern of the blood plasma. It has been reported that the FAA pattern of blood plasma from the heart reflects the availability of amino acids from different dietary proteins 10, 11 ; . The ratios obtained in this report from heart plasma of HS and RS groups cor respond to the ratio calculated from the results of Smith and Scott 11 ; for HSand RS-containing diets. One of the aims of the present research was to check whether the FAA pattern of hepatic portal vein plasma is a better indicator of the availability of amino acids than that of heart plasma. The differences between the FAA of HS and RS diets are more pro DISCUSSION nounced in the hepatic portal vein than in The FAA pattern of the intestinal con the heart plasma. tents points to an overall reduction in The FAA pattern of the small intestine amino acid availability in chicks on the RS can serve for comparison of actual amino diet. A more pronounced effect was ob acid availability of protein feeds from the tained for some of the essential amino same source, processed differently or con acids, which was intensified by increasing taining inhibitors and ifex.
Table 1. Emetic risk of intravenous antineoplastic agents Emetic risk estimated incidence without prophylaxis ; High 90% ; Agent of emesis Cisplatin Mechlorethamine Streptozotocin Cyclophosphamide 1500 mg m2 Carmustine Dacarbazine Oxaliplatin Cytarabine 1 gm m2 Carboplatin Ifosfamide Cyclophosphamide 1500 mg m2 Doxorubicin Daunorubicin Epirubicin Idarubicin Irinotecan Paclitaxel Docetaxel Mitoxantrone Topotecan Etoposide Pemetrexed Methotrexate Mitomycin Gemcitabine Cytarabine 100 mg m2 5-Fluorouracil Bortezomib Cetuximab Trastuzumab Bleomycin Busulfan 2-Chlorodeoxyadenosine Fludarabine Vinblastine Vincristine Vinorelbine Bevacizumab.
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FIG. 2. Time-dependent sperm immobilization in the presence of cyclohexenyl thiourea and urea derivatives. Highly motile fraction of sperm 107 ml; 95% progressively motile with curvilinear velocity 100 m sec ; were incubated at 37 C assay medium in the presence of 500 M of bromo compound 5a ; - or chloro compound 6a ; -substituted cyclohexenyl thiourea or their structural urea analogs compounds 5b and 6b ; or 0.5% DMSO alone. Samples were analyzed by CASA just prior to and following addition of the test agents 30 sec ; and at timed intervals of 1 min for up to 10 min for compounds 5b and 6b and every 10 min for up to 180 min for compounds 5a and 6a. Each data point represents the mean from 35 independent experiments. T1 2 values were obtained by nonlinear regression analysis.
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To permit comparison between growth hormone GH ; results obtained using the Pharmacia polyclonal assay and the Delfia monoclonal assay, we used both methods to measure GH concentrations in peak GH responses to the PD-GHRH ; test and in unstimulated samples from 40 healthy adults and 31 patients with suspected GH deficiency. Ratio plots were used for the comparison, and acceptability criteria were based on inherent analytical imprecision and on analytical quality specifications. The mean ratio r; Pharmacia Delfia ; for the peak GH responses in 40 healthy adults was calculated to be 1.59, and the 95% prediction interval for ratios fulfilling the imprecision criterion was applied. For GH values 1 mIU L, the peak and unstimulated GH ratios in healthy adults and patients were within the 95% prediction interval, and fulfilled the biological criterion as well. Therefore, the conversion factor of 1.59 is applicable for the evaluation of GH-stimulation tests. The diagnosis of growth hormone deficiency GHD ; 3 in adults is a clinical challenge. It requires clinical experience and demands reliable diagnostic tools in particular a reliable method for measuring serum growth hormone GH ; . Plasma contains 100 forms of GH, and what is commonly understood as "plasma GH, " i.e., the free monomeric 22-kDa form, represents only 21% of the total immunoreactivity in plasma 1 ; . However, the 22-kDa form of GH is the most prevalent form and is the prototype of pituitary GH. This form is a single-chain, 191-amino acid protein. The 20-kDa form is the second most abundant in the circulation. During peak secretion, the relative amounts of the 22-kDa and 20-kDa forms are fairly stable and independent of secretagogues 2 ; , the relative mean percentage concentrations being 76.4% and 15.8%, respectively. This is in contrast to the basal state, where only a fraction of immunoreactive GH in the blood can be attributed to known GH forms 3 ; . From the above description of the nonhomogeneity of GH, it is clear that the antibodies used in an assay would be of great importance. The use of polyclonal antibodies would yield higher results, because epitopes on different GH forms could bind the antibodies, in contrast to monoclonal antibodies directed only against the 22-kDa form of GH. The degree of cross-reactivity for the monoclonal and polyclonal assays has been quantified and specific differences between the two methods shown 4 ; . Because we previously had evaluated a new stimulation test, the PD-GHRH ; test, including a reliable cutoff limit for the test 5 ; , it was with some doubt we started comparisons between the well-established Pharmacia assay and the new Delfia assay. The problems with hormones in general, e.g., deterioration and lack of transferability, and with GH in particular suggested that it would be difficult to compare results obtained from the Pharmacia method based on polyclonal antibodies and those obtained from the Delfia method using monoclonal antibodies specific to the 22kDa GH form of the hormone. The difficulties with comparisons between assays were demonstrated in a recent paper 4 these difficulties may contribute to the lack of confidence in GH stimulation tests 6 ; . To permit comparison between results obtained with the Pharmacia and the Delfia methods, we used both methods to measure GH concentrations in samples from 71 individuals: 40 healthy adults and 31 patients with suspected GHD. Both basal samples and peak GH responses after stimulation with pyridostigmine PD ; in combination with GHRH were studied. We chose to compare the results using ratio plots, a modification of the.
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Several of trials have compared the two induction regimens , with the majority demonstrating a cr advantage in the idarubicin arm but no reproducible survival advantage.
F ~ g RV-CM Rg Developing capsids. Note the frayed appearance of the spec~allzed end arrows ; An abnormally short nucleocapsid is also present. Bar 93 m. nc: nucleocapsid. Fig, Developing parbcles of dtffetent ages associated with the same plece of membrane. Bar 93nm.c: capsid; CO: capsid originator: nc: n ~ c 7.Empty c a p Fig. and nucleocapsld apparently occupying the same envelope. Bar 93 nm. c : capsid; nc: sucleocapsid. Wg. Montage of abnormally long and short capsids Bar 93 nm. sa: specialized apex and intal.
Patients Eligibility criteria for entering the study were unequivocal diagnosis of de novo AML based on morphologic, cytochemical, and immunophenotypical criteria20, 21; phenotypically aberrant blast cells at diagnosis10, 13; mCR with induction therapy22; and corresponding mCR BM sample for immunophenotypical investigation of MRD. Overall, 126 consecutive patients with AML fulfilled these prerequisites and were included in the present study. The initial series of patients consisted on 233 consecutive patients with de novo AML; of these, 175 patients 75% ; displayed aberrant immunophenotypes at diagnosis. Among these patients, 126 72% ; achieved mCR and are the focus of the present study. Fifty-two of the 126 patients are described in a preliminary report.3 Sixty-five are men and 61 are women, and their mean age is 43 18 years median, 42 years ; . Distribution according to FrenchAmericanBritish FAB ; classification was as follows: M0 11 patients ; , M1 21 patients ; , M2 19 patients ; , M3 44 patients ; , M4 14 patients ; , M5 16 patients ; , and M6 1 patient ; . Median ages of patients with and without APL were 39 17 and 45 18 years, respectively. All patients were uniformly treated according to the Spanish Pethema Cooperative group protocols of 1991 and 1996. Remission-induction therapy included 1 or 2 courses of anthracycline 60 mg m2 daunorubicin or 12 mg m2 idarubicin ; and cytosine arabinoside ARA-C ; 200 mg m2 101 patients were administered one course, and the remaining 25 were administered 2 courses. Subsequently, all patients underwent one identical consolidation cycle, followed by intensification therapy with 2 courses of high-dose ARA-C 3 g m2 every 12 hours for a total of 8 dosages ; and either daunorubicin 45 mg m2 ; or idarubicin 12 mg m2 ; for 3 days. In 16 patients, intensification chemotherapy was replaced by an autologous transplantation, and in 12 patients it was replaced by allogeneic stem cell transplantation. Relapse-free survival and overall survival times were not significantly different in patients who underwent transplantation than in those receiving conventional chemotherapy P .8 ; . Forty of the 44 M3 patients were uniformly treated with all-trans retinoic acid plus chemotherapy.7, 8 Overall, the mean follow-up time was 28 23 months median, 20 months ; , and 42 patients have already relapsed. Median overall and relapse-free survival times are 79 and 67 months, respectively. Morphologic CR was defined by the criteria proposed by Cheson at al22: 1 ; less than 5% blast cells without detectable Auer rods in a BM sample displaying more than 20% cellularity with maturation of all hemopoietic cell lines in the BM aspirate; 2 ; absence of extramedullary leukemia; 3 ; absence of leukemic blasts in PB; and 4 ; PB neutrophil count greater than 1.5 109 L and platelet count greater than 100 109 L. The following variables collected at diagnosis were included in the database: age, white blood cell WBC ; count, platelet count, hemoglobin and idarubicin.
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TABLE I Effects of different substrates on therate of oxygen uptake and the steady state reduction of cytochrome b 6 in inner membranes from E. ~ coli strain GR84NhNGlOl.
At 10 4; in addition patients 16 and 18 were negative at complete remission CR ; and patients 17 and 19 were positive; none of these patients received idarubicin and none have yet had follow-up polymerase chain reaction PCR ; tests. From CR date. PCR showed the long isoform although at presentation only the short form was detected, suggesting that 5-month result was a false positive; the PCRs at 9 and 11 months were negative, adding credence to this suggestion. PCR showed the short isoform although at presentation only the long form was detected, suggesting that 5-month result was a false positive; the PCR at 8 months was negative, supporting this suggestion. But t 15; 17 ; present at diagnosis and iressa.
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