scholarly journals Hydroxyurea as Part of a Salvage Regimen for Heavily Pretreated Patients With Advanced HIV Infection

Author(s):  
Mathias Grunke ◽  
Claudia Dechant ◽  
Peter L??w ◽  
Astrid Rascu ◽  
Joachim Robert Kalden ◽  
...  
Author(s):  
Mathias Grunke ◽  
Claudia Dechant ◽  
Peter Löw ◽  
Astrid Rascu ◽  
Joachim Robert Kalden ◽  
...  

Author(s):  
Mathias Grunke ◽  
Claudia Dechant ◽  
Peter Löw ◽  
Astrid Rascu ◽  
Joachim Robert Kalden ◽  
...  

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 1-1
Author(s):  
Claudio Cerchione ◽  
Lucio Catalano ◽  
Davide Nappi ◽  
Anna Emanuele Pareto ◽  
Gerardo Musuraca ◽  
...  

Background Pomalidomide is a new generation IMID, with a very good compliance, thanks to oral administration, which can be used also in heavily pretreated patients, in a domestic setting. Aims In this retrospective observational trial, It has been evaluated efficacy and tolerance of pomalidomide plus dexamethasone (PD) as salvage regimen in heavily pretreated patients with relapsed and refractory MM (rrMM), whose prognosis is particularly severe. Methods 57 patients (31 M/26 F), with rrMM, median age at diagnosis 69 years (r. 52-86), and median age at start of treatment 76 years (r.56-90) treated with several lines of treatments (median 7, r. 2-11), every refractory to all the drugs previously received (also Bortezomib, Thalidomide and Lenalidomide), received Pomalidomide-Dexamethasone (Pomalidomide 4 mg for 21 days, Dexamethasone 40 mg days 1,8,15,22, pegfilgrastim day +8) every 28 days, until progression. ISS was equally distributed, and cytogenetic at relapse was evaluable in 14 patients. All the patients had previously been treated with schedule containing bortezomib and IMIDs. 63% (36/57) had undergone at least to a single ASCT. All patients were relapsed and refractory to last therapies received before PD. Results Pomalidomide was well tolerated, with grade 3-4 transfusion-dependent anemia in 58% (33/57) of patients, 44% (23/57) grade 3-4 neutropenia (pegfilgrastim in primary prophylaxis was given, no hospitalization was required, no septic shocks were observed), 40% (23/57) grade 3-4 thrombocytopenia without hemorrhagic events and transfusion-dependence. No severe extra-hematologic toxicity was observed. According to IMWG, ORR1 (≥PR) was 47.3% (27/57: 5 CR, 11 VGPR, 7 PR, 4 MR), but, considering that we are evaluating a cohort of heavily pretreated patients, with poor prognosis, another parameter should be considered, ORR2 (≥SD), considering stable disease as a successful result in progressive MM. ORR2 was 77.1% (17 SD). These can be considered as impressive result in this subset of patients. Oral treatment gives a really good compliance, in frail and unfit patients, and response, when present, is always really fast (median time to response: 2 months (r.1-6)), median OS from diagnosis was 94 months (range 21-234), median OS from start of pomalidomide was 9 months (range 1-25). Nine patients have surprisingly achieved a notable response (3 VGPR, 4 PR, 2 MR) after failure of novel agents (i.e. Carfilzomib, Daratumumab and Pomalidomide). Conclusions Pomalidomide-dexamethasone has shown significant efficacy and a very good compliance, thanks to oral administration, in a particularly severe setting of heavily pretreated patients, relapsed and refractory to all available therapeutic resources, also after failure of novel agents. Disclosures Lucchesi: Novartis: Honoraria; Pfizer: Honoraria; Incyte: Honoraria.


Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 5022-5022
Author(s):  
Claudio Cerchione ◽  
Lucio Catalano ◽  
Davide Nappi ◽  
Anna Emanuele Pareto ◽  
Fabrizio Pane ◽  
...  

Abstract Pomalidomide is a new generation IMID, with a very good compliance, thanks to oral administration, which can be used also in heavily pretreated patients, in a domestic setting. In this retrospective observational trial, It has been evaluated efficacy and tolerance of pomalidomide plus dexamethasone (PD) as salvage regimen in heavily pretreated patients with relapsed and refractory MM (rrMM), whose prognosis is particularly severe. 57 patients (31 M/26 F), with rrMM, median age at diagnosis 69 years (r. 52-86), and median age at start of treatment 76 years (r.56-90) treated with several lines of treatments (median 7, r. 2-11), every refractory to all the drugs previously received (also Bortezomib, Thalidomide and Lenalidomide), received Pomalidomide-Dexamethasone (Pomalidomide 4 mg for 21 days, Dexamethasone 40 mg days 1,8,15,22, pegfilgrastim day +8) every 28 days, until progression. ISS was equally distributed, and cytogenetic at relapse was evaluable in 14 patients. All the patients had previously been treated with schedule containing bortezomib and IMIDs. 63% (36/57) had undergone at least to a single ASCT. All patients were relapsed and refractory to last therapies received before PD. Pomalidomide was well tolerated, with grade 3-4 transfusion-dependent anemia in 58% (33/57) of patients, 44% (23/57) grade 3-4 neutropenia (pegfilgrastim in primary prophylaxis was given, no hospitalization was required, no septic shocks were observed), 40% (23/57) grade 3-4 thrombocytopenia without hemorrhagic events and transfusion-dependence. No severe extra-hematologic toxicity was observed. According to IMWG, ORR1 (≥PR) was 47.3% (27/57: 5 CR, 11 VGPR, 7 PR, 4 MR), but, considering that we are evaluating a cohort of heavily pretreated patients, with poor prognosis, another parameter should be considered, ORR2 (≥SD), considering stable disease as a successful result in progressive MM. ORR2 was 77.1% (17 SD). These can be considered as impressive result in this subset of patients. Oral treatment gives a really good compliance, in frail and unfit patients, and response, when present, is always really fast (median time to response: 2 months (r.1-6)), median OS from diagnosis was 94 months (range 21-234), median OS from start of pomalidomide was 9 months (range 1-25). Nine patients have surprisingly achieved a notable response (3 VGPR, 4 PR, 2 MR) after failure of novel agents (i.e. Carfilzomib, Daratumumab and Pomalidomide). Pomalidomide-dexamethasone has shown significant efficacy and a very good compliance, thanks to oral administration, in a particularly severe setting of heavily pretreated patients, relapsed and refractory to all available therapeutic resources, also after failure of novel agents. Disclosures Martinelli: Stemline Therapeutics: Consultancy; Incyte: Consultancy; Pfizer: Consultancy, Speakers Bureau; Roche: Consultancy; Celgene /BMS: Consultancy, Speakers Bureau; Daichii Sankyo: Consultancy; Jazz Pharmaceuticals: Consultancy; Abbvie: Consultancy; Astellas: Consultancy, Speakers Bureau.


Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 2883-2883
Author(s):  
Christine I. Chen ◽  
Tracy Nagy ◽  
Qi-long Yi ◽  
Armand Keating ◽  
Michael Crump

Abstract Background: Inability to collect adequate numbers of PBSCs remains an obstacle to curative ASCT in heavily pretreated patients with relapsed or refractory lymphoma and other malignancies. Retrospective data from our institution have shown that pts with greater exposure to marrow toxic agents have only a 50% rate of successful stem cell collection versus 87% in pts with lesser exposure. We identified heavily pretreated patients at high risk of mobilization failure as rated by a previously validated chemotherapy scoring system (Drake et al. Br J Hematol, 1997;98:745) and used a more intensive regimen of SCF, G-CSF and CY for first-line stem cell mobilization. Methods: Pts with acute myeloid leukemia (AML) or relapsed/refractory Hodgkin’s disease (HD) or non-Hodgkin’s lymphoma (NHL) with a chemotherapy score >42 were eligible. Following completion of salvage or consolidation chemotherapy, consenting patients were mobilized with CY 2.5 g/m2(day 1), SCF 20 ug/kg/day and G-CSF 10 ug/kg/day, both starting day 4, and continuing until completion of leukapheresis. PBSC collection began day 11 (if PB CD34 cells were >5/mL) and continued to a target of 2 x 106 CD34+ cells/kg or for a maximum of 5 days. Results: Twenty-seven pts were enrolled. Diagnoses: NHL n=22; HD n=1; AML n=4. M:F ratio = 14:13; median age 52 yrs (range 17–63); time from diagnosis to study entry, median 18 mos (range 5–70 mos). Nineteen of 23 lymphoma pts received 6–8 cycles of CHOP/ABVD followed by salvage chemotherapy. The other 4 pts had transformed lymphoma and received CVP or chlorambucil prior to transformation. Sixteen pts responded after 1 salvage regimen; 7 pts required 2 salvage regimens [ESHAP, GDP, DHAP, miniBEAM, or CHOP (for transformed pts)]. AML pts were in CR at time of study entry and had received ≥2 consolidation cycles with high-dose cytarabine. Sixteen of 27 pts (59%)[95% CI 44–78%] were successfully collected (median of 3.21x 106 CD34+ cells/kg (range 2.21–14.41) in a median of 1 apheresis (range 1–5; 11 were collected with a single apheresis). However, 3 of the 4 AML pts did not mobilize. Neutrophils <1.0x109/L and platelets <50x109/L (grade 3) on day 11 (start date for apheresis) were the only factors found to be predictive of collection failure. Age, gender, baseline bloodcounts, LDH, BM involvement, duration of disease, and disease status at study entry (CR/PR) were not associated with mobilization outcome. There were no significant allergic or anaphylactic reactions to the SCF and no grade 4 toxicities seen. Summary: The combination of SCF, G-CSF, and CY results in successful PBSC mobilization in 59% of pts at high risk of failure due to prior heavy chemotherapy exposure. This success rate is not significantly improved over the estimated 50% expected rate with standard G-CSF and CY mobilization. Nevertheless, our approach of selecting high risk pts for alternative strategies may be more rational than incurring the costs and toxicities of repeated mobilization attempts.


Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 5648-5648
Author(s):  
Claudio Cerchione ◽  
Davide Nappi ◽  
Anna Emanuele Pareto ◽  
Fabrizio Pane ◽  
Lucio Catalano

Abstract Background: Pomalidomide is a new generation IMID, with a very good compliance, thanks to oral administration, which can be used also in heavily pretreated patients, in a domestic setting. Aims: In this retrospective observational trial, It has been evaluated efficacy and tolerance of pomalidomide plus dexamethasone (PD) as salvage regimen in heavily pretreated patients with relapsed and refractory MM (rrMM), whose prognosis is particularly severe. Methods: 33 patients (19 M/14 F), with rrMM, median age at diagnosis 69 years (r. 52-84), and median age at start of treatment 76 years (r.56-89) treated with several lines of treatments (median 7, r. 2-11), every refractory to all the drugs previously received (also Bortezomib, Thalidomide and Lenalidomide), received Pomalidomide-Dexamethasone (Pomalidomide 4 mg for 21 days, Dexamethasone 40 mg days 1,8,15,22, pegfilgrastim day +8) every 28 days, until progression. ISS was equally distributed, and cytogenetic was evaluable in 14 patients, and in particular three del13q and one t(11;14) were present. All the patients had previously been treated with schedule containing bortezomib and IMIDs. 60% (20/33) of them had undergone at least to a single ASCT. All patients were relapsed and refractory to last therapies received before PD. Results: Pomalidomide was well tolerated, with grade 3 anemia in 51% (17/33) of patients, 36.3% (12/33) grade 3 neutropenia (pegfilgrastim in primary prophylaxis was given, no hospitalization was required, no septic shocks were observed), 30.3% (10/33) grade 3-4 thrombocytopenia without hemorrhagic events and transfusion-dependence. No severe extra-hematologic toxicity was observed. According to IMWG, ORR1 (≥PR) was 45.4% (15/33: 4 CR, 5 VGPR, 6 PR), but, considering that we are evaluating a cohort of heavily pretreated patients without any other alternative treatment, with really poor prognosis, another parameter should be considered, ORR2 (≥SD), considering stable disease as a successful result in progressive MM. ORR2 was 78.7% (26/33: 4 CR, 5 VGPR, 6 PR, 11 SD). These can be considered as impressive result in this subset of patients. Oral treatment gives a really good compliance, in frail and unfit patients, and response, when present, is always really fast (median time to response: 2 months (r.1-6)), median OS from diagnosis was 92 months (range 21-234), median OS from start of pomalidomide was 9 months (range 1-25). Conclusions: Pomalidomide-dexamethasone has shown significant efficacy and a very good compliance, thanks to oral administration, in a particularly severe setting of heavily pretreated patients, relapsed and refractory to all available therapeutic resources. Disclosures No relevant conflicts of interest to declare.


1995 ◽  
Vol 13 (8) ◽  
pp. 2056-2065 ◽  
Author(s):  
J S Abrams ◽  
D A Vena ◽  
J Baltz ◽  
J Adams ◽  
M Montello ◽  
...  

PURPOSE To provide paclitaxel, an investigational drug at the inception of this study, to women with chemotherapy-refractory metastatic breast cancer and to evaluate response and toxicity in these patients. PATIENTS AND METHODS Two hundred sixty-seven patients with progressive disease (PD) following at least two chemotherapy regimens for metastatic breast cancer and a contraindication to further doxorubicin treatment received paclitaxel either at 175 mg/m2 intravenously (IV) over 24 hours or at 135 mg/m2 if they had prior irradiation to 30% of marrow-bearing bone or a cumulative dose of mitomycin > or = 20 mg/m2. RESULTS In a subgroup of patients (n = 172) with measurable disease, four complete responses (CRs) and 36 partial responses (PRs) occurred, for an overall response rate of 23% (95% confidence interval [CI], 17% to 30%). No differences in response rates were noted according either to the number of prior chemotherapy regimens received or to whether patients were considered refractory to doxorubicin. The dose and schedule used in this trial resulted in febrile neutropenia in 45% of patients and a hospitalization rate of 49%. CONCLUSION Paclitaxel's activity in this multiinstitutional trial in heavily pretreated patients confirms the encouraging results attained in single-institution trials. Although at this dose and schedule paclitaxel may be considered too myelosuppressive for palliative care, supportive measures such as colony-stimulating factors and antibiotics were not used prophylactically. Current research efforts are focusing on whether paclitaxel's activity against breast cancer is dose- and/or schedule-dependent, and on what role it has in patients with less advanced disease.


2017 ◽  
Vol 40 (2) ◽  
pp. 140-145 ◽  
Author(s):  
Joseba Rebollo ◽  
Manuel Sureda ◽  
Elena M. Martinez ◽  
Francisco J. Fernández-Morejón ◽  
José Farré ◽  
...  

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