Aleksander Skotnicki

Publications of Aleksander Skotnicki

• The efficacy and safety of the low-thalidomide dose CTD (cyclophosphamide, thalidomide, dexamethasone) regimen in patients with multiple myeloma--a report by the Polish Myeloma Study Group.

  Authors: Anna Dmoszynska, Adam Walter-Croneck, Iwona Hus, Norbert Grzasko, Joanna Manko, Wieslaw Wiktor Jedrzejczak, Grzegorz Charlinski, Lidia Usnarska-Zubkiewicz, Aleksander Skotnicki, Teresa Wolska-Smolen, Jaroslaw Piszcz, Janusz Kloczko

  Leukemia research. 10/2010; 34(10):1330-5.

  Multiple myeloma (MM) remains an incurable disease, but response rates to new drugs are promising, offering the majority of patients a significant prolongation of overall survival. The objective ofMultiple myeloma (MM) remains an incurable disease, but response rates to new drugs are promising, offering the majority of patients a significant prolongation of overall survival. The objective of this study was to evaluate time to progression (TTP), event-free survival (EFS), and overall survival (OS) in MM patients treated with a combination of cyclophosphamide (CY), thalidomide (THAL) and dexamethasone (DEX). This study included 132 untreated and relapsing/resistant patients treated with the low-thalidomide dose CTD regimen. The patients received CY 500 mg/m(2)i.v. or 625 mg/m(2) orally at day 1, THAL 100mg/day á la longue and DEX 20mg/day at days 1-4 and 8-11, every 28 days. Patients received 6-9 cycles; ORR by 3 months was 59.1%, by 6 months 65.6% and by 9 months 75.6%. In patients responding to CTD therapy (CR, nCR, PR), the probability of survival for 20 months was 89.3%. The outpatient low-thalidomide dose CTD regimen is well tolerated and produces a significant response rate both in untreated and relapsing/resistant MM patients.

• Frequency of BCR-ABL gene mutations in Polish patients with chronic myeloid leukemia treated with imatinib: a final report of the MAPTEST study.

  Authors: Krzysztof Lewandowski, Krzysztof Warzocha, Andrzej Hellmann, Aleksander Skotnicki, Witold Prejzner, Kajetana Foryciarz, Tomasz Sacha, Michał Gniot, Mirosław Majewski, Iwona Solarska, Grazyna Nowak, Bartosz Wasag, Mikołaj Kobelski, Cezary Scibiorski, Marek Siemiatkowski, Maria Lewandowska, Mieczysław Komarnicki

  Polskie archiwum medycyny wewnȩtrznej. 12/2009; 119(12):789-94.

  INTRODUCTION: The presence of BCR-ABL oncogene mutations in patients with chronic myeloid leukemia (CML) may be responsible for the failure of tyrosine kinase inhibitor treatment. OBJECTIVES: The aimINTRODUCTION: The presence of BCR-ABL oncogene mutations in patients with chronic myeloid leukemia (CML) may be responsible for the failure of tyrosine kinase inhibitor treatment. OBJECTIVES: The aim of the study was to evaluate the frequency of BCR-ABL gene mutations in patients with CML (the MAPTEST study) treated with imatinib (IM). PATIENTS AND METHODS: Direct sequencing analysis of BCR-ABL gene was performed in 92 patients treated with IM for more than 3 months. The mean time of IM treatment was 18 months. At the time of the analysis, 75 patients were in the first chronic phase (CP), 4 in the second CP, 5 in the acceleration and 8 in the blastic phase. Fifty-seven patients (62%) were treated with IM at a daily dose of 400 mg and 35 patients with higher doses (600 or 800 mg daily). Inclusion criteria were based on the European Leukemia Net definitions for failure and suboptimal response to IM. RESULTS: Twelve mutations were detected in 11 of 92 patients, including 4 mutations (36.7%) diagnosed during CP, 3 (27.3%) in acceleration, and 4 (36.7%) in blast crisis. In 1 patient with lymphoid blast crisis of CML coexisting F359V and Y253F mutations were detected. In the whole group mutations were detected in 2 of 5 patients (40%) with primary resistance (M351T, F359V + Y253F) and in 9 of 87 patients (10.3%) (E255K, T315I-3x, M351T, E355G, F359V-2x) with acquired resistance to IM. CONCLUSIONS: The study confirmed the usefulness of BCR-ABL gene mutation screening in patients with CML resistant to IM therapy.

• Neopterin and other inflammatory markers in the early period following allogeneic bone marrow transplantation: series of 3 cases.

  Authors: Beata Kuśnierz-Cabala, Dorota Hawrylecka, Patrycja Mensah-Glanowska, Beata Piątkowska-Jakubas, Bogdan Solnica, Aleksander Skotnicki, Paulina Dumnicka

  Polskie archiwum medycyny wewnetrznej. 11/2009; 119(11):756-760.

  The 3 case reports presented here constitute a pilot study assessing the profile of changes in concentrations of selected inflammatory markers, including C-reactive protein, serum amyloid A,The 3 case reports presented here constitute a pilot study assessing the profile of changes in concentrations of selected inflammatory markers, including C-reactive protein, serum amyloid A, neopterin, and interleukin 18, in an early period after allogeneic stem cell transplantation.

• Infectious complications in patients with acute myeloid leukemia treated according to the protocol with daunorubicin and cytarabine with or without addition of cladribine. A multicenter study by the Polish Adult Leukemia Group (PALG).

  Authors: Ewa Lech-Maranda, Marek Seweryn, Sebastian Giebel, Jerzy Holowiecki, Beata Piatkowska-Jakubas, Joanna Wegrzyn, Aleksander Skotnicki, Marek Kielbinski, Kazimierz Kuliczkowski, Monika Paluszewska [......] Barbara Zdziarska, Grazyna Palynyczko, Lech Konopka, Tomasz Szpila, Krzysztof Gawronski, Kazimierz Sulek, Jaroslaw Sokolowski, Janusz Kloczko, Krzysztof Warzocha, Tadeusz Robak

  International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases. 08/2009;

  OBJECTIVES: The addition of cladribine to the standard regimen consisting of daunorubicin and cytarabine has been reported to increase the efficacy of induction therapy in acute myeloid leukemiaOBJECTIVES: The addition of cladribine to the standard regimen consisting of daunorubicin and cytarabine has been reported to increase the efficacy of induction therapy in acute myeloid leukemia (AML). The goal of this study was to determine the effect of this modification on the incidence and spectrum of infectious complications. METHODS: Case report forms of 309 patients with newly diagnosed AML who had been enrolled in the prospective, randomized 'DAC-7 vs. DA-7' trial were reviewed. The frequency, etiology, localization, severity, and outcome of infections were compared for patients receiving only daunorubicin and cytarabine (DA-7) and those additionally treated with cladribine (DAC-7). RESULTS: A total of 443 febrile episodes were reported with no significant difference between the treatment groups. A trend towards a higher frequency of bacteremias was observed among DA-7 patients compared to those in the DAC-7 group (31% vs. 21%; p=0.08). The treatment arms did not differ in terms of the distribution of the isolated Gram-positive, Gram-negative, fungal, and viral organisms. However, when bacteremias were considered, Gram-positive blood cultures tended to be more frequent in the DA-7 compared to the DAC-7 group (16% vs. 8.5%; p=0.07). This difference reached statistical significance when major blood bacteremias were analyzed separately (13% vs. 5%; p=0.02). Complete recovery from infections was observed in the majority of patients across both treatment arms and no significant difference was noted regarding infection-related mortality. CONCLUSIONS: The addition of cladribine to standard induction chemotherapy has no impact on the incidence and spectrum of infectious complications in newly diagnosed AML patients.

• Impact of granulocyte colony stimulating factor administered during induction and consolidation of adults with acute lymphoblastic leukemia on survival: long-term follow-up of the Polish adult leukemia group 4-96 study.

  Authors: Sebastian Giebel, Jerzy Holowiecki, Malgorzata Krawczyk-Kulis, Krystyna Jagoda, Beata Stella-Holowiecka, Maria Sadus-Wojciechowska, Andrzej Hellmann, Anna Dmoszynska, Monika Paluszewska, Tadeusz Robak, Lech Konopka, Ilona Seferynska, Aleksander Skotnicki, Slawomira Kyrcz-Krzemien

  Leukemia & lymphoma. 06/2009;

• Detection of specific lytic and latent transcripts can help to predict the status of Epstein-Barr virus infection in transplant recipients with high virus load.

  Authors: Barbara Zawilinska, Anna Kosinska, Marzena Lenart, Jolanta Kopec, Beata Piatkowska-Jakubas, Aleksander Skotnicki, Magdalena Kosz-Vnenchak

  Acta biochimica Polonica. 12/2008;

  Epstein-Barr virus (EBV), a member of the family Herpesviridae, is widely spread in the human population and has the ability to establish lifelong latent infection. In immunocompetent individuals theEpstein-Barr virus (EBV), a member of the family Herpesviridae, is widely spread in the human population and has the ability to establish lifelong latent infection. In immunocompetent individuals the virus reactivation is usually harmless and unnoticeable. In immunocompromised patients productive infection or type III latency may lead to EBV-associated post-transplant lymphoproliferative disorder (PTLD). The aim of our research was to investigate the utility of PCR-based methods in the diagnosis and monitoring of EBV infections in bone marrow transplant recipients. Thirty-eight peripheral blood leukocyte samples obtained from 16 patients were analysed, in which EBV DNA was confirmed by PCR. We used semi-quantitative PCR to estimate the viral load and reverse-transcription PCR (RT-PCR) to differentiate between latent and productive EBV infection. In 14 patients we confirmed productive viral infection. We observed a correlation between higher number of EBV genome copies and the presence of transcripts specific for type III latency as well as clinical symptoms.

• Dasatinib or high-dose imatinib for chronic-phase chronic myeloid leukemia after failure of first-line imatinib: a randomized phase 2 trial.

  Authors: Hagop Kantarjian, Ricardo Pasquini, Nelson Hamerschlak, Philippe Rousselot, Jerzy Holowiecki, Saengsuree Jootar, Tadeusz Robak, Nina Khoroshko, Tamas Masszi, Aleksander Skotnicki, Andrzej Hellmann, Andrey Zaritsky, Anatoly Golenkov, Jerald Radich, Timothy Hughes, Athena Countouriotis, Neil Shah

  Blood. 06/2007; 109(12):5143-50.

  Therapeutic options for chronic myelogenous leukemia (CML) resistant to 400 to 600 mg imatinib are limited. Escalating imatinib doses may overcome resistance. Dasatinib, a significantly more potentTherapeutic options for chronic myelogenous leukemia (CML) resistant to 400 to 600 mg imatinib are limited. Escalating imatinib doses may overcome resistance. Dasatinib, a significantly more potent inhibitor of BCR-ABL, is safe and effective in this population. Patients with imatinib-resistant chronic-phase (CP) CML were randomized 2:1 to 140 mg dasatinib (n=101) or 800 mg imatinib (n=49). With a median follow up of 15 months, complete hematologic responses were observed in 93% and 82% of patients receiving dasatinib and high-dose imatinib (P=.034), respectively. Dasatinib resulted in higher major cytogenetic response rates (52%) than high-dose imatinib (33%) (P=.023); this included complete cytogenetic response in 40% and 16% (P=.004). Major molecular responses were also more frequent with dasatinib (16% versus 4%; P=0.038). Treatment failure (hazard ratio [HR], 0.16; P<.001) and progression-free survival (HR, 0.14; P<.001) both favored dasatinib. Superficial edema (42% versus 15%) and fluid retention (45% versus 30%) were more prevalent with imatinib; pleural effusion was more common with dasatinib (17% versus 0%). Grade 3 to 4 nonhematologic toxicity was minimal. Cytopenias were more frequent and severe with dasatinib. Dasatinib represents a safe and effective therapy for CP-CML resistant to conventional imatinib doses with improved cytogenetic and molecular response rates and progression-free survival relative to high-dose imatinib.

• Randomized phase III trial of fludarabine plus cyclophosphamide with or without oblimersen sodium (Bcl-2 antisense) in patients with relapsed or refractory chronic lymphocytic leukemia.

  Authors: Susan O'Brien, Joseph O Moore, Thomas E Boyd, Loree M Larratt, Aleksander Skotnicki, Benjamin Koziner, Asher A Chanan-Khan, John F Seymour, R Gregory Bociek, Steve Pavletic, Kanti R Rai

  Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 04/2007; 25(9):1114-20.

  PURPOSE: Expression of Bcl-2 protein is associated with chemotherapy resistance and decreased survival in chronic lymphocytic leukemia (CLL). We evaluated whether oblimersen would improve response toPURPOSE: Expression of Bcl-2 protein is associated with chemotherapy resistance and decreased survival in chronic lymphocytic leukemia (CLL). We evaluated whether oblimersen would improve response to chemotherapy in patients with relapsed or refractory CLL. PATIENTS AND METHODS: Patients had received at least one prior fludarabine-containing regimen and were stratified on the basis of prior fludarabine response, number of prior regimens, and duration of response to last prior therapy. Patients were randomly assigned to 28-day cycles of fludarabine 25 mg/m2/d plus cyclophosphamide 250 mg/m2/d administered intravenously for 3 days with or without oblimersen 3 mg/kg/d as a 7-day continuous intravenous infusion (beginning 4 days before chemotherapy) for up to six cycles. The primary end point was the proportion of patients who achieved complete response (CR) or nodular partial response (nPR). RESULTS: Of 241 patients randomly assigned, CR/nPR was achieved in 20 (17%) of 120 patients in the oblimersen group and eight (7%) of 121 patients in the chemotherapy-only group (P = .025). Achievement of CR/nPR was correlated with both an extended time to progression and survival (P < .0001). In patients who remained sensitive to fludarabine, oblimersen was associated with a four-fold increase in the CR/nPR rate and a significant survival benefit (P = .05). Oblimersen was frequently associated with thrombocytopenia and, rarely, tumor lysis syndrome and cytokine release reactions; the incidence of opportunistic infections and second malignancies was similar in both groups. CONCLUSION: The addition of oblimersen to fludarabine plus cyclophosphamide significantly increases the CR/nPR rate in patients with relapsed or refractory CLL (particularly fludarabine-sensitive patients), as well as response duration among patients who achieve CR/nPR.

• Fludarabine, cytarabine, and mitoxantrone (FLAM) for the treatment of relapsed and refractory adult acute lymphoblastic leukemia. A phase study by the Polish Adult Leukemia Group (PALG).

  Authors: Sebastian Giebel, Malgorzata Krawczyk-Kulis, Maria Adamczyk-Cioch, Beata Jakubas, Grazyna Palynyczko, Krzysztof Lewandowski, Anna Dmoszynska, Aleksander Skotnicki, Katarzyna Nowak, Jerzy Holowiecki

  Annals of hematology. 10/2006; 85(10):717-22.

  Outcome of adults with acute lymphoblastic leukemia (ALL) who fail to achieve complete remission (CR) or who relapse soon after initial response is poor. The goal of this phase II study by the PolishOutcome of adults with acute lymphoblastic leukemia (ALL) who fail to achieve complete remission (CR) or who relapse soon after initial response is poor. The goal of this phase II study by the Polish Adult Leukemia Group (PALG) was to evaluate safety and efficacy of a new salvage regimen (FLAM) consisting of sequential fludarabine, cytarabine, and mitoxantrone. Fifty patients were included with primary (n = 13) or secondary (n = 5) refractoriness, early (<12 months) first relapse (n = 15), first relapse after hematopoietic cell transplantation (HCT) regardless CR duration (n = 13), and second or subsequent relapse (n = 4). Median age was 31(18-60) years, 28% of patients were bcr/abl-positive. CR rate equaled 50% and was significantly higher for patients in whom FLAM was administered as a second-line therapy compared to those more heavily pre-treated (66 vs 13%, p = 0.02). Seventeen patients had leukemia regrowth after initial cytoreduction, whereas, eight patients died in aplasia. The incidence of early death was higher in patients aged > or =40 years compared to the younger subgroup (33 vs 8%, p=0.03). Septic infections were the most frequent severe complication. At 3 years, the probability of disease-free survival for patients who achieved CR equaled 16%. Seven patients underwent allogeneic HCT. FLAM regimen is feasible for relapsed and refractory adults with ALL and could be recommended in particular for younger patients as a second-line treatment. However, as the remission duration is short, allogeneic HCT (alloHCT) should be considered as soon as possible.

• [Epstein-Barr virus (EBV) infections in patients treated with allogenic hematopoietic cells transplantation (allo-HCT)]

  Authors: Barbara Zawilińska, Beata Piatkowska-Jakubas, Jolanta Kopeć, Ewa Daszkiewicz, Ewa Kleszcz, Sława Szostek, Patrycja Mensah-Glanowska, Dorota Hawrylecka, Aleksander Skotnicki

  Przegla̧d epidemiologiczny. 02/2006; 60(1):87-92.

  OBJECTIVE: Assessment of frequency and clinical course of EBV infection in patients that underwent non-manipulated allo-HCT from matched-related donors. METHODS: Active EBV infection was confirmedOBJECTIVE: Assessment of frequency and clinical course of EBV infection in patients that underwent non-manipulated allo-HCT from matched-related donors. METHODS: Active EBV infection was confirmed based on the presence of anti-EA antibodies (ELISA) and/or viral DNA (nPCR) isolated from peripheral leukocytes. For positive DNA-isolations semi-quantitative analysis were done. Patients were examined repeatedly, the time of monitoring was approximately 6 +/- 5 months. RESULTS: Active EBV infection was confirmed in 27 among 56 examined allo-HCT recipients. Primary infection was detected in 5 patients, in the remaining patients it was probably the result of virus reactivation. In most cases EBV-load was approximately 200 copies per 1 million of leukocytes, 1 patient with lymphoproliferative disorder (PTLD) had 2 million copies. EBV infection was asymptomatic in most cases (17), in 7 cases aminotransferase levels were insignificantly increased, in 2--diarrhea was observed and in 4 patients GvHD was intensified. CONCLUSIONS: In recipients without risk of PTLD, permanent monitoring of the EBV-load has no clinical justification.

• The treatment of advanced chronic lower limb ischaemia with marrow stem cell autotransplantation.

  Authors: Rafał Nizankowski, Tomasz Petriczek, Aleksander Skotnicki, Andrzej Szczeklik

  Kardiologia polska. 11/2005; 63(4):351-60; discussion 361.

  INTRODUCTION: Conventional methods of critical leg ischaemia treatment are of limited efficacy. Amputation, as an ultimate solution, is not so rare. The results of marrow stem cell therapy as aINTRODUCTION: Conventional methods of critical leg ischaemia treatment are of limited efficacy. Amputation, as an ultimate solution, is not so rare. The results of marrow stem cell therapy as a potential novel approach to peripheral artery disease management were presented in 2002 by Tateishi-Yuyamy. AIM: To assess efficacy and safety of critical lower limb ischaemia treatment with marrow stem cell autotransplantation. METHODS: Ten patients suffering from chronic leg ischaemia in Fontaine IV stadium were involved in the study. They did not require emergency amputation and had previously been unsuccessfully treated with conventional therapy. Autologic marrow stem cells were condensated by a separator from bone marrow samples taken from the iliac crest. The cells were delivered intramuscularly by repeated injections into the pedal and tibial regions. The number of CD34 and AC133 positive mononuclear cells in each sample was evaluated by flow cytometry. After two weeks and one, two, three and twelve months the following parameters were measured: Laser Doppler Flux (LDF), percutaneous oxygen partial pressure, ankle-brachial index (ABI), visual analgesic scale (VAS), analgesic therapy requirement and ulceration area. Also, lower leg angiography and scintigraphy were performed. RESULTS: An improvement of the peripheral blood flow assessed by Laser Doppler Flux and percutaneous oxygen partial pressure was found. Pain severity decreased in the majority of patients. Amputation was required in three patients in whom the therapy failed. No side effects of the therapy were observed. The clinical effect of the treatment did not correlate with the amount of cells injected. CONCLUSION: Marrow stem cell autotransplantation into the ischaemic lower limb seems to be a potentially effective method of peripheral perfusion enhancement. Further studies are needed to clarify the underlying mechanisms of such improvement.

• The microarray expression analysis identifies BAX as a mediator of beta-carotene effects on apoptosis.

  Authors: Marek Bodzioch, Aldona Dembinska-Kiec, Jadwiga Hartwich, Katarzyna Lapicka-Bodzioch, Agnieszka Banas, Anna Polus, Joanna Grzybowska, Iwona Wybranska, Joanna Dulinska, Dorota Gil, Piotr Laidler, Wojciech Placha, Magdalena Zawada, Agnieszka Balana-Nowak, Tomasz Sacha, Beata Kiec-Wilk, Aleksander Skotnicki, Christoph Moehle, Thomas Langmann, Gerd Schmitz

  Nutrition and cancer. 02/2005; 51(2):226-35.

  Beta-carotene is a ubiquitous compound rich in foods. However, there are conflicting reports regarding its role in carcinogenesis. We performed a microarray expression analysis in normal [humanBeta-carotene is a ubiquitous compound rich in foods. However, there are conflicting reports regarding its role in carcinogenesis. We performed a microarray expression analysis in normal [human umbilical vein endothelial cells (HUVECs)] and neoplastic (melanoma A375 and myelomonocytic leukemia U937) actively proliferating cells and found evidence that beta-carotene stimulated vital cellular functions in the former and suppressed them in the latter. These differential effects correlated with the expression of the proapoptotic BCL2-associated X protein (BAX), which was downregulated in HUVECs and upregulated in the two neoplastic cell lines. The quantitative expression analysis using real-time polymerase chain reaction largely confirmed the inhibition of B-cell CLL/lymphoma 2 (BCL2) pathway-mediated apoptosis in HUVECs and its activation in melanoma and leukemic cells. The assays for apoptosis, detecting DNA breaks and caspase activation, showed consistent proapoptotic and antiapoptotic effects in U937 and HUVEC lines, respectively. However, beta-carotene-induced expression changes of BAX and other BCL2 pathway genes did not lead to the predicted induction of apoptosis in the A375 cells.

• [The role of endothelial progenitor cells for neovascularization].

  Authors: Aldona Dembińska-Kieć, Łukasz Partyka, Anna Polus, Joanna Grzybowska, Beata Kieć-Wilk, Rafał Nizankowski, Aleksander Skotnicki, Antoni Basta, Mariusz Ratajczak

  Kardiologia polska. 12/2003; 59 Suppl 2:II32-40.

• [Autologous hematopoietic stem cell transplantation for the treatment of aggressive non-Hodgkin's lymphoma. The experience of Polish lymphoma research group]

  Authors: Jerzy Hołowiecki, Sebastian Giebel, Jan Walewski, Małgorzata Krawczyk-Kuliś, Andrzej Hellmann, Aleksander Skotnicki, Anna Dmoszyńska, Joanna Romejko, Jarosław Czyz, Wojciech Jurczak, Łucja Kachel, Jerzy Wojnar, Beata Stella-Hołowiecka, Maria Saduś-Wojciechowska, Kazimierz Sułek, Wiesław Jedrzejczak, Tadeusz Robak, Bozena Mariańska, Cezary Szczylik, Krzysztof Warzocha

  Polskie archiwum medycyny wewnȩtrznej. 08/2003; 110(2):863-8.

  We analysed the outcome of 200 patients, aged 38 (13-72) years, with aggressive non-Hodgkin's lymphoma (NHL) treated with high-dose chemotherapy followed by autologous haematopoietic stem cellWe analysed the outcome of 200 patients, aged 38 (13-72) years, with aggressive non-Hodgkin's lymphoma (NHL) treated with high-dose chemotherapy followed by autologous haematopoietic stem cell transplantation (autoHSCT) in ten oncohaematological centres belonging to Polish Lymphoma Research Group (PLRG). The source of stem cells for transplantation was peripheral blood (autoPBSCT, n = 153), bone marrow (autoBMT, n = 40) or both blood and bone marrow (n = 7). The probability of overall survival (OS) and progression-free survival at 10 years was 51% (+/- 7%). The transplant-related mortality rate equalled 7%. In multivariate analysis, the only factor influencing independently the probability of OS was disease status at transplantation (p < 0.00001). The outcome of patients transplanted in first or subsequent complete remission or first partial remission (PR) was significantly better compared with subjects given autoHSCT in PR 2 or those with primary or secondary refractoriness. Regarding histological subtypes, the highest OS rate (87%) was observed for anaplastic large T cell lymphoma. The outcome after autoBMT was better compared with autoPBSCT (OS probability: 67% vs. 43%), although the difference did not reach statistical significance. We conclude that high-dose therapy followed by autoHSCT is an effective option for high-risk aggressive NHL. Remission status is a major factor determining long-term outcome. This should be taken into account when referring patients for autoHSCT.

• G-CSF administered in time-sequenced setting during remission induction and consolidation therapy of adult acute lymphoblastic leukemia has beneficial influence on early recovery and possibly improves long-term outcome: a randomized multicenter study.

  Authors: Jerzy Hołowiecki, Sebastian Giebel, Sławomira Krzemień, Małgorzata Krawczyk-Kuliś, Krystyna Jagoda, Małgorzata Kopera, Beata Hołowiecka, Sebastian Grosicki, Andrzej Hellmann, Anna Dmoszyńska, Monika Paluszewska, Tadeusz Robak, Lech Konopka, Stanisław Maj, Jerzy Wojnar, Maria Wojciechowska, Aleksander Skotnicki, Wojciech Baran, Maria Cioch

  Leukemia & lymphoma. 03/2002; 43(2):315-25.

  Sixty-four untreated adult acute lymphoblastic leukemia (ALL) patients were randomized to receive chemotherapy alone, n = 31 or chemotherapy and granulocyte colony stimulating factor (G-CSF), n = 33.Sixty-four untreated adult acute lymphoblastic leukemia (ALL) patients were randomized to receive chemotherapy alone, n = 31 or chemotherapy and granulocyte colony stimulating factor (G-CSF), n = 33. During induction patients received G-CSF for 5 days between four weekly Epirubicin+Vcr administrations, starting 36 h after each application and finishing 48 h before the next one with the intention to possibly generate a cell cycle dependent protection of normal hematopoietic progenitors and to stimulate granulopoiesis. The complete remission (CR) rate equaled 94% in the G-CSF group and 87% in controls. Patients who received G-CSF, if compared to the controls, had shorter granulocytopenia during induction and consolidation, displayed a lower infection rate, completed the induction-consolidation quicker and stayed shorter in hospital during induction, p < 0.001-0.04. Follow-up at 2 years revealed a rather higher probability of survival (59 vs. 27%, p = 0.04) and a lower relapse rate (32 vs. 60%) in G-CSF arm than in controls. The beneficial influence of G-CSF administered in time-sequenced fashion on survival needs further confirmation.