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1. Long-term results of all-trans retinoic acid and arsenic trioxide in non-high-risk acute promyelocytic leukemia: update of the APL0406 Italian-German randomized trial

Author

Cicconi, L, Platzbecker, U, Avvisati, G, Paoloni, F, Thiede, C, Vignetti, M, Fazi, P, Ferrara, F, Divona, M, Albano, F, Efficace, F, Sborgia, M, Di Bona, E, Breccia, M, Borlenghi, E, Cairoli, R, Rambaldi, A, Melillo, L, La Nasa, G, Fiedler, W, Brossart, P, Hertenstein, B, Salih, H, Annibali, O, Wattad, M, Lubbert, M, Brandts, C, Hanel, M, Rollig, C, Schmitz, N, Lin, H, Frairia, C, Fozza, C, Maria D’Arco, A, Di Renzo, N, Cortelezzi, A, Fabbiano, F, Dohner, K, Ganser, A, Dohner, H, Amadori, S, Mandelli, F, Teresa Voso, M, Ehninger, G, Schlenk, R, Lo-Coco, F, Cicconi L, Platzbecker U, Avvisati G, Paoloni F, Thiede C, Vignetti M, Fazi P, Ferrara F, Divona M, Albano F, Efficace F, Sborgia M, Di Bona E, Breccia M, Borlenghi E, Cairoli R, Rambaldi A, Melillo L, La Nasa G, Fiedler W, Brossart P, Hertenstein B, Salih HR, Annibali O, Wattad M, Lubbert M, Brandts C, Hanel M, Rollig C, Schmitz N, Lin H, Frairia C, Fozza C, Maria D’Arco A, Di Renzo N, Cortelezzi A, Fabbiano F, Dohner K, Ganser A, Dohner H, Amadori S, Mandelli F, Teresa Voso M, Ehninger G, Schlenk RF, Lo-Coco F., Cicconi, L, Platzbecker, U, Avvisati, G, Paoloni, F, Thiede, C, Vignetti, M, Fazi, P, Ferrara, F, Divona, M, Albano, F, Efficace, F, Sborgia, M, Di Bona, E, Breccia, M, Borlenghi, E, Cairoli, R, Rambaldi, A, Melillo, L, La Nasa, G, Fiedler, W, Brossart, P, Hertenstein, B, Salih, H, Annibali, O, Wattad, M, Lubbert, M, Brandts, C, Hanel, M, Rollig, C, Schmitz, N, Lin, H, Frairia, C, Fozza, C, Maria D’Arco, A, Di Renzo, N, Cortelezzi, A, Fabbiano, F, Dohner, K, Ganser, A, Dohner, H, Amadori, S, Mandelli, F, Teresa Voso, M, Ehninger, G, Schlenk, R, Lo-Coco, F, Cicconi L, Platzbecker U, Avvisati G, Paoloni F, Thiede C, Vignetti M, Fazi P, Ferrara F, Divona M, Albano F, Efficace F, Sborgia M, Di Bona E, Breccia M, Borlenghi E, Cairoli R, Rambaldi A, Melillo L, La Nasa G, Fiedler W, Brossart P, Hertenstein B, Salih HR, Annibali O, Wattad M, Lubbert M, Brandts C, Hanel M, Rollig C, Schmitz N, Lin H, Frairia C, Fozza C, Maria D’Arco A, Di Renzo N, Cortelezzi A, Fabbiano F, Dohner K, Ganser A, Dohner H, Amadori S, Mandelli F, Teresa Voso M, Ehninger G, Schlenk RF, and Lo-Coco F.

Published
2020

2. VERY LONG-TERM RESULTS OF ALL-TRANS RETINOIC ACID AND ARSENIC TRIOXIDE IN NON-HIGH RISK ACUTE PROMYELOCYTIC LEUKEMIA: LATEST UPDATE OF THE ITALIAN-GERMAN APL0406 RANDOMIZED TRIAL

Author

Cicconi, L, Platzbecker, U, Avvisati, G, Paoloni, F, Thiede, C, Vignetti, M, Fazi, P, Ferrara, F, Divona, M, Albano, F, Efficace, F, Sborgia, M, Di Bona, E, Breccia, M, Borlenghi, E, Cairoli, R, Rambaldi, A, Melillo, L, La Nasa, G, Fiedler, W, Brossart, P, Hertenstein, B, Salih, H, Annibali, O, Wattad, M, Lubbert, M, Brandts, C, Hanel, M, Rollig, C, Schmitz, N, Lin, H, Frairia, C, Fozza, C, Maria D’Arco, A, Di Renzo, N, Cortelezzi, A, Fabbiano, F, Dohner, K, Ganser, A, Dohner, H, Amadori, S, Mandelli, F, Teresa Voso, M, Ehninger, G, Schlenk, R, Lo-Coco, F, Cicconi L, Platzbecker U, Avvisati G, Paoloni F, Thiede C, Vignetti M, Fazi P, Ferrara F, Divona M, Albano F, Efficace F, Sborgia M, Di Bona E, Breccia M, Borlenghi E, Cairoli R, Rambaldi A, Melillo L, La Nasa G, Fiedler W, Brossart P, Hertenstein B, Salih HR, Annibali O, Wattad M, Lubbert M, Brandts C, Hanel M, Rollig C, Schmitz N, Lin H, Frairia C, Fozza C, Maria D’Arco A, Di Renzo N, Cortelezzi A, Fabbiano F, Dohner K, Ganser A, Dohner H, Amadori S, Mandelli F, Teresa Voso M, Ehninger G, Schlenk RF, Lo-Coco F., Cicconi, L, Platzbecker, U, Avvisati, G, Paoloni, F, Thiede, C, Vignetti, M, Fazi, P, Ferrara, F, Divona, M, Albano, F, Efficace, F, Sborgia, M, Di Bona, E, Breccia, M, Borlenghi, E, Cairoli, R, Rambaldi, A, Melillo, L, La Nasa, G, Fiedler, W, Brossart, P, Hertenstein, B, Salih, H, Annibali, O, Wattad, M, Lubbert, M, Brandts, C, Hanel, M, Rollig, C, Schmitz, N, Lin, H, Frairia, C, Fozza, C, Maria D’Arco, A, Di Renzo, N, Cortelezzi, A, Fabbiano, F, Dohner, K, Ganser, A, Dohner, H, Amadori, S, Mandelli, F, Teresa Voso, M, Ehninger, G, Schlenk, R, Lo-Coco, F, Cicconi L, Platzbecker U, Avvisati G, Paoloni F, Thiede C, Vignetti M, Fazi P, Ferrara F, Divona M, Albano F, Efficace F, Sborgia M, Di Bona E, Breccia M, Borlenghi E, Cairoli R, Rambaldi A, Melillo L, La Nasa G, Fiedler W, Brossart P, Hertenstein B, Salih HR, Annibali O, Wattad M, Lubbert M, Brandts C, Hanel M, Rollig C, Schmitz N, Lin H, Frairia C, Fozza C, Maria D’Arco A, Di Renzo N, Cortelezzi A, Fabbiano F, Dohner K, Ganser A, Dohner H, Amadori S, Mandelli F, Teresa Voso M, Ehninger G, Schlenk RF, and Lo-Coco F.

Published
2019

3. Characteristics and outcome of patients with core-binding factor acute myeloid leukemia and FLT3-ITD: results from an international collaborative study

Author

Kayser S, Kramer M, Martinez-Cuadron D, Grenet J, Metzeler K, Sustkova Z, Luskin M, Brunner A, Elliott M, Gil C, Marini S, Racil Z, Cetkovsky P, Novak J, Perl A, Platzbecker U, Stolzel F, Ho A, Thiede C, Stone R, Rollig C, Montesinos P, Schlenk R, and Levis M

Subjects
Adult, Aged, 80 and over, Core Binding Factors, Remission Induction, Hematopoietic Stem Cell Transplantation, Middle Aged, Prognosis, Leukemia, Myeloid, Acute, Young Adult, fms-Like Tyrosine Kinase 3, Mutation, Humans, Aged, Retrospective Studies
Abstract

The aim of this study was to evaluate the prognostic impact of FLT3-ITD in core-binding factor acute myeloid leukemia (CBFAML) in an international, multicenter survey of 97 patients of whom 52% had t(8;21)(q22;q22) and 48% had inv(16)(p13q22)/t(16;16)(p13;q22). The median age of the patients was 53 years (range, 19-81). Complete remission after anthracycline-based induction (n=86) and non-intensive therapy (n=11) was achieved in 97% and 36% of the patients, respectively. The median follow-up was 4.43 years (95% confidence interval [95% CI]: 3.35-7.39 years). The median survival after intensive and non-intensive treatment was not reached and 0.96 years, respectively. Among intensively treated patients, inv(16) with trisomy 22 (n=11) was associated with a favorable 4-year relapse-free survival rate of 80% (95% CI: 59-100%) as compared to 38% (95% CI: 27-54%; P=0.02) in all other patients with CBFAML/ FLT3-ITD (n=75). Overall, 24 patients underwent allogeneic hematopoietic cell transplantation (HCT), 12 in first complete remission and 12 after relapse. Allogeneic HCT in first complete remission was not beneficial (P=0.60); however, allogeneic HCT seemed to improve median survival in relapsed patients compared to that of patients treated with chemotherapy (not reached vs. 0.6 years, respectively; P=0.002). Excluding patients with inv(16) with trisomy 22, our data indicate that compathe outcome of CBF-AML patients with FLT3-ITD may be inferior to that of patients without FLT3-ITD (based on previously published data), suggesting that prognostically CBF-AML patients with FLT3-ITD should not be classified as favorable-risk. FLT3-inhibitors may improve the outcome of these patients.

Published
2021

4. VERY LONG-TERM RESULTS OF ALL-TRANS RETINOIC ACID AND ARSENIC TRIOXIDE IN NON-HIGH RISK ACUTE PROMYELOCYTIC LEUKEMIA: LATEST UPDATE OF THE ITALIAN-GERMAN APL0406 RANDOMIZED TRIAL

Author

Cicconi L, Platzbecker U, Avvisati G, Paoloni F, Thiede C, Vignetti M, Fazi P, Ferrara F, Divona M, Albano F, Efficace F, Sborgia M, Di Bona E, Breccia M, Borlenghi E, Cairoli R, Rambaldi A, Melillo L, La Nasa G, Fiedler W, Brossart P, Hertenstein B, Salih HR, Annibali O, Wattad M, Lubbert M, Brandts C, Hanel M, Rollig C, Schmitz N, Lin H, Frairia C, Fozza C, Maria D’Arco A, Di Renzo N, Cortelezzi A, Fabbiano F, Dohner K, Ganser A, Dohner H, Amadori S, Mandelli F, Teresa Voso M, Ehninger G, Schlenk RF, Lo-Coco F., Cicconi, L, Platzbecker, U, Avvisati, G, Paoloni, F, Thiede, C, Vignetti, M, Fazi, P, Ferrara, F, Divona, M, Albano, F, Efficace, F, Sborgia, M, Di Bona, E, Breccia, M, Borlenghi, E, Cairoli, R, Rambaldi, A, Melillo, L, La Nasa, G, Fiedler, W, Brossart, P, Hertenstein, B, Salih, H, Annibali, O, Wattad, M, Lubbert, M, Brandts, C, Hanel, M, Rollig, C, Schmitz, N, Lin, H, Frairia, C, Fozza, C, Maria D’Arco, A, Di Renzo, N, Cortelezzi, A, Fabbiano, F, Dohner, K, Ganser, A, Dohner, H, Amadori, S, Mandelli, F, Teresa Voso, M, Ehninger, G, Schlenk, R, and Lo-Coco, F

Subjects
Hematology
Published
2019

5. PF261 A RANDOMIZED, OPEN‐LABEL, PHASE II STUDY OF SELINEXOR VERSUS PHYSICIAN'S CHOICE (PC) IN OLDER PATIENTS WITH RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML)

Author

Sweet, K., primary, Blum, W., additional, Donner, H., additional, Flinn, I., additional, Frankfurt, O., additional, Heuser, M., additional, Kota, V., additional, Liu, H., additional, Raffoux, E., additional, Roboz, G., additional, Rollig, C., additional, Savona, M., additional, Showel, M., additional, Strickland, S., additional, Vives, S., additional, Tang, S., additional, Unger, T., additional, Kauffman, M., additional, Shah, J., additional, Shacham, S., additional, and Montesinos, P., additional

Published
2019
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6. Carfilzomib and dexamethasone versus bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma (ENDEAVOR): And randomised, phase 3, open-label, multicentre study

Author

Dimopoulos, Ma, Moreau, P, Palumbo, A, Joshua, D, Pour, L, Hájek, R, Facon, T, Ludwig, H, Oriol, A, Goldschmidt, H, Rosiñol, L, Straub, J, Suvorov, A, Araujo, C, Rimashevskaya, E, Pika, T, Gaidano, G, Weisel, K, Goranova Marinova, V, Schwarer, A, Minuk, L, Masszi, T, Karamanesht, I, Offidani, M, Hungria, V, Spencer, A, Orlowski, Rz, Gillenwater, Hh, Mohamed, N, Feng, S, Chng, Wj, ENDEAVOR Investigators: Leahy, M, Kerridge, I, Durrant, S, Cooney, J, Horvath, N, Rowlings, P, Hahn, U, Fay, K, Renwick, W, Quach, H, Taylor, K, Ho, Sj, Johnston, A, Kasparu, H, Delforge, M, Schots, H, Vekemans, Mc, Offner, F, Wu, Kl, Doyen, C, Bittencourt, R, Duarte, G, Maiolino, A, Schaan, M, Scheliga, A, Zadra, C, Gercheva, L, Mihaylov, G, Grudeva Popova, Z, Sandhu, I, Reiman, A, Kanjeekal, S, Dueck, G, Leblanc, R, Tay, J, White, D, Maisnar, V, Scudla, V, Gregora, E, Hajek, R, Stoppa, Am, Karlin, L, Garderet, L, Fermand, Jp, Lenain, P, Rigaudeau, S, Eveillard, Jr, Escoffre Barbe, M, Knop, S, Kropff, M, Rollig, C, Munder, M, Langer, C, Mugge, Lo, Hanel, M, Niederwieser, D, Dimopoulos, M, Egyed, M, Szomor, A, Borbenyi, Z, Illes, A, Yehuda, Db, Benyamini, N, Nagler, A, Mittleman, M, Izhar, H, Cavo, M, De Fabritiis, P, Petrini, Mario, Foa, R, Gobbi, M, Rossi, G, Guglielmelli, T, Lazzaro, A, Musto, P, Gozzetti, A, Takazako, N, Izumi, T, Chou, T, Ozaki, S, Hatake, K, Suzuki, K, Uike, N, Asakura, S, Kosugi, H, Handa, H, Matsumoto, M, Tobinai, K, Iida, S, Kizaki, M, Miyamoto, T, Shibayama, H, Ando, K, Ishikawa, T, Ishida, T, Sugiura, I, Izutsu, K, Taniwaki, M, Lee, Jh, Kim, K, Kim, Js, Min, Ck, Yoon, Ss, Lee, Jo, Suh, C, Simpson, D, Ganly, P, Blacklock, H, Doocey, R, Chiruka, S, Hellmann, A, Gornik, S, Komarnicki, M, Malgorzata, Calbecka, Grosicki, S, Jurczyszyn, A, Stoia, R, Gheorghita, E, Danaila, Cd, Abdulkadyrov, K, Zaritskiy, A, Andreeva, N, Balakireva, T, Podoltseva, E, Rossiev, V, Pristupa, A, Hsieh, Ws, Gopalakrishnan, Sk, Mistrik, M, Rocafiguera, Ao, Mateos, V, Rubia, J, Dachs, Lr, Sanchez, Jm, Alegre, A, Bargay, J, de Oteyza JP, Martinez, J, Chen, Ty, Lin, Tl, Liu, Jh, Wang, Mc, Yeh, Sp, Huang, Sy, Vinnyk, Y, Kriachok, I, Pylypenko, H, Shparyk, Y, Kaplan, P, Karamanesht, L, Rekhtman, G, Romanyuk, N, Kaiser, M, Mehta, A, Williams, C, Basu, S, Rabin, N, Ramasamy, K, Hunter, H, Tholouli, E, Lebovic, D, Siegel, D, Wang, M, Niesvizky, R, Kovacsovics, T, Hurd, D, Gabrail, N, Matous, J, Pendergrass, K, Agrawal, M, Boccia, R, Chandra, S, Kassim, A, Stanisic, S, Coleman, M, Gersten, T, Braunschweig, I, Chowdhury, S, Sahovic, E., Dimopoulos, Meletios A, Moreau, Philippe, Palumbo, Antonio, Joshua, Dougla, Pour, Ludek, Hájek, Roman, Facon, Thierry, Ludwig, Heinz, Oriol, Albert, Goldschmidt, Hartmut, Rosiñol, Laura, Straub, Jan, Suvorov, Aleksandr, Araujo, Carla, Rimashevskaya, Elena, Pika, Toma, Gaidano, Gianluca, Weisel, Katja, Goranova-Marinova, Vesselina, Schwarer, Anthony, Minuk, Leonard, Masszi, Tamá, Karamanesht, Ievgenii, Offidani, Massimo, Hungria, Vania, Spencer, Andrew, Orlowski, Robert Z, Gillenwater, Heidi H, Mohamed, Nehal, Feng, Shibao, Chng, Wee-Joo, Cavo, M, Laboratory of Molecullar and Cellular Therapy, and Clinical sciences

Subjects
Oncology, Male, Clinical Trial, Phase III, Dexamethasone, Ixazomib, Bortezomib, chemistry.chemical_compound, 0302 clinical medicine, immune system diseases, hemic and lymphatic diseases, Antineoplastic Combined Chemotherapy Protocols, Elotuzumab, Multiple myeloma, education.field_of_study, Research Support, Non-U.S. Gov't, Medicine (all), Anemia, Multicenter Study, Survival Rate, 030220 oncology & carcinogenesis, Randomized Controlled Trial, Hypertension, Retreatment, Oligopeptide, Female, Multiple Myeloma, Oligopeptides, Human, medicine.drug, medicine.medical_specialty, Aged, Disease-Free Survival, Follow-Up Studies, Humans, Pneumonia, Thrombocytopenia, Population, Follow-Up Studie, 03 medical and health sciences, Internal medicine, medicine, Comparative Study, education, Antineoplastic Combined Chemotherapy Protocol, business.industry, medicine.disease, Carfilzomib, Surgery, chemistry, Proteasome inhibitor, business, 030215 immunology
Abstract

BACKGROUND: Bortezomib with dexamethasone is a standard treatment option for relapsed or refractory multiple myeloma. Carfilzomib with dexamethasone has shown promising activity in patients in this disease setting. The aim of this study was to compare the combination of carfilzomib and dexamethasone with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma. METHODS: In this randomised, phase 3, open-label, multicentre study, patients with relapsed or refractory multiple myeloma who had one to three previous treatments were randomly assigned (1:1) using a blocked randomisation scheme (block size of four) to receive carfilzomib with dexamethasone (carfilzomib group) or bortezomib with dexamethasone (bortezomib group). Randomisation was stratified by previous proteasome inhibitor therapy, previous lines of treatment, International Staging System stage, and planned route of bortezomib administration if randomly assigned to bortezomib with dexamethasone. Patients received treatment until progression with carfilzomib (20 mg/m(2) on days 1 and 2 of cycle 1; 56 mg/m(2) thereafter; 30 min intravenous infusion) and dexamethasone (20 mg oral or intravenous infusion) or bortezomib (1·3 mg/m(2); intravenous bolus or subcutaneous injection) and dexamethasone (20 mg oral or intravenous infusion). The primary endpoint was progression-free survival in the intention-to-treat population. All participants who received at least one dose of study drug were included in the safety analyses. The study is ongoing but not enrolling participants; results for the interim analysis of the primary endpoint are presented. The trial is registered at ClinicalTrials.gov, number NCT01568866. FINDINGS: Between June 20, 2012, and June 30, 2014, 929 patients were randomly assigned (464 to the carfilzomib group; 465 to the bortezomib group). Median follow-up was 11·9 months (IQR 9·3-16·1) in the carfilzomib group and 11·1 months (8·2-14·3) in the bortezomib group. Median progression-free survival was 18·7 months (95% CI 15·6-not estimable) in the carfilzomib group versus 9·4 months (8·4-10·4) in the bortezomib group at a preplanned interim analysis (hazard ratio [HR] 0·53 [95% CI 0·44-0·65]; p

Published
2016

8. STRATUS(TM) (MM 010): A Single Arm, Phase 3b Study Evaluating Safety and Efficacy of Pomalidomide (POM) + Low Dose Dexamethasone (LoDEX) in Patients (Pts) With Refractory or Relapsed and Refractory Multiple Myeloma (RRMM)

Author

Dimopoulos, M.A., primary, Palumbo, A., additional, Corradini, P., additional, Cavo, M., additional, Delforge, M., additional, Weisel, K., additional, Ocio, E., additional, Di Raimondo, F., additional, Rollig, C., additional, Oriol, A., additional, Simcock, M., additional, Miller, N., additional, Slaughter, A., additional, Biyukov, T., additional, Peluso, T., additional, Sternas, L., additional, Zaki, M., additional, and Moreau, P., additional

Published
2015
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10. Induction of short-term remission with single agent eltrombopag in refractory nucleophosmin-1-mutated acute myeloid leukemia

Author

Platzbecker, U., primary, Sockel, K., additional, Schonefeldt, C., additional, Nowak, D., additional, Helas, S., additional, Rollig, C., additional, Mossner, M., additional, Jann, J. C., additional, Ehninger, G., additional, Hofmann, W.-K., additional, Bornhauser, M., additional, Thiede, C., additional, and Wermke, M., additional

Published
2014
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13. Long-term results of all-trans retinoic acid and arsenic trioxide in non-high-risk acute promyelocytic leukemia: update of the APL0406 Italian-German randomized trial

Author

Marco Sborgia, Marco Vignetti, Massimo Breccia, Fabio Efficace, Roberto Cairoli, Hartmut Link, Uwe Platzbecker, Norbert Schmitz, Ombretta Annibali, Agostino Cortelezzi, Francesca Paoloni, Eros Di Bona, Nicola Di Renzo, Alfonso Maria D'Arco, Lorella Melillo, Francesco Lo-Coco, Peter Brossart, Felicetto Ferrara, Chiara Frairia, Franco Mandelli, Christoph Röllig, Laura Cicconi, Claudio Fozza, Konstanze Döhner, Walter Fiedler, Bernd Hertenstein, Francesco Fabbiano, Richard F. Schlenk, Mariadomenica Divona, Francesco Albano, Mohammed Wattad, Maria Teresa Voso, Christian Thiede, Christian Brandts, Paola Fazi, Gerhard Ehninger, Mathias Hänel, Sergio Amadori, Alessandro Rambaldi, Giorgio La Nasa, Helmut R. Salih, Hartmut Döhner, Michael Lübbert, Giuseppe Avvisati, Arnold Ganser, Erika Borlenghi, Cicconi, L, Platzbecker, U, Avvisati, G, Paoloni, F, Thiede, C, Vignetti, M, Fazi, P, Ferrara, F, Divona, M, Albano, F, Efficace, F, Sborgia, M, Di Bona, E, Breccia, M, Borlenghi, E, Cairoli, R, Rambaldi, A, Melillo, L, La Nasa, G, Fiedler, W, Brossart, P, Hertenstein, B, Salih, H, Annibali, O, Wattad, M, Lubbert, M, Brandts, C, Hanel, M, Rollig, C, Schmitz, N, Lin, H, Frairia, C, Fozza, C, Maria D’Arco, A, Di Renzo, N, Cortelezzi, A, Fabbiano, F, Dohner, K, Ganser, A, Dohner, H, Amadori, S, Mandelli, F, Teresa Voso, M, Ehninger, G, Schlenk, R, and Lo-Coco, F

Subjects
Adult, Male, Oncology, Acute promyelocytic leukemia, Cancer Research, medicine.medical_specialty, Adolescent, Retinoic acid, Tretinoin, Follow-Up Studie, law.invention, Young Adult, chemistry.chemical_compound, Leukemia, Promyelocytic, Acute, Randomized controlled trial, law, Germany, Internal medicine, medicine, acute leukemia, Arsenic trioxide, Aged, Antineoplastic Combined Chemotherapy Protocol, business.industry, All trans, Hematology, Long term results, Middle Aged, APL, arsenic trioxide, medicine.disease, Clinical trial, Prospective Studie, Leukemia, Treatment Outcome, Italy, chemistry, Female, business, Settore MED/15 - Malattie del Sangue, Human
Published
2019

14. Time from diagnosis to treatment has no impact on survival in newly diagnosed acute myeloid leukemia treated with venetoclax-based regimens.

Author

Baden D, Zukunft S, Hernandez G, Wolgast N, Steinhauser S, Pohlmann A, Schliemann C, Mikesch JH, Steffen B, Sauer T, Hanoun M, Schafer-Eckart K, Krause SW, Hanel M, Einsele H, Jost E, Brummendorf TH, Scholl S, Hochhaus A, Neubauer A, Burchert A, Kaufmann M, Niemann D, Schaich M, Blau W, Kiani A, Gorner M, Kaiser U, Kullmer J, Weber T, Berdel WE, Ehninger G, Muller-Tidow C, Platzbecker U, Serve H, Bornhauser M, Rollig C, Baldus CD, and Fransecky L

Subjects
Humans, Aged, Male, Female, Aged, 80 and over, Middle Aged, Time-to-Treatment, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Antineoplastic Combined Chemotherapy Protocols adverse effects, Treatment Outcome, Adult, Retrospective Studies, Antineoplastic Agents therapeutic use, Bridged Bicyclo Compounds, Heterocyclic therapeutic use, Bridged Bicyclo Compounds, Heterocyclic administration & dosage, Sulfonamides therapeutic use, Sulfonamides administration & dosage, Leukemia, Myeloid, Acute drug therapy, Leukemia, Myeloid, Acute mortality, Leukemia, Myeloid, Acute diagnosis
Abstract

In newly diagnosed acute myeloid leukemia (AML), immediate initiation of treatment is standard of care. However, deferral of antileukemic therapy may be indicated to assess comorbidities or pretherapeutic risk factors. We explored the impact of time from diagnosis to treatment on outcomes in newly diagnosed AML undergoing venetoclax-based therapy in two distinct cohorts. By querying the Study Alliance Leukemia database and the global health network TriNetX, we identified 138 and 717 patients respectively with an average age of 76 and 72 years who received venetoclax-based first-line therapy. When comparing patients who started treatment earlier or later than 10 days after initial diagnosis, no significant difference in median overall survival was observed - neither in the SAL cohort (7.7 vs. 9.6 months; P=0.42) nor in the TriNetX cohort (7.5 vs. 7.2 months; P=0.41). Similarly, severe infections, bleeding, and thromboembolic events were equally observed between early and later treatments, both in the overall patient groups and specific subgroups (age ≥75 years or leukocytes ≥20x109/L). This retrospective analysis indicates that delaying the start of venetoclax-based therapy in newly diagnosed AML might be a safe option for selected patients, provided that close clinical monitoring is performed.

Published
2024
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15. Long-term results of all-trans retinoic acid and arsenic trioxide in non-high-risk acute promyelocytic leukemia: update of the APL0406 Italian-German randomized trial.

Author

Cicconi L, Platzbecker U, Avvisati G, Paoloni F, Thiede C, Vignetti M, Fazi P, Ferrara F, Divona M, Albano F, Efficace F, Sborgia M, Di Bona E, Breccia M, Borlenghi E, Cairoli R, Rambaldi A, Melillo L, La Nasa G, Fiedler W, Brossart P, Hertenstein B, Salih HR, Annibali O, Wattad M, Lubbert M, Brandts CH, Hanel M, Rollig C, Schmitz N, Link H, Frairia C, Fozza C, Maria D'Arco A, Di Renzo N, Cortelezzi A, Fabbiano F, Dohner K, Ganser A, Dohner H, Amadori S, Mandelli F, Voso MT, Ehninger G, Schlenk RF, and Lo-Coco F

Subjects
Adolescent, Adult, Aged, Female, Follow-Up Studies, Germany, Humans, Italy, Male, Middle Aged, Prospective Studies, Treatment Outcome, Young Adult, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Arsenic Trioxide administration & dosage, Leukemia, Promyelocytic, Acute drug therapy, Tretinoin administration & dosage
Published
2020
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16. Management of obstructive uropathy patients with advanced prostate cancer - a systematic review.

Author

Rollig C, Wockel A, and Weissbach L

Subjects
Comorbidity, Humans, Incidence, Male, Risk Assessment, Risk Factors, Survival Analysis, Survival Rate, Treatment Outcome, Prostatic Neoplasms mortality, Prostatic Neoplasms therapy, Ureteral Obstruction mortality, Ureteral Obstruction therapy
Abstract

Background: The optimal management of malignant ureteral obstruction in prostate cancer patients remains under debate and there exist no evidence-based recommendations to assist clinicians in advising patients., Material and Methods: Four databases were searched for the best available evidence for the treatment of ureteral obstruction and subsequent obstructive uropathy in prostate cancer regarding efficacy, overall survival and side effects. Treatment options considered were percutaneous nephrostomy (PCN), retrograde stenting and androgen deprivation (AD). The retrieved publications were screened for inclusion and exclusion criteria and assessed for methodological quality., Results: Of 987 identified publications, 13 were included in the review. The identified evidence consists of 3 cohort studies and 10 case series. More data and higher rates of successful decompression are published for PCN than for internal stenting. The results show inferior overall survival in patients pretreated with AD and high response rates for hormone-naive patients when treated with AD. There are no consistent results regarding the influence of unilateral or bilateral obstruction on overall survival., Conclusions: Various methodological flaws reduce the validity and generalisability of these results. There is currently no scientific evidence allowing for a reliable answer to the optimal management of malignant ureteral obstruction in prostate cancer patients.

Published
2009
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