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4. Pomalidomide, bortezomib, and dexamethasone for patients with relapsed or refractory multiple myeloma previously treated with lenalidomide (OPTIMISMM): a randomised, open-label, phase 3 trial

Author

Richardson, Paul G, Oriol, Albert, Beksac, Meral, Liberati, Anna Marina, Galli, Monica, Schjesvold, Fredrik, Lindsay, Jindriska, Weisel, Katja, White, Darrell, Facon, Thierry, San Miguel, Jesus, Sunami, Kazutaka, O'Gorman, Peter, Sonneveld, Pieter, Robak, Pawel, Semochkin, Sergey, Schey, Steve, Yu, Xin, Doerr, Thomas, Bensmaine, Amine, Biyukov, Tsvetan, Peluso, Teresa, Zaki, Mohamed, Anderson, Kenneth, Dimopoulos, Meletios, OPTIMISMM trial investigators, Abildgaard N, Adler H, Altuntas F, Akay OM, Amin B, Anagnostopoulos A, Anderson L, Anttila P, Araujo C, Arce-Lara C, Aydin Y, Basu S, Battini R, Beeker T, Benboubker L, Ben-Yehuda D, Bladé J, Blau IW, Boccia R, Burke L, Byeff P, Cascavilla N, Cavo M, Chantry A, Charles Y, Chaudhry A, Corso A, Coyne M, De Arriba F, Delimpasi S, Desjardins P, Dhakal B, Di Bartolomeo P, Di Raimondo F, Dürig J, Engelhardt M, Escoffre-Barbe M, Esteves G, Flogegard M, Gabrail N, Gamberi B, Garrison M, Gay J, Gisslinger H, Goldschmidt H, Goncalves C, Gressot L, Grosicki S, Hanna W, Hayden P, Henriques Bernardo MM, Hermann R, Holden V, Honkalehto K, Huben M, Huffman J, Hunter H, Hus M, Jagasia M, Jagganath S, Janakiram M, Jaiyesimi I, Jenner M, João C, Johnson P, Jurcyszyn A, Kalayoğlu Beşişik S, Kambhampati S, Kanate A, Karadoğan I, Khojasteh A, Kirkel D, Komarnicki M, Krauth MT, Kuriakose P, Larocca A, Lauri B, Leleu X, Lucio P, Luppi M, Mangiacavalli S, Mariette C, Matsue K, Mellqvist UH, Mendeleeva L, Meshad M, Miller C, Mohrbacher A, Moreau P, Morelli AM, Müldür E, Naassan A, Nahi H, Nair R, O'Dwyer M, Öngören Aydin S, Openshaw T, O'Rourke T, Osswald M, Overton L, Pati A, Pavic M, Pegourie B, Pehlivan M, Pierola AA, Plesner T, Pluta A, Rabin N, Ramasamy K, Rambaldi A, Rodriguez P, Röllig C, Rosenblatt J, Rosenbluth J, Salomo M, Samoylova O, Sastre Moral J, Sati H, Selleri C, Shafeek S, Shinagawa A, Sleckman B, Smith C, Sonmez M, Stone C, Streetly M, Suzuki K, Taetle R, Tafuri A, Takezako N, Teke HÜ, Vapaatalo M, Vassilopoulos G, Verma A, Vidito S, Viterbo L, Vural F, Wang XS, Yağci M, Yee A., Richardson, Paul G, Oriol, Albert, Beksac, Meral, Liberati, Anna Marina, Galli, Monica, Schjesvold, Fredrik, Lindsay, Jindriska, Weisel, Katja, White, Darrell, Facon, Thierry, San Miguel, Jesu, Sunami, Kazutaka, O'Gorman, Peter, Sonneveld, Pieter, Robak, Pawel, Semochkin, Sergey, Schey, Steve, Yu, Xin, Doerr, Thoma, Bensmaine, Amine, Biyukov, Tsvetan, Peluso, Teresa, Zaki, Mohamed, Anderson, Kenneth, Dimopoulos, Meletio, OPTIMISMM trial investigator, Abildgaard N, Adler H, Altuntas F, Akay OM, Amin B, Anagnostopoulos A, Anderson L, Anttila P, Araujo C, Arce-Lara C, Aydin Y, Basu S, Battini R, Beeker T, Benboubker L, Ben-Yehuda D, Bladé J, Blau IW, Boccia R, Burke L, Byeff P, Cascavilla N, Cavo M, Chantry A, Charles Y, Chaudhry A, Corso A, Coyne M, De Arriba F, Delimpasi S, Desjardins P, Dhakal B, Di Bartolomeo P, Di Raimondo F, Dürig J, Engelhardt M, Escoffre-Barbe M, Esteves G, Flogegard M, Gabrail N, Gamberi B, Garrison M, Gay J, Gisslinger H, Goldschmidt H, Goncalves C, Gressot L, Grosicki S, Hanna W, Hayden P, Henriques Bernardo MM, Hermann R, Holden V, Honkalehto K, Huben M, Huffman J, Hunter H, Hus M, Jagasia M, Jagganath S, Janakiram M, Jaiyesimi I, Jenner M, João C, Johnson P, Jurcyszyn A, Kalayoğlu Beşişik S, Kambhampati S, Kanate A, Karadoğan I, Khojasteh A, Kirkel D, Komarnicki M, Krauth MT, Kuriakose P, Larocca A, Lauri B, Leleu X, Lucio P, Luppi M, Mangiacavalli S, Mariette C, Matsue K, Mellqvist UH, Mendeleeva L, Meshad M, Miller C, Mohrbacher A, Moreau P, Morelli AM, Müldür E, Naassan A, Nahi H, Nair R, O'Dwyer M, Öngören Aydin S, Openshaw T, O'Rourke T, Osswald M, Overton L, Pati A, Pavic M, Pegourie B, Pehlivan M, Pierola AA, Plesner T, Pluta A, Rabin N, Ramasamy K, Rambaldi A, Rodriguez P, Röllig C, Rosenblatt J, Rosenbluth J, Salomo M, Samoylova O, Sastre Moral J, Sati H, Selleri C, Shafeek S, Shinagawa A, Sleckman B, Smith C, Sonmez M, Stone C, Streetly M, Suzuki K, Taetle R, Tafuri A, Takezako N, Teke HÜ, Vapaatalo M, Vassilopoulos G, Verma A, Vidito S, Viterbo L, Vural F, Wang XS, Yağci M, Yee A., and Hematology

Subjects
Oncology, Adult, Male, medicine.medical_specialty, Adolescent, Population, Dexamethasone, Bortezomib, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Internal medicine, hemic and lymphatic diseases, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, education, Survival rate, Lenalidomide, Multiple myeloma, Aged, Salvage Therapy, education.field_of_study, business.industry, Pomalidomide, bortezomib, dexamethasone, Middle Aged, Pomalidomide, medicine.disease, Prognosis, Thalidomide, Survival Rate, Regimen, Drug Resistance, Neoplasm, 030220 oncology & carcinogenesis, Female, Neoplasm Recurrence, Local, business, Multiple Myeloma, 030215 immunology, medicine.drug, Follow-Up Studies
Abstract

Background As lenalidomide becomes increasingly established for upfront treatment of multiple myeloma, patients refractory to this drug represent a population with an unmet need. The combination of pomalidomide, bortezomib, and dexamethasone has shown promising results in phase 1/2 trials of patients with relapsed or refractory multiple myeloma. We aimed to assess the efficacy and safety of this triplet regimen in patients with relapsed or refractory multiple myeloma who previously received lenalidomide. Methods We did a randomised, open-label, phase 3 trial at 133 hospitals and research centres in 21 countries. We enrolled patients (aged >= 18 years) with a diagnosis of multiple myeloma and measurable disease, an Eastern Cooperative Oncology Group performance status of 0-2, who received one to three previous regimens, including a lenalidomide-containing regimen for at least two consecutive cycles. We randomly assigned patients (1:1) to bortezomib and dexamethasone with or without pomalidomide using a permutated blocked design in blocks of four, stratified according to age, number of previous regimens, and concentration of beta(2) microglobulin at screening. Bortezomib (1.3 mg/m(2)) was administered intravenously until protocol amendment 1 then either intravenously or subcutaneously on days 1,4, 8, and 11 for the first eight cycles and subsequently on days 1 and 8. Dexamethasone (20 mg [10 mg if age >75 years]) was administered orally on the same days as bortezomib and the day after. Patients allocated pomalidomide received 4 mg orally on days 1-14. Treatment cycles were every 21 days. The primary endpoint was progression-free survival in the intention-to-treat population, as assessed by an independent review committee. Safety was assessed in all patients who received at least one dose of study medication. This trial is registered at ClinicalTrials.gov, number NCT01734928; patients are no longer being enrolled. Findings Between Jan 7, 2013, and May 15,2017,559 patients were enrolled. 281 patients were assigned pomalidomide, bortezomib, and dexamethasone and 278 were allocated bortezomib and dexamethasone. Median follow-up was 15.9 months (IQR 9.9-21.7). Pomalidomide, bortezomib, and dexamethasone significantly improved progression-free survival compared with bortezomib and dexamethasone (median 11.20 months [95% CI 9.66-13-73] vs 7.10 months [5.88-8-48]; hazard ratio 0.61, 95% CI 0.49-0-77; p

Published
2019

6. Pomalidomide, bortezomib, and dexamethasone for patients with relapsed or refractory multiple myeloma previously treated with lenalidomide (OPTIMISMM): a randomised, open-label, phase 3 trial

Author

Richardson, P.G. Oriol, A. Beksac, M. Liberati, A.M. Galli, M. Schjesvold, F. Lindsay, J. Weisel, K. White, D. Facon, T. San Miguel, J. Sunami, K. O'Gorman, P. Sonneveld, P. Robak, P. Semochkin, S. Schey, S. Yu, X. Doerr, T. Bensmaine, A. Biyukov, T. Peluso, T. Zaki, M. Anderson, K. Dimopoulos, M. Abildgaard, N. Adler, H. Altuntas, F. Akay, O.M. Amin, B. Anagnostopoulos, A. Anderson, L. Anttila, P. Araujo, C. Arce-Lara, C. Aydin, Y. Basu, S. Battini, R. Beeker, T. Benboubker, L. Ben-Yehuda, D. Bladé, J. Blau, I.W. Boccia, R. Burke, L. Byeff, P. Cascavilla, N. Cavo, M. Chantry, A. Charles, Y. Chaudhry, A. Corso, A. Coyne, M. De Arriba, F. Delimpasi, S. Desjardins, P. Dhakal, B. Di Bartolomeo, P. Di Raimondo, F. Dürig, J. Engelhardt, M. Escoffre-Barbe, M. Esteves, G. Flogegard, M. Gabrail, N. Gamberi, B. Garrison, M. Gay, J. Gisslinger, H. Goldschmidt, H. Goncalves, C. Gressot, L. Grosicki, S. Hanna, W. Hayden, P. Henriques Bernardo, M.M. Hermann, R. Holden, V. Honkalehto, K. Huben, M. Huffman, J. Hunter, H. Hus, M. Jagasia, M. Jagganath, S. Janakiram, M. Jaiyesimi, I. Jenner, M. João, C. Johnson, P. Jurcyszyn, A. Kalayoğlu Beşişik, S. Kambhampati, S. Kanate, A. Karadoğan, I. Khojasteh, A. Kirkel, D. Komarnicki, M. Krauth, M.-T. Kuriakose, P. Larocca, A. Lauri, B. Leleu, X. Lucio, P. Luppi, M. Mangiacavalli, S. Mariette, C. Matsue, K. Mellqvist, U.-H. Mendeleeva, L. Meshad, M. Miller, C. Mohrbacher, A. Moreau, P. Morelli, A.M. Müldür, E. Naassan, A. Nahi, H. Nair, R. O'Dwyer, M. Öngören Aydin, S. Openshaw, T. O'Rourke, T. Osswald, M. Overton, L. Pati, A. Pavic, M. Pegourie, B. Pehlivan, M. Pierola, A.A. Plesner, T. Pluta, A. Rabin, N. Ramasamy, K. Rambaldi, A. Rodriguez, P. Röllig, C. Rosenblatt, J. Rosenbluth, J. Salomo, M. Samoylova, O. Sastre Moral, J. Sati, H. Selleri, C. Shafeek, S. Shinagawa, A. Sleckman, B. Smith, C. Sonmez, M. Stone, C. Streetly, M. Suzuki, K. Taetle, R. Tafuri, A. Takezako, N. Teke, H.Ü. Vapaatalo, M. Vassilopoulos, G. Verma, A. Vidito, S. Viterbo, L. Vural, F. Wang, X.S. Yağci, M. Yee, A. OPTIMISMM trial investigators

Subjects
hemic and lymphatic diseases
Abstract

Background: As lenalidomide becomes increasingly established for upfront treatment of multiple myeloma, patients refractory to this drug represent a population with an unmet need. The combination of pomalidomide, bortezomib, and dexamethasone has shown promising results in phase 1/2 trials of patients with relapsed or refractory multiple myeloma. We aimed to assess the efficacy and safety of this triplet regimen in patients with relapsed or refractory multiple myeloma who previously received lenalidomide. Methods: We did a randomised, open-label, phase 3 trial at 133 hospitals and research centres in 21 countries. We enrolled patients (aged ≥18 years)with a diagnosis of multiple myeloma and measurable disease, an Eastern Cooperative Oncology Group performance status of 0–2, who received one to three previous regimens, including a lenalidomide-containing regimen for at least two consecutive cycles. We randomly assigned patients (1:1)to bortezomib and dexamethasone with or without pomalidomide using a permutated blocked design in blocks of four, stratified according to age, number of previous regimens, and concentration of β2 microglobulin at screening. Bortezomib (1·3 mg/m2)was administered intravenously until protocol amendment 1 then either intravenously or subcutaneously on days 1, 4, 8, and 11 for the first eight cycles and subsequently on days 1 and 8. Dexamethasone (20 mg [10 mg if age >75 years])was administered orally on the same days as bortezomib and the day after. Patients allocated pomalidomide received 4 mg orally on days 1–14. Treatment cycles were every 21 days. The primary endpoint was progression-free survival in the intention-to-treat population, as assessed by an independent review committee. Safety was assessed in all patients who received at least one dose of study medication. This trial is registered at ClinicalTrials.gov, number NCT01734928; patients are no longer being enrolled. Findings: Between Jan 7, 2013, and May 15, 2017, 559 patients were enrolled. 281 patients were assigned pomalidomide, bortezomib, and dexamethasone and 278 were allocated bortezomib and dexamethasone. Median follow-up was 15·9 months (IQR 9·9–21·7). Pomalidomide, bortezomib, and dexamethasone significantly improved progression-free survival compared with bortezomib and dexamethasone (median 11·20 months [95% CI 9·66–13·73]vs 7·10 months [5·88–8·48]; hazard ratio 0·61, 95% CI 0·49–0·77; p

Published
2019

8. Real-World Evidence of Triplet Therapy in Metastatic Hormone-Sensitive Prostate Cancer: An Austrian Multicenter Study.

Author

Kafka M, Giannini G, Artamonova N, Neuwirt H, Ofner H, Kramer G, Bauernhofer T, Luger F, Höfner T, Loidl W, Griessner H, Lusuardi L, Bergmaier A, Berger A, Winder T, Weiss S, Bauinger S, Krause S, Drerup M, Heinrich E, Schneider M, Madersbacher S, Vallet S, Stoiber F, Laimer S, Hruby S, Schachtner G, Nagele U, Lenart S, Ponholzer A, Pfuner J, Wiesinger C, Kamhuber C, Müldür E, Bektic J, Horninger W, and Heidegger I

Subjects
Humans, Male, Androgen Antagonists therapeutic use, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Austria, Docetaxel therapeutic use, Hormones, Positron Emission Tomography Computed Tomography, Randomized Controlled Trials as Topic, Prostatic Neoplasms drug therapy, Prostatic Neoplasms pathology
Abstract

Introduction: Two randomized trials demonstrated a survival benefit of triplet therapy (androgen deprivation therapy [ADT]) plus androgen receptor pathway inhibitor [ARPI] plus docetaxel) over doublet therapy (ADT plus docetaxel), thus changing treatment strategies in metastatic hormonesensitive prostate cancer (mHSPC)., Patients and Methods: We conducted the first real-world analysis comprising 97 mHSPC patients from 16 Austrian medical centers, among them 79.4% of patients received abiraterone and 17.5% darolutamide treatment. Baseline characteristics and clinical parameters during triplet therapy were documented. Mann-Whitney U test for continuous or X²-test for categorical variables was used. Variables on progression were tested using logistic regression analysis and tabulated as hazard ratios (HR), 95% confidence interval (CI)., Results: Of 83.5% patients with synchronous and 16.5% with metachronous disease were included. 83.5% had high-volume disease diagnosed by conventional imaging (48.9%) or PSMA PET-CT (51.1%). While docetaxel and ARPI were administered consistent with pivotal trials, prednisolone, prophylactic gCSF and osteoprotective agents were not applied guideline conform in 32.5%, 37%, and 24.3% of patients, respectively. Importantly, a nonsimultaneous onset of chemotherapy and ARPI, performed in 44.3% of patients, was associated with significantly worse treatment response (P = .015, HR 0.245). Starting ARPI before chemotherapy was associated with significantly higher probability for progression (P = .023, HR 15.781) than vice versa. Strikingly, 15.6% (abiraterone) and 25.5% (darolutamide) low-volume patients as well as 14.4% (abiraterone) and 17.6% (darolutamide) metachronous patients received triplet therapy. Adverse events (AE) occurred in 61.9% with grade 3 to 5 in 15% of patient without age-related differences. All patients achieved a PSA decline of 99% and imaging response was confirmed in 88% of abiraterone and 75% of darolutamide patients., Conclusions: Triplet therapy arrived in clinical practice primarily for synchronous high-volume mHSPC. Regardless of selected therapy regimen, treatment is highly effective and tolerable. Preferably therapy should be administered simultaneously, however if not possible, chemotherapy should be started first., Competing Interests: Disclosure All authors declare that there are no conflicts of interest. The study was performed in accordance with the local ethical standards., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Published
2024
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9. IKAROS expression in distinct bone marrow cell populations as a candidate biomarker for outcome with lenalidomide-dexamethasone therapy in multiple myeloma.

Author

Bolomsky A, Hübl W, Spada S, Müldür E, Schlangen K, Heintel D, Rocci A, Weißmann A, Fritz V, Willheim M, Zojer N, Palumbo A, and Ludwig H

Subjects
Dexamethasone therapeutic use, Gene Expression, Humans, Ikaros Transcription Factor metabolism, Immunologic Factors genetics, Lenalidomide, Multiple Myeloma mortality, Multiple Myeloma pathology, Survival Rate, Thalidomide analogs & derivatives, Thalidomide therapeutic use, Treatment Outcome, Biomarkers, Tumor analysis, Bone Marrow Cells chemistry, Ikaros Transcription Factor analysis, Immunologic Factors therapeutic use, Multiple Myeloma drug therapy
Abstract

Immunomodulatory drugs (IMiDs) are a cornerstone in the treatment of multiple myeloma (MM), but specific markers to predict outcome are still missing. Recent work pointed to a prognostic role for IMiD target genes (e.g. CRBN). Moreover, indirect activity of IMiDs on immune cells correlated with outcome, raising the possibility that cell populations in the bone marrow (BM) microenvironment could serve as biomarkers. We therefore analysed gene expression levels of six IMiD target genes in whole BM samples of 44 myeloma patients treated with lenalidomide-dexamethasone. Expression of CRBN (R = 0.30, P = .05), IKZF1 (R = 0.31, P = .04), IRF4 (R = 0.38, P = .01), MCT-1 (R = 0.30, P = .05), and CD147 (R = 0.38, P = .01), but not IKZF3 (R = -0.15, P = .34), was significantly associated with response. Interestingly, IKZF1 expression was elevated in BM environmental cells and thus selected for further investigation by multicolor flow cytometry. High IKAROS protein levels in total BM mononuclear cells (median OS 83.4 vs. 32.2 months, P = .02), CD19 + B cells (median OS 71.1 vs. 32.2 months, P = .05), CD3 + CD8 + T cells (median OS 83.4 vs 19.0 months, P = .008) as well as monocytes (median OS 53.9 vs 18.0 months, P = .009) were associated with superior overall survival (OS). In contrast, IKAROS protein expression in MM cells was not predictive for OS. Our data therefore corroborate the central role of immune cells for the clinical activity of IMiDs and built the groundwork for prospective analysis of IKAROS protein levels in distinct cell populations as a potential biomarker for IMiD based therapies., (© 2017 Wiley Periodicals, Inc.)

Published
2017
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10. Lenalidomide and dexamethasone for acute light chain-induced renal failure: a phase II study.

Author

Ludwig H, Rauch E, Kuehr T, Adam Z, Weißmann A, Kasparu H, Autzinger EM, Heintel D, Greil R, Poenisch W, Müldür E, and Zojer N

Subjects
Acute Kidney Injury chemically induced, Acute Kidney Injury mortality, Acute Kidney Injury pathology, Aged, Aged, 80 and over, Anemia chemically induced, Anemia pathology, Dexamethasone adverse effects, Female, Glomerular Filtration Rate, Humans, Immunoglobulin Light Chains, Immunologic Factors adverse effects, Lenalidomide, Male, Middle Aged, Multiple Myeloma immunology, Multiple Myeloma mortality, Multiple Myeloma pathology, Renal Dialysis, Survival Analysis, Thalidomide administration & dosage, Thalidomide adverse effects, Thrombocytopenia chemically induced, Thrombocytopenia pathology, Treatment Outcome, Acute Kidney Injury drug therapy, Dexamethasone administration & dosage, Immunologic Factors administration & dosage, Multiple Myeloma drug therapy, Thalidomide analogs & derivatives
Abstract

We prospectively evaluated the activity and tolerance of lenalidomide-dexamethasone in 35 patients with acute light chain-induced renal failure. The lenalidomide dose was adapted to the estimated glomerular filtration rate and dexamethasone was given at high dose in cycle one and at low dose thereafter. Four patients died within the first two cycles, and five discontinued therapy leaving 26 patients for the per-protocol analysis. Responses were observed in 24/35 (68.6%) patients of the intent-to-treat population. Complete response was noted in seven patients (20%), very good partial response in three patients (8.6%), partial response in 14 patients (40%), and minimal response in one patient (2.9%). Renal response was observed in 16 (45.7%) patients: five (14.2%) achieved complete, four (11.4%) partial and seven (20%) minor renal responses. Five of 13 patients who were dialysis dependent at baseline became dialysis independent. The median time to myeloma and to renal response was 28 days for both parameters, while the median time to best myeloma and best renal response was 92 and 157 days, respectively. The median estimated glomerular filtration rate increased significantly in patients with partial response or better from 17.1 mL/min at baseline to 39.1 mL/min at best response (P=0.001). The median progression-free and overall survival was 5.5 and 21.8 months, respectively, in the intent-to-treat population and 12.1 and 31.4 months, respectively, in the per-protocol group. Infections, cardiotoxicity, anemia and thrombocytopenia were the most frequent toxicities. In conclusion, the lenalidomide-dexamethasone regimen achieved rapid and substantial myeloma and renal responses. The trial was registered under EUDRACT number 2008-006497-15., (Copyright© Ferrata Storti Foundation.)

Published
2015
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11. Patient with high-grade fever, night sweats, and hepatosplenomegaly.

Author

Müldür E, Chott A, Mirzaei S, Zojer N, and Ludwig H

Subjects
Adult, Antibodies, Monoclonal, Murine-Derived administration & dosage, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Biopsy, Cyclophosphamide administration & dosage, Doxorubicin administration & dosage, Female, Humans, Immunohistochemistry, Lymphoma, Large B-Cell, Diffuse complications, Lymphoma, Large B-Cell, Diffuse drug therapy, Lymphoma, Large B-Cell, Diffuse physiopathology, Positron-Emission Tomography, Prednisone administration & dosage, Rituximab, Treatment Outcome, Vascular Neoplasms complications, Vascular Neoplasms drug therapy, Vascular Neoplasms physiopathology, Vincristine administration & dosage, Fever etiology, Hepatomegaly etiology, Lymphoma, Large B-Cell, Diffuse diagnosis, Splenomegaly etiology, Sweating, Vascular Neoplasms diagnosis
Published
2011
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