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  1. AU="González Villarroel, Paula"
  2. AU="Gakuya, F."
  3. AU="Belloni-Fortina, Anna"
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  1. Article ; Online: Venous Thromboembolism In Cancer Patients: "From Evidence to Care".

    Salgado, Mercedes / Brozos-Vázquez, Elena / Campos, Begoña / González-Villarroel, Paula / Pérez, María Eva / Vázquez-Tuñas, María Lidia / Arias, David

    Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis

    2022  Volume 28, Page(s) 10760296221098717

    Abstract: This article seeks to review the current status of treatment and prevention of venous thromboembolic disease (VTE) in cancer patients after the addition of direct oral anticoagulants (DOAC) to the therapeutic arsenal available. The suitability of DOAC ... ...

    Abstract This article seeks to review the current status of treatment and prevention of venous thromboembolic disease (VTE) in cancer patients after the addition of direct oral anticoagulants (DOAC) to the therapeutic arsenal available. The suitability of DOAC use in complex clinical situations, poorly represented in clinical trials, is controversial and difficult for care activity, making the recommendations in clinical practice guidelines the focus of special attention in this area. Recently, several randomized trials have compared low molecular weight heparin (LMWH) to DOAC for the management of CAT. Potential drug interactions with DOACs or the increased risk of bleeding in intraluminal tumors require special precautions, as do metastatic or primary brain disease and comorbid conditions, such as renal or liver failure, which are not suitably represented in pivotal studies. Furthermore, few data are available for situations involving elevated bleeding risk, with thrombocytopenia levels below the inclusion criterion of clinical trials, or recurrence during active anticoagulant therapy. Similarly, it is less clear that patients and physicians accept the presumption that oral DOAC administration is more convenient than subcutaneous LMWH, particularly when drug absorption may be compromised. The non-inclusion or under-representation of patients at higher risk for complications with anticoagulation in randomized clinical trials, makes their use complex in certain situations in health care. This paper provides a practical review of current clinical guideline recommendations regarding LMWH and/ or DOAC to treat and prevent CAT, as well as the most controversial clinical conditions for their use.
    MeSH term(s) Anticoagulants ; Hemorrhage/chemically induced ; Hemorrhage/prevention & control ; Heparin, Low-Molecular-Weight ; Humans ; Neoplasms/complications ; Neoplasms/drug therapy ; Venous Thromboembolism/drug therapy ; Venous Thromboembolism/etiology ; Venous Thromboembolism/prevention & control
    Chemical Substances Anticoagulants ; Heparin, Low-Molecular-Weight
    Language English
    Publishing date 2022-05-11
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1237357-6
    ISSN 1938-2723 ; 1076-0296
    ISSN (online) 1938-2723
    ISSN 1076-0296
    DOI 10.1177/10760296221098717
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Prediction of survival in patients with advanced, refractory colorectal cancer in treatment with trifluridine/tipiracil: real-world vs clinical trial data.

    Fernández Montes, Ana / Carmona-Bayonas, Alberto / Jimenez-Fonseca, Paula / Vázquez Rivera, Francisca / Martinez Lago, Nieves / Covela Rúa, Marta / Cousillas Castiñeiras, Antía / Gonzalez Villarroel, Paula / De la Cámara Gómez, Juan / Méndez, José Carlos Méndez / Carriles Fernández, Carmen / Sanchez Cánovas, Manuel / Garcia García, Teresa

    Scientific reports

    2021  Volume 11, Issue 1, Page(s) 14321

    Abstract: Trifluridine/tipiracil increases overall survival (OS) in patients with refractory, metastatic colorectal cancer (mCRC). A post hoc exploratory analysis of the RECOURSE randomized clinical trial (RCT) established two categories, a good prognosis ... ...

    Abstract Trifluridine/tipiracil increases overall survival (OS) in patients with refractory, metastatic colorectal cancer (mCRC). A post hoc exploratory analysis of the RECOURSE randomized clinical trial (RCT) established two categories, a good prognosis corresponding to subjects having a low tumor burden and indolent disease. Other models in refractory mCRC are the FAS-CORRECT and Colon Life nomogram. The main objective was to externally validate the prognostic factors of the RECOURSE and FAS-CORRECT trials, and the Colon Life nomogram in a multicenter, real-world series of mCRC treated in 3rd and successive lines with trifluridine/tipiracil. The secondary aim was to develop an OS predictive model, TAS-RECOSMO. Between 2016 and 2019, 244 patients were recruited. Median OS was 8.15 vs 8.12 months for the poor (85% of the subjects) and good (15%) prognosis groups from the RESOURCE trial, respectively, log-rank p = 0.9. The most common grade 3-4 toxicities were neutropenia (17%), asthenia (6%), and anemia (5%). The AFT lognormal model TAS-RECOSMO included six variables: ECOG-PS, KRAS/NRAS/BRAF mutation status, time between diagnosis of metastasis and beginning of trifluridine/tipiracil, NLR, CEA, and alkaline phosphatase. The model's bootstrapped bias-corrected c-index was 0.682 (95% CI, 0.636-0.722). The factors from the Colon Life model, FAS-CORRECT, and RECOURSE displayed a c-index of 0.690, 0.630, and 0.507, respectively. TAS-RECOSMO, FAS-CORRECT, and the Colon Life nomogram appear to predict OS in patients with refractory mCCR who begin trifluridine/tipiracil treatment in the real world. The prognostic groups of the RECOURCE RCT were unable to capture the situation of real-world subjects treated with trifluridine/tipiracil in this series.
    MeSH term(s) Adolescent ; Adult ; Aged ; Aged, 80 and over ; Asthenia/drug therapy ; Colorectal Neoplasms/drug therapy ; Drug Combinations ; Female ; Humans ; Male ; Middle Aged ; Multicenter Studies as Topic ; Neutropenia/drug therapy ; Pyrrolidines/therapeutic use ; Thymine/therapeutic use ; Trifluridine/therapeutic use ; Young Adult
    Chemical Substances Drug Combinations ; Pyrrolidines ; trifluridine tipiracil drug combination ; Thymine (QR26YLT7LT) ; Trifluridine (RMW9V5RW38)
    Language English
    Publishing date 2021-07-12
    Publishing country England
    Document type Journal Article
    ZDB-ID 2615211-3
    ISSN 2045-2322 ; 2045-2322
    ISSN (online) 2045-2322
    ISSN 2045-2322
    DOI 10.1038/s41598-021-93732-5
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Efficacy and safety of FOLFIRI/aflibercept (FA) in an elderly population with metastatic colorectal cancer (mCRC) after failure of an oxaliplatin-based regimen.

    Martínez-Lago, Nieves / Cameselle García, Soledad / Alonso de Castro, Beatriz / Gómez-Randulfe Rodríguez, Martín I / Carmona Campos, Marta / González Villarroel, Paula / Salgado Fernández, Mercedes / De la Cámara Gómez, Juan C / Romero Reinoso, Carlos / Cousillas Castiñeiras, Antía / Méndez Méndez, José Carlos / Vidal Insua, Yolanda / Fernández-Montes, Ana

    PloS one

    2022  Volume 17, Issue 6, Page(s) e0269399

    Abstract: Background: The VELOUR study showed the benefit of FOLFIRI-Aflibercept (FA) versus FOLFIRI in patients with metastatic colorectal cancer (mCRC) in second-line treatment. However, only 36% of the included patients were ≥65 years. Thus, we seek to ... ...

    Abstract Background: The VELOUR study showed the benefit of FOLFIRI-Aflibercept (FA) versus FOLFIRI in patients with metastatic colorectal cancer (mCRC) in second-line treatment. However, only 36% of the included patients were ≥65 years. Thus, we seek to evaluate the efficacy and safety of FA in the elderly population in the context of routine practice.
    Materials and methods: We conducted an observational, retrospective, multicenter, observational study of patients ≥70 years with mCRC treated with FA after progression to oxaliplatin chemotherapy in routine clinical practice in 9 hospitals of the GITuD group.
    Results: Of 388 patients treated with FA between June 2013 and November 2018, 75 patients ≥70 years were included. The median number of cycles was 10 and the objective response (ORR) and disease control rates (DCR) were 33.8% and 72.0%, respectively. With a median follow-up of 27.1 months, median Progression-free survival (PFS) was 6.6 months and median Overall Survival (OS) was 15.1 months. One third fewer metastasectomies were performed in the ≥75 years' subgroup (24 vs. 52%, p = 0.024) and more initial FOLFIRI dose reductions (68 vs. 36%, p = 0.014). ORR (23.8% vs. 38.3%), DCR (42.8% vs. 85.1%), and PFS (4 vs. 7.8 months; p = 0.017) were significantly less, without difference in OS (9.9 vs. 17.1 months; p = 0.129). The presence of prior hypertension (HT) (PFS 7.9 vs. 5.7 months, p = 0.049) and HT ≥ grade 3 during treatment (PFS 7.6 vs. 6.6 months, p = 0.024) were associated with longer PFS. The most frequent grade 3/4 adverse events were: asthenia (21.3%), neutropenia (14.7%), and diarrhea (14.7%). 57.3% required FOLFIRI dose reduction; 34.7% of aflibercept, including discontinuation (5.3% and 18.7%, respectively).
    Conclusions: FA combination is effective in patients ≥70 years. The occurrence of HT is predictive of efficacy. Close monitoring of toxicity and initial dose adjustment is recommended.
    MeSH term(s) Aged ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Camptothecin/adverse effects ; Colonic Neoplasms/drug therapy ; Colorectal Neoplasms/pathology ; Fluorouracil/adverse effects ; Humans ; Leucovorin/adverse effects ; Oxaliplatin ; Receptors, Vascular Endothelial Growth Factor/therapeutic use ; Recombinant Fusion Proteins/adverse effects ; Rectal Neoplasms/drug therapy ; Retrospective Studies
    Chemical Substances Recombinant Fusion Proteins ; Oxaliplatin (04ZR38536J) ; aflibercept (15C2VL427D) ; Receptors, Vascular Endothelial Growth Factor (EC 2.7.10.1) ; Leucovorin (Q573I9DVLP) ; Fluorouracil (U3P01618RT) ; Camptothecin (XT3Z54Z28A)
    Language English
    Publishing date 2022-06-03
    Publishing country United States
    Document type Journal Article ; Multicenter Study ; Observational Study
    ZDB-ID 2267670-3
    ISSN 1932-6203 ; 1932-6203
    ISSN (online) 1932-6203
    ISSN 1932-6203
    DOI 10.1371/journal.pone.0269399
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Effect of antiangiogenic-based treatment and systemic inflammatory factors on outcomes in patients with BRAF v600-mutated metastatic colorectal cancer: a real-world study in Spain.

    Martínez-Lago, Nieves / Fernández-Montes, Ana / Covela, Marta / Brozos, Elena M / De la Cámara, Juan / Méndez Méndez, José C / Jorge-Fernández, Mónica / Cousillas Castiñeiras, Antía / Reboredo, Cristina / Arias Ron, David / Pellón Augusto, María L / González Villarroel, Paula / Graña, Begoña / Salgado Fernández, Mercedes / Carral Maseda, Alberto / Vázquez Rivera, Francisca / Candamio Folgar, Sonia / Reboredo López, Margarita

    BMC cancer

    2021  Volume 21, Issue 1, Page(s) 64

    Abstract: Background: Outcomes are poorer in metastatic colorectal cancer (mCRC) patients with BRAF V600E mutations than those without it, but the effect of these mutations on treatment response is unclear. This real-world study assessed the effects of ... ...

    Abstract Background: Outcomes are poorer in metastatic colorectal cancer (mCRC) patients with BRAF V600E mutations than those without it, but the effect of these mutations on treatment response is unclear. This real-world study assessed the effects of antiangiogenic-based treatment and systemic inflammatory factors on outcomes in patients with BRAF V600-mutated mCRC.
    Methods: This real-world, multicenter, retrospective, observational study included patients with BRAF V600-mutated mCRC treated in eight hospitals in Spain. The primary endpoints were overall survival (OS) and progression-free survival (PFS); overall response rate (ORR) and disease control rate (DCR) were also assessed. The effect of first- and second-line treatment type on OS, PFS, ORR, and DCR were evaluated, plus the impact of systemic inflammatory markers on these outcomes. A systemic inflammation score (SIS) of 1-3 was assigned based on one point each for platelet-lymphocyte ratio (PLR) ≥200, neutrophil-lymphocyte ratio (NLR) ≥3, and serum albumin < 3.6 g/dL.
    Results: Of 72 patients, data from 64 were analyzed. After a median of 69.1 months, median OS was 11.9 months and median first-line PFS was 4.4 months. First-line treatment was triplet chemotherapy-antiangiogenic (12.5%), doublet chemotherapy-antiangiogenic (47.2%), doublet chemotherapy-anti-EGFR (11.1%), or doublet chemotherapy (18.1%). Although first-line treatment showed no significant effect on OS, antiangiogenic-based regimens were associated with prolonged median PFS versus non-antiangiogenic regimens. Negative predictors of survival with antiangiogenic-based treatment were NLR, serum albumin, and SIS 1-3, but not PLR. Patients with SIS 1-3 showed significantly prolonged PFS with antiangiogenic-based treatment versus non-antiangiogenic-based treatment, while those with SIS=0 showed no PFS benefit.
    Conclusions: Antiangiogenic-based regimens, SIS, NLR, and albumin were predictors of survival in patients with mCRC, while SIS, NLR and serum albumin may predict response to antiangiogenic-based chemotherapy.
    Trial registration: GIT-BRAF-2017-01.
    MeSH term(s) Adult ; Aged ; Aged, 80 and over ; Angiogenesis Inhibitors/therapeutic use ; Biomarkers, Tumor/analysis ; Blood Platelets/pathology ; Colorectal Neoplasms/drug therapy ; Colorectal Neoplasms/genetics ; Colorectal Neoplasms/immunology ; Colorectal Neoplasms/pathology ; Female ; Follow-Up Studies ; Humans ; Inflammation/pathology ; Lymphocytes/pathology ; Male ; Middle Aged ; Mutation ; Neoplasm Metastasis ; Neutrophils/pathology ; Prognosis ; Proto-Oncogene Proteins B-raf/genetics ; Retrospective Studies ; Spain ; Survival Rate
    Chemical Substances Angiogenesis Inhibitors ; Biomarkers, Tumor ; BRAF protein, human (EC 2.7.11.1) ; Proto-Oncogene Proteins B-raf (EC 2.7.11.1)
    Language English
    Publishing date 2021-01-14
    Publishing country England
    Document type Journal Article ; Multicenter Study ; Observational Study
    ISSN 1471-2407
    ISSN (online) 1471-2407
    DOI 10.1186/s12885-020-07758-5
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: First-line panitumumab plus capecitabine for the treatment of older patients with wild-type RAS metastatic colorectal cancer. The phase II, PANEL study.

    Méndez Méndez, José Carlos / Salgado Fernández, Mercedes / de la Cámara Gómez, Juan / Pellón Augusto, Mari Luz / Covela Rua, Marta / Quintero Aldana, Guillermo / Fernández Montes, Ana / Reboredo López, Margarida / Valladares Ayerbes, Manuel / Jorge Fernández, Mónica / González Villarroel, Paula / Romero Reinoso, Carlos / Ramos Vázquez, Manuel

    Journal of geriatric oncology

    2020  Volume 11, Issue 8, Page(s) 1263–1267

    Abstract: Background: Despite the high morbidity and mortality of metastatic colorectal cancer (mCRC) in older patients, they have been underrepresented in clinical trials and their optimal treatment is yet to be determined. This open-label phase II study ... ...

    Abstract Background: Despite the high morbidity and mortality of metastatic colorectal cancer (mCRC) in older patients, they have been underrepresented in clinical trials and their optimal treatment is yet to be determined. This open-label phase II study evaluated the benefits of panitumumab and capecitabine as a first-line chemotherapy regimen in older patients with wild-type [WT] RAS mCRC.
    Patients and methods: Patients (≥70 years; ECOG≤2) received 3-week cycles of panitumumab (9 mg/kg on day 1) plus capecitabine (850 mg/m
    Results: Twenty-seven patients (11 women; median age: 78 years; ECOG: 0 [26%], 1 [67%], 2 [7%]) were evaluated. Median follow-up was 17.7 months. Confirmed ORR (95%CI) was 44.4% (25.7-63.2), with 25.9% of patients achieving at least stable disease. Median (95%CI) DoR was 8.7 (5.5-10.4) months, and median TTR was 2.2 (1.9-2.8) months. Median TTP was 9.6 (4.8-11.5) months, with a median TTF of 5.2 (2.8-7.2) months. The median PFS was 7.5 (4.4-10.4) months, and the median OS was 23.7 (7.4-27.5) months. Seventeen (63%) patients reported panitumumab and/or capecitabine-related adverse events grade 3-4, with skin toxicity (18.5%) being the most common. Two (7.4%) deaths were treatment-related.
    Conclusion: This study suggests that panitumumab plus capecitabine is a safe and effective regimen in older patients with WT RAS mCRC.
    MeSH term(s) Aged ; Antibodies, Monoclonal/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Capecitabine/adverse effects ; Colorectal Neoplasms/drug therapy ; Female ; Fluorouracil/adverse effects ; Humans ; Panitumumab/therapeutic use ; Treatment Outcome
    Chemical Substances Antibodies, Monoclonal ; Capecitabine (6804DJ8Z9U) ; Panitumumab (6A901E312A) ; Fluorouracil (U3P01618RT)
    Language English
    Publishing date 2020-06-21
    Publishing country Netherlands
    Document type Clinical Trial, Phase II ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2556813-9
    ISSN 1879-4076 ; 1879-4068
    ISSN (online) 1879-4076
    ISSN 1879-4068
    DOI 10.1016/j.jgo.2020.06.003
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  6. Article: Do Clinical Trials Meet Current Care Needs? Views of Digestive Oncology Specialists in Galicia (Spain) Using the Delphi Method.

    Fernández Montes, Ana / Martinez-Lago, Nieves / de la Cámara Gomez, Juan / Brozos Vázquez, Elena María / Candamio Folgar, Sonia / Carmona Campos, Marta / Cousillas Castiñeiras, Antía / Covela Rúa, Marta / Gallardo Martín, Elena / González Villarroel, Paula / Graña Suarez, Begoña / Jorge Fernández, Mónica / Pellón Augusto, María Luz / Quintero Aldana, Guillermo / Romero Reinoso, Carlos / Salgado Fernández, Mercedes / Vázquez Rivera, Francisca / Ayuso Álvarez, Ana / Culqui, Dante R /
    Méndez Méndez, José Carlos / RIGhT-Sens Working Group

    Healthcare (Basel, Switzerland)

    2021  Volume 9, Issue 6

    Abstract: Background: ...

    Abstract Background:
    Language English
    Publishing date 2021-06-03
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2721009-1
    ISSN 2227-9032
    ISSN 2227-9032
    DOI 10.3390/healthcare9060665
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  7. Article ; Online: Parámetros antropométricos en la evaluación de la malnutrición en pacientes oncológicos hospitalizados; utilidad del índice de masa corporal y del porcentaje de pérdida de peso.

    Sotelo González, Silvia / Sánchez Sobrino, Paula / Carrasco Álvarez, Juan Antonio / González Villarroel, Paula / Páramo Fernández, Concepción

    Nutricion hospitalaria

    2013  Volume 28, Issue 3, Page(s) 965–968

    Abstract: Objective: To compare the BMI and the percentage of weight loss as markers for malnutrition in hospitalized cancer patients considering the Patient-Generated Global Subjective Assessment (PG-GSA) as the gold standard.: Method: Cross-sectional ... ...

    Title translation Anthropometric parameters in evaluating malnutrition in oncological patients; utility of body mass index and percentage of weight loss.
    Abstract Objective: To compare the BMI and the percentage of weight loss as markers for malnutrition in hospitalized cancer patients considering the Patient-Generated Global Subjective Assessment (PG-GSA) as the gold standard.
    Method: Cross-sectional descriptive study in patients admitted to the Medical Oncology Department of the Hospital Xeral de Vigo, from May to September of 2011.
    Results: 28 patients (15 males). Mean age 63.46 years ± 11.05. Mean BMI 23.75 kg/m² ± 3.62. Mean percentage of weight loss 8.53% ± 6.20. In group A (well nourished) the percentage of weight loss was 1.07 ± 1.85, in group B (moderately malnourished) 7.90 ± 1.73, and in group C (severely malnourished) 10.91 ± 6.91 (p = 0.034). The BMI showed no statistically significant differences.
    Conclusions: The BMI is not a proper parameter todetect malnutrition, by contrast with the percentage of weight loss that did show a direct association with the degree of hyponutrition.
    MeSH term(s) Body Height ; Body Mass Index ; Body Weight ; Cross-Sectional Studies ; Female ; Humans ; Male ; Malnutrition/diagnosis ; Malnutrition/etiology ; Middle Aged ; Neoplasms/complications ; Weight Loss
    Language Spanish
    Publishing date 2013-05
    Publishing country Spain
    Document type Comparative Study ; English Abstract ; Journal Article
    ZDB-ID 1481223-x
    ISSN 1699-5198 ; 0212-1611
    ISSN (online) 1699-5198
    ISSN 0212-1611
    DOI 10.3305/nh.2013.28.3.6369
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article: Megestrol acetate-induced adrenal insufficiency.

    González Villarroel, Paula / Fernández Pérez, Isaura / Páramo, Concepción / Gentil González, Marta / Carnero López, Beatriz / Vázquez Tuñas, M Lidia / Carrasco Alvarez, Juan A

    Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico

    2008  Volume 10, Issue 4, Page(s) 235–237

    Abstract: Megestrol acetate is a synthetic progestin that has been used since the 1970s for the treatment of advanced cancer and subsequently to treat anorexia, cachexia and weight loss in AIDS patients. It has been shown that high doses or prolonged treatment ... ...

    Abstract Megestrol acetate is a synthetic progestin that has been used since the 1970s for the treatment of advanced cancer and subsequently to treat anorexia, cachexia and weight loss in AIDS patients. It has been shown that high doses or prolonged treatment with this drug may cause Cushing's syndrome, new-onset diabetes and suppression of plasma ACTH and cortisol levels. Megestrol acetate may cause suppression of the pituitary-adrenal axis due to the affinity of this compound for the glucocorticoid receptor. Recognising the glucocorticoid-like activity of megestrol and its effects at the axis level is important for the diagnosis of sub-clinical adrenal insufficiency. We present the case of a 74-year-old woman with infiltrating ductal breast carcinoma refractory to prolonged hormonal treatment with megestrol acetate, presenting with adrenal insufficiency.
    MeSH term(s) Adrenal Insufficiency/chemically induced ; Adrenal Insufficiency/physiopathology ; Aged ; Antineoplastic Agents, Hormonal/adverse effects ; Breast Neoplasms/drug therapy ; Carcinoma, Ductal, Breast/drug therapy ; Female ; Humans ; Megestrol Acetate/adverse effects ; Pericardial Effusion/etiology ; Pericardial Effusion/surgery
    Chemical Substances Antineoplastic Agents, Hormonal ; Megestrol Acetate (TJ2M0FR8ES)
    Language English
    Publishing date 2008-04-14
    Publishing country Italy
    Document type Case Reports ; Journal Article
    ZDB-ID 2397359-6
    ISSN 1699-3055 ; 1699-048X
    ISSN (online) 1699-3055
    ISSN 1699-048X
    DOI 10.1007/s12094-008-0188-7
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