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  • American Society of Clinical Oncology (ASCO)  (32)
  • 1
    Online Resource
    Online Resource
    Clinical Presentation and Outcomes of Patients With Cancer-Associated Isolated Distal Deep Vein Thrombosis
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO)
    Abstract: Patients with isolated distal deep vein thrombosis (DVT) have lower rates of adverse outcomes (death, venous thromboembolism [VTE] recurrence or major bleeding) than those with proximal DVT. It is uncertain if such findings are also observed in patients with cancer. METHODS Using data from the international Registro Informatizado de la Enfermedad TromboEmbolica venosa registry, we compared the risks of adverse outcomes at 90 days (adjusted odds ratio [aOR]; 95% CI) and 1 year (adjusted hazard ratio [aHR; 95% CI] ) in 886 patients with cancer-associated distal DVT versus 5,196 patients with cancer-associated proximal DVT and 5,974 patients with non–cancer-associated distal DVT. RESULTS More than 90% of patients in each group were treated with anticoagulants for at least 90 days. At 90 days, the adjusted risks of death, VTE recurrence, or major bleeding were lower in patients with non–cancer-associated distal DVT than in patients with cancer-associated distal DVT (reference): aOR = 0.16 (0.11-0.22), aOR = 0.34 (0.22-0.54), and aOR = 0.47 (0.27-0.80), respectively. The results were similar at 1-year follow-up: aHR = 0.12 (0.09-0.15), aHR = 0.39 (0.28-0.55), and aHR = 0.51 (0.32-0.82), respectively. Risks of death, VTE recurrence, and major bleeding were not statistically different between patients with cancer-associated proximal versus distal DVT, both at 90 days: aOR = 1.11 (0.91-1.36), aOR = 1.10 (0.76-1.62), and aOR = 1.18 (0.76-1.83), respectively, and 1 year: aHR = 1.01 (0.89-1.15), aHR = 1.02 (0.76-1.35), and aHR = 1.10 (0.76-1.61), respectively. However, more patients with cancer-associated proximal DVT, compared with cancer-associated distal DVT, developed fatal pulmonary embolism (PE) during follow-up: The risk difference was 0.40% (95% CI, 0.23 to 0.58). CONCLUSION Cancer-associated distal DVT has serious and relatively comparable outcomes compared with cancer-associated proximal DVT. The lower risk of fatal PE from cancer-associated distal DVT needs further investigation.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.23.00429
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
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  • 2
    Online Resource
    Online Resource
    Tolerability of raltitrexed when it is used in monotherapy and in combination with oxaliplatin (TOMOX) as advanced colorectal cancer treatment in normal clinical practice.
    American Society of Clinical Oncology (ASCO) ; 2013
    In:  Journal of Clinical Oncology Vol. 31, No. 15_suppl ( 2013-05-20), p. e14648-e14648
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. e14648-e14648
    Abstract: e14648 Background: Fluoropyrimidines (FP) based chemotherapy continue to be the cornerstone of advanced colorectal cancer (aCRC) treatment. However, FP cannot be appropriated for some patients (FP intolerance, DPD deficit, history of ischemic heart disease, etc). In these cases, Raltitrexed (R) in monotherapy or in combination with oxaliplatin (TOMOX) could be an effective alternative to FP. Methods: We assessed in an observational retrospective study the patient profile and the tolerability of R when it is used in monotherapy or in combination with oxaliplatin (TOMOX) as aCRC treatment in the normal clinical practice setting. Data from patients treated between 2010 and 2012 were collected from 15 Spanish hospitals. Reason for choosing R as aCRC treatment, patient and disease characteristics, previous treatment and toxicity were gathered. Results: The data from 144 patients treated with R (72) and TOMOX (72) were included in the analysis (64% male, median age 68 years, ECOG PS 0/1/2 in 18%/62%/19%). The main reasons to choose R were: similar efficacy and safety to other treatments (19%), convenience of the administration (18%), cardiovascular disease (17%), resistance to FP (14%), previous FP inacceptable toxicity (10%) and old age (11%). R was mainly used as third or successive treatment line (64%) while TOMOX was equally used in all treatment lines (37%, 28% and 35%). The mean number of cycles was 5 (1-15). The dose was reduced in 26% of the patients and the treatment administration was delayed in 53%. The creatinine clearance was only calculated in 20% of the cycles. The most common grade 3-4 toxicities were neutropenia (8%), anaemia (5%), nausea (2%), vomiting (1%), diarrhoea (7%) and hepatic toxicity (4%). There were 2 toxic deaths (1.4%). Conclusions: R and TOMOX represent a safe alternative for aCRC patients in which FP are not appropriated. Despite R good tolerance in normal clinical practice, it is a must to assess creatinine clearance before each cycle.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2013.31.15_suppl.e14648
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2013
    detail.hit.zdb_id: 2005181-5
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  • 3
    Online Resource
    Online Resource
    Determining viability of circulating tumor cells (CTCs) as a predictive biomarker for response in patients (pts) with metastatic castrate resistant prostate cancer (mCRPC) treated with Radium 223 (Ra).
    American Society of Clinical Oncology (ASCO) ; 2015
    In:  Journal of Clinical Oncology Vol. 33, No. 15_suppl ( 2015-05-20), p. e16051-e16051
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 33, No. 15_suppl ( 2015-05-20), p. e16051-e16051
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2015.33.15_suppl.e16051
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2015
    detail.hit.zdb_id: 2005181-5
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  • 4
    Online Resource
    Online Resource
    Pilot SCAT trial: Spanish customized adjuvant chemotherapy (CT) based on BRCA1 mRNA expression levels (l) in resected stage II-IIIA non-small cell lung cancer (NSCLC) patients (p).
    American Society of Clinical Oncology (ASCO) ; 2012
    In:  Journal of Clinical Oncology Vol. 30, No. 15_suppl ( 2012-05-20), p. 7011-7011
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. 7011-7011
    Abstract: 7011 Background: Surgical resection is the standard treatment in early stages of NSCLC. Nonetheless, long-term survival rate even after surgical resection is disappointing. Several randomized trials and meta-analyses confirmed the survival benefit of adjuvant cisplatin-based CT for stage II and IIIA. BRCA1 is a component of multiple DNA repair pathways, functions as a molecular determinant of response to cytotoxic chemotherapeutics agents, and is an independent prognostic variable in resected p. Since BRCA1 mRNA expression has been linked to differential sensitivity to cisplatin and antimicrotubule drugs, BRCA1 expression may provide additional information for customizing adjuvant CT. Methods: Completely resected p with pathological lymph node involvement (N1, N2) received 4 cycles of customized adjuvant CT according BRCA1 l. Low l: gemcitabine-cisplatin, intermediate l: docetaxel-cisplatin, high l: docetaxel. Overall survival (OS) was the primary endpoint. Multivariate analysis for time to relapse (TTR) and survival was performed. Results: Eighty-three p were elegible. Most of the patients were male (83%). Type of surgery: 23% pneumonectomy, and 77% lobectomy or bilobectomy. Fifty-three per cent had low BRCA1 l, 33,7% intermediate l, and 13,3% expressed high l. Most of the tumors with adenocarcinoma histology had low l (71%). With a median follow-up of 41.6 months (m), median TTP for the whole group was 22.9 m (13.4-32.5): 20.3 m for low l, 56.5 m for intermediate l, and 51.9 m for high l (P=0.31). Median OS for the whole group was 63.6 m (33.3-93.9): 55 m for low l, and not reached for intermediate and high l (P=0.58). Forty-three p (51.8%) are still alive. Conclusions: Selection of customized CT based on BRCA1 expression l is feasible and could increase time to relapse and survival in resected N1-N2 p. No statistical differences for survival: 55 months for gemcitabine-cisplatin, and not reached for docetaxel-cisplatin and for docetaxel as single agent. Randomized phase III SCAT trial with the addition of a non-pharmacogenomic control arm is ongoing (372 patients included).
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2012.30.15_suppl.7011
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2012
    detail.hit.zdb_id: 2005181-5
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  • 5
    Online Resource
    Online Resource
    Predicting the risk of VISIT emergency department (ED) in lung cancer patients using machine learning.
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. 2042-2042
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. 2042-2042
    Abstract: 2042 Background: Lung cancer patients commonly need unplanned visits to ED. Many of these visits could be potentially avoidable if it were possible to identify patients at risk when the previous scheduled visit takes place. At that moment, it would be possible to perform elective actions to manage patients at risk to consult the ED in the near future. Methods: Unplanned visits of patients in active cancer therapy (i.e. chemo or immunotherapy) are attended in our own ED facilities. Our Electronic Health Record (EHR) includes specific modules for first visit, scheduled visits and unplanned visits. Lung cancer patients with at least two visits were eligible. The event of interest was patient visit to ED within 21 or 28 days (d) from previous visit. Free text data collected in the three modules were obtained from EHR in order to generate a feature vector composed of the word frequencies for each visit. We evaluate five different machine learning algorithms to predict the event of interest. Area under the ROC curve (AUC), F1 (harmonic mean of precision and recall), True Positive Rate (TPR) and True Negative Rate (TNR) were assessed using 10-fold cross validation. Results: 2,682 lung cancer patients treated between March 2009 and October 2019 were included from which 819 patients were attended at ED. There were 2,237 first visits, 47,465 scheduled visits (per patient: range 1-174; median 12) and 2,125 unplanned visits (per patient: range 1-20; median 2). Mean age at diagnosis was 64 years. The majority of patients had late stage disease (34.24 % III, 51.56 % IV). The Adaptive Boosting Model yields the best results for both 21 d or 28 d prediction. Conclusions: Using unstructured data from real-world EHR enables the possibility to build an accurate predictive model of unplanned visit to an ED within the 21 or 28 following d after a scheduled visit. Such utility would be very useful in order to prevent ED visits related with cancer symptoms and to improve patients care. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.2042
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
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  • 6
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    NeoHx study: Perioperative treatment with trastuzumab in combination with capecitabine and oxaliplatin (XELOX-T) in patients with HER2 resectable stomach or esophagogastric junction (EGJ) adenocarcinoma—R0 resection, pCR, and toxicity analysis.
    American Society of Clinical Oncology (ASCO) ; 2013
    In:  Journal of Clinical Oncology Vol. 31, No. 15_suppl ( 2013-05-20), p. 4098-4098
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. 4098-4098
    Abstract: 4098 Background: Perioperative chemotherapy has demonstrated better OS and DFS than surgery alone in resectable stomach or EGJ adenocarcinoma. Trastuzumab has improved OS when added to chemotherapy in pts with HER-2 + metastatic gastric cancer and is interesting to explore its role in the perioperative setting. Methods: A Spanish, multicenter, open-label phase II study evaluated the efficacy and toxicity profile of perioperative XELOX-T (capecitabine 1000 mg/m2/12h po days 1-14, oxaliplatin 130 mg/m2 day 1, trastuzumab 8 mg/kg→ mg/kg day 1, q3w ; 3 preoperative cycles and 3 postsurgery cycles followed by 12 cycles of trastuzumab monotherapy) in patients with T1-2N+M0 or T3-4NxM0 resectable stomach or EGJ adenocarcinoma, HER-2+ ( IHQ3+ or IHQ2+/FISH+). The primary endpoint was 18 months DFS, secondary endpoint included pCR, R0 resection rate, ORR and toxicity of preoperative treatment (NCI CTC v3.0 criteria). Results: From June 2010 to March 2012, 36 pts were included: median age 65 (39-85); ECOG 0/1/2: 16/19/1 pts; localization: stomach 21 pts, EGJ 15 pts; histologic type: intestinal: 23 pts, diffuse: 4 pts, mixed: 1pt, not specified 8 pts; TNM: T 4: 7 pts; N+: 31 pts. Preoperative XELOX-T: Response: PR: 14 pts (39%), SD: 18 pts, PD: 0 pts, NE: 4 pts. G-3-4 toxicity (≥ 5% of pts): diarrhea 22% and asthenia 5%. Surgery was performed in 31 pts: R0: 28 pts (78%, 95% CI: 61-90%), R1: 1 pt, R2: 2 pts (1 had peritoneal carcinomatosis); pCR was observed in 7 pts (19 %; 95% CI: 8-36%) and 22 pts (61%) were pN0. Two pts died due to surgical complications,. We do not have mature data about postoperative XELOX-T yet. Follow-up is still too short for DFS and OS. Conclusions: This preliminary analysis suggests that perioperative XELOX+T in HER-2 positive resectable stomach or esophagogastric junction adenocarcinoma is feasible and has interesting activity. Clinical trial information: NCT01130337.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2013.31.15_suppl.4098
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2013
    detail.hit.zdb_id: 2005181-5
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  • 7
    Online Resource
    Online Resource
    NEOHX study: Perioperative treatment with trastuzumab in combination with capecitabine and oxaliplatin (XELOX-T) in patients with HER-2 resectable stomach or esophagogastric junction (EGJ) adenocarcinoma—18 m DFS analysis.
    American Society of Clinical Oncology (ASCO) ; 2015
    In:  Journal of Clinical Oncology Vol. 33, No. 3_suppl ( 2015-01-20), p. 107-107
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 33, No. 3_suppl ( 2015-01-20), p. 107-107
    Abstract: 107 Background: Perioperative chemotherapy has demonstrated better OS and DFS than surgery alone in resectable stomach or EGJ adenocarcinoma. Trastuzumab has improved OS when added to chemotherapy in pts with HER-2 + metastatic gastric cancer and is interesting to explore its role in the perioperative setting. Methods: A Spanish, multicenter, open-label phase II study evaluated the efficacy and toxicity profile of perioperative XELOX-T (Capecitabine 1000 mg/m2/12h po days 1-14, oxaliplatin 130 mg/m2 day 1, trastuzumab 8 mg/kgà6 mg/kg day 1, q3w ; 3 preoperative cycles and 3 postsurgery cycles followed by 12 cycles of trastuzumab monotherapy) in patients with T1-2N+M0 or T3-4NxM0 resectable stomach or EGJ adenocarcinoma, HER-2+ ( IHQ3+ or IHQ2+/FISH+). The primary endpoint was 18 months DFS, secondary endpoint included pCR, R0 resection rate, ORR, toxicity of preoperative treatment (NCI CTC v3.0 criteria) and biomarker analysis. Results: From June 2010 to March 2012, 36 pts were included: median age 65 (39-85); ECOG 0/1/2: 16/19/1 pts; localization: stomach 21 pts, EGJ 15 pts; histologic type: intestinal: 23 pts, diffuse: 4 pts, mixed: 1pt, not specified 8 pts; TNM: T 4: 7 pts; N+: 31 pts. Preoperative XELOX-T: Response: PR: 14 pts (39%), SD: 18 pts, PD: 0 pts, NE: 4 pts. Surgery was performed in 31 pts: R0: 28 pts (78%, 95% CI: 61-90%), R1: 1 pt, R2: 2 pts (1 had peritoneal carcinomatosis); pCR was observed in 3 pts (8.3 %; 95% CI: 2-22%). Two pts died due to surgical complications. After R0/R1 resection, postoperative XELOX-T was administered to 24 patients, 22 of whom underwent T monotherapy. G3-4 toxicity ( 〉 5% of pts): diarrhea 33%, nauseas and vomiting 8% and pneumonia, anemia, neutropenia, anorexia, asthenia and pleural effusion with pneumothorax: 5.5%. With a median follow up of 24.1 months, 18m DFS is 71% (95% CI: 53-83%), 24 m DFS is 60% and median DFS and OS has not been reached. Conclusions: These data suggest that perioperative XELOX+T in HER-2 positive resectable stomach or esophagogastric junction adenocarcinoma is feasible and has promising activity. Clinical trial information: NCT01130337.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2015.33.3_suppl.107
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2015
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  • 8
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    Online Resource
    Evaluation of safety and efficacy of somatuline autogel in combination with molecular targeted therapies (MTT) in patients with neuroendocrine tumors (NETs): Data from one Spanish cohort.
    American Society of Clinical Oncology (ASCO) ; 2012
    In:  Journal of Clinical Oncology Vol. 30, No. 15_suppl ( 2012-05-20), p. e14671-e14671
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. e14671-e14671
    Abstract: e14671 Background: Analysis of the mechanisms of action of somatostatin analogs (SSAs) and mTOR inhibitors or tyrosine kinase inhibitors suggest that they may provide synergistic effects when used in combination for the treatment of pts with NETs. Methods: This is a Spanish multicenter cohort of pts with NETs treated with the SSAs lanreotide (LAN) and MTTs at 35 Spanish referral centers. Data of 159 combined treatments (133 pts) was retrospectively collected in order to evaluate the efficacy and safety of such combinations. Results: 133 pts (52,6% M) with a median age of 59,9 years; ECOG 0/1/2/3: 34%/49%/16%/1%; Lung/Pancreas/Gastrointestinal//Unknown(UK) origin: 9%/48% /32%/11%; G1/G2/G3/UK: 41%/32%/1%/26%; Non Functioning/ Functioning (69%/31%) received treatment with MTT + LAN for synergistic antiproliferative purpose in 85% of the cases, hormonal control (13,5%) or both objectives (1,5%). 115 pts received one combination treatment and 18 pts received between 2 (12 pts) and 5 (1 pt). LAN was administrated in combination with sunitinib (61), everolimus (73), bevazucimab (9), sorafenib (8) and pazopanib (8). The reported toxicity was determined by the MTT profile with no significant additional severe adverse events related to the combination with LAN. The probability of progression-free survival (PFS) at 6, 12 and 18months was 89%, 73% and 67% respectively for those pts who received LAN and sunitinib (n=50) and 78%, 69% and 57%, respectively for those pts who received LAN and everolimus (n=56). Median PFS was not reached at the time of analysis. Conclusions: The combination of LAN and MTT, mainly everolimus and sunitinib, is widely used in clinical practice without unexpected toxicities. Median PFS will be higher than data observed in phase III studies with sunitinib and everolimus, raising the hypothesis of enhanced efficacy combining SSAs and MTT that should be confirmed in randomized prospective clinical trials. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2012.30.15_suppl.e14671
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2012
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  • 9
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    Online Resource
    A multicenter analysis of the outcome of cancer patients with neutropenia and COVID-19 infection optionally treated with granulocyte colony-stimulating factor (G-CSF).
    American Society of Clinical Oncology (ASCO) ; 2021
    In:  Journal of Clinical Oncology Vol. 39, No. 15_suppl ( 2021-05-20), p. 12105-12105
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. 12105-12105
    Abstract: 12105 Background: Infection by SARS-CoV-2 can turn into an acute respiratory infection. Approximately 15% of patients will develop a distress syndrome responsible in most cases of mortality. A host hyperinflammatory response induced by a cytokine storm, is the main cause of this severe complication. Chemotherapy myelosuppression is associated with higher risk of infections and mortality in cancer patients. There have been no previous reports about the clinical management of patients with neutropenia and concomitant COVID-19. Herein, we present a multicenter experience in several hospitals during COVID-19 outbreak in neutropenic cancer patients infected by SARS-Cov-2. Methods: Retrospective clinical data were collected from clinical reports. Protocol was approved by a Clinical Research Ethics Committee (HULP: PI-4194). Inclusion criteria were cancer patients with neutropenia ( 〈 1500 cells/mm3) and concomitant COVID-19 infection. Comorbidities, tumor type and stage, treatment, neutropenia severity, filgrastim (G-CSF), COVID-19 parameters and mortality were analyzed. Exploratory analysis included a description of all data collected and bivariate analyses among different pairs of variables, including their impact in mortality in this cohort. In addition, multivariable logistic regression was used to predict respiratory failure and death as a function of multiple variables. Results: Among 943 patients with cancer screened in 14 hospitals in Spain, eighty-three patients (8%) had a febrile neutropenia and COVID-19 infection. Lung (26%), breast (22%), colorectal (13%) and digestive non-colorectal (17%) cancers were the main locations and most patients had advanced disease (67%). Fifty-three (63%) of patients included died because respiratory failure. Neumonia was presented in 76% of patients, bilateral in 47% and 12% of all patients had thrombotic events. The median of neutrophils was 650cls/mm3 and 49% received G-CSF with a median of days on treatment around 4,5 days. Among all variables related with mortality in neutropenic cancer patients with COVID-19 infection, we found that the number of days with G-CSF showed a significant trend toward worse outcome and higher mortality. In particular, a logistic regression model was developed to predict respiratory failure, as a function of the number of days of G-CSF treatment. As adjusting covariates, sex, age, treatment purpose (palliative vs curative, to adjust for patient status), tumor type, and the lowest level of neutrophils in the patient (to adjust for neutropenic status) were used. A significant effect was obtained for the days of G-CSF treatment (OR = 1.4, 95% CI [1.03, 1.92], p-value = 0.01 ). Conclusions: Our findings suggest that a prolonged G-CSF treatment could be disadvantageous for these cancer patients with COVID-19, with a higher probability of worse outcome.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2021.39.15_suppl.12105
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2021
    detail.hit.zdb_id: 2005181-5
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  • 10
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    Analysis of the efficacy and safety of naloxegol administered to patients with cancer and opioid-induced constipation with laxative-inadequate response: A real-world 12 months of follow-up study.
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. e24155-e24155
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. e24155-e24155
    Abstract: e24155 Background: Naloxegol is a peripherally acting, µ-opioid receptor antagonist for treatment of opioid-induced constipation (OIC). The main objective of this study was to analyze the efficacy and safety of naloxegol in patients with cancer in a real-world 12-month follow-up study. Methods: An observational prospective study was conducted in 16 Spanish centers. Patients older than 18 years, with active oncological disease who were under treatment with opioids for pain control and Karnofsky ≥ 50 were selected. OIC with inadequate response to treatment with laxative (s) was the main diagnostic. All the patients received treatment with naloxegol according to clinical criteria. Efficacy was measured by the response rate and symptoms evolution measured by means of PAC-SYM questionnaire. Intensity of pain was measured by a 0-10-point visual analogue scale (VAS). Intent to treat last observation carried forward was applied. Results: A total of 126 patients were included in the study. About 58.7% were men, with a mean age of 61.5 years (34-89). Lung cancer was observed in 35.7%, breast cancer in 16.7%, 10.3% digestive cancer and 8.7% had prostate cancer. About 67.5% had metastases. Naloxegol at doses of 25 mg/day was administered to 88.1% and with concomitant laxatives in 48.4%. At 12 months, 77.8% of the patients were responders to naloxegol treatment: 78.6% at doses of 12.5 mg/day, and 78.4% with 25 mg/day. Furthermore, response was observed in 78.5% of patients without concomitant laxative treatment and 77% of patients with any concomitant laxative. PAC-SYM total score and all the dimensions improved from baseline (p 〈 0.0001). VAS pain intensity was reduced and controlled from baseline onwards (Baseline-12 months: 4.6 to 3.6, p 〈 0.001). A total of 28 adverse reactions mainly gastrointestinal were observed in 15.1% of the patients (19/126), 75% (21) mild, 17.9% (5) moderate and 7.1% (2) severe. Most adverse reactions (67.9%) were observed the first 15 days of treatment with naloxegol. Conclusions: The results of this first real-world-data study in patients with cancer confirm the long-term efficacy of naloxegol for the treatment of OIC in this group of patients. Naloxegol is safe and well tolerated in patients with cancer while maintaining pain control.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.e24155
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
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