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1.
BMC Cancer ; 24(1): 803, 2024 Jul 05.
Article in English | MEDLINE | ID: mdl-38970024

ABSTRACT

BACKGROUND: Trabectedin in combination with pegylated liposomal doxorubicin (PLD) is approved for the treatment of patients with platinum-sensitive relapsed ovarian cancer. Nevertheless, there is currently limited information regarding this treatment in elderly patients with ovarian cancer in a real-world setting. METHODS: This observational and multicentric study retrospectively evaluated trabectedin plus PLD in a real-world setting treatment of elderly patients diagnosed with platinum-sensitive relapsed ovarian cancer, treated according to the Summary of Product Characteristics (SmPC) from 15 GEICO-associated hospitals. Patients ≥ 70 years old at the time of treatment initiation and platinum-free intervals ≥ 6 months were considered eligible. RESULTS: Forty-three patients with a median age of 74.0 years were treated between January 1st, 2015, and December 31st, 2019 in 15 Spanish centers. Four patients achieved complete response (9.3%), 14 (32.6%) partial response, and 13 (30.2%) stable disease as the best radiological response. In the analysis of biological overall response according to CA125 serum levels (i.e., Rustin criteria), 14 responded to the treatment (32.6%), 11 responded and normalized (25.6%), three patients stabilized (7.0%) and three progressed (7.0%). Median progression-free survival (PFS) and overall survival (OS) in the study population were 7.7 and 19.5 months, respectively. The most common grade 3/4 adverse events were neutropenia (n = 8, 18.7%) and asthenia (n = 5, 11.6%). CONCLUSIONS: This analysis demonstrated that trabectedin combined with PLD is a feasible and effective treatment in elderly patients with platinum-sensitive relapsed ovarian cancer, showing an acceptable safety profile, which is crucial in the palliative treatment of these patients.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols , Doxorubicin , Neoplasm Recurrence, Local , Ovarian Neoplasms , Polyethylene Glycols , Trabectedin , Humans , Trabectedin/therapeutic use , Trabectedin/administration & dosage , Female , Doxorubicin/analogs & derivatives , Doxorubicin/therapeutic use , Doxorubicin/adverse effects , Doxorubicin/administration & dosage , Aged , Ovarian Neoplasms/drug therapy , Ovarian Neoplasms/pathology , Ovarian Neoplasms/mortality , Retrospective Studies , Polyethylene Glycols/therapeutic use , Polyethylene Glycols/adverse effects , Polyethylene Glycols/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Aged, 80 and over , Neoplasm Recurrence, Local/drug therapy , Treatment Outcome
2.
Cancers (Basel) ; 15(11)2023 Jun 01.
Article in English | MEDLINE | ID: mdl-37296992

ABSTRACT

Genomic Instability (GI) is a transversal phenomenon shared by several tumor types that provide both prognostic and predictive information. In the context of high-grade serous ovarian cancer (HGSOC), response to DNA-damaging agents such as platinum-based and poly(ADP-ribose) polymerase inhibitors (PARPi) has been closely linked to deficiencies in the DNA repair machinery by homologous recombination repair (HRR) and GI. In this study, we have developed the Scarface score, an integrative algorithm based on genomic and transcriptomic data obtained from the NGS analysis of a prospective GEICO cohort of 190 formalin-fixed paraffin-embedded (FFPE) tumor samples from patients diagnosed with HGSOC with a median follow up of 31.03 months (5.87-159.27 months). In the first step, three single-source models, including the SNP-based model (accuracy = 0.8077), analyzing 8 SNPs distributed along the genome; the GI-based model (accuracy = 0.9038) interrogating 28 parameters of GI; and the HTG-based model (accuracy = 0.8077), evaluating the expression of 7 genes related with tumor biology; were proved to predict response. Then, an ensemble model called the Scarface score was found to predict response to DNA-damaging agents with an accuracy of 0.9615 and a kappa index of 0.9128 (p < 0.0001). The Scarface Score approaches the routine establishment of GI in the clinical setting, enabling its incorporation as a predictive and prognostic tool in the management of HGSOC.

3.
J Clin Oncol ; 41(16): 2904-2910, 2023 06 01.
Article in English | MEDLINE | ID: mdl-37058687

ABSTRACT

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.We report the final prespecified analysis for overall survival (OS), along with updated progression-free survival (PFS) and objective response rate (ORR), and safety from the open-label, randomized, phase III Study 309/KEYNOTE-775. In total, 827 patients with advanced, recurrent, or metastatic endometrial cancer (EC) were randomly assigned to receive lenvatinib 20 mg orally once daily plus pembrolizumab 200 mg intravenously once every 3 weeks (n = 411) or chemotherapy of the treating physician's choice (doxorubicin 60 mg/m2 intravenously once every 3 weeks or paclitaxel 80 mg/m2 intravenously once weekly [3 weeks on; 1 week off] [n = 416]). Efficacy was reported for patients with mismatch repair proficient (pMMR) tumors and all-comers, and by subgroups (histology, prior therapy, MMR status). Updated safety was also reported.Lenvatinib plus pembrolizumab showed benefits in OS (pMMR HR, 0.70; 95% CI, 0.58 to 0.83; all-comer HR, 0.65; 95% CI, 0.55 to 0.77), PFS (pMMR HR, 0.60; 95% CI, 0.50 to 0.72; all-comer HR, 0.56; 95% CI, 0.48 to 0.66), and ORR (pMMR patients, 32.4% v 15.1%; all-comers, 33.8% v 14.7%) versus chemotherapy. OS, PFS, and ORR favored lenvatinib plus pembrolizumab in all subgroups of interest. No new safety signals were observed. Lenvatinib plus pembrolizumab continued to show improved efficacy versus chemotherapy and manageable safety in patients with previously treated advanced EC.


Subject(s)
Antibodies, Monoclonal, Humanized , Endometrial Neoplasms , Female , Humans , Antibodies, Monoclonal, Humanized/therapeutic use , Endometrial Neoplasms/drug therapy , Phenylurea Compounds/adverse effects , Antineoplastic Combined Chemotherapy Protocols/adverse effects
4.
Eur J Cancer ; 181: 42-52, 2023 03.
Article in English | MEDLINE | ID: mdl-36634389

ABSTRACT

BACKGROUND: The phase III PAOLA-1/ENGOT-ov25 study (NCT02477644) showed that addition of olaparib to bevacizumab maintenance improved progression-free survival (PFS) in patients with newly diagnosed advanced ovarian cancer. We evaluated maintenance olaparib plus bevacizumab in older patients in PAOLA-1. METHODS: Baseline clinical and molecular data, and PFS, were compared between older (aged ≥65 years) and younger patients (<65 years). Factors associated with olaparib efficacy, and safety in age subgroups, were also assessed. RESULTS: Of 806 randomised patients, 292 (36.2%) were ≥65 years. A lower proportion of older versus younger patients had an Eastern Cooperative Oncology Group performance status of 0 (61.0% versus 76.2%) and upfront surgery (42.0% versus 55.7%). Older patients were less likely to have a BRCA1/2 mutation (17.1% versus 36.7%) or homologous recombination deficiency-positive status (34.1% versus 55.7%). After median follow-up of 22.1 months, median PFS was 21.6 months with olaparib versus 16.6 months with placebo in the older population (hazard ratio [HR] 0.55, 95% confidence interval [CI] 0.41-0.75), comparable with the younger population (median 22.9 versus 16.9 months; HR 0.61, 95% CI 0.49-0.77). PFS benefits were observed in patients with a BRCA mutation or homologous recombination deficiency-positive tumours. Incidence of olaparib-related grade ≥3 adverse events in older patients was comparable with that of younger patients (36.8% versus 31.7%) although hypertension and anaemia were more common in older patients. No treatment-related deaths occurred in older patients receiving olaparib. CONCLUSION: Older patients enrolled in PAOLA-1 achieved similar PFS benefits compared with younger patients, with a similar safety profile.


Subject(s)
Ovarian Neoplasms , Humans , Female , Aged , Bevacizumab/adverse effects , Ovarian Neoplasms/drug therapy , Ovarian Neoplasms/genetics , Ovarian Neoplasms/pathology , Phthalazines/adverse effects , Piperazines/adverse effects , Neoplasm Recurrence, Local/drug therapy
5.
J Pers Med ; 12(11)2022 Nov 04.
Article in English | MEDLINE | ID: mdl-36579549

ABSTRACT

Germline and tumor BRCA testing constitutes a valuable tool for clinical decision-making in the management of epithelial ovarian cancer (EOC) patients. Tissue testing is able to identify both germline (g) and somatic (s) BRCA variants, but tissue preservation methods and the widespread implementation of NGS represent pre-analytical and analytical challenges that need to be managed. This study was carried out on a multicenter prospective GEICO cohort of EOC patients with known gBRCA status in order to determine the inter-laboratory reproducibility of tissue sBRCA testing. The study consisted of two independent experimental approaches, a bilateral comparison between two reference laboratories (RLs) testing 82 formalin-paraffin-embedded (FFPE) EOC samples each, and a Ring Test Trial (RTT) with five participating clinical laboratories (CLs) evaluating the performance of tissue BRCA testing in a total of nine samples. Importantly, labs employed their own locally adopted next-generation sequencing (NGS) analytical approach. BRCA mutation frequency in the RL sub-study cohort was 23.17%: 12 (63.1%) germline and 6 (31.6%) somatic. Concordance between the two RLs with respect to BRCA status was 84.2% (gBRCA 100%). The RTT study distributed a total of nine samples (three commercial synthetic human FFPE references, three FFPE, and three OC DNA) among five CLs. The median concordance detection rate among them was 64.7% (range: 35.3-70.6%). Analytical discrepancies were mainly due to the minimum variant allele frequency thresholds, bioinformatic pipeline filters, and downstream variant interpretation, some of them with consequences of clinical relevance. Our study demonstrates a wide range of concordance in the identification and interpretation of BRCA sequencing data, highlighting the relevance of establishing standard criteria for detecting, interpreting, and reporting BRCA variants.

6.
Eur J Cancer ; 174: 221-231, 2022 10.
Article in English | MEDLINE | ID: mdl-36067615

ABSTRACT

BACKGROUND: PAOLA-1/ENGOT-ov25 (NCT02477644) demonstrated a significant progression-free survival (PFS) benefit with maintenance olaparib plus bevacizumab versus placebo plus bevacizumab in newly diagnosed, advanced ovarian cancer. We report the prespecified main second progression-free survival (PFS2) analysis for PAOLA-1. METHODS: This randomised, double-blind, phase III trial was conducted in 11 countries. Eligible patients had newly diagnosed, advanced, high-grade ovarian cancer and were in response after first-line platinum-based chemotherapy plus bevacizumab. Patients were randomised 2:1 to olaparib (300 mg twice daily) or placebo for up to 24 months; all patients received bevacizumab (15 mg/kg every 3 weeks) for up to 15 months. Primary PFS end-point was reported previously. Time from randomisation to second disease progression or death was a key secondary end-point included in the hierarchical-testing procedure. RESULTS: After a median follow-up of 35.5 months and 36.5 months, respectively, median PFS2 was 36.5 months (olaparib plus bevacizumab) and 32.6 months (placebo plus bevacizumab), hazard ratio 0.78; 95% confidence interval (CI) 0.64-0.95; P = 0.0125. Median time to second subsequent therapy or death was 38.2 months (olaparib plus bevacizumab) and 31.5 months (placebo plus bevacizumab), hazard ratio 0.78; 95% CI 0.64-0.95; P = 0.0115. Seventy-two (27%) patients in the placebo plus bevacizumab group received a poly(ADP-ribose) polymerase inhibitor as first subsequent therapy. No new safety signals were observed for olaparib plus bevacizumab. CONCLUSION: In newly diagnosed, advanced ovarian cancer, maintenance olaparib plus bevacizumab provided continued benefit beyond first progression, with a significant PFS2 improvement and a time to second subsequent therapy or death delay versus placebo plus bevacizumab.


Subject(s)
Antineoplastic Agents , Ovarian Neoplasms , Antineoplastic Agents/therapeutic use , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Bevacizumab , Carcinoma, Ovarian Epithelial/drug therapy , Double-Blind Method , Female , Humans , Ovarian Neoplasms/drug therapy , Phthalazines/adverse effects , Piperazines , Poly(ADP-ribose) Polymerase Inhibitors/therapeutic use , Progression-Free Survival
7.
Eur J Cancer ; 166: 229-239, 2022 05.
Article in English | MEDLINE | ID: mdl-35316750

ABSTRACT

INTRODUCTION: Patients with cancer (PC) are at high risk of acquiring COVID-19 and can develop more serious complications. Deeper understanding of vaccines immunogenicity in this population is crucial for adequately planning vaccines programs. The ONCOVac study aimed to comprehensively assess the immunogenicity of mRNA-1273 vaccine in terms of humoral and cellular response. METHODS: We conducted a prospective, single-center study including patients with solid tumours treated with cyclin-dependent kinases 4 and 6 inhibitors (CDK4/6i), immunotherapy (IT) or chemotherapy (CT). Patients were enrolled previously to vaccination with mRNA-1273. We also involved health care workers (HCW) to serve as a control group. We took blood samples before first dose administration (BL), after first dose (1D), and after second dose (2D). The primary objective was to compare the rate and magnitude of T cell response after second dose whereas safety and humoral response were defined as secondary objectives. We also collected patient reported outcomes after both the first and second vaccine dose and a six-month follow-up period to diagnose incident COVID-19 cases was planned. RESULTS: The rate of specific anti-S serologic positivity (anti-S IgG cut-off point at 7,14 BAU/mL) was significantly higher in HCW compared to PC after 1D (100% versus 83.8%; p = 0.04), but similar after 2D (100% versus 95.8%; p = 0.5). This difference after 1D was driven by PC treated with CT (100% versus 64.5%; p = 0.001). Cellular response after 2D was significantly lower in PC than in HCW for both CD4+ (91.7% versus 59.7%; p = 0.001) and CD8+ (94.4% versus 55.6%; p < 0.001) T cells. We found a difference on pre-existing CD4+ T cell response in HCW comparing to PC (36% and 17%, p = 0.03); without difference in pre-existing CD8+ T cell response (31% and 23%, p = 0.5). After excluding patients with pre-existing T cell response, PC achieved even lower CD4+ (50.9% versus 95.5%, p < 0.001) and CD8+ (45.5% versus 95.5%, p < 0.001) T cell response compared with HCW. Regarding safety, PC reported notably more adverse events than HCW (96.6% versus 69.2%, p < 0.001). CONCLUSION: We demonstrated that PC showed a similar humoral response but a lower T cell response following two doses of mRNA-1273 vaccination. Further studies are needed to complement our results and determine the implication of low T cell response on clinical protection of PC against COVID-19.


Subject(s)
COVID-19 , Neoplasms , 2019-nCoV Vaccine mRNA-1273 , Antibodies, Viral , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Humans , Neoplasms/therapy , Prospective Studies , SARS-CoV-2 , Vaccines, Synthetic , mRNA Vaccines
8.
N Engl J Med ; 386(6): 544-555, 2022 02 10.
Article in English | MEDLINE | ID: mdl-35139273

ABSTRACT

BACKGROUND: Patients with recurrent cervical cancer have a poor prognosis. Cemiplimab, the fully human programmed cell death 1 (PD-1)-blocking antibody approved to treat lung and skin cancers, has been shown to have preliminary clinical activity in this population. METHODS: In this phase 3 trial, we enrolled patients who had disease progression after first-line platinum-containing chemotherapy, regardless of their programmed cell death ligand 1 (PD-L1) status. Women were randomly assigned (1:1) to receive cemiplimab (350 mg every 3 weeks) or the investigator's choice of single-agent chemotherapy. The primary end point was overall survival. Progression-free survival and safety were also assessed. RESULTS: A total of 608 women were enrolled (304 in each group). In the overall trial population, median overall survival was longer in the cemiplimab group than in the chemotherapy group (12.0 months vs. 8.5 months; hazard ratio for death, 0.69; 95% confidence interval [CI], 0.56 to 0.84; two-sided P<0.001). The overall survival benefit was consistent in both histologic subgroups (squamous-cell carcinoma and adenocarcinoma [including adenosquamous carcinoma]). Progression-free survival was also longer in the cemiplimab group than in the chemotherapy group in the overall population (hazard ratio for disease progression or death, 0.75; 95% CI, 0.63 to 0.89; two-sided P<0.001). In the overall population, an objective response occurred in 16.4% (95% CI, 12.5 to 21.1) of the patients in the cemiplimab group, as compared with 6.3% (95% CI, 3.8 to 9.6) in the chemotherapy group. An objective response occurred in 18% (95% CI, 11 to 28) of the cemiplimab-treated patients with PD-L1 expression greater than or equal to 1% and in 11% (95% CI, 4 to 25) of those with PD-L1 expression of less than 1%. Overall, grade 3 or higher adverse events occurred in 45.0% of the patients who received cemiplimab and in 53.4% of those who received chemotherapy. CONCLUSIONS: Survival was significantly longer with cemiplimab than with single-agent chemotherapy among patients with recurrent cervical cancer after first-line platinum-containing chemotherapy. (Funded by Regeneron Pharmaceuticals and Sanofi; EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9 ClinicalTrials.gov number, NCT03257267.).


Subject(s)
Adenocarcinoma/drug therapy , Antibodies, Monoclonal, Humanized/therapeutic use , Antineoplastic Agents, Immunological/therapeutic use , Carcinoma, Adenosquamous/drug therapy , Neoplasm Recurrence, Local/drug therapy , Uterine Cervical Neoplasms/drug therapy , Adenocarcinoma/mortality , Adult , Aged , Aged, 80 and over , Antibodies, Monoclonal, Humanized/adverse effects , Antineoplastic Agents, Immunological/adverse effects , Biomarkers, Tumor/metabolism , Carcinoma, Adenosquamous/mortality , Disease Progression , Female , Humans , Middle Aged , Neoplasm Recurrence, Local/mortality , Programmed Cell Death 1 Receptor/metabolism , Quality of Life , Survival Analysis , Uterine Cervical Neoplasms/mortality
9.
Gynecol Oncol ; 164(2): 254-264, 2022 02.
Article in English | MEDLINE | ID: mdl-34952708

ABSTRACT

OBJECTIVES: Adding maintenance olaparib to bevacizumab provided a significant progression-free survival (PFS) benefit in patients with newly diagnosed, advanced ovarian cancer in the randomized, double-blind PAOLA-1/ENGOT-ov25 trial (NCT02477644). We analyzed PFS by clinical risk and biomarker status. METHODS: Patients received olaparib 300 mg twice daily for up to 24 months plus bevacizumab 15 mg/kg every 3 weeks for up to 15 months in total, or placebo plus bevacizumab. This post hoc exploratory analysis evaluated PFS in patients classified as higher risk (stage III with upfront surgery and residual disease or neoadjuvant chemotherapy; stage IV) or lower risk (stage III with upfront surgery and no residual disease), and by biomarker status. RESULTS: Of 806 randomized patients, 74% were higher risk and 26% were lower risk. After a median 22.9 months of follow-up, PFS favored olaparib plus bevacizumab versus placebo plus bevacizumab in higher-risk patients (hazard ratio [HR] 0.60; 95% confidence interval [CI] 0.49-0.74) and lower-risk patients (0.46; 0.30-0.72). Olaparib plus bevacizumab provided a substantial PFS benefit versus bevacizumab alone in the homologous recombination deficiency (HRD)-positive subgroup (higher risk: HR 0.39; 95% CI 0.28-0.54 and lower risk: 0.15; 0.07-0.30), with 24-month PFS rates in lower-risk patients of 90% versus 43%, respectively (Kaplan-Meier estimates). CONCLUSIONS: In PAOLA-1, maintenance olaparib plus bevacizumab provided a substantial PFS benefit in HRD-positive patients with a reduction of risk of progression or death of 61% in the higher-risk group and of 85% in the lower-risk group compared with bevacizumab alone.


Subject(s)
Antineoplastic Agents, Immunological/therapeutic use , Bevacizumab/therapeutic use , Carcinoma, Ovarian Epithelial/drug therapy , Hereditary Breast and Ovarian Cancer Syndrome/drug therapy , Ovarian Neoplasms/drug therapy , Phthalazines/therapeutic use , Piperazines/therapeutic use , Poly(ADP-ribose) Polymerase Inhibitors/therapeutic use , Adult , Aged , Aged, 80 and over , Carcinoma, Ovarian Epithelial/genetics , Carcinoma, Ovarian Epithelial/pathology , Cytoreduction Surgical Procedures , Female , Genes, BRCA1 , Genes, BRCA2 , Hereditary Breast and Ovarian Cancer Syndrome/genetics , Humans , Maintenance Chemotherapy , Middle Aged , Ovarian Neoplasms/genetics , Ovarian Neoplasms/pathology , Progression-Free Survival
10.
N Engl J Med ; 381(25): 2416-2428, 2019 12 19.
Article in English | MEDLINE | ID: mdl-31851799

ABSTRACT

BACKGROUND: Olaparib has shown significant clinical benefit as maintenance therapy in women with newly diagnosed advanced ovarian cancer with a BRCA mutation. The effect of combining maintenance olaparib and bevacizumab in patients regardless of BRCA mutation status is unknown. METHODS: We conducted a randomized, double-blind, international phase 3 trial. Eligible patients had newly diagnosed, advanced, high-grade ovarian cancer and were having a response after first-line platinum-taxane chemotherapy plus bevacizumab. Patients were eligible regardless of surgical outcome or BRCA mutation status. Patients were randomly assigned in a 2:1 ratio to receive olaparib tablets (300 mg twice daily) or placebo for up to 24 months; all the patients received bevacizumab at a dose of 15 mg per kilogram of body weight every 3 weeks for up to 15 months in total. The primary end point was the time from randomization until investigator-assessed disease progression or death. RESULTS: Of the 806 patients who underwent randomization, 537 were assigned to receive olaparib and 269 to receive placebo. After a median follow-up of 22.9 months, the median progression-free survival was 22.1 months with olaparib plus bevacizumab and 16.6 months with placebo plus bevacizumab (hazard ratio for disease progression or death, 0.59; 95% confidence interval [CI], 0.49 to 0.72; P<0.001). The hazard ratio (olaparib group vs. placebo group) for disease progression or death was 0.33 (95% CI, 0.25 to 0.45) in patients with tumors positive for homologous-recombination deficiency (HRD), including tumors that had BRCA mutations (median progression-free survival, 37.2 vs. 17.7 months), and 0.43 (95% CI, 0.28 to 0.66) in patients with HRD-positive tumors that did not have BRCA mutations (median progression-free survival, 28.1 vs. 16.6 months). Adverse events were consistent with the established safety profiles of olaparib and bevacizumab. CONCLUSIONS: In patients with advanced ovarian cancer receiving first-line standard therapy including bevacizumab, the addition of maintenance olaparib provided a significant progression-free survival benefit, which was substantial in patients with HRD-positive tumors, including those without a BRCA mutation. (Funded by ARCAGY Research and others; PAOLA-1 ClinicalTrials.gov number, NCT02477644.).


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Bevacizumab/administration & dosage , Ovarian Neoplasms/drug therapy , Phthalazines/administration & dosage , Piperazines/administration & dosage , Poly(ADP-ribose) Polymerase Inhibitors/therapeutic use , Adult , Aged , Aged, 80 and over , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Bevacizumab/adverse effects , Combined Modality Therapy , Double-Blind Method , Female , Humans , Maintenance Chemotherapy , Middle Aged , Ovarian Neoplasms/mortality , Ovarian Neoplasms/surgery , Phthalazines/adverse effects , Piperazines/adverse effects , Poly(ADP-ribose) Polymerase Inhibitors/adverse effects , Progression-Free Survival , Quality of Life
11.
Case Rep Oncol ; 12(2): 447-455, 2019.
Article in English | MEDLINE | ID: mdl-31275136

ABSTRACT

Ovarian cancer is the seventh most common type of cancer and the fifth leading cause of cancer death among women worldwide. The current usual therapeutic approach in this disease includes optimal cytoreductive therapy followed by platinum-based adjuvant chemotherapy, along with neoadjuvant chemotherapy prior to surgery in selected cases. The platinum-free interval (PFI) continues to be the most useful tool to assist in the selection of the subsequent therapy and to predict response to treatment. The combination of trabectedin and pegylated liposomal doxorubicin (PLD) is useful in patients with partially platinum-sensitive recurrent ovarian cancer, in patients who have previously received two or more platinum-based chemotherapy regimens, in patients who have already experienced a platinum-induced hypersensitivity reaction and in patients who have previously failed to respond to a platinum-based treatment. CASE PRESENTATION: A 64-years-old postmenopausal woman with pain, abdominal distension, and an altered intestinal transit and with partially platinum-sensitive recurrent ovarian cancer, was successfully treated with a second line of trabectedin chemotherapy in combination with PLD, followed by trabectedin in monotherapy. This case proves the effectiveness of the combination of trabectedin and PLD and demonstrates how the administration of trabectedin, even in monotherapy, allows to maintain an adequate clinical response with good tolerance to the treatment during more than two years of drug administration.

12.
Farm. hosp ; 41(6): 674-677, nov.-dic. 2017. ilus, tab
Article in Spanish | IBECS | ID: ibc-169374

ABSTRACT

Objetivo: Realizar un análisis modal de fallos y efectos (AMFE) aplicado a la utilización de jeringas orales. Métodos: Un grupo multidisciplinar dentro del Comité de Seguridad analizó las etapas en la administración oral de los medicamentos líquidos, identificándose las más críticas y estableciendo modos potenciales de fallo que podrían producir un error. El riesgo asociado a cada modo de fallo se calculó utilizando el número de prioridad de riesgo (NPR). Se sugirieron acciones preventivas. Resultados: Se identificaron cinco modos de fallo, todos clasificados de alto riesgo (NPR>100). Siete de las ocho recomendaciones fueron implementadas. Conclusiones: La aplicación de la metodología AMFE ha sido una herramienta muy útil que ha permitido conocer los riesgos, analizar las causas que los pueden provocar y saber los efectos que tienen en la seguridad del paciente; todo ello con el fin de implantar acciones para reducirlos (AU)


Objective: To carry out a Failure Mode and Effects Analysis (FMEA) to the use of oral syringes. Methods: A multidisciplinary team was assembled within the Safety Committee. The stages of oral administration process of liquid medication were analysed, identifying the most critical and establishing the potential modes of failure that can cause errors. The impact associated with each mode of failure was calculated using the Risk Priority Number (RPN). Preventive actions were proposed. Results: Five failure modes were identified, all classified as high risk (RPN> 100). Seven of the eight preventive actions were implemented. Conclusions: The FMEA methodology was a useful tool. It has allowed to know the risks, analyse the causes that cause them, their effects on patient safety and the measures to reduce them (AU)


Subject(s)
Humans , Syringes , Healthcare Failure Mode and Effect Analysis/methods , Pharmaceutical Preparations/administration & dosage , Pharmaceutical Preparations/classification , Enteral Nutrition , Syringes/standards , Healthcare Failure Mode and Effect Analysis/organization & administration , Healthcare Failure Mode and Effect Analysis/standards , Administration, Oral
13.
Farm Hosp ; 41(6): 674-677, 2017 Nov 01.
Article in English | MEDLINE | ID: mdl-29112492

ABSTRACT

OBJECTIVE: To carry out a Failure Mode and Effects Analysis (FMEA) to the use of oral syringes. METHODS: A multidisciplinary team was assembled within the Safety Committee.  The stages of oral administration process of liquid  medication were analysed, identifying the most critical and establishing the  potential modes of failure that can cause errors. The impact associated with  each mode of failure was calculated using the Risk Priority Number (RPN).  Preventive actions were proposed. RESULTS: Five failure modes were identified, all classified as high risk (RPN>  100). Seven of the eight preventive actions were implemented. CONCLUSIONS: The FMEA methodology was a useful tool. It has allowed to know  the risks, analyse the causes that cause them, their effects on patient safety and  the measures to reduce them.


Objetivo: Realizar un análisis modal de fallos y efectos (AMFE) aplicado a la utilización de jeringas orales.Métodos: Un grupo multidisciplinar dentro del Comité de Seguridad analizó las etapas en la administración oral de los medicamentos líquidos, identificándose las más críticas y estableciendo modos potenciales de fallo que podrían producir un error. El riesgo asociado a cada modo de fallo se calculó  utilizando el número de prioridad de riesgo (NPR). Se sugirieron acciones preventivas.Resultados: Se identificaron cinco modos de fallo, todos clasificados de alto  riesgo (NPR>100). Siete de las ocho recomendaciones fueron implementadas.Conclusiones: La aplicación de la metodología AMFE ha sido una herramienta muy útil que ha permitido conocer los riesgos, analizar las causas que los pueden provocar y saber los efectos que tienen en la seguridad del paciente; todo ello con el fin de implantar acciones para  reducirlos.


Subject(s)
Administration, Oral , Healthcare Failure Mode and Effect Analysis , Pharmaceutical Solutions/administration & dosage , Humans , Patient Safety , Prospective Studies , Risk Assessment , Syringes
14.
Endocrinol Nutr ; 56(4): 201-4, 2009 Apr.
Article in Spanish | MEDLINE | ID: mdl-19627737

ABSTRACT

Parasellar and hypothalamic metastases are uncommon. Their principal clinical manifestation is diabetes insipidus. Associated hypopituitarism is very rare. We report the case of a 54-year-old man with small cell lung cancer and hypopituitarism. A brain magnetic resonance imaging scan revealed a mass in the anterior region of the third ventricle with no clear etiology. The patient began chemotherapy treatment and the mass disappeared, which confirmed the diagnosis of secondary hypopituitarism caused by hypothalamic metastasis from small cell lung cancer.


Subject(s)
Carcinoma, Small Cell/secondary , Hypopituitarism/etiology , Hypothalamic Neoplasms/secondary , Lung Neoplasms/pathology , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carcinoma, Small Cell/complications , Carcinoma, Small Cell/diagnosis , Carcinoma, Small Cell/drug therapy , Carcinoma, Small Cell/radiotherapy , Combined Modality Therapy , Cranial Irradiation , Headache/etiology , Hormone Replacement Therapy , Humans , Hydrocortisone/therapeutic use , Hypopituitarism/drug therapy , Hypothalamic Neoplasms/complications , Hypothalamic Neoplasms/diagnosis , Hypothalamic Neoplasms/drug therapy , Hypothalamic Neoplasms/radiotherapy , Lung Neoplasms/complications , Lung Neoplasms/diagnostic imaging , Lung Neoplasms/drug therapy , Magnetic Resonance Imaging , Male , Middle Aged , Thyroxine/therapeutic use , Tomography, X-Ray Computed
15.
Endocrinol. nutr. (Ed. impr.) ; 56(4): 201-203, abr. 2009. ilus, tab
Article in Spanish | IBECS | ID: ibc-61710

ABSTRACT

Las metástasis en la región selar e hipotalámica son raras y la principal manifestación clínica es la diabetes insípida. Un hipopituitarismo concomitante se produce en muy pocas ocasiones. Presentamos el caso de un varón de 54 años con carcinoma microcítico de pulmón e hipopituitarismo. Una resonancia magnética cerebral reveló una lesión en la cara anterior del tercer ventrículo sin etiología clara. El paciente inició tratamiento con quimioterapia y la lesión desapareció. Por lo tanto, el paciente fue diagnosticado de hipopitituarismo secundario a metástasis hipotalámica de carcinoma microcítico de pulmón (AU)


Parasellar and hypothalamic metastases are uncommon. Their principal clinical manifestation is diabetes insipidus. Associated hypopituitarism is very rare. We report the case of a 54-year-old man with small cell lung cancer and hypopituitarism. A brain magnetic resonance imaging scan revealed a mass in the anterior region of the third ventricle with no clear etiology. The patient began chemotherapy treatment and the mass disappeared, which confirmed the diagnosis of secondary hypopituitarism caused by hypothalamic metastasis from small cell lung cancer (AU)


Subject(s)
Humans , Male , Middle Aged , Carcinoma, Small Cell/pathology , Hypopituitarism/etiology , Hypothalamic Neoplasms/secondary , Neoplasm Metastasis/pathology , Lung Neoplasms/pathology
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