GLORIA

GEOMAR Library Ocean Research Information Access

X

Your email was sent successfully. Check your inbox.

An error occurred while sending the email. Please try again.

Proceed reservation?

Export
  • 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
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 2
    Online Resource
    Online Resource
    Differential protein expression profile in skin biopsies from patients with hand-foot syndrome who have benefited from topical heparin treatment.
    American Society of Clinical Oncology (ASCO) ; 2013
    In:  Journal of Clinical Oncology Vol. 31, No. 15_suppl ( 2013-05-20), p. 9641-9641
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. 9641-9641
    Abstract: 9641 Background: Hand-foot syndrome (HFS) is a dose-limiting toxicity of capecitabine (CAP), leading to significant morbidity in patients receiving this agent. Interruption or dose reduction of CAP is the only effective strategy. The purpose of our study is to define the pathophysiology and risk factors predictors of CAP-induced HFS. Previously, we had conducted a clinical trial in patients who developed HFS secondary to CAP. Topical heparin was administered in palms and soles of patients four times/day for three weeks (w), evidencing clinical improvement in 99% of patients. Methods: Paired-skin biopsies of palms at baseline and after 3w from 21 patients were obtained. An iTRAQ (isobaric tags for relative and absolute quantitation) proteomics approach was performed to identify molecular pathways associated with HFS reversion. Results: Comparative analysis between baseline and post-treatment skin samples identified 1876 proteins with high confidence ( 〉 99%). The involvement of the identified proteins in biological networks served to characterize molecular pathways associated with HFS reversion. Conclusions: Several proteins identified in this study have a close relationship with keratinocyte terminal differentiation and keratinocyte intercellular strength. Also, we describe differential expression among proteins involved in inflammatory processes, skin immunity and cell death. In summary, our study not only served to uncover molecular mechanisms associated with HFS reversion, but also to reveal the biomarker role of several proteins in this syndrome. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2013.31.15_suppl.9641
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2013
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 3
    Online Resource
    Online Resource
    Multicenter Phase II Study of Lurbinectedin in BRCA -Mutated and Unselected Metastatic Advanced Breast Cancer and Biomarker Assessment Substudy
    American Society of Clinical Oncology (ASCO) ; 2018
    In:  Journal of Clinical Oncology Vol. 36, No. 31 ( 2018-11-01), p. 3134-3143
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 36, No. 31 ( 2018-11-01), p. 3134-3143
    Abstract: This multicenter phase II trial evaluated lurbinectedin (PM01183), a selective inhibitor of active transcription of protein-coding genes, in patients with metastatic breast cancer. A unicenter translational substudy assessed potential mechanisms of lurbinectedin resistance. Patients and Methods Two arms were evaluated according to germline BRCA1/2 status: BRCA1/2 mutated (arm A; n = 54) and unselected ( BRCA1/2 wild-type or unknown status; arm B; n = 35). Lurbinectedin starting dose was a 7-mg flat dose and later, 3.5 mg/m 2 in arm A. The primary end point was objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST). The translational substudy of resistance mechanisms included exome sequencing (n = 13) and in vivo experiments with patient-derived xenografts (n = 11) from BRCA1/2-mutated tumors. Results ORR was 41% (95% CI, 28% to 55%) in arm A and 9% (95% CI, 2% to 24%) in arm B. In arm A, median progression-free survival was 4.6 months (95% CI, 3.0 to 6.0 months), and median overall survival was 20.0 months (95% CI, 11.8 to 26.6 months). Patients with BRCA2 mutations showed an ORR of 61%, median progression-free survival of 5.9 months, and median overall survival of 26.6 months. The safety profile improved with lurbinectedin dose adjustment to body surface area. The most common nonhematologic adverse events seen at 3.5 mg/m 2 were nausea (74%; grade 3, 5%) and fatigue (74%; grade 3, 21%). Neutropenia was the most common severe hematologic adverse event (grade 3, 47%; grade 4, 10%). Exome sequencing showed mutations in genes related to the nucleotide excision repair pathway in four of seven tumors at primary or acquired resistance and in one patient with short-term stable disease. In vivo, sensitivity to cisplatin and lurbinectedin was evidenced in lurbinectedin-resistant (one of two) and cisplatin-resistant (two of three) patient-derived xenografts. Conclusion Lurbinectedin showed noteworthy activity in patients with BRCA1/2 mutations. Response and survival was notable in those with BRCA2 mutations. Additional clinical development in this subset of patients with metastatic breast cancer is warranted.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2018.78.6558
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2018
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 4
    Online Resource
    Online Resource
    Correlation between classical prognostic factors and overexpression of HER2 and HER3 in localized gastric cancer.
    American Society of Clinical Oncology (ASCO) ; 2012
    In:  Journal of Clinical Oncology Vol. 30, No. 15_suppl ( 2012-05-20), p. e14589-e14589
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. e14589-e14589
    Abstract: e14589 Background: Although HER2 overexpression has been identified as a predictive factor for targeted therapy in advanced gastric cancer (GC), little is known about its role in localized GC. Recent studies suggest that not only HER2 but also HER3 might have a role in prognosis in GC. Our study aimed to identify the prevalence of HER2 and HER3 overexpression in a series of localized GC and to describe correlations of these with traditional prognostic factors Methods: We performed a retrospective analysis of HER2 and HER3 overexpression in archived tumour samples in pts diagnosed with GC at stage I-III. HER2 was assessed with herceptest, (negative if 0 or 1+, or positive with 2+ or 3+). Staining of HER3 was determined with the Rajkumar score (HER3+ when score 〉 or = 8). Correlation between the HER receptors expression and the clinicopathologic parameters was statistically analyzed. Statistical analysis of the correlation of HER2 and HER3 with other variables was performed with chi-square test or with the Mann Witney U for continuous variables. Impact on survival was analysed with Kaplan-Meier and log-rank tests. Results: From Jan 2003 to Sep 2011, 125 patients with clinical stage I-III GC were included. Median age was 73 years (35-91) and most frequent location was antrum (47.2%). Up to 43.2% of the patients were treated with preoperative chemotherapy. HER2 was + in 18 patients (14.4%) and HER3 in 38 (30.4%). HER2 was more likely to be overexpressed in older patients (median age: 78.4 vs 68.4; p 〈 0.0001) and in low grade adenocarcinomas (grade 1-2: 13.8% vs grade 3: 1.1%; p=0.006). HER3 was more frequently overexpressed at advanced stages (I and IIA: 10.3% vs IIB and III: 20.3%; p=0.004) and in adenocarcinoma with intestinal subtype (intestinal: 21.4% vs difuse/mixed: 8.5%; p=0.03) or without evidence of signet ring cells (absent: 26.8% vs present: 4.1%; p=0.03) . HER2 and HER3 were significantly related (p=0.0012) with an OR of 3,52 times more frequently HER3+, if HER2 was +. No significant impact was shown in survival for either HER2 or HER3. Conclusions: HER2 and HER3 overexpression seems to identify a particular subgroup of patients with favourable classical prognostic factors.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2012.30.15_suppl.e14589
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2012
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 5
    Online Resource
    Online Resource
    Primary prevention and smoking habit among BRCA1/2 mutation carriers.
    American Society of Clinical Oncology (ASCO) ; 2019
    In:  Journal of Clinical Oncology Vol. 37, No. 15_suppl ( 2019-05-20), p. e13061-e13061
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 37, No. 15_suppl ( 2019-05-20), p. e13061-e13061
    Abstract: e13061 Background: Smoking is the leading cause of avoidable death in the world. Although controversial for years, current prospective studies suggest that smoking increases the risk of cancer in women with a deleterious BRCA1/2 mutation. Actually, we have very limited information about tobacco habit among BRCA1/2 carriers. Methods: We report an observational retrospective study of a consecutive sample of 198 BRCA1/2 carriers studied between April 2014 and March 2018 at the Family Cancer Clinic of the University Hospital of Coruña (NW-Spain). The main objective of the study is to know the prevalence of smoking in BRCA1/2 women, and to determine if carriers undergoing risk-reducing surgeries (RRS) abandon their tobacco habit as part of the primary prevention strategy. Results: The sample includes 136 patients affected by cancer (84% breast, 19% ovary) and 62 healthy women. During their follow-up [Median = 22, (1-43) months], 85 carriers underwent RRS (29% mammary, 54% prophylactic salpingo-oophorectomy, 16% both). At first visit, 46 were active smokers, 47 ex-smokers, 77 non-smokers and 28 did not specify their habit. The percentage of smokers and never smokers is similar between sick and healthy BRCA1/2 carriers, presenting a greater proportion of former smokers among those affected of cancer (30% vs. 23%), and of active smokers among healthy women (35% vs. 23%) [p 〉 0.5)]. Moreover, 23% of BRCA1/2 carriers are active smokers despite a previous diagnosis of cancer. RRS are not associated to a greater tobacco cessation, persisting in the habit 18% of the women that underwent any preventive surgery (p 〉 0.5). Conclusions: Smoking habit is high (55%) among BRCA1/2 carriers followed at our family cancer clinic. At least 23% of our BRCA1/2 positive women are active smokers despite a previous diagnosis of cancer.The performance of aggressive RRS is not associated with greater abandonment of tobacco in carriers, persisting in the smoking habit 18% of operated women.It is essential to improve anti-tobacco strategies in family cancer consultations if we want to be efficient in the management of high-risk cancer individuals.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2019.37.15_suppl.e13061
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2019
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 6
    Online Resource
    Online Resource
    Observational cross-sectional study to evaluate the prognostic factors influencing the selection of bevacizumab combined with chemotherapy in patients with HER2-negative metastatic breast cancer in routine clinical practice. ONCOSUR-AVALOX study.
    American Society of Clinical Oncology (ASCO) ; 2012
    In:  Journal of Clinical Oncology Vol. 30, No. 15_suppl ( 2012-05-20), p. e11074-e11074
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. e11074-e11074
    Abstract: e11074 Background: Combining bevacizumab (BEV) with chemotherapy (CT) improves survival in HER2-negative metastatic breast cancer (MBC). We investigated the influence of age, ECOG, hormonal status, number of sites and location of metastases and patient decision on the selection of BEV combined with CT in MBC. Methods: Observational cross-sectional multicenter study in pts with HER2-negative MBC who have received first-line CT with BEV. Results: From November 2010 to November 2011, 124 pts were included: median age 51 (45-64) yr; ECOG: 0=50%; 60% pre-menopausic; 23% triple-negative (TN); 77% hormone receptor-positive (HR+). Metastatic disease: ≥3 sites=42% (TN: 32%; HR+: 45%); location: 44% bone, 35% lung, 30% liver. Most frequent BEV-based combinations were paclitaxel/BEV (53%) and docetaxel/BEV (14.5%); median no. of CT cycles: 6 (5-8). A disease-free survival (DFS) ≥12 months was achieved by 73%; TN: 68%; HR+: 76%. Overall response rate (ORR) was 58%: 51% partial response (PR), 7% complete response (CR); 28% stable disease (SD) and 10% disease progression. TN: ORR 44% (40% PR), clinical benefit 80% (36% SD); HR+: ORR 62% (54% PR), clinical benefit 87% (25% SD). 58% presented at least one toxicity, mainly grade 1-2; 26% BEV-related: only 3 (2.4%) grade 3 toxicities; no grade 4. Receiving adjuvant hormonal therapy was associated to DFS ≥12 months (p 〈 0.05). ER+ tumors (OR: 0.215; 95% CI: 0.08-0.56; p=0.002) and one metastatic site, vs. ≥3 sites (OR: 0.309; 95% CI: 0.12-0.83; p=0,020) were independent factors associated with the selection of paclitaxel-BEV therapy in the overall population (TN or HR+). Metastases in the liver were significantly related to paclitaxel-BEV administration (p 〈 0.01). Conclusions: Our findings suggest that first-line CT with BEV is an active and tolerable treatment option for pts with TN and HR+ MBC. ER+ tumors and a single metastatic site were identified as independent factors for the selection of a paclitaxel-BEV therapy. The presence of metastases in the liver was significantly associated to the administration of a paclitaxel-BEV regimen.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2012.30.15_suppl.e11074
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2012
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 7
    Online Resource
    Online Resource
    Advance directives among patients with advanced cancer in Mexico.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 28_suppl ( 2022-10-01), p. 186-186
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 28_suppl ( 2022-10-01), p. 186-186
    Abstract: 186 Background: Completion of advance directives can help to ensure consistency with people´s preferences at the end of life. However, disparities in access to advance care planning is common among Hispanic population and little is known about their end-of life wishes. Although in Mexico, advance directives were legalized in 2008, only 21% of people know about it. Objective: To describe end-of-life wishes among patients with advanced cancer planning in a third level hospital in Mexico City. Methods: We conducted a cross-sectional analysis of advance directives planning from patients with advanced cancer included in a multidisciplinary patient navigator-led supportive care program in Mexico City (Te Acompañamos). Patients with a life expectancy of 6 months or less were invited to complete advance directives (AD). Life expectancy was calculated using the palliative performance scale (PPS). Descriptive statistics were used for this analysis. Results: From September 2017 to November 2021, a total of 238 patients were invited to complete AD and 55 (23.1%) completed it, 14.5% in 2017, 29% in 2018, 34.5% in 2019, 9% in 2020 and 12.7% in 2021. The mean age among those who completed AD was 65.8 years (range 38-91), 52.7% were women and 61.8% had gastrointestinal cancer. Forty-three (78.1%) patients stated their wish to die at home, 18.1% to have cardiopulmonary reanimation, 9% invasive mechanical ventilation, 24.4% tube feeding, 90.9% pain medications, 10.9% organ donation, 40% cremation, 38.1% a funeral and 50.9% a death ritual. At median follow up of 5 months (0-39), 43 (78.1%) patients have died, and their endo-of-life wishes were respected in 77.5 % of them concerning the place of death and in 96.7% regarding cardiopulmonary reanimation and invasive mechanical ventilation. Conclusions: In our patient navigator-led supportive program approximately a quarter of patients with advanced cancer and a life expectancy of 6 month or less completed AD and end-of-life wishes were respected in a significant proportion of them. Telemedicine methods used to invite patients during COVID-19 pandemic decreased the proportion of AD completion. Although, advanced care planning is associated with improved in quality of care at the end of life, several barriers and disparities exist among Hispanics and strategies to improve their completion are needed.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.28_suppl.186
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 8
    Online Resource
    Online Resource
    Overall survival (OS) and healthcare utilization results of a randomized controlled trial (RCT) assessing a patient navigation (PN) intervention to increase early access to supportive care (SC) for patients with metastatic cancer in a resource-limited setting.
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. 12112-12112
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. 12112-12112
    Abstract: 12112 Background: We previously reported improvements in access to SC, advance directive completion, and pain control in a RCT comparing a patient navigator-led early SC intervention vs. usual care among patients with newly-diagnosed metastatic cancer in Mexico (NCT03293849). We now present results on healthcare utilization and OS. Methods: Patients were randomized to PN or usual oncology care. Patients in the PN arm received SC interventions by a navigator-led multidisciplinary team (palliative care, physical therapy, geriatrics, psychology) in the first 12 weeks after diagnosis. At 12-weeks, patients allocated to usual care were able to cross-over to PN and receive multidisciplinary SC. We analyzed the number (no.) of emergency room (ER) visits, their cause, and whether they were potentially avoidable (as determined by expert consensus), using descriptive statistics and X2 tests. OS was estimated using the Kaplan-Meier method and the log-rank test. Results: 133 patients (median age 60, range 23-93; 52% male) were randomized (66 PN, 67 control) from 08/17 to 04/18. Median follow-up was 22.8 months. 61% had gastrointestinal tumors, and 45% had a calculated life expectancy ≤6 months. 69% of patients randomized to usual care crossed-over to PN and received SC interventions. 80% of patients attended the ER ≥once (median no. of visits = 2). No difference was found between patients randomized to early SC or usual care in ER visits (2.4 vs. 2.3, p = 0.58). Out of a total 316 ER visits, the most common reason was infections (n = 69, 22%), followed by pain (n = 40, 13%), and indwelling catheter-related complications (n = 23, 7%). 41% of ER visits were considered as potentially avoidable, with no difference in avoidable visits found between arms (1.7 vs. 1.7, p = 0.49). No differences between arms were found in no. of hospitalizations (0.8 vs. 0.6 p = 0.82). Survival results were assessed after 64% of patients had died (n = 85), finding no statistically significant OS difference between the early SC intervention and the usual care arms (11.0 vs 13.0 months, p = 0.77) Conclusions: In the context of a limited-resource healthcare system, the early delivery of SC did not improve healthcare utilization, reduce avoidable ER visits, or prolong OS compared to the implementation of SC at a later time, which might be partially explained by the unavailability of hospice or home care, and by high rates of cross-over between arms. Clinical trial information: NCT03293849 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.12112
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 9
    Online Resource
    Online Resource
    Balixafortide (a CXCR4 antagonist) plus eribulin in HER2 negative metastatic breast cancer: Dose-response analysis of efficacy from phase I single-arm trial.
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. e15209-e15209
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. e15209-e15209
    Abstract: e15209 Background: Balixafortide (B) is a potent, selective antagonist of the chemokine receptor CXCR4. High CXCR4 levels correlate with aggressive metastatic phenotypes and poor prognosis in metastatic breast cancer (MBC). Efficacy and safety data were published recently from the Phase 1 trial investigating B + eribulin (E) in patients with HER2 negative MBC 1 . We report the final efficacy analyses from this trial, including assessment of dose-response. Methods: In this single-arm, dose escalation trial, patients (pts) received E + increasing doses of B using a 3+3 design in 3 parts: Part I (cohorts received low E doses); Part II (dose-escalation cohort for B [1−5.5mg/kg] + 1.4mg/m 2 E); Expanded Cohort (EC; 5.5mg/kg B + 1.4mg/m 2 E) to confirm safety and efficacy. Results: At entry, all 56 women (age range 33−82 years) were HER2-negative (IHC and/or FISH), CXCR4 positive. The majority were Caucasian. Most pts were heavily pre-treated in the metastatic setting (line of chemotherapy on study: 29% 2 nd line, 50% 3 rd line, 21% 4 th line). 75% were hormone receptor positive and 23% had triple negative breast cancer. Conclusions: A consistent dose response effect for B + E was suggested in heavily pretreated pts with HER2 negative MBC across all efficacy endpoints. A comparison of these efficacy results, and particularly response data, with single agent data for E in similar populations 2, 3 showed that pts in the EC had a more profound benefit observed consistently throughout all efficacy endpoints. Further data and analysis will be forthcoming for presentation. 1. 3 patients from Part II also included in EC because they received the B dose selected for EC (5.5mg/kg). 2. Part I was an initial safety run-in with lower E doses, and so is not included in the table. 1. Pernas S et al. Lancet Oncol. 2018; 19: 812−24 2. Cortes J et al. Lancet. 2011; 377: 914−923 3. Kaufman PA et al. J Clin Oncol. 2015; 33: 594−601. Clinical trial information: NCT01837095 . [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.e15209
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 10
    Online Resource
    Online Resource
    Laboratory cross-comparison of tumor BRCA1/2 analysis in a multicenter epithelial ovarian cancer series: The BORNEO GEICO60-0 study.
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. 6055-6055
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. 6055-6055
    Abstract: 6055 Background: Epithelial ovarian cancer (EOC) identification of BRCA1 and BRCA2 mutations is usually carried out in germline, representing around 17% in high grade serous ovarian cancer (HGSOC) and further 5-7% are only identified in the tumor (somatic). The aim of this study was to identify in EOC tumor BRCA mutation frequency and inter-laboratory reproducibility using different Next-generation Sequencing (NGS) approaches. Methods: In an ambispective study design, a population of unselected consecutive non mucinous EOC was clinically annotated and Formalin-Fixed Paraffin-Embedded (FFPE) tumor BRCA1/2 mutation analysis was undertaken in two laboratories (Lab-1 and Lab-2) simultaneously. Both laboratories used their own validated NGS panels; variant allele frequency threshold was 5% for single nucleotide polymorphism and 10% for indels. Each laboratory classified variants into three categories based on ACMG criteria: non-mutated (class 1-2), Variants of Uncertain Significance (VUS: class 3) and likely pathogenic/pathogenic (class 4-5). Germline BRCA analysis was available according to local clinical practice or centralized in Lab-1 if histology was low grade. Results: Ninety FFPE samples were received, 8 had insufficient material to be analyzed in both laboratories and 6 cases were discarded due to tumor cellularity below 20% leaving 76 cases to be sequenced. The population had a median age of 58 (25-84) years, 87% (66/76) of HGSOC histology and 70% of advanced stages (III-IVB: 53) and 14.5% (11) germline BRCA mutations (3 with not available results). Lab-1 identified 17 class 4-5 mutations, 11 correspond to germline, 4 (5.3%) are just somatic and 2 have germline results not available yet. Lab-2 had one not valuable analysis and identified 16 class 4-5 mutations, 10 corresponding to germline and 4 somatic variants. Percentage of concordance between both laboratories was 96% (kappa coefficient 0.883; p value 〈 0.0001). Three discordant out of 18 class 4-5 mutations included 2 undetected (VAF of 14.9% and 60.3% respectively) and one class 4 in Lab-2 classified as VUS in Lab-1 due to different interpretation criteria. Conclusions: The global BRCA mutation frequency in our series was 22.3% for Lab-1 and 21.0% for Lab-2. Concordance between tumor BRCA mutation analysis was high (96%). Nevertheless, further effort is required on harmonizing the technical and analytical aspects in tumor mutational analysis.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.6055
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
Close ⊗
This website uses cookies and the analysis tool Matomo. More information can be found here...