scholarly journals Olaparib in the maintenance treatment of platinum-sensitive relapse of BRCA mutant ovarian cancer in routine clinical practice: first results of observational study in Russian patients

2018 ◽  
Vol 20 (3) ◽  
pp. 19-25
Author(s):  
E V Artamonova ◽  
E I Kovalenko ◽  
A V Snegovoy ◽  
A A Aksarin ◽  
T A Anciferova ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Clinical Practice ◽  
Maintenance Treatment ◽  
Patient Characteristics ◽  
Complete Response ◽  
Routine Clinical Practice ◽  
Fallopian Tube Cancer ◽  
Platinum Sensitive ◽  
Sensitive Relapse

Background and aims. There is no data on olaparib efficacy and safety in Russian routine clinical practice. Methods. We analysed the 30 consecutive patients who received maintenance olaparib treatment for platinum-sensitive relapse (PSR) of ovarian or fallopian tube cancer in Russian Cancer Centers. Patients were prescribed olaparib capsules 400 mg twice daily. Radiographic assessments were done every 8 weeks. Patient characteristics. Age median 55 (range 39-68); 26 (86,6%) patients had gBRCA1, 2 (6,6%) patients had sBRCA1, 2 (6,6%) patients had gBRCA2. Number of relapse: median 1 (range 1-10), number of lines of chemotherapy: median 2 (range 2-11). Last regimen of chemotherapy: taxane + platinum (± bevacizumab) 90% (27/30), platinum monotherapy 10% (3/30). Best response to the last chemotherapy complete response 43,3% (13/30), partial response 36,7% (11/30), stable disease 20% (6/30). Results. Median follow-up in 13 CR patients was 12 mos. 1 CR patient progressed after 9 mos of maintenance olaparib. Median follow-up in 11 PR patients was 7 mos. 3 PR patients achieved CR on olaparib. 1 PR patient progressed after 6 mos of olaparib maintenance. Median follow-up in SD patients was 12 mos. 1 SD patient achieved PR on olaparib, there were no progressions. 10 (30%) patients had adverse events (AEs). 1 patient had grade 3 AE and 2 patients had AEs leading to dose reduction. There were no grade 4 AEs. Conclusions. Olaparib is safe and effective maintenance treatment of PSR ovarian cancer in routine clinical settings.

P1257ETNA-AF Europe: First 1-year follow-up snapshot analysis of more than 7,500 AF patients treated with edoxaban in routine clinical practice

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
R De Caterina ◽  
P Kelly ◽  
P Monteiro ◽  
J C Deharo ◽  
C De Asmundis ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Creatinine Clearance ◽  
Major Bleeding ◽  
Intracranial Haemorrhage ◽  
Patient Characteristics ◽  
Routine Clinical Practice ◽  
Comparable Efficacy ◽  
All Cause Mortality ◽  
First Occurrence

Abstract Introduction Edoxaban has been approved for stroke prevention in patients with atrial fibrillation based on its comparable efficacy and superior safety compared to warfarin in the pivotal ENGAGE AF-TIMI 48 trial. ETNA-AF Europe (NCT02944019) was initiated in agreement with the EMA to evaluate benefits and risks of edoxaban treatment in unselected patients in routine clinical practice. Methods 13,980 patients from across 825 hospital and office-based physicians from 10 European countries (Austria, Belgium, Germany, Ireland, Italy, The Netherlands, Portugal, Spain, Switzerland and United Kingdom) were enrolled, and will be followed-up for 4 years. This snapshot analysis includes baseline and first outcome data of 7,672 patients (56.3% of all enrolled patients) that have completed their first 1-year follow-up visit (mean follow-up: 343.5 days). Results The average age of patients was 73.4 years, the mean weight was 81.9 kg (Table 1). Frequent comorbidities include hypertension (77.2%), valvular heart disease (17.4%), congestive heart failure (5.8%) and history of myocardial infarction (4.2%). Patients receiving the 30 mg dose (22.9%) were older, had a lower creatinine clearance and had a higher risk for both stroke and bleeding as compared to those on the 60 mg dose (77.1%). Overall, the incidence of clinical events was low: all-cause mortality: 3.56%/y, major bleeding 0.95%/y, intracranial haemorrhage 0.28%/y, any stroke or systemic embolic events 0.88%/y. Patient characteristics at Year 1 Patient characteristics All patients Edoxaban 60 mg Edoxaban 30 mg [7,672] [5,916 (77.1%)] [1,756 (22.9%)] Age [years] mean (SD) 73.4 (9.26) 71.8 (8.98) 79.1 (7.81) Body weight [kg] mean (SD) 81.9 (17.33) 84.1 (16.80) 74.3 (16.93) CrCl (CG) [mL/min] mean (SD) 75.0 (30.29) 82.5 (29.14) 51.2 (19.75) CHA2DS2-VASc mean (SD) 3.1 (1.38) 2.9 (1.34) 3.8 (1.28) HAS-BLED mean (SD) 2.5 (1.10) 2.4 (1.07) 2.9 (1.08) First occurrence of all-cause mortality (n, %/year) 257 (3.56%) 129 (2.31%) 128 (7.90%) First occurrence of intracranial haemorrhage (n, %/year) 20 (0.28%) 16 (0.29%) 4 (0.25%) First occurrence of major bleeding (n, %/year) 68 (0.95%) 49 (0.88%) 19 (1.18%) First occurrence of stroke/SEE (n, %/year) 63 (0.88%) 45 (0.81%) 18 (1.11%) CG, Cockcroft-Gault; CrCl, creatinine clearance; SD, standard deviation; SEE, systemic embolic events. Conclusions We found low bleeding and stroke rates in 7,672 unselected, mainly elderly AF patients treated with edoxaban in routine clinical practice. These findings were consistent across edoxaban doses and reinforce the effectiveness and safety of NOACs such as edoxaban in routine clinical care in Europe. Acknowledgement/Funding Daiichi Sankyo Europe GmbH, Munich, Germany

Real-World Management of Trabectedin/Pegylated Liposomal Doxorubicin in Platinum-Sensitive Recurrent Ovarian Cancer Patients: A National Survey

2017 ◽  
Vol 27 (6) ◽  
pp. 1141-1148 ◽  
Author(s):  
Gabriella Ferrandina ◽  
Giulia Amadio ◽  
Ida Paris ◽  
Mariagrazia Distefano ◽  
Eleonora Palluzzi ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Clinical Practice ◽  
Dose Reduction ◽  
Real World ◽  
Liposomal Doxorubicin ◽  
Pegylated Liposomal Doxorubicin ◽  
Recurrent Ovarian Cancer ◽  
Routine Clinical Practice ◽  
Platinum Sensitive ◽  
Medical Oncologists

BackgroundTrabectedin (T) plus pegylated liposomal doxorubicin (PLD) is approved for treatment of platinum-sensitive recurrent ovarian cancer (ROC). Despite the recommendations and guidelines, variations in managing T/PLD administration in routine clinical practice cannot be excluded. We aimed at setting up an Italian survey collecting data about management of T/PLD administration in ROC patients.MethodsWe carried out the development of a questionnaire-based survey on routine clinical practice in the management of ROC patients administered T/PLD. The survey registered the physicians’ approach to modification/discontinuation of treatment, type of modifications, reasons why, and so on. The survey was transmitted to medical oncologists and gynecologic oncologists practicing in national centers/institutions.ResultsFifty-eight Italian centers/institutions returned the compiled questionnaire; participants practiced at community cancer centers or hospitals (56.9%), academic institutions (36.2%), and other settings (private clinics, etc) (6.9%). There was no statistically significant difference in the distribution of practice setting according to geographic areas. Most responders were medical oncologists (84.5%) and were members (82.8%) of at least 1 scientific society or cooperative group. Almost 31.5% of responders reported interruption of the whole treatment, mostly because of toxicity (41.2%), followed by patients’ choice (29.4%), or achievement of clinical benefit (23.5%). Dose reduction was referred by 47.4% of responders. Reduction of dose for both drugs was referred by 88.5% of responders, and the extent of dose reduction ranged between 10% and 30%.ConclusionsThis survey highlights the gaps in transposing evidence-based or consensus guidelines in the real-world management of T/PLD administration; these findings could be useful in order to focus the attention on specific knowledge and/or experience gaps and plan pertinent educational programs.

Discontinuation and relapse with paliperidone palmitate three-monthly for maintenance of schizophrenia: Two year follow-up of use in clinical practice

2021 ◽  
pp. 026988112110097
Author(s):  
Phoebe Wallman ◽  
Ivana Clark ◽  
David Taylor
Keyword(s):  
Clinical Practice ◽  
Treatment Duration ◽  
Maintenance Treatment ◽  
Clinical Care ◽  
Paliperidone Palmitate ◽  
Reduce Risk ◽  
Patient Refusal ◽  
Long Acting ◽  
Post Hoc

Background: The use of antipsychotic long-acting injections (LAI) aims to reduce risk of relapse and hospitalisation in patients with schizophrenia compared with oral medication. Paliperidone palmitate is currently the only LAI that can be administered at three-monthly intervals for maintenance treatment of schizophrenia. Aim: This prospective study aimed to evaluate relapse and continuation in licensed use of paliperidone palmitate three-monthly (PP3M) over a 2-year follow-up in clinical practice. Method: Non-interventional, observational study of patients treated in the South London and The Maudsley NHS Foundation Trust. Results: A total of 166 patients initiated on PP3M, 55 were excluded from the study (non-F20 diagnosis ( n = 43); F20 >65 years old ( n = 12)). Of the 111 patients included, 67 (60%) continued PP3M for 2 years. Overall 102 patients received more than one dose of PP3M and 92 (90%) remained on the same dose of PP3M for the whole of their treatment duration. Relapse (defined as a step-up in clinical care) occurred in eight patients (7%) while on PP3M. The most common reason for discontinuation was patient refusal and the most frequent medication prescribed after discontinuation was paliperidone palmitate one-monthly (PP1M). Post hoc, we analysed outcome in those continuing any form of PPLAI (those continuing with PP3M and those switching back to PP1M). Continuation over 2 years with any PPLAI formulation was 73% (81/111) and relapse was recorded in 9% (10/111). Conclusion: Overall, PP3M was an effective maintenance treatment for schizophrenia after stabilisation on PP1M in a clinical setting.

scholarly journals Personalized management of differentiated thyroid cancer in real life – practical guidance from a multidisciplinary panel of experts

Endocrine ◽  
2020 ◽  
Vol 70 (2) ◽  
pp. 280-291
Author(s):  
Alfredo Campennì ◽  
Daniele Barbaro ◽  
Marco Guzzo ◽  
Francesca Capoccetti ◽  
Luca Giovanella
Keyword(s):  
Nuclear Medicine ◽  
Thyroid Cancer ◽  
Clinical Practice ◽  
Molecular Imaging ◽  
Routine Clinical Practice ◽  
Whole Body ◽  
Neck Ultrasound ◽  
Long Term Follow Up

Abstract Purpose The standard of care for differentiated thyroid carcinoma (DTC) includes surgery, risk-adapted postoperative radioiodine therapy (RaIT), individualized thyroid hormone therapy, and follow-up for detection of patients with persistent or recurrent disease. In 2019, the nine Martinique Principles for managing thyroid cancer were developed by the American Thyroid Association, European Association of Nuclear Medicine, Society of Nuclear Medicine and Molecular Imaging, and European Thyroid Association. In this review, we present our clinical practice recommendations with regard to implementing these principles in the diagnosis, treatment, and long-term follow-up of patients with DTC. Methods A multidisciplinary panel of five thyroid cancer experts addressed the implementation of the Martinique Principles in routine clinical practice based on clinical experience and evidence from the literature. Results We provide a suggested approach for the assessment and diagnosis of DTC in routine clinical practice, including the use of neck ultrasound, measurement of serum thyroid-stimulating hormone and calcitonin, fine-needle aspiration, cytology, and molecular imaging. Recommendations for the use of surgery (lobectomy vs. total thyroidectomy) and postoperative RaIT are also provided. Long-term follow-up with neck ultrasound and measurement of serum anti-thyroglobulin antibody and basal/stimulated thyroglobulin is standard, with 123/131I radioiodine diagnostic whole-body scans and 18F-fluoro-2-deoxyglucose positron emission tomography/computed tomography suggested in selected patients. Management of metastatic DTC should involve a multidisciplinary team. Conclusions In routine clinical practice, the Martinique Principles should be implemented in order to optimize clinical management/outcomes of patients with DTC.

Phase II consolidation trial with anti-Lewis-Y monoclonal antibody (hu3S193) in platinum-sensitive ovarian cancer after a second remission

2021 ◽  
pp. ijgc-2020-002239
Author(s):  
Oren Smaletz ◽  
Gustavo Ismael ◽  
Maria Del Pilar Estevez-Diz ◽  
Ivana L O Nascimento ◽  
Ana Luiza Gomes de Morais ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Monoclonal Antibody ◽  
Epithelial Ovarian Cancer ◽  
Phase Ii ◽  
Progression Free Survival ◽  
Complete Response ◽  
Free Survival ◽  
Platinum Sensitive ◽  
Platinum Based Chemotherapy ◽  
Lewis Y

ObjectiveTo investigate the efficacy and safety of hu3S193, a humanized anti-Lewis-Y monoclonal antibody, as a consolidation strategy in patients with platinum-sensitive recurrent epithelial ovarian cancer who achieved a second complete response after salvage platinum-doublet chemotherapy.MethodsThis single-arm phase II study accrued patients with recurrent epithelial ovarian cancer with Lewis-Y expression by immunohistochemistry who had achieved a second complete response after five to eight cycles of platinum-based chemotherapy. Patients received intravenous infusions of hu3S193, 30 mg/m2 every 2 weeks starting no more than 8 weeks after the last dose of chemotherapy and continuing for 12 doses, until disease progression, or unacceptable toxicity. The primary endpoint was progression-free survival of the second remission. Secondary objectives were safety and pharmacokinetics.ResultsTwenty-nine patients were enrolled. Most had a papillary/serous histology tumor (94%), stage III disease at diagnosis (75%), and five (17%) underwent secondary cytoreduction before salvage chemotherapy. Two patients were not eligible for efficacy but were considered for toxicity analysis. Eighteen patients (62%) completed the full consolidation treatment while nine patients progressed on treatment. At the time of analysis, 23 patients (85%) of the eligible population had progressed and seven of these patients (26%) had died. Median progression-free survival of the second remission was 12.1 months (95% CI: 10.6–13.9), with a 1-year progression-free survival of the second remission rate of 50.1%. The trial was terminated early since it was unlikely that the primary objective would be achieved. The most commonly reported treatment-related adverse events were nausea (55%) and vomiting (51%).ConclusionsHu3S193 did not show sufficient clinical activity as consolidation therapy in patients with recurrent epithelial ovarian cancer who achieved a second complete response after platinum-based chemotherapy.Trial registrationNCT01137071.

Predictive value of systematic inflammatory response biomarkers (NLR, LMR, PLR) in patients with ovarian cancer.

2017 ◽  
Vol 53 (3) ◽  
pp. 139-146
Author(s):  
Urszula Rychlik ◽  
Ewa Wójcik ◽  
Jadwiga Tarapacz ◽  
Katarzyna Brandys ◽  
Zofia Stasik ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Complete Response ◽  
Response To Treatment ◽  
Line Treatment ◽  
First Line ◽  
Lymphocyte Ratio ◽  
Lymphocyte To Monocyte Ratio ◽  
Progression Of Disease ◽  
First Line Treatment

Introduction: The aim of the study was to assess the prognostic value of indicators calculated on the basis of initial hematology test results of neutrophil, lymphocyte, monocyte and platelet counts (NLR – neutrophil-to-lymphocyte ratio, LMR – lymphocyte-to-monocyte ratio, PLR – platelet-to-lymphocyte ratio) in patients with ovarian cancer and their compliance with the overall response to treatment. Materials and methods: Hematological tests were performed before first course of first-line chemotherapy in 145 patients with ovarian cancer. Response to treatment was assessed according to the RECIST1.1 criteria in all patients. Results: After the completion of first-line treatment, 70 (48.3%) patients had a complete response (CR) to the therapy. In this group, progression of disease occurred in 22 (31.4%) patients during 12 months of follow-up. In the CR group with progression, 17 (77.2%) presented high NLR and PLR levels. Among 48 (68.6%) patients with CR without progression after 12 months of follow-up, high levels of NLR and PLR were observed in 21 (43.8%) and 17 (35.4%) of them, respectively. Low LMRs were observed in 16 (72.7%) patients with progression and 16 (33.3%) without progression. Conclusion: High levels of NLR and PLR and low levels of LMR before treatment seems to predict 12-month disease progression in patients with complete response to first-line treatment.

Salvage radiation therapy for localized recurrent ovarian cancer

2019 ◽  
Vol 29 (5) ◽  
pp. 916-921
Author(s):  
Alicia Smart ◽  
Yu-Hui Chen ◽  
Teresa Cheng ◽  
Martin King ◽  
Larissa Lee
Keyword(s):  
Ovarian Cancer ◽  
Overall Survival ◽  
Clear Cell ◽  
Recurrent Ovarian Cancer ◽  
Salvage Radiotherapy ◽  
Platinum Sensitive ◽  
Long Term Survivors ◽  
Disease Free

IntroductionTo evaluate clinical outcomes for patients with localized recurrent ovarian cancer treated with salvage radiotherapy.MethodsIn a retrospective single institutional analysis, we identified 40 patients who received salvage radiotherapy for localized ovarian cancer recurrence from January 1995 to June 2011. Recurrent disease was categorized as: pelvic peritoneal (45%, 18), extraperitoneal/nodal (35%, 14), or vaginal (20%, eight). Actuarial disease-free and overall survival estimates were calculated by Kaplan–Meier and prognostic factors evaluated by the Cox proportional hazards model.ResultsMedian follow-up was 42 months. Median patient age was 54 years (range, 27–78). Histologic subtypes were: serous (58%, 23), endometrioid (15%, six), clear cell (13%, five), mucinous (8%, three), and other (8%, three). At the time of salvage radiotherapy, surgical cytoreduction was performed in 60% (24) and 68% (27) had platinum-sensitive disease. Most patients (63%, 25) received salvage radiotherapy at the time of first recurrence. Relapse after salvage radiotherapy occurred in 29 patients at a median time of 16 months and was outside the radiotherapy field in 62%. 18 At 3 years, disease-free and overall survival rates were 18% and 80%, respectively. On multivariate analysis, non-serous histology (hazards ratio 0.3, 95% CI 0.1–0.7) and platinum-sensitivity (hazards ratio 0.2, 95% CI 0.1–0.5) were associated with lower relapse risk. Platinum-sensitivity was also associated with overall survival (hazards ratio 0.4, 95% CI 0.1–1.0). Four patients (10%) were long-term survivors without recurrence 5 years after salvage radiotherapy. Of the five patients with clear cell histology, none experienced relapse at the time of last follow-up.DiscussionPatients with non-serous and/or platinum-sensitive ovarian cancer had the greatest benefit from salvage radiotherapy for localized recurrent disease. Although relapse was common, radiotherapy prolonged recurrence for > 1 year in most patients and four were long-term survivors.

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