scholarly journals QOLP-02. PATIENT-REPORTED OUTCOMES FOLLOWING PERTUZUMAB PLUS HIGH-DOSE TRASTUZUMAB IN PATIENTS WITH HER2-POSITIVE METASTATIC BREAST CANCER (MBC) AND CENTRAL NERVOUS SYSTEM (CNS) PROGRESSION POST-RADIOTHERAPY

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii174-ii175
Author(s):  
Priya Kumthekar ◽  
Solmaz Sahebjam ◽  
Mark Pegram ◽  
Nuhad Ibrahim ◽  
Jesse Sussell ◽  
...  
Keyword(s):  
Brain Tumor ◽  
Brain Metastases ◽  
Stable Disease ◽  
Symptom Severity ◽  
Clinical Benefit ◽  
Patient Reported Outcomes ◽  
High Dose ◽  
Her2 Positive ◽  
Severity Scores ◽  
Patient Reported

Abstract Effective therapies are needed for the treatment of patients with HER2-positive MBC who develop brain metastases. In the open-label, phase II PATRICIA study (NCT02536339), 40 patients with HER2-positive MBC with CNS metastases and CNS progression post-radiotherapy (median age 48 years [range, 34–69]; prior CNS treatment [whole brain radiotherapy 71%, stereotactic radiosurgery 59%, both 31%]) were enrolled to receive pertuzumab plus high-dose trastuzumab (6-mg/kg weekly) until CNS or systemic disease progression or unacceptable toxicity. Following a median (range) treatment duration of 4.5 (0.3–37.3) months, the CNS-confirmed objective response rate per Response Assessment in Neuro-Oncology Brain Metastases criteria (primary endpoint) was 11% (95% confidence interval: 3.03, 25.42), and the clinical benefit rate at 4 months was 68%, indicating sustained clinical stability. Patient-reported outcomes (PROs) were evaluated using the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT), which includes sub-scales for symptom severity (average of 13 core symptom and 9 brain-tumor specific items) and symptom interference (average of 6 interference-with-life items representing overall symptom distress). Among 36 patients included in the PRO analyses, mean (standard deviation [SD]) symptom severity scores at baseline and weeks 12 and 28 were 1.65 (1.62), 2.24 (2.14), and 1.94 (2.55), respectively. Mean (SD) symptom interference scores at baseline and weeks 12 and 28 were 2.51 (2.63), 2.81 (3.39), and 1.76 (2.43), respectively. Mean (SD) changes in symptom severity and interferences scores from baseline to week 12 were 0.34 (1.54) and 0.33 (3.08), respectively. On average, patients who did not achieve stable disease or better in the CNS following treatment had worsened symptom severity and symptom interference scores over 12 weeks, while those with stable disease or better in the CNS exhibited stable or improving scores. Pertuzumab plus high-dose trastuzumab provided clinical benefit to the majority (68%) of patients in PATRICIA, without a decrement in quality of life.

scholarly journals Patient-reported outcomes before and after treatment of major depressive disorder

2014 ◽  
Vol 16 (2) ◽  
pp. 171-183 ◽  
Keyword(s):  
Depressive Symptom ◽  
Symptom Severity ◽  
Patient Reported Outcomes ◽  
Burden Of Illness ◽  
Major Depressive ◽  
Patient Reported ◽  
Before And After ◽  
Depressive Symptom Severity ◽  
The Impact ◽  
Level 2

Patient reported outcomes (PROs) of quality of life (QoL), functioning, and depressive symptom severity are important in assessing the burden of illness of major depressive disorder (MDD) and to evaluate the impact of treatment. We sought to provide a detailed analysis of PROs before and after treatment of MDD from the large Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study. This analysis examines PROs before and after treatment in the second level of STAR*D. The complete data on QoL, functioning, and depressive symptom severity, were analyzed for each STAR*D level 2 treatment. PROs of QoL, functioning, and depressive symptom severity showed substantial impairments after failing a selective serotonin reuptake inhibitor trial using citalopram (level 1). The seven therapeutic options in level 2 had positive statistically (P values) and clinically (Cohen's standardized differences [Cohen's d]) significant impact on QoL, functioning, depressive symptom severity, and reduction in calculated burden of illness. There were no statistically significant differences between the interventions. However, a substantial proportion of patients still suffered from patient-reported QoL and functioning impairment after treatment, an effect that was more pronounced in nonremitters. PROs are crucial in understanding the impact of MDD and in examining the effects of treatment interventions, both in research and clinical settings.

scholarly journals Niraparib Maintenance Therapy in Patients With Recurrent Ovarian Cancer After a Partial Response to the Last Platinum-Based Chemotherapy in the ENGOT-OV16/NOVA Trial

2019 ◽  
Vol 37 (32) ◽  
pp. 2968-2973 ◽  
Author(s):  
Josep M. del Campo ◽  
Ursula A. Matulonis ◽  
Susanne Malander ◽  
Diane Provencher ◽  
Sven Mahner ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Partial Response ◽  
Maintenance Therapy ◽  
Clinical Benefit ◽  
Patient Reported Outcomes ◽  
Progression Free Survival ◽  
Recurrent Ovarian Cancer ◽  
Free Survival ◽  
Platinum Based Chemotherapy ◽  
Patient Reported

PURPOSE In the ENGOT-OV16/NOVA trial (ClinicalTrials.gov identifier: NCT01847274 ), maintenance therapy with niraparib, a poly(ADP-ribose) polymerase inhibitor, prolonged progression-free survival in patients with platinum-sensitive, recurrent ovarian cancer who had a response to their last platinum-based chemotherapy. The objective of the study was to assess the clinical benefit and patient-reported outcomes in patients who had a partial response (PR) and complete response (CR) to their last platinum-based therapy. PATIENTS AND METHODS A total of 553 patients were enrolled in the trial. Of 203 patients with a germline BRCA mutation (g BRCAmut), 99 had a PR and 104 had a CR to their last platinum-based therapy; of 350 patients without a confirmed g BRCAmut (non–g BRCAmut), 173 had a PR and 177 had a CR. Post hoc analyses were carried out to evaluate safety and the risk of progression in these patients according to g BRCAmut status and response to their last platinum-based therapy. Ovarian cancer–specific symptoms and quality of life were assessed using the Functional Assessment of Cancer Therapy–Ovarian Symptom Index. RESULTS Progression-free survival was improved in patients treated with niraparib compared with placebo in both the g BRCAmut cohort (PR: hazard ratio [HR], 0.24; 95% CI, 0.131 to 0.441; P < .0001; CR: HR, 0.30; 95% CI, 0.160 to 0.546; P < .0001) and the non–g BRCAmut cohort (PR: HR, 0.35; 95% CI, 0.230 to 0.532; P < .0001; CR: HR, 0.58; 95% CI, 0.383 to 0.868; P = .0082). The incidence of any-grade and grade 3 or greater adverse events was manageable. No meaningful differences were observed between niraparib and placebo in PR and CR subgroups with respect to patient-reported outcomes. CONCLUSION Patients achieved clinical benefit from maintenance treatment with niraparib regardless of response to the last platinum-based therapy.

scholarly journals Difficulty Diagnosing a Brain Tumor during Clinical Maintenance of a Complete Response to anti-HER2 Treatments for Metastatic Breast Cancer: A Case Report

2020 ◽  
Vol 13 (3) ◽  
pp. 1311-1316
Author(s):  
Ryoko Semba ◽  
Yoshiya Horimoto ◽  
Atsushi Arakawa ◽  
Yoko Edahiro ◽  
Tomoiku Takaku ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Brain Tumor ◽  
Ductal Carcinoma ◽  
Metastatic Breast ◽  
Stage Iv ◽  
B Cell Lymphoma ◽  
High Dose ◽  
Her2 Positive ◽  
Stage Iv Breast Cancer ◽  
The Right

A 46-year-old woman with erythema of the right breast presented to our hospital and was diagnosed with stage IV breast cancer (HER2-positive invasive ductal carcinoma). She received 4 courses of anthracycline-based regimens and 4 courses of trastuzumab + pertuzumab + docetaxel (Tmab + Pmab + DTX). Since she responded well to these therapies, only Tmab + Pmab was continued thereafter. Twenty-three months after starting treatment, she developed a headache. A tumor was identified in the right temporal lobe. Craniotomy was performed for definitive diagnosis. Intraoperative pathological assessment suggested the tumor to be brain metastasis of breast cancer. However, the final pathological diagnosis was diffuse large B-cell lymphoma of central nervous system (DLBCL-CNS) based on re-assessment with immunohistochemical examinations. Therefore, the Tmab + Pmab was discontinued, and 6 courses of high-dose methotrexate therapy were administered. This case highlights the importance of considering rare entities, such as DLBCL, when diagnosing a solitary brain tumor in a patient with a primary cancer, based on imaging and pathological findings.

scholarly journals Clinical benefit of high dose IL-2 (HD IL-2) therapy: evidence for improved overall survival in patients with stable disease

2013 ◽  
Vol 1 (S1) ◽  
Author(s):  
Tasha Hughes ◽  
Gail Iodice ◽  
Sanjib Basu ◽  
Steven Bines ◽  
Howard Kaufman
Keyword(s):  
Overall Survival ◽  
Stable Disease ◽  
Clinical Benefit ◽  
High Dose

Tu2063 IBS Symptom Severity Subtypes and Their Relationships With Psychosocial Factors: Improving the Sensitivity and Meaning of Patient Reported Outcomes

2013 ◽  
Vol 144 (5) ◽  
pp. S-917 ◽  
Author(s):  
Jeffrey M. Lackner ◽  
James Jaccard ◽  
Charles Baum ◽  
Laurie Keefer ◽  
Darren M. Brenner
Keyword(s):  
Psychosocial Factors ◽  
Symptom Severity ◽  
Patient Reported Outcomes ◽  
Patient Reported
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