Radiation Therapy Oncology Group (RTOG) 9413: Randomized trial comparing whole pelvic radiotherapy (WPRT) to prostate only (PORT) and neoadjuvant hormone therapy (NHT) to adjuvant hormone therapy (AHT).

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 96-96 ◽  
Author(s):  
Mack Roach ◽  
Yan Yan ◽  
Colleen Anne Lawton ◽  
I-Chow Joe Hsu ◽  
Robert A. Lustig ◽  
...  
Keyword(s):  
Hormone Therapy ◽  
Radiation Therapy Oncology Group ◽  
Progression Free Survival ◽  
Late Toxicity ◽  
Adjuvant Hormone Therapy ◽  
Entire Cohort ◽  
Local Progression ◽  
Increased Risk ◽  
First Occurrence ◽  
Secondary Endpoints

96 Background: RTOG 9413 demonstrated that NHT+WPRT improved progression-free survival (PFS) compared to NHT+PORT, WPRT+AHT and PORT+AHT. We update primary and secondary endpoints (SE): biochemical failure (BF), time to metastasis (Mets), prostate specific survival (PSS) and overall survival (OS). Methods: RTOG 9413 opened on April 1, 1995, and closed on June 1, 1999, with 1275 eligible pts who were required to have a risk of lymph node (LN) involvement >15% but LN-positive pts were ineligible. They were stratified by T Stage, GS (<7 vs 7-10) and PSA (>30 vs < 30ng/ml) and randomized to PORT +/- WPRT to 70 Gy and NHT or AHT. Hormonal therapy (HT) consisted of flutamide, and leuprolide or goserelin, monthly x 4 mos, beginning 2 mos before RT and continued until RT is completed (NHT) or beginning at the completion of RT (AHT). For this analysis PFS was defined as the first occurrence of local/regional or LN progression, Mets, BF (PSA nadir+2ng/mL), or death from any cause. PSS is defined as a death due to prostate cancer, treatment toxicity or unknown causes with local progression, Mets or BF. Results: For the entire cohort WPRT or NHT did not appear to improve any endpoint compared with PORT or AHT, (although there was a trend for improvement in regional failure for WPRT vs PORT, (p=0.07)). However, there were complex sequence/volume dependent interactions between HT and RT and statistically significant differences between the 4 arms in PFS (p=0.03). There was a trend for NHT+WPRT to improved PFS compared to NHT+PO (p=0.07) and WPRT+AHT (p=0.04). NHT+WPRT was associated with an increased risk of late GI toxicity, 5% compared to 0.6%, 2% and 2% for NHT+PORT, WPRT+AHT and PORT+AHT (p<0.001) but not in GU late toxicity. Conclusions: The failure to improve SE or definitively impact PFS may reflect sample size, pt selection, and inadequate RT doses. RTOG 0924 will test the hypotheses that modern techniques and doses will improve OS without increasing late toxicity.

scholarly journals Predictors of Discontinuation of Adjuvant Hormone Therapy in Patients With Breast Cancer

2015 ◽  
Vol 33 (20) ◽  
pp. 2262-2269 ◽  
Author(s):  
Wei He ◽  
Fang Fang ◽  
Catherine Varnum ◽  
Mikael Eriksson ◽  
Per Hall ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Hormone Therapy ◽  
Aromatase Inhibitors ◽  
Hormone Replacement ◽  
Hormonal Treatment ◽  
Linkage Study ◽  
Adjuvant Hormone Therapy ◽  
Breast Cancer Outcomes ◽  
Drug Register ◽  
Increased Risk

Purpose To identify predictors of discontinuation of adjuvant hormone therapy in patients with breast cancer. Patients and Methods We conducted a record-linkage study based on data from Stockholm-Gotland Breast Cancer Register, Swedish Prescribed Drug Register, and self-reported questionnaire. Women diagnosed with breast cancer between 2005 and 2008 in Stockholm, Sweden, were prospectively followed for 5 years until 2013, starting from their first prescription of tamoxifen or aromatase inhibitors (N = 3,395). Results Family history of ovarian cancer (hazard ratio [HR], 1.55; 95% CI, 1.19 to 2.02); younger (< 40 years; HR, 1.39; 95% CI, 1.08 to 1.78) and older (≥ 65 years; HR, 1.15; 95% CI, 1.03 to 1.28) age; higher Charlson comorbidity index (≥ 2 v 0; HR, 1.35; 95% CI, 1.03 to 1.76); and use of analgesics (HR, 1.33; 95% CI, 1.16 to 1.52), hypnotics/sedatives (HR, 1.24; 95% CI, 1.07 to 1.43), GI drugs (HR, 1.25; 95% CI, 1.08 to 1.43), and hormone replacement therapy (HR, 1.27; 95% CI, 1.08 to 1.49) were identified as baseline predictors for hormonal treatment discontinuation. Use of analgesics (HR, 1.22; 95% CI, 1.08 to 1.37), hypnotics/sedatives (HR, 1.21; 95% CI, 1.07 to 1.37), antidepressants (HR, 1.22; 95% CI, 1.06 to 1.40), or GI drugs (HR, 1.27; 95% CI, 1.13 to 1.43), and switching therapy between tamoxifen and aromatase inhibitors (HR, 1.50; 95% CI, 1.23 to 1.83) during the first year of hormonal treatment were associated with increased risk of discontinuation during the next 4 years. Conclusion Predictors identified in our study can be used in developing targeted intervention to prevent adjuvant hormone therapy discontinuation and subsequently to improve breast cancer outcomes.

scholarly journals Efficacy and Tolerability of CyberKnife Stereotactic Robotic Radiotherapy for Primary or Secondary Orbital Lesions: A Single-Center Retrospective Experience

2019 ◽  
Vol 18 ◽  
pp. 153303381881856
Author(s):  
Isacco Desideri ◽  
Giulio Francolini ◽  
Giulio Alberto Carta ◽  
Vanessa Di Cataldo ◽  
Laura Masi ◽  
...  
Keyword(s):  
Local Control ◽  
Response Rate ◽  
Progression Free Survival ◽  
Late Toxicity ◽  
Complete Response ◽  
Optic Chiasm ◽  
Target Volume ◽  
Local Progression ◽  
Mean Time ◽  
Orbital Lesions

Introduction: Orbital lesions are rare, but are likely to become symptomatic and can impact on patients’ quality of life. Local control is often difficult to obtain, because of proximity to critical structures. CyberKnife stereotactic robotic radiotherapy could represent a viable treatment option. Materials and Methods: Data on patients treated for intraorbital lesions from solid malignancies were retrospectively collected. All patients underwent treatment with CyberKnife system. We analyzed local control, response rate, symptoms control, progression-free survival and overall survival, acute and late toxicity. Results: From January 2012 to May 2017, 20 treatments on 19 patients were performed, with dose ranging from 24 to 35 Gy in 1 to 5 fractions, prescribed at an average isodose line of 79.5% (range: 78-81). After a mean follow-up of 14.26 months (range: 0-58), overall response rate was 75%, with 2 and 4 patients presenting a partial and complete response, respectively. Mean time to best measured response was 15.16 months (range: 2-58). Thirteen patients were alive, with a local control rate of 79%. Mean time to local progression was 5 months (range: 3-7). Three patients reported improvement in symptoms after treatment. Mean planning target volume dose coverage was 97.2% (range: 93.5-99.7). Mean maximum dose (D max) to eye globe, optic nerve, optic chiasm, and lens was 2380.8 cGy (range: 290-3921), 1982.82 cGy (range: 777.3-2897.8), 713.14 cGy (range: 219.5-2273), and 867.9 cGy (range: 38-3118.5). Four patients presented acute toxicity. Conclusion: This current retrospective series demonstrated that CyberKnife robotic stereotactic radiotherapy is a feasible and tolerable approach for intraorbital lesions.

Phase III Trial Comparing Whole-Pelvic Versus Prostate-Only Radiotherapy and Neoadjuvant Versus Adjuvant Combined Androgen Suppression: Radiation Therapy Oncology Group 9413

2003 ◽  
Vol 21 (10) ◽  
pp. 1904-1911 ◽  
Author(s):  
M. Roach ◽  
M. DeSilvio ◽  
C. Lawton ◽  
V. Uhl ◽  
M. Machtay ◽  
...  
Keyword(s):  
Hormonal Therapy ◽  
Radiation Therapy Oncology Group ◽  
Specific Antigen ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Psa Failure ◽  
First Occurrence ◽  
Estimated Risk ◽  
Androgen Suppression

Purpose: This trial tested the hypothesis that combined androgen suppression (CAS) and whole-pelvic (WP) radiotherapy (RT) followed by a boost to the prostate improves progression-free survival (PFS) by 10% compared with CAS and prostate-only (PO) RT. This trial also tested the hypothesis that neoadjuvant and concurrent hormonal therapy (NCHT) improves PFS compared with adjuvant hormonal therapy (AHT) by 10%. Materials and Methods: Eligibility included localized prostate cancer with an elevated prostate-specific antigen (PSA) ≤ 100 ng/mL and an estimated risk of lymph node (LN) involvement of 15%. Between April 1, 1995, and June 1, 1999, 1,323 patients were accrued. Patients were randomly assigned to WP + NCHT, PO + NCHT, WP + AHT, or PO + AHT. Failure for PFS was defined as the first occurrence of local, regional, or distant disease; PSA failure; or death for any cause. Results: With a median follow-up of 59.5 months, WP RT was associated with a 4-year PFS of 54% compared with 47% in patients treated with PO RT (P = .022). Patients treated with NCHT experienced a 4-year PFS of 52% versus 49% for AHT (P = .56). When comparing all four arms, there was a progression-free difference among WP RT + NCHT, PO RT + NCHT, WP RT + AHT, and PO RT + AHT (60% v 44% v 49% v 50%, respectively; P = .008). No survival advantage has yet been seen. Conclusion: WP RT + NCHT improves PFS compared with PO RT and NCHT or PO RT and AHT, and compared with WP RT + AHT in patients with a risk of LN involvement of 15%.

Phase II study of low-dose paclitaxel and cisplatin in combination with split-course concomitant twice-daily reirradiation (XRT) in recurrent squamous cell carcinoma of the head and neck (SCCHN): Long-term follow-up of Radiation Therapy Oncology Group (RTOG) protocol 9911.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 5583-5583 ◽  
Author(s):  
Corey J. Langer ◽  
Jonathan Harris ◽  
Eric M. Horwitz ◽  
Merrill S. Kies ◽  
Walter J. Curran ◽  
...  
Keyword(s):  
Radiation Therapy Oncology Group ◽  
Progression Free Survival ◽  
Second Primary ◽  
Hematologic Toxicity ◽  
Grade 5 ◽  
Primary Endpoints ◽  
Incident Cancer ◽  
Recurrent Squamous Cell Carcinoma ◽  
Long Term Follow Up ◽  
Secondary Endpoints

5583 Background: Loco-regionally recurrent SCCHN or new second primary tumor (SPT) in a previous radiation field, if not curable by surgery, is virtually always fatal. Chemotherapy alone yields a median survival time (MST) of no more than 10 to 11 months, 1- and 2- year overall survival (OS) rates of 35% and 10-15% at best. Concurrent re-irradiation and chemotherapy is an alternative strategy. Methods: Eligibility for RTOG protocol 9911 stipulated measurable, recurrent SCCHN or SPT in a previous radiation field, PS 0-1, and adequate end-organ indices. Patients (pts) received twice-daily XRT (1.5 Gy per fraction BID x 5 d every 2 weeks x4), plus cisplatin 15 mg/m2 IV QD x 5 and paclitaxel 20 mg/m2 IV QD x 5 every 2 weeks x 4. G-CSF was administered days 6 - 13 of each 2-week cycle. Primary endpoints were OS and progression-free survival PFS at 1 and 2 yrs. Secondary endpoints included acute/late toxicities and patterns of failure. Results: 105 patients were enrolled from March 2000 through June 2003. 100 patients were analyzable (76% male, med age 60 yrs). Oropharynx (41%) and oral cavity (27%) were the predominant primary sites. 23% had SPT. Median prior XRT dose was 65.7 Gy. 73% of pts completed all chemotherapy. Grade > 4 acute toxicity occurred in 28%, grade > 4 acute hematologic toxicity in 21%. 9 treatment-related deaths (9%) occurred: five in the acute setting, four late (including three carotid hemorrhages at 116, 427 and 2772 days). 1-, 2-, and 5-year OS rates were 50%, 27%, and 15% respectively. PFS at 1, 2, and 5 yrs were 35%, 18%, and 7%. 64.9% died from the incident cancer, 3.2% from SPT, and 21.2% from other, non-cancer causes. Estimated 10 yr survival is 5% with 6 pts still alive, including 2 free from relapse. Conclusions: Despite a high incidence of grade 5 toxicity, 1-, 2-, and 5- yr OS rates for split-course bid XRT and concurrent cisplatin/paclitaxel exceed results usually seen with chemotherapy alone. At 5-10 yrs, we have observed longterm survivors free of recurrence.

Efficacy and toxicity from phase II study of dose escalation to intraprostatic tumor nodule in localized prostate cancer.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 102-102
Author(s):  
Julia Murray ◽  
Emma Alexander ◽  
Alison Tree ◽  
Helen McNair ◽  
Vibeke Hansen ◽  
...  
Keyword(s):  
External Beam Radiotherapy ◽  
Late Toxicity ◽  
Free Survival ◽  
Radiation Boost ◽  
Local Progression ◽  
High Risk Disease ◽  
Integrated Boost ◽  
Secondary Endpoints ◽  
Prospective Phase

102 Background: Intra-prostatic boost to dominant nodule is an attractive method for biological dose augmentation. Aim of study was to assess clinical feasibility of radiation boost to mp-MRI visible tumour using external beam radiotherapy. We report a planned analysis of toxicity and efficacy in the first two dose cohorts in this study. Methods: DELINEATE (ISRCTN04483921) was a single centre prospective phase 2 multi-cohort study including standard (Cohort A (A): 74Gy/37F) and moderately hypofractionated (Cohort B (B): 60Gy/20F) prostate image-guided IMRT regimens. Patients treated in A and B received integrated boost of 82Gy and 67Gy to mp-MRI-visible lesions. 55 patients were recruited to A and 158 patients recruited to B; the first 50 sequentially treated patients in B were included in analysis. Duration of androgen deprivation therapy was at clinician discretion. Primary endpoint was RTOG late toxicity at 1 year. Secondary endpoints included acute and late toxicity timepoints and biochemical relapse (BCR) free survival, using Phoenix definition. Treatment related toxicity was measured by RTOG, CTCAE v4 scales, IPSS and EPIC-26. Results: Between July 2011 and January 2015, 105 patients were treated within A&B. Median follow up for A was 74.5 months and 52 months for B. Median age was 71 years (range 57-80). In A and B, there were 27% and 40% of patients respectively classified with NCCN high risk disease. Cumulative RTOG toxicity in Table. 6 patients had BCR (5 patients: A and 1 patient: B). Within A, 1 patient had pelvic nodal progression and 1 local progression; patient in B had local progression. Conclusions: Delivery of intra-prostatic boost to dominant nodule is feasible with acceptable toxicity and good efficacy. Intra-prostatic boost is now part of the randomised phase 3 PIVOTALboost trial (ISRCTN80146950). Clinical trial information: 04483921. [Table: see text]

scholarly journals SAT0456 REAL-LIFE RISK OF FRACTURE AND TREATMENT PREVALENCE IN DRUG-INDUCED OSTEOPOROSIS IN ITALY USING A NEW ALGORITHM

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1185.1-1186
Author(s):  
G. Adami ◽  
A. Fassio ◽  
A. Giollo ◽  
G. Orsolini ◽  
O. Viapiana ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Zoledronic Acid ◽  
Fracture Risk ◽  
Hormone Therapy ◽  
Osteoporotic Fracture ◽  
Real Life ◽  
Drug Induced ◽  
Adjuvant Hormone Therapy ◽  
Risk Of Fracture ◽  
Increased Risk

Background:Glucocorticoid-induced osteoporosis and osteoporosis induced by adjuvant hormone therapy for breast cancer are the most common forms of secondary osteoporosis.Objectives:The exact real-life prevalence of treatment with anti-osteoporotic drugs in women with drug-induced osteoporosis is not known. In the present study, using a new mathematical and computerized algorithm, we investigate the profile of risk of fracture of women with drug-induced osteoporosis and the prevalence of treatment with anti-osteoporotic drugs.Methods:We have retrospectively analyzed the 10-year risk of major osteoporotic fracture calculated with the DeFRAcalc79 tool in postmenopausal women aged over 50 years that were initiating an anti-osteoporotic treatment (fully reimbursed according to the Nota 79). DeFRAcalc79 is a new web-based fracture risk-assessment tool (https://defra-osteoporosi.it) that arithmetically adjusts the risk based on multiple risk factors contemplated by the Nota 79, which regulates the reimbursability for osteoporosis medications in Italy (Italian Agency for Drugs, AIFA), including demographic and anthropometric data, femoral and/or lumbar spine BMD T-score, family history of femoral or vertebral fractures, number and site of previous osteoporotic fracture (including vertebral, femoral, and non-vertebral non-femoral fractures), glucocorticoid treatment (> 3 or > 12 months, ≥5 mg prednisone or equivalent), adjuvant hormone therapy for breast cancer, and comorbidities that induce an increased risk of fracture (rheumatoid arthritis and other connective tissue diseases, chronic obstructive pulmonary disease, inflammatory bowel diseases, Parkinson’s disease, multiple sclerosis, human immunodeficiency virus infection, diabetes, or severe physical handicap). This is a sub-analysis of the cross-sectional observational study to validate and further develop the DeFRA algorithm for the estimation of the risk of osteoporotic fractures, promoted by Verona hospital with the unconditional support of Amgen Srl.Results:Among 208 women, 116 (55.8%) were treated with adjuvant hormone therapy for breast cancer and 92 (44.2%) were on glucocorticoid ≥5 mg/day. Women on glucocorticoids had a greater mean 10-year risk of fracture compared to women on adjuvant hormone therapy for breast cancer (67.0% vs 39.1% p<0.01). 50.7% of women on adjuvant hormone therapy for breast cancer used denosumab, 28.0% zoledronic acid and 17.3% alendronate. In glucocorticoid-induced osteoporosis, 17.6% of the women used teriparatide, 37.3% alendronate, 29.4% zoledronic acid and 13.7% denosumab.Conclusion:In our cohort of patients, treatment with adjuvant hormone therapy for breast cancer was slightly more common than glucocorticoids. Women with glucocorticoid-induced osteoporosis had a greater risk of fracture compared to patients treated with adjuvant hormone therapy for breast cancer. Half of the patients on adjuvant hormone therapy for breast cancer were prescribed with denosumab. One-fifth of the patients with glucocorticoid-induced osteoporosis was treated with teriparatide. DeFRAcalc79 is a useful and practical tool for the integrated evaluation of fracture risk in drug-induced osteoporosis.Disclosure of Interests:Giovanni Adami: None declared, Angelo Fassio Speakers bureau: Angelo Fassio reports personal fees from: Abiogen and Novartis, outside the submitted work., Alessandro Giollo: None declared, Giovanni Orsolini: None declared, Ombretta Viapiana: None declared, Davide Gatti Speakers bureau: Davide Gatti reports personal fees from Abiogen, Amgen, Janssen-Cilag, Mundipharma, outside the submitted work., Maurizio Rossini Speakers bureau: AbbVie, Abiogen, Amgen, BMS, Eli-Lilly, Novartis, Pfizer, Sanofi, Sandoz and UCB

scholarly journals ETMR-14. TREATMENT OF EMBRYONAL TUMOURS WITH MULTILAYERED ROSETTES (ETMR) WITH CARBOPLATIN-ETOPOSIDE INDUCTION AND TANDEM HIGH-DOSE CHEMOTHERAPY WITHIN THE PROSPECTIVE HIT-TRIALS AND REGISTRIES

2020 ◽  
Vol 22 (Supplement_3) ◽  
pp. iii325-iii326
Author(s):  
Björn-Ole Juhnke ◽  
Marco Gessi ◽  
Nicolas Ulrich Gerber ◽  
Carsten Friedrich ◽  
Christine Haberler ◽  
...  
Keyword(s):  
Progression Free Survival ◽  
High Dose Chemotherapy ◽  
High Dose ◽  
Disease Relapse ◽  
Total Resection ◽  
Free Survival ◽  
Entire Cohort ◽  
Innovative Therapies ◽  
Embryonal Tumours ◽  
Aggressive Tumors

Abstract BACKGROUND Embryonal tumours with multilayered rosettes (ETMR) are highly aggressive tumors, mostly occurring in infants. Published clinical data refer to retrospective cohorts of inhomogeneously treated patients. Here, we describe the outcome of patients, who were prospectively treated within the P-HIT2000-trial, the subsequent HIT2000-interim-registry and earlier HIT-trials. PATIENTS AND METHODS Nineteen patients from the P-HIT2000-trial (2001–2011), 12 patients from the subsequent HIT2000-interim-registry (2012–2014) and 4 patients from earlier HIT-trials with centrally reviewed neuropathological and molecularly-confirmed diagnosis of ETMR were included. Outcome of 18 patients treated with carboplatin-etoposide-induction followed by tandem-high-dose chemotherapy (“CARBO-ETO+HDCT”) with stage-stratified radiotherapy administered in case of persistant disease, relapse or progression were compared to patients treated with HIT-SKK chemotherapy ± radiotherapy (n=9) or other regimens (n=8). RESULTS Median age at diagnosis was 2.9(1.0–5.3) years. Metastases at diagnosis were detected in 9 patients (26%). For the entire cohort of n=35, 5-year overall survival (OS) was 26.7%, and progression-free survival (PFS) was 18.5%. Five-year OS for patients with CARBO-ETO+HDCT, SKK chemotherapy or other regimens was 44.4%, 13.0% and 0%, respectively (p=0.006). Five-year PFS was 33.3%, 0% and 0%, respectively (p=0.119). Of 10 survivors, n=8 were treated with CARBO-ETO+HDCT; n=4 had craniospinal, n=2 local and n=4 no radiotherapy. Impact of initial gross-total-resection (p=0.231) and non-metastatic disease (p=0.097) was limited. CONCLUSIONS We show improved survival with carboplatin-etoposide-induction followed by tandem-high-dose chemotherapy, indicating that a cure is possible for some patients. However, despite intensive treatment, outcome is unsatisfactory and innovative therapies urgently need to be included in an upfront setting.

scholarly journals Treatment of Angiosarcoma with Pazopanib and Paclitaxel: Results of the EVA (Evaluation of Votrient® in Angiosarcoma) Phase II Trial of the German Interdisciplinary Sarcoma Group (GISG-06)

Cancers ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 1223
Author(s):  
Daniel Pink ◽  
Dimosthenis Andreou ◽  
Sebastian Bauer ◽  
Thomas Brodowicz ◽  
Bernd Kasper ◽  
...  
Keyword(s):  
Immune Checkpoint Inhibitors ◽  
Median Overall Survival ◽  
Phase Ii Trial ◽  
Checkpoint Inhibitors ◽  
Progression Free Survival ◽  
Free Survival ◽  
Safety And Efficacy ◽  
Future Studies ◽  
Entire Cohort

We aimed to evaluate the efficacy and toxicity of paclitaxel combined with pazopanib in advanced angiosarcoma (AS). The primary end point was progression-free survival (PFS) rate at six months (PFSR6). Planned accrual was 44 patients in order to detect a PFSR6 of >55%, with an interim futility analysis of the first 14 patients. The study did not meet its predetermined interim target of 6/14 patients progression-free at 6 months. At the time of this finding, 26 patients had been enrolled between July 2014 and April 2016, resulting in an overrunning of 12 patients. After a median follow-up of 9.5 (IQR 7.7–15.4) months, PFSR6 amounted to 46%. Two patients had a complete and seven patients a partial response. Patients with superficial AS had a significantly higher PFSR6 (61% vs. 13%, p = 0.0247) and PFS (11.3 vs. 2.7 months, p < 0.0001) compared to patients with visceral AS. The median overall survival in the entire cohort was 21.6 months. A total of 10 drug-related serious adverse effects were reported in 5 patients, including a fatal hepatic failure. Although our study did not meet its primary endpoint, the median PFS of 11.6 months in patients with superficial AS appears to be promising. Taking recent reports into consideration, future studies should evaluate the safety and efficacy of VEGFR and immune checkpoint inhibitors with or without paclitaxel in a randomized, multiarm setting.

Elevation of pulse pressure in middle age is associated with the risk of dementia: data from a population-based cohort

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
D Kim ◽  
H Jung ◽  
P.S Yang ◽  
H.T Yu ◽  
T.H Kim ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Pulse Pressure ◽  
Middle Age ◽  
Population Based ◽  
Entire Cohort ◽  
Incident Dementia ◽  
Increased Risk ◽  
Diagnosis Of Dementia ◽  
History Of ◽  
The Mean

Abstract Aims Pulse pressure (PP) is a well-known risk factor for cardiovascular disease. However, the association between the PP and dementia is not well identified. This study aimed to determine the effect of PP on the risk of dementia development in different age subgroups using a longitudinal, population-based, and stroke-free cohort from the general population. Methods The association of PP with the development of incident dementia was assessed from January 1, 2005, to December 31, 2013, in 433,154 participants without a history of dementia or stroke from the Korea National Health Insurance Service-Health Screening cohort. The diagnosis of dementia was defined using the 10th revision of the International Classification of Disease codes. Results The mean age of the cohort was 55.7±9.2 years, 45.7% were women. Hypertension was 23.6%. The mean systolic and diastolic blood pressure of the entire cohort were 125.9±16.6 and 78.4±10.7 mmHg, respectively. Mean PP was 47.5±10.9 mmHg. In the middle-age group (40 to 50 year-old), increasing of 10 mmHg of PP was associated with incident dementia after adjusting mean blood pressure and clinical variables with a hazard ratio (HR) of 1.21 (95% confidence interval [CI]: 1.19–1.23, p&lt;0.001). The association was still significant even after censoring for stroke (HR: 1.16, 95% CI: 1.08–1.22, p&lt;0.001). In the older population, elevation of PP was not associated with dementia development (HR: 0.98, 95% CI: 0.95–1.01, p=0.247) Conclusion PP was associated with increased risk of dementia only in middle-aged population beyond that of mean arterial pressure. Funding Acknowledgement Type of funding source: None

scholarly journals CTIM-03. PHASE II STUDY OF REGORAFENIB IN BEVACIZUMAB REFRACTORY RECURRENT GLIOBLASTOMA

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii33-ii33
Author(s):  
Yasmeen Rauf ◽  
Cathy Schilero ◽  
David Peereboom ◽  
Manmeet Ahluwalia
Keyword(s):  
Dose Escalation ◽  
Therapeutic Option ◽  
Objective Response ◽  
Progression Free Survival ◽  
Recurrent Glioblastoma ◽  
Weekly Dose ◽  
Cellular Functions ◽  
Molecule Inhibitor ◽  
Secondary Endpoints ◽  
Magnetic Resonance Imaging Mri

Abstract BACKGROUND Most patients with glioblastoma (GBM) receive bevacizumab as part of their treatment. There is no good therapeutic option after bevacizumab failure. Regorafenib has potent preclinical antitumor activity and long-lasting anti-angiogenic activity as measured by dynamic contrast enhanced (DCE) – magnetic resonance imaging (MRI). Regorafenib is a small molecule inhibitor of multiple membrane-bound and intracellular kinases involved in normal cellular functions and in pathologic processes such as oncogenesis, tumor angiogenesis, and maintenance of the tumor microenvironment. METHODS Patients with progression of GBM after treatment with Bevacizumab will be eligible for the study. Oral administration of Regorafenib at 160 mg once daily will be administered for 3 weeks on /1 week off. Weekly dose escalation of regorafenib from 80 mg to 160 mg/day will be employed as per the Redos strategy. Patients start the treatment 80 mg/day in week 1, with weekly dose escalation to 120 mg in week 2, then 160 mg week in 3 if no significant drug-related toxicities are observed. They will be continued on treatment with Regorafenib 160 md /day till tumor progression or toxicity. They will get MRI brain every 4 weeks during the study. RESULTS Primary endpoint is median Overall survival. Secondary endpoints include progression free survival at 6 months and the median time to progression and objective response rate using the modified RANO criteria. The overall safety and tolerability of regorafenib by CTCAE version 5.0. will also be reported. CONCLUSION This is an ongoing clinical trial.

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