scholarly journals Abiraterone Acetate for Metastatic Castration-Sensitive Prostate Cancer

2021 ◽  
Vol 1 (5) ◽  
Author(s):  
Amanda Shane ◽  
Melissa Walter
Keyword(s):  
Prostate Cancer ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Abiraterone Acetate ◽  
Discontinue Treatment ◽  
Cancer Specific Survival ◽  
Free Survival ◽  
Life Threatening ◽  
Grade Iii

The use of abiraterone acetate for the treatment of metastatic castration-sensitive prostate cancer is clinically effective. Compared with standard of care, abiraterone acetate was associated with increased overall survival, increased prostate cancer–specific survival, increased progression-free survival, and improved quality of life. Patients treated with abiraterone acetate were at higher risk for grade III to grade V adverse events (severe, life-threatening, or fatal) and were more likely to discontinue treatment compared with standard of care. The incremental cost-effectiveness ratios for both brand and generic abiraterone acetate were estimated to be higher than common willingness-to-pay thresholds.

scholarly journals Cabazitaxel for Metastatic Castration-Resistant Prostate Cancer: Retrospective Data Analysis from an Indian Centre

2016 ◽  
Vol 9 (2) ◽  
pp. 506-515
Author(s):  
Vanita Noronha ◽  
Amit Joshi ◽  
Vamshi Krishna Muddu ◽  
Vijay Maruti Patil ◽  
Kumar Prabhash
Keyword(s):  
Prostate Cancer ◽  
Specific Antigen ◽  
Progression Free Survival ◽  
Castration Resistant Prostate Cancer ◽  
Free Survival ◽  
Castration Resistant ◽  
Retrospective Data Analysis ◽  
Grade 3 ◽  
Named Patient Programme

Objective: To determine the efficacy and safety of cabazitaxel in metastatic castration-resistant prostate cancer (mCRPC) patients from the named patient programme (NPP) at our centre. Methods: mCRPC patients who progressed on docetaxel were given cabazitaxel intravenously every 3 weeks until disease progression or unacceptable toxicity occurred. Overall survival, progression-free survival, prostate-specific antigen response, quality of life (QOL) changes, and safety were reported. Results: Nine men received cabazitaxel (median: 7 cycles; range: 1–27) under the NPP and were followed until death. Median survival was 14.07 months (1.07–23.80) and progression-free survival was 2.67 months (1.07–20.27). QOL was stable for most patients. Common adverse events (grade ≥3) were neutropenia (n = 8), anaemia (n = 4), and leucopenia (n = 4). Conclusion: These data from 9 patients are consistent with the results reported in the TROPIC study with a manageable safety profile.

scholarly journals More than a Decade of Tyrosine Kinase Inhibitors in the Treatment of Solid Tumors: What We Have Learned and What the Future Holds

2015 ◽  
Vol 10s3 ◽  
pp. BMI.S22436 ◽  
Author(s):  
Maria Vergoulidou
Keyword(s):  
Tyrosine Kinase ◽  
Small Molecules ◽  
Solid Tumors ◽  
Tyrosine Kinase Inhibitors ◽  
Kinase Inhibitors ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Free Survival ◽  
Free Treatment

The use of tyrosine kinase inhibitors (TKIs) in the treatment of solid tumors is the expected standard of care for many types of tumors. Since the description of signal transduction pathways, followed by the development of small molecules designed to inhibit those pathways, there has been significant improvement not only in progression-free survival and overall survival but also in aiming toward chemotherapy-free treatment of solid tumors to maximize quality of life. This article reviews available TKIs and discusses toxicity, dosing, and resistance.

Treatments for metastatic hormone-sensitive prostate cancer: A systematic review.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 346-346
Author(s):  
Belal Firwana ◽  
Mohamad Bassam Sonbol ◽  
Fade A. Mahmoud ◽  
Konstantinos Arnaoutakis
Keyword(s):  
Prostate Cancer ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
P Value ◽  
Free Survival ◽  
Appropriate Treatment ◽  
Individual Trial ◽  
Efficacy Outcome ◽  
Significant Difference ◽  
Hormone Sensitive

346 Background: Over the past few years, the treatment of metastatic hormone sensitive prostate cancer (mHSPC) was revolutionized with the addition of docetaxel (DOC) or abiraterone (ABI) to the previous standard of care androgen deprivation treatment (ADT). Here, we sought to compare the effectiveness of docetaxel and abiraterone directly against ADT and indirectly to each other. Methods: We included randomized controlled trials (RCT) evaluating the efficacy of treatments in adults with newly diagnosed mHSPC. First-line treatments with DOC and ABI were considered. Efficacy outcome measures are overall survival (OS) and failure-free survival as (FFS) as defined by individual trial. If FFS was not reported, biochemical progression-free survival was considered FFS due to its specificity. The overall effect was pooled using the DerSimonian random effects model. Testing for subgroup difference was conducted using meta-regression method. Results: A total of five RCTs were included; three RCTs compared DOC+ADT versus ADT involving 2,992 participants, and two RCT compared ABI+ADT versus ADT involving 2,201 participants. The addition of DOC to ADT showed a significant improvement in OS compared to ADT monotherapy (HR 0.77, 95% CI 0.66 to 0.89) as well did the addition of ABI to ADT (HR 0.62, 95% CI 0.53 to 0.71). p-value for subgroup interaction was <0.05, suggesting a significant difference between pooled DOC and ABI effects, favoring the addition of ABI vs. DOC to ADT. Similar effects were found in significantly improving FFS when adding DOC (HR 0.64, 95% CI 0.58 to 0.70) or ABI (HR 0.30, 95% CI 0.27 to 0.34) to ADT compared to ADT monotherapy. p-value for interaction subgroup interaction was again significant <0.05 favoring the addition of ABI vs. DOC to ADT. Conclusions: The addition of either DOC or ABI to ADT showed significant improvement in OS and FFS when compared to ADT monotherapy in patients with mHSPC. Test for interaction suggests better outcome of ABI in comparison against DOC. Discussion with patients is encouraged to choose the appropriate treatment considering the adverse event profile for each. Further head-to-head comparison is needed to determine the effect.

scholarly journals Upfront docetaxel with androgen deprivation therapy in the elderly patient with metastatic hormone-naïve prostate cancer: Single institution experience.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 328-328 ◽  
Author(s):  
Lindsay Jennifer Andrew Rayner ◽  
Amarnath Challapalli ◽  
Eve Blackmore ◽  
Katherine Rea ◽  
Natasha Wells ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
The Elderly ◽  
Rank Test ◽  
Free Survival ◽  
Kaplan Meier ◽  
Elderly Cohort ◽  
Docetaxel Chemotherapy ◽  
Dose Reductions

328 Background: Following CHAARTED & STAMPEDE, upfront Docetaxel chemotherapy became standard of care for metastatic hormone-naïve prostate cancer (mHNPC). We sought to evaluate our experience in the elderly group of patients (>70 yrs) compared with the non-elderly cohort. Methods: A retrospective analysis was undertaken of 38 patients commenced on upfront docetaxel chemotherapy, from Jan 16 - Jan 17. Patients were stratified as low (LR) and high risk (HR), as per the LATITUDE study. Progression was defined as per PCWG-3 criteria. The progression free survival (PFS) was calculated as time from start of treatment to date of progression and analysed by Kaplan-Meier estimates and log-rank test. Rates of febrile neutropenia (FN) were also evaluated. Results: The median age was 69 (range: 53-80) yrs, with 50% (19/38) HR patients. The median PFS was 11.5m for progressors (P; 42%) and not reached for non-progressors (NP; 58%), (p<0.0001). Granulocyte colony stimulating factor (G-CSF) was used in 13/38 (34%) patients; these did not experience FN. The overall rate of FN was 20% where G-CSF was not used. Overall 31/38 (81.6%) completed 6 cycles of chemotherapy, with 26% requiring dose reductions (Table). Overall, of the 9/16 (56.3%) patients who progressed within 6m of completing docetaxel, 3 had Cabazitaxel as the next treatment (P: 2/3 (66.7%), median PFS 6.2m) and 6 had novel androgen receptor targeted therapy (P: 5/6 (83.3%), median PFS 3.3m). Conclusions: Upfront docetaxel is reasonably well tolerated in the elderly with comparable median PFS to younger patients. Use of GCSF significantly minimizes the risk of FN in this group and should be considered as standard of care. In patients who progress within 6m of completing docetaxel, we feel optimal sequencing to be Cabazitaxel followed by subsequent therapies.[Table: see text]

Time to second progression (PFS2) in patients (pts) from TITAN with metastatic castration-sensitive prostate cancer (mCSPC) by first subsequent therapy (hormonal vs. taxane).

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 82-82 ◽  
Author(s):  
Neeraj Agarwal ◽  
Simon Chowdhury ◽  
Anders Bjartell ◽  
Byung Ha Chung ◽  
Andrea Juliana Pereira de Santana Gomes ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Disease Progression ◽  
Progression Free Survival ◽  
High Volume ◽  
Abiraterone Acetate ◽  
Double Blind Study ◽  
Double Blind ◽  
Free Survival ◽  
Disease Characteristics ◽  
Post Hoc

82 Background: TITAN, a phase 3, randomized, double-blind study of apalutamide (APA) vs placebo (PBO) added to androgen deprivation therapy (ADT), demonstrated significant improvement in radiographic progression-free survival and overall survival in a broad pt population with mCSPC who received APA (Chi KN et al. NEJM 2019). This post hoc analysis evaluates whether type of 1st life-prolonging subsequent therapy (hormonal vs taxane) has an effect on PFS2 benefit shown with APA + ADT. Methods: PFS2 (the time from randomization to disease progression on 1st subsequent therapy for prostate cancer or death, whichever occurs first) was evaluated for pts from TITAN based on 1st subsequent life-prolonging therapy (hormonal vs taxane) after study treatment. Analysis censored all other 1st subsequent systemic therapies after start of treatment. Results: 277 pts (APA, 87; PBO, 190) received subsequent systemic therapy for prostate cancer; 86 pts (APA, 24; PBO, 62) received hormonal therapy (abiraterone acetate + prednisone or enzalutamide) and 99 (APA, 30; PBO, 69) received taxane (docetaxel or cabazitaxel) as 1st subsequent therapy. Baseline demographic and disease characteristics were generally similar between groups. The taxane group had a higher proportion of pts with high volume and pts with > 10 bone metastases, and a lower proportion with prior docetaxel exposure when compared with the hormonal group. Median treatment duration with APA and PBO was 11.9 and 11.1 mos in the hormonal group and 11.0 and 11.3 mos in the taxane group. Regardless of subsequent therapy, PFS2 was significantly longer for APA vs PBO (HR 0.66 [95% CI 0.50-0.87], p = 0.0026). Pts in both groups who received APA had a significant reduction in risk of 2nd progression compared with PBO (hormonal: HR 0.68 [0.48-0.97], p = 0.0326; taxane: HR 0.67 [0.48-0.94], p = 0.0189; medians not reached). Safety analyses were not conducted; all pts had discontinued therapy, most due to disease progression. Conclusions: The addition of APA to ADT for treatment of mCSPC results in risk reduction of 2nd progression regardless of choice of hormonal or taxane as the 1st life-prolonging subsequent therapy. Clinical trial information: NCT02489318.

scholarly journals IMMU-04. VACCINATING AGAINST NOVEL CYTOMEGALOVIRUS ANTIGENS IN GLIOBLASTOMA USING A PEPTIDE VACCINE IN COMBINATION WITH TEMOZOLOMIDE

2021 ◽  
Vol 3 (Supplement_4) ◽  
pp. iv5-iv5
Author(s):  
Kelly Hotchkiss ◽  
Kirit Singh ◽  
Kristen Batich ◽  
Gerald Archer ◽  
Pamela Norberg ◽  
...  
Keyword(s):  
Peptide Vaccine ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Newly Diagnosed ◽  
Vaccination Site ◽  
Free Survival ◽  
Vaccine Potency ◽  
Cytokine Levels ◽  
Grade Ii ◽  
Grade Iii

Abstract INTRODUCTION Cytomegalovirus (CMV) antigens are excellent anti-tumor immunotherapeutic targets in glioblastoma (GBM). The PERFORMANCE trial (IRB-pro34208, IND-15846) assessed the feasibility, safety and optimal adjuvant temozolomide (TMZ) regimen to be used with PEP-CMV vaccination in adults with newly-diagnosed GBM. METHODS Seropositive CMV patients (n=16) were randomized into two arms and treated with standard of care RT-TMZ (SOC) (150-200 mg/m2/day on days 1-5 per 28-day cycle) or dose-intensive TMZ (DI) (75-100 mg/m2/day on days 1-21 per 28-day cycle). Patients received intradermal PEP-CMV vaccines (500μg of CMVpp65 synthetic long peptide (SLP) mixed with Montanide ISA-51) on days 23, 37 and 51 following TMZ. All patients received tetanus/diphtheria toxoid (Td) preconditioning at the vaccination site on day 22. Serum cytokine levels were measured pre-vaccination, 1-hour and 2-hours post vaccination. PEP-CMV specific circulating PBMCs were quantified at baseline and after each vaccine. RESULTS Of the 16 trial patients, 7 experienced site-reactions, 4 had grade-II Immune Related Adverse Events (IRAEs), and 4 experienced flu-like grade-III IRAEs. Inflammatory cytokines (IL-2, IFNγ, MIP-1a, IL-8, TNFα, and IL-10) were elevated in patients with grade-III responses 2-hours post vaccine 1. Td p2/p30 specific PBMC levels were similar between IRAEs. However, pp65 responsive PBMCs were elevated at baseline in patients with grade-III reactions compared to site-reaction suggesting pre-existing peptide specific responses may lead to increased vaccine immunogenicity. PBMCs specific for pp65 increased with number of consecutive vaccines. No difference in progression free survival (PFS) or overall survival (OS) was observed between TMZ regimens. CONCLUSION PEP-CMV vaccination with Td preconditioning is feasible and generates immune responses specific to pp65 in patients with newly diagnosed GBM. Importantly, IRAEs were associated with antitumor efficacy. The mild IRAEs in PERFORMANCE are likely indicative of vaccine potency and can be managed through standard premedication as has been used in other trials with similar IRAEs.

scholarly journals Androgen Receptor Targeted Therapy + Radiotherapy in Metastatic Castration Resistant Prostate Cancer

2021 ◽  
Vol 11 ◽  
Author(s):  
Maria Massaro ◽  
Giuseppe Facondo ◽  
Gianluca Vullo ◽  
Anna Maria Aschelter ◽  
Alessandro Rossi ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Androgen Receptor ◽  
Targeted Therapy ◽  
Progression Free Survival ◽  
Conformal Radiotherapy ◽  
Abiraterone Acetate ◽  
Castration Resistant Prostate Cancer ◽  
Free Survival ◽  
Castration Resistant

ObjectivesTo investigate whether radiotherapy as metastasis-directed therapy (MDT) on oligo-progressive sites in metastatic castration-resistant prostate cancer (mCRPC) patients during treatment with androgen receptor-targeted therapy (ARTT) may lead to control resistant lesions, prolonging ARTT. We analysed progression free survival, overall survival and prognostic parameters that can identify patients that best suit to this approach.Patients and MethodsRetrospective analysis of a total of 67 lesions in 42 mCRPC patients treated with ablative or palliative RT to oligoprogressive lesions during ARTT. Twenty-eight patients (67%) underwent ARTT with Abiraterone acetate and 14 patients (33%) underwent ARTT with Enzalutamide. Median time between the start of ADT and ARTT beginning was 50.14 months (range 3.37-219 months). We treated 58 lesions (87%) with 3D conformal radiotherapy (3DCRT) and nine lesions (13%) with stereotactic body radiotherapy (SBRT). The Kaplan Meier method was used to assess the median overall survival (OS) and the progression-free survival (PFS).ResultsMedian follow-up was 28 months (range 3-82 months). Median OS was 32.5 months (95% CI 25.77-39.16), 1 and 2-year OS were 71.6% and 64.1%, respectively. Median PFS was 19,8 months (95% CI 11.34–28.31), 1 and 2-year PFS were 67.2% and 47.4%, respectively. Median OS for patients that underwent radiotherapy before 6 months from the start of ARTT was 23.4 months (95% CI 2.04-44.89) and 45.5 months (95% CI 31.19-59.8) for patients that underwent radiotherapy after 6 months (p = 0.009).ConclusionLocal ablative radiation therapy directed to progressive metastasis is a non-invasive, well tolerated treatment with efficacy on prolonging clinical benefit of systemic therapies with ARTT. Patients who underwent RT &gt;6 months from the start of ARTT presented a statistically better OS and PFS compared with patients who underwent radiotherapy &lt;6 months from the start of ARTT.

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