Application of abiraterone acetate (AA) in chemo-naïve metastatic castration-resistant prostate cancer (mCRPC) patients who did not fulfil the patient inclusion criteria in the COU-AA-302 study.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 317-317
Author(s):  
Darren M. C. Poon ◽  
Chan Kuen ◽  
S.H. Lee ◽  
T.W. Chan ◽  
Chun-Kin Sze ◽  
...  
Keyword(s):  
Performance Status ◽  
Poor Performance ◽  
Abiraterone Acetate ◽  
Poor Performance Status ◽  
Inclusion Criteria ◽  
Study Results ◽  
Significant Difference ◽  
Visceral Metastases ◽  
Clinical Records ◽  
The Impact

317 Background: Visceral metastases or poor performance status (ECOG 2 or above) were the major exclusion criteria in the COU-AA-302 study, and hence the efficacy of abiraterone acetate (AA) in chemo-naïve mCRPC patients with these characteristics remain undetermined. Our study compares the clinical efficacy of AA in chemo-naïve mCRPC patients with or without the aforementioned characteristics. Methods: The clinical records of chemo-naïve mCRPC patients from all 6 public oncology centers in Hong Kong between August 2011 and December 2014 were reviewed. Patients with visceral disease who were medically unfit for, or who declined, chemotherapy, were allowed for AA in the study period. The median overall survival (OS), progression-free survival (PFS), patient and disease characteristics were compared between groups which satisfied, and did not satisfy, the inclusion criteria of COU-AA-302 study. Results: Fifty-eight consecutive chemo-naïve mCRPC patients had received AA in the review period, of which 29 fulfilled the inclusion criteria for the COU-AA-302 study (Group Eligible). All the remaining patients (Group Ineligible) had ECOG 2 or above, including 3 who had non-nodal visceral metastases. Group Ineligible had higher baseline PSA, haemoglobin and alkaline phosphatase level than Group Eligible, but otherwise there was no significant difference in the baseline characteristics between the groups for age, Gleason score, and co-morbidities. Group Ineligible had significantly shorter OS than Group Eligible (7.7 vs 25.0 months, p = 0.0095) and also a shorter PFS that did not reach statistical significance (5.3 vs 9.8 months, p = 0.2936). The duration of use of AA, and frequency of employment of post-AA treatment were comparable between the groups. Conclusions: Our study demonstrated a poor efficacy of AA in chemo-naïve patients who did not fulfil the inclusion criteria for COU-AA-302 study, by virtue of poor performance status or presence of visceral metastases. The impact of AA in this group of patients warrants further examination in clinical trials before its routine clinical use in this subgroup.

Predicting survival in resected pancreatic cancer: A Canadian provincial experience.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 361-361
Author(s):  
Gillian Gresham ◽  
Sylvia Ng ◽  
Anderson Chang ◽  
Shannon Valdez ◽  
Sharlene Gill
Keyword(s):  
Pancreatic Cancer ◽  
Histological Grade ◽  
Performance Status ◽  
Poor Performance ◽  
Poor Performance Status ◽  
Significant Difference ◽  
Cancer Agency ◽  
Trial Outcomes ◽  
Grade 3 ◽  
Poor Outcomes

361 Background: Surgical resection offers the only hope for long-term disease control in patients (pts) with pancreatic adenocarcinoma. Randomized trials (ESPAC 1, ESPAC3) further support a role for adjuvant chemotherapy (AC) in the management of pancreatic cancer (PC). Trial outcomes may not reflect clinical reality due to pt selection bias, and it is often difficult to predict which pts are most likely to benefit from adjuvant intervention. Methods: Consecutive pts between 2003 and 2008 referred to the BC Cancer Agency (BCCA) with operative intent at diagnosis (dx) were retrospectively reviewed. Results: 145 pts were identified; median age 65 years (y) (range 38-84), male/female (45.5%, 54.5%). EUS/PET staging was performed in 21% of pts. Median CA19-9 value at dx was 210 ku/L. Pancreaticoduodenectomy was performed in 65% of pts. Complete resection (RO) of tumours occurred in 87 pts (60%) overall. 66% of pts were node positive. 43% of pts were subsequently treated with adjuvant therapy (AT) where 5% of these pts received chemoradiotherapy and 95% received AC (65% gemcitabine). There was no statistically significant difference in either OS (p=0.39) or DFS (p=0.28) amongst resected pts who were treated by sx alone versus pts who received AC. In subgroup analysis, AC was associated with significantly improved OS in pts (n=58) with positive margins (R1) (median 17.3 mos vs 8.9 mos, p=0.0045) but benefit was not seen in R0 pts (n=87) (22.9 mos vs 22.4 mos, p=0.20). In multivariate analysis, poor performance status (ECOG 3-4), weight loss of more than 10% of initial body weight, baseline CA19-9 value greater than 210 ku/L, positive nodes, R1 status and histological grade 3-4 were significant adverse prognostic factors. Conclusions: PC continues to have poor outcomes with a 5yOS of 5% in pts treated with sx alone. Among pts with resectable PC treated at the BCCA, AC tended towards increased DFS and OS. Although R1 status was associated with inferior OS, the benefit of AT was greater in this subgroup. [Table: see text]

Patient risk factors and pegfilgrastim use in cabazitaxel-treated prostate cancer pateints in an academic setting.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 224-224
Author(s):  
Marina Dusevic Kaymakcalan ◽  
Sherri Stuver ◽  
Christopher Sweeney ◽  
Toni K. Choueiri ◽  
Aymen Elfiky
Keyword(s):  
Prostate Cancer ◽  
Risk Factors ◽  
Performance Status ◽  
Poor Performance ◽  
Prior History ◽  
Poor Performance Status ◽  
Castration Resistant Prostate Cancer ◽  
Exact Test ◽  
Potential Risk Factors ◽  
The Impact

224 Background: Cabazitaxel can offer a survival advantage in patients (pts) with metastatic castration resistant prostate cancer (mCRPC). Febrile neutropenia (FN) has emerged as a serious complication, with a rate of 8% in the TROPIC trial (de Bono, Lancet 2010). Prophylaxis with pegfilgrastim (P) can decrease the risk of FN, although predictors of FN continue to evolve. We performed an analysis on the effect of prophylactic P use on FN and the impact of certain risk factors on FN rates. Methods: We conducted a retrospective analysis of mCRPC patients treated with cabazitaxel from June 2010 to August 2013 at Dana-Farber Cancer Institute. Patient clinical and treatment variables were extracted. Fisher’s exact test was used to evaluate the association between potential risk factors and FN. Results: A total of 89 patients were treated at our institution and included in this analysis. All patients received at least one dose of cabazitaxel and received a mean of four cycles. Five pts (5.6%) developed FN; 3 out of 70 (4.3%) receiving P and 2 out of 19 (10.5%) not receiving P (p=0.3). Of the 24 patients that started cabazitaxel at a reduced dose, none developed FN. No toxic death was reported. Among several risk factors including P use, age older than 65, pre-existing neutropenia, prior chemotherapy, pre-existing infection, poor performance status, liver and renal dysfunction, and recent surgery, only a prior history of palliative radiation had a significant association with FN (p=.002). Conclusions: The rate of FN in a large academic practice is similar to what was reported in the TROPIC trial. Prior radiation may be a risk factor for FN in cabazitaxel-treated mCRPC patients. Other factors that may help better predict the risk of FN in different groups of patients receiving cabazitaxel must be identified.

Atezolizumab (atezo) therapy for locally advanced/metastatic urinary tract carcinoma (mUTC) in patients (pts) with poor performance status (PS): Analysis of the prospective global SAUL study.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 5035-5035
Author(s):  
Daniel Castellano ◽  
Craig Gedye ◽  
Giuseppe Fornarini ◽  
Andre P. Fay ◽  
Jens Voortman ◽  
...  
Keyword(s):  
Performance Status ◽  
Locally Advanced ◽  
Poor Performance ◽  
Poor Performance Status ◽  
World Population ◽  
Dismal Prognosis ◽  
Visceral Metastases ◽  
Baseline Factors ◽  
Poor Outcomes ◽  
Ecog Ps

5035 Background: Pts with PS > 1 have a poor prognosis and are often excluded from clinical trials. The single-arm SAUL study (NCT02928406) evaluated atezo in a ‘real-world’ population. Overall, safety and efficacy were consistent with prior trials. However, ECOG PS 2 pts had worse overall survival (OS) but fewer adverse events (AEs) than ECOG PS 0/1 pts [Sternberg, 2019], likely reflecting shorter treatment duration and warranting exploration. Methods: Pts with mUTC received atezo 1200 mg q3w until loss of clinical benefit or unacceptable toxicity. The primary endpoint was safety. Post hoc analyses compared baseline factors, AEs and efficacy in pts with ECOG PS 2 vs 0/1. In this analysis, AE incidences were restricted to the first 45 days of atezo to adjust for differing treatment exposure. Results: None of the baseline factors explored was significantly associated with worse OS or disease control rate (DCR) in ECOG PS 2 pts. However, pts with visceral metastases and ECOG PS 2 had particularly poor outcomes. Safety appeared similar between subgroups. Conclusions: ECOG PS 2 pts have a dismal prognosis. The higher proportion with poor prognostic factors despite similar age in ECOG PS 2 vs 0/1 pts may suggest that poor PS was related to disease rather than comorbidities. Risk/benefit should be considered especially carefully when treating pts with ECOG PS 2 due to high-burden/visceral disease. Clinical trial information: NCT02928406 . [Table: see text]

scholarly journals Randomized Phase II Study of Gefitinib Compared With Placebo in Chemotherapy-Naive Patients With Advanced Non–Small-Cell Lung Cancer and Poor Performance Status

2009 ◽  
Vol 27 (13) ◽  
pp. 2253-2260 ◽  
Author(s):  
Glenwood Goss ◽  
David Ferry ◽  
Rafal Wierzbicki ◽  
Scott A. Laurie ◽  
Joyce Thompson ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Performance Status ◽  
Poor Performance ◽  
Small Cell ◽  
Gene Copy ◽  
Poor Performance Status ◽  
Small Cell Lung ◽  
Significant Difference

Purpose To compare gefitinib with placebo in chemotherapy naïve patients with advanced non–small-cell lung cancer (NSCLC) and poor performance status. Patients and Methods NSCLC patients (chemotherapy naïve, WHO performance status 2 or 3; unfit for chemotherapy; stage IIIB/IV) were randomly assigned to gefitinib (250 mg/d) plus best supportive care (BSC; n = 100) or placebo plus BSC (n = 101). The primary end point was progression-free survival (PFS). Secondary end points included overall survival (OS), objective response rate (ORR), quality of life (QOL), pulmonary symptom improvement (PSI), and safety. Correlation of gefitinib efficacy with EGFR gene copy number (fluorescent in situ hybridization [FISH]) was explored. Results Hazard ratios (HRs; gefitinib:placebo) were 0.82 (95% CI, 0.60 to 1.12; P = .217) for PFS and 0.84 (95% CI, 0.62 to 1.15; P = .272) for OS. As expected for this patient population, OS for both arms was poor, at about 3 months. ORRs were 6.0% (gefitinib) and 1.0% (placebo). QOL and PSI rates were 21.1% and 28.3% (gefitinib) and 20.0% and 28.3% (placebo), respectively. In EGFR FISH-positive patients (n = 32), HRs were 0.29 (95% CI, 0.11 to 0.73) for PFS and 0.44 (95% CI, 0.17 to 1.12) for OS. No unexpected adverse events occurred. Conclusion There was no statistically significant difference in PFS, OS, and ORRs after treatment with gefitinib or placebo, in the overall population; improvements in QOL and symptoms were similar in both groups. Tolerability profile of gefitinib was consistent with previous studies. PFS was statistically significantly improved for gefitinib-treated patients with EGFR FISH-positive tumors.

scholarly journals Disease Characteristics, Patterns of Care, and Survival in Very Elderly Patients with Diffuse Large B-Cell Lymphoma

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 4480-4480
Author(s):  
Jessica N. Williams ◽  
Ashish Rai ◽  
Joseph Lipscomb ◽  
Jean L. Koff ◽  
Loretta J. Nastoupil ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Performance Status ◽  
Poor Performance ◽  
B Cell Lymphoma ◽  
Stage Iii ◽  
Poor Performance Status ◽  
Very Elderly ◽  
Selection Factors ◽  
The Impact ◽  
To Receive

Abstract Context: Despite having the highest incidence of diffuse large B-cell lymphoma (DLBCL), individuals older than 80 years are rarely included in DLBCL clinical trials or epidemiological studies. We sought to better characterize DLBCL presentation, treatment, and survival patterns for this age group. Objective: We investigated demographic and clinical characteristics at diagnosis, treatment selection factors, and the impact of treatment regimen on overall survival (OS) and lymphoma-related survival (LRS) for DLBCL patients >80 years. We hypothesized that patients >80 years were more likely to undergo observation and less likely to receive standard-of-care rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). We also hypothesized that patients >80 years who received R-CHOP would have superior OS and LRS, even after controlling for demographic and clinical factors. Methods: We used the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database to examine DLBCL patients diagnosed from 1999-2009 and followed through 2010. Our population-based cohort contained 5,924 DLBCL patients aged ≥66 years; 1,422 were >80 years. Only patients treated within 6 months of diagnosis with R-CHOP; cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP); cyclophosphamide, vincristine, and prednisone (CVP); rituximab plus CVP (R-CVP); or patients undergoing observation were included in order to examine factors associated with the use of anthracyclines. Chi-squared tests compared characteristics and initial treatments of DLBCL patients >80 years and 66-80 years. Multivariable logistic regression models examined treatment selection factors in patients >80 years. Standard and propensity score-adjusted multivariable Cox proportional hazards models adjusted for patient demographics, clinical characteristics, comorbidities, performance status, and year of diagnosis examined relationships between treatment regimen, treatment duration, and survival. Results: Among patients >80 years, 58% were female, 91% were Caucasian, 36% had stage III/IV disease, 39% had extranodal involvement, 7% had B-symptoms, 28% had poor performance status, and 14% had ≥2 comorbidities. Patients >80 years were less likely to receive R-CHOP (43% vs. 61%) and more likely to be observed (30% vs. 15%) or receive R-CVP (12% vs. 4%); all p<0.0001. Sex, marital status, area-level poverty, year of diagnosis, performance status, and disease site were associated with R-CHOP treatment in patients >80 years. The initial receipt of R-CHOP was more commonly associated with female sex (odds ratio (OR) 1.31, 95% confidence interval 1.01-1.71), being married (OR 1.69, 1.07-2.66) and a diagnosis after 2001 (OR for 2002 11.71, 6.32-21.70; persistently increased ORs thereafter). The initial receipt of R-CHOP was less commonly associated with extranodal disease (OR 0.71, 0.55-0.91), poor performance status (OR 0.57, 0.44-0.75), and residence in a census tract with >12% of residents living in poverty (OR 0.69, 0.50-0.96). Initial observation was more commonly associated with the same factors that were less commonly associated with R-CHOP use and was less commonly associated with stage III/IV disease (OR 0.66, 0.50-0.87). Kaplan-Meier survival curves revealed that in patients >80 years, R-CHOP was associated with the best OS and LRS. Multivariable Cox proportional hazards models revealed that R-CHOP for >4 cycles was associated with the best OS in patients >80 years of all stages (hazard ratio (HR) 0.48, 0.37-0.62). Among stage III/IV patients, R-CHOP for >4 cycles (HR 0.48, 0.31-0.72) and R-CVP for >4 cycles (HR 0.40, 0.21-0.76) demonstrated significantly longer OS. Conclusions:Although DLBCL patients >80 years were less likely to receive R-CHOP, this regimen conferred the best survival. The failure of very elderly DLBCL patients to receive R-CHOP may occur due to clinical factors such as poor performance status, but commonly varies across demographic factors such as area-level poverty, which may reflect bias in the under-utilization of R-CHOP in very elderly patients that is not based on clinical parameters. Further studies are needed to characterize the impact of DLBCL treatment on quality of life in very elderly patients, and algorithms should be developed to help guide therapy in this population. Disclosures No relevant conflicts of interest to declare.

scholarly journals EPICANCER—Cancer Patients Presenting to the Emergency Departments in France: A Prospective Nationwide Study

2020 ◽  
Vol 9 (5) ◽  
pp. 1505
Author(s):  
Olivier Peyrony ◽  
Jean-Paul Fontaine ◽  
Sébastien Beaune ◽  
Abdo Khoury ◽  
Jennifer Truchot ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Emergency Departments ◽  
Performance Status ◽  
Case Fatality ◽  
Poor Performance ◽  
Cross Sectional Study ◽  
Poor Performance Status ◽  
Cross Sectional ◽  
The Impact ◽  
Prevalence Of Cancer

Background: We aimed to estimate the prevalence of cancer patients who presented to Emergency Departments (EDs), report their chief complaint and identify the predictors of 30-day all-cause mortality. Patients and methods: we undertook a prospective, cross-sectional study during three consecutive days in 138 EDs and performed a logistic regression to identify the predictors of 30-day mortality in hospitalized patients. Results: A total of 1380 cancer patients were included. The prevalence of cancer patients among ED patients was 2.8%. The most frequent reasons patients sought ED care were fatigue (16.6%), dyspnea (16.3%), gastro-intestinal disorders (15.1%), trauma (13.0%), fever (12.5%) and neurological disorders (12.5%). Patients were admitted to the hospital in 64.9% of cases, of which 13.4% died at day 30. Variables independently associated with a higher mortality at day 30 were male gender (Odds Ratio (OR), 1.63; 95% CI, 1.04–2.56), fatigue (OR, 1.65; 95% CI, 1.01–2.67), poor performance status (OR, 3.00; 95% CI, 1.87–4.80), solid malignancy (OR, 3.05; 95% CI, 1.26–7.40), uncontrolled malignancy (OR, 2.27; 95% CI, 1.36–3.80), ED attendance for a neurological disorder (OR, 2.38; 95% CI, 1.36–4.19), high shock-index (OR, 1.80; 95% CI, 1.03–3.13) and oxygen therapy (OR, 2.68; 95% CI, 1.68–4.29). Conclusion: Cancer patients showed heterogeneity among their reasons for ED attendance and a high need for hospitalization and case fatality. Malignancy and general health status played a major role in the patient outcomes. This study suggests that the emergency care of cancer patients may be complex. Thus, studies to assess the impact of a dedicated oncology curriculum for ED physicians are warranted.

scholarly journals P14.35 The modern management of brain metastases

2019 ◽  
Vol 21 (Supplement_3) ◽  
pp. iii74-iii75
Author(s):  
N D Wallace ◽  
P J Kelly
Keyword(s):  
Decision Making ◽  
Brain Metastases ◽  
Performance Status ◽  
Treatment Options ◽  
Poor Performance ◽  
Best Supportive Care ◽  
Poor Performance Status ◽  
Trade Off ◽  
Cns Penetration ◽  
The Impact

Abstract BACKGROUND Technological and clinical advances have improved outcomes for patients with brain metastases. They have also added significantly to the complexity of decision-making in such cases. We set out to review the roles of different treatment options to guide management for patients with newly-diagnosed brain metastases. MATERIAL AND METHODS We undertook a comprehensive literature review to examine all treatment options for brain metastases. We particularly focused on recent advances and where these can be applied to clinical practice.We examined the impact of the improvement of SRS technology from older frame-based setups to modern linear accelerator based treatment with the capacity for fractionated stereotactic radiotherapy (SRT). We identified clinical situations where either SRS or WBRT, or a combination of the two, should be most strongly considered. Several novel targeted systemic therapies cross the blood-brain-barrier so we have explored their outcomes for patients with brain metastases from BRAF-mutated melanoma and EGFR or ALK/ROS1 mutated NSCLC. By examining these techniques in detail, we have formulated an algorithm-based approach which can inform management. RESULTS Surgery is most beneficial in patients with a reasonable prognosis and where other treatment options are unlikely to provide equivalent control. SRS to the surgical cavity can frequently be used alone for post-operative consolidation. SRS and fractionated SRT are valuable treatment options for increasingly large lesions and for increasing numbers of lesions. The choice between SRS and WBRT is, in many cases, a trade-off between the improved intracranial control of WBRT and the more favourable side effect profile of SRS. Upfront therapy with some systemic agents with CNS penetration is an acceptable approach in carefully-selected patients whose outcome is felt to be more related to their extracranial disease. Best supportive care is preferable for many patients with poor performance status and/or short prognosis, although more aggressive measures have a role in the case of symptomatic lesions. CONCLUSION A multidisciplinary approach involving Neurosurgeons, and both Radiation and Medical Oncologists is needed to fully evaluate the options for individual patients. As many of the treatment decisions are a trade-off between quality of life and outcome metrics, shared decision-making with patients is also critical to ensure that patients receive the best treatment for them.

scholarly journals Stunning Response with Low-Dose Enzalutamide after Abiraterone Acetate Failure in a Patient Diagnosed with Metastatic Castration-Resistant Prostate Cancer: A Case Report

2021 ◽  
pp. 634-640
Author(s):  
Luigi Rossi ◽  
Giuseppe Cimino ◽  
Elisa Gozzi ◽  
Marsela Sinjari ◽  
Martina Brandi ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Low Dose ◽  
Performance Status ◽  
Poor Performance ◽  
Abiraterone Acetate ◽  
Poor Performance Status ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Biochemical Progression ◽  
Lh Rh

We report a case of an elderly patient with metastatic castration-resistant prostate cancer, initially treated with abiraterone acetate (1,000 mg/day) combined with LH-RH antagonist, prednisone (10 mg/day), and zoledronic acid to manage bone metastases. In consideration of his poor performance status, radiological and biochemical progression of the disease, we decided to switch abiraterone to enzalutamide (160 mg/day). Due to adverse events, we reduced enzalutamide to a dose of 80 mg/day. Currently, the disease is under control despite the use of a low dose of enzalutamide.

Sign in / Sign up

Export Citation Format

Share Document