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 Role of Stereotactic Body Radiotherapy in the Treatment of Elderly and Poor Performance Status Patients With Pancreatic Cancer

2017 ◽  
Vol 13 (3) ◽  
pp. 157-166 ◽  
Author(s):  
Lauren M. Rosati ◽  
Joseph M. Herman
Keyword(s):  
Pancreatic Cancer ◽  
Stereotactic Body Radiotherapy ◽  
Group Performance ◽  
Performance Status ◽  
Single Agent ◽  
Locally Advanced ◽  
Poor Performance ◽  
Tumor Control ◽  
Poor Performance Status ◽  
Patient Reported

Literature on the management of nonmetastatic pancreatic ductal adenocarcinoma in patients who are elderly or have poor performance status is sparse. The median survival of this unique cohort of patients is < 6 months, and most patients are only offered single-agent gemcitabine or supportive care. Recently, adding nanoparticle albumin-bound paclitaxel to gemcitabine was shown to improve survival of patients with metastatic disease with Eastern Cooperative Group performance status of 2. Although standard chemoradiotherapy provides long-term locoregional control in locally advanced pancreatic cancer, it is difficult for this group of patients to tolerate 6 weeks of therapy. Stereotactic body radiotherapy (SBRT) can be delivered in only 3 to 5 days, does not require concurrent chemotherapy, and has limited toxicity, and tumor control rates appear to be equivalent to or better than those achieved with standard chemoradiotherapy. Additionally, SBRT has been shown to improve cancer-related pain and patient-reported quality of life. Given the favorable toxicity profile, SBRT seems like an obvious choice for patients who are elderly, have multiple comorbidities, or have poor performance status. Herein, we review the literature on SBRT in this unique patient population and discuss future directions.

What can we do for gastrointestinal cancer patients with poor performance status (PS)?

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 19629-19629
Author(s):  
K. Shitara ◽  
M. Munakata ◽  
O. Muto ◽  
M. Kasai ◽  
Y. Sakata
Keyword(s):  
Cancer Patients ◽  
Tumor Markers ◽  
Gastrointestinal Cancer ◽  
Survival Benefit ◽  
Performance Status ◽  
Poor Performance ◽  
Poor Performance Status ◽  
Ecog Ps ◽  
To Receive ◽  
Measurable Lesion

19629 Background: The prognosis of advanced gastrointestinal cancer patients, especially those with poor PS, is generally dismal. Needless to say, such patients are ineligible for participation in clinical studies. However, there are many patients with poor PS who wish to receive chemotherapy. Methods: From June 2000 to October 2006, a total of 508 patients with advanced cancer, including 304 gastrointestinal cancer patients, were treated by chemotherapy in our hospital. Of these, 110 gastrointestinal cancer patients (gastric=35, colorectal=30, pancreatic=26, biliary tract=11, esophageal=8) had poor PS (ECOG PS 3 = 68 patients, PS 4 = 42 patients). In 103 patients with at least one measurable lesion, a partial response according to RECIST criteria was obtained in 13 patients (12.6%). In 60 patients with ascites (47 patients), pleural effusion (25 patients), or both (12 patients), 11 of the patients (18.3%) achieved decreased fluid accumulation. A decline in tumor markers (>25%) was observed in 28 patients. Improvement in PS was seen in 13 patients (11.8%). As a result, 35 patients (31.8 %, including 9 patients with PS 4) achieved a tumor response, a decrease in accumulated fluid, or a decline in tumor markers, which resulted in a survival benefit compared to the other 75 patients without effect (6.4 months vs. 2.3 months, p<0.001). Alleviation of some symptoms was observed in 28 out of 98 symptomatic patients (30.4%). A better response and/or a decline in tumor markers significantly correlated with alleviation of symptoms (p<0.001). No treatment related death was seen. Conclusions: With regard to response rate, chemotherapy was rarely effective for patients with advanced gastrointestinal cancer with poor PS. However, more than a few patients gained a certain survival benefit and alleviation of symptoms. Thus, chemotherapy may be warranted in cases of patients with advanced gastrointestinal cancer who wish to receive chemotherapy despite the low possibility of response. No significant financial relationships to disclose.

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]

Should all patients (pts) with advanced biliary cancers receive first-line treatment with cisplatin and gemcitabine (GC)?

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 244-244
Author(s):  
Vanessa Costa Miranda ◽  
Luiza Dib-Faria ◽  
Maria Ignez Freitas Melro Braghiroli ◽  
Jorge Sabbaga ◽  
Daniel Fernandes Saragiotto ◽  
...  
Keyword(s):  
Median Survival ◽  
Cox Regression ◽  
Performance Status ◽  
Multivariable Analysis ◽  
Poor Performance ◽  
Median Number ◽  
Poor Performance Status ◽  
Poor Survival ◽  
First Line ◽  
Dismal Prognosis

244 Background: GC is considered the standard of care for pts with advanced biliary tract cancer (BTC), providing median survival of nearly one year. (Valle J et al. NEJM 2010) Nevertheless, many pts experience poor outcomes, leading to a growing interest to identify pts who might benefit from such treatment. Here we aimed to investigate clinical and laboratory factors associated with poor survival among BTC pts treated with GC. Methods: We retrospectively evaluated all consecutive pts with advanced/metastatic BTC who received first line GC at the Instituto do Cancer do Estado de Sao Paulo, Brazil, in a 2 year-period. Clinical and laboratory variables that could influence pts’ outcomes were gathered from medical charts. Cox regression proportional hazard model was used to investigate the following prognostic factors for death: pre-treatment biliary deobstruction, baseline Ca 19.9, any GC interruptions or dose reductions, baseline ECOG status, Charlson Comorbidity Index (CCI) and age. P values < 0.05 in multivariable analysis were considered significant. Results: From January/2009 to July/2011, 72 pts were identified. The median age was 60 years (range 30-80 years), 45 pts (62.5%) were female and 50 (69.4%) presented baseline ECOG 0-1. The median number of cycles of CG was 4 (range 1-9). Grade 3 /4 neutropenia and thrombocytopenia occurred in 16.6% and 12.5% of pts, respectively. Median survival of the whole cohort was 9.53 months (95% CI: 6.2 - 11.4). Median survival in pts with ECOG 0/1 was 13.5 months (95% CI: 9,5 – NR) and among pts with ECOG 2/3 3,5 months (95% CI: 1-7). In the Cox multivariable model, ECOG 2 /3 versus 0/1 (HR: 8.4, 95% CI: 3.4 to 20.7; p<0.001) and CCI score ≥ 2 (HR: 9.5 95% CI: 1.6 to 55.3; p= 0.012) significantly predicted for poor survival. There was a trend for improved survival among pts who had biliary drainage before starting GC (HR: 2.3 95% CI: 1.0 - 5.3; p= 0.051). Conclusions: In this retrospective cohort of unselected pts with advanced BTC treated with first line GC, poor performance status and multiple comorbid illnesses were associated with dismal prognosis. Treatment with GC should be carefully discussed before being offered to these pts.

Is there a role for chemotherapy in metastatic colorectal cancer patients with a poor performance status?

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 534-534
Author(s):  
Hui-li Wong ◽  
Kathryn M Field ◽  
Jeanne Tie ◽  
Suzanne Kosmider ◽  
Jeremy David Shapiro ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Metastatic Colorectal Cancer ◽  
Clinical Care ◽  
Performance Status ◽  
Poor Performance ◽  
Poor Performance Status ◽  
Routine Practice ◽  
Ecog Ps ◽  
To Receive

534 Background: The management of patients with poor performance status (PS) remains challenging in the absence of data on optimal treatment. Here we assessed the treatment and outcomes of patients with metastatic colorectal cancer (mCRC) with poor Eastern Cooperative Oncology Group (ECOG) PS (≥ 2) in routine clinical care. Methods: Analysis of patients prospectively entered onto the TRACC (Treatment of Recurrent and Advanced Colorectal Cancer) database, a clinician-designed initiative to collect comprehensive data on consecutive patients with mCRC from sites across Australia. Data collection commenced in July 2009 and is ongoing at 14 participating public and private centres. Results: Of the 679 patients entered, 129 (19.0%) had an ECOG PS ≥ 2. In total, 77 (11.3%) were PS 2, 41 (6.0%) PS 3 and 11 (1.6%) PS 4. Chemotherapy was administered to 55 (71.4%) PS 2 and 15 (36.6%) PS 3 patients, with none of the PS 4 patients being treated. Overall, poor PS patients were significantly less likely to receive any chemotherapy compared to their good PS (PS 0-1) counterparts (55.0% versus 86.8%, p<0.0001) and, when chemotherapy was given, significantly less likely to receive combination chemotherapy (38.0% vs 71.6%, p<0.0001) or bevacizumab (15.5% vs 46.9%, p<0.0001). Overall survival (OS) was reduced with declining PS, with medians of 31.2, 9.0, 3.0 and 0.8 months for PS 0-1, 2, 3 and 4 patients respectively (p<0.0001). Poor PS patients treated with chemotherapy had a better OS outcome (9.8 vs 4.1 months for untreated patients, p<0.0001). At one and two years, 22 (31.4%) and 8 (11.4%) treated poor PS patients were alive. Conclusions: In routine practice many patients with a poor PS, particularly those that are PS 2, receive active treatment. Although overall survival for poor PS patients is poor, some patients appear to benefit from treatment. Further data analysis, particularly to define subsets that may benefit most from treatment, is planned as further sites around Australia contribute data to the project.

Outcomes of patients (pts) with metastatic urothelial cancer (mUC) and poor performance status (PS) receiving anti-PD(L)1 agents.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 4525-4525
Author(s):  
Ali Raza Khaki ◽  
Leonidas Nikolaos Diamantopoulos ◽  
Ang Li ◽  
Michael Edward Devitt ◽  
Alexandra Drakaki ◽  
...  
Keyword(s):  
Checkpoint Inhibitors ◽  
Performance Status ◽  
Wholesale Price ◽  
Poor Performance ◽  
Wald Test ◽  
Median Number ◽  
Hospital Death ◽  
Poor Performance Status ◽  
Metastatic Urothelial Cancer ◽  
Ecog Ps

4525 Background: Anti-PD(L)1 immune checkpoint inhibitors (ICI) prolong overall survival (OS) after platinum chemotherapy in mUC. However, clinical outcomes in pts with poor PS at time of ICI initiation are unknown. We hypothesized that ICI initiation in pts with ECOG PS 2-3 would be associated with worse outcomes vs. pts with ECOG PS < 2, and impact death location. Methods: A retrospective cohort study in 8 institutions identified pts with mUC who received ICI. Demographic, clinicopathologic, treatment (tx) patterns, tx response, and outcomes were collected. Primary endpoint: overall response rate (ORR). Secondary endpoints: median (m) OS in pts receiving ICI as 1st and 2nd line (1L, 2L); odds of dying in hospital (vs elsewhere) for pts receiving ICI (vs no tx) within 30 days of death; and estimated drug cost for pts with ICI within 30 days of death based on average wholesale price. Unadjusted logistic regression was used to assess association between ORR and ECOG PS (2-3 vs < 2) and wald test was used to compare mOS between ECOG PS (2-3 vs < 2). Results: 194 consecutive pts (30% women, 41% never smokers, median age at diagnosis 69) treated with ICI for mUC were identified. Median number of total tx lines was 2; all pts received ≥1 ICI line (6 pts received 2 ICI lines); 97, 79, 17 and 7 pts received ICI in 1L, 2L, 3L and 4L, respectively; 26% pts with ICI in 1L and 2L had ECOG PS 2-3. ORR and mOS are shown in table. Among 106 pts who died, 96 had available death location; of those, 8% received ICI within 30 days of death. Starting ICI within 30 days of death (vs no tx) was associated with higher odds of hospital death (OR 6.05, 95%CI 1.3-27.6). Estimated average ICI cost/pt within 30 days of death was $1400.58. Conclusions: Pts with ECOG PS 2-3 at time of ICI initiation had similar ORR vs ECOG PS < 2 but worse mOS. ICI initiation within 30 days from death was associated with higher likelihood of hospital death. ICI may not circumvent the negative prognostic role of poor PS, so biomarker-based pt selection is critical. Limitations include lack of adjustment for selection bias and other confounders at time of ICI initiation; data validation is ongoing. [Table: see text]

Modified FOLFIRINOX as a second-line treatment in pancreatic adenocarcinoma patients with poor performance status.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e15796-e15796
Author(s):  
Adarsh Das ◽  
Andrew Peter Dean ◽  
Domenic Higgs
Keyword(s):  
Pancreatic Adenocarcinoma ◽  
Performance Status ◽  
Locally Advanced ◽  
Poor Performance ◽  
Poor Performance Status ◽  
Line Treatment ◽  
Second Line ◽  
Second Line Therapy ◽  
Line Therapy ◽  
Metastatic Pancreatic Adenocarcinoma

e15796 Background: FOLFIRINOX is well known to be a highly effective treatment in pancreatic cancer for young patients with good performance status. As the original ACCORD study was carried out with patient’s performance status 0 or 1, many oncologists feel uncertain administering modified dose FOLFIRINOX (m-FOLFIRINOX) as a second-line therapy. We have previously reported our experience in 35 patients (aged 27 – 85) where we concluded that m-FOLFIRINOX can be administered safely with appropriate dose reductions. More recently, the systematic review and meta-analysis by Tong et al. concluded that m-FOLFIRINOX is a good choice of therapy even for those with poor performance status. This retrospective analysis assessed the efficacy of m-FOLFIRINOX in second-line treatment of pancreatic adenocarcinoma. Methods: Using an electronic database, patients with either locally advanced or metastatic pancreatic adenocarcinoma were identified who had received first-line gemcitabine plus nab-paclitaxel, followed by second-line m-FOLFIRINOX between January 2013 and July 2018. All patients had an ECOG performance status of 2 or less. Overall survival (OS) was estimated by the Kaplan-Meier method. Results: Fifty-two patients were identified, with 65% of the patients having metastatic pancreatic disease. Median age of patients was 75 (range, 27 – 86). Dose intensity of m-FOLFIRINOX was 65% for oxaliplatin, 68% for irinotecan, 18% for bolus 5-fluorouracil (5-FU) and 68% for infusional 5-FU. From diagnosis, the median OS of all patients was 45.0 months (95% CI, 25.0 – 63.0). The median OS of the locally advanced and metastatic pancreatic adenocarcinoma was 63.0 months (95% CI, 45.0 – 70.0) and 22.5 months (95% CI, 18.0, 38.0), respectively. Conclusions: Our study demonstrates the safety and efficacy of m-FOLFIRINOX as a second-line therapy after gemcitabine plus nab-paclitaxel failure. These findings correlate with the findings of Tong et al.’s findings of the benefits of m-FOLFIRINOX for advanced pancreatic cancer in patients with poor performance status.

scholarly journals Analysis of a prospectively randomized comparison of doxorubicin versus 5-fluorouracil, doxorubicin, and BCNU in advanced gastric cancer: implications for future studies.

1986 ◽  
Vol 4 (9) ◽  
pp. 1348-1355 ◽  
Author(s):  
J A Levi ◽  
R M Fox ◽  
M H Tattersall ◽  
R L Woods ◽  
D Thomson ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Performance Status ◽  
Single Agent ◽  
Locally Advanced ◽  
Poor Performance ◽  
Poor Performance Status ◽  
Measurable Disease ◽  
Duration Of Response ◽  
And Performance

A multi-institutional cooperative study of patients with locally advanced, recurrent, or metastatic gastric adenocarcinoma who had not previously received chemotherapy was conducted, prospectively randomizing patients to receive either doxorubicin or the three-drug combination, 5-fluorouracil (5-FU), doxorubicin (Adriamycin; Adria Laboratories, Columbus, Ohio), and BCNU (FAB). The 187 evaluable patients were initially stratified according to the presence of measurable or evaluable disease and performance status. There was a significantly higher response rate observed for FAB (40%) compared with doxorubicin (13%) among the 145 measurable-disease patients. Duration of response and survival were significantly longer for FAB in the measurable-disease group, but for the total patient population an early advantage for FAB in time to disease progression and survival was lost with continued follow-up. Median survival was 33 weeks for patients receiving FAB and 19 weeks for those receiving doxorubicin. Significant pretreatment factors adversely affecting survival included poor performance status, weight loss of greater than 10%, and more than two sites of metastases. Toxicity was not severe in either treatment arm, and only thrombocytopenia occurred significantly more often with FAB. It is contended that in the treatment of advanced gastric cancer, chemotherapy only exerts a relatively short-term and modest beneficial effect, most apparent in patients with intermediate tumor bulk. 5-FU remains the most active single agent, and combination chemotherapy has not yet proven its overall worth. Further studies are indicated comparing the most active combinations with 5-FU using optimal doses and schedules, and consideration must be given to the incorporation of no-treatment controls.

Is there a role for chemotherapy in metastatic colorectal cancer patients with a poor performance status?

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e14583-e14583
Author(s):  
Hui-li Wong ◽  
Kathryn M Field ◽  
Jeanne Tie ◽  
Suzanne Kosmider ◽  
Jeremy David Shapiro ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Metastatic Colorectal Cancer ◽  
Clinical Care ◽  
Performance Status ◽  
Poor Performance ◽  
Poor Performance Status ◽  
Routine Practice ◽  
Ecog Ps ◽  
To Receive

e14583 Background: The management of patients with poor performance status (PS) remains challenging in the absence of data on optimal treatment. Here we assessed the treatment and outcomes of patients with metastatic colorectal cancer (mCRC) with poor Eastern Cooperative Oncology Group (ECOG) PS (≥ 2) in routine clinical care. Methods: Analysis of patients prospectively entered onto the TRACC (Treatment of Recurrent and Advanced Colorectal Cancer) database, a clinician-designed initiative to collect comprehensive data on consecutive patients with mCRC from sites across Australia. Data collection commenced in July 2009 and is ongoing at 14 participating public and private centers. Results: Of the 864 patients entered, 161 (18.6%) had an ECOG PS ≥ 2. In total, 95 (11.0%) were PS 2, 54 (6.3%) PS 3 and 12 (1.4%) PS 4. Chemotherapy was administered to 65 (68.4%) PS 2 and 17 (31.5%) PS 3 patients, with none of the PS 4 patients being treated. Overall, poor PS patients were significantly less likely to receive any chemotherapy compared to their good PS (PS 0-1) counterparts (51.6% versus 86.8%, p<0.0001) and, when chemotherapy was given, significantly less likely to receive combination chemotherapy (67.5% vs 81.1%, p=0.0057) or bevacizumab (31.3% vs 55.8%, p<0.0001). Overall survival (OS) was reduced with declining PS, with medians of 28.7, 8.9, 3.5 and 0.8 months for PS 0-1, 2, 3 and 4 patients respectively (p<0.0001). Poor PS patients treated with chemotherapy had a better OS outcome (9.0 vs 3.5 months for untreated patients, p<0.0001). At one and two years, 24 (28.9%) and 7 (8.4%) treated poor PS patients were alive. Conclusions: In routine practice many patients with a poor PS, particularly those that are PS 2, receive active treatment. Although overall survival for poor PS patients is poor, some patients appear to benefit from treatment. Further data analysis, particularly to define subsets that may benefit most from treatment, is planned as further sites around Australia contribute data to the project.

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.

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