Is metronomic cyclophosphamide (mCTX) a therapeutic option for metastatic castration-resistant prostate cancer (mCRPC) patients (pts) in the era of new agents (NAs)? A retrospective multicenter Italian study.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 326-326
Author(s):  
Orazio Caffo ◽  
Ugo De Giorgi ◽  
Francesco Ferraú ◽  
Maddalena Donini ◽  
Gaetano Facchini ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Clinical Outcomes ◽  
Therapeutic Option ◽  
Objective Response ◽  
Progression Free Survival ◽  
Abiraterone Acetate ◽  
Consecutive Series ◽  
Castration Resistant Prostate Cancer ◽  
Grade 3 ◽  
Clinical Records

326 Background: Several NAs, such as abiraterone acetate (AA), cabazitaxel (CABA), and enzalutamide (ENZ), are able to significantly prolong mCRPC pts survival after docetaxel (DOC) failure. Nevertheless, all pts eventually show progressive disease with NAs and several pts may require further treatment. mCTX was considered as a feasible and tolerable therapeutic option after DOC failure before the introduction of NAs in the clinical practice. The present retrospective study describes the clinical outcomes of mCTX, used in mCRPC pts after the failure of both DOC and at least one NA. Methods: We retrospectively reviewed the clinical records of all mCRPC pts treated in 8 Italian hospitals after the introduction of NAs in the clinical practice. We considered as eligible for the present analysis all pts who received mCTX after DOC and at least one NA. All pts were treated with CTX 50 mg po daily until disease progression. Results: From December 2011 to June 2015, a consecutive series of 48 mCRPC pts, median age 72 yrs (56-90), with bone (94%), nodal (67%) or visceral (25%) mets, was treated with mCTX. All pts have previously received a DOC-based chemotherapy followed by only one NA in 21 cases, two NAs in 20, and all three NAs in 7. The median duration of the treatment was 10.4 wks (range 3.6-61.1). Recorded grade 3-4 toxicities were: anemia (5 pts), leucopenia (1), thrombocytopenia (2), fatigue (2), and anorexia (1). Seven pts (14%) achieved a PSA reduction ≥ 50% and 2 (4%) an objective response. The median progression free survival (PFS) was 3.5 mos with 7 pts (14%) showing a PFS ≥ 9 mos. The median overall survival was 6.9 mos. Conclusions: In our experience, mCTX was a feasible and well tolerated therapeutic option in heavily pre-treated pts with very advanced mCRPC. Despite its activity was limited, the clinical outcomes of this cheap treatment are similar to those observed with NAs administered in third/fourth line with a quote of pts experiencing a prolonged disease control. Prospective studies are needed to define the therapeutic role of mCTX after NAs in mCRPC pts.

Activity of new agents (NAs) as third-line treatment in metastatic castration-resistant prostate cancer (mCRPC) patients (pts) showing a primary resistance (PRes) to NAs-based second line therapy after docetaxel (DOC): Preliminary results from a multicenter Italian study.

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 216-216
Author(s):  
Orazio Caffo ◽  
Ugo De Giorgi ◽  
Gaetano Facchini ◽  
Lucia Fratino ◽  
Donatello Gasparro ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Objective Response ◽  
Progression Free Survival ◽  
Consecutive Series ◽  
Line Treatment ◽  
Second Line ◽  
Castration Resistant Prostate Cancer ◽  
Primary Resistance ◽  
Third Line ◽  
Third Line Treatment

216 Background: The androgen receptor machinery remains the ultimate target of NAs in mCRPC post-DOC, abiraterone acetate (AA), cabazitaxel (CAB), and enzalutamide (ENZ). It is postulated that some mechanisms of resistance may be common to all NAs. This may be crucial in planning their sequential use, mainly when a PRes to one of them is observed. The present study assessed the activity of NAs in pts who previously experienced a PRes to another NA administered after DOC. Methods: We collected data of pts who received sequentially two NAs after DOC in 32 Italian hospital. For each pt we recorded the clinical outcomes of all treatments received after DOC. For the study purpose, we consider with PRes all pts progressing within 3 months after second line NA start. All other pts were considered as without PRes. Results: A consecutive series of 271 mCRPC pts, median age 71 yrs (46-91), with bone (89%), nodal (56%) or visceral (19%) mets, was collected. All pts received NAs as second line after DOC (AA 54% – CAB 34%– ENZ 12%) and 54 (20%) showed a PRes. Among these, third line treatment [AA (31%), CAB (42%), and ENZ (27%)], produced a biochemical and an objective response rate of 11% in both cases, with a median progression free survival (PFS) and a median overall survival (OS) of 4 mos and 8 mos, respectively. No statistically significant differences were observed in terms of clinical outcomes on the basis of NA sequences (see Table). Conclusions: It appears from this preliminary data, that the activity of NAs in pts showing a PRes to second line NAs is very limited, regardless the NA is administered. [Table: see text]

Clinicians’ attitudes and preferences in choosing the first line drug for metastatic castration resistant prostate cancer (mCRPC): Preliminary results from a multicenter Italian study after the introduction of abiraterone acetate (AA) in the clinical practice.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 332-332
Author(s):  
Orazio Caffo ◽  
Cinzia Ortega ◽  
Teodoro Sava ◽  
Cosimo Sacco ◽  
Sandro Barni ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Therapeutic Option ◽  
Performance Status ◽  
Clinical History ◽  
Consecutive Series ◽  
Castration Resistant Prostate Cancer ◽  
First Line ◽  
Line Setting ◽  
Clinical Records ◽  
Line Drug

332 Background: For one decade, docetaxel (DOC) represented the only therapeutic option for mCRPC pts. Recently, AA and enzalutamide demonstrated a survival gain in first line setting. Lacking direct comparison with DOC and considering some differences in selection criteria of the pivotal trials, the choice between DOC and these hormonal agents, which have a quite different toxicity profile, is often driven by pts’ characteristics and feelings and by clinicians’ attitudes and preferences as well. To date, only AA is available in Italy, from September 2014, for the first line setting and the present study explores the attitudes and preferences of clinicians in choosing between DOC and AA. Methods: We retrospectively reviewed the clinical records of all mCRPC pts who received a first-line treatment in 5 Italian hospitals after the introduction of AA in the clinical practice. All pts were treated with AA 1,000 mg po + prednisone (PDN) 10 mg po daily or with DOC at the dose of 75 mg/sqm i.v. every three wks. For each pt we have recorded the pre-first line clinical history and the baseline characteristics. Results: From September 2014 to August 2015, we collected a consecutive series of 70 mCRPC pts: 49 received AA, 21 DOC. The median age was 74 yrs (range 46-90), 6% had visceral mets; 8% had a performance status 2; 47% had pain. Pts treated with AA were significantly older (75.8 vs 69.7 yrs; p = 0.002); received more previous hormone therapies (2.19 vs 1.76; p = 0.03), had a longer interval between first hormone therapy and the start of mCRPC first line (47.6 vs 21.2 mos; p = 0.01) and finally, were less frequently symptomatic (27% vs 67%; p = 0.02%). Conclusions: The present study is the first to explore the clinicians’ attitudes and preferences, in the routine clinical practice, in choosing the first line drug for mCRPC pts. From our preliminary data, it appears that some pts characteristics are important in driving the choice of the clinicians between AA and DOC. Data collection is ongoing in other Italian hospitals.

Safety and clinical outcome of a cohort of patients (pts) with castration resistant prostate cancer (CRPC) treated with abiraterone acetate (AA) in a named patient program (NPP): Updated results of a retrospective study from an Italian cooperative group.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 253-253 ◽  
Author(s):  
Orazio Caffo ◽  
Lucia Fratino ◽  
Giovanni Lo Re ◽  
Umberto Basso ◽  
Alessandro D'Angelo ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Retrospective Study ◽  
Clinical Outcome ◽  
Specific Antigen ◽  
Progression Free Survival ◽  
Abiraterone Acetate ◽  
Consecutive Series ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Clinical Records

253 Background: Abiraterone acetate (AA) provided a survival advantage compared to placebo in patients (pts) with castration resistant prostate cancer (CRPC) who had received docetaxel (de Bono JS et al, NEJM 2011). The present retrospective study is aimed to assess safety and clinical outcome in an unselected CRPC population which received AA in a named patient program (NPP). Methods: We retrospectively reviewed the clinical records of all pts treated with AA for CRPC by NPP in our institutions. All pts have been previously treated with a docetaxel-based first-line chemotherapy and received the standard AA dose of 1,000 mg daily plus prednisone 10 mg daily. For each pt we recorded the pre- and post-AA clinical history, the AA treatment details toxicities and clinical outcomes. Results: To date we have collected a consecutive series of 245 pts from 18 Italian hospitals. The median age was 73 (range 45 to 91). The median baseline prostate-specific antigen (PSA) level was 100 ng/ml (range 0.33->100.000); 79% of the pts had bone metastases, while nodal, lung and liver metastases were observed in 52%, 9%, and 7% of the pts, respectively. The median duration of AA treatment was 5 months (range, 1 to 26). Grade 3 to 4 toxicities were anemia (11 pts), fatigue (nine pts), bone pain (four pts), constipation (two pts), thrombocytopenia (two pts), nausea (one pt), diarrhea (one pt), dyspnea (one pt), edema (one pt), hypertension (one pt), hyperbilirubinemia (one pt), and hypokaliemia (one pt). A PSA reduction of more than 50% was observed in 50.9% of the pts. The median progression-free survival (PFS) and overall survival (OS) were 6 months and 15 months, respectively; the 1 year PFS and OS rates were 24.3% and 56.9%, respectively. Conclusions: Our results have confirmed the safety and efficacy of AA in an unselected population of pts with pre-treated CRPC outside clinical trials and provided further support concerning the good safety profile of the drug.

Activity of new agents (NAs) as third-line treatment in metastatic castration-resistant prostate cancer (mCRPC) patients (pts) after a long-term disease control (LTDC) with abiraterone acetate (AA) or enzalutamide (ENZ) post docetaxel (DOC): Preliminary results from a multicenter Italian study.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 325-325
Author(s):  
Antonello Veccia ◽  
Ugo De Giorgi ◽  
Gaetano Facchini ◽  
Lucia Fratino ◽  
Donatello Gasparro ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Progression Free Survival ◽  
Abiraterone Acetate ◽  
Consecutive Series ◽  
Line Treatment ◽  
Second Line ◽  
Castration Resistant Prostate Cancer ◽  
Progression Of Disease ◽  
Third Line ◽  
Third Line Treatment

325 Background: Although the expected median progression free survival (mPFS) with AA and ENZ in DOC-pretreated pts is 6-8 mos, a quote of pts may experience a LTDC without progression of disease (PD) for more than 12 mos. Since the androgen receptor machinery remains the ultimate target of NAs in mCRPC post-DOC, some mechanisms of resistance could be common to all NAs. This may be crucial in planning their sequential use, mainly when a LTDC is observed in hormone NAs-based (HNAs) second line. The present study was aimed to assess the activity of NAs in pts who previously showed a LTDC with HNAs administered after DOC. Methods: We collected data of pts who received sequentially two NAs after DOC in 38 Italian hospitals. For each pt we recorded the clinical outcome of all treatments received after DOC. For the study purpose, LTDC was defined as the absence of PD ≥ 12 mos in pts treated with second-line AA or ENZ. Results: A consecutive series of 291 mCRPC pts, median age 71 yrs (46-91), with bone (88%), nodal (53%) or visceral (18%) mets, was collected. All pts received NAs as second line after DOC: in particular 160 (55%) received AA and 32 (11%) ENZ, with 41 pts (21%) showing a LTDC (36 AA – 5 ENZ). Among LTDC pts, third line treatment was cabazitaxel (CABA) in 25 cases and one hormonal NA in the remaining (2 AA - 14 ENZ). The clinical outcomes of the third line therapy are detailed in the table. Conclusions: From this preliminary data, it appears that third line CABA could be slightly more active in pts achieving a LTDC with HNAs in second line LTDC, despite the clinical outcomes were not significantly different compared to HNAs. Analyses on larger patients populations are needed to confirm these findings. [Table: see text]

Outcomes of metastatic castration-resistant prostate cancer (mCRPC) patients (pts) treated with different new agents (NAs) sequence in post-docetaxel (DOC) setting: Final analysis from a multicenter Italian study.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 5030-5030 ◽  
Author(s):  
Orazio Caffo ◽  
Emilio Bria ◽  
Ugo De Giorgi ◽  
Marcello Tucci ◽  
Luca Galli ◽  
...  
Keyword(s):  
Objective Response ◽  
Progression Free Survival ◽  
Final Analysis ◽  
Abiraterone Acetate ◽  
Consecutive Series ◽  
Castration Resistant Prostate Cancer ◽  
Free Survival ◽  
Castration Resistant ◽  
Significant Difference

5030 Background: Abiraterone acetate (AA), cabazitaxel (CABA), and enzalutamide (ENZ) may prolong survival in mCRPC pts progressing after DOC, although it is not clear how to use NAs to best exploit their efficacy and avoiding their possible cross resistances. In 2015, we reported the outcomes of a series of 260 mCRPC pts, receiving at least 2 NAs, after DOC progression in routine clinical practice (Eur Urol. 2015;68:147-53). In the present study we updated the analysis with longer follow-up and by assessing a larger series of pts. Methods: Based on a multi-institutional collaboration, we collected data of pts who received at least 2 NAs after DOC: we assessed biochemical (bRR) and objective response rates (oRR) and progression free survival (PFS) of each NA by treatment line; moreover, we evaluated the overall survival (OS) from the second line start by sequence strategy. For the OS analysis we differentiated three different types of NAs sequences after DOC: one new hormone agent (AA or ENZ) followed by CABA (NHA→CABA); CABA followed by AA or ENZ (CABA →NHA); one NHA followed by the other NHA (NHA →NHA). Results: A consecutive series of 476 mCRPC pts with bone (86%), nodal (56%) or visceral (15%) mets, was collected. All received NAs as 2nd and 3rdline after DOC. The outcomes by both treatment lines and NAs are detailed in the table. We observed a statistically significant difference in terms of OS when compared the three sequence strategies: the median OS of pts treated with NHA→CABA, CABA→NHA, and NHA→NHA was respectively 12.9 mos, 14.2 mos, and 8.8 mos, respectively (p = 0.01). Conclusions: At our knowledge this retrospective study reports the highest number of pts treated post-DOC with at least 2 NAs. Our data confirmed that the activity of NAs decreased in the 3rd line compared to the 2nd line and suggested a cumulative OS advantage when CABA is used in the sequence. [Table: see text]

A hypothesis-generating exploratory analysis of efficacy and safety of abiraterone acetate (AA) in African American (Af Am) patients (pts) with metastatic castration-resistant prostate cancer (mCRPC).

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 55-55
Author(s):  
Eleni Efstathiou ◽  
Vasily J. Assikis ◽  
Scott A. North ◽  
John Showel ◽  
Thomas E. Hutson ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Safety Profile ◽  
Progression Free Survival ◽  
Abiraterone Acetate ◽  
Double Blind Study ◽  
Efficacy And Safety ◽  
Castration Resistant Prostate Cancer ◽  
Double Blind ◽  
Psa Response ◽  
Grade 3

55 Background: The reported increased prostate cancer lethality in Af Ams has been attributed by some to altered androgen receptor (AR) signaling. We compared toxicity, PSA response, time-to-PSA progression (TTPP), and radiographic progression-free survival (rPFS) in Af Am vs non Af Am pts with CRPC treated with AA + prednisone (P) vs placebo + P. We hypothesized that differences in response to AA may be observed if differences in AR signaling exist in Af Ams. Methods: COU-AA-301 is a randomized double blind study of AA (1000 mg + P 5 mg po BID) vs placebo + P post-docetaxel. Results: TTPP, rPFS, and PSA response rate were higher with AA vs placebo. In Af Am pts, treatment emergent AEs (TEAEs) for AA vs placebo occurred in 96.4% vs 100.0% of pts (50.0% and 66.7%, respectively, grade 3/4); serious TEAEs occurred in 42.9% and 33.3% of pts (28.6% and 26.7%, respectively, grade 3/4). The safety profile of AA appears comparable between the Af Am and overall study populations. Conclusions: Although the small number of Af Am pts in this study precludes formal conclusions regarding efficacy and safety of AA in this pt population, the overall trend suggests these pts experienced clinical benefit from AA with a safety profile comparable to the overall study population. These findings do not appear to support the hypothesis that AR signaling accounts for the increased lethality of prostate cancer seen in Af Ams. Further studies of AA in Af Am pts are planned to understand the potential benefit in this population. Additional efforts are needed to increase participation of Af Am pts in clinical trials. [Table: see text]

Clinical outcomes of patients (pts) age 80 or older treated with docetaxel (DOC) as first-line chemotherapy for castration-resistant prostate cancer (CRPC): Results of an Italian multicenter retrospective study (DELPHI study).

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 92-92 ◽  
Author(s):  
Antonello Veccia ◽  
Salvatore Luca Burgio ◽  
Giuseppe di Lorenzo ◽  
Cinzia Ortega ◽  
Florinda Scognamiglio ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Retrospective Study ◽  
Clinical Outcomes ◽  
Daily Living ◽  
Consecutive Series ◽  
Weekly Schedule ◽  
Castration Resistant Prostate Cancer ◽  
First Line ◽  
Castration Resistant ◽  
Clinical Records

92 Background: Docetaxel (DOC) represents the treatment of choice in the first line treatment for patients (pts) with castration-resistant prostate cancer (CRPC). However, when CRPC is diagnosed in pts age 80 or older, the fear of high toxicity degree usually limits chemotherapy use due to both pts frailty and several comorbidities occurrence. The present retrospective study is aimed to assess the clinical outcomes in this very elderly CRPC population. Methods: In this multicentric retrospective study, after Ethical Committee approval, we have reviewed the clinical records of all pts age 80 and older CRPC pts from participating institutions, treated with DOC in clinical practice, recording the pre- and post-DOC clinical history, the DOC treatment details and outcomes. Results: To date we collected a consecutive series of 115 pts from 28 Italian hospitals. The median age was 82 (range 80 to 90). The median baseline prostate-specific antigen (PSA) was 92 ng/ml (range 3 to 2,981); 83% of the pts had bone metastases, while nodal, lung and liver metastases were observed in 39%, 9%, and 8% of the pts, respectively. Median Cumulative Illness Rating Scale score was 3 (range 0 to 11), median Activity Daily Living index score was 0 (range 0 to 5), median Instrumental Activities of Daily Living score was 0 (range 0 to 5). The DOC was administered on 3 week or weekly schedule basis (43%/57%). A PSA reduction greater than 50% was observed in 55% of the pts; an objective response was observed in 15% of the 60 pts who underwent a radiological re-evaluation at the treatment end. Grade 3-4 toxicities were: anemia (2%), neutropenia (10%) , thrombocytopenia (2%), fatigue (10%), diarrhea (4%), nausea (2%), renal (2%), and febrile neutropenia (2%). The median progression-free survival (PFS) and overall survival (OS )were 7 months and 20 months, while the 1 year PFS and OS rates were 21.2% and 71.5%, respectively. Conclusions: This data suggests that selected very older (age 80 and older) CRPC pts may received DOC with a good toxicity profile. In this pts population the treatment, both on 3 week or weekly schedule, is able to produce survival outcomes comparable to pivotal trials (18 months).

Sequential administration of new agents (NAs) after docetaxel (DOC) in metastatic castration-resistant prostate cancer (mCRPC) patients (pts): Impact of disease control (DC) duration in second line on the subsequent line outcomes.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 210-210
Author(s):  
Francesca Maines ◽  
Ugo De Giorgi ◽  
Gaetano Facchini ◽  
Lucia Fratino ◽  
Donatello Gasparro ◽  
...  
Keyword(s):  
Disease Control ◽  
Clinical Outcomes ◽  
Abiraterone Acetate ◽  
Consecutive Series ◽  
Second Line ◽  
Castration Resistant Prostate Cancer ◽  
Primary Resistance ◽  
Sequential Administration ◽  
Progression Of Disease ◽  
Third Line

210 Background: Abiraterone acetate (AA), cabazitaxel (CABA), and enzalutamide (ENZ) are NAs which demonstrated their efficacy in mCRPC pts who have previously treated with DOC. Unfortunately all pts develop a resistance to these drugs and eventually show a progression of disease. Since the androgen receptor machinery remains the ultimate target of NAs in mCRPC post-DOC, some mechanisms of resistance could be common to all NAs. To date, NAs are sequentially administered in the hope of obtaining a cumulative survival benefit. To date it is unknown if the DC duration influence the outcomes of the subsequent treatments. The present study was aimed to retrospectively assess this issue in a large series of mCRPC pts. Methods: We recorded the clinical outcomes of all treatments received after DOC. For the study purpose, we categorized the pts according to the duration of DC (absence of progression) during NA-based second line: DC ≤ 3 mos (primary resistance – PRe); DC from 3.1 to 11.9 mos (intermediate sensitivity – IS); DC ≥ 12 mos (long term disease control – LTDC). Results: A consecutive series of 291 mCRPC pts, median age 71 yrs (46-91), with bone (88%), nodal (53%) or visceral (18%) mets, was collected. All pts received a NA-based as second line after DOC: 160 (55%) received AA, 99 (33%) CABA and 32 (11%) ENZ. PRe was observed in 56 pts (23 AA – 25 CABA – 8 ENZ), IS in 178 (101 AA – 58 CABA – 19 ENZ), LTDC in 57 (36 AA – 16 CABA – 5 ENZ). The third-line clinical outcomes are detailed in the table. Conclusions: From this data, it appears that DC duration may be a prognostic factor, as a probable result of pts/disease selection. In fact, pts progressing more than 12 mos from the start of NA-based second line appear to have more probabilities to live longer, compared to pts progressing earlier, when they receive another NA-based third line therapy. [Table: see text]

A clinical study to evaluate the efficacy and safety of docetaxel with ribavirin in patients with progressive castration resistant prostate cancer who have previously received docetaxel alone.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e14010-e14010 ◽  
Author(s):  
Takeo Kosaka ◽  
Takahiro Maeda ◽  
Toshiaki Shinojima ◽  
Hirohiko Nagata ◽  
Ryuichi Mizuno ◽  
...  
Keyword(s):  
Clinical Study ◽  
Adverse Events ◽  
Disease Progression ◽  
Response Rate ◽  
Objective Response ◽  
Progression Free Survival ◽  
Hepatic Function ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Grade 3

e14010 Background: We have previously reported a novel cell reprogramming approach, named drug efficacy reprogramming, as a new model for identifying candidate antitumor drugs targeting cancer stemness related gene network and identified ribavirin as a candidate drug for overcoming docertaxel resistant castration resistant prostate cancer.This non-randamized and open-labelled pilot clinical study explored the safety and efficacy of ribavirin, anti-virus drug, in combination with docetaxel in patients with progressive CRPC. Methods: In this clinical study, patients received intravenous docetaxel 60-70 mg/mm2 on day 1 of 3-6 weeks cycles plus Ribavirin 600 mg twice daily. The primary endopoint was safety, PSA response and objective response rate. Secondary end ponts included health-related quality of life overall survival.Patients with progressive CRPC based on PSA and/or radiographic criteria, PS 0-1, normal renal and hepatic function were eligible. Results:Five patients were enrolled in this study. Medium age was 73. Median serum PSA concentration was 53.1 ng/ml (range: 5.1-370.5).The median cycle and total dose of docetaxel received before the study was 31 cycles and 3625 mg, respectively. 80% of patients who had disease progression during docetaxel treatment. The median time from last docetaxel dose to disease progression before the participation was 1.5 months.Safety: Medium number of treatment cycles were 7 (range: 3-8) cycles. Grade 3/4 adverse events requiring dose modification were not observed. Grade 3 anemia and neutropenia were seen in two patients. Common adverse events were less than Grade 2. Efiicacy: 3 (60%) had some degree of PSA decline and 2 (40%) had a decline of ≧30 %. Median follow-up was 10.0 month. Median progression free survival was 6 month. Conclusions: This combination was well tolerated with promising response rate, justifying further investigation in docetaxel resistant CRPC. Clinical trial information: UMIN000012521.

Treatment and clinical outcomes of very elderly (≥ 80 yrs) metastatic castration-resistant prostate cancer (mCRPC) patients (pts): A single-institution retrospective analysis.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 327-327
Author(s):  
Orazio Caffo ◽  
Stefania Kinspergher ◽  
Francesca Maines ◽  
Sveva Macrini ◽  
Antonello Veccia
Keyword(s):  
Clinical Practice ◽  
Clinical Outcomes ◽  
Elderly Population ◽  
The Elderly ◽  
Daily Clinical Practice ◽  
Survival Outcomes ◽  
Consecutive Series ◽  
Castration Resistant Prostate Cancer ◽  
Very Elderly ◽  
Radium 223

327 Background: The development of mCRPC is generally observed in senior adults and in the daily clinical practice it is frequent to treat pts ≥ 80 yrs. In this population comorbidities can influence the treatment choices and, consequently, the clinical outcomes. The aim of this retrospective study was to describe management and clinical outcomes in mCRPC pts ≥ 80 yrs treated in the daily clinical practice. Methods: We retrospectively evaluated all mCRPC pts treated in our Institution from 02/2002 to 06/2015 and recorded their medical history, anticancer treatments and survival outcomes. Results: We evaluated a consecutive series of 45 pts aged ≥ 80 yrs: median age was 83 yrs (range 81-90 yrs). At the time of mCRPC development bone, nodal, and lung mets were present in 84%, 60%, and 9% of the cases, respectively; no pts with liver mets were observed. Pain was present 53.3% of the pts, the ECOG PS 2 rate was 17.1%. These baseline characteristics were not statistically different compared to those of the younger counterpart. Most of the elderly pts received docetaxel (78%), although this rate was significantly higher (96%) in the younger population (p < 0.0001); similarly elderly pts received less frequently cabazitaxel (CAB) (2% vs 16%, p = 0.01). On the contrary elderly population received more frequently only new generation hormonal agents [abiraterone (AA) or enzalutamide ENZ)] without any chemotherapy (22% vs 4%, p < 0.0001). The median cumulative overall survival (OS) from the start of the first treatment line for mCRPC was 20.5 mos (compared to 21.1 of younger pts). In the elderly population a significant different median OS was observed by comparing pts who received the new agents [NAs (AA, CAB, ENZ, Radium 223)] e those who did not (22.9 vs 13.0 mos, p = 0.001). Conclusions: Although the limitation due to its retrospective nature, our analysis showed that mCRPC pts ≥ 80 yrs were managed differently than younger ones. Nevertheless, the survival outcomes did not differ from the younger counterpart and also very elderly pts benefitted from the introduction of NAs in the daily clinical practice.

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