P105 Treatment options in patients with metastatic castrate-resistant prostate cancer (mCRPC) previously treated with a docetaxel-containing regimen: A single UK cancer centre's experience using patients within the early access programme and cancer drugs fund

2013 ◽  
Vol 12 (6) ◽  
pp. 171
Author(s):  
C.J. Hague ◽  
C.L.S. Kelly ◽  
S.A. Cornthwaite ◽  
A.J. Birtle
Keyword(s):  
Prostate Cancer ◽  
Treatment Options ◽  
Cancer Drugs ◽  
Early Access ◽  
Access Programme ◽  
Castrate Resistant Prostate Cancer ◽  
Previously Treated ◽  
Castrate Resistant

Cabazitaxel in patients with metastatic castrate-resistant prostate cancer previously treated with a docetaxel-containing regimen: A single U.K. cancer center's experience using Early Access Programme and Cancer Drugs Fund.

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 224-224
Author(s):  
Claire L. S. Kelly ◽  
Christina J. Hague ◽  
Stephanie A. Cornthwaite ◽  
Alison J. Birtle
Keyword(s):  
Median Number ◽  
Electronic Prescribing ◽  
Cancer Drugs ◽  
Disease Response ◽  
Early Access ◽  
Chemotherapy Administration ◽  
Access Programme ◽  
Castrate Resistant Prostate Cancer ◽  
Castrate Resistant ◽  
Number Of Cycles

224 Background: The TROPIC Trial demonstrated improved overall survival in patients with mCRPC who progressed during or after treatment with docetaxel. The trial established cabazitaxel as a tolerable and viable second line treatment option in these patients. We report our experience with cabazitaxel in patients receiving treatment within the Early Access Programme (EAP) and via the Cancer Drugs Fund (CDF). Methods: Retrospective review of patients receiving cabazitaxel chemotherapy from 1st January 2011 to 1st January 2012. Chemotherapy administration was corroborated via the electronic prescribing system. Patient records provided documentation regarding disease response and treatment toxicities. For patients within the EAP, data was confirmed and supplemented via the Trials Office. Results: 22 patients were identified, of which 20 received cabazitaxel. 12 were treated within the EAP and 8 via the CDF. Median age was 68.5 years (59-83) within the EAP group and 70 years (52-78) within the CDF group, whilst median number of cycles was 6 (1-10) and 5.5 (1-8) respectively. 83.3% of EAP patients received full dose throughout, compared with 62.5% of the CDF patients. Primary GCSF was used in 91.6% of EAP patients and 75% of CDF patients, with secondary GCSF in 8.3% and 12.5% respectively. 3/20 patients had treatment discontinued due to progressive disease (after a minimum of 3 cycles). 13/20 patients had a positive biochemical and/or clinical response. 15/20 patients (Gleason score ≥ 8, 7 of 15) remain alive with a mean survival of 12.1 months (3.4-19.4). There were no treatment related deaths. Treatment related adverse events are shown in the Table. Conclusions: Our results are comparable with the TROPIC data, suggesting cabazitaxel offers demonstrable response rates and meaningful survival with an acceptable toxicity profile. [Table: see text]

Enzalutamide in men with prostate cancer resistant to docetaxel and abiraterone.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 247-247 ◽  
Author(s):  
Mark Creamer Scholz ◽  
Richard Y. Lam ◽  
Jeffrey S. Turner ◽  
Khang N. Chau ◽  
Lauren K. Becker ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Stable Disease ◽  
Retrospective Chart Review ◽  
Early Access ◽  
Fda Approval ◽  
Heavily Pretreated ◽  
Psa Response ◽  
Castrate Resistant Prostate Cancer ◽  
Psa Progression ◽  
Castrate Resistant

247 Background: Since FDA approval in 2011, abiraterone (Zytiga) has supplanted docetaxel as preferred first-line treatment for metastatic castrate-resistant prostate cancer. In August 2012 enzalutamide (Xtandi) was FDA-approved for the treatment of castrate-resistant prostate cancer after docetaxel (Taxotere). We performed a retrospective chart review at a large medical oncology clinic specializing in prostate cancer to determine the PSA response rates of enzalutamide administered to men who had previously progressed on both abiraterone and docetaxel. This report includes some patients who participated in the Astellas/Medivation-sponsored Early Access Program; however, it represents the author’s independent clinical experience. Methods: Enzalutamide was administered at a dose of 160 mg daily. Patients were subsequently followed with monthly physical examination, PSA and routine blood tests. No hepatotoxicity or seizures occurred. Men were considered evaluable for PSA response if they received enzalutamide for twelve weeks. A PSA decline of 30% from baseline after 12 weeks was defined as a response. A PSA increase of 30% from baseline within 12 weeks was defined as disease progression. Men with neither a 30% increase nor a 30% decline were classified as having stable disease. Results: 66 men were treated and 63 were evaluable for PSA response. Median age was 67. Median baseline PSA was 68.5. All participants had disease that had progressed on abiraterone. 55 men received previous docetaxel. 38 had received previous Provenge. Two men stopped before 12 weeks because of intolerable fatigue. One man died of progressive disease before 12 weeks. After a median follow up of 12.5 weeks, 18(29%) men met criteria for PSA response. 13(21%) men had stable disease and 32(51%) men had PSA progression. Conclusions: Enzalutamide has activity in a heavily pretreated population of men resistant to abiraterone and docetaxel.

Application of a novel method weighing drug costs against survival in castrate-resistant prostate cancer cancer.

2013 ◽  
Vol 31 (31_suppl) ◽  
pp. 271-271
Author(s):  
Helmy M. Guirgis
Keyword(s):  
Prostate Cancer ◽  
Drug Costs ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Castrate Resistant Prostate Cancer ◽  
Previously Treated ◽  
Novel Method ◽  
Different Populations ◽  
Initial Survey ◽  
Castrate Resistant

271 Background: In the last few years, 5 new anticancer drugs have been introduced for the treatment of castration-resistant prostate cancer (CRPC). The objective was to apply a simplified methodology of weighing drug costs against overall survival (OS) in CRPC. Methods: Estimated cost in United Sates (US) dollars of an entire treatment course of an evaluated drug was divided by previously reported median OS gain over control. An initial survey of 45 drugs demonstrated that the maximal cost/OS/day gain was $757. Accordingly, a scale of crude scores was constructed with a 0% assigned to a cost/OS gain greater than $1,000 and 100% to a cost/OS gain of $1. Value scores were calculated after adjusting for quality of life (QoL), adverse events (AEs), and specialized administration and preparation (AP). Results: The lowest cost/OS gain and highest value score were demonstrated by generic docetaxel. Enzalutamide in previously-treated and abiraterone in chemo-naïve and treated patients x 6 months showed cost/OS gain lower than that of docetaxel but significantly higher than cabazitaxel. Pricing of sipuleucel-T based on cost of the entire course partly accounted for its highest cost/OS and lowest scores. Extending abiraterone and enzalutamide treatment to 12 months increased cost/OS gain and decreased scores. Conclusions: Methodology was proposed to weigh drug cost against OS/day gain with and without adjustment for QoL, AEs, and AP. Results in CRPC tend to support use of docetaxel, abiraterone, and enzalutamide rather than cabazitaxel and sipuleucel-T. Varying drug indications and different populations within the CRPC spectrum preclude direct drug comparison.

Cabozantinib (C) plus docetaxel (D) and prednisone (P) in metastatic castrate-resistant prostate cancer (mCRPC).

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 235-235 ◽  
Author(s):  
Fatima Karzai ◽  
Ravi Amrit Madan ◽  
Marc Robert Theoret ◽  
Philip M. Arlen ◽  
Nancy Ann Dawson ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Acquired Resistance ◽  
Maximum Tolerated Dose ◽  
Cross Resistance ◽  
Published Data ◽  
Phase 2 ◽  
Tumor Resistance ◽  
Castrate Resistant Prostate Cancer ◽  
Previously Treated ◽  
Castrate Resistant

235 Background: Docetaxel (D) improves overall survival in metastatic castrate-resistant prostate cancer (mCRPC), but benefits remain short-lived. Clinical data suggests patients (pts) with mCRPC treated with anti-androgen therapy like abiraterone (AA) or enzalutamide (ENZA) have decreased responses to subsequent therapy due to cross-resistance in the androgen pathway targeted by D, AA, or ENZA(van Soest et al, Eur J Cancer 49:18, 2013). Combining D with other agents, like cabozantinib (C), could target different cellular signaling pathways potentially minimizing tumor resistance. Methods: D naive pts receive 75 mg/m2 IV on day 1 of a 21 day cycle, and prednisone (P) 5 mg po q12 hours with C at 3 dose levels: 20, 40, or 60 mg po daily until maximum tolerated dose (MTD) is defined. In phase 2, pts who have progressed on AA or ENZA, enroll on a randomized 2 arm cohort comparing D plus C to D alone. Results: 20 pts have been accrued; 4 at 20 mg C, 8 at 40 mg C, and 7 at 60 mg C. On phase 2, 1 pt is randomized to D alone. Median age is 68 (44-84 yrs). Median baseline PSA is 94.7 (0.01-754.1 ng/mL). Gleason score is 9 (7-10). Median cycles is 9.5 (1-33). 8 pts have bone only disease, 12 pts have bone and soft tissue disease. Common grade 2 and grade 3 adverse events possibly related to C: hand/foot syndrome (4/16), oral mucositis (4/16), hypophosphatemia (4/16), and fatigue (3/16). The MTD of C is 40 mg daily with D. 15 pts were previously treated with AA or ENZA. In 13 patients previously treated with AA, median PFS has not been reached, with a median potential follow up of 12.4 months. Six month PFS is 77.8% and 9 month PFS is 60.5%. Conclusions: D plus P may have limited benefits after disease progression on AA as seen in 3 retrospective analyses demonstrating a median PFS survival of 4.6 months or less (Mezynski J, et al. Ann Oncol 23;11, 2012) (Aggarwal R, et al. Clin Genitourin Cancer 12;5, 2014) (Schweizer MT, et al. Eur Urol 66;4, 2014). PFS results seen in this trial compare favorably to previously published data of treatment with D after AA in mCRPC, suggesting the addition of C to D may help overcome acquired resistance. Further randomized trials will determine if C in combination with D will enhance clinical outcomes. Clinical trial information: NCT01683994.

The sequential use of abiraterone and enzalutamide in metastatic castrate resistant prostate cancer patients: Experience from seven U.K. centers.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 125-125 ◽  
Author(s):  
Robert Stevenson ◽  
David Gareth Fackrell ◽  
Daniel Ford ◽  
John Glaholm ◽  
Ahmed El-Modir ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Randomised Trial ◽  
Specific Antigen ◽  
Phase Iii ◽  
Early Access ◽  
Castrate Resistant Prostate Cancer ◽  
Castrate Resistant ◽  
The Uk ◽  
Taxane Chemotherapy ◽  
Patients Experience

125 Background: Phase III studies have demonstrated survival benefits from abiraterone (Abi), and enzalutamide (Enz) following disease progression in metastatic castrate resistant prostate cancer (mCRPC). Abi is now available for treatment of mCRPC in the UK in patients previously treated with docetaxel. Enz has recently become available, via the UK cancer drugs fund (CDF), for progressive disease post docetaxel, prior to exposure to Abi. There has been no randomised trial on sequential usage of Enz post-Abi. We therefore, report the experience of hospitals in Coventry, Cardiff, and five centers in Birmingham. Methods: We searched the pharmacy database for patients who have received Enz as part of an early access scheme, and identified 79 patients who started treatment between the August 2012 and April 2013. A detailed notes review was carried out of these patients. Results: Median age was 74 (range of 55 to 87). All patients had received hormone androgen deprivation therapy and taxane chemotherapy (docetaxel and/or cabazitaxel) 75 patients had received previous Abi, 62 of these patients receiving Abi as the last treatment prior to Enz. The mean time to progression (TTP) for Abi in these 62 patients was 37.44 weeks (range 4 to 104). At the time of submission 55 patients had stopped Enz due to prostate-specific antigen progression with a mean TTP of 15.87 weeks and 28 patients had died. Conclusions: The AFFIRM study demonstrated TTP of 36 weeks in patients post-docetaxel. In this audit of patients receiving Enz post-Abi the TTP was only 15.87 weeks, suggesting possible reduced efficacy in patients receiving Enz post-Abi and docetaxel. Trials are underway comparing Abi alone or in combination with Enz which may improve efficacy.

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