Weekly cabazitaxel in elderly patients (EP) with metastatic castration resistant prostate cancer (mCRPC) progressing after docetaxel treatment: WeCabE, a phase II study.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 300-300 ◽  
Author(s):  
Bruno Castagneto ◽  
Ilaria Stevani ◽  
Roberto Bortolus ◽  
Alessandra Bearz ◽  
Roberta Buosi ◽  
...  
Keyword(s):  
Task Force ◽  
Daily Practice ◽  
Median Number ◽  
Castration Resistant Prostate Cancer ◽  
Data Set ◽  
Docetaxel Treatment ◽  
Psa Response ◽  
Daily Prednisone ◽  
Number Of Cycles ◽  
To Receive

300 Background: Docetaxel (Doc) and Cabazitaxel (Cab) every 3 weeks with daily prednisone are standard first and second line chemotherapies in mCRPC. In daily practice, many mCRPC pts are aged > 65 years and around 20% are aged > 75years. MATuRITY registry shows that taxanes therapy provides EP with increased chances of surviving even in case of frailty. EP unfit due to their comorbidities are at risk of AE related to the chemo-treatment, so an appropriate adjustment of the dosage and schedule should be take into account. According to SIOG guidelines, G-8 Screening Tool represents a key tool to identify a suitable subset of EP able to receive cab. Methods: WeCabE enrolled mCRPC EP ≥ 70 and < 85 years, G8 Score 8-14, PS 0-2. Cab was administered at a dose of 8mg /m2 (10mg/m2 if well tolerated) for 4 out 5 weeks Use of G-CSF was allowed. Median PFS, primary endpoint, was evaluated according to PCWG-2. Secondary endpoints were: PSA Response, ORR, OS, Safety, Geriatric assessment (Minimal Data Set according with Elderly Task Force EORTC) on outcomes. PSA response, safety, impact of the treatment on pain and G8 score pre and post cab were analysed. Results: At time of this analysis 14 EP enrolled in WeCabE were analysed. Median age was 78 years, 35.7% of pts were 80-85 years. Median number of cycles received, in pts who ended treatment was 4. Overall 55.6% of pts reached a PSA response while 33.3% achieved a stability. 42.8% of pts ended therapy without a worsening/rising of symptoms, 42.8% and 14.4% showed, respectively, mild and severe pain at end of cab. G8 best score improvement during treatment was 1.28 (median). The most common AE G 3-4 was fatigue (20%) while G1-2 toxicities were diarrhea (40%) and fatigue (60%). Only one pt experienced neutropenia and anemia G3-4. Conclusions: These preliminary results confirm the usefulness of G8 tool to identify elderly mCRPC pts suitable to receive chemotherapy. It suggests that weekly cabazitaxel, in elderly mCRPC, is effective including in very old pts ( > 80 ), with a manageable safety profile. Additional results will be presented at ASCO GU meeting. Trial partially supported by Sanofi Genzyme Clinical trial information: 2014-001647-20.

From trial to practice: The Princess Margaret Hospital (PMH) experience with docetaxel and prednisone for men with metastatic castration resistant prostate cancer (mCRPC).

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 125-125
Author(s):  
Arnoud Templeton ◽  
Lisa Wang ◽  
Francisco Vera-Badillo ◽  
Mirna Attalla ◽  
Paulo De Gouveia ◽  
...  
Keyword(s):  
Cox Regression ◽  
Performance Status ◽  
Daily Practice ◽  
Median Number ◽  
Primary Treatment ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Kaplan Meier ◽  
Fda Approval ◽  
Psa Response

125 Background: Docetaxel (75mg/m2every 3 weeks [q3w]) plus prednisone (5mg bid) is standard first-line chemotherapy for men with mCRPC since FDA approval in 2004. It is unclear how results from trials translate to daily practice. Our hypothesis was that patients (pts) treated in trials would have better outcome and less toxicity. Methods: We reviewed all pts with mCRPC treated with docetaxel at PMH until the end of 2011. Primary outcomes were overall survival (OS) and PSA response rate (confirmed decline ≥ 50%). Secondary outcomes were reasons for discontinuation, febrile neutropenia and predictive factors for the primary outcomes. Data were analyzed using the Kaplan-Meier method and Cox regression for OS. Results: 438 men were treated between 2001 and 2011. At start of treatment median age was 71 (range 44 – 90) years, 80 (18%) had visceral metastasis, and the median number of docetaxel cycles was 6 (range 1 – 15). Outcomes are shown in the table. Reasons for treatment discontinuation were progressive disease (38%), completion of treatment (27%), toxicity (22%), death within 30 days of last administration (5%), and other reasons (8%). In multivariate analysis better performance status (p < 0.0001), and more recent treatment (p < 0.0001) were baseline factors associated with longer OS for pts receiving primary treatment with docetaxel q3w. Conclusions: In less selected pts with CRPC treated with docetaxel/prednisone PSA response rates are similar, OS shorter and toxicity more frequent as compared to men treated in the pivotal or in other trials. Supported by a research grant from CIHR. [Table: see text]

UnCHAARTED territory: The role of docetaxel rechallenge following chemohormonal therapy for metastatic castrate-sensitive prostate cancer.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 117-117
Author(s):  
Mary Mahler ◽  
Esmail Mutahar Al-Ezzi ◽  
Noa Shani Shrem ◽  
Eric Winquist ◽  
Christina M. Canil ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Lymph Node ◽  
Median Time ◽  
Median Number ◽  
Time To Progression ◽  
Chemohormonal Therapy ◽  
Radium 223 ◽  
Psa Response ◽  
Number Of Cycles

117 Background: Since docetaxel has been advanced to the metastatic castrate-sensitive prostate cancer (mCSPC) setting, there is a lack of evidence guiding its re-introduction upon castrate-resistant (CR) progression. We sought to identify clinical characteristics and outcomes of patients subjected to docetaxel rechallenge (DR) following prior docetaxel exposure in the mCSPC realm. Methods: Patients rechallenged with docetaxel following treatment in the mCSPC setting were identified from three academic centres in Ontario, Canada. Retrospective chart reviews were performed to identify clinical, treatment and outcome variables. Results: Of the 45 patients with DR initiated between 06/2015 and 07/2020, the median age was 65, 60% had a Gleason score of ≥8, and 64% had an ECOG of ≤1. 56% had bone only metastasis, 4% lymph node only metastasis, 29% bone and lymph node metastasis, and 11% had visceral metastasis. In the mCSPC setting, 98% of patients received 6 cycles of docetaxel with 13% requiring dose delays. Of 43 informative patients, all had a PSA response to chemohormonal therapy. 91% achieved at least a 50% PSA response (PSA50), of which 40% had a 50-89% PSA reduction and 51% had a ≥90% PSA reduction. 29% of patients obtained a PSA nadir of < 0.2 ng/mL. 16% had CR progression in < 6 months, 56% in 6-12 months, and 28% in > 12 months. DR was initiated after a median of 20.8 months (range 6.0-40.4) following the last dose of docetaxel for mCSPC, and was given as first line treatment for CR disease to 7%, second line to 51%, third line to 40%, and fourth line or beyond to 2% of patients. 69% of patients had received an androgen-receptor axis targeted therapy prior to DR, 18% radium 223, and 7% had received a trial drug. Notably, no patients had received cabazitaxel prior to DR. The median number of cycles of docetaxel received at rechallenge was 5 (range 1-11) with 18% of patients requiring treatment delays. 64% of patients stopped treatment due to progression, 16% due to side effects, 7% at the patient’s request, 7% due to completion of the planned number of cycles, and 6% due to death or other causes. Among 44 informative patients, 23% achieved at least a PSA50, with 18% having a 50-90% PSA reduction, and 5% having a ≥90% PSA reduction. The median time to progression (biochemical, radiographic, or death) was 2.3 months (95%CI 1.7-4.4) and the median overall survival was 11.0 months (95%CI 8.5-14.3). Conclusions: DR following exposure to docetaxel in the mCSPC setting resulted in a PSA50 in only around one quarter of patients. Both the median time to progression and overall survival were found to be short. With future investigations, we hope to identify clinical variables that will help predict which patients might benefit most from DR.

Randomized phase II study of gemcitabine-oxaliplatin or gemcitabine-cisplatin in chemonaive patients with advanced non-small cell lung cancer (NSCLC)-CLEO 05

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 7097-7097 ◽  
Author(s):  
T. Le Chevalier ◽  
S. Thezenas ◽  
J. Breton ◽  
J. Pujol ◽  
B. Coudert ◽  
...  
Keyword(s):  
Objective Response ◽  
Stage Iv ◽  
Patient Characteristics ◽  
Median Number ◽  
Stage Iiib ◽  
Randomized Phase Ii ◽  
Secondary Endpoints ◽  
Number Of Cycles ◽  
To Receive

7097 Background: Gemcitabine-cisplatin is one of the reference doublets used in NSCLC. Oxaliplatin is a platin analog which offers a promising efficacy/tolerance profile in NSCLC. The combination of gemcitabine and oxaliplatin has been proven feasible and active in solid tumors. Methods: Patients with chemonaive, measurable, PS 0 or 1, stage IIIB/ IV NSCLC were randomized to receive either gemcitabine 1,250 mg/m2 day 1 & 8 plus oxaliplatin 130 mg/m2 day 1 (GEMOX) or gemcitabine 1,250 mg/m2 day 1 & 8 plus cisplatin 80 mg/m2day 1 (GEMCIS). Cycles were given every 3 weeks. The primary endpoint of the study was the response rate according to the RECIST criteria. Secondary endpoints included tolerance, survival and quality of life. Results: Between October 2003 and December 2004, 130 patients (66 in GEMOX and 64 in GEMCIS) were accrued at 12 centres. Baseline patient characteristics were similar in the 2 groups. Mean age was 61. There were 96 males and 34 females; 27% of patients were PS 0 and 73% were PS 1; 15% had stage IIIB and 85% had stage IV. Median number of cycles was 5 in each group. Objective response rates were 36% in GEMOX (CI 95%: 25%-50%) and 39% in GEMCIS (CI 95%: 28%-54%) respectively. Time to progression was 173 days in the GEMOX group and 163 days in the GEMCIS group. Median survival was 10.8 months in the GEMOX group and 10.4 months in the GEMCIS group. Grade III/IV neutropenia was observed in 38% of patients after GEMOX and 41% after GEMCIS; thrombocytopenia was observed in 40% and 33% of cases respectively. Grade 2+ neurotoxicity was more frequent after GEMOX (18% vs 3%). Conclusions: GEMOX has an activity comparable to GEMCIS and may be an alternative for those patients with advanced NSCLC who have a contra-indication to cisplatin. [Table: see text]

A phase II study of the anti-IGFR antibody MK-0646 in combination with cetuximab and irinotecan in the treatment of chemorefractory metastatic colorectal cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 4127-4127
Author(s):  
D. J. Watkins ◽  
J. Tabernero ◽  
H. J. Schmoll ◽  
T. Trarbach ◽  
F. J. Ramos ◽  
...  
Keyword(s):  
Phase Ii ◽  
Drug Combination ◽  
Phase Ii Study ◽  
Study Drug ◽  
Skin Toxicity ◽  
Median Number ◽  
Tissue Samples ◽  
Radiological Response ◽  
Number Of Cycles ◽  
To Receive

4127 Background: Evidence of cross-talk between EGFR and IGFR signaling pathways provide a logical rationale for combining anti-EGFR and anti-IGFR strategies in the treatment of cancer. Prior to commencing a blinded randomised phase II study, an opened-labelled safety run-in was undertaken to assess the tolerability of a three-drug combination utilizing irinotecan (Ir), cetuximab (Cx) and two schedules of MK-0646 (Mk). Methods: Eligible patients (pts) had previously failed both Ir and oxaliplatin and had progressed on or within 3 months of their last therapy. Pts were required to have measurable disease and tissue samples available for tumour KRAS testing. Pts were randomised to receive either Mk 10mg/kg weekly (Arm A) or Mk 15mg/kg loading followed by 7.5mg/kg every alternate week (Arm B). All randomised pts also received Cx 400mg/m2 loading followed by 250mg/m2 weekly and Ir according to the same dose and schedule as they had previously received. Patients continued on treatment until disease progression with radiological response assessments undertaken every 6 weeks. Results: 10 pts were recruited to Arm A and 8 to Arm B. Pt characteristics: median age 60.5 years, male 67%, PS 0/1 33%/67%. Median number of prior chemotherapy regimens 3. The median number of cycles of Mk received in Arm A and B is 25 and 8 respectively. Reported grade III/IV toxicities in Arm A and Arm B were: neutropenia 30% and 0%, diarrhoea 30% and 25%, hypomagnesemia 0% and 25%. Hyperglycemia (≥ grade 2) was seen in 10% of Arm A and 25% in Arm B. Acneiform skin toxicity (≥ grade 2) was seen in 30% of Arm A and 62% of Arm B. The radiological response rate was 33% in Arm A and 14% in Arm B. The median time on study drug is 5.8 months in Arm A and 3.9 months in Arm B. 2 pts on Arm A and 1 in Arm B remain on study therapy. Tumour KRAS testing is in progress. Conclusions: The combination of MK-0646, cetuximab and irinotecan is tolerable with no concerning overlapping toxicities highlighted. PFS and KRAS data will be available for presentation. The efficacy of this three drug combination is under evaluation in an ongoing randomised phase II/III study. [Table: see text]

Retrospective registry evaluating the PSA flare phenomenon with cabazitaxel in metastatic castration-resistant prostate cancer (mCRPC).

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 122-122 ◽  
Author(s):  
Antoine Angelergues ◽  
Florence Mercier ◽  
Aude Flechon ◽  
Aline Guillot ◽  
Sylvestre Le Moulec ◽  
...  
Keyword(s):  
Soft Tissues ◽  
Progression Free Survival ◽  
Median Number ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Response Table ◽  
C Cycle ◽  
Psa Response ◽  
Definition Of ◽  
Early Rise

122 Background: PSA initial flare followed by a decrease is documented in up to 18% of mCRPC patients (pts) treated with docetaxel (D). There is no standard definition of this phenomenon, and its significance in terms of treatment efficacy and prognosis remains unclear. We evaluated the PSA flare incidence and characteristics with cabazitaxel (C), a new taxane developed to overcome D resistance, and its impact on outcome. Methods: A retrospective review of 84 consecutive pts (median 67 yrs) treated with C for mCRPC progressing during or after D was conducted in 8 French centers. Baseline characteristics, disease history, PSA values before and during C, overall survival (OS) and radiological or clinical progression-free survival (PFS) were collected. Results: At C initiation, most pts (84%) were ECOG 0-1, 59.5% had pain and 23.8% received ≥2 chemotherapy lines. Metastases were located in bone (92.9%), lymph nodes (48.8%) and visceral/soft tissues (9.5%). Median number of C cycles was 6 (range 2-14). Median OS and PFS from first C cycle were 16.4 and 6.7 months, respectively. Flare incidence, PFS and OS varied with the definition used (table). Definition [3] seems to us the most clinically relevant, and showed a close estimate of PFS compared to pts with immediate PSA decrease from baseline. We recommend to use this definition in clinical practice. Conclusions: PSA flare occurred in 16% pts treated with C and was associated with as good outcome as immediate responders. C should not be withdrawn prematurely in case of isolated initial PSA rise. This finding supports the PCWG 2 recommendation that early rise (prior to 12 weeks) with cytotoxics should be ignored in determining PSA response. [Table: see text]

Cisplatin in Combination With Either Gemcitabine or Irinotecan in Carcinomas of Unknown Primary Site: Results of a Randomized Phase II Study—Trial for the French Study Group on Carcinomas of Unknown Primary (GEFCAPI 01)

2003 ◽  
Vol 21 (18) ◽  
pp. 3479-3482 ◽  
Author(s):  
Stéphane Culine ◽  
Alain Lortholary ◽  
Jean-Jacques Voigt ◽  
Roland Bugat ◽  
Christine Théodore ◽  
...  
Keyword(s):  
Phase Ii Study ◽  
Median Number ◽  
Primary Site ◽  
Unknown Primary ◽  
Unknown Primary Site ◽  
Randomized Phase Ii ◽  
French Study ◽  
Number Of Cycles ◽  
To Receive

Purpose: To evaluate the efficacy and toxicity of novel chemotherapy combinations including cisplatin with gemcitabine (GC) or irinotecan (IC) for patients with carcinomas of an unknown primary site. Patients and Methods: Eighty patients were randomly assigned to receive GC or IC. In the GC arm, chemotherapy consisted of cycles combining gemcitabine 1,250 mg/m2 intravenously (IV) on days 1 and 8, and cisplatin 100 mg/m2 IV on day 1 at 3-week intervals. Patients in the IC arm originally received 3-week cycles of irinotecan 200 mg/m2 IV on day 1 and cisplatin 80 mg/m2 IV on day 1. After the inclusion of 15 patients in that arm, the toxicity profile required the irinotecan doses to be reduced to 150 mg/m2 per cycle. Independent histologic and radiologic reviews were done. Results: A total of 78 patients were assessable for efficacy and toxicity. The median number of cycles was four in each arm. Objective responses were observed in 21 patients (55%) in the GC arm (95% CI, 34% to 66%) and in 15 patients (38%) in the IC arm (95% CI, 23% to 54%). Treatment had to be stopped because of toxicity in seven patients in the GC arm and in eight patients in the IC arm. With a median follow-up of 22 months, the median survivals were 8 and 6 months in the GC and IC arms, respectively. Conclusion: This study demonstrates the activity of both the GC and IC regimens. There was toxicity associated with both regimens. Additional studies of combination chemotherapy regimens are required.

Effect of sorafenib on chemotherapy resistance and refractoriness in castration-resistant prostate cancer (CRPC)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e16105-e16105
Author(s):  
C. Nabhan ◽  
K. Tolzien ◽  
T. M. Lestingi ◽  
A. Galvez ◽  
J. D. Bitran
Keyword(s):  
Clinical Benefit ◽  
Kinase Inhibitor ◽  
Chemotherapy Resistance ◽  
Complete Response ◽  
Median Number ◽  
Castration Resistant Prostate Cancer ◽  
Chemotherapy Agent ◽  
Hand Foot Syndrome ◽  
Psa Response ◽  
Grade 3

e16105 Background: There is no standard for CRPC once chemotherapy fails. In studies employing docetaxel (D), 35–39% of pts did not complete therapy due to progression and only 45–50% had a PSA response. This implies that many pts develop resistance to D. Sorafenib is a multi kinase inhibitor with antiangiogenesis properties. We hypothesized that sorafenib could overcome chemotherapy resistance in these pts. Methods: Eligible pts must have progressed while on either D or mitoxantrone (M). They received sorafenib at 400 mg orally twice/daily in addition to the chemotherapy agent they were on. Sorefinib/chemotherapy combination was given for a maximum of 6 cycles followed by sorafenib monotherapy until progression. Primary end point was safety of the sorafenib/chemotherapy combination. Secondary end points included the overall clinical benefit calculated as the sum of complete response (CR), partial response (PR), and stable disease (SD), toxicity, and time to disease progression (TTP). Results: To date, 15 pts have been enrolled; 14 are evaluable. Eleven pts were on D and 4 on M. Median age was 68 (range 61–83), median PSA was 111.2 ng/ml (13.6–1703.9). Nine pts (60%) had visceral and bone disease. Median PSA-DT pre-study was 2 months (0.5–6) and median time from last chemotherapy to starting study was 4 weeks. Median number of given cycles was 6.5 (2–12). Six pts did not require dose reduction, 2 others were re-escalated to the full dose. Sorafenib was safely combined with chemotherapy with 6 pts experiencing grade 3 fatigue, 3 developing grade 3 hand/foot syndrome, and 1 experiening grade 3 diarrhea. Eleven pts (73%) had SD radiographically that lasted a median of 6.7 months. In all, 6 out of 14 pts (42%) had a PSA decline after adding sorafenib and 3 (21%) had stable PSA. Of these 9 pts (PR+SD), 2 never doubled their PSA. Two pts had PSA decline after withdrawing sorafenib. Median TTP for PSA was 3.75 months. PSA responses did not correlate with radiographic changes or clinical benefit. With a median follow-up of 8 months, 5 pts (33%) remain alive with 1 continuing on therapy without progression. Conclusions: Sorafenib overcomes chemotherapy-refractoriness and failures in CRPC. [Table: see text]

Novel predictive markers of PSA response to abiraterone acetate in men with metastatic castration-resistant-prostate-cancer (mCRPC).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 5058-5058 ◽  
Author(s):  
Raya Leibowitz-Amit ◽  
Arnoud J. Templeton ◽  
Eshetu G. Atenafu ◽  
Francisco Emilio Vera-Badillo ◽  
Muralidharan Chllamma ◽  
...  
Keyword(s):  
Multivariable Analysis ◽  
Predictive Biomarkers ◽  
Abiraterone Acetate ◽  
Castration Resistant Prostate Cancer ◽  
Logistic Regression Models ◽  
Predictors Of Response ◽  
Docetaxel Treatment ◽  
Psa Response ◽  
Pre Treatment ◽  
Different Response

5058 Background: Abiraterone acetate (AA) prolongs survival in men with mCRPC pre- and post- chemotherapy. To date, clinical predictive biomarkers of response remain poorly characterized. The aim of this retrospective study was to identify and analyze predictors of response to AA in men with mCRPC. Methods: All men receiving AA at the Princess Margaret Cancer Centre between November 2009 and December 2012 were reviewed. PSA response rate (RR) was defined according to PCWG2 criteria and assessed 12 weeks after AA start. Potential predictive factors were analyzed using uni- and multivariable logistic regression models. Results: In total, 70 patients were evaluable for response: 34 men were chemotherapy naive and had a PSA RR of 44% (95% CI 27-62%); 36 men had prior chemotherapy and had a PSA RR of 33% (95% CI 17-50%). In univariable analysis, pre-treatment lactate dehydrogenase (LDH) level >220 U/L (ULN) and a neutrophil-to-lymphocyte ratio (NLR) >5 were both significantly associated with a lack of PSA response. On multivariable analysis, NLR>5 remained significantly associated with lack of a PSA response (Table 1A). Men were then stratified into three groups according to these two variables. These groups were significantly associated with RRs (Table 1B). PSA RR was not found to be associated with the Gleason score, initial stage, time from initial diagnosis to mCRPC or to AA initiation, prior ketoconazole or docetaxel treatment, pre-treatment alkaline phosphate or PSA doubling time. Conclusions: A pretreatment NLR>5 and an LDH>ULN were both strongly associated with a lack of PSA response to AA. These factors may be key in stratifying men into different response groups to AA. [Table: see text]

Which data for cabazitaxel (Cbz) from the real world? The safety experience from the Italian centres participating in the Expanded Access Programme (EAP).

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 189-189 ◽  
Author(s):  
Sergio Bracarda ◽  
Paolo Marchetti ◽  
Donatello Gasparro ◽  
Angela Gernone ◽  
Francesco Boccardo ◽  
...  
Keyword(s):  
Safety Profile ◽  
Median Number ◽  
Castration Resistant Prostate Cancer ◽  
Effective Treatment Option ◽  
Expanded Access Programme ◽  
Wide Range ◽  
Access Programme ◽  
Clinical Benefits ◽  
Psa Response ◽  
Ecog Ps

189 Background: A significant percentage of metastatic castration-resistant prostate cancer (mCRPC) patients (pts) progressing during or after a docetaxel (D) based therapy are candidates for additional effective treatments. Taxanes remain the mainstay of treatment for a wide range of tumours including mCRPC. Cabazitaxel, a next generation of taxane, was approved based on results from the TROPIC study (NCT00417079). Cbz plus prednisone (P) was associated with a higher overall survival than mitoxantrone (MTX) (15.1 vs 12.7 mo, HR=0.70; P<0.0001). Moreover CbzP was associated with clinical benefits, better PFS, maintenance of ECOG PS, improved tumour and PSA response, longer time to tumour and PSA progression while pain control was similar to MTX. These clear benefits supported a global EAP. Methods: Here we report, the preliminary safety analysis of 165 pts entered in the study from 25 Italian centres between Jan and Nov 2011. Pts received Cbz 25 mg/m2(intravenous every 3 weeks) plus P 10 mg (oral daily). Results: Median age was 70 years (21.8% of the cases were ≥75 years); pts with PS 0-1=98.2%; median number of previous D cycles was 8; 30.8% received 450 ÷ 675 mg, 14.7% received 675 ÷ 900 mg and 28.2% received ≥ 900 mg of D. Median time from last D dose to first CbzP dose was 5 months including any other eventual chemotherapy treatment. 49.1% of the pts entered in this EAP because refractory to D (PD during or within 3 months since the last D administration), overall 72 % of pts had 2 or more met sites. At the time of this analysis approximately 50% of pts received 4 cycles. A total of 68 pts discontinued CbzP due to PD (38.2%), AEs related and not related (38.2)%, Investigator’s decision (2.9%) or other reasons (20.6%). The most common G 3/4 AEs were neutropenia (35.2%), leukopenia (17.6%), anaemia (5.5%) febrile neutropenia (4.2%); main non-haematological AEs were asthenia (4.8%) and fatigue (4.2%). Conclusions: This large analysis confirms a manageable safety profile of cabazitaxel in routine clinical practice. The safety profile showed in EAP study suggests cabazitaxel a safe and effective treatment option in mCRPC pts progressing during or after a docetaxel based therapy. Clinical trial information: NCT01254279.

Post marketing surveillance study of cabazitaxel (CBZ) in Japanese patients with castration resistant prostate cancer (CRPC) in real world settings.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 290-290
Author(s):  
Hideyasu Matsuyama ◽  
Nobuaki Matsubara ◽  
Tomoyuki Taguchi ◽  
Takeshi Seto ◽  
Kazuhiro Suzuki
Keyword(s):  
Real World ◽  
Initial Dose ◽  
Response Rate ◽  
Specific Antigen ◽  
Daily Practice ◽  
Japanese Patients ◽  
Castration Resistant Prostate Cancer ◽  
Post Marketing Surveillance ◽  
Significant Difference ◽  
Psa Response

290 Background: The study evaluated safety and efficacy of CBZ in Japanese patients (pts) with CRPC in real world settings. Methods: This prospective, observational study targeted all CRPC pts receiving CBZ in daily practice between September 2014 and June 2015. Observation period was 1 year after first dose of CBZ given. Adverse drug reactions (ADRs) were evaluated for safety by CTCAE 4.0. Overall survival (OS), time to treatment failure (TTF) and prostate specific antigen (PSA) response rate (≥30% PSA decrease) were the efficacy endpoints. Two groups, those given 25mg/m2 of CBZ as initial dose (C25) and those given 20mg/m2 of CBZ (C20), were comparatively analyzed. This study was supported by Sanofi. Results: Of 662 enrolled pts with CRPC treated with CBZ, 660 pts were analyzed. ADRs occurred in 511 pts (77.4%). Most frequent all grade ADRs were neutropenia (49.2%), febrile neutropenia (18.0%) and anemia (14.2%). Median OS and TTF were 319 and 116 days, respectively. Of 540 PSA evaluable pts, 158 (29.3%) achieved PSA response. Populations for post hoc analysis were 159 pts for C25 and 190 pts for C20. Patient characteristics were similar C25 and C20 groups. Statistical significant differences were observed between C25 and C20 groups for OS (Hazzard Ratio [HR] = 0.71) and TTF (HR = 0.78) in favor of C25 group. Initial dose of CBZ remained as the independent prognostic factor for OS and TTF in univariate and multivariate analysis. There was no significant difference for PSA response rate. ≥ Grade 3 ADRs with C25 and C20 occurred in 129 pts (81.1%) and 116 pts (61.1%), respectively. Conclusions: Safety profile of CBZ was generally consistent with clinical studies conducted before approval in Japan. Although there are some limitations of studies done in real world settings, there were significant differences for OS and TTF between C25 and C20. Less ADRs occurred with C20. [Table: see text]

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