Determine of the optimal number of cycles of docetaxel in the treatment of metastatic castration-resistant prostate cancer

35 Background: The optimal number of cycles of docetaxel for patients (pts) with mCRPC is not known, and in practice, treatment breaks are common. The current study was designed to test the safety and efficacy of utilizing 6 cycles of standard docetaxel with chemo free intervals in patients who achieve and maintain a response to docetaxel. Methods: Pts with mCRPC, no prior chemo, and KPS > 60% were eligible. Pts were treated with “induction” docetaxel 75 mg/m2 q 3 weeks, and prednisone 5 mg po bid. PSAWG1 criteria were used to define response and progression. After 6 cycles, responding pts stopped chemo and were randomized to observation (Obs) or to GM-CSF, 250 mcg/m2 daily for 14 days out of every 28-day cycle. Pts were followed with monthly PSA and imaging every 2 cycles until progression, at which point docetaxel was reinitiated for another 6 cycles, followed by the same “off chemo” regimen. The primary endpoint was the time to progression while on chemo (time to chemo resistance). Results: 114 pts have been enrolled: 3 are undergoing induction, and 111 are therefore evaluable. Of these pts, 82 completed induction, (10 did not due to PD, 9 due to adverse events (AE), 10 due to pt or MD choice). Of 111 evaluable pts, 48 (43%) had a response to chemo and were eligible for randomization. 22 were randomized to Obs and 26 to GM-CSF. Of 48 randomized pts, 25 restarted chemo, all for PSA PD. (23 pts did not re-start chemo because of AE, other therapy being started, or pt choice; 1 pt is still on GM-CSF.) 6/25 (24%) pts experienced a response to the 2nd series of chemo, and 1/6 (17%) to the 3rd. The time to chemo re-initiation (n=25) was 3.1 mos in Obs pts and 4.2 mos in GM-CSF pts. Conclusions: 43% of patients met criteria for undergoing intermittent chemo. The response proportion to the 1st, 2nd, and 3rd series of docetaxel was 43%, 24% and 17%, respectively. GM-CSF may modestly delay the time to chemo re-initiation, but the sample size is small and insufficient to assess the impact of GM-CSF on time to chemo resistance.

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Evaluating the Value of Number of Cycles of Docetaxel and Prednisone in Men With Metastatic Castration-Resistant Prostate Cancer

European Urology ◽

10.1016/j.eururo.2011.06.034 ◽

2012 ◽

Vol 61 (2) ◽

pp. 363-369 ◽

Cited By ~ 28

Author(s):

Gregory R. Pond ◽

Andrew J. Armstrong ◽

Brian A. Wood ◽

Melissa Brookes ◽

Lance Leopold ◽

...

Keyword(s):

Prostate Cancer ◽

Castration Resistant Prostate Cancer ◽

Castration Resistant ◽

Number Of Cycles

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Reply to YiJun Shen and DingWei Ye's Letter to the Editor re: Gregory R. Pond, Andrew J. Armstrong, Brian A. Wood, et al. Evaluating the Value of Number of Cycles of Docetaxel and Prednisone in Men With Metastatic Castration-Resistant Prostate Cancer. Eur Urol 2012;61:363–9

European Urology ◽

10.1016/j.eururo.2011.07.055 ◽

2012 ◽

Vol 61 (2) ◽

pp. e4-e5

Author(s):

Guru Sonpavde ◽

Gregory R. Pond ◽

Andrew J. Armstrong

Keyword(s):

Prostate Cancer ◽

Castration Resistant Prostate Cancer ◽

Castration Resistant ◽

Letter To The Editor ◽

Number Of Cycles

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Cabazitaxel versus abiraterone or enzalutamide in metastatic castration-resistant prostate cancer: post hoc analysis of the CARD study excluding chemohormonal therapy for castrate-naive disease

Japanese Journal of Clinical Oncology ◽

10.1093/jjco/hyab028 ◽

2021 ◽

Author(s):

Hiroyoshi Suzuki ◽

Daniel Castellano ◽

Johann de Bono ◽

Cora N Sternberg ◽

Karim Fizazi ◽

...

Keyword(s):

Prostate Cancer ◽

Adverse Events ◽

Clinical Outcomes ◽

Specific Antigen ◽

Tumour Response ◽

Progression Free Survival ◽

Median Number ◽

Castration Resistant Prostate Cancer ◽

Castration Resistant ◽

Number Of Cycles

Abstract Background In the CARD study (NCT02485691), cabazitaxel significantly improved clinical outcomes versus abiraterone or enzalutamide in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel and the alternative androgen-signalling-targeted inhibitor. However, some patients received docetaxel or the prior alternative androgen-signalling-targeted inhibitor in the metastatic hormone-sensitive (mHSPC) setting. Therefore, the CARD results cannot be directly translated to a Japanese population. Methods Patients (N = 255) received cabazitaxel (25 mg/m2 IV Q3W, prednisone, G-CSF) versus abiraterone (1000 mg PO, prednisone) or enzalutamide (160 mg PO) after prior docetaxel and progression ≤12 months on the alternative androgen-signalling-targeted inhibitor. Patients who received combination therapy for mHSPC were excluded (n = 33) as docetaxel is not approved in this setting in Japan. Results A total of 222 patients (median age 70 years) were included in this subanalysis. Median number of cycles was higher for cabazitaxel versus androgen-signalling-targeted inhibitors (7 versus 4). Clinical outcomes favoured cabazitaxel over abiraterone or enzalutamide including, radiographic progression-free survival (rPFS; median 8.2 versus 3.4 months; P < 0.0001), overall survival (OS; 13.9 versus 11.8 months; P = 0.0102), PFS (4.4 versus 2.7 months; P < 0.0001), confirmed prostate-specific antigen response (37.0 versus 14.4%; P = 0.0006) and objective tumour response (38.9 versus 11.4%; P = 0.0036). For cabazitaxel versus androgen-signalling-targeted inhibitor, grade ≥ 3 adverse events occurred in 55% versus 44% of patients, with adverse events leading to death on study in 2.7% versus 5.7%. Conclusions Cabazitaxel significantly improved outcomes including rPFS and OS versus abiraterone or enzalutamide and are reflective of the Japanese patient population. Cabazitaxel should be considered the preferred treatment option over abiraterone or enzalutamide in this setting.

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Re: Gregory R. Pond, Andrew J. Armstrong, Brian A. Wood, et al. Evaluating the Value of Number of Cycles of Docetaxel and Prednisone in Men with Metastatic Castration-Resistant Prostate Cancer. Eur Urol 2012;61:363–9

European Urology ◽

10.1016/j.eururo.2011.07.056 ◽

2012 ◽

Vol 61 (2) ◽

pp. e3

Author(s):

YiJun Shen ◽

DingWei Ye

Keyword(s):

Prostate Cancer ◽

Castration Resistant Prostate Cancer ◽

Castration Resistant ◽

Number Of Cycles

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Appropriate Number of Docetaxel Cycles in Castration-Resistant Prostate Cancer Patients Considering Peripheral Neuropathy and Oncological Control

Chemotherapy ◽

10.1159/000510900 ◽

2021 ◽

pp. 1-6

Author(s):

Yasushi Nakai ◽

Nobumichi Tanaka ◽

Kazuki Ichikawa ◽

Makito Miyake ◽

Satoshi Anai ◽

...

Keyword(s):

Prostate Cancer ◽

Peripheral Neuropathy ◽

Specific Antigen ◽

Optimal Number ◽

Progression Rate ◽

Castration Resistant Prostate Cancer ◽

Cancer Specific Survival ◽

Castration Resistant ◽

Median Cumulative Dose ◽

Number Of Treatment

Background: The number of cycles of docetaxel required for castration-resistant prostate cancer (CRPC) is unclear. This study estimated peripheral neuropathy (PN) incidence and the optimal number of treatment cycles in patients receiving docetaxel for CRPC. Patients and Methods: The study retrospectively reviewed 82 patients receiving docetaxel for CRPC at an institution between January 2005 and January 2017. Docetaxel (70 or 75 mg/m2) was administered every 3 weeks, and prednisone 5 mg or dexamethasone 0.5 mg was administered twice a day. Results: PN (grade ≥2) was noted in 32 (39.0%) patients. The median cumulative dose of docetaxel associated with PN was 675 mg/m2. No factor significantly predicted the occurrence of PN. The prostate-specific antigen progression rate, prostate cancer-specific survival, and overall survival were significantly better with ≥8 cycles of docetaxel than with <8 cycles (p < 0.05). Conclusion: The incidence of PN is high, and 8 treatment cycles are optimal for patients receiving docetaxel for CRPC.

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Do we need daily corticosteroid combined with docetaxel when treating against castration-resistant prostate cancer?

Journal of Clinical Oncology ◽

10.1200/jco.2016.34.2_suppl.184 ◽

2016 ◽

Vol 34 (2_suppl) ◽

pp. 184-184

Author(s):

Tatsuya Shimomura

Keyword(s):

Prostate Cancer ◽

Survival Benefit ◽

Castration Resistant Prostate Cancer ◽

Castration Resistant ◽

Significant Difference ◽

The Difference ◽

Group 2 ◽

Number Of Cycles ◽

Almost All ◽

Group 1

184 Background: Depend on the result of TAX 327, docetaxel are usually used with daily corticosteroid (prednisone) against castration resistant prostate cancer (CRPC). However there is no evidence that combination of daily corticosteroid itself with docetaxel improve survival rate. In this study we investigated whether daily corticosteroid have survival benefit in our docetaxel treatment cohort. Methods: Total of 120 CRPC cases were treated with docetaxel in our department between 2011 and 2014. We compared the group 1 (with daily corticosteroid) and group 2 (without daily corticosteroid) and evaluated their clinical outcome. In group 2, there was no case using estramustine or any estrogen medicine. Results: Group 1 was 104 cases and group 2 was 11 cases in this study. In terms of clinical and pathological demographics at diagnosis of prostate cancer and at starting docetaxel, almost all of the factors did not have significant difference between group1 and 2 other than white blood cell count(mean 7142 and 5664, respectively. p = 0.0449). About the treatment outcome, there were no significant difference in overall survival (p = 0.8696) , PSA response rate (39.2% vs 52.0%, p = 0.2348), PSA decline ³a50% (38.4% vs 45.5%,p = 0.651), PSA decline ³a90% (14.4% vs 36.4%, p = 0.062) and number of cycles (Mean 7.19 vs 8.33, p = 0.174) between group 1 and 2. Conclusions: Although this study was retrospective and the cohort was small, we did not find the difference of outcome among the 2 groups. At least, we could say that there was no survival benefit in the daily corticosteroid groups. And there is a possibility that we do not need to combine daily corticosteroid with docetaxel. We will need prospective randomized trial to prove this hypothesis.

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