A Randomised Phase 2 Trial of Dexamethasone Versus Prednisolone in Castration-resistant Prostate Cancer

Venkitaraman, Ramachandran; Lorente, David; Murthy, Vedang; Thomas, Karen; Parker, Lydia; Ahiabor, R.; Dearnaley, David P.; Huddart, Robert; Bono, Johann S. de; Parker, Chris

doi:10.1016/j.eururo.2014.10.004

Cited by 85 publications

(73 citation statements)

References 31 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Other clinical data have also suggested that dexamethasone may be more active than prednisone for CRPC [8,9,10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26]. Recently, a randomized phase II trial was conducted to compare the efficacies of dexamethasone and prednisone in CRPC patients; this study suggested that dexamethasone may be more active than prednisone [38]. Dexamethasone has a longer half-life and can achieve greater suppression of adrenocorticotrophic hormone, leading to the reduced synthesis of adrenal androgens.…”

Section: Discussionmentioning

confidence: 99%

Low-Dose Docetaxel Combined with Dexamethasone Is Feasible for Patients with Castration-Resistant Prostate Cancer

et al. 2015

View full text Add to dashboard Cite

Aim: Docetaxel-based chemotherapy against castration-resistant prostate cancer (CRPC) has recently been shown to be effective and tolerable. The objective of this study was to retrospectively evaluate the efficacy and toxicity of low-dose docetaxel in combination with dexamethasone. Methods: Thirty-seven CRPC patients were administered a treatment regimen consisting of 50 mg/m² docetaxel once every 3-4 weeks and 1 mg dexamethasone daily at our institution, between November 2004 and April 2014. Results: Twenty-four patients (65%) had a decrease in serum prostate-specific antigen (PSA) >50%. The median overall survival (OS) and PSA progression-free survival were 26.2 and 10.0 months, respectively. Ten of 12 patients (83%) taking analgesic agents reduced their intake because of decreased pain levels. Grade 3 febrile neutropenia occurred in 2 patients (5%). Nonhematological toxicities were less frequent but sometimes severe. Treatment-related death occurred in 2 octogenarian patients, 1 due to gastric bleeding and the other due to infective endocarditis. Conclusion: Low-dose docetaxel in combination with dexamethasone is feasible in Japanese CRPC patients. Hematological toxicity is less than that seen with standard docetaxel therapy, but it is necessary to monitor patients for severe nonhematological toxicities, particularly very elderly patients.

show abstract

Section: Discussionmentioning

confidence: 99%

Low-Dose Docetaxel Combined with Dexamethasone Is Feasible for Patients with Castration-Resistant Prostate Cancer

et al. 2015

View full text Add to dashboard Cite

show abstract

“…In this prospective randomized trial, the therapeutic efficacy of flutamide versus prednisone was evaluated, and the authors did not find any statistically significant differences in terms of time to progression, overall survival (OS), and symptomatic response; however, gastrointestinal toxicity and quality of life were in favor of prednisone [17]. A recently published randomized phase II trial evaluated the therapeutic efficacy of dexamethasone 0.5 mg/day and prednisone 2×5 mg/day in a cohort of 82 men with mCRPC [18] with a PSA decrease ≥ 50% as the primary endpoint. The primary endpoint was met with a PSA response rate of 47 versus 24% (p < 0.05) in favor of dexamethasone.…”

Section: First-line Treatmentmentioning

confidence: 99%

Systemic Medical Treatment in Men with Metastatic Castration-Resistant Prostate Cancer: Recommendations for Daily Routine

Herden

Heidegger²,

Paffenholz³

et al. 2015

Oncol Res Treat

View full text Add to dashboard Cite

The approval or clinical evaluation of several new agents - cabazitaxel, abiraterone acetate, enzalutamide, sipuleucel-T, and radium-223 - has significantly changed the management of patients with metastatic castration-resistant prostate cancer (mCRPC) prior to or after docetaxel-based chemotherapy. All of these agents have resulted in a significant survival benefit as compared to their control group. However, treatment responses might differ depending on the associated comorbidities and the extent and biological aggressiveness of the disease. Furthermore, treatment-associated side effects differ between the various drugs. As new drugs become approved, new treatment strategies and markers to best select which patients will best respond to which drug are needed. It is the aim of the current article to i) summarize the data of established treatment options in mCRPC, ii) highlight new developments in medical treatment, iii) provide clinically useful algorithms for the daily routine, and iv) point out future developments in medical treatment.

show abstract

“…

…”

mentioning

confidence: 99%

“…The author suggests that dexamethasone might offer advantages over prednisone or prednisolone in combination with abiraterone acetate for certain populations of mCRPC patients. As we emphasized in our review [9], the risks of each regimen must be weighed against the benefits.Will the "steroid switch" [2] or monotherapy [3] results with prostate-specific antigen translate into improved survival when dexamethasone is combined with abiraterone acetate compared with the Food and Drug Administration-approved prednisone combination? A confirmation of this hypothesis can only come with welldesigned and adequately powered prospective clinical studies comparing the two combinations in the future.…”

mentioning

confidence: 99%

In Reply

Auchus

Nguyen

et al. 2015

The Oncologist

View full text Add to dashboard Cite

We thank Dizdar [1] for citing two studies [2,3] in which dexamethasone was used after or instead of prednisolone or prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). Currently, abiraterone acetate is approved for the treatment of mCRPC only in combination with prednisone or prednisolone. This indication is based on the results of two pivotal phase III trials [4][5][6][7][8] that showed improved survival in the group receiving combination therapy over prednisone or prednisolone alone. The author suggests that dexamethasone might offer advantages over prednisone or prednisolone in combination with abiraterone acetate for certain populations of mCRPC patients. As we emphasized in our review [9], the risks of each regimen must be weighed against the benefits.Will the "steroid switch" [2] or monotherapy [3] results with prostate-specific antigen translate into improved survival when dexamethasone is combined with abiraterone acetate compared with the Food and Drug Administration-approved prednisone combination? A confirmation of this hypothesis can only come with welldesigned and adequately powered prospective clinical studies comparing the two combinations in the future. RICHARD J. AUCHUS

show abstract

A Randomised Phase 2 Trial of Dexamethasone Versus Prednisolone in Castration-resistant Prostate Cancer

Cited by 85 publications

References 31 publications

Low-Dose Docetaxel Combined with Dexamethasone Is Feasible for Patients with Castration-Resistant Prostate Cancer

Low-Dose Docetaxel Combined with Dexamethasone Is Feasible for Patients with Castration-Resistant Prostate Cancer

Systemic Medical Treatment in Men with Metastatic Castration-Resistant Prostate Cancer: Recommendations for Daily Routine

In Reply

Contact Info

Product

Resources

About