Patient-reported outcomes following abiraterone acetate plus prednisone added to androgen deprivation therapy in patients with newly diagnosed metastatic castration-naive prostate cancer (LATITUDE): an international, randomised phase 3 trial

N., Kim; Protheroe, Andrew; Rodrı́guez-Antolı́n, A.; Facchini, Gaetano; Suttman, H.; Matsubara, Nobuaki; Ye, Zhangqun; Keam, Bhumsuk; Damião, Ronaldo; Li, Tracy; McQuarrie, Kelly; Jia, Bin; Porre, Peter De; Martin, Jeffrey W.; Todd, Mary B.; Fizazi, Karim

doi:10.1016/s1470-2045(17)30911-7

Cited by 141 publications

(118 citation statements)

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“…High risk was defined as having 2 or more of the following prognostic factors: 3 or more lesions assessed by a bone scan, the presence of measurable visceral metastasis (excluding lymph node disease), and a Gleason score ≥ 8. Details of the study design and eligibility criteria have been previously reported . As part of the exclusion criteria for LATITUDE, patients were ineligible if they had received any systemic pharmacotherapy with the exception of up to 3 months of ADT before study entry.…”

Section: Methodsmentioning

confidence: 99%

“…Most recently, abiraterone acetate plus prednisone (AA+P), added to ADT, demonstrated a statistically significant benefit in delaying progression and improving overall survival in comparison with ADT alone in metastatic castration‐naive prostate cancer . In the double‐blind, placebo‐controlled, phase 3, multinational LATITUDE clinical trial (NCT01715285), patients on ADT plus AA+P experienced a decrease in the risk of death of 38% (95% confidence interval [CI], 0.509‐0.756; P < .0001) and a decrease in the risk of progression or death of 53% (hazard ratio, 0.466; 95% CI, 0.394‐0.550; P < .0001) in comparison with patients on ADT plus placebos (ADT+placebos) . Patients treated with ADT+AA+P also showed clinical benefits with respect to the progression of pain, prostate cancer symptoms, fatigue, functional decline, and overall health‐related quality of life in comparison with patients treated with ADT alone in the LATITUDE trial …”

Section: Introductionmentioning

confidence: 99%

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Medical resource utilization of abiraterone acetate plus prednisone added to androgen deprivation therapy in metastatic castration‐naive prostate cancer: Results from LATITUDE

Franco‐Villalobos²,

Proskorovsky³

et al. 2018

Cancer

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Background Abiraterone acetate plus prednisone (AA+P), when added to androgen deprivation therapy (ADT), demonstrated significant improvements in overall survival and disease progression over dual placebos added to ADT in the LATITUDE clinical trial (NCT01715285). The objective of this study was to assess event‐driven medical resource utilization (MRU) of ADT plus AA+P (ADT+AA+P) versus ADT plus dual placebos (ADT+placebos) in LATITUDE. Methods Event‐driven MRU data from LATITUDE while patients were on treatment were used for analyses. Types of MRU included overnight hospitalizations and length of stay (LOS), emergency room (ER) visits, radiotherapy, surgery, imaging, and specialist and general practitioner (GP) visits. Rates by treatment (per 100 person‐years) and rate ratios comparing ADT+AA+P with ADT+placebos were estimated with zero‐inflated Poisson regression. The difference in the average hospital LOS between arms was assessed with repeated measures regression analyses. Reasons for hospitalization were explored. Sensitivity analyses were conducted to assess the robustness of the results. Results A total of 1199 patients were enrolled in LATITUDE. Significantly lower rates of hospitalization (a 24% reduction), imaging (a 36% reduction), and radiotherapy (a 50% reduction) were observed with ADT+AA+P versus ADT+placebos. There was a nonsignificant trend of lower rates of specialist visits and surgery. The rates of ER and GP visits and the average LOS per hospitalization episode were similar across arms. The most common hospitalization reasons were genitourinary, musculoskeletal, and respiratory tract symptoms/disorders. The results remained consistent in a sensitivity analysis. Conclusions Adding AA+P to ADT does not increase MRU and leads to lower rates of hospitalization, imaging, and radiotherapy. This likely reflects the more favorable clinical outcomes with ADT+AA+P therapy.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Medical resource utilization of abiraterone acetate plus prednisone added to androgen deprivation therapy in metastatic castration‐naive prostate cancer: Results from LATITUDE

Franco‐Villalobos²,

Proskorovsky³

et al. 2018

Cancer

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“…The LATITUDE trial also published patient‐reported outcomes as assessed by the BPI, FACT‐P, and EuroQoL (5‐Level EQ‐5D version) at baseline and periodically until the end of treatment . Overall patient‐reported outcomes consistently demonstrated a clinical benefit in the progression of pain, prostate cancer symptoms, fatigue, functional decline, and overall QOL in favor of patients treated with the combination of abiraterone and ADT.…”

Section: Introductionmentioning

confidence: 99%

“…The cost to the patient of abiraterone and docetaxel differ significantly and, despite the lack of a formal cost‐effective analysis, the copay for abiraterone usually is much higher than that of docetaxel and the total cost of 6 cycles of docetaxel is approximately the same as 3 or 4 months of treatment with abiraterone. In contrast, the safety data favor abiraterone as well as the efficacy of these regimens for patients with low‐volume disease …”

Section: Introductionmentioning

confidence: 99%

Metastatic castration‐sensitive prostate cancer: Abiraterone, docetaxel, or…

Barata

Sartor

2019

Cancer

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For decades, the management of patients with advanced prostate cancer has been hormonal therapy, known as androgen deprivation therapy, which is intended to lower testosterone levels. Further incremental progress in the treatment of men with metastatic hormone‐sensitive prostate cancer (mHSPC) has come from the addition of docetaxel or abiraterone acetate to androgen deprivation therapy for more aggressive upfront treatment regimens. Other combinatorial regimens testing the addition of novel therapies currently are in the late stages of development and are expected to further improve the clinical outcomes of these patients. The emergence of new positron emission tomography tracers specifically for prostate cancer, particularly prostate‐specific membrane antigen and fluciclovine, has increased the ability to detect metastatic disease earlier in the course of the disease and has helped to describe a new group of patients with mHSPC and oligometastatic disease. For this group of patients with mHSPC, the authors discuss the existing data with metastasis‐directed therapy and primary tumor‐directed therapy.

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“…For example, in the LATITUDE trial, abiraterone was given to patients with newly diagnosed, high-risk, metastatic, castration-native PCa (in contrast to conventional CRPC patients). The median rate of overall survival was not reached in the treatment group during the follow up of 30 months, whilst the placebo treated group had a median survival of 34.7 months (HR for death, 0.62; 95% CI 0.51-0.76) [44].…”

mentioning

confidence: 84%

Androgen Deprivation Therapy (ADT), Metabolic Syndrome and Metastatic Prostate Cancer: In Vivo and In Vitro Assessments of Effects of Metformin

Rhee¹

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Research Title -In vivo In this translational research PhD project, we conducted a randomized, placebo-controlled clinical trial named ADT and Adjuvant Metformin (ADMET) trial to determine the metabolic and therapeutic effects of treating hyperinsulinaemia in men starting ADT using a diabetic medication called metformin. Men who had been diagnosed with metastatic PCa and commencing ADT as a standard strategy provided the opportunity to study the physiological and pathological impact of the acute rise in insulin levels resulting from the iatrogenic hypogonadism [6]. To assess for the therapeutic benefits of metformin, we used a variety of novel technologies such as circulating tumour cell (CTC) enumeration, culture, transcriptomic analysis, and molecular imaging.The clinical trial was commenced in September 2014 and was completed in March 2017. It concluded that hyperinsulinaemia and MS is a phenomenon that affects most patients when using ADT, although the changes can be ameliorated by metformin. The use of medication was associated with the reduced need for treatment of MS with agents such as statins and progression to CRPC. Further, the trial confirmed that insulin resistance at the time of starting treatment is associated with early development of CRPC and progression of the disease.Progression free survival was also demonstrated using a novel molecular imaging called Prostate Specific

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Patient-reported outcomes following abiraterone acetate plus prednisone added to androgen deprivation therapy in patients with newly diagnosed metastatic castration-naive prostate cancer (LATITUDE): an international, randomised phase 3 trial

Cited by 141 publications

References 28 publications

Medical resource utilization of abiraterone acetate plus prednisone added to androgen deprivation therapy in metastatic castration‐naive prostate cancer: Results from LATITUDE

Medical resource utilization of abiraterone acetate plus prednisone added to androgen deprivation therapy in metastatic castration‐naive prostate cancer: Results from LATITUDE

Metastatic castration‐sensitive prostate cancer: Abiraterone, docetaxel, or…

Androgen Deprivation Therapy (ADT), Metabolic Syndrome and Metastatic Prostate Cancer: In Vivo and In Vitro Assessments of Effects of Metformin

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