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18 Renal & Urology News 

october 2013 www.renalandurologynews.com

MRI May Help Predict PCa Recurrence Positive findings are linked to a sixfold increased risk of biochemical relapse after radical surgery Multiparametric magnetic resonance imaging (MRI) may enable doctors to predict the likelihood of biochemical recurrence of prostate cancer (PCa) after radical prostatectomy, Japanese researchers reported. In a retrospective study that included 314 patients who underwent standard or laparoscopic radical prostatectomy, Seiya Hattori, MD, of the Keio University School of Medicine in Tokyo, and colleagues showed that positive findings on preoperative multiparametric MRI scans were significantly associated with a high clinical stage (cT2 or higher), a high positive biopsy core rate (greater than 0.2), a high biopsy Gleason score (8 or higher), and a high pathologic Gleason score (8 or higher). Positive findings on MRI were associated with a significant sixfold increased odds of biochemical recurrence compared with negative findings, the researchers reported online ahead of print in BJU International.

Novel Iron Drug Safe, Effective Soluble ferric pyrophosphate (SFP), an investigational parenteral iron formulation, maintains hemoglobin (Hb) levels better than placebo in hemodialysis (HD) patients, according to the results of a phase 3 study. The CRUISE-1 efficacy study included 300 HD patients randomized to receive SFP (149 patients) or placebo (151 patients). At baseline, the two groups had similar Hb levels (109.6 and 10.9.0 g/L in the SFP and placebo arms, respectively). From baseline to the end of the randomized treatment period, the SFP arm had a mean 0.6 g/L increase in Hb level and the placebo arm had a 3.0 g/L decrease, according to data reported by the drug’s developer, Rockwell Medical, of Wixom, Mich. Researchers found no significant difference in the frequency or severity of adverse events (AEs) or serious AEs between the groups. No case of anaphylaxis or hypersensitivity occurred in the SFP recipients. All FDA approved IV iron products

RUN1013_PCaMRI.indd 1

In addition, the study revealed that a pathologic Gleason score of 8 or higher was associated with a significant threefold increased odds of recurrence compared with a score of 7 or less. Positive surgical margins (PSM) were associated with a nearly fourfold increased odds of recurrence compared with negative surgical margins. “In terms of the clinical impact of the present findings,” the authors wrote, “MRI positivity is an independent, brief and non-invasive biomarker which can predict therapeutic effects preoperatively.” The investigators stated that MRI positivity “may have the potential to be an effective index for determination of a therapeutic strategy, as well as a follow-up strategy. This can be of benefit for clinicians as a strong- and easy-touse predictive factor.” The researchers used the variables significantly associated with biochemical recurrence to stratify patients into

for the treatment of iron deficiency anemia are iron-carbohydrate complexes, and it is the carbohydrate moiety that triggers the anaphylactoid or hypersensitivity reactions, explained Ajay Gupta, MD, Chief Scientific Officer for Rockwell. SFP does not contain carbohydrate, he said, pointing out that not a single anaphylactoid reaction has occurred in patients being given SFP. “This successful CRUISE-1 study data confirm our belief that SFP is an extremely safe drug that consistently maintains hemoglobin and that can effectively replace the general need for IV iron administration in dialysis patients,” Dr. Gupta said. SFP is a unique iron compound that is administered to HD patients via dialysate, replacing the 5-7 mg of iron lost during a dialysis treatment, according to Rockwell. SFP is introduced into the sodium bicarbonate concentrate that subsequently is mixed into dialysate. Once in the dialysate, SFP crosses the dialyzer membrane and enters the bloodstream where it immediately binds to transferrin and is delivered to the bone marrow, similar to the way dietary iron is processed in the human body. This is in contrast to IV iron products indicated for the treatment of iron-deficiency anemia. n

low-, intermediate-, and high-risk groups. Low-risk patients had zero or one risk factor (PSM or pathological Gleason score of 8 or higher); intermediate-risk patients had one risk factor (MRI positivity) or two risk factors

Preoperative scans potentially could aid in determining treatment strategy. (PSM or pathological Gleason score of 8 or higher); the high-risk group consisted of all other patients. The five-year biochemical recurrence-free rates were 99% in the low-risk group, 92% in the intermediate-risk group, and 72% in the high-risk group. In a separate development involving the use of multiparametric MRI for PCa, another team of Japanese

researchers demonstrated that this imaging technique can improve detection of anterior prostate tumors missed by transrectal 12-core biopsy. The study, published in The Journal of Urology (2013;190:867-873), included 324 men underwent prebiopsy multiparametric MRI and then 3D 26-core prostate biopsy, a combination of transrectal 12-core and transperineal 14-core biopsy. The overall cancer detection rate on 3-D 26-core prostate biopsy was 39%. Of these cancers, 28% were transrectal 12-core negative cancers, which the investigators defined as cancer detected by transperineal 14-core but not transrectal 12-core biopsy. Among men with and without an anterior lesion on MRI, 40% and 3.8%, respectively, had transrectal 12-core negative cancer. Prebiopsy multiparametric MRI revealed an anterior lesion in 92% of cases of significant transrectal 12-core negative cancer. n

Preop Hemoglobin, CRP Predict Bladder Cancer Survival Hemoglobin (Hb) and C-reactive

globin level below 10.5 g/L, a

protein (CRP) levels prior to radical

CRP level above 0.5 mg/dL,

cystectomy for bladder cancer inde-

and a disease stage of pT3a or

pendently predict patients’ disease-

higher each carries a value of 1.

specific survival, Japanese researchers

PSM has a value of 2. Thus, the

reported online in the International

maximum score is 5. Patients with a

Journal of Urology.

score of 0-1, 2, and 3-5 are

In an analysis of data from 249

classified as low, intermediate,

bladder cancer patients (mean age

and high risk. The four-year DSS in

71.1 years; 241 male) who underwent

patients in the low-, intermediate-,

radical cystectomy without neoadju-

and high-risk groups were 77.7%,

vant therapy, Takehiro Sejima, MD, of

23.6%, and 7.4%, respectively.

Tottori University Faculty of Medicine in

The researchers stated that their

Yonago, and colleagues found that low

report is the first to show the signifi-

Hb levels (less than 10.5 g/L) and high

cance of combining preoperative

CRP levels (greater than 0.5 mg/dL)

Hb with the pathology of radical cys-

independently predicted poor disease-

tectomy specimens as an independent

specific survival (DSS), as did pT3a

predictor for DSS. In addition,

or greater disease stage and positive

they noted, the study included the larg-

surgical margins (PSM).

est contemporary series to date dem-

Based on their findings Dr. Sejima’s

onstrating that two types of preopera-

group created a risk stratification

tive hematologic disorders, assessed

model to predict DSS. Each risk factor

by Hb and CRP, are independent predic-

is assigned a value, and these values

tors in bladder cancer patients treated

are added to arrive at a score. A hemo-

with radical cystectomy. n

9/24/13 10:38 AM

Renal & Urology News October 2013 Issue  

Clinical news for nephrologists and urologists.

Renal & Urology News October 2013 Issue  

Clinical news for nephrologists and urologists.

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