Background
We aimed to evaluate the effect of sarcopenia, a condition of low muscle mass, on the survival among patients who were undergoing radical nephroureterectomy (RNU) for urothelial carcinoma ...of the upper urinary tract (UCUT).
Methods
We retrospectively reviewed consecutive patients with UCUT (cTanyN0M0) who underwent RNU between 2003 and 2013 at our department and its affiliated institutions. Preoperative computed tomography images were used to calculate each patient’s skeletal muscle index, an indicator of whole-body muscle mass. Sarcopenia was defined according to the sex-specific consensus definitions, based on the patient’s skeletal muscle and body mass indexes. We analyzed the relapse-free survival (RFS), cancer-specific survival (CSS), and overall survival (OS) after RNU to identify factors that predicted patient survival.
Results
A total of 137 patients were included, and 90 patients (65.7 %) were diagnosed with sarcopenia. Compared to the non-sarcopenic patients, the sarcopenic patients had a significant inferior 5-year RFS (48.8 vs. 79.6 %,
p
= 0.0002), CSS (57.1 vs. 92.6 %,
p
< 0.0001), and OS (48.2 vs. 90.6 %,
p
< 0.0001). Multivariate analyses revealed that sarcopenia was an independent predictor of shorter RFS, CSS, and OS (all,
p
< 0.0001).
Conclusions
Sarcopenia was an independent predictor of survival among patients with UCUT who were undergoing RNU.
To compare the surgical outcomes between resection and enucleation in robot-assisted laparoscopic partial nephrectomy (RAPN) based on the Surface-Intermediate-Base margin score (SIB score).
This ...study included 282 patients who underwent RAPN between 2014 and 2016. SIB score was macroscopically evaluated immediately after the surgery. We divided the patients into the following two groups: enucleation (SIB score, 1-2) and resection (SIB score, 3-5). To minimize selection bias between the two surgical methods, patient variables were adjusted by 1:1 propensity score matching.
Of the 282 patients, 48 were assigned to the enucleation group and 234 to the resection group. After matching, 45 patients were included in each group. The mean preoperative estimated glomerular filtration rate (eGFR) was 70 mL/min/1.73 m
. The mean tumor size was 32-33 mm. The decrease in eGFR (5.6 vs 12%, p = 0.0365) and total perioperative complication (16% vs 38%, p = 0.0171) were significantly lower in the enucleation group than in the resection group. Estimated blood loss was higher in the enucleation group than in the resection group (129 cc vs 117 cc, p = 0.0088), despite a similar transfusion rate. The postoperative length of hospital stay was shorter in the enucleation group than in the resection group (4.1 vs 5.0 days, p = 0.0288). Operation time and surgical margin status were not significantly different between groups.
In carefully selected patients, enucleation was associated with more favorable surgical outcomes in the cohort than resection, including improved renal function and a lower complication rate.
Objective To assess surgical outcomes between the non-renorrhaphy and renorrhaphy techniques in open partial nephrectomy for ≥T1b renal tumors using volumetric studies. Methods We retrospectively ...analyzed the records of 91 patients with normal contralateral kidneys who underwent both open partial nephrectomy for ≥T1b renal tumors and pre- and postoperative enhanced computed tomography between 2010 and 2014. Volumetric studies to assess vascularized parenchymal volume of the operated kidney were performed within 2 months preoperatively and 6 months postoperatively. Using the non-renorrhaphy technique, we coagulated hemorrhagic areas on the surface of the renal parenchyma by monopolar soft coagulation, while a TachoSil tissue-sealing sheet was placed on the resected bed. Results A total of 50 patients underwent renorrhaphy and 41 patients underwent non-renorrhaphy. Patient backgrounds and R.E.N.A.L. nephrometry scores were not significantly different between the two groups. Cold ischemia time was significantly longer in the renorrhaphy than that in the non-renorrhaphy (52 vs 42 minutes, P = .0162). However, significant differences were not observed in the preservation rate of the vascularized parenchymal mass in the operated kidney (renorrhaphy, 71%; non-renorrhaphy, 70%; P = .5054) and global kidney function (renorrhaphy, 88%; non-renorrhaphy, 90%; P = .3653) between the two groups. Renal artery pseudoaneurysm occurred in 2 cases in both groups. Urinary fistula tended to occur more frequently in non-renorrhaphy (2 cases) than in renorrhaphy (5 cases), though this difference was not statistically significant ( P = .237). Conclusion The non-renorrhaphy technique failed to show a benefit in the preservation of vascularized parenchymal mass of the operated kidney and global renal function for ≥T1b renal tumors compared to the renorrhaphy technique.
More than 60% of 1c-RDI is needed for effective sunitinib treatment. Patient tolerability should be carefully monitored to avoid the development of dose-limiting toxicity during the early phase of ...treatment.
Abstract
Background
Relative dose intensity is an indicator of therapeutic efficacy in sunitinib treatment for metastatic renal cell carcinoma. However, the number of studies investigating the influence of decreased relative dose intensity during the early phase on oncological outcome is limited.
Methods
A total of 105 patients who received first-line sunitinib treatment for metastatic renal cell carcinoma were evaluated. We assessed the relative dose intensity during the initial first cycle (1c-RDI). We found that an optimal threshold of 1c-RDI was associated with progression-free survival and overall survival after the initiation of sunitinib treatment. Additionally, predictive factors for decreased 1c-RDI were analyzed.
Results
The 1c-RDI threshold was determined at 60%. Patients with low 1c-RDI (<60%, n = 26, 24.8%) had significantly shorter median progression-free survival (5.79 vs. 14.0 months, P = 0.0014) and overall survival (13.3 vs. 34.4 months, P = 0.0005) durations than those with high 1c-RDI (≥60%, n = 79 75.2%). Multivariate analysis showed that the development of dose-limiting toxicity was an independent factor for low 1c-RDI (odds ratio: 3.09, 95% confidence interval: 1.14–8.37, P = 0.0266) after adjustment with an initial dose of sunitinib.
Conclusions
More than 60% of 1c-RDI is needed for effective sunitinib treatment. Patient tolerability should be carefully monitored to avoid the development of dose-limiting toxicity during the early phase of treatment.
Objectives
To compare surgical outcomes between robot‐assisted laparoscopic partial nephrectomy and open partial nephrectomy in patients with chronic kidney disease.
Methods
Of 550 patients who ...underwent partial nephrectomy between 2012 and 2015, 163 patients with T1–2 renal tumors who had an estimated glomerular filtration rate between 30 and 60 mL/min/1.73 m2, and underwent robot‐assisted laparoscopic partial nephrectomy or open partial nephrectomy were retrospectively analyzed. To minimize selection bias between the two surgical methods, patient variables were adjusted by 1:1 propensity score matching.
Results
The present study included 75 patients undergoing robot‐assisted laparoscopic partial nephrectomy and 88 undergoing open partial nephrectomy. After propensity score matching, 40 patients were included in each operative group. The mean preoperative estimated glomerular filtration rate was 49 mL/min/1.73 m2. The mean ischemia time was 21 min in robot‐assisted laparoscopic partial nephrectomy (warm ischemia) and 35 min in open partial nephrectomy (cold ischemia). Preservation of the estimated glomerular filtration rate 3–6 months postoperatively was not significantly different between robot‐assisted laparoscopic partial nephrectomy and open partial nephrectomy (92% vs 91%, P = 0.9348). Estimated blood loss was significantly lower in the robot‐assisted laparoscopic partial nephrectomy group than in the open partial nephrectomy group (104 vs 185 mL, P = 0.0025). The postoperative length of hospital stay was shorter in the robot‐assisted laparoscopic partial nephrectomy group than in the open partial nephrectomy group (P < 0.0001). The prevalence of Clavien–Dindo grade 3 complications and a negative surgical margin status were not significantly different between the two groups.
Conclusions
In our experience, robot‐assisted laparoscopic partial nephrectomy and open partial nephrectomy provide similar outcomes in terms of functional preservation and perioperative complications among patients with chronic kidney disease. However, a lower estimated blood loss and shorter postoperative length of hospital stay can be obtained with robot‐assisted laparoscopic partial nephrectomy.
The low data publication rate for Food and Drug Administration (FDA)-approved drugs, and discrepancies between FDA-submitted versus published data, remain a concern. We investigated the publication ...statuses of sponsor-submitted clinical trials supporting recent anticancer drugs approved by the FDA, with a focus on immune checkpoint inhibitors (ICPis).
We identified all ICPis approved between 2011 and 2014, thereby obtaining 3 years of follow-up data. We assessed the clinical trials performed for each drug indication and matched each trial with publications in the literature. The primary benchmark was the publication status 2 years post-approval. We examined the association between time to publication and drug type using a multilevel Cox regression model that was adjusted for clustering within drug indications and individual covariates.
Between 2011 and 2014, 36 anticancer drugs including 3 ICPis were newly approved by the FDA. Of 19 trials investigating the 3 ICPis, 11 (58%) were published within 2 years post-approval. We randomly selected 10 of the 33 remaining anticancer drugs; 68 of 101 trials investigating these drugs (67%) were published. Overall, the publication rate was 66% at 2 years post-approval with a median time to publication of 2.3 years. There was no significant difference in the time to trial publication between ICPis and other anticancer drugs (adjusted hazard ratio HR, 1.1; 95% confidence interval CI, 0.8-1.7; P = 0.55). However, findings related to non-ICPis investigated specifically in randomized phase 2 or phase 3 trials were significantly more likely to be published earlier than those related to ICPis (adjusted HR, 7.4; 95% CI, 1.8-29.5; P = 0.005).
One in 3 sponsor-submitted trials of the most recently approved anticancer drugs remained unpublished 2 years post-FDA approval. We found no evidence that the drug type was associated with the time to overall trial publication.
Although cancer management in dialysis patients has become a commonly encountered issue, known as "onco-nephrology", few evidence-based clinical recommendations have been proposed. Here, we examined ...the variation in referral behaviors adopted by dialysis physicians on encountering dialysis patients with signs/symptoms suggestive of cancer.
We conducted a vignette-based study in August 2015. We sent a 14-page questionnaire to 191 dialysis physicians, including the representative dialysis facilities participating in a Japanese dialysis cohort (the Japan Dialysis Outcomes and Practice Patterns Study). Using vignette scenarios for respiratory, digestive, and urological areas, we assessed the referral behaviors (expert referral or not) adopted by dialysis physicians on encountering dialysis patients with symptoms suggestive of cancer. Each scenario contained three patient functional factors: age (60 or 75 years), performance status (PS 0 or 1), and cognitive dysfunction (absence or presence). We examined the association between physician factors, patient factors, and referral behaviors.
We obtained 94 replies (response rate: 49.2%). For the respiratory scenarios, 38.3% and 51.9% of physicians reported watchful waiting when encountering bilateral and unilateral pleural effusion, respectively. In digestive and urologic scenarios, most physicians (>85%) selected expert referral. We detected differences in referral behaviors between scenarios with different cancer biological factors. However, we found consistency in referral behaviors within the same scenario, even with different patient functional factors (intra-class correlation coefficients within each scenario all >0.7).
Physicians' referral behaviors for dialysis patients suspected of having cancer vary for different cancer biological factors (probability of having cancer). However, the referral behaviors are similar for different patient functional factors (age, PS, and cognitive dysfunction).
Abstract Objectives The effect of response to first-line tyrosine kinase inhibitor (TKI) therapy on second-line survival in patients with metastatic renal cell carcinoma who receive second-line ...molecular-targeted therapy (mTT) after first-line failure remains unclear. Materials and methods Sixty patients who developed disease progression after first-line TKI, without prior cytokine therapy, were enrolled. According to the median first-line time to progression (1L-TTP), patients were divided into 2 groups (i.e., short vs. long). Second-line progression-free survival (2L-PFS) and second-line overall survival (2L-OS) were defined as the time from second-line mTT initiation. Survival was calculated with the Kaplan-Meier method and compared using the log-rank test between patients with short and long 1L-PFS. Predictors for survivals were identified using Cox proportional hazards regression models. Results The median 1L-TTP was 8.84 months. Thirty patients (50.0%) with short 1L-TTP (<8.84 mo) had significantly shorter 2L-PFS and 2L-OS compared to patients with long 1L-TTP (2L-PFS: 4.96 vs. 10.2 mo, P = 0.0002; 2L-OS: 9.6 vs. 28.0 mo, P = 0.0036). Multivariable analyses for 2L-PFS and 2L-OS showed that 1L-TTP was an independent predictor both as a categorical classification (cutoff: 8.84 mo) and as a continuous variable (both P <0.05). The median follow-up duration was 13.1 months (interquartile range: 6.56–24.7). Conclusions Patients who achieve a long-term response after first-line TKI therapy could have a favorable prognosis with second-line mTT.
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