We determined the efficacy of anesthesia for prostate biopsy by periprostatic lidocaine injection.
A total of 90 consecutive patients undergoing prostate biopsies were randomized into lidocaine and ...placebo groups of 45 each in double-blind fashion. A 5 ml. dose of 1% lidocaine or 0.9% sodium chloride was injected via 23 gauge needles inserted through the transrectal ultrasound probe working channel and aimed at the prostatic neurovascular bundles bilaterally. Patients completed a symptom questionnaire applying a visual analog scale of 0—none to 10—maximal addressing pre-procedure anxiety, overall pain and discomfort throughout the procedure, pain during biopsy punctures and patient tolerance, as judged by the operator. Student's t test was used to analyze continuous variables and the chi-square test was applied for categorical data. Linear regression was done to determine intervariable influences.
The average pain level throughout the procedure was 3.06 in the lidocaine group versus 4.15 in the control group (p = 0.04), while the pain level during biopsy punctures was 1.51 versus 3.98 (p = 0.0001) and patient tolerance was 1.06 versus 1.93 (p = 0.018). The level of discomfort throughout the procedure was lower in the lidocaine group with borderline significance (4.31 versus 5.24, p = 0.077). The lidocaine and control groups were comparable regarding average patient age (65 and 66 years, respectively). Prostate volume was similar in the 2 groups (68.5 versus 63 ml.). The median number of biopsy punctures was 7 and 8, respectively. Cancer was identified in 10 patients (22.2%) per group.
Periprostatic lidocaine injection is an effective method of anesthesia for prostate biopsy.
The VEGFR/PDGFR inhibitor sunitinib was approved in Israel in 2008 for the treatment of metastatic renal cell carcinoma (mRCC), based on an international trial. However, the efficacy of sunitinib ...treatment in Israeli mRCC patients has not been previously reported.
To report the outcome and associated factors of sunitinib treatment in a large cohort of Israeli mRCC patients.
We conducted a retrospective study of an unselected cohort of mRCC patients who were treated with sunitinib during the period 2006-2013 in six Israeli hospitals. Univariate and multivariate analyses were performed to determine the association between treatment outcome and clinicopathologic factors.
We identified 145 patients; the median age was 65 years, 63% were male, 80% had a nephrectomy, and 28% had prior systemic treatment. Seventy-nine percent (n = 115) had clinical benefit (complete response 5%, n = 7; partial response 33%, n = 48; stable disease 41%, n = 60); 21% (n = 30) were refractory to treatment. Median progression-free survival (PFS) was 12 months and median overall survival 21 months. Factors associated with clinical benefit were sunitinib-induced hypertension: odds ratio (OR) 3.6, P = 0.042 and sunitinib dose reduction or treatment interruption (OR 2.4, P = 0.049). Factors associated with PFS were female gender hazard ratio (HR) 2, P = 0.0041, pre-sunitinib treatment neutrophil-to-lymphocyte ratio < or = 3 (HR 2.19, P = 0.002), and active smoking (HR 0.19, P < 0.0001). Factors associated with overall survival were active smoking (HR 0.25, P < 0.0001) and sunitinib-induced hypertension (HR 0.48, P = 0.005). To minimize toxicity, the dose was reduced or the treatment interrupted in 39% (n = 57).
The efficacy of sunitinib treatment for mRCC among Israeli patients is similar to that in international data.
OBJECTIVE
To assess the clinical pattern of progression and prostate‐specific antigen doubling time (PSA‐DT) after exposure to docetaxel‐based chemotherapy in patients with androgen‐independent ...prostate cancer (AIPC).
PATIENTS AND METHODS
Fifty‐five patients received docetaxel‐based chemotherapy; data were collected retrospectively from three different departments. Progression was known in 44 (79%) and the PSA‐DT was available in 33 patients.
RESULTS
Of the 29 patients with soft‐tissue and soft‐tissue plus bone metastases, 22 (76%) developed soft‐tissue progression. Among the 35 patients with bone and bone plus soft‐tissue metastases, 27 (77%) had osseous progression. There was no difference between the PSA‐DT at progression before and after docetaxel‐based therapy (mean 3.1 vs 2.7 months, P = 0.592, Student’s t‐test.). However, the median (range) PSA‐DT at progression after docetaxel‐based therapy was 0.84 (0.3–4) months in patients with a PSA response, significantly shorter than the median of 3.1 (0.3–12) months of patients with no biochemical response (P = 0.002, Student’s t‐test). The PSA‐DT dynamics at progression had no effect on survival (P = 0.63, log‐rank test).
CONCLUSION
The pattern of progression after docetaxel‐based chemotherapy is predominantly osseous in patient with bone metastases and mostly soft‐tissue in those with soft‐tissue disease. Progression after docetaxel‐based chemotherapy in AIPC does not modify the PSA‐DT before docetaxel. Evaluation of a larger population is needed to assess the clinical relevance of PSA dynamics after docetaxel therapy.
Abstract Background Although studies in several cancer types suggest that metformin has antitumor activity, its effect on the outcome of targeted therapies in metastatic renal cell carcinoma (mRCC) ...is poorly defined. We aimed to analyze the effect of metformin use on the outcome sunitinib treatment in diabetic patients with mRCC. Materials and Methods We performed a retrospective study of diabetic patients with mRCC, who were treated with sunitinib in 8 centers across 2 countries. Patients were divided into metformin users and nonusers. The effect of metformin use on response rate, progression free survival (PFS), and overall survival (OS), was tested. Furthermore, univariate and multivariate analyses of association between clinicopathologic factors and metformin use, and outcome were performed using the entire patient cohort. Results Between 2004-2014, 108 diabetic patients with mRCC were treated with sunitinib. There were 52 metformin users (group 1) and 56 nonusers (group 2). The groups were balanced regarding clinicopathologic factors. Clinical benefit (partial response + stable disease) in group 1 versus 2 was 96% vs 84% (p=0.054). Median PFS was 15 vs 11.5 months (p=0.1). Median OS was 32 vs 21 months (p=0.001). In multivariate analyses of the entire patient cohort (n=108), factors associated with PFS were active smoking and pre-treatment neutrophil to lymphocyte ratio >3. Factors associated with OS were metformin use (HR 0.21, p<0.0001), HENG risk, active smoking, liver metastases, and pre-treatment neutrophil to lymphocyte ratio > 3. Conclusions Metformin may improve the OS of diabetic patients with mRCC that are treated with sunitinib.
Purpose We examined the prevalence of malignancy in a synchronous ipsilateral renal lesion identified during partial nephrectomy and evaluated its clinical significance. Materials and Methods We ...retrospectively reviewed the records of 112 patients (114 renal units) who underwent nephron sparing surgery for a clinically localized sporadic renal mass between May 1995 and September 2005. Results In 37 patients (32%) an additional lesion was diagnosed and excised intraoperatively, while in 67% these lesions were known before the operation and believed to be simple cysts. During surgery the additional mass was suspicious in 8 cases and in the remainder the mass was described as simple cysts that were excised. The mean size of the primary mass was 3.1 cm (SD 1.4). In 29 (78%) cases the primary mass was malignant, in 23 (79%) of these the second mass was benign and in the remainder renal cell carcinoma was diagnosed. In 8 cases (22%) the primary mass was benign and in 2 (25%) the secondary mass was malignant. Overall 22% of all second masses were malignant, and all were low grade and low stage. We found that 7% of second ipsilateral masses could be expected to harbor malignancy. Conclusions Based on our data it is questionable whether total nephrectomy is mandatory as an immediate response to an ipsilateral synchronous second renal mass. The present findings may represent an increased appreciation of ipsilateral multicentricity compared to historical data.
To describe the clinical parameters of low PSA, progressive metastatic androgen-independent prostate cancer.
From April 1995 to May 1999, we selected 18 patients with clinically progressive ...androgen-independent prostate cancer and low PSA (</=10 ng/ml). Patients received cisplatin-based therapy. Specimens from the primary tumor were reviewed and neuroendocrine differentiation was determined with chromogranin-A and neuron-specific enolase immunocytochemical staining.
The median initial PSA level was 1.6 ng/ml (0-9.5). Each patient demonstrated elevation of at least one of the following markers: carcinoembryonic antigen, CA 19-9, CA15-3 and CA 125 CA. Metastases involved bone in 11 patients (61.1%) - 5 (27.7%) blastic, 2 (11.1%) lytic, and 4 (22.2%) combined - liver in 10 patients (55.5%), lymph nodes in 8 (44.4%), and lung in 6 (33.3%); solitary sites as orbit, skin and spleen were noted as well. A prostatic pelvic mass was detected in 13 patients (72.2%). Of the 12 patients who consented to chemotherapy, 8 (66.6%) achieved an objective response (95% CI, 34. 8-90%), including 1 patient with complete response. Hematoxylin and eosin evaluation revealed two major groups: neuroendocrine tumors, either pure small cell cancer in 6 patients (37.5%) or combined small cell cancer and adenocarcinoma in 8 (50%), and predominant poorly differentiated prostate cancer in 2 (12.5%). Neuroendocrine immunoreactivity was detected in all the specimens.
Progressive androgen-independent prostate cancer with low serum PSA is characterized by visceral metastases, high proportion of lytic bone disease, sensitivity to cisplatin-based chemotherapy, and histological features of small cell or poorly differentiated prostate cancer. In this subgroup of patients, selection of the therapeutic approach can be based on clinical parameters. The rise of the serum markers may aid in the diagnosis and follow-up of these patients.
Epistaxis during Treatment with Paclitaxel Yarom, Nirit; Cyjon, Arnoldo; Kovel, Svetlana ...
Basic & clinical pharmacology & toxicology,
March 2009, Volume:
104, Issue:
3
Journal Article
Peer reviewed
Open access
: The purpose of this study was to determine the incidence and severity of epistaxis in patients treated with paclitaxel. Patients who were treated with paclitaxel filled a questionnaire regarding ...their general health, medications and incidents of epistaxis. Relevant clinical information was obtained from the patients’ charts. Forty‐seven consecutive patients were recruited to the study. Twenty‐four (51%) of the patients reported epistaxis during paclitaxel therapy. Twenty‐three of 39 (59%) patients who received weekly paclitaxel had epistaxis at least once during treatment, compared with one out of eight patients who were treated every 3 weeks (P = 0.045). All episodes of epistaxis were mild, occurred with normal platelets counts and did not require blood product transfusions or treatment modification. The majority of the patients experienced the first episode of epistaxis on the third week of weekly paclitaxel treatment and then repeatedly throughout therapy. It is concluded that epistaxis is a common mild side‐effect of weekly paclitaxel that has not been reported previously. In this trial, epistaxis did not have any major clinical consequences. However, when paclitaxel is combined with other drugs that may cause bleeding, such as bevacizumab, physicians should be alerted to the potential risk of this phenomenon.
Of 920 patients with histologically confirmed renal cell carcinoma (RCC) seen at University of Texas M. D. Anderson Hospital over a 10‐year period, 44 (4.8%) had the sarcomatoid variant. The authors ...show that, although sarcomatoid RCC has as common denominators with classic RCC in certain epidemiologic parameters such as age and sex, its biologic behavior is different. It is more malignant, has a higher metastatic rate, ultimate recurrence in localized disease which translates to a shorter survival time. Metastasis at presentation, advanced age (older than 59 years) and female sex were a associate with a worse prognosis. This entity is characterized by a high incidence of bone metastasis at presentation (48%) and by a tendency toward pathologic bone fractures. All of the untreated patients died very soon after diagnosis (median, 3.8 months), whereas all of the patients treated with the various systemic modalities initiated only in the presence of metastatic disease survived significantly longer (median, 13.0 months). Of the eight patients who were treated with doxorubicin HCl chemotherapy regimens two (on CYVADIC) showed complete responses and are the only survivors (50, 65 months). Four patients treated with interferon had the longest median survival (41.0 months). These results suggest that CYVADIC chemotherapy should be combined with interferon in this entity. Since surgery is not curative in early stages of sarcomatoid RCC, adjuvant therapy with those agents should be considered.