Active Surveillance of Papillary Thyroid Cancer: Frequency and Time Course of the Six Most Common Tumor Volume Kinetic Patterns.

Background: The change in size of the papillary thyroid cancer (PTC) nodule during active surveillance has traditionally been characterized as either stable, increasing, or decreasing based on changes in maximal tumor diameter or tumor volume. More recently, it has been observed that the changes in tumor size observed during observation are more complex with tumor volume kinetic patterns that can be characterized either as stable (Pattern I), early increase in volume (Pattern II), later increase in volume (Pattern III), early increase in volume followed by stability (Pattern IV), stability followed by an increase in volume (Pattern V), or a decrease in tumor volume (Pattern VI). Methods: The frequency, time course, and clinical correlates of these six tumor volume kinetic patterns were analyzed in a cohort of 483 patients with low-risk PTC up to 1.5 cm in maximal diameter followed with active surveillance at our center for a median of 3.7 years. Results: The cumulative incidence of an increase in tumor volume for the entire cohort was 15.9% [confidence interval (CI) 11.8-20.0] at 5 years. At 5 years, most tumors demonstrated stability (78.8%, Pattern I) with 10.0% showing early growth (Pattern II), 4.1% late growth (Pattern III), 1.9% growth then stability (Pattern IV), 0.6% stability then growth (Pattern V), and 5.6% with a decrease in tumor volume (Pattern VI). Tumor volume doubling time during exponential growth significantly differed across the kinetic patterns, with median values of 2.4, 7.1, and 3.3 years for Patterns II, III, and IV, respectively (p < 0.01). Similarly, the time to a change in tumor volume was significantly different across the kinetic patterns, with median values of 1.5, 3, 1.6, 4.7, and 4.1 years for Patterns II, III, IV, V, and VI, respectively (analysis of variance, p < 0.01). Clinical correlates at baseline were not associated with tumor volume kinetic pattern. Conclusions: These six kinetic tumor volume patterns provide a comprehensive description of the changes in PTC tumor volume observed during the first 5 years of active surveillance.

Natural History and Tumor Volume Kinetics of Papillary Thyroid Cancers During Active Surveillance.

Importance: Active surveillance of low-risk papillary thyroid cancer (PTC) is now an accepted alternative to immediate surgery, but experience with this approach outside of Japan is limited. The kinetics (probability, rate, and magnitude) of PTC tumor growth under active surveillance have not been well defined. Objective: To describe the kinetics of PTC tumor growth during active surveillance. Design, Setting, and Participants: Cohort study of 291 patients undergoing active surveillance for low-risk PTC (intrathyroidal tumors ≤1.5 cm) with serial tumor measurements via ultrasonography at a tertiary referral center in the United States. Intervention: Active surveillance. Main Outcomes and Measures: The cumulative incidence, rate, and magnitude of the change in tumor diameter or volume, as well as associations with patient and tumor characteristics. Results: Of the 291 patients, 219 (75.3%) were women; mean (SD) age was 52 (15) years. During a median (range) active surveillance of 25 (6-166) months, growth in tumor diameter of 3 mm or more was observed in 11 of 291 (3.8%) patients, with a cumulative incidence of 2.5% (2 years) and 12.1% (5 years). No regional or distant metastases developed during active surveillance. In all cases, 3-dimensional measurements of tumor volume allowed for earlier identification of growth (median, 8.2 months; range, 3-46 months before increase in tumor diameter). In multivariable analysis, both younger age at diagnosis (hazard ratio per year, 0.92; 95% CI, 0.87-0.98; P = .006) and risk category at presentation (hazard ratio for inappropriate, 55.17; 95% CI, 9.4-323.19; P < .001) were independently associated with the likelihood of tumor growth. Of the tumors experiencing volume growth, kinetics demonstrated a classic exponential growth pattern, with a median doubling time of 2.2 years (range, 0.5-4.8 years; median r2 = 0.75; range, 0.42-0.99). Conclusions and Relevance: The rates of tumor growth during active surveillance in a US cohort with PTCs measuring 1.5 cm or less were low. Serial measurement of tumor volumes may facilitate early identification of tumors that will continue to grow and thereby inform the timing of surveillance imaging and therapeutic interventions.

Causes of Avascular Hypoechoic Testicular Lesions Detected at Scrotal Ultrasound: Can They Be Considered Benign?

OBJECTIVE: The purposes of this study were to determine the cause of avascular hypoechoic lesions detected at scrotal ultrasound and to assess usefulness of sonographic and clinical features in differentiating benign from malignant etiologic factors. MATERIALS AND METHODS: This retrospective study included 58 patients with avascular hypoechoic lesions detected at testicular ultrasound. The sonographic features recorded were lesion size and margins and presence of peripheral vascularity and focal calcifications. Also recorded were patient age, symptoms, risk factors, lesion palpability, and levels of serum tumor markers. The reference standard was pathologic results or at least 2-year stability documented with serial follow-up ultrasound studies. Features associated with malignant, including burnt-out, lesions and benign lesions were examined by Fisher exact test, Wilcox-on rank sum test, and the generalized estimating equations method for multivariable models. RESULTS: Sixty-three lesions were identified in 58 patients; 40 of the 63 (63.5%) were benign. Patients with malignant lesions had elevated serum tumor marker levels more often than patients who had benign lesions (26.1% versus 5.7%, p = 0.043). The clinical palpability of lesions and history of testicular cancer were not statistically significantly different between patients with malignant and those with benign lesions. Poorly defined margins of a lesion and focal calcification within the lesion were more often found in malignant lesions. Maximal size of a lesion and peripheral vascularity were not associated with either the benign or the malignant nature of a lesion. CONCLUSION: Although most avascular hypoechoic testicular lesions are benign, a substantial proportion are malignant. The ultrasound characteristics of a lesion, the patient's clinical presentation, and serum tumor marker status may be useful in differentiating malignant from benign lesions.

Incidental Detection of Femoral Pseudoaneurysm at 18F-FDG PET/CT.

A 72-year-old man with history of lung cancer and melanoma was referred for routine follow-up with 18F-FDG PET/CT. CT images showed a new mass in the right groin associated with mild FDG activity on 18F-FDG PET images. Subsequent ultrasound obtained the same day demonstrated flow within the lesion to be a pseudoaneurysm of the right femoral artery.

SERIAL NECK ULTRASOUND IS MORE LIKELY TO IDENTIFY FALSE-POSITIVE ABNORMALITIES THAN CLINICALLY SIGNIFICANT DISEASE IN LOW-RISK PAPILLARY THYROID CANCER PATIENTS.

OBJECTIVE: American Thyroid Association (ATA) low-risk papillary thyroid cancer (PTC) patients without structural evidence of disease on initial posttreatment evaluation have a low risk of recurrence. Despite this, most patients undergo frequent surveillance neck ultrasound (US). The objective of the study was to evaluate the clinical utility of routine neck US in ATA low-risk PTC patients with no structural evidence of disease after their initial thyroid surgery. METHODS: We performed a retrospective review of 171 ATA low-risk PTC patients after total thyroidectomy, with or without radioactive iodine (RAI) ablation, who had a neck US without suspicious findings after therapy. The main outcome measure was a comparison of the frequency of finding false-positive US abnormalities and the frequency of identifying structural disease recurrence. RESULTS: Over a median follow-up of 8 years, 171 patients underwent a median of 5 neck US (range 2-17). Structural recurrence with low-volume disease (≤1 cm) was identified in 1.2% (2/171) of patients at a median of 2.8 years (range 1.6-4.1 years) after their initial diagnosis. Recurrence was associated with rising serum thyroglobulin (Tg) level in 1 of the 2 patients and was detected without signs of biochemical recurrence in the other patient. Conversely, false-positive US abnormalities were identified in 67% (114/171) of patients after therapy, leading to additional testing without identifying clinically significant disease. CONCLUSION: In ATA low-risk patients without structural evidence of disease on initial surveillance evaluation, routine screening US is substantially more likely to identify false-positive results than clinically significant structural disease recurrence.

Frequent screening with serial neck ultrasound is more likely to identify false-positive abnormalities than clinically significant disease in the surveillance of intermediate risk papillary thyroid cancer patients without suspicious findings on follow-up ultrasound evaluation.

CONTEXT: American Thyroid Association (ATA) intermediate-risk thyroid cancer patients who achieve an excellent treatment response demonstrate a low risk of structural disease recurrence. Despite this fact, most patients undergo frequent surveillance neck ultrasound (US) during follow-up. OBJECTIVE: The objective of the study was to evaluate the clinical utility of routine screening neck US in ATA intermediate-risk patients documented to have a nonstimulated thyroglobulin less than 1.0 ng/mL and a neck US without suspicious findings after therapy. PATIENTS AND DESIGN: Retrospective review of 90 ATA intermediate-risk papillary thyroid carcinoma patients treated with total thyroidectomy and radioactive iodine ablation in a tertiary referral center. MAIN OUTCOME MEASURES: A comparison between the frequency of finding false-positive US abnormalities and the frequency of identifying structural disease recurrence in the study cohort was measured. RESULTS: Over a median of 10 years, 90 patients had a median of six US (range 2-16). Structural disease recurrence was identified in 10% (9 of 90) at a median of 6.3 years. Recurrence was associated with other clinical indicators of disease in 5 of the 90 patients (5.6%, 5 of 90) and was detected without other signs of recurrence in four patients (4.8%, 4 of 84). False-positive US abnormalities were identified in 57% (51 of 90), leading to additional testing, which failed to identify clinically significant disease. CONCLUSIONS: In ATA intermediate-risk patients who have a nonstimulated thyroglobulin less than 1.0 ng/mL and a neck US without suspicious findings after therapy, frequent US screening during follow-up is more likely to identify false-positive abnormalities than clinically significant structural disease recurrence.

Randomized phase II trial of weekly vs. every 2 weeks vs. every 3 weeks nanoparticle albumin-bound paclitaxel with bevacizumab as first-line chemotherapy for metastatic breast cancer.

BACKGROUND: Nanoparticle albumin-bound paclitaxel (nab-P) and bevacizumab have each demonstrated efficacy in patients with MBC. This trial was designed to further develop nab-P by evaluating its efficacy and safety using every 3 weeks (q3w), every 2 weeks (q2w), or weekly scheduling in combination with bevacizumab as first-line treatment of MBC. PATIENTS AND METHODS: This open-label phase II study randomized patients to nab-P 260 mg/m(2) q3w (arm A) vs. 260 mg/m(2) q2w with filgrastim (arm B) vs. 130 mg/m(2) weekly uninterrupted, all with bevacizumab (15 mg/kg q3w arm A, 10 mg/kg q2w arms B and C). The primary endpoints were overall response rate (ORR) and toxicity. Time to tumor progression (TTP) and overall survival were secondary endpoints. RESULTS: Of 212 patients randomized, 208 (arm A, 75; arm B, 54; arm C, 79) were treated. Arm B was closed early due to toxicity, with more grade ≥ 2 fatigue (arm A, 46%; arm B, 62%; arm C, 62%) and bone pain (arm A, 11%; arm B, 23%; arm C, 5%). Neurotoxicity grade ≥ 2 was equivalent across the arms (> 50%) and reversible for most patients. Febrile neutropenia occurred in ≤ 3% of patients in all arms. ORR was similar among the arms (arm A, 45%; arm B, 41%; arm C, 46%). Median TTP was slightly longer in arm C (9.0 months) vs. arms A (8.0 months) and B (5.8 months) (overall, P = .105). CONCLUSIONS: Significant antitumor activity was observed in all the arms. Weekly nab-P with bevacizumab appeared to have the highest therapeutic index. However, sensory neuropathy was treatment limiting, which suggests that a 3 weeks on and 1 week off schedule should be explored.

Phase II trial of weekly nanoparticle albumin-bound paclitaxel with carboplatin and trastuzumab as first-line therapy for women with HER2-overexpressing metastatic breast cancer.

PURPOSE: This multicenter phase II trial evaluated the efficacy and safety of weekly nanoparticle albumin-bound paclitaxel with carboplatin and weekly trastuzumab as first-line therapy for women with HER2-overexpressing metastatic breast cancer (MBC). PATIENTS AND METHODS: We treated 32 patients who had measurable MBC that was HER2-positive defined by an immunohistochemical staining score of 3+ or gene amplification by fluorescence in situ hybridization, required for those with an IHC of 2+. Patients were treated with albumin-bound paclitaxel 100 mg/m2 and carboplatin at area under the curve (AUC) = 2 on days 1, 8, and 15 of a 28-day cycle. Trastuzumab was administered at 2 mg/kg weekly after a loading dose of 4 mg/kg. Because of hypersensitivity reactions occurring during carboplatin infusion numbers 6-8 in 4 of the first 13 patients with this premedication-free regimen, the protocol was amended for carboplatin and dosed at AUC = 6 day 1 each 28-day cycle, in lieu of introducing steroid prophylaxis. Patients were treated with 6 cycles and allowed to continue with all 3 drugs or trastuzumab alone if free of progression and unacceptable toxicity after 6 cycles. RESULTS: The overall response rate (ORR) was 62.5% (95% CI, 45.7%-79.3%) with 3 confirmed complete responders (CRs; 9%) and 17 confirmed partial responses (PRs; 53%). An additional 6 patients (19%) had stable disease (SD) for greater than 16 weeks for a clinical benefit rate (ORR + SD > 16 weeks) of 81%. As of April 16, 2009, 20 patients (63%) had progressed with a median progression-free survival (PFS) of 16.6 months (95% CI, 7.5-26.5 months). Antitumor activity was similar for patients treated with weekly carboplatin and every-4-week carboplatin (ORR, 65% vs. 67%, respectively). Hematologic toxicities were the only grade 4 toxicities noted and were infrequent with grade 4 neutropenia in 3 patients (9%) and 1 febrile neutropenia. Grade 2/3 peripheral neuropathy was uncommon (13%/3%). CONCLUSION: Weekly albumin-bound paclitaxel with carboplatin and trastuzumab is highly active in HER2-overexpressing MBC. In the absence of corticosteroid premedication, which we avoided with albumin-bound paclitaxel, carboplatin seems best dosed every 4 weeks rather than weekly because of carboplatin-associated hypersensitivity reactions. The regimen was very well tolerated with few grade 3 and 4 nonhematologic toxicities experienced, and severe hematologic toxicity and peripheral neuropathy were infrequent.

Metanephric adenoma of the kidney: clinical and radiological study of nine cases.

OBJECTIVE To analyse the clinical and radiological features of metanephric adenoma (MA, a rare benign renal tumour) in nine patients, and to review previous reports. PATIENTS AND METHODS From 1992 to 2007, we identified nine patients (eight women and one man) with MA at our institution. Four patients had a radical nephrectomy and five a partial nephrectomy. Preoperative imaging was reviewed by a senior radiologist. Renal colour Doppler ultrasonography (US), abdominal computed tomography and abdominal magnetic resonance imaging were used in seven, eight and four patients, respectively. RESULTS The mean (range) age of the patients was 46.8 (19-79) years. Six tumours were discovered incidentally. Three patients were symptomatic (two with haematuria and one with polycythaemia). There was no vascular flow on colour Doppler US within the tumours. There were peripheral and/or central calcifications in six of the tumours. All the tumours were well-circumscribed with minimal enhancement after injection with non-ionic intravenous contrast or gadolinium. CONCLUSIONS Renal MA is a benign tumour occurring mainly in young and middle-aged women. Polycythaemia is associated in approximately 10%. Generally, MA is solid, well-circumscribed and hypovascular, often with calcifications. Based on a combination of clinical and imaging features, it might be possible to suspect the diagnosis of MA and propose a preoperative diagnostic biopsy, a partial nephrectomy or active surveillance.

Contemporary radiologic imaging of renal cortical tumors.

Contemporary radiologic imaging has resulted in an increasing number of smaller renal cortical tumors being identified. The ability of imaging to classify these tumors is limited, although certain features may help classify the renal cortical neoplasm. The important role of radiologic imaging in tumor detection, characterization, staging, and follow-up of patients who have renal cortical tumors is reviewed in this article.

Tumor location does not affect long-term renal function after partial nephrectomy.

OBJECTIVES: To study the effect of central tumor location on the glomerular filtration rate (GFR) after partial nephrectomy for renal cortical tumor. METHODS: We reviewed our institutional database to identify patients who had undergone partial nephrectomy from January 1995 to July 2005. Central tumors were defined as those encroaching on the collecting system or renal sinus or that did not distort the renal contour; all others were categorized as peripheral on preoperative abdominal imaging. We calculated the GFR preoperatively, during the hospital stay, and at 1 and 12 months after surgery. Linear regression models were fit to determine the association of tumor location with the changes in GFR at each period, after controlling for age, sex, operative and ischemic times, comorbidities, and blood loss. RESULTS: A total of 248 central and 333 peripheral tumors were available for analysis. Patients with central tumors were younger than those with peripheral tumors (62 versus 59 years, P = 0.014) and experienced longer intraoperative renal ischemia times (40 versus 29 minutes, P <0.001) and longer operations (195 versus 179 minutes, P = 0.004). On multivariate analysis, tumor location was not significantly associated with the change in GFR at any of the intervals, after adjusting for the covariates. CONCLUSIONS: The results of our study have indicated that tumor location does not appear to affect long-term renal function. Thus, partial nephrectomy should not be withheld from this subset of patients.

A case of Castleman's disease that presented as a retroperitoneal mass.

BACKGROUND: A 35-year -old man presented to a local emergency room with acute left-flank pain and a medical history of nephrolithiasis. There were no aggravating or relieving factors for the left-flank pain and no other presenting symptoms, and the physical examination was unremarkable. INVESTIGATIONS: Complete blood count, urinalysis, serum tumor markers, scrotal ultrasonography, CT scan of the abdomen (with and without contrast), MRI of the abdomen. DIAGNOSIS: Unicentric Castleman's disease (hyaline-vascular type). MANAGEMENT: Surgical exploration and excision. Pathologic and immunohistochemical work-up confirmed the diagnosis. CT scan after 7 months was normal with no evidence of recurrence.

Predicting the histology of renal masses using preoperative Doppler ultrasonography.

PURPOSE: Traditional imaging techniques cannot differentiate among benign, indolent and malignant renal neoplasms. Since conventional clear cell carcinomas are highly vascular, we used preoperative color and/or power Doppler ultrasonography to evaluate the association between vascular flow in a renal mass and surgical pathology. MATERIALS AND METHODS: Nephrectomies performed at our institution between January 2001 and December 2004 were retrospectively evaluated. Any detection of flow in the renal mass on color Doppler ultrasonography was defined as vascular flow. A prospective validation study was then performed from January 2005 to October 2005 and a nomogram was constructed to predict clear cell histology. RESULTS: Of 299 renal lesions in the retrospective cohort 210 (70%) had evidence of vascular flow, including 156 of 169 conventional clear cell carcinomas (92%) (p <0.0001). On logistic regression analysis vascular flow was associated with conventional clear cell histology (OR 16.9, 95% CI 8.7-32.8; p <0.0001). This finding was validated prospectively in 97 patients. Vascular flow was detected in 54 of 65 renal masses (83%) with conventional clear cell histology (p <0.0001), which was associated with an OR of 10.8 (95% CI 4.0-29.0; p <0.0001). A nomogram incorporating vascular flow along with clinical variables (clinical size, patient sex and age) to predict conventional clear cell histology was constructed on the retrospective cohort and validated on the prospective data set (concordance index 0.82 and 0.76, respectively). CONCLUSIONS: Vascular flow detected by color Doppler ultrasonography is strongly associated with conventional clear cell histology. A nomogram incorporating vascular flow on color Doppler ultrasonography and clinical parameters may aid in the preoperative characterization of renal lesions.

Imaging of kidney cancer.

Advances in molecular genetics have expanded the understanding of renal cell tumors. Now it is understood that renal cortical tumors are a family of neoplasms with distinct cytogenetics and molecular defects, unique histopathologic features, and different malignant potentials. Imaging contributes to clinical management of patients with renal tumors in providing diagnostic information for tumor detection, characterization, staging, treatment planning, and follow-up.

Imaging of bladder cancer.

Bladder cancer is a heterogeneous and frequently multifocal disease with a variable clinical course. The management of bladder cancer is therefore challenging and complicated. CT and MR imaging have replaced the traditional excretory urography and are emerging as the imaging modalities of choice for work-up of patients who have bladder cancer. Imaging provides essential diagnostic information for detection, staging, and post-treatment follow-up of bladder cancer.

Incidence of benign lesions for clinically localized renal masses smaller than 7 cm in radiological diameter: influence of sex.

PURPOSE: We determined the incidence of benign renal lesions in patients undergoing definitive surgery for localized renal masses 7 cm or less in maximum radiological diameter, and assessed preoperative and clinical parameters associated with benign histology. MATERIALS AND METHODS: The records of 1,184 patients who underwent consecutive partial or radical nephrectomies between January 2000 and January 2005 were retrospectively reviewed. We excluded 208 patients with lesions more than 7 cm in maximum radiological diameter, 17 with evidence of renal vein or vena caval invasion, 75 with suspected or documented metastatic disease, 28 with a history of renal cell carcinoma and 41 with no available imaging. Logistic regression was done to determine clinical factors associated with benign renal masses, including radiological tumor size, cystic vs solid appearance, patient sex, age, presenting symptoms and race. RESULTS: Of 815 nephrectomies in our data set 134 (16.4%) were associated with benign lesions, including oncocytoma in 87 (10.7%), angiomyolipoma in 17 (2%), simple cysts in 10 (1.2%), metanephric adenoma in 8 (1%), cystic nephroma in 5 (0.6%) and other in 7. On multivariate logistic regression analysis only sex was significantly associated with benign histology with females having an OR of 1.8 (95% CI 1.2 to 2.6, p = 0.002). Tumor size was not independently associated with benign histology (p = 0.13). CONCLUSIONS: A significant number (16.4%) of benign lesions less than 7 cm in radiological diameter were operated on based on suspicious preoperative imaging. Women had almost twice the likelihood of having a benign lesion.

The impact of tumour location on the histological subtype of renal cortical tumours.

OBJECTIVE: To determine whether the location of renal cortical tumours (RCTs) is a possible factor affecting tumour behaviour, by investigating whether exophytic vs a central location is associated with a difference in histological subtype distribution, as recognized prognostic factors for RCTs include size, stage, grade, and histological subtype. PATIENTS AND METHODS: Between 1 January 1996 and 1 June 2003, we evaluated 485 consecutive RCTs in 469 patients who had renal imaging studies and underwent either partial or radical nephrectomy at our institution. A radiologist and a urologist independently reviewed the imaging studies of all patients to determine exophytic vs central location. An exophytic lesion was defined as one that clearly both pushed out the renal contour and did not extend into the collecting system, hilum, or renal sinus. A lesion that did not meet these criteria was defined as a central lesion. Logistic regression analysis was used to determine if either type of lesion had a greater representation of any histological subtype. A two-tailed P < or = 0.05 was considered to indicate significance. RESULTS: Of the 485 RCTs, 171 (35%) were exophytic and 314 (65%) were central, while 308 (64%) were clear cell and 177 (36%) were non-clear cell tumour histology. Of the exophytic lesions, 52.0% were clear cell, while 69.7% of central lesions were clear cell (P < 0.001). Conversely, 71.1% of clear cell tumours were central, while 53.7% of non-clear cell tumours were central (P = 0.003). After controlling for size and stage, tumour location remained associated with histological subtype (P = 0.003). CONCLUSIONS: Exophytic lesions are significantly more likely than central lesions to be non-clear cell tumours, and clear cell tumours are significantly more likely than non-clear cell tumours to be central. As studies indicate that the clear cell histological subtype portends a worse prognosis than the non-clear cell subtype, our results imply that tumour location affects the prognosis in RCTs, with exophytic lesions having a better prognosis than central lesions. This result may have important implications for physicians and patients when planning partial vs radical nephrectomy by either open or minimally invasive techniques.

Comparison of outcomes in elective partial vs radical nephrectomy for clear cell renal cell carcinoma of 4-7 cm.

OBJECTIVE: To compare the outcomes of patients who had a elective partial nephrectomy (PN) or radical nephrectomy (RN) for clear cell renal cell carcinoma (RCC) of 4-7 cm. PATIENTS AND METHODS: From March 1998 to July 2004, 45 and 151 patients underwent PN and RN, respectively, for clear cell RCC. A multivariate Cox model was constructed for disease-free survival with adjustment for markers of disease severity, and a propensity-score approach used as a confirmatory analysis. RESULTS: In the PN and RN cohorts the treatment failed in one and 20 patients, respectively; the median follow-up was 21 months. The hazard ratio (95% confidence interval) for PN after adjusting for disease severity was 0.36 (0.05-2.82; P = 0.3). Using planned PN as a predictor (intent-to-treat analysis) the hazard ratio was 1.06 (0.32-3.53; P = 0.9). In the propensity-score model, planned PN was associated with a hazard ratio of 1.75 (0.50-6.14; P = 0.4). The serum creatinine level 3 months after surgery was significantly lower in patients who had PN, with a difference between the means of 0.36 (0.23-0.48; P < 0.001). CONCLUSIONS: Renal function was preserved after PN for 4-7 cm clear cell RCC tumours. When comparing the outcomes of PN and RN it is important to consider the intended operation as an independent variable. There was no clear evidence that PN was associated with worse cancer control, although a continued follow-up of this and other cohorts is warranted.

A phase II trial of gemcitabine in patients with metastatic breast cancer previously treated with an anthracycline and taxane.

PURPOSE: This study was designed to evaluate the efficacy and safety of single-agent gemcitabine for the treatment of patients with anthracycline- and taxane-pretreated metastatic breast cancer (MBC). Eligible patients were required to have bidimensionally measurable MBC that had been treated with 2-4 prior chemotherapy regimens that included an anthracycline and a taxane. Gemcitabine was delivered at a dose of 800 mg/m2 on days 1, 8, and 15 of a 28-day cycle until evidence of disease progression. PATIENTS AND METHODS: Twenty-two patients were enrolled and included in the safety analysis; 18 patients were evaluable for response. The median age of patients was 54 years (range, 36-70 years). The mean number of prior chemotherapy regimens for metastatic disease was 2.3, and the mean dose of gemcitabine delivered was 911 mg/m2 (range, 600-1600 mg/m2). RESULTS: Overall, gemcitabine was well tolerated with minimal grade 3 toxicities; the only grade 4 toxicity was 1 case of pulmonary embolus. Three patients had evidence of partial tumor regression (17%; 95% CI, 4%-41%), and 1 patient had a 41% decrease in tumor volume, including liver metastasis. CONCLUSIONS: Gemcitabine is active and well tolerated as monotherapy given in heavily pretreated patients with MBC after anthracyclines and taxanes. The activity and safety reported in this trial are consistent with previous reports in similar patients.

Pilot study prospectively evaluating the use of the measurement of preoperative sonographic endometrial thickness in postmenopausal patients with endometrial cancer.

OBJECTIVE: The value of sonographic evaluation of the endometrial thickness as a screening or a prognostic tool for endometrial cancer remains controversial. The objective of this study was to prospectively evaluate the endometrial thickness in women with known endometrial cancer to assess the predictive value of this modality and its preoperative use in this disease. DESIGN: In a prospective, nonrandomized trial, 29 patients with pathologically confirmed endometrial cancer had preoperative transvaginal ultrasound and endometrial thickness evaluated. Body mass index (BMI) and endometrial thickness were recorded and correlated with surgical and pathologic information. RESULTS: The median age at diagnosis of endometrial cancer was 61.6 years (range, 48-87 years). Tumor grade was as follows: grade 1, 23; grade 2, 3; and grade 3, 3. All patients had an endometrial stripe of 5.0 mm or more. The median preoperative sonographic endometrial stripe was 12.0 mm (range, 5.0-32.0 mm). After surgery, 25 patients (86%) were diagnosed with International Federation of Gynecology and Obstetrics (FIGO) stage I disease (IA, 8; IB, 14; IC, 3), 2 (7%) with stage II disease, and 2 (7%) with stage III disease. Median BMI was 33 (range, 20-56). The patients' BMIs were found to be directly associated with endometrial thickness (rank correlation = 0.39; P = 0.03). Stage was only marginally associated with endometrial thickness (correlation 0.23; P = 0.07). Sonographic endometrial thickness was not associated with depth of myometrial invasion. No correlation was found between endometrial thickness and patient age or tumor grade. CONCLUSIONS: Although patients with endometrial cancer and a high BMI are likely to have a thickened endometrial stripe, endometrial thickness does not correlate with tumor grade or stage. The use of preoperative transvaginal ultrasound in diagnosed endometrial cancer appears limited.