Treatment outcome and survival associated with metastatic renal cell carcinoma of non-clear-cell histology.

PURPOSE: To define outcome data for patients with metastatic renal cell carcinoma (RCC) with histology other than clear-cell type, including collecting duct (or medullary carcinoma), papillary, chromophobe, and unclassified histologies. PATIENTS AND METHODS: Sixty-four patients with metastatic non-clear-cell RCC histology were the subjects of this retrospective review. Included in the analysis were 22 (8%) of 286 patients from a clinical trials database, 19 of 1,166 patients from a surgery database, and 23 of 357 patients from a pathology database. RESULTS: The prevalent histology was collecting duct, present in 26 (41%) patients. The number of patients with chromophobe and papillary histologies was 12 (19%) and 18 (28%), respectively. Eight (12%) of the patients had tumors that could not be classified for specific tumor histology. Among the 43 patients treated with 86 systemic therapies, including 37 cytokine therapies, two patients (5%) were observed to have a partial response. The median overall survival time was 9.4 months (95% confidence interval, 8 to 14 months). The survival was longer for patients with chromophobe tumors compared with collecting duct or papillary histology, and this group included four patients with survival of greater than 3 years. CONCLUSION: RCC consists of a heterogeneous group of tumors including clear-cell, papillary, chromophobe, collecting duct, and unclassified cell types. Non-clear-cell histologies constitute less than 10% of patients in general populations of patients with advanced RCC treated on clinical trials. Metastatic non-clear-cell RCC is characterized by a resistance to systemic therapy and poor survival, with the survival for patients with chromophobe tumors longer than that for patients with metastatic collecting duct or papillary RCC. Treatment with novel agents on clinical trials is warranted.     

Pain Adversely Affects Outcomes to a Collaborative Care Intervention for Anxiety in Primary Care

BACKGROUND

Primary care patients with Panic Disorder (PD) and Generalized Anxiety Disorder (GAD) experience poorer than expected clinical outcomes, despite the availability of efficacious pharmacologic and non-pharmacologic treatments. A barrier to recovery from PD/GAD may be the co-occurrence of pain.

OBJECTIVE

To evaluate whether pain intensity interfered with treatment response for PD and/or GAD in primary care patients who had received collaborative care for anxiety disorders.

DESIGN

A secondary data analysis of a randomized, controlled effectiveness trial comparing a telephone-delivered collaborative care intervention for primary care patients with severe PD and/or GAD to their doctor’s “usual” care.

PARTICIPANTS

Patients had to have a diagnosis of PD and/or GAD and a severe level of anxiety symptoms. The 124 patients randomized at baseline to the collaborative care intervention were analyzed. Participants were divided into two pain intensity groups based on their response to the SF-36 Bodily Pain scale (none or mild pain vs. at least moderate pain).

MAIN MEASURES

Pain was assessed using the Bodily Pain scale of the SF-36. Anxiety symptoms were measured with the Hamilton Anxiety Rating Scale (HRS-A), Panic Disorder Severity Scale (PDSS) and Generalized Anxiety Disorder Severity Scale (GADSS). Measures were collected over 12 months.

KEY RESULTS

At baseline, patients with at least moderate pain were significantly more likely to endorse more anxiety symptoms on the HRS-A than patients with no pain or mild pain (P?<?.001). Among patients with severe anxiety symptoms, 65 % (80/124) endorsed experiencing at least moderate pain in the previous month. A significantly lesser number of patients achieved a 50 % improvement at 12 months on the HRS-A and GADSS if they had at least moderate pain as compared to patients with little or no pain (P?=?0.01 and P?=?0.04, respectively).

CONCLUSIONS

Coexisting pain was common in a sample of primary care patients with severe PD/GAD, and appeared to negatively affect response to anxiety treatment.     

Phase II clinical trial of parenteral hydroxyurea and hyper-fractionated, accelerated external beam radiation therapy in patients with advanced squamous cell carcinoma of the head and neck: toxicity and efficacy with continuous ribonucleoside reductase inhibition

BACKGROUND: Almost all concurrent chemoradiation regimens for head and neck are platinum based; however, cisplatin is associated with severe renal, oto-, and neurotoxicity. Hydroxyurea (HU) has been associated with fewer irreversible toxicities. We obtained HU in parenteral form to be administered continually during the radiation treatment. Intravenous HU promised better pharmacokinetics and cell cycle blockade. METHODS: Participants had biopsy-proven, untreated squamous cell carcinoma of the oral cavity, oropharynx (stage IV) and hypopharynx (stages II-IV). Radiation therapy consisted initially of 74.4 Gy administered in twice daily 1.2-Gy fractions. After 20 patients, the radiation dose was reduced to 60.0 Gy, and another 16 patients were enrolled. RESULTS: Patients received HU by Continuous Ambulatory Drug Delivery (CADD) pump on a daily x5 schedule during radiation therapy. Because of persistent long-term dysphagia, after 20 patients, the dose of external beam radiation therapy was reduced from 74 to 60 Gy, and the duration of concurrent HU was correspondingly reduced. The new regimen was much better tolerated. The median survival for the group as a whole was 30 months. Within this small study, there were no significant differences in survival, regional control, or local control between the 2 groups. CONCLUSIONS: Lower doses of concurrent parenteral HU and hyper-fractionated radiation therapy are tolerable and promising.     

Impact of race on survival in patients with clinically nonmetastatic prostate cancer who deferred primary treatment

BACKGROUND:

Prostate cancer (PCa) racial disparity studies typically focus on survival differences after curative treatment. The authors of this report hypothesized that comparing mortality rates between African American (AA) and Caucasian American (CA) patients who deferred primary treatment for clinically nonmetastatic PCa may provide a better assessment of the impact of race on the natural course of PCa.

METHODS:

The pathology database of the New York Veterans Administration Medical Center (VAMC), an equal access‐of‐care facility, was searched for patients with biopsy‐proven PCa. Inclusion criteria included 1) no evidence of metastatic disease or death within 3 years after diagnosis, 2) no primary treatment, and 3) a minimum of 5 years of follow‐up for survivors.

RESULTS:

In total, 518 patients met inclusion criteria between 1990 and 2005. AA patients were younger (P = .02) and had higher median prostate‐specific antigen (PSA) levels (P = .001) at the time of diagnosis compared with CA patients. In a multivariate model, higher Gleason score and PSA level were associated with increased mortality (P = .001 and P = .03, respectively), but race was not a predictor of death from PCa.

CONCLUSIONS:

The current data suggested that race did not have a major impact on survival in patients with PCa who deferred primary treatment for clinically nonmetastatic disease. Cancer 2012;118: 3145–52. © 2011 American Cancer Society.     

Characteristics of depression in hemodialysis patients: symptoms, quality of life and mortality risk

BACKGROUND: Depression is often underrecognized in patients with end-stage renal disease. We interviewed outpatients at an urban dialysis facility using a criterion-based case-finding instrument to assess the rates, clinical correlates and outcomes of depression. METHODS: The Primary Care Evaluation of Mental Disorders Mood Module and the nine-item Patient Health Questionnaire were used to assess depression. We measured health-related quality of life using the Kidney Disease and Quality of Life Short Form, and medical comorbidities were measured using the Charlson Comorbidity Index. We compared the sociodemographic and clinical characteristics and health-related quality of life of depressed and nondepressed patients using t tests and the chi-square test, and we used a Cox regression model to test the relationship between depression and mortality. RESULTS: We interviewed 62 patients and followed them for a mean of 29 months (range, 0.1-36). Seventeen (28%) had major or minor depression. Depressed patients were younger and had lower health-related quality of life than did nondepressed patients. Depression predicted mortality (HR=4.1, 95% CI=1.5-32.2, P<.05) after adjusting for age, gender, race, medical comorbidities, albumin, kt/V and/or the presence of diabetes. CONCLUSIONS: Depression is common and associated with decreased health-related quality of life and increased mortality in hemodialysis patients. Clinical trials are necessary to examine whether treatment of depression can improve these outcomes.     

Tutorial in biostatistics: Analyzing associations between total plasma homocysteine and B vitamins using optimal categorization and segmented regression

Data analysts consider standard regression models (e.g., generalized linear model) or nonparametric smoothing techniques (e.g., loess or splines) when examining the association between two variables. Before this step, a quantile-based summarization is typically used for exploring the exposure-response relationship. Unfortunately, these exploratory approaches may not be optimal or efficient for guiding the formal analysis in many biological and nutritional data settings. We suggest a recently developed method for selection of cutpoints as a tool of data summary and segmented regression as a modeling approach in the analysis of plasma total homocysteine and related vitamins. These methods are often complementary in discovering the underlying complex pattern of association.