Tarit K. Banerjee

Differential Effects of Paroxetine on Fatigue and Depression: A Randomized, Double-Blind Trial From the University of Rochester Cancer Center Community Clinical Oncology Program

PURPOSE Fatigue and depression typically occur together in cancer patients, suggesting a common etiology, perhaps based on serotonin. This randomized clinical trial tested whether paroxetine, a selective serotonin reuptake inhibitor antidepressant known to modulate brain serotonin, would reduce fatigue in cancer patients and whether any reduction was related to depression. PATIENTS AND METHODS Cancer patients undergoing chemotherapy for the first time were assessed for fatigue. Of 704 patients who reported fatigue at their second chemotherapy cycle, 549 patients were randomly assigned to receive either 20 mg of oral paroxetine hydrochloride daily or placebo for 8 weeks. The assessments of fatigue and depression were performed at cycles 3 and 4 of chemotherapy. RESULTS A total of 244 patients treated with paroxetine and 235 patients treated with placebo provided assessable data. No difference was detected in fatigue between patient groups. At the end of the study, there was a difference between groups in the mean level of depression (Center for Epidemiologic Studies Depression scores, 12.0 v 14.8, respectively; P <.01). CONCLUSION Paroxetine had no influence on fatigue in patients receiving chemotherapy. A possible explanation is that cancer-related fatigue does not involve a reduction in brain 5-HT levels.

Gabapentin for hot flashes in 420 women with breast cancer: a randomised double-blind placebo-controlled trial

BACKGROUND Most women receiving systemic therapy for breast cancer experience hot flashes. We undertook a randomised, double-blind, placebo-controlled, multi-institutional trial to assess the efficacy of gabapentin in controlling hot flashes in women with breast cancer. METHODS 420 women with breast cancer who were having two or more hot flashes per day were randomly assigned placebo, gabapentin 300 mg/day, or gabapentin 900 mg/day by mouth in three divided doses for 8 weeks. Each patient kept a 1-week, self-report diary on the frequency, severity, and duration of hot flashes before the start of the study and during weeks 4 and 8 of treatment. Analyses were by intention to treat. FINDINGS Evaluable data were available on 371 participants at 4 weeks (119 placebo, 123 gabapentin 300 mg, and 129 gabapentin 900 mg) and 347 at 8 weeks (113 placebo, 114 gabapentin 300 mg, and 120 gabapentin 900 mg). The percentage decreases in hot-flash severity score between baseline and weeks 4 and 8, respectively were: 21% (95% CI 12 to 30) and 15% (1 to 29) in the placebo group; 33% (23 to 43) and 31% (16 to 46) in the group assigned gabapentin 300 mg; and 49% (42 to 56) and 46% (34 to 58) in the group assigned gabapentin 900 mg. The differences between the groups were significant (p=0.0001 at 4 weeks and p=0.007 at 8 weeks by ANCOVA for overall treatment effect, adjusted for baseline values); only the higher dose of gabapentin was associated with significant decreases in hot-flash frequency and severity. INTERPRETATION Gabapentin is effective in the control of hot flashes at a dose of 900 mg/day, but not at a dose of 300 mg/day. This drug should be considered for treatment of hot flashes in women with breast cancer.

Traumatic stress symptoms among women with recently diagnosed primary breast cancer

This study examined the concurrent and longitudinal relationships between traumatic stress symptoms and demographic, medical, and psychosocial variables among women recently diagnosed with primary breast cancer. Participants were 117 women drawn from a parent study for women recently diagnosed with primary breast cancer. At baseline, the Impact of Event Scale (IES) total score was related to intensity of postsurgical treatment and lower emotional self-efficacy. At the 6-month follow-up, the IES total score was significantly related to younger age, to the increased impact of the illness on life, and to the baseline IES total score assessment. These results suggest that it is important to intervene for traumatic stress symptoms soon after the diagnosis of breast cancer. Furthermore, these results suggest women at greatest risk are those who are younger, who receive postsurgical cancer treatment, who are low in emotional self-efficacy and whose lives are most affected by having cancer.

Corticosteroid Administration and Localized Leukocyte Mobilization in Man

Abstract Mobilization of leukocytes into a serum-filled chamber was quantitatively measured in duplicate in normal subjects during two control periods and while they were receiving prednisone or de...

Replication linkage study for prostate cancer susceptibility genes

Since the publication of the first genome screen for prostate cancer (CaP) 5 years ago, over a dozen linkage studies have appeared. Most attention has been directed to chromosome 1, where two separate regions have been identified as harboring a prostate cancer susceptibility locus: HPC1 in the 1q24–25 interval and PCaP in the 1q42.2–43 interval. Linkage analysis of chromosome 16 has also provided evidence of harboring two loci predisposing to CaP.

Unusual manifestations of multiple cranial nerve palsies and mandibular metastasis in a patient with squamous cell carcinoma of the lip

A 70‐year‐old man who had squamous cell carcinoma of the lip later presented with right mental neuropathy, ipsilateral progressive involvement of all three divisions of the 5th, the 7th and 8th cranial nerves, and complete ophthalmoplegia. Biopsy proven metastasis to the mandible was demonstrated. Although repeated studies of CT scan of the head and cerebral angiography were negative, CSF examination revealed positive cytology, elevated protein and low sugar content. Although vascular dissemination from the primary lip lesion to the mandible and brain stem cannot be ruled out, extension through perineurial space via the 5th cranial nerve have been speculated. This case demonstrates two unusual features of squamous cell carcinoma of the lip, namely metastasis to the mandible and meningeal spread with multiple cranial neuropathies.

Comparative studies on localized leukocyte mobilization in patients with chronic myelocytic leukemia.

Using autologous serum as medium, localized leukocyte mobilization into a plastic chamber at the site of mechanical abrasion was quantified in 5 patients with florid CML, one patient with chronic eosinophilic leukemia in the florid state, 3 patients (5 studies) with CML and partial response (remission or relapse), 6 patients with CML in good remission, and in 7 patients with CML in die blastic phase. The cumulative total number of cells was expressed as total leukocyte mobilization (TLM) × 106/cm2 at 24 hrs. Leukocyte clearance/cm2 in 24 hrs. was expressed in milliliters of blood and was obtained by dividing TLM (corrected for non‐granulocytes) by the absolute granulocyte count in the peripheral blood. Although the median TLM was found to be elevated in CML with florid disease (130 × 106/cm2 at 24 hrs.) and in CML with partial remission and relapse (104 × 106), it fell to 74 × 106 in 6 patients in remission. This is to be compared with the median TLM for 46 normal subjects (76 × 106/cm2 at 24 hrs.). Median leukocyte clearances showed the lowest values in CML in the florid state (1.0 ml/cm2 in 24 hrs), improving to 4.4 ml when a partial response was present, and to 9.3 ml in remission. This compares with 19.7 ml/cm2 in 24 hours for 46 normal subjects. The median TLM in 7 patients with CML in blastic phase was 14 × 106/cm2 at 24 hrs., and the leukocyte clearance was reduced to 1.4 ml. These data suggest a defect in cell‐migration in all stages of CML, which is inversely correlated with clinical state. The data reinforce the reported prolongation of circulation time of leukocytes in CML, and suggest a mechanism for this in the impaired ability of CML leukocytes to migrate across the vessel wall.

Phase 1/2 dose escalating study of twice-monthly pemetrexed and gemcitabine in patients with advanced cancer and non-small cell lung cancer.

Introduction: Pemetrexed is synergistic with gemcitabine in preclinical models of non-small cell lung cancer (NSCLC). The optimal dose and utility of gemcitabine and pemetrexed was evaluated in a dose-escalating study. Methods: The phase 1 study included patients with advanced tumors, whereas the phase 2 study included patients with locally advanced or metastatic NSCLC. Gemcitabine was infused over 30 minutes, followed by pemetrexed administered over 10 minutes on day 1 of a 14-day cycle. Treatment continued for 12 cycles or until disease progression. All patients received folic acid, Vitamin B12, and steroid prophylaxis. Results: Maximum tolerated dose was gemcitabine 1500 mg/m2, followed by pemetrexed 500 mg/m2. Fifty-three patients (29 male, 24 female) were enrolled in the phase 2 study. Response rate was 20.8% (95% CI: 0.108–0.341), and the clinical benefit rate (CR + PR + SD) was 64.2%. Median time to disease progression was 4.6 months (95% CI: 2.79–6.18), median survival was 10.1 month (95% CI: 5.95–14.09, censorship = 20.75%), and 1-year survival was 41.0%. Common grade 3 or 4 adverse events (% of patients) were neutropenia (28.3%), fatigue (22.6%), and febrile neutropenia (9.4%). Conclusions: Twice-monthly gemcitabine and pemetrexed was well tolerated, with overall survival and clinical benefit indicating disease activity in NSCLC patients.

Vascular endothelial growth factor (VEGF) receptor antibody bevacizumab (avastin) induces regression of renal cell carcinoma in an adolescent resulting in residual tumorectomy.

Renal cell carcinoma is a chemo‐ and radiation‐resistant malignancy that is very rare in childhood. In advanced cases, survival is extremely poor, but cure can be achieved with complete tumorectomy. We report a 14‐year‐old female with left renal cell carcinoma, with regional lymphadenopathy extending up to the diaphragm. Complete tumor resection was impossible. The tumor progressed after 10 months of treatment with high‐dose interleukin‐2. After 7 months of outpatient vascular endothelial growth factor receptor antibody bevacizumab and no significant adverse effects, dramatic tumor shrinkage enabled complete resection. Pediatr Blood Cancer 2008;50:903–904.

Subjective assessment of cognitive function in the aging cancer patient: A URCC CCOP longitudinal study

9631 Background: Unique challenges face elderly cancer survivors, including issues of quality of life. Impaired cognitive function is a common complaint among aging cancer patients. The purpose of this multicenter longitudinal study was to investigate the frequency and severity of self-reported problems with memory and concentration over time. Methods: Patients undergoing treatment for solid tumors self-rated problems with memory and concentration using an 11-point Likert Scale (0 = Not present to 10 = “As bad as you can imagine”) at baseline before treatment began (T1), at their worst during treatment (T2), and at 6 months following treatment (T3). Any symptom level ≥ 7 was classified as “severe.” Repeated measures analyses were used to examine differences in symptoms over time and between patients treated with and without chemotherapy. Results: Of 595 participants, 351 (59%) were aged ≤64 years and 244 (41%) were ≥65 years; 356 (60%) received chemotherapy, with or without radiation and 239 (40%) radiati...