RECORD-2: phase II randomized study of everolimus and bevacizumab versus interferon α-2a and bevacizumab as first-line therapy in patients with metastatic renal cell carcinoma.

BACKGROUND: The open-label, phase II RECORD-2 trial compared efficacy and safety of first-line everolimus plus bevacizumab (EVE/BEV) with interferon plus bevacizumab (IFN/BEV) in patients with metastatic renal cell carcinoma. PATIENTS AND METHODS: Previously untreated patients were randomized 1:1 to bevacizumab 10 mg/kg every 2 weeks with either everolimus 10 mg/day (EVE/BEV) or interferon (9 MIU 3 times/week, if tolerated) (IFN/BEV). Tumor assessments occurred every 12 weeks. The primary objective was the assessment of treatment effect on progression-free survival (PFS), based on an estimate of the chance of a subsequent phase III trial success (50% threshold for phase II success). RESULTS: Baseline characteristics were balanced between the EVE/BEV (n = 182) and IFN/BEV (n = 183) arms. The median PFS was 9.3 and 10.0 months in the EVE/BEV and IFN/BEV arms, respectively (P = 0.485). The predicted probability of phase III success was 5.05% (hazard ratio = 0.91; 95% confidence interval 0.69-1.19). The median duration of exposure was 8.5 and 8.3 months for EVE/BEV and IFN/BEV, respectively. The percentage of patients discontinuing because of adverse events (AEs) was 23.4% for EVE/BEV and 26.9% for IFN/BEV. Common grade 3/4 AEs included proteinuria (24.4%), stomatitis (10.6%), and anemia (10.6%) for EVE/BEV and fatigue (17.1%), asthenia (14.4%), and proteinuria (10.5%) for IFN/BEV. The median overall survival was 27.1 months in both arms. CONCLUSIONS: The efficacy of EVE/BEV and IFN/BEV appears similar. No new or unexpected safety findings were identified and, with the exception of proteinuria in about one-fourth of the population, EVE/BEV was generally well tolerated. CLINICAL TRIAL REGISTRY AND TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT00719264.

Attitudes towards cancer survivors: a small survey.

INTRODUCTION: The National Cancer Survivors Day Foundation defines a cancer "survivor" as anyone living with a history of cancer--from the moment of diagnosis through the remainder of life. Little is known about the size and make-up of this population or about the medical care experience of and social implications for patients who have had a diagnosis of cancer in Singapore. An opportunistic survey was undertaken to understand how members of the public believe about this population. METHODS: A sample of the general public was undertaken during the "CancerVive" event in 2004. Questionnaires regarding employment as well as attitudes towards cancer and cancer survivorship were distributed. RESULTS: Members of the public held certain misconceptions about cancer survivors. They also have certain negative attitudes toward cancer survivors. Beliefs and attitudes about cancer are similar for cancer survivors and the general public. Although members of the public had positive attitudes towards working with cancer survivors, the majority felt that cancer survivors should not be given equal opportunities at work, by not employing cancer survivors if they were in the position to hire. CONCLUSION: Further research with larger and more representative samples needs to be undertaken to extend the understanding into cancer survivorship issues.

An evaluation of point-of-care instrument for monitoring anticoagulation level in adult cardiac patients.

INTRODUCTION: Rapid point-of-care measurement of anticoagulation has become feasible with the advent of new portable devices and offers the potential for home monitoring. This study evaluates the accuracy and feasibility of such a point-of-care device, the ProTime analyser as compared with standard laboratory method (IL MCL2) for monitoring the International Normalised Ratio (INR) level in cardiac patients on oral anticoagulation therapy. MATERIALS AND METHODS: Fifty patients were studied. The majority were male (86% versus 14%). Chinese accounted for 37(74%) whereas Malay and Indian, constituted 9(18%) and 4(8%) respectively. The mean age was 55 +/- 12 years. Prosthetic heart valve replacement (46%) and atrial fibrillation (38%) were among the main indications for anticoagulation. The mean dosage of warfarin was 3.0 +/- 1.5 mg (range 1.0 to 6.5 mg) and the INR results ranged from 0.83 to 4.69 (based on the hospital laboratory method). Fingerstick and venous blood samples were collected from every patient and subjected to analysis by ProTime and IL MCL2 analysers. RESULTS: There was a good correlation of INRs between ProTime venous and IL MCL2 venous, ProTime fingerstick and IL MCL2 venous and ProTime venous and ProTime fingerstick samplings, with correlation coefficients (r) of 0.9248, 0.9403 and 0.9557, respectively. The Bland-Altman plot also showed a good correlation between the methods used without any systematic bias (limits of agreement ranged from -0.422 to +0.606 INR units on average). CONCLUSION: This rapid point-of-care device appears to have an acceptable level of accuracy for measuring INR values in the recommended target ranges in adult cardiac patients on oral anticoagulation therapy.

An interesting case of left atrial myxoma.

Myxoma is the most common type of primary tumours of the heart in adults. Majority of these myxomas are found in the left atrium, followed by the right atrium and ventricles. We describe herein a patient who had a left atrial myxoma with interesting investigational results.

Unusual case of bowel infarction with invasive Aspergillus in an immunocompromised patient.

INTRODUCTION: We report a patient with bowel infarction due to invasive Aspergillus infection as a result of prolonged chemotherapy-induced neutropenia. CLINICAL PICTURE: The patient was given neoadjuvant chemotherapy with doxorubicin, docetaxel, and capecitabine for a breast tumour. She developed prolonged neutropenia, Escherichia coli and Candida krusei sepsis, acute arterial thrombosis of the left lower limb, and invasive aspergillus infection. TREATMENT: She underwent a subtotal colectomy, small intestine resection and an above-knee amputation. OUTCOME: The hospitalisation was complicated with methicillin-resistant Staphylococcus aureus pneumonia and short gut syndrome. She subsequently underwent simple mastectomy with axillary clearance and received adjuvant chemotherapy and radiation without complication. CONCLUSION: Chemotherapy should be protocol-directed. In a non-trial situation, protocol must have a sound basis, proven safety, and efficacy. Aspergillus infection is uncommon in patients with solid tumours; prompt treatment must be started on high suspicion.

Measuring quality of life in Chinese cancer patients: a new version of the Functional Living Index for Cancer (Chinese).

INTRODUCTION: Since its translation into Chinese, the Functional Living Index for Cancer (FLIC) has not been widely received due to some of its difficulties. We modified its visual analogue scale (VAS) to an ordered categorical scale and changed some of the wording in the instrument. This study examined the measurement properties of the modified FLIC. MATERIALS AND METHODS: The modified version of FLIC and the Functional Assessment of Cancer Therapy (FACT-G Chinese version 4) were filled in by 140 patients recruited from the National Cancer Centre Singapore. The patients' FLIC scores were compared with their clinical characteristics to establish known-group validity. Convergent and divergent validity of FLIC were examined by correlation analysis with FACT-G and its sub-scales. Cronbach's alpha and relative efficiency were also examined. RESULTS: FLIC and most of its sub-scales could indicate a clear and statistically significant difference of quality of life (QOL) according to patients' performance status and treatment status. FLIC strongly correlated with FACT-G. The Physical, Psychological, and Symptoms sub-scales of FLIC converged to and diverged from FACT-G sub-scales as conceptually expected. Cronbach's alpha indicated a satisfactory level of reliability. FLIC appeared to be more efficient than FACT-G, meaning that a smaller sample size will be required for FLIC than for FACT-G to achieve the same research purpose. CONCLUSIONS: The modified version of FLIC was found to have achieved satisfactory measurement properties. This is a user-friendly alternative to the original FLIC.

After-hour home care service provided by a hospice in Singapore.

A home care Hospice programme was set up to provide care to the patients with advanced diseases and their families in Singapore. After office-hour, the service is managed by a doctor on weekdays, with the assistance of a nurse during daytime on Saturdays, Sundays and public holidays. The doctor on-call made an average of 3.1 phone calls and 1.3 visits each weekday evening. Over the weekends and public holidays, there were a mean of 16.7 phone calls and 6 visits each day. More than half of the visits (50.3%) were made for certification of death. The commonest symptoms that prompted visits were dyspnoea (20%) and pain (12.2%). The busiest period during weekdays was between 6.00 pm and 11.00 pm, when our doctors did most of their visits. The workload of the hospice home care service is likely to increase and resources such as family health physicians can be explored to help to meet this increasing demand. This can be achieved through the provision of comprehensive training and easy accessibility to medical records which are kept with patients.

Gefitinib is more effective in never-smokers with non-small-cell lung cancer: experience among Asian patients.

We retrospectively analysed the results of patients with advanced non-small-cell lung cancer treated with gefitinib to derive clinical factors predictive of response and a favourable survival outcome. Patients were treated with gefitinib 250 mg per day and re-evaluated 4-8 weeks later with repeat CT scan and every 8 weeks thereafter to assess response and the duration of response. Pathology review by a histopathologist was conducted, in particular to confirm a recently published result of bronchioloalveolar carcinoma histology or its components as predictive of response to gefitinib. Logistic regression and Cox regression analytical methods were applied to determine factors that could predict for response and improved overall survival. A total of 110 patients were treated. The overall response rate was 32% partial responses (PRs). Only never-smoking status was predictive of response in the logistic regression analysis, adjusted OR=6.1, 95% CI=1.7, 21.5. The presence of a PR and good performance status were predictive of a favourable survival outcome from the Cox regression modelling. Responders had an adjusted HR of 3.0, 95% CI=1.5-5.8 compared to nonresponders, while patients with ECOG status 0-1 had an adjusted HR of 0.42, 95% CI=0.25-0.72, compared with patients with ECOG status 2-4. Bronchioloalveolar carcinoma or its components were distinctly absent on pathology review. In conclusions, Never-smoking status is an important clinical predictor of a favourable response to gefitinib.

Finasteride and bicalutamide as primary hormonal therapy in patients with advanced adenocarcinoma of the prostate.

BACKGROUND: Medical or surgical castration is effective in advanced prostate cancer but with profound side-effects, particularly on sexual function. Effective, less toxic therapies are needed. This study examined whether the addition of finasteride to high-dose bicalutamide enhanced disease control, as measured by additional decreases in serum prostate-specific antigen (PSA). PATIENTS AND METHODS: Forty-one patients with advanced prostate cancer received bicalutamide (150 mg/day). Finasteride (5 mg/day) was added at first PSA nadir. Serum PSA was measured every 2 weeks until disease progression. Questionnaires were administered to assess sexual function. RESULTS: Median follow-up is 3.9 years. At the first PSA nadir, median decrease in PSA from baseline was 96.5%. Thirty of 41 patients (73%) achieved a second PSA nadir and median decrease of 98.5% from baseline. Median time to each nadir was 3.7 and 5.8 weeks, respectively. Median time to treatment failure was 21.3 months. Toxicities were minor, including gynecomastia. Seventeen of 29 (59%) and 12 of 24 (50%) men had normal sex drive at baseline and at second PSA nadir, respectively. One-third of men had spontaneous erection at both time points. CONCLUSION: Finasteride provides additional intracellular androgen blockade when added to bicalutamide. Duration of control is comparable to castration, with preserved sexual function in some patients.