International Validation of the EORTC QLQ-ANL27, a Field Study to Test the Anal Cancer-Specific Health-Related Quality-of-Life Questionnaire.

PURPOSE: The European Organisation for Research and Treatment of Cancer (EORTC) health-related quality of life questionnaire for anal cancer (QLQ-ANL27) supplements the EORTC cancer generic measure (QLQ-C30) to measure concerns specific to people with anal cancer treated with chemoradiotherapy. This study tested the psychometric properties and acceptability of the QLQ-ANL27. METHODS AND MATERIALS: People with anal cancer were recruited from 15 countries to complete the QLQ-C30 and QLQ-ANL27 and provide feedback on the QLQ-ANL27. Item responses, scale structure (multitrait scaling, factor analysis), reliability (internal consistency and reproducibility) and sensitivity (known group comparisons and responsiveness to change) of the QLQ-ANL27 were evaluated. RESULTS: Data from 382 people were included in the analyses. The EORTC QLQ-ANL27 was acceptable, comprehensive, and easy to complete, taking an average 8 minutes to complete. Psychometric analyses supported the EORTC QLQ-ANL27 items and reliability (Cronbach's α ranging from 0.71-0.93 and test-retest coefficients above 0.7) and validity of the scales (particularly nonstoma bowel symptoms and pain/discomfort). Most scales distinguished people according to treatment phase and performance status. Bowel (nonstoma), pain/discomfort, and vaginal symptoms were sensitive to deteriorations over time. The stoma-related scales remained untested because of low numbers of people with a stoma. Revisions to the scoring and question ordering of the sexual items were proposed. CONCLUSIONS: The QLQ-ANL27 has good psychometric properties and is available in 16 languages for people treated with chemoradiotherapy for anal cancer. It is used in clinical trials and has a potential role in clinical practice.

Factors that Affect Patients' Decision-Making about Mastectomy or Breast Conserving Surgery, and the Psychological Effect of this Choice on Breast Cancer Patients.

BACKGROUND: Breast cancer is the most common cancer in women. Primary treatment is surgery, with breast conserving surgery (BCS) being widely used for early-stage disease. Due to changes in body image, depressive symptoms can occur after surgery. Here, we evaluate factors that affect patients' decision on surgery, and investigate differences in the level of depression after mastectomy or BCS in a population of Turkish patients. PATIENTS AND METHODS: One hundred breast cancer patients who had undergone mastectomy or BCS and were followed up at our institution between 2007 and 2008 were included. Patients were questioned about their involvement in surgical decision-making. Depression was diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-III) criteria via a Structural Clinical Interview for DSM (SCID). Severity of depression was evaluated by using the Beck Depression Inventory (BDI). RESULTS: Patients who were older than 50 years, had more than 1 child, a history of lactation, and a positive family history of breast cancer mostly preferred mastectomy. However, patients who sought a second opinion and further information on BCS preferred BCS (p < 0.005). There was no statistical correlation between marital status, first childbearing age, and educational status and the decision on surgery type (p > 0.005). Mastectomy patients were prone to depression, but this was not statistically significant (p = 0.099). CONCLUSION: Age, parenthood, lactation, and positive familial history, as well as thorough information about the type of surgery were important factors for the patients' decision. After breast cancer surgery, patients might experience depression affecting treatment and quality of life. Therefore, adequate information and communication are essential.

Pulmonary toxicity in patients receiving docetaxel chemotherapy.

Pulmonary toxicity can rarely be seen with cytotoxic agents. We aimed at investigating the pulmonary toxicity of docetaxel in patients other than lung carcinoma. Forty patients were investigated prospectively. Spirometry, DLCO and high-resolution computed tomography (HRCT) scans were applied to all patients before and 14-21 days after completion of docetaxel. We used a HRCT scoring system that was based on the previous studies. We have seen no pulmonary symptoms that may reflect pulmonary toxicity. There were statistically significant differences between pre- and post-treatment values of FEV1 (L/s), FEV1/FVC (%), DLCO/VA (DLCO/L), DLCO/VA (%) (P<0.05), FEF25-75 (L/s), FEF25-75 (%) (P<0.01), DLCO (mL/mmHg/min), DLCO (%) (P<0.001), Also, there was a statistically significant difference between the pre- and post-treatment HRCT scores. There was a statistical relationship between post-treatment HRCT scores, number of docetaxel cycles (r=0.49, P<0.0001) and docetaxel cumulative dose (r=0.61, P<0.0001). Docetaxel caused a significant decline in pulmonary function tests (PFTs) and progression in HRCT scores but the symptoms of patients were not consistent with these differences. The negative effects of docetaxel on PFTs and HRCT scores should be investigated more reliably by increasing the number of patients with further studies.

Concurrent chemoradiotherapy with low dose weekly gemcitabine in stage III non-small cell lung cancer.

BACKGROUND: Combined chemoradiotherapy (CRT) is the treatment of choice for stage III NSCLC. Gemcitabine (G) is a novel deoxycitidine analogue that has been proven to be a potent radiosensitizer. Twenty-two consecutive patients were treated with concurrent CRT to demonstrate the tolerability and efficacy of low dose G given weekly as radiosensitizer in stage III NSCLC. METHODS: Patients with KPS >or=70, adequate bone marrow reserve, with no prior radiotherapy (RT) and surgery were included. Eighteen patients had received prior induction chemotherapy (CT). G (75 mg/m2/week) was infused over 1 hour for 6 weeks. Thoracic RT was given two hours later over 6 weeks at 1.8 Gy/day fractions (total dose of 61.2 Gy). Pulmonary toxicity was evaluated with computed tomography scans in 6 weeks. RESULTS: Median age was 60 years (range, 48-75), median follow-up was 15 months (range, 2-40). Sixty-eight percent of patients were male and median KPS score was 90. Conformal 3D-RT planning was used in 64% of patients. G was given for a median of 5 weeks (range 1-9). Twelve patients (54.6%) received all planned CT. G was stopped because of intolerance in 6 and death in 2 patients. Seven patients (31.8%) had radiation pneumonitis. Twenty patients were evaluated for overall response, 1 patient (4.5%) had clinical CR, 81.8% had PR while 9.5% had SD. Median overall survival (OS) was 14 +/- 5 months (95% CI 3-25). One- and 2-year OS rates were 55% and 38%. Sixteen patients died of disease-related events (6 with progression of primary tumor, 8 due to metastatic disease), 2 patients died of other causes. One- and 2-year progression-free survival and local control rates were 56%, 27% and 79%, 51%, respectively. CONCLUSION: G might be used as radiosensitizer for patients with stage III NSCLC who could not receive full doses CT with concurrent RT.

Results of paclitaxel (day 1 and 8) and carboplatin given on every three weeks in advanced (stage III-IV) non-small cell lung cancer.

BACKGROUND: Both paclitaxel (P) and carboplatin (C) have significant activity in non-small cell lung cancer (NSCLC). The weekly administration of P is active, dose intense, and has a favorable toxicity profile. We retrospectively reviewed the data of 51 consecutive patients receiving C and day 1 and 8 P chemotherapy (CT) regimen in advanced stage NSCLC to evaluate the efficacy and toxicity. METHODS: Patients treated in our institutions having pathologically proven NSCLC, no CNS metastases, adequate organ function and performance status (PS) ECOG 0-2 were given P 112.5 mg/m2 intravenously (IV) over 1 hour on day 1 and 8, followed by C AUC 5 IV over 1 hour, repeated in every three weeks. PC was given for maximum of 6 cycles. RESULTS: Median age was 58 (age range 39-77) and 41 patients (80%) were male. PS was 0/1/2 in 29/17/5 patients and stage was IIIA/IIIB/IV in 3/14/34 patients respectively. The median number of cycles administered was 3 (1-6). Seven patients (14%) did not complete the first 3 cycles either due to death, progression, grade 3 hypersensitivity reactions to P or lost to follow up. Best evaluable response was partial response (PR) in 45% and stable disease (SD) in 18%. Twelve patients (24%) received local RT. Thirteen patients (25%) received 2nd line CT at progression. At a median follow-up of 7 months (range, 1-20), 25 (49%) patients died and 35 patients (69%) progressed. Median overall survival (OS) was 11 +/- 2 months (95% CI; 6 to 16), 1-year OS ratio was 44%. Median time to progression (TTP) was 6 +/- 1 months (95% CI; 4 to 8), 1-year progression free survival (PFS) ratio was 20%. We observed following grade 3 toxicities: asthenia (10%), neuropathy (4%), anorexia (4%), anemia (4%), hypersensitivity to P (2%), nausea/vomiting (2%), diarrhea (2%) and neutropenia (2%). Two patients (4%) died of febrile neutropenia. Doses of CT were reduced or delayed in 12 patients (24%). CONCLUSIONS: P on day 1 and 8 and C every three weeks is practical and fairly well tolerated outpatient regimen. This regimen seems to be comparably active to regimens given once in every three weeks.

99m-Tc-MDP-Scintimammography in the evaluation of breast masses or tumor angiogenesis.

BACKGROUND: Vascular endothelial growth factor (VEGF) is a prognostic factor in breast cancer. One of the mechanisms of extra-skeletal uptake of Tc-99m-methylenediphosphonate (MDP) is suggested to be tumor vascularity. We studied the correlation between MDP uptake and VEGF and compared the diagnostic accuracy of mammography versus MDP-scintimammography (MDP-S). MATERIALS AND METHODS: Fifty-four patients with suspicion of breast cancer were evaluated. Breast images were collected 5-10 minutes after injection of Tc-99m-MDP prior to biopsy. Tissue slides were stained using a rabbit-polyclonal anti-VEGF. RESULTS: MDP-S showed a diagnostic accuracy of 83.3% in BIRADS category 4 lesions. Four out of 23 benign lesions were false-positive. The tumor to background (TM/BG) ratio of early images of MDP-S was correlated with VEGF staining (p: 0.014) and with tumor size (p: 0.006). CONCLUSION: Early images of Tc-99m-MDP-S may satisfactorily identify cancers with increased neovascularization. MDP-S seems to be an accurate imaging modality, especially in BIRADS category 4 lesions.

Serum leptin concentration and advanced gastrointestinal cancers: a case controlled study.

BACKGROUND: Serum leptin level is associated with appetite and energy expenditure in healthy individuals. We aimed to evaluate the serum leptin concentration and the other factors which may be associated with weight loss in patients with advanced gastrointestinal cancer. METHODS: Forty-four patients with advanced gastrointestinal cancer (25 gastric and 19 colorectal cancer) and 25 healthy controls were enrolled. Serum leptin levels were measured as ng/ml via enzyme linked immuno-sorbent assay (ELISA) method in all subjects. The difference in serum leptin concentration between cancer and control group, the factor associated with its serum level and the relationship between serum leptin concentration and weight loss was evaluated. RESULTS: Serum leptin concentration of cancer group was significantly lower than controls (p = 0.002). Female subjects had significantly higher serum leptin concentration than male subjects in control group (p = 0.01), while not in cancer group (p > 0.05). Serum leptin concentration was significantly related with gender in controls (p = 0.023, beta = 0.479), while no gender difference was observed in cancer group (p > 0.05). No relationship was found between serum leptin concentration and weight loss percentage in cancer group in linear regression analysis (p > 0.05). No significant difference was observed in serum leptin concentrations between colon and gastric cancer sub-groups (p > 0.05). CONCLUSION: Independently from the site of gastrointestinal tract, serum leptin concentration in advanced gastrointestinal cancer is lower than controls and it is not a determinant factor in weight loss. In contrast to healthy subjects, gender does not effect the serum leptin concentration in patients with advanced gastrointestinal cancer.

Patient satisfaction in the outpatients' chemotherapy unit of Marmara University, Istanbul, Turkey: a staff survey.

BACKGROUND: We conducted a survey to find out how patients feel about the care they receive in the outpatient chemotherapy unit of Marmara University Hospital. METHODS: The American College of Physicians Patient Satisfaction survey translated into Turkish was used. A meeting was held with all involved staff, before conducting the survey, to review the purpose and determine the process. The study was conducted with 100 random patients. RESULTS: Consistent with cancer frequency, most patients had either lung, colorectal or breast cancer. Their insurance was government sponsored in close to 90%. The educational levels were above Turkish median but consistent with the area the hospital is serving. They were coming to the unit on average 8.5 months. The responses were not influenced by the surveyed diagnosis, age, sex or educational status (p > 0,05). Particularly health care team's attention, trust and courtesy came forward as strong points. The weaknesses noted as difficulties in booking an outpatient doctor visit appointment because the phone line was busy or the secretary was not courteous, the excessive amount of time and effort it required to get laboratory and radiology results. CONCLUSION: The health care system is basically a service based industry and customer satisfaction is at utmost importance just as in other service-oriented sectors. We hope this study will shed light in that area and Turkish health care providers will pay closer attention to how their patients feel about the services that they are getting.