The role of loco-regional treatment in long-term quality of life in de novo stage IV breast cancer patients: protocol MF07-01Q.

BACKGROUND/OBJECTIVE: Since more solid evidence has emerged supporting the effectiveness of loco-regional treatment (LRT), clinicians consider LRT a treatment option for selected de novo stage IV breast cancer (BC) patients. This is the first report on long-term quality of life (QoL) in a cohort of patients who were randomized to receive either LRT and then systemic treatment (ST) or ST alone in the protocol MF07-01. We aimed to evaluate QoL in patients living at least 3 years since randomization using scores from the SF-12 health survey. METHODS: SF-12 (V2) forms were completed during visits of patients who were living 36 months after the randomization. We first calculated PCS-12 (Physical Health Composite Scale) and MCS-12 (Mental Health Composite Scale) scores from de novo stage IV BC patients and compared them with the scores of patients diagnosed with stage I-III BC who lived more than 3 years. Further, PCS-12 and MCS-12 scores were compared between the LRT and ST groups with de novo stage IV BC. Additionally, general health, physical functioning, role functioning, bodily pain, vitality, mental health, and social functioning were evaluated and compared between the groups. Considering age-related changes in QoL, we also compared PCS-12 and MCS-12 scores of patients below or above 55 and 65 years of age. Responses to four additional questions (compare your physical health, mental health, daily activities, and energy currently vs. at diagnosis of BC) were recorded, considering cultural differences. RESULTS: There were 81 patients in this analysis; 68% of patients (n = 55) had LRT, and 32% (n = 26) received ST. General health was good or very good in 62% (n = 34) in the LRT group and 66% (n = 17) in the ST-only group (p = 0.63). Mean PCS-12 score was 40.8 + 1.6, and mean MCS-12 score was 43.4 + 2.0 (p = 0.34 and p = 0.54, respectively). PCS-12 and MCS-12 score difference was lower than that of the general Turkish population (PCS-12 = 49.3 + 12.8 and MCS-12 = 46.8 + 13.0) and stage I-III BC patients (PCS-12 = 51.1 ± 0.5, MCS-12 = 45.7 ± 0.6). PCS-12 and MCS-12 scores were similar between the LRT and ST-only groups in patients younger and older than 55 and 65, but QoL scores were much better in stage I-III BC patients younger than 65 when compared to the scores of those with de novo stage IV BC. Although treatment with or without LRT did not affect physical health, mental health, daily activities, and energy at 3 years vs. at diagnosis of BC in de novo stage IV BC patients (p > 0.05), these variables were significantly better in stage I-III BC patients (p < 0.001). CONCLUSION: The current MF07-01Q study demonstrates that patient who had LRT has similar physical and mental health outcomes compared to ST only in a cohort of patients who lived longer than 3 years. Trial registration This study is registered on clinicaltrials.gov with identifier number NCT00557986.

Randomized Trial Comparing Resection of Primary Tumor with No Surgery in Stage IV Breast Cancer at Presentation: Protocol MF07-01.

BACKGROUND: The MF07-01 trial is a multicenter, phase III, randomized, controlled study comparing locoregional treatment (LRT) followed by systemic therapy (ST) with ST alone for treatment-naïve stage IV breast cancer (BC) patients. METHODS: At initial diagnosis, patients were randomized 1:1 to either the LRT or ST group. All the patients were given ST either immediately after randomization or after surgical resection of the intact primary tumor. RESULTS: The trial enrolled 274 patients: 138 in the LRT group and 136 in the ST group. Hazard of death was 34% lower in the LRT group than in the ST group (hazard ratio [HR], 0.66; 95% confidence interval [CI], 0.49-0.88; p = 0.005). Unplanned subgroup analyses showed that the risk of death was statistically lower in the LRT group than in the ST group with respect to estrogen receptor (ER)/progesterone receptor (PR)(+) (HR 0.64; 95% CI 0.46-0.91; p = 0.01), human epidermal growth factor 2 (HER2)/neu(-) (HR 0.64; 95% CI 0.45-0.91; p = 0.01), patients younger than 55 years (HR 0.57; 95% CI 0.38-0.86; p = 0.007), and patients with solitary bone-only metastases (HR 0.47; 95% CI 0.23-0.98; p = 0.04). CONCLUSION: In the current trial, improvement in 36-month survival was not observed with upfront surgery for stage IV breast cancer patients. However, a longer follow-up study (median, 40 months) showed statistically significant improvement in median survival. When locoregional treatment in de novo stage IV BC is discussed with the patient as an option, practitioners must consider age, performance status, comorbidities, tumor type, and metastatic disease burden.

Changes in 18F-FDG-PET/CT tumor metabolism are not consistent with pathologic complete response in hormone-positive breast cancer.

PURPOSE: Current evaluation of response to neoadjuvant chemotherapy (NAC) shows that it could achieve pathological complete response (pCR). The purpose of this study was to assess the consistency of maximum uptake values (SUVmax) changes and pCR in hormone-positive locally advanced breast cancer (LABC). METHODS: Ninety hormone-positive LABC patients treated at Marmara University Medical Oncology Clinic, Istanbul, Turkey, between 2009 and 2015 were retrospectively studied. All eligible patients (n=5) received NAC (4-8 cycles) and were evaluated for pCR. 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18FFDG- PET/CT) scan was performed before and after the completion of NAC. The relative changes of SUVmax both in the primary tumor and the axilla were assessed for consistency with pCR. RESULTS: The patient median age was 46 years (range 26- 76). The patients 13.7% achieved pCR. Values of >50% (n=40) and <50% (n=11) SUVmax changes were not associated with pCR (15% and 18% respectively) (p=1.00). Patients with >75% SUVmax changes could achieve pCR of 20%. Interestingly, most patients with complete metabolic response did not achieve pCR (81%). The difference of the Ki67 levels before and after NAC, tumor localization, HER- 2 positivity, menopausal status, grade of differentiation, lymphovascular and perineural invasion were not associated with pCR. CONCLUSION: SUVmax changes in later cycles of NAC as commonly practised in oncology clinics were not consistent with pCR (p=1.0). Complete metabolic response may not be associated with pCR in hormone-positive LABC. However, almost 80% of patients had >50% decrease in SUVmax and may still have a chance for conservative surgery and less postoperative morbidity. Therefore, 18F-FDG-PET/CT may still have a role to evaluate the tumor response with a need of larger studies and analysis for cost-effectiveness.

Effects of serial casting in the treatment of flexion contractures of proximal interphalangeal joints in patients with rheumatoid arthritis and juvenile idiopathic arthritis: A retrospective study.

AIM: To analyze the effects of serial casting (SC) in the treatment of proximal interphalangeal (PIP) joint flexion contractures in patients with rheumatoid arthritis and juvenile idiopathic arthritis. STUDY DESIGN: Retrospective case-series. METHODS: The data of 18 patients treated with SC were obtained from their patient records. The angular changes in the finger joints were analyzed and compared statistically using t-tests. RESULTS: A total of 49 fingers were serially casted with plaster of Paris over a 14-year period. The SC resulted in significant (26.8°; p < 0.001) reduction in the PIP joint extension loss. Small, but statistically significant, losses in flexion were associated with these gains. (p < 0.001). Angular changes were also observed in the other finger joints. The magnitude of the initial extension loss was the only factor to explain the amount of motion gained (p < 0.001; R2 = 0.38). CONCLUSION: SC is an effective method to correct flexion contractures in PIP joints in selected patients with arthritis. The gain is partially related to the magnitude of initial extension loss.

Efficacy of single voxel 1H MR spectroscopic imaging at 3T for the differentiation of benign and malign breast lesions.

PURPOSE: The aim of our study was to evaluate the effect of 1H Magnetic Resonance Spectroscopy (MRS) in differentiating breast lesions. MATERIALS AND METHODS: Single voxel 1H Magnetic Resonance Spectroscopy (1H-MRS) was performed with 3T magnet in 45 women. The choline cut off point was set semi-quantitavely. Sensitivity, specificity and accuracy of MRS were calculated. RESULTS: Twenty-four of 25 (96%) malignant and 9 of 26 (35%) benign lesions had choline peak. With the use cutoff value of 19,5 MRS provided a 96% sensitivity, 65% specificity and 80% accuracy. CONCLUSION: MRS has a high diagnostic accuracy in differentiating breast lesions.

The development of a new orthosis (neuro-orthosis) for patients with carpal tunnel syndrome: its effect on the function and strength of the hand.

Static wrist orthoses (SWOs) are used in the treatment of carpal tunnel syndrome (CTS) with some drawbacks. As an alternate approach to SWOs, an active closed-loop wrist control strategy based on the principles of functional electrical stimulation was proposed to limit wrist movements. The purpose of the study was to determine whether the proposed 'neuro-orthosis' (NeO) system resulted in less restriction in the hand compared to clinically accepted custom-made SWOs while limiting the wrist movements. A case-control study was designed to determine the specific effects of the system on patients with CTS. A total of 24 right-handed female volunteers (12: CTS, 12: healthy) participated in the study. Function, dexterity, and strengths were measured under three different testing conditions: without orthosis, with SWO, and with the NeO system. Maximum angles in one subtest while the NeO system was on and off and general discomfort levels in SWO and NeO test conditions were recorded. The NeO system resulted in less restriction with respect to SWO and provided considerable angular limitation compared to placebo. It was concluded that the proposed prototype control system can be a good candidate to limit the wrist movements in place of SWOs with a better degree of freedom in patients with CTS.

Antihypertensive drug utilization at health centres in a district of Istanbul.

OBJECTIVE: Since irrational use of antihypertensives has considerable clinical and economical consequences, this study was conducted to evaluate antihypertensive drug utilization in hypertension at seven State Health Centres in Istanbul. METHOD: A total of 297 hypertensive patients who accepted to participate in the study were evaluated by a face-to-face questionnaire and a copy of their prescriptions were collected for prescription analysis. RESULTS: Angiotensin-converting enzyme (ACE) inhibitors (31.7%), calcium channel blockers (28.8%), diuretics (16.2%), beta blockers (7.5%) and others (15.8%) have been prescribed. There were no statistically significant relation between prescribed antihypertensive drug groups and gender, age, and NSAIDs co-prescribing. The most frequent comorbidity in hypertensive patients was diabetes mellitus (10.4%) and calcium channel blockers (35.5%) have been prescribed to them as a first antihypertensive medication. Average cost per prescription was $42.7 +/- 38.1. According to the patients' self-reporting, the majority of them (85%) were prescribed without a physical examination. The physicians failed to write the prescriptions appropriately; only 5% of the scripts contained all information about the drug(s) and use instructions in full format. CONCLUSION: The present study indicates that GPs working at primary healthcare centres were rational in terms of antihypertensive drug choice. However, they poorly applied rational pharmacotherapy principles such as (a) writing a "good" prescription which is easily readable by the pharmacist and the patient and that contains full essential information; (b) a medical examination of the patient to assess her/his current clinical condition; and (c) taking care of not prescribing drugs with potential interaction like antihypertensives and NSAIDs together.