Effect of Exercise on Taxane Chemotherapy–Induced Peripheral Neuropathy in Women With Breast Cancer: A Randomized Controlled Trial

BackgroundChemotherapy-induced peripheral neuropathy (CIPN) is a dose-limiting adverse effect of taxanes. We sought to evaluate the effect of exercise on taxane CIPN in women with breast cancer.Patients and MethodsWomen (n = 27) were randomized to immediate exercise (IE, during taxane chemotherapy) or delayed exercise (DE, after chemotherapy). Supervised aerobic, resistance, and balance training was offered 3 days a week for 8-12 weeks. CIPN symptoms and quality of life were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30 and CIPN20 (scored from 0 to 100). The percentage of participants reporting moderate to severe sensory symptoms (‘3/4’ or ‘4/4’ for CIPN20 sensory items) was also evaluated, along with clinical sensory testing at the lower limb (vibration sense and pinprick). Taxane treatment adherence, including relative dose intensity, was extracted from patient medical records. Assessments occurred at: baseline (before taxane chemotherapy), pre-cycle 4 (before the final taxane cycle), the end of chemotherapy, and follow-up (10-15 weeks after chemotherapy).ResultsNo differences in the EORTC QLQ CIPN20 symptom scores were detected between groups at any time point. At pre-cycle 4, there was a significant difference between groups in patient-reported moderate to severe numbness in the toes or feet (IE: n = 1, 9%, DE: n = 7, 50%, P = .04) and impaired vibration sense in the feet (IE: n = 2, 18%, DE: n = 10, 83%, P < .01). Overall global health status/quality of life was higher in IE compared to DE at the end of chemotherapy (P = .05), yet both groups had worse CIPN20 sensory (Δ24.3 ± 4.6, P < .01) and motor symptom scores (Δ10.5 ± 1.9, P < .01) relative to baseline. By the end of chemotherapy, no differences between groups were found for moderate to severe numbness in the toes or feet (P = 1.0) or impaired vibration sense in the feet (P = .71). More IE participants received ≥ 85% relative dose intensity (IE: n = 12, 100%, DE: n = 10, 67%, P < .05).ConclusionExercise may attenuate CIPN over the course of taxane chemotherapy and possibly improve taxane adherence in women with breast cancer. These findings, as well as whether exercise can attenuate CIPN by the end of taxane chemotherapy, should be confirmed in larger trials.     

Reliability and Validity of the Quality of Life –Family Version (QOL-FV) in Turkish Family Caregivers of Patients with Cancer

Objectives: Family caregivers (FCs) are often the primary source of social and emotional support for cancerpatients and play a major role in how well they manage their illness. The aim of this study was to create an Turkishversion of the Quality of Life - Family Version (QOL-FV) and to evaluate its psychometric properties in a sampleof FCs of cancer patients. Materials and Methods: This study was carried out with the FCs of 218 patients withcancer. Data were collected with a Demographic Questionnaire and the QOL-FV and The Multidimentional Scaleof Perceived Social Support (MSPSS). The QOL-FV was developed by Ferrell and Grant and is composed of 4subdimensions. Linguistic validity, translation, back translation, and content validity were tested with expertopinions. Test-retest reliability, and internal consistency reliability were assessed. Construct validity was testedby factor analysis and with the scale of the MSPSS. Results: The family caregivers were between the ages of46-56 (32.6%), a great number of them being male (52.8%). The scale is made up of four subdimensions. Theresult of the test-retest analysis of this scale was calculated as r:0.86. As a result of the reliability analysis, sixitems were eliminated from the scale, factor analyses were fulfilled according to varimax transformation throughthe method of principal components. Four new subdimensions were restrustured at the end of the analysis. Thescale of Cronbach α coefficient was calculated as 0.90. Concurrent validity showed low correlations with theMSPSS (r=0.29). Conclusions: The QOL-FV, adapted into Turkish, was found to have sufficient reliability andvalidity.     

Can Mindfulness-Based Stress Reduction Influence the Quality of Life,Anxiety, and Depression of Women Diagnosed with Breast Cancer? —A Review

Introduction: Breast cancer is the most common form of cancerous disease worldwide. Its treatment leads to a variety of physiological and psychological side effects. This review investigates the question of how mindfulness-based stress reduction (MBSR), a stress management program, can influence the quality of life, anxiety, and depression of women diagnosed with breast cancer. Methods: A systematic literature search was conducted in PubMed/MEDLINE and Cochrane Library. Screening by title, abstract and full text was performed, whereby only those articles were included that fit the inclusion criteria. A risk of bias assessment was performed for each included study. Results: Overall, six studies were included, but not every study investigated all three outcomes. Two studies found positive impacts on quality of life, whereas three did not find a positive correlation between the intervention and quality of life. Four out of six studies found a positive relation between MBSR and anxiety scores, but only half of the included studies found positive results for the interaction between MBSR and depression scores. Conclusion: Published data suggest that anxiety can be positively influenced by MBSR, which can be used to improve the psychological care of breast cancer patients, both during and after treatment. However, further studies with larger patient numbers and longer observation periods should be conducted in order to elucidate the full potential of MSBR on important areas such as depression and quality of life.     

Quality assurance for radical hysterectomy for cervical cancer: the view of the European Organization for Research and Treatment of Cancer—Gynecological Cancer Group (EORTC-GCG)

Radical hysterectomy combined with a pelvic lymphadenectomy or chemoradiation are traditionally the mainstays of treatment of International Federation of Gynecology and Obstetrics stages Ia2–IIa cervical cancer. The quality of radical surgery for cervical cancer influences local tumor control and survival. Hence, it is important to optimize and ensure the quality of surgical care for cervical cancer patients. In this paper, we discuss factors that are related to outcome after radical hysterectomy and propose a set of quality indicators that can be used to audit and improve the quality of surgical care for cervical cancer patients.     

Activity and safety of crizotinib in patients with advanced clear-cell sarcoma with MET alterations: European Organization for Research and Treatment of Cancer phase II trial 90101 ‘CREATE’

BackgroundClear-cell sarcoma (CCSA) is an orphan malignancy, characterized by a specific t(12;22) translocation, leading to rearrangement of the EWSR1 gene and overexpression of MET. We prospectively investigated the efficacy and safety of the tyrosine kinase inhibitor crizotinib in patients with advanced or metastatic CCSA.Patients and methodsPatients with CCSA received oral crizotinib 250 mg twice daily. Primary end point was objective response rate (ORR), secondary end points included duration of response, disease control rate (DCR), progression-free survival (PFS), progression-free rate (PFR), overall survival (OS), OS rate and safety. The study design focused on MET+ disease with documented rearrangement of the EWSR1 gene by fluorescence in situ hybridization.ResultsAmong 43 consenting patients with the local diagnosis of CCSA, 36 had centrally confirmed CCSA, 28 of whom were eligible, treated and assessable. Twenty-six out of the 28 patients had MET+ disease, of whom one achieved a confirmed partial response and 17 had stable disease (SD) (ORR 3.8%, 95% confidence interval: 0.1–19.6). Further efficacy end points in MET+ CCSA were DCR: 69.2% (48.2% to 85.7%), median PFS: 131 days (49–235), median OS: 277 days (232–442). The 3-, 6-, 12- and 24-month PFR was 53.8% (34.6–73.0), 26.9% (9.8–43.9), 7.7% (1.3–21.7) and 7.7% (1.3–21.7), respectively. Among two assessable MET− patients, one had stable disease and one had progression. The most common treatment-related adverse events were nausea [18/34 (52.9%)], fatigue [17/34 (50.0%)], vomiting [12/34 (35.3%)], diarrhoea [11/34 (32.4%)], constipation [9/34 (26.5%)] and blurred vision [7/34 (20.6%)].ConclusionsThe PFS with crizotinib in MET+ CCSA is similar to results achieved first-line in non-selected metastatic soft tissue sarcomas with single-agent doxorubicin. The PFS is similar to results achieved with pazopanib in previously treated sarcoma patients.Clinical trial numberEORTC 90101, EudraCT number 2011-001988-52, NCT01524926.     

In the Era After the European Organisation for Research and Treatment of Cancer ‘Boost’ Study,is the Additional Radiotherapy to the Breast Tumour Bed Still Beneficial for Young Women?

AimsThe European Organisation for Research and Treatment of Cancer (EORTC) 22,881–10,882 trial showed significant benefit of a radiotherapy boost (RTB) in women ≤40 years in a pre-hormone therapy (HT) era. We determined how the use of HT and RTB changed in response to clinical guidelines and whether the benefit of routine RTB was still observed in the HT era.Materials and methodsBetween 1996 and 2004, a provincial database identified all women ≤40 years with breast cancer who met the inclusion criteria of the EORTC trial. In total, 411 patients were classified into three eras defined by the guidelines: era 1 (discretionary HT, discretionary RTB); era 2 (routine HT, discretionary RTB); era 3 (routine HT, routine RTB). HT use, RTB use and cumulative incidence of local recurrence were calculated and compared across eras.ResultsHT use increased after the first policy change from 13% to 75% for oestrogen receptor-positive patients (P < 0.01). RTB use also increased from 33% to 76% following the second policy change (P < 0.01). At 10 years, the cumulative incidence of local recurrence was 12% in era 1, 6% in era 2 and 6% in era 3 (era 2 versus era 3, P = 0.92). For patients in the routine HT era (eras 2 and 3 combined) there was no significant difference in local recurrence between RTB and ‘no RTB’ patients (6% versus 7%, P = 0.81).ConclusionsThe routine use of HT and RTB increased significantly after new practice guidelines. Introduction of the HT guideline was associated with a 6% improvement in local recurrence at 10 years. No improvement in local recurrence was associated with the introduction of the RTB guideline in the HT era. The routine use of a boost in unselected young women with negative margins should be re-evaluated in the current HT era.     

Quality of Life of Postmenopausal Women in the ATAC (“Arimidex”, Tamoxifen, Alone or in Combination) Trial after Completion of 5 years' Adjuvant Treatment for Early Breast Cancer

The impact of treatment on health-related quality of life (HRQoL) is an important consideration in the adjuvant treatment of operable breast cancer. Here we report mature HRQoL outcomes from the ATAC trial, comparing anastrozole with tamoxifen as primary adjuvant therapy for postmenopausal women with localized breast cancer. Patients completed the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire plus endocrine subscale (ES) at baseline, 3 and 6 months, and every 6 months thereafter. Baseline characteristics in the HRQoL sub-protocol were well balanced between the anastrozole (n = 335) and tamoxifen (n = 347) groups in the primary analysis population. As with previously published results at 2 years, there was no statistically significant difference in the Trial Outcome Index of the FACT-B, the primary endpoint of the study, between treatments at 5 years. There were no statistically significant differences between treatment groups in ES total scores. Consistent with the 2-year analysis, there were differences between treatment groups in patient-reported side effects: diarrhea (anastrozole 3.1% vs. tamoxifen 1.3%), vaginal dryness (18.5% vs. 9.1%), diminished libido (34.0% vs. 26.1%), and dyspareunia (17.3% vs. 8.1%) were significantly more frequent with anastrozole compared to tamoxifen. Dizziness (3.1% vs. 5.4%) and vaginal discharge (1.2% vs. 5.2%) were significantly less frequent with anastrozole compared to tamoxifen. In this, the first report of HRQoL over 5 years of initial adjuvant therapy with an aromatase inhibitor, we conclude that anastrozole and tamoxifen had similar impacts on HRQoL, which was maintained or slightly improved during the treatment period for both groups.     

Clinical and radiologic predictors of invasive pulmonary aspergillosis in cancer patients: should the European Organization for Research and Treatment of Cancer/Mycosis Study Group (EORTC/MSG) criteria be revised?

BACKGROUND: Invasive pulmonary aspergillosis (IPA) is a life-threatening infection in immunocompromised patients. The outcome of such infections depends on early diagnosis and prompt initiation of therapy. The objective of the current study was to determine the significant predictive factors that characterize IPA in patients with cancer. METHODS: The clinical characteristics and computed tomography (CT) findings for 47 cases with IPA were retrospectively reviewed and compared with 49 controls (patients diagnosed on autopsy with nonfungal pneumonias). Data from all 96 patients were modeled using multivariate logistic regression. Subgroups of patients with common characteristics and outcomes were identified. RESULTS: Leukemia, neutropenia, cavitation, and nodular lesions occurred significantly more often among cases than controls (P = 0.04, 0.004, 0.04, and 0.02, respectively). A quantitative scoring system was developed that could be used to identify patients as being at low, medium, and high risk for IPA. CONCLUSIONS: IPA should be highly suspected in leukemia patients with profound neutropenia, pleuritic chest pain, and cavitary or nodular lesions detected on CT scan. These predictive factors can be used to indicate when early prophylactic and therapeutic antifungal interventions should be initiated.     

Observational Study on Patient’s Satisfactions and Quality of Life (QoL) Among Cancer Patients Receiving Treatment with Palliative Care Intent in a Tertiary Hospital in Malaysia

The main objective of palliative treatment for cancer patients has been to maintain, if not improve, the qualityof life (QoL). There is a lack of local data on satisfaction and QoL among cancer patients receiving palliativetreatment in Malaysia. This study covers patients with incurable, progressive cancer disease receiving palliativetreatment in a teaching hospital in Kuala Lumpur, comparing the different components of QoL and correlationswith patient satisfaction. A cross-sectional survey using Malay validated SF36 QoL and PSQ-18 (Short Form)tools was carried out between July 2012 -January 2013 with 120 cancer patients receiving palliative treatment,recruited into the study after informed consent using convenient sampling. Results showed that highest satisfactionwere observed in Communication Aspect (50.6±9.07) and the least in General Satisfaction (26.4±5.90). TheMental Component Summary (44.9±6.84) scored higher when compared with the Physical Component Summary(42.2±7.91). In this study, we found that patient satisfaction was strongly associated with good quality of lifeamong cancer patients from a general satisfaction aspect (r=0.232). A poor significant negative correlation wasfound in Physical Component (technical quality, r=-0.312). The Mental Component showed there was a poornegative correlation between time spent with doctor (r=-0.192) and accessibility, (r=-0.279). We found that feelingat peace and having a sense of meaning in life were more important to patients than being active or achievinggood physical comfort. More studyis needed to investigate patients who score poorly on physical and mentalcomponent aspects to understand their needs in order to achieve better cancer care.