TomoBreast is a unicenter, non-blinded randomized trial comparing conventional radiotherapy (CR) vs. hypofractionated Tomotherapy (TT) for post-operative treatment of breast cancer. The purpose of the trial is to compare whether TT can reduce heart and pulmonary toxicity. We evaluate early toxicities.
The trial started inclusion in May 2007 and reached its recruitment in August 2011. Women with stage T1-3N0M0 or T1-2N1M0 breast cancer completely resected by tumorectomy (BCS) or by mastectomy (MA) who consented to participate were randomized, according to a prescribed computer-generated randomization schedule, between control arm of CR 25x2 Gy/5 weeks by tangential fields on breast/chest wall, plus supraclavicular-axillary field if node-positive, and sequential boost 8x2 Gy/2 weeks if BCS (cumulative dose 66 Gy/7 weeks), versus experimental TT arm of 15x2.8 Gy/3 weeks, including nodal areas if node-positive and simultaneous integrated boost of 0.6 Gy if BCS (cumulative dose 51 Gy/3 weeks). Outcomes evaluated were the pulmonary and heart function. Comparison of proportions used one-sided Fisher's exact test.
By May 2010, 70 patients were randomized and had more than 1 year of follow-up. Out of 69 evaluable cases, 32 were assigned to CR (21 BCS, 11 MA), 37 to TT (20 BCS, 17 MA). Skin toxicity of grade ≥1 at 2 years was 60% in CR, vs. 30% in TT arm. Heart function showed no significant difference for left ventricular ejection fraction at 2 years, CR 4.8% vs. TT 4.6%. Pulmonary function tests at 2 years showed grade ≥1 decline of FEV1 in 21% of CR, vs. 15% of TT and decline of DLco in 29% of CR, vs. 7% of TT (P = 0.05).
There were no unexpected severe toxicities. Short course radiotherapy of the breast with simultaneous integrated boost over 3 weeks proved feasible without excess toxicities. Pulmonary tests showed a slight trend in favor of Tomotherapy, which will need confirmation with longer follow-up of patients.
Early breast cancer; Hypofractionation; Simultaneous integrated boost (SIB); Image guided radiation treatment (IGRT); Intensity modulated radiotherapy (IMRT)
A variety of hypofractionated radiotherapy schedules has been proposed after breast conserving surgery in the attempt to shorten the overall treatment time. The aim of the present study is to assess acute and late toxicity of using daily fractionation of 2.25 Gy to a total dose of 45 Gy to the whole breast in a mono-institutional series.
Eighty-five women with early breast cancer were assigned to receive 45 Gy followed by a boost to the tumour bed. Early and late toxicity were scored according to the Radiation Therapy Oncology Group criteria. For comparison, a group of 70 patients with similar characteristics and treated with conventional fractionation of 2 Gy to a total dose of 50 Gy in 25 fractions followed by a boost, was retrospectively selected.
Overall median treatment duration was 29 days for hypofractionated radiotherapy and 37 days for conventional radiotherapy. Early reactions were observed in 72/85 (85%) patients treated with hypofractionation and in 67/70 (96%) patients treated with conventional fractionation (p = 0.01). Late toxicity was observed in 8 patients (10%) in the hypofractionation group and in 10 patients (15%) in the conventional fractionation group, respectively (p = 0.4).
The hypofractionated schedule delivering 45 Gy in 20 fractions shortened the overall treatment time by 1 week with a reduction of skin acute toxicity and no increase of late effects compared to the conventional fractionation. Our results support the implementation of hypofractionated schedules in clinical practice.
While evidence on safety and efficacy of primary hypofractionated radiotherapy in prostate cancer is accumulating, data on postoperative hypofractionated treatment of the prostate bed and of the pelvic lymph nodes is still scarce. This phase II trial was initiated to investigate safety and feasibility of hypofractionated treatment of the prostate bed alone or with the pelvic lymph nodes.
A total of 80 prostate cancer patients with the indication for adjuvant radiotherapy will be enrolled, where 40 patients with a low risk of lymph node involvement (arm 1) and another 40 patients with a high risk of lymph node involvement (arm 2) will each receive 54 Gy in 18 fractions to the prostate bed. Arm 2 will be given 45 Gy to the pelvic lymph nodes additionally. Helical Tomotherapy and daily image guidance will be used.
This trial was initiated to substantiate data on hypofractionated treatment of the prostate bed and generate first data on adjuvant hypofractionated radiotherapy of the pelvic lymph nodes.
Prostate cancer; Radiotherapy; Hypofractionation; Helical tomotherapy; Prostate bed; Pelvic lymph nodes
Breast cancer survivors who participate in physical activity (PA) are reported to experience improved health-related quality of life (HRQOL). However, the quantitative research exploring the relationship between the team-based activity of dragon boat racing and the HRQOL of breast cancer survivors is limited. Given the rising number of breast cancer survivors, and their growing attraction to dragon boating, further exploration of the influence of this activity on HRQOL is warranted.
This study is designed to: 1) quantitatively assess whether and how breast cancer survivors’ participation in a season of dragon boat racing is related to HRQOL and 2) qualitatively explore the survivors’ lived experience of dragon boating and how and why this experience is perceived to influence HRQOL. A mixed methods sequential explanatory design was used with the purpose of complementing quantitative findings with qualitative data. Quantitative data measuring HRQOL were collected at baseline and post-season (N = 100); semi-structured qualitative interviews were used to elicit a personal account of the dragon boat experience (N = 15).
Statistically significant improvements were shown for HRQOL, physical, functional, emotional and spiritual well-being, breast cancer-specific concerns and cancer-related fatigue. A trend towards significance was shown for social/family well-being. Qualitative data elaborated on the quantitative findings, greatly enhancing the understanding of how and why dragon boat racing influences HRQOL.
The use of a mixed methods design effectively captured the complex yet positive influence of dragon boating on survivor HRQOL. These findings contribute to a growing body of literature supporting the value of dragon boat racing as a viable PA intervention for enhancing survivor HRQOL.
Breast cancer diagnosis and treatment can have a profound influence on a woman's physical, psychosocial, and overall well-being. We examined the prevalence of depressive symptoms and its association with health-related quality of life (HRQOL) in women who are survivors of breast cancer. We also assessed if factors, including metastasis, cancer recurrence, diagnosis of new primary cancers, and comorbid conditions, are associated with depressive symptoms.
The Patient Health Questionnaire (PHQ-8) and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 were mailed to assess depressive symptoms and HRQOL, respectively, in breast cancer patients who received cancer treatment in a large tertiary cancer center.
Two hundred forty patients participated (56% response rate and 6–13 years since treatment). The mean score on the PHQ-8 scale was 4 points (standard deviation [SD] 4.8, median 2.0). Sixteen percent had PHQ-8 score ≥10 and were categorized as depressed. Depression was inversely associated with HRQOL subscales for functioning, financial, and global health and positively associated with symptoms. Logistic regression showed that younger age (odds ratio [OR] age in years 0.92, 95% confidence interval [CI] 0.86- 0.99, p<0.02), rheumatoid arthritis (OR 8.4, 95%CI 1.3-57.4, p<0.03), and years from treatment (OR 0.70, 95% CI 0.46-0.99, p<0.05) were significant correlates of depression.
Depression is a significant health concern for breast cancer survivors and is associated with lower HRQOL. The results suggest the need to monitor women with breast cancer for depression and provide resources for treating depression during the survival period.
Interest in health-related quality of life (HRQoL) outcome research in dermatology is increasing, especially in the systemic treatment of psoriasis with biologic agents. In other specialties, such as oncology, the application of a HRQoL intervention is considered to be an aid for monitoring disease and treatment over time, for the communication with the patient, and for improving treatment outcome. However, in dermatology practice, the application of this intervention is relatively new. Moreover, evidence on the effectiveness of a HRQoL intervention in dermatology is missing. It is hypothesized that the application of a HRQoL intervention in dermatology practice will have a positive impact on patients’ HRQoL as well as on doctor-patient communication.
In a prospective multicenter cluster randomized controlled trial, patients diagnosed with moderate to severe psoriasis who receive biologic treatment, will be followed for 48 weeks. The study sites, and not the patients, will be randomly allocated via a computer-based randomization system to either the intervention (treatment with etanercept and standardized HRQoL assessment and communication) or the control group (treatment with etanercept alone). The HRQoL intervention will include 1) the electronic assessment of the Skindex-29, a well-studied dermatology-specific HRQoL questionnaire, and 2) the communication of the resulting Skindex-29 data with the patient. Prior to study start, dermatologists in the intervention group will be educated and trained in standardized HRQoL assessment and communication using the Skindex-29. At six consecutive visits, patients at study sites in the intervention group will be asked to complete the Skindex-29 on a desk-top pc at the clinic, just before their consultation with the dermatologist. A print-out of the completed questionnaire will be made and, guided by this print-out, feedback on the HRQoL scores will be given during the consultation. Primary outcome parameters are the impact of the HRQoL intervention on patients’ HRQoL, and the effect of the HRQoL intervention on doctor-patient communication. Secondary outcomes include health status and disease severity.
The Netherlands National Trial Register (NTR): NTR1364.
Dermatology; Randomized controlled trial; Patient-reported outcomes; Health-related quality of life; Intervention; Skindex-29; Psoriasis; Biologic; Etanercept
Health-related quality of life (HRQOL) has been hypothesized to predict time to additional breast cancer events and all-cause mortality in breast cancer survivors.
Women with early stage breast cancer (n=2967) completed the SF-36 (mental and physical health-related quality of life) and standardized psychosocial questionnaires to assess social support, optimism, hostility, and depression prior to randomization into a dietary trial. Cox regression was performed to assess whether these measures of quality of life and psychosocial functioning predicted time to additional breast cancer events and all-cause mortality; hazard ratios were the measure of association.
There were 492 additional breast cancer events and 301 deaths occurred over a median 7.3 years (range: 0.01–10.8 years) of follow-up. In multivariate models, poorer physical health was associated with both decreased time to additional breast cancer events and all-cause mortality (p trend=0.005 and 0.004, respectively), while greater hostility predicted additional breast cancer events only (p trend=0.03). None of the other psycho-social variables predicted either outcome. The hazard ratios comparing persons with poor (bottom two quintiles) to better (top three quintiles) physical health were 1.42 (95% CI: 1.16, 1.75) for decreased time to additional breast cancer events and 1.37 (95% CI: 1.08, 1.74) for all-cause mortality. Potentially modifiable factors associated with poor physical health included higher BMI, lower physical activity, lower alcohol consumption, and more insomnia (p<0.05 for all).
Interventions to improve physical health should be tested as a means to increase time to additional breast cancer events and mortality among breast cancer survivors.
physical health; breast cancer; oncology; survival
New highly conformal irradiation modalities have emerged for treatment of Hodgkin lymphoma. Helical tomotherapy offers both intensity-modulated irradiation and accurate patient positioning and was shown to significantly decrease radiation doses to the critical organs. Here we review some of the most promising applications of helical tomotherapy in Hodgkin disease. By decreasing doses to the heart or the breast, helical tomotherapy might decrease the risk of long-term cardiac toxicity or secondary breast cancers, which are major concerns in patients receiving chest radiotherapy. Other strategies, such as debulking radiotherapy prior to stem cell transplantation or total lymphoid irradiation may be clinically relevant. However, helical tomotherapy may also increase the volume of tissues that receive lower doses, which has been implicated in the carcinogenesis process. Prospective assessments of these new irradiation modalities of helical tomotherapy are required to confirm the potential benefits of highly conformal therapies applied to hematological malignancies.
Hodgkin lymphoma; Helical tomotherapy; Cardiac toxicity; Secondary cancers
Tomotherapy for intensity-modulated radiation has been demonstrated to reduce unnecessary irradiations to adjacent organs at risk (OARs). The purpose of this study was to compare the dosimetric parameters between Tomotherapy and three-dimensional conformal radiotherapy (3D-CRT) in rectal cancer patients.
Materials and methods
We redesigned three-dimensional conformal plans for 20 rectal cancer patients who had received short-course preoperative radiotherapy with Tomotherapy. The target coverage for 3D-CRT and Tomotherapy was evaluated with the following including the mean dose, VnGy, Dmin, Dmax, radiation conformality index (RCI), and radical dose homogeneity index (rDHI).
The mean PTV dose for Tomotherapy is significantly higher than that observed for the 3D-CRT (p = 0.043). However, there is no significant difference in the V23.25Gy, V26.25Gy, V27.5Gy, and RCI values between Tomotherapy and 3D-CRT. However, the average rDHI (p < 0.001) value for Tomotherapy was significantly lower than that reported for the 3D-CRT. Tomotherapy significantly lowered the mean level of irradiation doses to the bladder, small bowel, and femur heads as compared to 3D-CRT.
Tomotherapy could produce a favorable target coverage and significant dose reduction for the OARs at the expense of acceptable dose inhomogeneity of the PTV compared with 3D-CRT in rectal cancer patients.
Conformal; Dosimetry; Preoperative radiotherapy; Rectal cancer; Tomotherapy
To identify the influence of lymphedema on health-related quality of life (HRQOL) more than 1 year after breast cancer surgery.
Ninety-six breast cancer patients who survived more than 1 year after surgery and 104 members of the general population were recruited. Patients were divided into 2 groups according to the presence of lymphedema. HRQOL was evaluated with the Short-Form 36-Item Health Survey.
There were no statistically significant differences in any scales between groups: groups of breast cancer survivors with and without lymphedema. Compared with the general population, breast cancer survivors had lower quality of life scores in all scales, although the vitality and mental health scales did not differ from chance variation at the 5% level.
In this study, the presence of lymphedema in breast cancer patients who survived over 1 year after surgery might not affect the quality of life. However quality of life of breast cancer survivors is lower than in general population except for some mental health components.
Breast neoplasms; Lymphedema; Quality of life
The purpose of this work was to conduct a systematic review and meta-analysis of all randomized controlled trials comparing the efficacy and side effect profile of hypofractionated versus conventional external-beam radiation therapy for prostate cancer.
Several databases were searched, including Medline, EmBase, LiLACS, and Central. The endpoints were freedom from biochemical failure and side effects. We performed a meta-analysis of the published data. The results are expressed as the hazard ratio (HR) or risk ratio (RR), with the corresponding 95% confidence interval (CI).
The final analysis included nine trials comprising 2702 patients. Freedom from biochemical failure was reported in only three studies and was similar in patients who received hypofractionated or conventional radiotherapy (fixed effect, HR 1.03, 95% CI 0.88–1.20; P = 0.75), with heterogeneity [χ2 = 15.32, df = 2 (P = 0.0005); I2 = 87%]. The incidence of acute adverse gastrointestinal events was higher in the hypofractionated group (fixed effect, RR 2.02, 95% CI 1.45–2.81; P < 0.0001). We also found moderate heterogeneity on this analysis [χ2 = 7.47, df = 5 (P = 0.19); I2 = 33%]. Acute genitourinary toxicity was similar among the groups (fixed effect, RR 1.19, 95% CI 0.95–1.49; P = 0.13), with moderate heterogeneity [χ2 = 5.83, df = 4 (P = 0.21); I2 = 31%]. The incidence of all late adverse events was the same in both groups (fixed effect, gastrointestinal toxicity, RR 1.17, 95% CI 0.79–1.72, P = 0.44; and acute genitourinary toxicity, RR 1.16, 95% CI 0.80–1.68, P = 0.44).
Hypofractionated radiotherapy in localized prostate cancer was not superior to conventional radiotherapy and showed higher acute gastrointestinal toxicity in this meta-analysis. Because the number of published studies is still small, future assessments should be conducted to clarify better the true role of hypofractionated radiotherapy in patients with prostate cancer.
hypofractionated; radiotherapy; prostate cancer; systematic review; acute radiation effects
The risk of ipsilateral breast tumour recurrence (IBTR) following breast conservation surgery (BCS) for invasive breast cancer (IBC) and radiotherapy is dependent on patient-, tumour- and treatment-related variables. In the Cambridge Breast Unit, breast conserving surgery has been performed with a target radial margin of 5 mm for IBC, in combination with 40-Gy hypofractionated (15 fractions) breast radiotherapy, since 1999.
PATIENTS AND METHODS
An audit was performed of cases treated between 1999 and 2004. A total of 563 patients underwent BCS for invasive breast cancer with 90.4% receiving radiotherapy (RT) and 60.4% of patients receiving boost RT (3 fractions of 3-Gy).
After a median follow-up of 58 months, five of the 563 (0.9%) patients developed IBTR. The 5-year actuarial IBTR rate was 1.1%. In terms of distant disease recurrence (DDR), 29 of the 563 (5.2%) had DDR during follow-up, giving a 5-year actuarial DDR rate of 5.4%. The 5-year breast cancer specific survival was 95%, with the poorer NPI groups having worse breast cancer specific survival (Log-rank, P < 0.0001). More importantly, patients with IBTR had a shorter breast cancer-specific survival than those who were IBTR-free (Log-rank, P < 0.0001).
Our treatment regimen, combining BCS with a 5-mm target margin and hypofractionated 40-Gy RT, results in an extremely low rate of IBTR, and compares favourably with the target IBTR rate of < 5% defined by the Association of Breast Surgeons (ABS) at BASO guidelines.
Breast conserving surgery; Radiotherapy; Ipsilateral breast tumour recurrence
Health-related quality of life (HRQOL) has become an increasingly important endpoint in cancer studies; however, the research into the HRQOL of patients with high-grade glioma (HGG) is sparse compared with that for patients with other neoplasms. Owing to the specific location and poor prognosis, it is more important and difficult to study HRQOL in patients with HGG than in those with other tumors; furthermore, the study of HRQOL in patients with HGG differs from that for patients with other tumors. In this review, we identified and compared the most frequently used instruments to assess HRQOL; analyzed specific facets and determinants of HRQOL (such as sex, tumor location and histological classification, depression, and cognitive function), as well as the association between HRQOL and survival; and appraised the effects of new treatments on HRQOL in patients with HGG from randomized controlled trials. Furthermore, we detected broadly existing problems and many contradictory outcomes and gave some proper interpretation and suggestions regarding them.
cognitive function; depression; health-related quality of life; high-grade glioma; instruments; survival
Health-related quality of life (HRQOL), body mass index (BMI), and physical activity (PA) levels have all been associated with prognosis following breast cancer and may partially explain higher mortality for breast cancer in certain race/ethnic sub-groups. In this study, we examined associations between PA, BMI, and HRQOL by race in a sample of breast cancer survivors.
Measures of PA, BMI, and HRQOL as well as demographic and medical characteristics of women (N=3013, 13% nonwhite) who participated in the Women’s Healthy Eating and Living Study were assessed at baseline. Analysis of covariance was used to examine the relationship between PA and obesity with HRQOL outcomes. Statistical tests were two-sided.
African-American women were less likely to meet guidelines for PA and more likely to be obese than women from other ethnic groups (P < 0.05). In adjusted models, women who met guidelines for PA reported significantly higher physical health composite (point differences ranged from 10.5 to 21.2 points, all P <0.05) and vitality (point differences ranged from 9.9 to 16.5 points, all P <0.05) scores than those who did not, regardless of race/ethnicity. Associations between obesity and HRQOL were mixed with fewer associations for Asian-American and African-American women and stronger associations for whites.
Breast cancer survivors from racially and ethnically diverse populations have lower levels of PA and higher rates of obesity that are generally associated with poorer HRQOL. Culturally sensitive PA and weight loss interventions may improve these lifestyle characteristics and result in improved HRQOL.
breast neoplasm; African American; disparities; Hispanic; obesity; quality of life; cancer survivors
Stereotactic ablative radiotherapy (SABR) has emerged as a new treatment option for patients with oligometastatic disease. SABR delivers precise, high-dose, hypofractionated radiotherapy, and achieves excellent rates of local control. Survival outcomes for patients with oligometastatic disease treated with SABR appear promising, but conclusions are limited by patient selection, and the lack of adequate controls in most studies. The goal of this multicenter randomized phase II trial is to assess the impact of a comprehensive oligometastatic SABR treatment program on overall survival and quality of life in patients with up to 5 metastatic cancer lesions, compared to patients who receive standard of care treatment alone.
After stratification by the number of metastases (1-3 vs. 4-5), patients will be randomized between Arm 1: current standard of care treatment, and Arm 2: standard of care treatment + SABR to all sites of known disease. Patients will be randomized in a 1:2 ratio to Arm 1:Arm 2, respectively. For patients receiving SABR, radiotherapy dose and fractionation depends on the site of metastasis and the proximity to critical normal structures. This study aims to accrue a total of 99 patients within four years. The primary endpoint is overall survival, and secondary endpoints include quality of life, toxicity, progression-free survival, lesion control rate, and number of cycles of further chemotherapy/systemic therapy.
This study will provide an assessment of the impact of SABR on clinical outcomes and quality of life, to determine if long-term survival can be achieved for selected patients with oligometastatic disease, and will inform the design of a possible phase III study.
Clinicaltrials.gov identifier: NCT01446744
Oligometastases; Stereotactic radiotherapy; Quality of life; Cancer; Survival
Breast cancer is the most common form of cancer in American women across most ethnic groups. Although the psychosocial impact of breast cancer is being studied, there is little information on women from diverse ethnic and socioeconomic backgrounds.
We conducted a qualitative study with breast cancer survivors (BCS) of various ethnicities. A total of 102 BCS participated in focus group interviews (24 African Americans, 34 Asians, 26 Latinas and 18 Caucasians); 20 health professionals participated in key informant interviews. Important ethnic differences in type of treatment were noted, Asians and Latinas were more likely to receive mastectomies and African American BCS were least likely to receive adjuvant therapies, including radiation and chemotherapy. These BCS enjoyed a fairly good overall health-related quality of life (HRQOL) with some persistent concerns. The prevailing concerns among all women included overall health, moderate physical concerns, cancer recurrence or metastases, psychosocial concerns related to worry about children and burdening the family, and body image and sexual health concerns. Additional challenges included: lack of knowledge about breast cancer; medical care issues such as insurance, cost and amount of time spent with physician; cultural sensitivity of providers, language barriers, cultural factors related to beliefs about illness, gender role and family obligations (e.g. self-sacrifice). These BCS, particularly the women of color, voiced that their spiritual beliefs and practices are central to their coping. This study accomplishes two goals; it adds to the sparse literature concerning the psychosocial sequelae of breast cancer among women of color, and it increases our knowledge of specific cultural influences (e.g. dietary practices, coping) and socio-ecological factors on HRQOL. More importantly, the study addressed areas that have not been studied before, specifically, an in-depth study on BCS QOL comparing multiple ethnic groups in the US. The results of this investigation will provide preliminary information to survivors and health-care providers about the impact of culture and socio-ecological contexts on survivorship.
Among women of all major ethnic groups, breast cancer is the most common form of cancer and the second leading cause of cancer death (American Cancer Society (ACS), 2002). In 2002, over 203,000 women in the United States will be diagnosed with breast cancer (ACS, 2002). Ethnic disparities exist for cancer stage, diagnosis, survival, morbidity and mortality. In general, ethnic minority women are diagnosed with more advanced disease and experience greater morbidity and mortality (Haynes & Smedley, 1999; Miller et al., 1996; Ries et al., 2000; Shinagawa, 2000).
In general, increases in survival rates have prompted greater interest in the quality of life (QOL) of breast cancer survivors (BCS) over the past two decades. Additionally, the QOL of cancer survivors from diverse ethnic, cultural and socioeconomic backgrounds is an emerging priority area for studies on survivorship research and clinical care (Haynes and Smedley, 1999; National Cancer Institute (NCI), 2002; President’s Cancer Panel, 2000).
Long-term survivors of head and neck cancer may suffer from psychological distress and reduced quality of life because of late side-effects of the treatment. In a follow-up study of patients randomised to two different radiation fractionating regimens, 204 patients filled in a mailed questionnaire 7-11 years after treatment. The questionnaire consisted of the General Health Questionnaire, 20-item version (GHQ-20), and the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30). There were no differences in psychological distress between patients receiving conventional radiotherapy and those receiving a slightly hypofractionated regimen. A high prevalence of psychological distress was found in both treatment groups (30% of 'cases' according to the GHQ-20), especially in patients with impaired cognitive or social function, or with pain. Clinicians need to be aware of this morbidity, and their ability to detect patients with psychological problems needs to be improved. The GHQ-20 can facilitate the communication process in a clinical setting. With an increased awareness of these problems and by using valid instruments for identification of patients at risk, the clinicians may intervene and help the patients to reduce their psychological distress.
This review examines health-related quality of life in patients with primary brain tumors.
Health-related quality of life (HRQOL) has become an important outcome measure in clinical trials in primary brain tumor (i.e., glioma) patients, because they have an incurable disease. HRQOL is assessed using self-reported, validated questionnaires, addressing physical, psychological, emotional, and social issues. In addition to generic HRQOL instruments, disease-specific questionnaires have been developed, including for brain tumor patients. For the analysis and interpretation of HRQOL measurements, low compliance and missing data are methodological challenges.
HRQOL in glioma patients may be negatively affected by the disease itself as well as by side effects of treatment. But treatment with surgery, radiotherapy, and chemotherapy may improve patient functioning and HRQOL, in addition to extending survival.
Although HRQOL has prognostic significance in brain tumor patients, it is not superior to well-known clinical parameters, such as age and performance status. In clinical practice, assessing HRQOL may be helpful in the communication between doctor and patient and may facilitate treatment decisions.
Quality of life; Patient-reported outcome; Brain tumor; Cognition; Side effects of treatment
The palliative role of chemoradiation in the treatment of patients with locally advanced, inoperable non-small-cell lung cancer stage III and negative prognostic factors remains unresolved.
Patients not eligible for curative radiotherapy were randomised to receive either chemoradiation or chemotherapy alone. Four courses of intravenous carboplatin on day 1 and oral vinorelbin on days 1 and 8 were given with 3-week intervals. Patients in the chemoradiation arm also received radiotherapy with fractionation 42 Gy/15, starting at the second chemotherapy course. The primary end point was overall survival; secondary end points were health-related quality of life (HRQOL) and toxicity.
Enrolment was terminated due to slow accrual after 191 patients from 25 Norwegian hospitals were randomised. Median age was 67 years and 21% had PS 2. In the chemotherapy versus the chemoradiation arm, the median overall survival was 9.7 and 12.6 months, respectively (P<0.01). One-year survival was 34.0% and 53.2% (P<0.01). Following a minor decline during treatment, HRQOL remained unchanged in the chemoradiation arm. The patients in the chemotherapy arm reported gradual deterioration during the subsequent months. In the chemoradiation arm, there were more hospital admissions related to side effects (P<0.05).
Chemoradiation was superior to chemotherapy alone with respect to survival and HRQoL at the expense of more hospital admissions due to toxicity.
advanced NSCLC; chemoradiotherapy; palliation; vinorelbin; carboplatin; lung cancer
Compared to conventional radiotherapy (RT), intensity-modulated radiotherapy (IMRT) significantly reduces the rate of treatment-induced late toxicities in head and neck cancer. However, a clear survival benefit of IMRT over conventional RT has not yet been shown. This study is among the first comparative study to compare the survival rates between conventional RT and helical tomotherapy in head and neck cancer.
Materials and Methods
From January 2008 to November 2011, 37 patients received conventional RT and 30 patients received helical tomotherapy for management of head and neck cancer. We retrospectively compared the survival rates between patients treated with conventional RT and helical tomotherapy, and analyzed the prognostic factors for survival.
The 1- and 2-year locoregional recurrence-free survival rates were 61.2% and 58.1% for the conventional RT group, 89.3% and 80.3% for the helical tomotherapy group, respectively. The locoregional recurrence-free survival rates of the helical tomotherapy group were significantly higher than conventional RT group (p = 0.029). There were no significant differences in the overall and distant metastasis-free survival between the two groups. RT technique, tumor stage, and RT duration were significant prognostic factors for locoregional recurrence-free survival.
This study showed the locoregional recurrence-free survival benefits of helical tomotherapy in the treatment of head and neck cancers.
Helical tomotherapy; Conventional radiotherapy; Survival rate; Head and neck cancer
Small samples with few minority women and/or the absence of comparisons to peers without cancer histories have limited previous research suggesting racial differences in breast cancer survivors’ health-related quality of life (HRQoL). The present study not only compares HRQoL of African American and white breast cancer survivors, but also compares the HRQoL of these women to that of same race women with no cancer history.
Data from the Women’s Health Initiative-Observational Study were used including 5,021 cancer survivors and 88,532 women without a history of cancer. Multivariable regression analyses estimated differences in breast cancer survivors’ baseline HRQoL (RAND36), depressive symptoms (CES-D short-form), and sleep quality (WHIIRS).
African American breast cancer survivors reported worse physical functioning and general health compared to white survivors. Among African Americans, survivors reported worse role limitations due to physical health, pain, general health, and vitality than women without a history of cancer. This was most evident in those with more recent diagnoses. Most significant differences between groups were small in magnitude (Cohen’s d=.21-.36).
These results add to the increasing knowledge of cancer disparities by showing that African American women have small but clinically meaningful decrements in physical HRQoL compared to white survivors and to African American women without cancer. Since African American women also face diagnosis with higher grade tumors and higher breast cancer mortality, more research is needed to examine the physical and psychosocial experiences of African American breast cancer survivors to elucidate the mechanisms leading to poorer outcomes.
breast cancer; quality of life; health status; race
Radiation therapy is an essential modality in the treatment of breast cancer. Addition of radiotherapy to surgery has significantly increased local control and survival rates of the disease. However, radiotherapy is also associated with side effects, such as tissue fibrosis or enhanced vascular morbidity. Modern radiotherapy strategies, such as intensity modulated radiotherapy (IMRT), can shorten the overall treatment time by integration of the additional tumor bed boost significantly. To what extent this might be possible without impairing treatment outcome and cosmetic results remains to be clarified.
The IMRT-MC2 study is a prospective, two armed, multicenter, randomized phase-III-trial comparing intensity modulated radiotherapy with integrated boost to conventional radiotherapy with consecutive boost in patients with breast cancer after breast conserving surgery. 502 patients will be recruited and randomized into two arms: patients in arm A will receive IMRT in 28 fractions delivering 50.4 Gy to the breast and 64.4 Gy to the tumor bed by integrated boost, while patients in arm B will receive conventional radiotherapy of the breast in 28 fractions to a dose of 50.4 Gy and consecutive boost in 8 fractions to a total dose of 66.4 Gy.
Primary objectives of the study are the evaluation of the cosmetic results 6 weeks and 2 years post treatment and the 2- and 5-year local recurrence rates for the two different radiotherapy strategies. Secondary objectives are long term overall survival, disease free survival and quality of life.
ClinicalTrials.gov Protocol ID: NCT01322854.
There are limited long-term randomized controlled trials of growth hormone (GH) supplementation to adult height and few published reports of the health-related quality of life (HRQOL) following treatment. The present follow-up study of young adults from a long-term controlled trial of GH treatment in patients with Turner syndrome (TS) yielded data to examine whether GH supplementation resulted in a higher HRQOL (either due to taller stature or from the knowledge that active treatment and not placebo had been received) or alternatively a lower HRQOL (due to medicalization from years of injections).
The original trial randomized 154 Canadian girls with TS aged 7-13 years from 13 centres to receive either long-term GH injections at the pharmacologic dose of 0.3 mg/kg/week or to receive no injections; estrogen prescription for induction of puberty was standardized. Patients were eligible for the follow-up study if they were at least 16 years old at the time of follow-up. The instrument used to study HRQOL was the SF-36, summarized into physical and mental component scales (PCS and MCS); higher scores indicate better HRQOL.
Thirty-four of the 48 eligible participants (71%) consented to participate; data were missing for one patient. Both groups (GH and no treatment) had normal HRQOL at this post-treatment assessment. The GH group had a (mean ± SD) PCS score of 56 ± 5; the untreated group 58 ± 4; mean score for 16-24 year old females in the general population 53.5 ± 6.9. The GH group had a mean MCS score of 52 ± 6; the untreated group 49 ± 13; mean score for 16-24 year old females in the general population 49.6 ± 9.8. Secondary analyses showed no relationship between HRQOL and height.
We found no benefit or adverse effect on HRQOL either from receiving or not receiving growth hormone injections in a long-term randomized controlled trial, confirming larger observational studies. We suggest that it remains ethically acceptable as well as necessary to maintain a long-term untreated control group to estimate the effects of pharmacological agents to manipulate adult height. Young adult women with TS have normal HRQOL suggesting that they adjust well to their challenges in life.
ClinicalTrials.gov Identifier NCT00191113.
The impact of lymphedema or related arm symptoms on health-related quality of life (HRQOL) in breast cancer (BrCa) survivors has not been examined using a large population-based cohort.
Patients and Methods
The Iowa Women's Health Study (IWHS) collected self-report data for lymphedema, arm symptoms, and HRQOL (Medical Outcomes Study Short Form-36) in 2004 and data for cancer diagnosis, treatment, and behavioral and health characteristics between 1986 and 2003. We studied 1,287 women, age 55 to 69 years at baseline, who developed unilateral BrCa. We used cross-sectional analyses to describe the prevalence of lymphedema and arm symptoms and multivariate-adjusted generalized linear models to compare HRQOL (physical functioning, bodily pain, general health, physical and emotional role limitations, vitality, social functioning, and mental health) between the following three survivor groups: women with lymphedema (n = 104), women with arm symptoms without diagnosed lymphedema (n = 475), and women without lymphedema or arm symptoms (n = 708).
The mean (± SE) time between BrCa diagnosis and lymphedema survey was 8.1 ± 0.2 years. Of BrCa survivors, 8.1% self-reported diagnosed lymphedema, and 37.2% self-reported arm symptoms. Knowledge of lymphedema was low among survivors without diagnosed lymphedema (n = 1,183). After multivariate adjustment, women with diagnosed lymphedema or arm symptoms without diagnosed lymphedema had lower physical and mental HRQOL compared with women without lymphedema or arm symptoms. Effect sizes were mild to moderate. There was a dose-response relation between number of arm symptoms and lower HRQOL.
In the IWHS, HRQOL was lower for BrCa survivors with diagnosed lymphedema and for those with arm symptoms without diagnosed lymphedema. Clinical trials are needed to determine what interventions can improve lymphedema and impact HRQOL for BrCa survivors.
The purpose of this study was to identify parameters capable of predicting the deterioration of hepatic function after helical tomotherapy in patients with unresectable locally advanced hepatocellular carcinoma.
Between March 2006 and February 2012, 72 patients were eligible for this study. All patients received hypofractionated radiotherapy using the TomoTherapy Hi-Art (TomoTherapy, Madison, WI, USA) at Seoul St. Mary's Hospital and Incheon St. Mary's Hospital, the Catholic University of Korea. The radiation dose was a median 50 Gy (range: 40–50 Gy) in 10 fractions to 95% of the planning target volume. Radiation-induced hepatic toxicity was defined as an increase of at least 2 points in the Child-Pugh (CP) score within 3 months after completion of helical tomotherapy.
An increase of at least 2 points in the CP score occurred in 32 of the 72 patients (44.4%). Multivariate logistic regression analysis revealed that pretreatment CP class and V15Gy were significant parameters associated with an increase in CP score (p = 0.009 and p < 0.001, respectively). The area under receiver operating characteristic curve was 0.863 for V15Gy (p < 0.001). For V15Gy, with a cutoff value of 43.2%, the accuracy was 0.806 (58/72) with a sensitivity of 0.938 and a specificity of 0.725.
An increase of at least 2 points in the CP score is a radiation dose-limiting factor, and the non-target normal liver receiving a dose more than 15 Gy (V15Gy) should be <43.2% to reduce the risk of the deterioration of hepatic function.
Hepatocellular carcinoma (HCC); Helical tomotherapy; Radiation-induced hepatic toxicity (RIHT); Child-Pugh score (CP score); Dosimetric parameter; The deterioration of hepatic function