Preference for the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with HER2-positive early breast cancer (PHranceSCa): A randomised, open-label phase II study.

AIM: The aim of the study was to assess patient preference for the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PH FDC SC) in patients with HER2-positive early breast cancer in PHranceSCa (NCT03674112). MATERIALS AND METHODS: Patients who completed neoadjuvant P + H + chemotherapy + surgery were randomised 1:1 to three intravenous (IV) P + H cycles followed by three cycles of PH FDC SC or vice versa (crossover) and then chose subcutaneous (SC) injection or IV infusion to continue up to 18 cycles (continuation). Assessments were via patient and healthcare professional (HCP) questionnaires. RESULTS: One hundred and sixty patients were randomised (cut-off: 24 February 2020); 136 (85.0%, 95% confidence interval: 78.5-90.2%) preferred SC; 22 (13.8%) preferred IV; 2 (1.3%) had no preference. The main reasons for SC preference were reduced clinic time (n = 119) and comfort during administration (n = 73). One hundred and forty-one patients (88.1%) were very satisfied/satisfied with SC injection versus 108 (67.5%) with IV infusion; 86.9% chose PH FDC SC continuation. HCP perceptions of median patient treatment room time ranged from 33.0-50.0 min with SC and 130.0-300.0 min with IV. Most adverse events (AEs) were grade 1/2 (no 4/5s); serious AE rates were low. AE rates before and after switching were similar (cycles 1-3 IV → cycles 4-6 SC: 77.5% → 72.5%; cycles 1-3 SC → cycles 4-6 IV: 77.5% → 63.8%). CONCLUSION: Most patients strongly preferred PH FDC SC over P + H IV. PH FDC SC was generally well tolerated, with no new safety signals (even when switching), and offers a quicker alternative to IV infusion.

Association of Treatment Adherence With Oncologic Outcomes for Patients With Rectal Cancer: A Post Hoc Analysis of the CAO/ARO/AIO-04 Phase 3 Randomized Clinical Trial.

Importance: Despite numerous published phase 3 trials, the association of treatment adherence with outcomes for patients with rectal cancer remains largely unexplored. Objective: To analyze the association of treatment adherence with disease-free survival (DFS) among patients with rectal cancer in the CAO/ARO/AIO-04 trial. Design, Setting, and Participants: This post hoc analysis of a phase 3 randomized clinical trial was conducted from July 25, 2006, to February 26, 2010, among 1232 patients from 80 centers with T3 to T4 or node-positive rectal adenocarcinoma. Statistical analysis was performed from May 5, 2019, to February 2, 2020. Interventions: A total of 625 patients received neoadjuvant fluorouracil-based chemoradiotherapy (nCRT), and a total of 607 patients received fluorouracil-based nCRT with addition of oxaliplatin. Of the 1126 patients who underwent curative surgery, 439 started fluorouracil-based adjuvant chemotherapy and 419 started fluorouracil-based adjuvant chemotherapy with oxaliplatin. Main Outcomes and Measures: The association of adherence with nCRT and adjuvant chemotherapy with DFS was assessed in both groups in the as-treated population. Results: Among the 625 patients (442 men; mean age, 63.0 years) who received fluorouracil nCRT and the 607 patients (430 men; mean age, 63.0 years) who received fluorouracil-based nCRT with addition of oxaliplatin, after a median follow-up of 50 months (interquartile range, 38-61 months), 3-year DFS in the as-treated population was 71.1% in the fluorouracil group and 75.8% in the fluorouracil-oxaliplatin group (hazard ratio [HR], 0.803; 95% CI, 0.651-0.990; P = .04). Overall, 419 patients in the fluorouracil nCRT group (67.0%) and 434 patients in the fluorouracil-oxaliplatin nCRT group (71.5%) received full doses of preoperative nCRT. Likewise, 253 of 439 patients in the fluorouracil group (57.6%) and 134 of 419 patients in the fluorouracil-oxaliplatin group (32.0%) received full doses of adjuvant chemotherapy. Adherence to nCRT was associated with 3-year DFS in both the fluorouracil group (complete vs near complete: HR, 1.325; 95% CI, 0.959-1.832; P = .09; complete vs reduced: HR, 1.877; 95% CI, 1.147-3.072; P = .01) and the fluorouracil-oxaliplatin group (complete vs near complete: HR, 1.501; 95% CI, 0.980-2.299; P = .06; complete vs reduced: HR, 1.724; 95% CI, 1.144-2.596; P = .009) in multivariable analyses. In contrast, adjuvant chemotherapy was not associated with DFS in both the fluorouracil group (complete vs near complete: HR, 0.900; 95% CI, 0.559-1.448; P = .66; complete vs incomplete: HR, 1.057; 95% CI, 0.807-1.386; P = .69) and the fluorouracil-oxaliplatin group (complete vs near complete: HR, 1.155; 95% CI, 0.716-1.866; P = .56; complete vs incomplete: HR, 1.073; 95% CI, 0.790-1,457; P = .65). Conclusions and Relevance: To our knowledge, this is the first analysis of a phase 3 trial to assess the association of treatment adherence with some clinical outcomes for patients with rectal cancer. The findings emphasize the need for appropriate trial design with optimized nCRT dose and schedule and supportive strategies to facilitate good adherence and precision delivery, especially for intensified nCRT. Trial Registration: ClinicalTrials.gov Identifier: NCT00349076.

Quality of life of locally advanced cervical cancer patients after neoadjuvant chemotherapy followed by chemoradiation versus chemoradiation alone (CIRCE trial): a randomized phase II trial.

OBJECTIVE: The CIRCE trial (NCT01973101) investigated the efficacy, safety, and quality of life of the addition of neoadjuvant chemotherapy with cisplatin and gemcitabine to standard chemoradiation for locally advanced cervical cancer (stages IIB-IVA). The impact of both treatment arms on quality of life is reported in the present study. METHODS: Patients completed the European Organization of Research and Treatment of Cancer questionnaire QLQ-C30 and CX24 before treatment and at 3, 6, 9, and 12 months after treatment. Linear mixed models were fitted to analyze differences in quality of life over time and between groups. Differences in mean quality of life scales >10 points and p<0.05 were considered clinically relevant and statistically significant, respectively. Inclusion criteria were: (1) histological diagnosis of locally advanced invasive carcinoma of the uterine cervix, International Federation of Gynecology and Obstetrics stages IIB-IVA; (2) signed informed consent to participate in the CIRCE trial; and (3) answered at least one quality of life questionnaire. Excluded were patients who did not complete any quality of life questionnaire. Relevant exclusion criteria for the CIRCE trial included Eastern Cooperative Oncology Group performance status >2 and peripheral neuropathy >2. Mann-Whitney U tests were performed to assess differences between groups in quality of life at baseline. To evaluate differences between treatment arms, linear mixed models were fitted using the transformed quality of life scores as a dependent variable and time of follow-up and study arm as factors. RESULTS: A total of 107 patients were enrolled (n=55 neoadjuvant chemotherapy arm; n=52 chemoradiation arm). Quality of life compliance rates were higher for the chemoradiation group at every assessment time (ranging from 75-86.5% in the chemoradiation arm vs 55-81.8% in the neoadjuvant chemotherapy arm). For quality of life results at baseline, no statistically significant difference between the groups was seen. For both groups, most scales showed improvements over time, except for worsening of the summary score, sexual enjoyment, peripheral neuropathy, and menopausal symptoms. For chemoradiation, body image was lower (p<0.001) and patients presented more lymphedema (p<0.001) and sexual worry (p<0.001) at 12 months compared with baseline. Comparing study arms, neoadjuvant chemotherapy showed significantly lower scores in the menopausal symptoms scale (p=0.03) and higher scores for sexual/vaginal functioning (p=0.01). At 12 months, clinical differences were seen only for body image and menopausal symptoms scale, with neoadjuvant chemotherapy presenting better body image scores and a lower burden of menopausal symptoms. CONCLUSION: After treatment for locally advanced cervical cancer, patients improved in most quality of life aspects. However, worsening was observed in sexual enjoyment, peripheral neuropathy, and menopausal symptoms. To improve patients' quality of life, efforts should be made to prevent and treat these long term effects of locally advanced cervical cancer treatment.

The effect of perceived social support on chemotherapy-related symptoms in patients with breast cancer: A prospective observational study.

OBJECTIVE: Few studies have examined the effect of perceived social support (PSS) on chemotherapy-related symptoms (CRS). This study examined the effect of PSS on CRS in 184 patients with breast cancer. METHODS: Participants were consecutively enrolled from a tertiary general hospital in Seoul, South Korea. CRS were assessed eight times, from before the first neoadjuvant chemotherapy to six months after the end of neoadjuvant chemotherapy, with the MD Anderson Symptom Inventory. PSS was evaluated once, before the first neoadjuvant chemotherapy session, using the Multidimensional Scale of Perceived Social Support (MSPSS). Two groups were formed based on MSPSS scores: the low PSS group (n = 62) and the moderate-to-high PSS group (n = 122). Linear mixed model analyses were used to compare the change in CRS severity between the two groups during chemotherapy. RESULTS: Results indicated a significant group-by-time (low PSS or moderate-to-high PSS; 8 periods of chemotherapy) interaction for pain (p = .005), nausea (p = .033), insomnia (p < .001), distress (p = .003), dyspnea (p = .014), memory loss (p = .021), vomiting (p = .016), and numbness (p = .008) in which the moderate-to-high PSS group showed significantly lower levels of increase in those symptoms during chemotherapy. Moreover, the effect of PSS on CRS differed depending on the sources of PSS. CONCLUSION: Patients with moderate-to-high PSS experience less severe CRS compared with patients with low PSS during chemotherapy. The current findings indicate the potential benefits of providing social support in the management of CRS.

Patient's quality of life after surgery and radiotherapy for extremity soft tissue sarcoma - a retrospective single-center study over ten years.

BACKGROUND AND OBJECTIVES: The purpose of this study is to analyze major complication rates and different aspects of health-related quality of life (HRQoL) in extremity soft tissue sarcoma (STS) patients treated with or without radio (chemo) therapy and surgery. METHODS: We performed a retrospective analysis of all patients who underwent Extremity STS excision from 2004 to 2014 (182 patients included). Patients' data were collected from patients' records. HRQoL was assessed by using EORTC QLQ-C30. RESULTS: A total of 182 patients underwent sarcoma resection. After neoadjuvant radiochemotherapy (RCT), the major-complication rate amounted to 28% (vs. 7%, no radiotherapy, p <  0.001). Major-complication rates after adjuvant radiotherapy (RT) occurred in 8% (vs. 7%, no radiotherapy, p = 0.265). Comparison QoL scores between treating with neoadjuvant RCT or without RT revealed significant worse scores with neoadjuvant RCT. Further stratification of disease control of these patients showed significant reduced scores in the group of disease-free patients with neoadjuvant RCT compared to irradiated disease-free patients. DISCUSSION: To date, there have only been a few investigations of QoL in STS. Retrospective study on quality of life have limitations, like a lack of baseline evaluation of QoL. Patient candidated to radiation therapy could have had worse QoL baseline due to more advanced disease. Disease status of the patients who answered the questionnaires could have been an influence of QoL and we could show reduced scores in the group of disease-free patients with neoadjuvant RCT, but not for the patients with recurrence or metastasis, so it is very hard to discriminate whether radiation therapy could really have an impact or not. CONCLUSION: This study might assist in further improving the understanding of QoL in STS patients and may animate for prospective studies examining the oncological therapies impact on HRQoL.

Patient-reported outcomes with neoadjuvant vs adjuvant systemic therapy for operable breast cancer.

BACKGROUND: Neoadjuvant systemic therapy (NAST) is used for large operable or highly proliferative breast cancers. It is not known whether psychological outcomes differ according to the treatment sequence (chemotherapy or surgery first) or tumour response. METHODS: This was a planned analysis of a multi-institutional single arm longitudinal study of patients considering NAST for operable breast cancer. Participants completed patient reported outcome questionnaires before and after the decision about NAST, between chemotherapy and surgery, and 12 months after diagnosis. RESULTS: Fifty-nine women enrolled. Fourteen of 51 (28%) who received NAST experienced pathological complete response (pCR). Patients who had surgery first (n = 7) had higher baseline anxiety, and a greater decrease in anxiety at 12 months follow up, compared with patients who received NAST (n = 50) (a decrease from baseline of 34 pts vs 17 points; p = 0.033). Distress declined at a similar rate in surgery first and NAST groups. Mean satisfaction with decision score post-decision was significantly lower in the adjuvant group compared with NAST (22 vs 26, p = 0.02). No differences were seen between patients with pCR vs residual cancer in: distress, anxiety, satisfaction with decision, fear of progression, and decision regret. CONCLUSION: Most patients in this study proceeded with NAST when their surgeon offered it as an option. This exploratory analysis suggests that patients who chose surgery first tended to be more anxious, and had lower satisfaction with their decision, than those who had NAST. In patients who had NAST, lack of pCR does not appear to correlate with adverse psychological outcomes.

Patients' preferences for treatment after neoadjuvant chemoradiotherapy for oesophageal cancer.

BACKGROUND: After neoadjuvant chemoradiotherapy (nCRT) plus surgery for oesophageal cancer, 29 per cent of patients have a pathologically complete response in the resection specimen. Active surveillance after nCRT (instead of standard oesophagectomy) may improve health-related quality of life (HRQoL), but patients need to undergo frequent diagnostic tests and it is unknown whether survival is worse than that after standard oesophagectomy. Factors that influence patients' preferences, and trade-offs that patients are willing to make in their choice between surgery and active surveillance were investigated here. METHODS: A prospective discrete-choice experiment was conducted. Patients with oesophageal cancer completed questionnaires 4-6 weeks after nCRT, before surgery. Patients' preferences were quantified using scenarios based on five aspects: 5-year overall survival, short-term HRQoL, long-term HRQoL, the risk that oesophagectomy is still necessary, and the frequency of clinical examinations using endoscopy and PET-CT. Panel latent class analysis was used. RESULTS: Some 100 of 104 patients (96·2 per cent) responded. All aspects, except the frequency of clinical examinations, influenced patients' preferences. Five-year overall survival, the chance that oesophagectomy is still necessary and long-term HRQoL were the most important attributes. On average, based on calculation of the indifference point between standard surgery and active surveillance, patients were willing to trade off 16 per cent 5-year overall survival to reduce the risk that oesophagectomy is necessary from 100 per cent (standard surgery) to 35 per cent (active surveillance). CONCLUSION: Patients are willing to trade off substantial 5-year survival to achieve a reduction in the risk that oesophagectomy is necessary.

Disease-specific and general health-related quality of life in newly diagnosed prostate cancer patients: the Pros-IT CNR study.

BACKGROUND: The National Research Council (CNR) prostate cancer monitoring project in Italy (Pros-IT CNR) is an observational, prospective, ongoing, multicentre study aiming to monitor a sample of Italian males diagnosed as new cases of prostate cancer. The present study aims to present data on the quality of life at time prostate cancer is diagnosed. METHODS: One thousand seven hundred five patients were enrolled. Quality of life is evaluated at the time cancer was diagnosed and at subsequent assessments via the Italian version of the University of California Los Angeles-Prostate Cancer Index (UCLA-PCI) and the Short Form Health Survey (SF-12). RESULTS: At diagnosis, lower scores on the physical component of the SF-12 were associated to older ages, obesity and the presence of 3+ moderate/severe comorbidities. Lower scores on the mental component were associated to younger ages, the presence of 3+ moderate/severe comorbidities and a T-score higher than one. Urinary and bowel functions according to UCLA-PCI were generally good. Almost 5% of the sample reported using at least one safety pad daily to control urinary loss; less than 3% reported moderate/severe problems attributable to bowel functions, and sexual function was a moderate/severe problem for 26.7%. Diabetes, 3+ moderate/severe comorbidities, T2 or T3-T4 categories and a Gleason score of eight or more were significantly associated with lower sexual function scores at diagnosis. CONCLUSIONS: Data collected by the Pros-IT CNR study have clarified the baseline status of newly diagnosed prostate cancer patients. A comprehensive assessment of quality of life will allow to objectively evaluate outcomes of different profile of care.

The impact on health-related quality of life in the first 12 months: A randomised comparison of preoperative short-course radiation versus long-course chemoradiation for T3 rectal cancer (Trans-Tasman Radiation Oncology Group Trial 01.04).

PURPOSE: To assess health-related quality of life (HRQOL) in patients participating in a randomised trial of neoadjuvant short course radiation (SC) or long course chemoradiation (LC) for operable rectal cancer. PATIENTS AND METHODS: Eligible patients with T3N0-2M0 rectal cancer completed the European Organisation for Research and Treatment of Cancer quality of life questionnaire (QLQ-C30) and the colorectal cancer specific module (QLQ C38) at randomisation and 1, 2, 3, 6, 9 and 12 months later. RESULTS: Of 326 patients randomised, 297 (SC 143, LC 154) were eligible for completion of HRQOL questionnaires. Baseline scores were comparable across the SC and LC groups. Patients reported low scores on sexual functioning and sexual enjoyment. Defaecation problems were the worst of the symptoms at baseline. Surgery had the most profoundly negative effect on HRQOL, seen in both the SC and LC treatment groups to the same extent. The most severely affected domains were physical function and role function and the most severely affected symptoms were fatigue, pain, appetite, weight loss and male sexual problems. Most domains and symptoms returned to baseline levels by 12 months apart from body image, sexual enjoyment and male sexual problems. Future perspective was better than prior to treatment. CONCLUSION: There is no overall difference in HRQOL between SC and LC neoadjuvant treatment strategies, in the first 12 months, after surgery. In the immediate postoperative period HRQOL was adversely affected in both groups but for the most part was temporary. Some residual sexual functioning concerns persisted at 12 months.

Exploring patient experiences of neo-adjuvant chemotherapy for breast cancer.

BACKGROUND AND PURPOSE: Neo-adjuvant chemotherapy is recommended for 'inoperable' locally advanced and inflammatory breast cancers. For operable breast cancers, trials indicate no survival differences between chemotherapy given pre or post-surgery. Communicating evidence based information to patients is complex and studies examining patient experiences of neo-adjuvant chemotherapy are lacking. This study aims to explore the experiences of women who received neo-adjuvant chemotherapy for breast cancer. METHODS: A qualitative approach using in-depth interviews with 20 women who had completed neo-adjuvant chemotherapy for breast cancer. Interview data were analysed using thematic analysis. RESULTS: The sample included a relatively young group of women, with caring responsibilities. Five main themes emerged: coping with the rapid transition from 'well' to 'ill', information needs and decision making, needing support and empathy, impact on family, and creating a new 'normal'. More support was needed towards the end of chemotherapy, when side effects were at their most toxic, and decisions about forthcoming surgery were being made. Some women were referred to psychological services, but usually when a crisis point had been reached. CONCLUSION: Information and support would have been beneficial at key time points. This information is vital in developing services and interventions to meet the complex needs of these patients and potentially prevent late referral to psychological services. Specialist oncology nurses are able to develop empathetic relationships with patients and have the experience, knowledge and skills to inform and support women experiencing neo-adjuvant chemotherapy. Targeting key time points and maintaining relationship throughout neo-adjuvant chemotherapy would be highly beneficial.

Deciding about (neo-)adjuvant rectal and breast cancer treatment: Missed opportunities for shared decision making.

BACKGROUND: The first step in shared decision making (SDM) is creating choice awareness. This is particularly relevant in consultations concerning preference-sensitive treatment decisions, e.g. those addressing (neo-)adjuvant therapy. Awareness can be achieved by explicitly stating, as the 'reason for encounter', that a treatment decision needs to be made. It is unknown whether oncologists express such reason for encounter. This study aims to establish: 1) if 'making a treatment decision' is stated as a reason for the encounter and if not, what other reason for encounter is provided; and 2) whether mentioning that a treatment decision needs to be made is associated with enhanced patient involvement in decision making. MATERIAL AND METHODS: Consecutive first consultations with: 1) radiation oncologists and rectal cancer patients; or 2) medical oncologists and breast cancer patients, facing a preference-sensitive treatment decision, were audiotaped. The tapes were transcribed and coded using an instrument developed for the study. Oncologists' involvement of patients in decision making was coded using the OPTION-scale. RESULTS: Oncologists (N = 33) gave a reason for encounter in 70/100 consultations, usually (N = 52/70, 74%) at the start of the consultation. The reason for encounter stated was 'making a treatment decision' in 3/100 consultations, and 'explaining treatment details' in 44/100 consultations. The option of foregoing adjuvant treatment was not explicitly presented in any consultation. Oncologist' involvement of patients in decision making was below baseline (Md OPTION-score = 10). Given the small number of consultations in which the need to make a treatment decision was stated, we could not investigate the impact thereof on patient involvement. CONCLUSION: This study suggests that oncologists rarely express that a treatment decision needs to be made in consultations concerning preference-sensitive treatment decisions. Therefore, patients might not realize that foregoing (neo-)adjuvant treatment is a viable choice. Oncologists miss a crucial opportunity to facilitate SDM.

Quality of life associated factors in head and neck cancer patients in a developing country using the FACT-H&N.

Health-related quality of life (HRQoL) associated factors are vital considerations prior to treatment decision-making for head and neck cancer patients. The study aimed to identify potential socio-demographic and clinical prognostic value of HRQoL in head and neck cancer patients in a developing country. The Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N)-V4 in Urdu language was administered among 361 head and neck cancer patients. Data were statistically tested through multivariate analysis of variance (MANOVA) and regression modeling to identify the potentially associated factors. Treatment status, tumor stage and tumor site had the strongest negative impact on patients HRQoL, with a statistically significant decrement in FACT summary scales (effect size >0.15). Moderate associated factors of HRQoL included treatment type, marital status, employment status and age (effect size range 0.06-0.15). Weak associated factors of HRQoL with a small effect size (>0.01-0.06) included tumor size and type, gender, education level and ethnicity. This study reports 12 socio-demographic and clinical variables that have a significant impact on HRQoL of head, and neck cancer patients, and that should be considered during treatment decision-making by multidisciplinary teams and also in future HRQoL studies conducted in other developing countries.

A systematic review of patient preference elicitation methods in the treatment of colorectal cancer.

AIM: This systematic review aimed to assess the use of patient preference in colorectal cancer treatment. Eliciting patient preference is important for shared decision-making in colorectal cancer treatment. The introduction of newer treatments, which balance quality of life and overall survival, makes this an important future focus. METHOD: A systematic search strategy of MEDLINE, Embase, PsycINFO, CINAHL and the Cochrane Database for Systematic Reviews was undertaken to obtain relevant articles. Information regarding the type of patients included, preference instruments, study settings, outcomes and limitations was extracted. RESULTS: The eight articles comprising this review each described an empirical study using a validated instrument to define patient preference for an aspect of colorectal cancer treatment. The evidence suggests that patients are prepared to trade significant reductions in life expectancy to avoid certain complications of colorectal surgery, particularly stoma formation. In the adjuvant setting, patients are prepared to risk significant treatment side effects to gain small potential increases in life expectancy and chance of survival. Where neoadjuvant or adjuvant treatment risks worsening function, however, patients generally forgo any potential increase in survival to improve bowel function and therefore quality of life. The only predictors of preference were tertiary education and previous cancer treatment. CONCLUSION: Most patients judge a moderate survival benefit to be sufficient to make adjuvant therapy for colorectal cancer worthwhile, but they are willing to trade a potential reduction in life expectancy and survival to avoid certain unwanted surgical sequelae.

Quality of life issues in head and neck cancer.

UNLABELLED: Head and neck cancer (HNC) constitutes approximately 3% of all cancers in the UK, with in excess of 8500 new cases annually. Management of HNC depends on site, extent, histology, previous medical history and patient choice. A multidisciplinary approach is required to optimize patient wellbeing, owing to the significant functional and psychosocial implications that can impact on quality of life. Members of the dental team, to include the general dental practitioner, have a key role in patient care; therefore the dental team should be knowledgeable in the short-term and longer-term implications and how this impacts on quality of life. CLINICAL RELEVANCE: This article offers the dental team with an overview of how HNC and the various treatments, such as surgery, radiotherapy and chemotherapy, impact upon quality of life, both in the short-term and longer-term.

Development of the Greek version of the University of Washington quality of life questionnaire for patients with head and neck cancer.

The University of Washington quality of life (UW-QOL) questionnaire, created in 1993 to evaluate health related quality of life, has been widely used in English-speaking populations and translated and validated in other languages. The aim of the present study was to carefully translate and psychometrically validate the UW-QOL questionnaire in Greek. The revised version of the questionnaire was obtained by forward and backward translation of the original English version, according to internationally accepted guidelines. Validation was performed in 120 patients with head and neck cancer treated in a Greek Anticancer Institute in Athens, during their follow-up visits. Eligible patients completed the Greek version of the questionnaire and two other previously validated quality of life questionnaires (EORTC QLQ H&N35 and C-30). Related data and the patients' demographics were extracted from the patient's notes. Strong internal consistency (mean Cronbach α value of 0.83) was shown, with good construct validity. Statistically significant differences were noted between tumour staging and treatment modality and global quality of life. Strong correlation was shown between previously validated EORTC questionnaires and the translated UW-QOL questionnaire. In conclusion, the Greek version of the UW-QOL questionnaire appears to be culturally appropriate and psychometrically valid.

Decision regret in men undergoing dose-escalated radiation therapy for prostate cancer.

PURPOSE: Decision regret (DR) is a negative emotion associated with medical treatment decisions, and it is an important patient-centered outcome after therapy for localized prostate cancer. DR has been found to occur in up to 53% of patients treated for localized prostate cancer, and it may vary depending on treatment modality. DR after modern dose-escalated radiation therapy (DE-RT) has not been investigated previously, to our knowledge. Our primary aim was to evaluate DR in a cohort of patients treated with DE-RT. METHODS AND MATERIALS: We surveyed 257 consecutive patients with localized prostate cancer who had previously received DE-RT, by means of a validated questionnaire. RESULTS: There were 220 responses (85.6% response rate). Image-guided intensity modulated radiation therapy was given in 85.0% of patients and 3-dimensional conformal radiation therapy in 15.0%. Doses received included 73.8 Gy (34.5% patients), 74 Gy (53.6%), and 76 Gy (10.9%). Neoadjuvant androgen deprivation (AD) was given in 51.8% of patients and both neoadjuvant and adjuvant AD in 34.5%. The median follow-up time was 23 months (range, 12-67 months). In all, 3.8% of patients expressed DR for their choice of treatment. When asked whether they would choose DE-RT or AD again, only 0.5% probably or definitely would not choose DE-RT again, compared with 8.4% for AD (P<.01). CONCLUSION: Few patients treated with modern DE-RT express DR, with regret appearing to be lower than in previously published reports of patients treated with radical prostatectomy or older radiation therapy techniques. Patients experienced more regret with the AD component of treatment than with the radiation therapy component, with implications for informed consent. Further research should investigate regret associated with individual components of modern therapy, including AD, radiation therapy and surgery.

Impact of neoadjuvant chemotherapy on physical fitness, physical activity, and health-related quality of life of patients with resectable esophageal cancer.

OBJECTIVE: Neoadjuvant chemotherapy (NAC) followed by radical surgery is the standard treatment for patients with resectable esophageal squamous cell carcinoma (ESCC) in Japan. However, some adverse events associated with NAC may result in a decrease in physical fitness that may influence the patient's ability to tolerate surgery. The purpose of this study was to evaluate the impact of NAC on physical fitness, physical activity, and health-related quality of life (HRQOL) of patients with ESCC. METHODS: In this prospective study, we investigated 27 consecutive patients with newly diagnosed resectable ESCC who were scheduled to receive NAC followed by surgery between January 2009 and November 2010. Primary endpoints were change from baseline in physical fitness (knee extensor muscle strength and 6-min walking distance) and physical activity after NAC. A secondary endpoint was change from baseline in HRQOL. RESULTS: Physical fitness and physical activity level after NAC did not differ significantly from those before NAC. With regard to HRQOL, only social functioning was significantly different (P=0.04). The change in physical activity demonstrated a significant correlation with the change in 6-minute walking distance (r=0.45, P=0.02). CONCLUSIONS: NAC had no impact on physical fitness and physical activity in patients with ESCC. This result indicated that there was no need for a physiotherapy intervention during NAC to prevent a decline in these parameters.