Long-Term Toxicity and Health-Related Quality of Life After Adjuvant Chemoradiation Therapy or Radiation Therapy Alone for High-Risk Endometrial Cancer in the Randomized PORTEC-3 Trial.

PURPOSE: The survival results of the PORTEC-3 trial showed a significant improvement in both overall and failure-free survival with chemoradiation therapy versus pelvic radiation therapy alone. The present analysis was performed to compare long-term adverse events (AE) and health-related quality of life (HRQOL). METHODS AND MATERIALS: In the study, 660 women with high-risk endometrial cancer were randomly assigned to receive chemoradiation therapy (2 concurrent cycles of cisplatin followed by 4 cycles of carboplatin/paclitaxel) or radiation therapy alone. Toxicity was graded using Common Terminology Criteria for Adverse Events, version 3.0. HRQOL was measured using EORTC QLQ-C30 and CX24/OV28 subscales and compared with normative data. An as-treated analysis was performed. RESULTS: Median follow-up was 74.6 months; 574 (87%) patients were evaluable for HRQOL. At 5 years, grade ≥2 AE were scored for 78 (38%) patients who had received chemoradiation therapy versus 46 (24%) who had received radiation therapy alone (P = .008). Grade 3 AE did not differ significantly between the groups (8% vs 5%, P = .18) at 5 years, and only one new late grade 4 toxicity had been reported. At 3 and 5 years, sensory neuropathy toxicity grade ≥2 persisted after chemoradiation therapy in 6% (vs 0% after radiation therapy, P < .001) and more patients reported significant tingling or numbness at HRQOL (27% vs 8%, P < .001 at 3 years; 24% vs 9%, P = .002 at 5 years). Up to 3 years, more patients who had chemoradiation therapy reported limb weakness (21% vs 5%, P < .001) and lower physical (79 vs 87, P < .001) and role functioning (78 vs 88, P < .001) scores. Both treatment groups reported similar long-term global health/quality of life scores, which were better than those of the normative population. CONCLUSIONS: This study shows a long-lasting, clinically relevant, negative impact of chemoradiation therapy on toxicity and HRQOL, most importantly persistent peripheral sensory neuropathy. Physical and role functioning impairments were seen until 3 years. These long-term data are essential for patient information and shared decision-making regarding adjuvant chemotherapy for high-risk endometrial cancer.

Ability to Predict New-Onset Psychological Distress Using Routinely Collected Health Data: A Population-Based Cohort Study of Women Diagnosed With Breast Cancer.

Objectives: The primary objective of this study was to identify the predictors of new-onset psychological distress available in routinely collected administrative health databases for women diagnosed with breast cancer. The secondary objective was to explore whether the predictors vary based on the period of cancer care. Methods: A population-based cohort study followed 16,495 female patients with newly diagnosed breast cancer who did not experience psychological distress during the 14 months before breast cancer surgery. The incidence of psychological distress was reported overall and by type of mental health problem. Time-varying Cox proportional hazards models were developed to identify predictors of new-onset psychological distress during 2 key periods of cancer care: (1) hospital-based treatment during which women undergo treatment with breast surgery, chemotherapy, and/or radiation, and (2) 1-year transitional survivorship when women begin follow-up care. Results: The incidence of psychological distress was 16% within each period. Anxiety was present in 85.1% and 65.5% of new cases during hospital-based treatment and transitional survivorship, respectively. Predictors during both periods were younger age, receipt of axillary lymph node dissection, rheumatologic disease, and baseline menopausal symptoms, as well as new opioid dispensations, emergency department visits, and hospital contacts that occurred during follow-up. Other predictors varied based on the period of cancer care. More advanced breast cancer and type of treatment were associated with onset of psychological distress during hospital-based treatment. Psychological distress during transitional survivorship was predicted by diagnosis of localized breast disease, shorter duration of hospital-based treatment, receipt of additional hospital-based treatment in survivorship, and newly diagnosed comorbidities or symptoms. Conclusions: This study identified the predictors of new-onset psychological distress available in routinely collected administrative health databases, and showed how predictors change between hospital-based treatment and transitional survivorship periods. The results highlight the importance of developing predictive models tailored to the period of cancer care.

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.

Quality of life outcomes of transoral robotic surgery with or without adjuvant therapy for oropharyngeal cancer.

OBJECTIVES/HYPOTHESIS: To compare quality of life (QOL) of patients who underwent transoral robotic surgery (TORS) alone, with adjuvant radiation therapy (RT), or adjuvant chemoradiation therapy (CRT) in the treatment of oropharyngeal squamous cell cancer (OPSCCA). STUDY DESIGN: Prospective cohort study. METHODS: Medical records were reviewed for 111 patients treated for OPSCCA from 2008 to 2015. Patients were administered the Head and Neck Cancer Inventory (HNCI) to evaluate QOL preoperatively, and at 3 weeks, 3 months, 6 months, and 1 year postsurgery. QOL data were compared between 13 patients treated with TORS alone, 31 with adjuvant RT, and 67 with adjuvant CRT by a linear mixed effects model. RESULTS: Mean follow-up was 35 months. The HNCI response rates at 3 weeks and 3, 6, and 12 months were 80%, 60%, 55%, and 46%, respectively. TORS alone reported significantly higher eating scores than adjuvant RT or CRT at 3 and 6 months, and higher speech scores compared to adjuvant CRT at 3 months and adjuvant RT at 6 months. TORS alone and adjuvant RT reported less social disruption compared to adjuvant CRT at 3 months. Adjuvant CRT had consistently lower overall QOL scores until 6 months. No TORS-alone patient required percutaneous endoscopic gastrostomy, and no study patient required tracheostomy during treatment. CONCLUSIONS: TORS alone maintained higher QOL than adjuvant RT or CRT in eating, social function, speech, and overall QOL postsurgery. QOL and functional metrics were better for 6 months in TORS-alone patients, and at 12 months, the differences were not significant. LEVEL OF EVIDENCE: 4. Laryngoscope, 128:403-411, 2018.

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.

Breast cancer morbidity: questionnaire survey of patients on the long term effects of disease and adjuvant therapy.

BACKGROUND: Many women have symptoms of various kinds after being treated for breast cancer. It is unclear how frequently these different side effects of treatment arise. METHOD: All women who underwent surgery for breast cancer and subsequently received adjuvant systemic treatment in a single certified breast-cancer center from 2006 to 2010 were asked to fill out a standardized questionnaire. Medical data were retrieved from their charts and statistically analyzed together with the questionnaire responses. The questionnaire was also given to an age-adjusted control group. RESULTS: 734 questionnaires were filled out and returned (response rate, 70%). The mean interval from the diagnosis of breast cancer to the time of response to the questionnaire was 38 months. The median age at time of response to the questionnaire was 65 years (range, 30 to 91 years). The distribution of UICC stages at the time of initial diagnosis was as follows: I 46%, II 42%, III 12%. 78% of the patients underwent breat conserving surgery, 85% had radio - therapy, 85% had antihormonal treatment, and 49% had chemotherapy. 91% were satisfied or very satisfied with the outcome of surgery. 34% reported operation site pain; 35% reported limitations of shoulder or arm function. Younger patients suffered from emotional sequelae more than older ones did. 25% reported a change in their relationship with their spouse. Before being diagnosed with breast cancer, 9% had consulted a psychiatrist or psychotherapist; after the diagnosis, 19% did. 14% had taken psychoactive medication before the diagnosis, and 26% did afterward. CONCLUSION: Treatment for breast cancer has negative physical, emotional, and social effects on many patients. They suffer these effects to varying degrees depending on age, type of surgery, and systemic treatment.

Depressive symptom trajectories during and after adjuvant treatment for breast cancer.

BACKGROUND: The course of depressive symptoms during and after breast cancer treatment is not well understood. PURPOSE: We identified patient subgroups based on distinct trajectories of depressive symptoms and determined whether subgroups could be distinguished by personal characteristics and coping strategies. METHODS: Breast cancer patients completed the Center for Epidemiologic Studies-Depression Scale on clinically meaningful occasions and during the posttreatment period. The Illness Management Questionnaire was completed prior to treatment. RESULTS: A three-class mixture model provided the best fit to the data. Subgroup membership was significantly (p < .05) associated with marital status, history of depression, and focusing on symptoms. In multivariate analysis, marital status and focusing on symptoms remained significant (p < .05) predictors of subgroup membership. CONCLUSIONS: Distinct trajectories can be identified during and after adjuvant breast cancer therapy. Predictors of these trajectories have implications for addressing depressive symptoms in this clinical population and for future research.

Health-related quality of life during postoperative chemoradiotherapy with oral uracil-tegafur and leucovorin in rectal cancer patients.

BACKGROUND/AIMS: The objective of this study was to report on the quality of life of locally advanced rectal cancer patients that were treated with uracil-tegafur (UFT)/leucovorin (LV)-based concurrent chemoradiotherapy. METHODOLOGY: Twenty-five patients were enrolled into this prospective study. Radiotherapy (50.4Gy) was given with concurrent UFT (300mg/m2/day) and LV (30mg/day). Turkish versions of EORTC-QLQC30 and EORTC QLQCR38 were applied at the beginning (HRQoL-1) and at the end (HRQoL-2) of chemoradiotherapy. Paired samples t-test was used to compare the difference of means for each scale between HRQoL1 and HRQoL2 and p values <0.05 were considered statistically significant. RESULTS: Study compliance was 80.6%. From baseline to the end of chemoradiotherapy, the mean scores of dyspnea (p=0.006) diarrhea (p=0.005) and micturition (p=0.005) increased significantly. Chemotherapy side effects also increased at the end of therapy (p=0.07). Seventy-six percent (76%) of male patients replied to questions related to sexual problems and functions, whereas no female patients replied. CONCLUSIONS: Although, diarrhea and micturition are the major problems, quality of life scores indicate that concurrent oral fluoropyrimidine-based chemoradiotherapy is a feasible treatment.

[Preservation of organ function in head and neck cancer]. / Funktionserhalt nach der Therapie von Kopf-Hals-Tumoren.

Preservation of function is a crucial aspect for the evaluation of therapies applied in the field of head and neck cancer. However, preservation of anatomic structures does not equalize preservation of function. Particularly for the evaluation of alternative treatment options with equivalent oncologic outcome functional outcome becomes increasingly important. Present studies collect with varying emphasize (1) the effects of therapy on essential body functions, (2) additional therapy-induced toxic effects, and (3) health-related quality of life. The present article summarizes vital aspects of clinical research from the last years. Preservation of function after surgical and non-surgical treatment approaches are presented according to tumour localisation and staging criteria. Additional methodological aspects of study design and documentation as well as challenges and present activities for the transformation into clinical practise are discussed.

Evaluation of factors affecting post-treatment quality of life in oral and oropharyngeal cancer patients primarily treated with curative surgery: an exploratory study.

The aim was to explore the impact of important clinico-demographic factors on the post-treatment quality of life (QOL) in surgically treated oral and oropharyngeal cancer patients. 63 consecutive follow-up oral and oropharyngeal cancer patients treated primarily with surgery were recruited. 55 patients sent the completed questionnaires and finally included in this study. QOL and important sub-domains of the QOL were assessed. Mean QOL scores (SD) were computed, level of significance was set at P < 0.05. The mean composite QOL score and standard deviation (SD) for oral and oropharyngeal cancer patients were 76.6 (15.2) and 73.4 (13.9), respectively. Patients with higher T-stage (T3 and T4) and higher overall-stage (III and IV) had lower mean QOL scores as against early T (T1 and T2) and overall early-stage (I and II); mean scores (SD) 64.3 (13.6) and 72.3 (13.8), and 76.6 (13.6) and 81.7 (14.1), respectively. Younger patients had lower mean scores (SD) than older patients; mean QOL scores (SD) 69.7 (14.0) and 79.6 (SD), respectively. Patients with reconstruction had lower mean QOL scores as compared to those without reconstruction; mean scores (SD) 67.6 (16.0) and 77.4 (12.5), respectively. In conclusion, tumor-stage, overall-stage, age of patients, and reconstruction had a significant direct effect on the post-treatment QOL of oral and oropharyngeal cancer patients.

Quality of life of Croatian breast cancer patients receiving adjuvant treatment--comparison to long-term breast cancer survivors.

Quality of life (QoL) is an important outcome in assessment of breast cancer treatment. Data comparing QoL after different adjuvant treatments and QoL data on long-term survivors are modest. The aim of this study was to compare QoL scores of patients receiving adjuvant treatment with long-term breast cancer survivors, and to correlate QoL scores with clinical data. Sixty patients were recruited for the study: 20 during adjuvant radiotherapy, 20 during adjuvant chemotherapy, and 20 long-term breast cancer survivors. QoL was assessed using the self-administered EORTC core questionnaire QLQ-C30 and breast cancer-specific module QLQ-BR23. QoL scores between groups were compared using Kruskal-Wallis test and effects of clinical factors on QoL domains were tested using multiple regression analysis. No differences between three groups were observed in terms of all QoL scores. As measured by QLQ-C30, least affected QoL scales were cognitive functioning, social functioning, and physical functioning in all three patients group, while insomnia and pain scales were the most detrimentally affected. Among the groups, the highest scores of global health status and other functional scales were in adjuvant chemotherapy group. Measured by QLQ-BR23, body image scale was most affected, while sexual functioning scale was minimally affected, in all three groups. Multiple regression analysis has shown that the patient age were the only statistically significant predictor for global health status scale, and constipation scale. Our results demonstrated similar and favorable QoL in all three groups of patients and provided basic information on QoL in Croatian breast cancer patients.