Work engagement in cancer care: The power of co-worker and supervisor support.

PURPOSE: Co-worker and supervisor support can provide knowledge, advice and expertise which may improve motivation, confidence and skills. This exploratory study aimed to examine the association of co-worker and supervisor support, and other socio-demographic and practice variables with work engagement for cancer workers. METHODS: The study surveyed 573 cancer workers in Queensland (response rate 56%). Study participants completed surveys containing demographics and psychosocial questionnaires measuring work engagement, co-worker and supervisor support. Of these respondents, a total of 553 responded to the items measuring work engagement and this forms the basis for the present analyses. Oncology nurses represented the largest professional group (37%) followed by radiation therapists (22%). About 54% of the workforce was aged >35 years and 81% were female. Multiple regression analysis was performed to identify explanatory variables independently associated with work engagement for cancer workers. RESULTS: After adjusting for the effects of other factors, co-worker and supervisor support were both significantly associated with work engagement. Having 16 years or more experience, being directly involved in patient care, having children and not being a shift worker were positively associated with work engagement. Annual absenteeism of six days or more was associated with low work engagement. The fitted model explained 23% of the total variability in work engagement. CONCLUSIONS: This study emphasises that health care managers need to promote co-worker and supervisor support in order to optimise work engagement with special attention to those who are not directly involved in patient care.

Evaluation of the effect of a 1-day interventional workshop on recovery from job stress for radiation therapists and oncology nurses: A randomised trial.

INTRODUCTION: Cancer care workers experience high levels of occupational stress that can have adverse mental and physical health consequences. Educating health professionals about self-care practices throughout their careers can potentially build resilience. Our study aimed to evaluate the effects of an educational intervention to improve recovery from job stress, increase satisfaction with current self-care practices and improve sleep quality. METHODS: An equivalent, randomised comparison, pretest-post-test intervention design was used to investigate the effects of a 1-day workshop (plus educational material) compared with written educational material alone, on measures of recovery experiences (i.e. psychological detachment from work, relaxation, mastery experiences and control over leisure), satisfaction with recovery-related self-care practices and perceived sleep quality of 70 cancer care workers. RESULTS: Workshop participants reported greater mean changes 6 weeks post-workshop for total recovery experiences (F(1,69) = 8.145, P = .008), self-care satisfaction (F(1,69) = 8.277, P = .005) and perceived sleep quality (F(1,69) = 9.611, P = .003). There was a decline in the scores of the control group over the 6-week period for all measures. Workshop participants not only avoided this decline, but demonstrated increased mean scores, with a significant main effect 6 weeks post-workshop, compared with the control group (F(3,63) = 4.262, P = .008). CONCLUSIONS: A 1-day intervention workshop improved recovery skills, satisfaction with self-care practices and perceived sleep quality of oncology nurses and radiation therapists. Outcomes were enhanced when participants actively participated in experiential group-based learning compared with receiving written material alone. This intervention has the potential to enhance resilience and prevent burnout at different points in a cancer worker's career.

Recovery experience and burnout in cancer workers in Queensland.

PURPOSE: Two key recovery experiences mediating the relationship between work demands and well-being are psychological detachment and relaxation over leisure time. The process of recovery from work-related stress plays an important role in maintaining well-being, but is poorly understood in cancer workers. The aim of this exploratory study was to examine the relationships of burnout, psychological well-being and work engagement with the recovery experiences of psychological detachment and relaxation in oncology staff. METHODS: A cross sectional survey of 573 cancer workers in Queensland was conducted (response rate 56%). Oncology nurses (n = 211) represented the largest professional group. Staff completed surveys containing demographics and psychosocial questionnaires measuring burnout, psychological distress, work engagement and recovery experience. Multiple regression analyses were performed to identify explanatory variables which were independently associated with Recovery Experience Score (RES). RESULTS: There was a negative association between the RES and burnout (p = 0.002) as well as psychological distress (p < 0.0001), but not work engagement. Age >25 years was negatively correlated with RES as was having a post graduate qualification, being married or divorced, having carer commitments. Participating in strenuous exercise was associated with high recovery (p = 0.015). CONCLUSIONS: The two recovery experiences of psychological detachment and relaxation had a strong negative association to burnout and psychological well-being, but not work engagement. Further research needs to be undertaken to better understand if improving recovery experience reduces burnout and improves the well-being of cancer workers.

A cross-sectional study of stressors and coping mechanisms used by radiation therapists and oncology nurses: Resilience in Cancer Care Study.

INTRODUCTION: Occupational stress and burnout are well-recognised experiences reported by cancer care workers. The aim was to describe the frequency and severity of potential stressors as well as the effectiveness of coping skills of radiation therapists (RTs) and oncology nurses (ONs), which make up the two largest occupational groups in cancer care. METHODS: A questionnaire was distributed to RTs and ONs in two large tertiary hospitals in Queensland. Descriptive data regarding severity of potential stressors at home and work as well as the perceived effectiveness of preferred coping styles for each stressor was compared for each professional group. Respondents were asked questions about their personal circumstances and to also complete five standardised questionnaires measuring resilience, mental well-being, depression, anxiety and burnout. RESULTS: There were 71 respondents representing a response rate of 26%. The types of stressors differed between the two groups but both reported that heavy workload was the most severe workplace stressor. RTs reported higher stressor and coping strategy frequency than ONs. There were no identifiable differences between RTs and ONs in the types or effectiveness of coping strategies employed at home or work. Mental well-being for both groups was inversely correlated with depression, anxiety and burnout and positively correlated with resilience. CONCLUSIONS: RTs experienced higher mean scores for stressors and coping than ONs. There were no significant between-group differences for anxiety, depression, burnout, mental well-being or resilience.

The complex relationship between lung tumor volume and survival in patients with non-small cell lung cancer treated by definitive radiotherapy: a prospective, observational prognostic factor study of the Trans-Tasman Radiation Oncology Group (TROG 99.05).

BACKGROUND AND PURPOSE: To investigate the hypothesis that primary tumor volume is prognostic independent of T and N stages in patients with non-small cell lung cancer (NSCLC) treated by definitive radiotherapy. MATERIALS AND METHODS: Multicenter prospective observational study. Patient eligibility: pathologically proven stage I-III non-small cell lung cancer planned for definitive radiotherapy (minimum 50 Gy in 20 fractions) using CT-based contouring. Volumes of the primary tumor and enlarged nodes were measured according to a standardized protocol. Survival was adjusted for the effect of T and N stage. RESULTS: There were 509 eligible patients. Five-year survival rates for tumor volume grouped by quartiles were, for increasing tumor volume, 22%, 14%, 15% and 21%. Larger primary tumor volume was associated with shorter survival (HR=1.060 (per doubling); 95% CI 1.01-1.12; P=0.029). However, after adjusting for the effects of T and N stage, there was no evidence for an association (HR=1.029, 95% CI, 0.96-1.10, P=0.39). There was evidence, however, that larger primary tumor volume was associated with an increased risk of dying, independently of T and N stage, in the first 18 months but not beyond. CONCLUSIONS: In patients treated by non-surgical means we were unable to show that lung tumor volume, overall, provides additional prognostic information beyond the T and N stage (TNM, 6th edition). There is evidence, however, that larger primary tumor volume adversely affects outcome only within the first 18 months. Larger tumor size alone should not by itself exclude patients from curative (chemo)radiotherapy.

Factors associated with subjective well-being in cancer workers in Queensland.

INTRODUCTION: This study aims to describe factors associated with subjective well-being (SWB) in cancer workers in Queensland and compares results to normative data for the Australian population. METHOD: This study was based on a cross-sectional survey of 544 cancer workers in Queensland with a response rate of 54%. SWB was measured using the Personal Wellbeing Index for Adults. Multiple regression analyses were performed to identify explanatory variables, which were independently associated with SWB. Results were compared with normative Australian data. RESULTS: The overall mean SWB for study participants was 74.63, which was comparable to the mean of 75.02 for the Australian population (P = 0.47). Female cancer workers had significantly lower levels of SWB compared to the normative data of female Australians (74.44 compared to 75.7, P = 0.03). Multiple regression analyses showed that higher levels of SWB were associated with having 11-30 h of direct patient care hours per week, being married, no child or elder care commitments, good physical health, low levels of both psychological distress and burnout, and high levels of work engagement. CONCLUSIONS: Cancer workers' overall levels of SWB were similar to the national mean scores. Amount of time in direct patient care was linked with SWB, with an optimal time between 11 and 30 h per week associated with high SWB. The majority of the factors significantly associated with SWB were of a personal nature such as marital status and physical and mental health. These data provide a valuable baseline for future research in this area, especially in the area of interventions to promote SWB of workers.

Results of a prospective study of positron emission tomography-directed management of residual nodal abnormalities in node-positive head and neck cancer after definitive radiotherapy with or without systemic therapy.

BACKGROUND: The purpose of this study was to present our prospectively evaluated positron emission tomography (PET)-directed policy for managing the neck in node-positive head and neck squamous cell carcinoma (N+HNSCC) after definitive radiotherapy (RT) with or without concurrent systemic therapy. METHODS: One hundred twelve consecutive patients who achieved a complete response at the primary site underwent a 12-week posttherapy nodal response assessment with PET and diagnostic CT. Patients with an equivocal PET underwent a repeat PET 4 to 6 weeks later. Patients with residual CT nodal abnormalities deemed PET-negative were uniformly observed regardless of residual nodal size. RESULTS: Median follow-up from commencement of RT was 28 months (range, 13-64 months). Residual CT nodal abnormalities were present in 50 patients (45%): 41 PET-negative and 9 PET-positive. All PET-negative residual CT nodal abnormalities were observed without subsequent isolated nodal failure. CONCLUSION: PET-directed management of the neck after definitive RT in node-positive HNSCC appropriately spares neck dissections in patients with PET-negative residual CT nodal abnormalities.

Work engagement in cancer workers in Queensland: the flip side of burnout.

INTRODUCTION: The study aimed to investigate factors associated with work engagement and burnout in cancer workers in Queensland. METHODS: A cross-sectional survey of 579 cancer workers in Queensland was undertaken. Burnout was measured using the Oldenberg Burnout Inventory (OLBI) and work engagement was measured using the Utrecht Work and Well-being Survey. Multiple regression analyses were performed to identify explanatory variables that were independently associated with burnout and work engagement. RESULTS: The survey response rate was 57%. Total levels of burnout and work engagement in the sample were 31.1% and 34.5%, respectively. Multiple regression analyses showed that shift work, 6-9 years experience, working >20 hours/week, administrative professional stream and being single were associated with higher levels of burnout. There was a positive association between work engagement and nonshift workers, <5 years experience, medical and allied health workers, and workers >45 years of age. In this study, gender, income, hours of direct patient care, location of the centre in regional centres or within the private setting did not have an independent effect on the levels of burnout or work engagement. There was a negative association between burnout and work engagement (P < 0.001). CONCLUSIONS: Approximately one-third of the workers sampled reported burnout. Conversely, one-third reported being highly engaged in their work. Further research is required to study the effectiveness of interventions to improve personal resources and prevent burnout. Understanding the factors associated with work engagement is equally important in designing organisational programs to enhance employee engagement.

Hyperfractionated or accelerated radiotherapy for head and neck cancer.

BACKGROUND: Several trials have studied the role of altered fractionation radiotherapy in head and neck squamous cell carcinoma, but the effect of such treatment on survival is not clear. OBJECTIVES: The aim of this individual patient data (IPD) meta-analysis was to assess whether this type of radiotherapy could improve survival. SEARCH STRATEGY: We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; CENTRAL (2010, Issue 3); PubMed; EMBASE; CINAHL; Web of Science; BIOSIS Previews; Cambridge Scientific Abstracts; ISRCTN and additional sources for published and unpublished trials. The date of the most recent search was 8 August 2010. SELECTION CRITERIA: We identified randomised trials comparing conventional radiotherapy with hyperfractionated or accelerated radiotherapy, or both, in patients with non-metastatic head and neck squamous cell carcinomas and grouped trials into three pre-specified treatment categories: hyperfractionated, accelerated and accelerated with total dose reduction. Trials were eligible if they began recruitment after 1969 and ended before 1998. DATA COLLECTION AND ANALYSIS: We obtained updated individual patient data. Overall survival was the main outcome measure. The secondary outcome measures were local or regional control rates (or both), distant control rates and cause-specific mortality. MAIN RESULTS: We included 15 trials with 6515 patients. The median follow up was six years. Tumour sites were mostly oropharynx and larynx; 5221 (74%) patients had stage III-IV disease (UICC 2002). There was a significant survival benefit with altered fractionation radiotherapy, corresponding to an absolute benefit of 3.4% at five years (hazard ratio (HR) 0.92, 95% CI 0.86 to 0.97; P = 0.003). The benefit was significantly higher with hyperfractionated radiotherapy (8% at five years) than with accelerated radiotherapy (2% with accelerated fractionation without total dose reduction and 1.7% with total dose reduction at five years, P = 0.02). There was a benefit in locoregional control in favour of altered fractionation versus conventional radiotherapy (6.4% at five years; P < 0.0001), which was particularly efficient in reducing local failure, whereas the benefit on nodal control was less pronounced. The benefit was significantly higher in the youngest patients (under 50 year old) (HR 0.78, 95% CI 0.65 to 0.94), 0.95 (95% CI 0.83 to 1.09) for 51 to 60 year olds, 0.92 (95% CI 0.81 to 1.06) for 61 to 70 year olds, and 1.08 (95% CI 0.89 to 1.30) for those over 70 years old; test for trends P = 0.007). AUTHORS' CONCLUSIONS: Altered fractionation radiotherapy improves survival in patients with head and neck squamous cell carcinoma. Comparison of the different types of altered radiotherapy suggests that hyperfractionation provides the greatest benefit. An update of this IPD meta-analysis (MARCH 2), which will increase the power of this analysis and allow for other comparisons, is currently in progress.

Radiotherapy for perineural invasion in cutaneous head and neck carcinomas: toward a risk-adapted treatment approach.

BACKGROUND: We retrospectively reviewed outcomes in patients treated with radiotherapy (RT) for cutaneous head and neck carcinoma with perineural invasion (PNI), with the aim of developing risk-adapted treatment guidelines. METHODS: A total of 118 patients were treated with RT between April 1992 and July 2000. Ninety-seven patients had PNI discovered through histology (pPNI) and 21 patients had symptoms/signs of PNI (cPNI). All received RT (median dose, 55 Gy; range, 17-74): 114 postoperatively and 4 definitively. Median follow-up was 84 months (range, 4-201). RESULTS: The 5-year local control (LC) rates were 90% with pPNI and 57% with cPNI (p < .0001). The pPNI and cPNI groups also differed in relapse-free survival (76% vs 46%, p = .003), disease-specific survival (90% vs 76%, p = .002), and overall survival (69% vs 57%, p = .03). pPNI patients with BCC histology (n = 42) had better LC (97% vs 84%, p = .02) than pPNI SCC (n = 55). CONCLUSION: Surgery plus RT provides a high rate of LC in patients with pPNI, particularly those with BCC. Therapeutic improvements are needed for patients with cPNI.

Multidisciplinary care in oncology: medicolegal implications of group decisions.

Consensus is growing that multidisciplinary meetings (MDMs) provide the best means of formulating comprehensive treatment plans for patients with cancer. Although many doctors attend MDMs and contribute to the decision-making process, only a few will become involved in a patient's care after the team meeting. Despite this, if a patient was grieved by a decision made in a MDM and wished to recover damages, all doctors present at the meeting would be personally accountable for decisions related to their area of expertise. Doctors should be made aware of the legal implications of their participation in such meetings. A greater awareness of these responsibilities and improved team dynamics should optimise outcomes for patients while limiting exposure of the participants to legal liability. Special attention should be given to providing patients with adequate information in this combined speciality setting.

Hyperfractionated or accelerated radiotherapy in head and neck cancer: a meta-analysis.

BACKGROUND: Several trials have studied the role of unconventional fractionated radiotherapy in head and neck squamous cell carcinoma, but the effect of such treatment on survival is not clear. The aim of this meta-analysis was to assess whether this type of radiotherapy could improve survival. METHODS: Randomised trials comparing conventional radiotherapy with hyperfractionated or accelerated radiotherapy, or both, in patients with non-metastatic HNSCC were identified and updated individual patient data were obtained. Overall survival was the main endpoint. Trials were grouped in three pre-specified categories: hyperfractionated, accelerated, and accelerated with total dose reduction. FINDINGS: 15 trials with 6515 patients were included. The median follow-up was 6 years. Tumours sites were mostly oropharynx and larynx; 5221 (74%) patients had stage III-IV disease (International Union Against Cancer, 1987). There was a significant survival benefit with altered fractionated radiotherapy, corresponding to an absolute benefit of 3.4% at 5 years (hazard ratio 0.92, 95% CI 0.86-0.97; p=0.003). The benefit was significantly higher with hyperfractionated radiotherapy (8% at 5 years) than with accelerated radiotherapy (2% with accelerated fractionation without total dose reduction and 1.7% with total dose reduction at 5 years, p=0.02). There was a benefit on locoregional control in favour of altered fractionation versus conventional radiotherapy (6.4% at 5 years; p<0.0001), which was particularly efficient in reducing local failure, whereas the benefit on nodal control was less pronounced. The benefit was significantly higher in the youngest patients (hazard ratio 0.78 [0.65-0.94] for under 50 year olds, 0.95 [0.83-1.09] for 51-60 year olds, 0.92 [0.81-1.06] for 61-70 year olds, and 1.08 [0.89-1.30] for over 70 year olds; test for trends p=0.007). INTERPRETATION: Altered fractionated radiotherapy improves survival in patients with head and neck squamous cell carcinoma. Comparison of the different types of altered radiotherapy suggests that hyperfractionation has the greatest benefit.

Patterns of lymph node spread of cutaneous squamous cell carcinoma of the head and neck.

BACKGROUND: Among patients with cutaneous squamous cell carcinoma (SCC) of the head and neck, recent studies have shown that those with involvement of the parotid gland also have a high incidence of neck node involvement. Treatment of the neck by either surgery or radiotherapy is therefore recommended among patients with parotid SCC, even if clinical examination is negative. The aim of this study was first to analyze patterns of metastatic spread in the parotid and cervical lymph nodes and then to correlate the pattern of involved nodes with the primary cutaneous site in order to guide the appropriate extent of surgery, should neck dissection be used to treat the neck in patients with parotid SCC. METHODS: A cohort of 209 patients with cutaneous SCC of the head and neck and clinically evident regional metastatic disease was reviewed retrospectively from 3 Australian institutions. The distribution of involved nodes was obtained from pathology reports; the anatomic sites of primary cutaneous cancers were then correlated with these findings. RESULTS: Among 209 patients, 171 (82%) had clinical parotid involvement. Of these, 28 had clinical neck disease, whereas 143 had parotid disease alone. Thirty-eight (18%) patients had neck disease only. A total of 199 patients were treated surgically, whereas 10 received radiotherapy alone. Surgery included 172 parotidectomies and 151 neck dissections (93 of which were elective). Primary sites were cheek (21.7%), pinna (20.4%), temple (15.8%), forehead (15.8%), postauricular region (5.9%), neck (5.3%), anterior scalp (5.3%), posterior scalp (3.3%), periorbital (3.3%), nose (2.6%), and chin (0.6%). Among pathologically positive necks, level II was most frequently involved (79%). Level IV (13%) and level V (17%) were only involved in extensive lymph node disease, the exception being for isolated level V metastases from the posterior scalp. CONCLUSIONS: Primary sites were mainly localized to the lateral aspect of the head. Among patients with cutaneous SCC involving the parotid and neck, level II was the most commonly involved neck level. The distribution of involved nodes suggests that in a patient with parotid involvement and a clinically negative neck with an anterolateral primary, a supraomohyoid neck dissection, always including the external jugular lymph node(s) would be appropriate. In the case of a posterior primary, level V should be dissected as well. In patients with parotid SCC and a clinically positive neck, a comprehensive neck dissection is recommended.

Does chemotherapy improve survival in high-risk stage I and II Merkel cell carcinoma of the skin?

PURPOSE: The effectiveness of synchronous carboplatin, etoposide, and radiation therapy in improving survival was evaluated by comparison of a matched set of historic control subjects with patients treated in a prospective Phase II study that used synchronous chemotherapy and radiation and adjuvant chemotherapy. PATIENTS AND METHODS: Patients were included in the analysis if they had disease localized to the primary site and nodes, and they were required to have at least one of the following high-risk features: recurrence after initial therapy, involved nodes, primary size greater than 1 cm, or gross residual disease after surgery. All patients who received chemotherapy were treated in a standardized fashion as part of a Phase II study (Trans-Tasman Radiation Oncology Group TROG 96:07) from 1997 to 2001. Radiation was delivered to the primary site and nodes to a dose of 50 Gy in 25 fractions over 5 weeks, and synchronous carboplatin (AUC 4.5) and etoposide, 80 mg/m(2) i.v. on Days 1 to 3, were given in Weeks 1, 4, 7, and 10. The historic group represents a single institution's experience from 1988 to 1996 and was treated with surgery and radiation alone, and patients were included if they fulfilled the eligibility criteria of TROG 96:07. Patients with occult cutaneous disease were not included for the purpose of this analysis. Because of imbalances in the prognostic variables between the two treatment groups, comparisons were made by application of Cox's proportional hazard modeling. Overall survival, disease-specific survival, locoregional control, and distant control were used as endpoints for the study. RESULTS: Of the 102 patients who had high-risk Stage I and II disease, 40 were treated with chemotherapy (TROG 96:07) and 62 were treated without chemotherapy (historic control subjects). When Cox's proportional hazards modeling was applied, the only significant factors for overall survival were recurrent disease, age, and the presence of residual disease. For disease-specific survival, recurrent disease was the only significant factor. Primary site on the lower limb had an adverse effect on locoregional control. For distant control, the only significant factor was residual disease. CONCLUSIONS: The multivariate analysis suggests chemotherapy has no effect on survival, but because of the wide confidence limits, a chemotherapy effect cannot be excluded. A study of this size is inadequately powered to detect small improvements in survival, and a larger randomized study remains the only way to truly confirm whether chemotherapy improves the results in high-risk MCC.

Combined-modality therapy for primary central nervous system lymphoma: long-term data from a Phase II multicenter study (Trans-Tasman Radiation Oncology Group).

PURPOSE: To assess, in a multicenter setting, the long-term outcomes of a brief course of high-dose methotrexate followed by radiotherapy for patients with primary central nervous system lymphoma (PCNSL). METHODS AND MATERIALS: Forty-six patients were entered in a Phase II protocol consisting of methotrexate (1 g/m(2) on Days 1 and 8), followed by whole-brain irradiation (45-50.4 Gy). The median follow-up time was 7 years, with a minimum follow-up of 5 years. RESULTS: The 5-year survival estimate was 37% (+/-14%, 95% confidence interval [CI]), with progression-free survival being 36% (+/-15%, 95% CI), and median survival 36 months. Of the original 46 patients, 10 were alive, all without evidence of disease recurrence. A total of 11 patients have developed neurotoxicity, with the actuarial risk being 30% (+/-18%, 95% CI) at 5 years but continuing to increase. For patients aged>60 years the risk of neurotoxicity at 7 years was 58% (+/-30%, 95% CI). CONCLUSION: Combined-modality therapy, based on high-dose methotrexate, results in improved survival outcomes in PCNSL. The risk of neurotoxicity for patients aged>60 years is unacceptable with this regimen, although survival outcomes for patients aged>60 years were higher than in many other series.

Synchronous postoperative adjuvant chemoradiation therapy for locally advanced carcinoma of the rectum.

BACKGROUND AND AIMS: The adjuvant management of locally advanced rectal cancer has been the subject of much debate over the past 10 years. Whilst it is now widely accepted that combined chemoradiation therapy is the treatment of choice for adjuvant therapy following resection of high-risk tumours, there is still no clear answer on the sequencing of the two modalities in the postoperative setting. PATIENTS AND METHODS: Soon after the NCI in the United States issued its recommendations on the management of resected rectal cancer, we decided to commence a phase 2 study to collect data prospectively on the toxicity of postoperative combined chemoradiation therapy. Radiation therapy was given early in combination with bolus chemotherapy using 5-fluorouracil ( n=80). The prescribed radiation dose was 50.4 Gy in 28 fractions, and the chemotherapy was 450 mg/m(2) given with fractions 1 - 3 and 26 - 28. On completion of the radiation therapy the patient was given a further four cycles of bolus 5-fluorouracil at monthly intervals. The patients were then closely monitored for side effects from the therapy and for signs of local and distant relapse. RESULTS: Acute toxicity of the therapy was significant, with 16% of patients experiencing severe bowel morbidity. The other major side effects of the therapy were skin reactions, neutropenia and bladder problems. Late bowel toxicity was also severe. The local in field relapse rate was 10%. The majority of relapses were at distant sites, mostly in the liver and lungs. The actuarial survival at 5 years was 55%. CONCLUSION: We conclude that the combined adjuvant postoperative chemoradiation therapy using this protocol is effective but has significant acute and late morbidity. The optimum regimen for those patients requiring postoperative adjuvant therapy is yet to be determined.

The effect of anaemia on efficacy and normal tissue toxicity following radiotherapy for locally advanced squamous cell carcinoma of the head and neck.

PURPOSE: The aims of this analysis were to determine the effect of anaemia on loco-regional control, relapse-free survival, cause-specific survival, overall survival, and acute and late radiation therapy toxicity in patients with Stage III and IV squamous cell carcinoma of the head and neck treated with radiotherapy. PATIENTS AND METHODS: Between 1991 and 1998, 350 patients were randomly assigned to either conventional radiotherapy, (70 Gy in 35 fractions in 49 days) or to accelerated radiotherapy (59.4 Gy in 33 fractions in 24 days). Patients were divided into two groups according to their haemoglobin level: a normal haemoglobin group (>/=13 g/dl in males, >/=12 g/dl in females) and a low haemoglobin group (<13 g/dl in males, <12 g/dl in females). The influence of anaemia on cause-specific survival and the development of confluent mucositis independent of other variables was tested using Cox proportional hazards model. RESULTS: Of 350 patients recruited to the trial, 238 had haemoglobin measurements and were eligible for inclusion in this secondary analysis. One hundred and ninety-three were considered to have normal haemoglobin, and 45 patients were considered to be anaemic. There were significant differences between the groups in loco-regional control, relapse-free survival, cause-specific survival and overall survival, with hazards ratios of 0.56 (95% confidence interval (CI) 0.34-0.94), 0.57 (95% CI 0.35-0.92), 0.49 (95% CI 0.29-0.85) and 0.43 (95% CI 0.26-0.70) in favour of the normal haemoglobin group. Using Cox proportional hazards modelling, haemoglobin level was a significant predictor of cause-specific survival in addition to disease site, stage, and Eastern Cooperative Oncology Group status. There were no statistically significant differences between the groups in the development of acute or late reactions. CONCLUSION: Significant reductions in loco-regional control, disease-free survival, cause-specific survival and overall survival occur in the presence of anaemia. No significant differences in normal tissue toxicity have been identified in this analysis.

Acute symptoms, not rectally administered sucralfate, predict for late radiation proctitis: longer term follow-up of a phase III trial--Trans-Tasman Radiation Oncology Group.

PURPOSE: To assess the potential for sucralfate administered rectally to reduce the risk of late rectal morbidity in patients undergoing nonconformal radiotherapy (RT) for carcinoma of the prostate and to study the variables potentially contributing to late rectal morbidity and particularly to explore the relationship between acute and late toxicity. METHODS AND MATERIALS: Eighty-six patients with localized prostate carcinoma were randomized in a double-blind, placebo-controlled study to a daily enema of 3 g of sucralfate in a 15-mL suspension or the same suspension without sucralfate. The enema began the first day of RT and was continued for 2 weeks after treatment completion. The primary end point of the study was acute Radiation Therapy Oncology Group (RTOG)/European Organization for Research and Treatment of Cancer (EORTC) toxicity; however, the patients were followed for an additional 5 years on a 6-month basis. The evaluation included late RTOG/EORTC toxicity and a patient self-assessment questionnaire. RESULTS: With a median follow-up of 5 years, the Kaplan-Meier probability of late Grade 2 RTOG/EORTC toxicity was 12% (95% confidence interval [CI] 2-22%) for placebo and 5% (95% CI 0-12%) for sucralfate (p = 0.26). The probability of late rectal bleeding was 59% (95% CI 45-73%) for placebo and 54% (95% CI 40-68%) for sucralfate. No statistically significant difference was found between the treatment arms for the peak incidence of any of the other patient self-assessment variables. Cox proportional hazards modeling indicated acute RTOG/EORTC toxicity of Grade 2 or greater was associated with a hazard ratio of 2.74 (95% CI 1.31-5.73) for the development of late toxicity of Grade 1 or greater. Substituting the patient self-assessment variables for acute RTOG/EORTC toxicity revealed that rectal pain of a moderate or severe grade during RT was the best predictor of the subsequent development of late toxicity, with a hazard ratio of 3.44 (95% CI 1.68-7). CONCLUSION: The results of this study do not support the use of sucralfate administered rectally as a method for reducing the late toxicity of nonconformal RT for prostate cancer. There appears to be an association between the development of acute and subsequent late toxicity, although the nature of this association remains to be determined.

Effect of surgery on normal tissue toxicity in patients treated with accelerated radiotherapy.

The aim of this study was to assess the effect of surgery on normal tissue toxicity in head and neck cancer patients treated with accelerated radiotherapy. Toxicity data from two trials of accelerated radiotherapy were compared. The first group was taken from a phase III trial of definitive radiotherapy and the second group from a phase II trial of postoperative radiotherapy. The general eligibility criteria (apart from surgery), data collection and radiotherapy details for both trials were similar. The definitive group included 172 eligible patients and the postoperative group 52 eligible patients. At 3 weeks into treatment, by which time the dose and rate of dose accumulation were identical, there was no difference in acute toxicity. Analysis of late toxicity showed greater subcutaneous fibrosis in the postoperative group.