Human Universal Energy Improved Health-related Quality of Life Outcomes 1 Month After External Beam Radiotherapy for Early-stage Breast Cancer.

BACKGROUND: The demand for the use of human universal energy (HUE) as a form of complementary alternative medicine (CAM) for cancer treatment is increasing, but scientific evidence of its efficacy is lacking. AIMS: The aims of this first randomized study of external beam radiotherapy (EBRT) + HUE versus EBRT + sham HUE in subjects with early breast cancer were to (1) document the changes in health related quality of life (HRQoL) during EBRT and immediately 1 mo after completion of radiation treatment within each subject group and to (2) compare the differences in HRQoL between the 2 groups of subjects. METHOD: Eligible subjects were randomized to either HUE (n = 16) or sham-HUE (n = 16). HRQoL measurements were taken in each patient group before starting treatment, during week 3 of EBRT, immediately after completing treatment, as well as 1 mo after EBRT. These results were evaluated using the validated functional assessment of cancer therapy-breast cancer (FACT-B) HRQoL instrument consisting of the FACT-G and breast cancer specific subscales and trial outcome index (TOI) summary scores. Changes in the scores relevant to both groups were compared using a Mann-Whitney U test. The effect of the HUE treatment was quantified by analysis of covariance (ANCOVA) models. All statistical analysis was done at a 95% confidence interval and the differences were considered significant if P ≤ .05. RESULTS: The tests associated with FACT-G, social wellbeing, and emotional well-being scores returned insignificant P value > .05. The test associated with physical well-being and FWB returned significant P value ≤ .05, but the (adjusted) quantified influence of the HUE treatment on these scores was less than the clinically significant threshold of 5 points, and the FWB clinically significant threshold of greater than 2.9 points. The test associated with FACT-B, breast cancer specific (BCS), and TOI scores returned significant or close to significant P value, α ≤ .05, and the (adjusted) quantified influence of HUE treatment on these scores is more than the accepted thresholds (5 points for BCS and 10 points for FACT-B and TOI) for clinical difference. CONCLUSION: Although some results, such as P values for Mann-Whitney U tests and coefficients of HUE treatment in initial ANCOVA models showed promising and positive effects of HUE treatment on the subject, further research with a larger sample size is necessary to confidently conclude whether HUE treatment has significant positive influence on subject HRQoL.

Palliative chemoradiotherapy versus radiotherapy alone for dysphagia in advanced oesophageal cancer: a multicentre randomised controlled trial (TROG 03.01).

BACKGROUND: A short course of radiotherapy is commonly prescribed for palliative relief of malignant dysphagia in patients with incurable oesophageal cancer. We compared chemoradiotherapy with radiotherapy alone for dysphagia relief in the palliative setting. METHODS: This multicentre randomised controlled trial included patients with advanced or metastatic oesophageal cancer who were randomly assigned (1:1) through a computer-generated adaptive biased coin design to either palliative chemoradiotherapy or radiotherapy alone for treatment of malignant dysphagia at 22 hospitals in Australia, Canada, New Zealand, and the UK. Eligible patients had biopsy-proven oesophageal cancer that was unsuitable for curative treatment, symptomatic dysphagia, Eastern Cooperative Oncology Group performance status 0-2, and adequate haematological and renal function. Patients were stratified by hospital, dysphagia score (Mellow scale 1-4), and presence of metastases. The radiotherapy dose was 35 Gy in 15 fractions over 3 weeks for patients in Australia and New Zealand and 30 Gy in ten fractions over 2 weeks for patients in Canada and the UK. Chemotherapy consisted of one cycle of intravenous cisplatin (either 80 mg/m2 on day 1 or 20 mg/m2 per day on days 1-4 of radiotherapy at clinician's discretion) and intravenous fluorouracil 800 mg/m2 per day on days 1-4 of radiotherapy in week 1. Patients were assessed weekly during treatment. The primary endpoint was dysphagia relief (defined as ≥1 point reduction on the Mellow scale at 9 weeks and maintained 4 weeks later), and key secondary endpoints were dysphagia progression-free survival (defined as a worsening of at least 1 point on the Mellow scale from baseline or best response) and overall survival. These endpoints were analysed in the intention-to-treat population. This study is registered at ClinicalTrials.gov, number NCT00193882. This trial is closed. FINDINGS: Between July 7, 2003, and March 21, 2012, 111 patients were randomly assigned to chemoradiotherapy and 109 patients to radiotherapy. One patient in the chemoradiotherapy group was omitted from analysis because of ineligibility. 50 (45%, 95% CI 36-55) patients in the chemoradiotherapy group and 38 (35%, 26-44) in the radiotherapy group obtained dysphagia relief (difference 10·6%, 95% CI -2 to 23; p=0·13). Median dysphagia progression-free survival was 4·1 months (95% CI 3·5-4·8) versus 3·4 months (3·1-4·3) in the chemoradiotherapy and radiotherapy groups, respectively (p=0·58), and median overall survival was 6·9 months (95% CI 5·1-8·3) versus 6·7 months (4·9-8·0), respectively (p=0·88). Of the 211 patients who commenced radiotherapy, grade 3-4 acute toxicity occurred in 38 (36%) patients in the chemoradiotherapy group and in 17 (16%) patients in the radiotherapy group (p=0·0017). Anaemia, thrombocytopenia, neutropenia, oesophagitis, diarrhoea, nausea and vomiting, and mucositis were significantly worse in patients who had chemoradiotherapy than in patients who had radiotherapy. INTERPRETATION: Palliative chemoradiotherapy showed a modest, but not statistically significant, increase in dysphagia relief compared with radiotherapy alone, with minimal improvement in dysphagia progression-free survival and overall survival with chemoradiotherapy but at a cost of increased toxicity. A short course of radiotherapy alone should be considered a safe and well tolerated treatment for malignant dysphagia in the palliative setting. FUNDING: National Health and Medical Research Council, Canadian Cancer Society Research Institute, Canadian Cancer Trials Group, Trans Tasman Radiation Oncology Group, and Cancer Australia.

Oral vinorelbine and cisplatin with concomitant radiotherapy in stage III non-small-cell lung cancer: an open-label phase II multicentre trial (COVeRT study).

Chemoradiotherapy regimens for stage III non-small-cell lung cancer (NSCLC) require ongoing evaluation. This South Australian multicentre prospective phase II study evaluated the safety, activity and outcomes of combination oral vinorelbine and cisplatin administered concurrently with radiotherapy for stage III NSCLC. Consecutive eligible patients received two cycles of oral vinorelbine 50 mg/m day 1 (D1), day 8 (D8) and intravenous cisplatin 50 mg/m D1 and D8 in a 21-day cycle. Chemotherapy was administered concurrently with radiotherapy at 60 Gy in 30 fractions, 2 Gy/fraction to the isocentre, all fields treated daily, 5 days a week over 6 weeks using 10 MV photons and three-dimensional conformal radiotherapy. The primary endpoint was to evaluate the progression-free survival (PFS). The secondary end points were safety, response rates and overall survival (OS). Forty-three eligible patients with stage III NSCLC - comprising 21 squamous cell carcinoma, 18 adenocarcinoma and four large cell carcinoma - were studied. Four patients did not complete the treatment. By intention-to-treat analysis, 25% showed a partial response and 65% had stable disease. None achieved a complete response. Of the 39 patients who completed protocol-specified treatment, 11 (28%) showed a partial response and 28 (72%) had stable disease. The median PFS was 25.2 months and the median OS was 48.3 months. Toxicities were manageable and generally mild, with the majority being either grade 1 (n=38) or grade 2 (n=21). Toxicities were mainly of oesophagitis, pneumonitis, fatigue, nausea and dysphagia. Two cycles of chemotherapy with oral vinorelbine and cisplatin administered concurrently with radical radiation had an acceptable toxicity profile and was active in inoperable stage III NSCLC. PFS and OS outcomes were encouraging. This regimen warrants further investigation.