Randomized phase II placebo-controlled study to evaluate the efficacy of topical pure emu oil for joint pain related to adjuvant aromatase inhibitor use in postmenopausal women with early breast cancer: JUST (Joints Under Study).

PURPOSE: Aromatase inhibitors are standard of care in women with hormone receptor-positive early breast cancer. Published evidence demonstrates that adverse effects may have an impact on drug compliance, with arthralgias being one of the most commonly reported adverse effects. METHODS: Eligible patients were postmenopausal women who had experienced arthralgia following initiation of an aromatase inhibitor. Patients who experienced arthralgias following a minimum of a 3-month treatment on the aromatase inhibitor were randomized to emu oil or placebo oil. The primary endpoint was to assess for a reduction in pain as measured by a visual analogue score after 8 weeks of treatment. RESULTS: Seventy-three patients comprised the intent-to-treat population, and there was no statistically significant benefit with use of EO. However, there was a statistically significant improvement in pain (visual analogue score was -1.28; p < 0.001) and Brief Pain Inventory severity score -0.88 (p < 0.001), as well as functional interference (Brief Pain Inventory interference -1.10 (p < 0.001) for the entire population following an 8-week administration of EO or placebo oil. CONCLUSIONS: Arthralgias, as a result of aromatase inhibitor use, may be ameliorated by the use of topical oil massaged onto the joint. Further research into interventions for this common side effect is needed.

The Financial Impact on Reimbursement of Moderately Hypofractionated Postoperative Radiation Therapy for Breast Cancer: An International Consortium Report.

AIMS: Moderately hypofractionated breast irradiation has been evaluated in several prospective studies, resulting in wide acceptance of shorter treatment protocols for postoperative breast irradiation. Reimbursement for radiation therapy varies between private and public systems and between countries, impacting variably financial considerations in the use of hypofractionation. The aim of this study was to evaluate the financial impact of moderately hypofractionated breast irradiation by reimbursement system in different countries. MATERIALS AND METHODS: The study was designed by an international group of radiation oncologists. A web-questionnaire was distributed to representatives from each country. The participants were asked to involve the financial consultant at their institution. RESULTS: Data from 13 countries from all populated continents were collected (Europe: Denmark, France, Italy, the Netherlands, Spain, UK; North America: Canada, USA; South America: Brazil; Africa: South Africa; Oceania: Australia; Asia: Israel, Taiwan). Clinicians and/or departments in most of the countries surveyed (77%) receive remuneration based on the number of fractions delivered to the patient. The financial loss per patient estimated resulting from applying moderately hypofractionated breast irradiation instead of conventional fractionation ranged from 5-10% to 30-40%, depending on the healthcare provider. CONCLUSION: Although a generalised adoption of moderately hypofractionated breast irradiation would allow for a considerable reduction in social and economic burden, the financial loss for the healthcare providers induced by fee-for-service remuneration may be a factor in the slow uptake of these regimens. Therefore, fee-for-service reimbursement may not be preferable for radiation oncology. We propose that an alternative system of remuneration, such as bundled payments based on stage and diagnosis, may provide more value for all stakeholders.

Stereotactic radiotherapy for pediatric intracranial germ cell tumors.

PURPOSE: Intracranial germ cell tumors are rare, radiosensitive tumors seen most commonly in the second and third decades of life. Radiotherapy alone has been the primary treatment modality for germinomas, and is used with chemotherapy for nongerminomatous tumors. Stereotactic radiotherapy techniques minimize the volume of surrounding normal tissue irradiated and, hence, the late radiation morbidity. This study reports our experience with stereotactic radiotherapy in this group of tumors. METHODS AND MATERIALS: Between December 1992 and December 1998, 18 patients with intracranial germ cell tumors were treated with stereotactic radiotherapy. A total of 23 histologically proven tumors were treated. Thirteen patients had a histologic diagnosis of germinoma, and 5 patients had germinoma with nongerminomatous elements. Of those patients with a histologic diagnosis of germinoma, 5 had multiple midline tumors. The median age of the patients was 12.9 years (range, 5.6-17.5 years). RESULTS: A boost using stereotactic radiotherapy was delivered to 19 tumors following whole-brain radiation in 8 cases and craniospinal radiation in 11 cases. Three tumors were treated with stereotactic radiotherapy to the tumor volume alone following chemotherapy, and 1 tumor received a boost using stereotactic radiosurgery following craniospinal radiation. A median dose of 2520 cGy (range, 1500-3600) cGy was given to the whole brain, and a median dose of 2160 (range, 2100-2600) cGy was given to the spinal field. The median boost dose to the tumor was 2600 (range, 2160-3600) cGy, given by stereotactic radiotherapy delivered to the 95% isodose line. At a median follow-up time of 40 (range, 12-73) months, no local or marginal recurrences were reported in patients with germinoma. Two patients with nongerminomatous tumors have relapsed. One had elevation of tumor markers only at 37 months following treatment, and the other had persistent disease following chemotherapy and radiation therapy. Eight patients documented pituitary-hypothalamic dysfunction; in 7 (87.5%) of these patients, the dysfunction was present before commencing radiotherapy. Four patients (22%) developed newly diagnosed diabetes insipidus following surgery. Three patients (17%) received antidepressant medication at follow-up. CONCLUSION: Our series shows that stereotactic radiotherapy is achievable and well tolerated in this group of patients. Longer follow-up is required to fully assess the impact on long-term toxicity. Psychologic assessment of mood and affect should be performed as part of routine follow-up in this group of adolescent children.

Accrediting radiation technique in a multicentre trial of chemoradiation for pancreatic cancer.

Before a multicentre trial of 3-D conformal radiotherapy to treat cancer of the pancreas, participating clinicians were asked to complete an accreditation exercise. This involved planning two test cases according to the study protocol, then returning hard copies of the plans and dosimetric data for review. Any radiation technique that achieved the specified constraints was allowed. Eighteen treatment plans were assessed. Seven plans were prescribed incorrect doses and two of the planning target volumes did not comply with protocol guidelines. All plans met predefined normal tissue dose constraints. The identified errors were attributable to unforeseen ambiguities in protocol documentation. They were addressed by feedback and corresponding amendments to protocol documentation. Summary radiobiological measures including total weighted normal tissue equivalent uniform dose varied significantly between centres. This accreditation exercise successfully identified significant potential sources of protocol violations, which were then easily corrected. We believe that this process should be applied to all clinical trials involving radiotherapy. Due to the limitations of data analysis with hard-copy information only, it is recommended that complete planning datasets from treatment-planning systems be collected through a digital submission process.

CT planning for breast cancer.

Radiotherapy to the affected breast or chest wall is well established as an integral part of postoperative management of breast cancer. However, it is known to be associated with increased cardiac and pulmonary morbidities and mortalities. Modern technologies, such as CT planning, have shown to improve treatment planning by accurately delivering optimal doses to the target volumes, while minimizing doses to sensitive structures, thus reducing potential treatment-related adverse effects. The purpose of this study is to report on our experiences with CT planning of adjuvant radiotherapy for breast cancer.

Development of a clinical chart audit programme.

Radiation oncology charts containing medical information and treatment details are the major methods of communication between the various personnel involved in delivering radiation therapy to the patient. It is paramount to good patient care for this communication to be clear, precise and accurate in detail. A regular chart audit should be a part of the quality assurance programme of every radiation oncology department. The primary aim of this study was to develop and assess an objective and quantitative programme for reviewing radiation oncology charts, thereby improving the quality of communication and hence patient management. A secondary aim was to compare the charts of radically treated patients with those treated palliatively. A pilot study using a new chart review tool, developed at the Perth Radiation Oncology Centre, was carried out over an 8-month period. A sample of charts, representing 25% of our treatment group, were assessed using the tool on a monthly basis. A total of 156 charts were reviewed during this time period. Fifty-six per cent were radical treatments and 44% were palliative. The overall mean chart scores significantly improved over the time of this study (P < 0.001). The individual radiation oncologists' scores were also seen to improve during the study period. The alpha coefficients for intra-rater and inter-rater reliability were 0.99 and 0.88, respectively. The chart review programme was found to be an easy-to-use and a reliable tool by both medical and non-medical reviewers. It appeared to have a positive influence on the standard of radiation oncology charts in our department.

Patient satisfaction in radiation oncology.

As part of a quality improvement exercise at the Perth Radiation Oncology Centre, a survey was undertaken to ascertain the current level of patient satisfaction with the information they were receiving from their treating radiation oncologist. In addition, the effect of radiation on patients' anxiety levels was investigated. Two questionnaires were given to patients having radical radiotherapy for malignancy. The first questionnaire consisted of the Information Satisfaction Questionnaire and the State Trait Anxiety Index. It was given to patients before the commencement of their course of radiotherapy. The second questionnaire consisted of the State Trait Anxiety Index and was given at the completion of their radiotherapy. A total of 120 patients completed both the questionnaires. The majority of patients were satisfied/very satisfied with the explanation of their illness and radiation toxicities. Fewer patients were satisfied with the explanation of lifestyle (e.g. diet, exercise, smoking) and practical issues such as parking and treatment costs. The patients showed a statistically significant reduction in both their State and Trait Anxiety scores following radiotherapy. Following this study, we have developed new information booklets addressing lifestyle and practical issues, which were not being adequately addressed as shown in this study. Our next study will assess the effect of these new information booklets.

Acute arthritis as an unusual complication of malignancy.

A 59-year-old man presented with an inability to weight-bear due to an acute, red, hot, swollen knee joint which was subsequently found to be due to a malignant joint effusion consequent to colonic carcinoma. Treatment with radiation therapy relieved his symptoms. A review of the literature reveals that malignant joint effusion is rare and this is only the third reported case secondary to colonic carcinoma.

Breast conservation: long-term results from Westmead Hospital.

BACKGROUND: Breast conservation has been shown to be a safe and effective alternative to mastectomy in early-stage breast cancer. The present study reviews the long-term outcome and toxicity after treatment of early breast cancer by conservative surgery and radiation. METHODS: Between November 1979 and December 1989, 438 patients with Union Internationale Contre le Cancer (UICC) stage I or II breast cancer were treated with conservative surgery and radiation therapy (CS+RT) at Westmead Hospital. Surgery to the breast varied from a local excision to a quadrantectomy, depending on the preference of the referring surgeon. The axilla was surgically dissected in 299 patients (68%). All patients received postoperative breast irradiation. The whole breast was irradiated to 46-54 Gy (median dose, 50 Gy) using 6 Mev photons for 5-6.5 weeks. Boosts were given at the primary tumour site in 336 patients (78%), by electron therapy (88 patients), iridium-192 (247 patients) or photons (one patient). A total of 44 patients (10%) received adjuvant chemotherapy. RESULTS: The median follow-up period for surviving patients was 84 months (range: 56-172 months). The 5-year actuarial rate of local recurrence was 6% (312 patients at risk), and the 10-year rate was 10% (52 patients at risk). Very young patients (aged 34 years at diagnosis) had a 5-year actuarial rate of local recurrence of 13% compared to 5% for older patients (P = 0.04). Neither the total dose to the primary site nor the boost technique influenced local recurrence. The 5-year freedom from distant relapse was 83%. The side effects included rib fractures (2%), symptomatic pneumonitis (3%), fatty necrosis or fibrosis requiring surgery (4%), and moderate-severe oedema of the arm (7%). CONCLUSIONS: The long-term data show that CS+RT for UICC stage I or II breast cancer results in low rates of local recurrence which are influenced by age at diagnosis, but not by radiation dose or boost technique. These results confirm those of other international series that CS+RT is a safe alternative to mastectomy for most women with operable breast cancer.