A quality assurance audit: phase III trial of maximal androgen deprivation in prostate cancer (TROG 96.01)

In 1997 the Trans-Tasman Radiation Oncology Group (TROG) performed a quality assurance (QA) audit of its phase III randomized clinical trial investigating the effectiveness of different durations of maximal androgen deprivation prior to and during definitive radiation therapy for locally advanced carcinoma of the prostate (TROG 96.01). The audit reviewed a total of 60 cases from 15 centres across Australia and New Zealand. In addition to verification of technical adherence to the protocol, the audit also incorporated a survey of centre planning techniques and a QA time/cost analysis. The present report builds on TROG's first technical audit conducted in 1996 for the phase III accelerated head and neck trial (TROG 91.01) and highlights the significant progress TROG has made in the interim period. The audit provides a strong validation of the results of the 96.01 trial, as well as valuable budgeting and treatment planning information for future trials. Overall improvements were detected in data quality and quantity, and in protocol compliance, with a reduction in the rate of unacceptable protocol violations from 10 to 4%. Audit design, staff education and increased data management resources were identified as the main contributing factors to these improvements. In addition, a budget estimate of $100 per patient has been proposed for conducting similar technical audits. The next major QA project to be undertaken by TROG during the period 1998-1999 is an intercentre dosimetry study. Trial funding and staff education have been targeted as the key major issues essential to the continued success and expansion of TROG's QA programme.     

Quality assurance audit in an Australasian phase III trial of accelerated radiotherapy for head and neck cancer (TROG 91.01). Trans-Tasman Radiation Oncology Group

The Trans-Tasman Radiation Oncology Group (TROG) initiated a randomized trial, testing accelerated (twice daily) radiotherapy against conventional radiotherapy for stage III and stage IV squamous cell carcinoma of the head and neck in 1991. In 1996, the Trial Management Committee arranged for a technical audit of 76 cases from 11 institutions, conducted by investigators from interstate institutions. A 10% unacceptable protocol violation rate was detected, which compares favourably with initial Radiation Therapy Oncology Group (RTOG) experience in the late 1970s. Infrastructural deficits with poor quality of documentation, incomplete retrieval of films and document return have been demonstrated in some cases. The Trans-Tasman Radiation Oncology Group is actively pursuing procedural and resourcing issues in order to redress this and is actively expanding its Quality Assurance (QA) Programme with an intercentre dosimetry study. Ultimately, comprehensive clinical and technical QA site visits are planned.     

Intraarterial calcium stimulation (ASVS) for pancreatic insulinoma: comparison of preoperative localization procedures

PURPOSE: Evaluation of clinical relevance of the arterial stimulation procedure with venous sampling (ASVS) in the preoperative localization of insulinoma. METHODS: Thirteen patients with endogenous hyperinsulinism underwent preoperative transabdominal ultrasound (US), helical CT (CT), MRI, endoscopic ultrasound (EUS), and angiography (DSA) in conjunction with the ASVS-test for the detection of insulinoma. The results were compared with intraoperative findings, intraoperative ultrasound (IOUS) and histology. RESULTS: Sensitivity was as follows: US 8%, MRI 27%, CT 46%, EUS 50%,DSA 69%,and ASVS 92%. Intraoperative palpation and IOUS yielded a sensitivity of 77%. In 3 patients the tumors were neither palpable nor detectable by IOUS, the mode of resection was based on preoperative diagnostics. The ASVS procedure as a functional test was superior to all other modalities for the preoperative tumor detection. CONCLUSION: The ASVS was the most sensitive diagnostic modality. It should especially be considered in terms of health economical aspects when CT or MRI do not yield conclusive results.     

MQSA (Mammography Quality Standards Act) update--focusing on quality assurance

To have uniform national standards, Congress passed the Mammography Quality Standards Act (MQSA) in 1992. Screening and diagnostic facilities must now meet minimum quality standards for personnel, equipment and recordkeeping, and be certified by the FDA, the federal agency designated to implement MQSA. The FDA is responsible for developing final standards, approving accrediting bodies, certifying all mammography facilities in the U.S., evaluating the effectiveness of the program, and implementing sanctions for noncompliant facilities. Congress recognized the urgent need for national mammography standards, but realized that 10,000 mammography facilities could not be certified to meet the regulations before October 1, 1994. President Clinton signed legislation granting the FDA Interim Rule authority and allowing the FDA to adopt existing standards from the ACR, HCFA and state regulations. The Final Rules have significant changes in the Quality Assurance (QA) Sections (900.12 d and e) and indicate where staff must now conduct, document and evaluate the results of QA tests, taking responsibility for establishing and maintaining a QA program that ensures safety, reliability, clarity and accuracy of the mammography services they perform. The Rules also specify the roles of interpreting physicians, medical physicists and quality control technologists. Data indicates that such regulation has improved mammography in the U.S. By January 1997, the Government Accounting Office reported that 1,500 facilities had undergone two rounds of MQSA inspections. During the first year of MQSA, 26 percent had significant violations, while only 10 percent did on the second round.     

Early FDG PET response assessment of preoperative radiochemotherapy in locally advanced rectal cancer: correlation with long-term outcome

Purpose

The aim of the present study is to prospectively evaluate the prognostic value of previously defined [¹⁸F]2-fluoro-2-deoxy-D-glucose positron emission tomography (FDG PET) criteria of early metabolic response in patients with locally advanced rectal cancer (LARC) after long-term follow-up.

Methods

Forty-two patients with poor prognosis LARC underwent three biweekly courses of chemotherapy with oxaliplatin, raltitrexed and 5-fluorouracil modulated by levofolinic acid during pelvic radiotherapy. FDG PET studies were performed before and 12?days after the beginning of the chemoradiotherapy (CRT) treatment. Total mesorectal excision (TME) was carried out 8?weeks after completion of CRT. A previously identified cutoff value of ≥52?% reduction of the baseline mean FDG standardized uptake value (SUV_mean) was applied to differentiate metabolic responders from non-responders and correlated to tumour regression grade (TRG) and survival.

Results

Twenty-two metabolic responders showed complete (TRG1) or subtotal tumour regression (TRG2) and demonstrated a statistically significantly higher 5-year relapse-free survival (RFS) compared with the 20 non-responders (86 vs 55?%, p?=?.014) who showed TRG3 and TRG4 pathologic responses. A multivariate analysis demonstrated that early ?SUV_mean was the only pre-surgical parameter correlated to the likelihood of recurrence (p?=?.05).

Conclusion

This study is the first prospective long-term evaluation demonstrating that FDG PET is not only an early predictor of pathologic response but is also a valuable prognostic tool. Our results indicate the potential of FDG PET for optimizing multidisciplinary management of patients with LARC.     

Quality assurance procedures for the Peacock system.

The Peacock system is the product of technological innovations that are changing the practice of radiotherapy. It uses dynamic beam modulation technique and inverse planning algorithm, both of which are new methodologies, to perform intensity-modulation radiation therapy (IMRT). The quality assurance (QA) procedure established by Task Group No. 40 did not adequately consider these emerging modalities. A review of literature indicates that published articles on QA procedures concentrate primarily on the verification of dose delivered to phantom during commissioning of the system and dose delivered to phantom before treating patients. Absolute dose measurements using ion chambers and relative dose measurements using film dosimetry have been used to verify delivered doses. QA on equipment performance and equipment safety is limited. This paper will discuss QA on equipment performance, equipment safety, and patient setup reproducibility.     

Quality assurance procedures in radiotherapy--IEC specifications for equipment

The International Electrotechnical Commission (IEC) worked out international standards for requirements and tests of electrical, mechanical and radiation safety as well as for definition and tests of functional performance characteristics of radiotherapy equipments (medical electron accelerators, gamma beam teletherapy and afterloading equipments, simulators and accessories) and for clinical dosimeters and terminology for medical radiology. A survey is given on the actual state of standardization projects. The problems of such standards are shown for the standard for functional performance characteristics of medical electron accelerators as example.     

18F-FDG PET is an early predictor of pathologic tumor response to preoperative radiochemotherapy in locally advanced rectal cancer.

18F-FDG PET is a useful tool for assessing the effects of chemo- or radiotherapy. The aim of this study was to correlate the change in tumor 18F-FDG standardized uptake value (SUV) during and after preoperative radiochemotherapy, with the pathologic response achieved in locally advanced rectal cancer (LARC) patients. METHODS: Thirty-three patients with LARC underwent total mesorectal excision after preoperative treatment, including 3 cycles of oxaliplatin, raltitrexed, 5-fluorouracil, and folinic acid during pelvic radiotherapy (45 Gy). Staging procedures included endoscopic ultrasound, MRI, and CT. 18F-FDG PET scans were performed at baseline and 12 d after starting radiochemotherapy (intermediate) in all patients. Seventeen patients also had a presurgical scan. For each scan, mean and maximum SUVs were measured. The percentages of SUV decrease from baseline to intermediate (early change) and to presurgical scan (overall change) were assessed and correlated with pathologic response classified as tumor regression grade (TRG). RESULTS: Eighteen tumors (55%) showed complete (TRG1) or subtotal regression (TRG2) and were classified as responders, whereas 15 cases (45%; TRG3 or TRG4) were considered nonresponders. The early median decrease of tumor SUV significantly differed between responders (-62%; range, -44% to -100%) and nonresponders (-22%; range, -2% to -48%). A significant correlation was also found between TRGs and early SUV changes (P < 0.0001). Responders were identified correctly by an early decrease of the mean SUV of > or =52%. CONCLUSION: This study shows that early 18F-FDG PET can predict pathologic response to preoperative treatment. These findings support the usefulness of (18)F-FDG PET during the management with radiochemotherapy of LARC patients.