A Phase II trial of brachytherapy alone after lumpectomy for select breast cancer: tumor control and survival outcomes of RTOG 95-17.

PURPOSE: Radiation Therapy Oncology Group 95-17 is a prospective Phase II cooperative group trial of accelerated partial breast irradiation (APBI) alone using multicatheter brachytherapy after lumpectomy in select early-stage breast cancers. Tumor control and survival outcomes are reported. METHODS AND MATERIALS: Eligibility criteria included Stage I/II breast carcinoma confirmed to be <3 cm, unifocal, invasive nonlobular histology with zero to three positive axillary nodes without extracapsular extension. APBI treatment was delivered with either low-dose-rate (LDR) (45 Gy in 3.5-5 days) or high-dose-rate (HDR) brachytherapy (34 Gy in 10 twice-daily fractions over 5 days). End points evaluated included in-breast control, regional control, mastectomy-free rate, mastectomy-free survival, disease-free survival, and overall survival. The study was designed to analyze the HDR and LDR groups separately and without comparison. RESULTS: Between 1997 and 2000, 100 patients were accrued and 99 were eligible; 66 treated with HDR brachytherapy and 33 treated with LDR brachytherapy. Eighty-seven patients had T1 lesions and 12 had T2 lesions. Seventy-nine were pathologically N0 and 20 were N1. Median follow-up in the HDR group is 6.14 years with the 5-year estimates of in-breast, regional, and contralateral failure rates of 3%, 5%, and 2%, respectively. The LDR group experienced similar results with a median follow-up of 6.22 years. The 5-year estimates of in-breast, regional, and contralateral failure rates of 6%, 0%, and 6%, respectively. CONCLUSION: Patients treated with multicatheter partial breast brachytherapy in this trial experienced excellent in-breast control rates and overall outcome that compare with reports from APBI studies with similar extended follow-up.

Design, development, and implementation of the radiological physics center's pelvis and thorax anthropomorphic quality assurance phantoms.

The Radiological Physics Center (RPC) developed two heterogeneous anthropomorphic quality assurance phantoms for use in verifying the accuracy of radiation delivery: one for intensity-modulated radiation therapy (IMRT) to the pelvis and the other for stereotactic body radiation therapy (SBRT) to the thorax. The purpose of this study was to describe the design and development of these two phantoms and to demonstrate the reproducibility of measurements generated with them. The phantoms were built to simulate actual patient anatomy. They are lightweight and water-fillable, and they contain imageable targets and organs at risk of radiation exposure that are of similar densities to their human counterparts. Dosimetry inserts accommodate radiochromic film for relative dosimetry and thermoluminesent dosimetry capsules for absolute dosimetry. As a part of the commissioning process, each phantom was imaged, treatment plans were developed, and radiation was delivered at least three times. Under these controlled irradiation conditions, the reproducibility of dose delivery to the target TLD in the pelvis and thorax phantoms was 3% and 0.5%, respectively. The reproducibility of radiation-field localization was less than 2.5 mm for both phantoms. Using these anthropomorphic phantoms, pelvic IMRT and thoracic SBRT radiation treatments can be verified with a high level of precision. These phantoms can be used to effectively credential institutions for participation in specific NCI-sponsored clinical trials.

Consistency of absorbed dose to water measurements using 21 ion-chamber models following the AAPM TG51 and TG21 calibration protocols.

In 1999, the AAPM introduced a reference dosimetry protocol, known as TG51, based on an absorbed dose standard. This replaced the previous protocol, known as TG21, which was based on an air kerma standard. A significant body of literature has emerged discussing the improved accuracy and robustness of the absorbed dose standard, and quantifying the changes in baseline dosimetry with the introduction of the absorbed dose protocol. A significant component playing a role in the overall accuracy of beam output determination is the variability due to the use of different dosimeters. This issue, not adequately addressed in the past, is the focus of the present study. This work provides a comparison of absorbed dose determinations using 21 different makes and models of ion chambers for low- and high-energy photon and electron beams. The study included 13 models of cylindrical ion chambers and eight models of plane-parallel chambers. A high degree of precision (<0.25%) resulted from measurements with all chambers in a single setting, a sufficient number of repeat readings, and the use of high quality ion chambers as external monitors. Cylindrical chambers in photon beams show an improvement in chamber-to-chamber consistency with TG51. For electron dosimetry with plane-parallel chambers, the parameters Ngas and the product ND,w x k(ecal) were each determined in two ways, based on (i) an ADCL calibration, and (ii) a cross comparison with an ADCL-calibrated cylindrical chamber in a high-energy electron beam. Plane-parallel chamber results, therefore, are presented for both methods of chamber calibration. Our electron results with technique (i) show that plane-parallel chambers, as a group, overestimate the beam output relative to cylindrical chambers by 1%-2% with either protocol. Technique (ii), by definition, normalizes the plane-parallel results to the cylindrical results. In all cases, the maximum spread in output from the various cylindrical chambers is <2% implying a standard deviation of less than 0.5%. For plane-parallel chambers, the maximum spread is somewhat larger, up to 3%. A few chambers have been identified as outliers.

Design and implementation of an anthropomorphic quality assurance phantom for intensity-modulated radiation therapy for the Radiation Therapy Oncology Group.

PURPOSE: To design, construct, and evaluate an anthropomorphic phantom for evaluation of intensity-modulated radiation therapy (IMRT) dose planning and delivery, for protocols developed by the Radiation Therapy Oncology Group (RTOG) and other cooperative groups. METHODS AND MATERIALS: The phantom was constructed from a plastic head-shaped shell and water-equivalent plastics. Internal structures mimic planning target volumes and an organ at risk. Thermoluminescent dosimeters (TLDs) and radiochromic film were used to measure the absolute dose and the dose distribution, respectively. The reproducibility of the phantom's dosimeters was verified for IMRT treatments, and the phantom was then imaged, planned, and irradiated by 10 RTOG institutions. RESULTS: The TLD results from three identical irradiations showed a percent standard deviation of less than 1.6%, and the film-scanning system was reproducible to within 0.35 mm. Data collected from irradiations at 10 institutions showed that the TLD agreed with institutions' doses to within +/-5% standard deviation in the planning target volumes and +/-13% standard deviation in the organ at risk. Shifts as large as 8 mm between the treatment plan and delivery were detected with the film. CONCLUSIONS: An anthropomorphic phantom using TLD and radiochromic film can verify dose delivery and field placement for IMRT treatments.

Update of AAPM Task Group No. 43 Report: A revised AAPM protocol for brachytherapy dose calculations.

Since publication of the American Association of Physicists in Medicine (AAPM) Task Group No. 43 Report in 1995 (TG-43), both the utilization of permanent source implantation and the number of low-energy interstitial brachytherapy source models commercially available have dramatically increased. In addition, the National Institute of Standards and Technology has introduced a new primary standard of air-kerma strength, and the brachytherapy dosimetry literature has grown substantially, documenting both improved dosimetry methodologies and dosimetric characterization of particular source models. In response to these advances, the AAPM Low-energy Interstitial Brachytherapy Dosimetry subcommittee (LIBD) herein presents an update of the TG-43 protocol for calculation of dose-rate distributions around photon-emitting brachytherapy sources. The updated protocol (TG-43U1) includes (a) a revised definition of air-kerma strength; (b) elimination of apparent activity for specification of source strength; (c) elimination of the anisotropy constant in favor of the distance-dependent one-dimensional anisotropy function; (d) guidance on extrapolating tabulated TG-43 parameters to longer and shorter distances; and (e) correction for minor inconsistencies and omissions in the original protocol and its implementation. Among the corrections are consistent guidelines for use of point- and line-source geometry functions. In addition, this report recommends a unified approach to comparing reference dose distributions derived from different investigators to develop a single critically evaluated consensus dataset as well as guidelines for performing and describing future theoretical and experimental single-source dosimetry studies. Finally, the report includes consensus datasets, in the form of dose-rate constants, radial dose functions, and one-dimensional (1D) and two-dimensional (2D) anisotropy functions, for all low-energy brachytherapy source models that met the AAPM dosimetric prerequisites [Med. Phys. 25, 2269 (1998)] as of July 15, 2001. These include the following 125I sources: Amersham Health models 6702 and 6711, Best Medical model 2301, North American Scientific Inc. (NASI) model MED3631-A/M, Bebig/Theragenics model I25.S06, and the Imagyn Medical Technologies Inc. isostar model IS-12501. The 103Pd sources included are the Theragenics Corporation model 200 and NASI model MED3633. The AAPM recommends that the revised dose-calculation protocol and revised source-specific dose-rate distributions be adopted by all end users for clinical treatment planning of low energy brachytherapy interstitial sources. Depending upon the dose-calculation protocol and parameters currently used by individual physicists, adoption of this protocol may result in changes to patient dose calculations. These changes should be carefully evaluated and reviewed with the radiation oncologist preceding implementation of the current protocol.

Procedures for establishing and maintaining consistent air-kerma strength standards for low-energy, photon-emitting brachytherapy sources: recommendations of the Calibration Laboratory Accreditation Subcommittee of the American Association of Physicists in Medicine.

Low dose rate brachytherapy is being used extensively for the treatment of prostate cancer. As of September 2003, there are a total of thirteen 125I and seven 103Pd sources that have calibrations from the National Institute of Standards and Technology (NIST) and the Accredited Dosimetry Calibration Laboratories (ADCLs) of the American Association of Physicists in Medicine (AAPM). The dosimetry standards for these sources are traceable to the NIST wide-angle free-air chamber. Procedures have been developed by the AAPM Calibration Laboratory Accreditation Subcommittee to standardize quality assurance and calibration, and to maintain the dosimetric traceability of these sources to ensure accurate clinical dosimetry. A description of these procedures is provided to the clinical users for traceability purposes as well as to provide guidance to the manufacturers of brachytherapy sources and ADCLs with regard to these procedures.

Differences in electron beam dosimetry using two commercial ionization chambers and the TG-21 protocol: another reason to switch to TG-51.

Two of the most popular dosimetry systems used for calibration of megavoltage photon and electron beams in radiation therapy are (i) cylindrical Farmer-type chambers in liquid water and (ii) Holt Memorial parallel-plate chambers in clear polystyrene. Since implementation of the AAPM TG-21 calibration protocol, the Radiological Physics Center (which uses the Farmer in-water system) has compared machine calibrations on two occasions with those of Memorial Sloan-Kettering Cancer Center (which uses the Holt in-polystyrene system). Two years post publication of the TG-51 protocol, 70% of the clinics monitored by the RPC still use TG-21. Seventeen photon beams from cobalt-60 to 18 MV and 31 electron beams from 6 to 20 MeV were compared using the TG-21 protocol. These data represent the most comprehensive comparison of the two most popular systems in use. Based on the average percent difference, the two systems yielded the same absorbed dose to water at the reference point in phantom to within 1.5% for both modalities. No energy dependence was evident in the results; however, a systematic average percent difference between photons and electrons was seen, with the Farmer in-water system consistently predicting a dose 1.3% lower for electrons than the Holt in-polystyrene system. For photons both systems predicted the same dose to within 0.3% on average. When a physicist converts from TG-21 to TG-51, these data may be of assistance in explaining unexpected changes in output that are different from previously published values. Implementation of the TG-51 protocol should eliminate any of the observed differences in electron beam dosimetry between the two dosimetry systems because the Holt system cannot be used with TG-51.

A reanalysis of the Collaborative Ocular Melanoma Study Medium Tumor Trial eye plaque dosimetry.

PURPOSE: To recalculate the radiation doses delivered to structures of interest within the eye, i.e., the lens, tumor apex, 5-mm point, optic disk, and macula for patients treated with eye plaque radiotherapy on the Collaborative Ocular Melanoma Study (COMS) Medium Tumor Trial, using updated dosimetric data. METHODS AND MATERIALS: Using the Plaque Simulator planning system, doses were recalculated for a sampling of COMS patients for each plaque size. Dosimetry parameters incorporated into the recalculation were line source approximation, a 90% Silastic transmission factor, and a 0% gold transmission factor. Generic solutions were generated from the dose recalculations for each plaque size and structures of interest combination. Doses for the remainder of the patient population were recalculated using the generic solutions and compared with the originally reported COMS doses. RESULTS: Doses to all structures of interest were reduced 7%-21%, depending on the plaque size and structure combination. The reduction in dose for the macula, optic disc, lens, tumor apex, and 5-mm point was on average 10%, 18%, 8%, 11%, and 12%, respectively. The closer the macula and optic disk were to the plaque rim, the greater the dose reduction. Incorporation of the Silastic transmission factor accounted for a large part of the dose reduction. CONCLUSIONS: Incorporating anisotropy, line source approximation, and Silastic and gold shield attenuation into dose recalculations resulted in a significant and consistent reduction of doses to structures of interest within the eyes.

Radiotherapy: effects on expanded skin.

Although the combination of radiation and tissue expansion has been associated with a significant rate of complications, the specific pathophysiology has yet to be clearly elucidated. The objective of this study was to develop a model to identify and examine specific histologic changes associated with tissue expansion and irradiation. Rectangular 50-cc silicone tissue expanders were placed subcutaneously over the midline dorsum of 18 adult New Zealand white rabbits. Preoperative radiographic dosimetry demonstrated that the radiation portal was away from vital intraabdominal structures. The expanders were inflated with 10 cc of saline every other day for a total of 80 cc. Expanders were left in place for 2 to 3 weeks to allow fibrovascular capsule formation. The rabbits were then divided into three groups (six rabbits per group), each receiving one of three nonfractionated doses of radiation (20, 25, or 35 Gy). Half of the expanded skin was irradiated using a single dose, and the other half served as a nonirradiated control. Capsules and skin were harvested 6 weeks after the delivery of radiation, allowing the beginning of chronic radiation changes to occur. Using hematoxylin and eosin staining, histomorphometric analysis was performed. The data were analyzed using Student's test. Although irradiation did not affect dermal thickness, it did cause a statistically significant increase in epidermal thickness. At 20, 25, and 35 Gy the increase in epidermal thickness was 43, 90, and 130 percent, respectively. Although significant epidermal changes could be identified, capsular and dermal alterations were not evident. Further studies evaluating the long-term effects of alterations in capsular formation caused by radiation may be required.