Guidelines for comprehensive quality assurance in brachytherapy.

Brachytherapy treatment techniques can provide significant improvement in local control and overall survival, but only when quality assurance can be guaranteed. In the absence of well-trained personnel and inadequate equipment undesirable results usually follow. To establish brachytherapy quality assurance, basic requirements for three predetermined subdivisions of clinical institutions will be forwarded. These are: (1) centers having minimum requirements to provide brachytherapy, (2) intermediate centers such as regional or community hospitals, and (3) optimal centers such as university hospitals and cancer centers. A minimum center would have no board certified radiation personnel, would make use of services of a gynecologist or surgeon, be limited to afterloading or remote afterloading techniques for uterus cancer, and quality control would be guaranteed by using simple treatment protocols with fixed intrauterine applicators. Additional quality assurance such as leak testing, etc. would be provided by a parent organization (W.H.O. or Optimal Center). An intermediate center would have at least one certified radiation personnel with expansion of brachytherapy techniques to interstitial implants with several isotopes. Like the minimum center, no teaching would be provided but some quality assurance policies would be performed at the center (e.g., autoradiographs). The optimal center would have a full complement of personnel, have total brachytherapy capabilities, have teaching programs for its staff and possibly the minimum and intermediate centers and be able to provide its own quality assurance. This presentation will highlight personnel needs, equipment requirements, academic activities, clinical experience with these systems and proposed quality assurance guidelines.

High dose rate 60Co remote afterloading irradiation in cancer of the cervix in Haiti, 1977-1984.

From 1977 through 1984, 293 previously untreated patients with biopsy proven carcinoma of the uterine cervix were treated by whole pelvis irradiation and high intensity 60Co remote afterloading (RAL) intrauterine tandem techniques in Haiti. The treatment results were analyzed retrospectively to evaluate the therapeutic results and prognostic factors of a strict protocol involving 40 Gy to the whole pelvis (2 Gy/day, 5 days/week). In addition, on the 5th day of the 3rd week, the first outpatient 60Co remote afterloading intracavitary insertion, delivering 7.5 Gy to point "A" with each insertion, repeated 3 times by a week separation for a total of 4 times. The total TDF for external beam plus RAL was 158 and 175 for early and late effects respectively. One hundred-four patients were evaluable after 1 year or more follow-up, with a median of 26.5 months. No evidence of disease (NED) by Stage at 1 year was: Stage I of 100% (3/3), Stage II of 82% (9/11), Stage III of 80% (47/59), and Stage IV of 58% (18/31). The post-therapeutic complication rate was 7.7%, with no fistulas or requirement of surgical intervention. Those with documented follow-up of at least 2 years (74 patients) had comparable survival to other high dose rate and low dose rate studies. This study shows that outpatient brachytherapy can be carried out without sophisticated and expensive equipment with minimal staff trained in radiation therapy. A detailed description of this outpatient RAL technique and results are described so that this method can be adapted to other developing and industrialized nations where cost containment is becoming a key issue.

Quality control parameters of intraoperative radiation therapy.

We have tried to outline many of the factors which must be considered in the technical delivery of IORT and in subsequent evaluation of these patients. Unless careful attention is given to details of patient selection, surgery, pathology, radiation therapy and follow-up, it is likely that a vast morass of data will be obtained which will be very difficult to interpret. It is the hope of the IORT Working Group that other institutions using IORT will employ our recommendations with regard to dosimetry, follow-up, and the general technical approach. This will likely lead to an earlier understanding of the exact role of this modality in cancer therapy today.

Intraoperative radiation of the paraaortic nodes in cancer of the uterine cervix.

Intraoperative electron beam irradiation is being used for the therapeutic and prophylactic treatment of the paraaortic nodes in cancer of the uterine cervix. A Varian 18 meV accelerator is employed at an electron energy setting of 6--18 meV. Special aluminum and lucite collimators allow visualization of treatment area and keep the uninvolved small bowel out of the treatment beam. A one-time dose of 2000 rads is delivered in 4 minutes. The procedure presents no special surgical problems, is well tolerated, and appears as a promising supplement in cases where abdominal exploration for surgical staging of cervical carcinoma is carried out.

Intraoperative radiation in the treatment of advanced cervical cancer.

Nineteen patients with invasive cervical cancer were treated with intraoperative radiation and most of the patients subsequently received conventional external radiation therapy and intracavitary applications. The technique, resulting complications, and survival of the patients are discussed.

Preliminary clinical experience with intraoperative radiotherapy.

Intraoperative radiotherapy is the term applied to the irradiation of unresectable tumors, partially resectable tumors, and regional lymph nodes with external beam radiation at the time of surgical exposure. Since only one treatment is given at the time of surgery, one should consider the intraoperative technique as "boost" therapy which may allow us to raise the conventional external beam dose to the tumor by 50 to 100 percent. At Howard University Hospital and Cancer Research Center, seven advanced-stage cancer patients have been treated since 1976 with single doses of electron beam irradiation in the range of 1,300 to 2,000 rad. The preliminary evaluation of these patients has shown no serious acute radiation reactions.

Postoperative irradiation following immediate breast reconstruction using a temporary tissue expander.

Ten consecutive patients at Howard University Hospital underwent modified radical mastectomy with immediate breast reconstruction using a temporary tissue expander. Postoperative irradiation was delivered to the breast mound encompassing the tissue expander. The effects of expansion on the delivery of postoperative irradiation was assessed. Dosimetric measurements with thermoluminescent dosimeters revealed that the saline-filled expander attenuated the photon beam 3% less than tissue-equivalent material of equal volume. This dose variation was negligible, so no adjustments were made. Postoperative treatment consisted of 5040 cGy to 5220 cGy delivered in 5 to 10 weeks using 4 mV photon tangentials. Cosmesis was assessed over a 2-year period. Six patients completed reconstruction and irradiation without complications. Cosmesis was good in five and fair in one. One patient developed a moist reaction secondary to postoperative irradiation; however, final cosmesis was good. Three patients developed complications leading to the loss of the reconstructed breast. Successful final reconstruction can be achieved with careful patient selection and close follow-up by the plastic surgeon and radiation oncologist.

Intraoperative radiotherapy in childhood malignant astrocytoma.

A 12-year-old black male patient with glioblastoma multiforme was treated with intraoperative radiotherapy followed by conventional external beam radiation and chemotherapy. The authors' clinical experience with these therapeutic measures is discussed.

Particle radiation therapy: requiem or reveille.

The 1960s and 1970s witnessed a surge of many institutions devoted to electron therapy. Currently, many facilities are adding or have added particle types of radiation to their armamentarium against cancer. The authors review the concepts, problems, and potentials of this form of therapy.

Extrahepatic bile duct carcinoma: a case report.

The potential of local radiotherapy with intraoperative electron beam irradiation and trans t-tube iridium(192) brachytherapy for the management of carcinoma of the extrahepatic ducts is illustrated by this case report.

Use of interstitial hyperthermia to produce homogeneous heat distribution patterns.

The preliminary experience of the use of a prototype hyperthermia unit (Astro 200) for tumor regression in Howard University Hospital's Department of Radiotherapy is described. The purpose of this study was to produce homogeneous heat distribution patterns within a 5-cm cylinder in the middle of a phantom (ground beef) using radio frequency conducted through electrodes implanted in the medium. Homogeneous heat distribution was achieved by finding the optimal spatial distribution of electrodes within the phantom and by sequencing the radio frequency in the electrodes. Monitored observation revealed a steady state homogeneous temperature of 42.5 °C within a 4-cm diameter. There was a temperature difference of 0.5 °C within 1 cm of the periphery.Heat in the clinical range of 42 to 43 °C has caused tumor regression, and was found to be most effective when combined with another modality of radiation. At Howard University Hospital, hyperthermia is used in conjunction with conventional modalities-surgery, radiotherapy, and chemotherapy-in the treatment of tumors.

Anesthesia in intraoperative radiotherapy patients.

Intraoperative radiotherapy (IOR) is a relatively new modality for the treatment of carcinoma. This modality necessitates a multidisciplinary approach among the surgeon, anesthesiologist, radiotherapist, pathologist, and other members of the surgical support team. In addition to appropriate IOR and surgical techniques, the role of the anesthesiologist is crucial in determining patient outcome. Specifically, the degree of preoperative preparation has a direct correlation with a successful postoperative course. Patients considered for surgery are grouped in terms of: (1) primary tumor with no metastasis and/or unresectable loco-regional disease; (2) clinical and investigational evidence of tumor with no proven malignancy; and (3) those with known metastasis but in otherwise good general condition.The primary surgical goal is to localize the tumor, obtain a frozen-section biopsy, and evaluate for resectability at the same time as the radiotherapist evaluates whether IOR is indicated. Thus many facets come together to make the IOR procedures feasible and safe. The 148 patients treated at Howard University Hospital, uneventfully, should serve to justify intraoperative radiotherapy as both a practical and safe tool in the treatment of malignancy.

Radiation dose monitoring in a breast cancer patient with a pacemaker: a case report.

A pacemaker-bearing patient with left-sided breast cancer was treated with adjuvant external beam radiation therapy to the intact breast. She was treated via tangential fields and a single anterior supraclavicular field using 6-MV x-rays. The pacemaker, originally in the treatment field, was removed and a new one placed 4 cm outside the radiation field prior to treatment. Silicon diode chamber Keithley-Farmer type 0.6 cc ionization chamber, and lithium fluoride (LiF) (TLD) chips were used to measure, in vivo, the dose to the pacemaker. From all the fields treated, total dose to the pacemaker was 164 cGy by diode measurements, 182 cGy by ionization chamber measurements, and 171 cGy by TLD measurements. The pacemaker functioned normally throughout the course of treatment.

Twice-a-day treatment in the radiotherapeutic management of malignant mixed tumor of the parotid gland: A case report.

A patient with a 2,300 gm malignant mixed tumor of the parotid gland had recurrence 19 days post surgery. The recurrent mass failed to respond to daily fractions of 200 rad conventional irradiation four times per week and actually increased in size. A superfractionation scheme was substituted, employing twice-a-day 200 rad at 4-5½ hours intervals three times a week for 2½ weeks. At the completion of treatment, there was a 50 percent regression of the recurrent tumor mass and a 100 percent regression two weeks post irradiation. A protocol using a twice-a-day treatment is discussed.

Preliminary survivorship report on combined intraoperative radiation and hyperthermia treatments for unresectable pancreatic adenocarcinoma.

Five patients with unresectable pancreatic adenocarcinoma were treated with simultaneous intraoperative radiotherapy and intraoperative hyperthermia. Postoperative survivorship averaged 15.8 months, which compares favorably to a previous study in which 19 patients receiving intraoperative radiotherapy without intraoperative hyperthermia survived an average of 6.05 months. Three of the five patients following the experimental protocol of intraoperative radiotherapy and intraoperative hyperthermia with additional external beam radiotherapy are still alive, which may result in average postoperative survivorship exceeding 15.8 months.

The use of intraoperative radiotherapy and external beam therapy in the management of desmoid tumors.

Desmoid tumors are rare nonencapsulated benign lesions that invade the musculoaponeurotic tissues of the body. Such tumors infiltrate insidiously, and attempts to remove them frequently fail, usually leaving residual tumor. The use of adjuvant radiotherapy to decrease the recurrence rate in partially resected extra-abdominal desmoids has been reported by several authors. The role of irradiation in the management of desmoid tumors is illustrated in a case that combined surgery, intraoperative radiotherapy, and postoperative external beam radiotherapy in the management of this lesion.

Internal mammary implantation: the need for revival of a simple technique.

Available statistics on breast cancer indicate a high frequency of positive internal mammary nodes, which is associated with decreased five-year survival rates. The close proximity of the majority of internal mammary nodes (87 percent within 1 cm) to the internal mammary vessels makes them easily accessible to high-dose intravascular continuous irradiation by afterloading radioactive ribbons (iridium 192) in the internal mammary vessels that are surgically exposed. This is a simple technique that can be carried out at the time of mastectomy or as a separate procedure, either as a primary radiation modality, for post-XRT recurrence, or as a boost in combination with conventional parasternal radiation therapy. The step-by-step technique, indications, need for revival, and future implications are presented.

Intraluminal radiation for esophageal cancer: a Howard University technique.

The objective of radiotherapeutic management in esophageal cancer is to accomplish maximum tumor sterilization with minimal normal tissue damage. This sincere effort is most often countered by the differential in tumor dose response vs normal tissue tolerance. Intraluminal isotope radiation, with its inherent advantage of rapid dose falloff, spares the lungs, the spinal cord, and other vital structures, yet yields adequately high doses to esophageal tumor. Though in existence since the turn of the century, the method of intracavitary radium bougie application dropped out of favor due to technical difficulties imposed by the size of the radium source and radiation exposure to the personnel involved. The authors describe a simple "iridium 192 afterloading intraluminal technique" that eliminates technical problems and reduces radiation exposure considerably.

The first simultaneous intraoperative hyperthermia and radiotherapy procedure: dog experiment and technique.

The Department of Radiation Therapy of Howard University Hospital was the first to revive (1976) the use of intraoperative radiotherapy, or direct view irradiation, using electron beam (IORTe(-)) in the United States. Since that time, this pioneering effort has gained both national and international acceptance. Now, many leading centers employ this investigational treatment modality. Recently, a new mode of cancer therapy has been gaining acceptance, namely hyperthermia (the treatment of cancer by heat). Hyperthermia has been shown, both experimentally and clinically, to improve the rate of local control (thermal enchancement ratio [TER]) when combined with radiation therapy in the treatment of cancer. Maximal TER has been observed with simultaneous or immediate application of radiation and hyperthermia for both tumor and normal tissues. Therefore, to achieve maximum therapeutic gain, selective, intraoperative, simultaneous heating and irradiation of the tumor with mechanical retraction of the normal and sensitive structures from the treatment field seems a promising alternative.There have been no published reports, to the authors' knowledge, on the combination of simultaneous IORTe(-) with intraoperative hyperthermia (IOHT). To employ this combination in human subjects, several questions must be answered first using animal models, including the technical and practical feasibility, the toxicity and morbidity, as well as the pathologic changes that may arise. The technical aspects of the first animal case, using a mongrel dog, applying simultaneous IORTe(-) and IOHT are presented.