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The aim of this study was to investigate the role of 70 Gy salvage radiotherapy (SRT) combined with short-term neoadjuvant hormonal therapy (NHT) in the treatment of recurrent disease after radical prostatectomy (RP), and to consider quality of life (QoL), survival outcomes and impact of co-morbidities on treatment-related rectal-genitourinary toxicity. Electronic records of 184 SRT patients treated consecutively between October 2001 and February 2007 were analyzed. Median age was 64 years (median follow-up 48 months). NHT was given to 165 patients (median 3 months). Pre-RP and pre-SRT PSA, PSA doubling time, Gleason score (GS), seminal vesicle invasion (SVI) and detectable post-SRT PSA were recorded. Any detectable PSA or PSA >0.1 ng/ml + nadir was considered biochemical failure (BcF). The Charlson co-morbidity index was used to correlate co-morbidities and rectal-genitourinary toxicity. Scores from the health-related QoL EORTC QLQ-C30 and PR-25 questionnaires were also evaluated. In 116 (63%) patients, a long-lasting curative effect was indicated by undetectable PSA levels. In univariate analysis, using BcF as an outcome variable, p<0.001 was found for GS, pre-SRT PSA, SVI and detectable post-SRT PSA. Multivariate analysis showed p=0.01 for SVI, p=0.09 for GS, and detectable post-SRT PSA (p=0.01); with metastases as an outcome variable, only SVI was significant (p=0.007). Cancer-specific and overall survival were 99 and 95%, respectively. Although microscopy showed SVI or GS 8-10 in the prostatectomy specimens 17/40 (43%) and 13/29 (45%), respectively, of patients still showed undetectable PSA at long-term follow-up (median 55 months) after SRT. Likewise, 11/31 (36%) patients with pre-SRT PSA >1.0 ng/ml and 80/134 (60%) patients with PSA doubling time (PSADT) <10 still showed undetectable PSA after 50 months. Slightly elevated acute and late rectal-genitourinary grade 3-4 toxicity was observed. No association with co-morbidity/toxicity was found. EORTC QLQ-C30 scores were similar to or slightly better than reference values. SRT with 70 Gy combined with 3-month NHT results in long-term undetectable PSA in >50% of patients with recurrence after RP with acceptable rectal-genitourinary toxicity and without negatively affecting long-term QoL. Non-metastatic patients should not be disqualified from receiving SRT although presenting with poor prognostic factors at surgery.

We have reviewed the studies on radiation-induced vascular changes in human and experimental tumors reported in the last several decades. Although the reported results are inconsistent, they can be generalized as follows. In the human tumors treated with conventional fractionated radiotherapy, the morphological and functional status of the vasculature is preserved, if not improved, during the early part of a treatment course and then decreases toward the end of treatment. Irradiation of human tumor xenografts or rodent tumors with 5-10 Gy in a single dose causes relatively mild vascular damages, but increasing the radiation dose to higher than 10 Gy/fraction induces severe vascular damage resulting in reduced blood perfusion. Little is known about the vascular changes in human tumors treated with high-dose hypofractionated radiation such as stereotactic body radiotherapy (SBRT) or stereotactic radiosurgery (SRS). However, the results for experimental tumors strongly indicate that SBRT or SRS of human tumors with doses higher than about 10 Gy/fraction is likely to induce considerable vascular damages and thereby damages the intratumor microenvironment, leading to indirect tumor cell death. Vascular damage may play an important role in the response of human tumors to high-dose hypofractionated SBRT or SRS.

Nine patients with 11 primary or secondary liver non-neuroendocrine malignancies with mean and maximum diameters of 4.0 and 7.7 cm became long-term survivors after precision irradiation in a stereotactic body frame. Doses varied from 20 to 45 Gy split at 2-4 occasions a few days apart, with higher doses in the target centers. Occasional chemotherapy was stopped well before irradiation. No hospitalizations were needed because side effects, regional pain and nausea, were mild. All patients have now survived 5-14 years without recurrences. Two verified and one suspected secondary cancers occurred in organs close to the irradiated targets, and two of them could be resected for cure. Precision irradiation can thus cure selected liver malignancies. It is the first non-invasive method to achieve this, and the present patients are its first long-term survivors. A prolonged follow-up period is, however, necessary, because we have in other patients seen local tumor regrowth as late as four years after irradiation. The approach may cure some tumors, which are technically unsuited for other treatment modalities, and can be used for patients at high surgical risk. The success rate for local control seems good, but has to be defined by formal studies after optimization of radiation doses.

Purpose: To illustrate the effect that the quality of evidence has on clinical practice, we examined how the role of radiotherapy in treating breast cancer has changed over the years as the quality of evidence evolved from anecdotal evidence based on expert opinion to randomized clinical trials and meta-analyses., Methods: We searched the medical literature for key randomized studies and meta-analyses that have influenced the clinical use of postmastectomy irradiation since the first randomized trials in breast cancer in the 1950s. We discuss how clinical practice changed based on the outcomes of these trials, and then discuss the quality of those trials based on the criteria currently used to assess evidence from randomized trials (CONSORT) and meta-analysis (QUORUM)., Results: Evidence published from the early trials and meta-analyses on the role of postmastectomy irradiation had a strong effect on clinical practice. Examination of these studies, however, continues to show significant flaws in trial design that, by today's evidence-based standards, would not meet standards of quality., Conclusion: The quality of evidence has a strong effect on shaping clinical practice and needs to be continually assessed. Current guidelines developed to critique both individual randomized trials and meta-analyses are helping to establish high standards for trial design and interpretation. Evidence from older trials that were not guided by well-developed guidelines need to be reviewed, particularly when results from those trials are continually updated and used to generate evidence on which to base current clinical practice.

Purpose: To discuss the assumptions behind and current clinical evidence on three-dimensional conformal radiation therapy (3D-CRT) and dose escalation in the treatment of prostate cancer., Methods: We first define 3D-CRT in comparison to standard radiation therapy and discuss the assumptions on which the technology of 3D-CRT and dose escalation are based. We then examine the evidence on the benefits and limitations from the current most commonly cited studies on dose-escalation trials to treat prostate cancer., Results: The assumption that 3D-CRT can provide a tighter margin around the tumor area to allow for dose escalation is not yet proven by studies that show continual difficulty in defining the planning treatment volume because of extrinsic and intrinsic difficulties, such as imaging variabilities and patient and organ movement. Current short-term dose-escalation studies on the use of 3D-CRT to treat prostate cancer are limited in their ability to prove that increasing dose improves survival and does not incur potential long-term complications to normal tissue., Conclusion: Although 3D-CRT is a promising technology that many radiation oncologists and clinics are quickly adopting to treat such tumors as prostate cancer, the long-term evidence on the benefits and limitations of this technology is still lacking. Until we have solid long-term evidence on the true clinical potential of this new technology, let us not rush to judgment, but exercise caution, diligence, and thoughtfulness in using this new technology to treat our patients.

The advancements in radiation oncology in the past 50 years in the United States were probably more dramatic than those in the first half of the 20th century. Not only were there major technical achievements, but there was also an associated increase in the overall cure rates of cancer, from 20% at 5 years 50 years ago to now nearly 60% at 5 years. The cure rates in selected tumor sites at 5 years in 1950 and in 2000, respectively, were as follows: breast, 50% and 80%; colon and rectum, 40% and 85%; lung, 5% and 15%-20%; prostate, 40% and 80%; Hodgkin disease, 50% and more than 90%; cervix, 40% and 70%-80%; uterus (endometrium), 80% and more than 90%; bladder, 30% and 50%; head and neck, 30% and 60%; and esophagus, 2% and 15%. Much of this has been due to a broader array of techniques in radiation therapy available for treatment but also because of new emphasis on combined integrated modalitities (surgery, radiation therapy, and chemotherapy). New imaging techniques have contributed substantially, allowing better selection of patients for treatment and better selections of treatment modalities.

Six departments of radiology and six departments of radiation oncology from areas with low, medium, or high managed care penetration were asked to complete a questionnaire designed to address the impact of managed care on research and scholarly activity. Information, when available, was taken from fiscal years 1993 and 1998. Questionnaires were followed by site visits to the 12 departments. The study showed that departments with medium to high managed care penetration reported more dissatisfaction in their ability to remain active in their education and research goals. Results indicated that for the period surveyed, the departments needed to increase clinical time to make up for decreasing patient care revenues. In turn, this has reduced the time and money devoted to scholarly activities. Information from this study will be used to develop a trends database for all U.S. radiology and radiation oncology departments. This, together with a more comprehensive study by the RSNA, will assist in measuring the current and potential long-term impact of managed care and other system changes on the practice of radiology and radiation oncology.

Major changes have occurred in the last 25 years which have impacted significantly on the practice of radiation oncology. Twenty-five years ago, less than 40% of all patients had radiation therapy as a part of their management either for cure, palliation or in combination with surgery and/or chemotherapy. In 1998, about 60% of all patients had radiation therapy as a part of their treatment program either initially or at some time during the course of their disease process. Clearly, randomized clinical trials have made their contribution in cancer management but probably the most significant impact has been improving the standards of care relative to cancer treatment through better education and more cooperative efforts. It is extraordinarily difficult to predict the future for radiation oncology in the third millennium primarily because of the major changes in technology as well as the financial limitations with regards to treatment.

Three-dimensional conformal radiation therapy (3D-CRT) is a promising new treatment technique based on the principle that improved precision in both tumor definition and dose delivery will enhance outcomes by maximizing dose to the tumor area while minimizing dose to normal tissue. Using a cost-benefit analysis, in terms of outcomes, we first examined the overall risks and benefits of 3D-CRT. We then used the treatment of prostate cancer as a model to compare actual clinical outcomes reported between 3D-CRT and standard radiation therapy (SRT). Our analysis shows that application of 3D-CRT to the clinical setting remains difficult because of the continual difficulties of target definition, and that dose escalation cannot yet be justified on the basis of the lack of benefit found, and suggested increased late toxicity, in most of the dose escalation series compared with SRT.

Carcinoma in situ of the glottic larynx is a rare malignancy, comprising only 1% to 2% of laryngeal biopsy. The management of these lesions remains controversial. In this article, the authors present results and analysis of the management of 20 patients having these lesions treated by radiotherapy. A total of 20 patients who had carcinoma in situ of the glottis were treated with curative intent with radiotherapy at the Veterans Administration Medical Center, Minneapolis, Minnesota, U.S.A. from November 1972 through March 1993. Before radiotherapy, eight patients had only biopsies of the glottic larynx, five had one stripping procedure, and seven patients had two or three stripping procedures. Of the 20 patients, 19 are available for retrospective analysis, with a minimum follow-up of 4 years and a median follow-up of 7.3 years. Treatment was given to all patients by megavoltage units (cobalt 60, 2; 4-mV linear accelerator, 18). Patients were treated using bilateral opposed wedged 6-cm x 6-cm fields, with a dose of 1.75 Gy per fraction to a total median dose of 68.4 Gy in 40 fractions over 56 elapsed treatment days. The Kaplan-Meier method was used for survival analysis. The 4-year disease-free survival was 95% after irradiation. The actuarial disease-free survival for 5 and 10 years was 95%. Surgical salvage failed in one patient who had a laryngectomy for recurrent invasive squamous cell carcinoma at 34 months after radiotherapy. Two patients developed severe shortness of breath because of laryngeal edema, which required tracheostomy. Sixteen patients reported subjective significant improvement of their voice quality, and four reported no change. Radiotherapy is an excellent choice for patients who have recurrent carcinoma in situ after undergoing stripping procedures or for those patients who live too far from a medical facility to allow close follow-up and repetitive surgical procedures. These results are comparable to those of other investigators who used radiotherapy with higher dose per fraction.

The authors report the analysis and outcome of curative radiotherapy for stage II and III squamous cell carcinoma of the glottic larynx. Thirty-nine men with invasive, previously untreated squamous cell carcinoma of the glottic larynx were referred for curative radiotherapy from May 1976 through June 1991, to the Veterans Administration Medical Center in Minneapolis, Minnesota, U.S.A. Thirty-eight patients had T2N0 disease, and one had T2N1 disease. All patients were treated by megavoltage units (two by cobalt 60 and 37 by 4 mV-linear accelerator). The median fractional dose was 1.80 Gy, and the median total tumor dose was 70.20 Gy. Surgical salvage was reserved for irradiation failure. All patients had a minimum 5-year follow-up. The Kaplan-Meier method was used for survival analysis. The 5-year disease-free survival with voice preservation after radiotherapy was 70.2% (80% for T2a and 64% for T2b patients). The ultimate 5-year disease-free survival for all T2 patients after surgical salvage was 91%. In nine patients, ten second primary malignancies were diagnosed during follow-up. Nine of these second lesions occurred in the aerodigestive tract. Curative radiotherapy using conventional fractionation regimen with surgical salvage for irradiation failure is an efficacious modality for T2N0 and T2N1 squamous cell carcinoma of the glottic larynx. A high incidence of second malignancy was noted in our series.

A patient is diagnosed with an unknown primary of the head and neck when metastatic disease is present in the cervical lymph node or nodes and no primary lesion is detected by thorough physical examination, directed biopsies of suspicious or most likely primary sites, and imaging studies. The optimal management of patients who have this syndrome is still unclear and controversial. We report our results and analysis of the management of 24 patients with this syndrome. From 1976 through 1992, 24 patients who had metastatic squamous cell carcinoma in the cervical lymph nodes were seen in our medical center. A thorough search did not detect a primary lesion in any of them. Patients underwent radical neck dissection of the involved neck; 23 had unilateral and I had bilateral neck disease. Postoperative radiotherapy was delivered to both sides of the neck and to the potential primary mucosal and submucosal sites. The relation between clinical N stage, histologic findings of numerous involved lymph nodes, presence of extracapsular tumor extension, and survival were statistically analyzed. The Kaplan-Meier method was used for the survival analysis. The p values of log-rank test for the comparison of the two groups 1) N1 and N2 versus N3, and 2) presence of extracapsular tumor extension versus its absence are less than 0.005, with extracapsular tumor extension versus nonextracapsular tumor extension slightly smaller. The 5- and 10-year disease-free survival rate for the entire group was 54.2% (70.5% for N1 and N2, and 14.2% for N3). Three patients had locoregional failure, two in the primary sites, one in the nasopharynx, and the other in the oropharynx (the latter also had recurrent disease in the undissected neck). In 8 patients, distant metastases developed 7 to 38 months after radiotherapy. All 11 patients (45.8%) who had recurrent disease had advanced clinical N stage, microscopic findings of numerous involved lymph nodes, and prominent extracapsular tumor extension to the surrounding soft tissue and blood vessels. The high incidence of distant metastases shortly after treatment suggests a hematogenous spread before treatment in patients who had extensive nodal and extranodal disease. Our long-term disease-free survival beyond ten years seems to indicate combined treatment modalities, including radical neck dissection with postoperative radiotherapy of the neck, and the potential primary site in patients with N2 and N3 disease (our N1 group is too small for analysis). Further improvement of cure rate can be expected in the future with early detection and treatment.

Adjuvant therapy in the treatment of breast cancer commonly refers to therapies that supplement primary treatment, traditionally mastectomy and, more recently, breast-conserving surgery. The present paper examines the evolution of systemic therapies and radiotherapy in their role as adjuvants to mastectomy, and offers a brief description of current treatment regimens for early and locally advanced disease.

Background: The potential of 3D conformal radiation therapy to improve the efficacy of radiotherapy is one of the most important technical advances in recent years. The potential benefit of improved local control from dose escalation must be weighed against the potential cost of increased complications to normal tissue., Method and Results: We evaluated the cost-benefit of 3D conformal radiation therapy in terms of the benefit to tumor cure weighed against the cost of complications to normal tissue. Assessment of current data shows that problems remain in adequately defining variables that contribute to both the tumor cure probability (benefit) and normal tissue complication probability (cost). For tumor cure probability, identifying the dose escalation needed for cure for the most tumor sites as well as precisely defining tumor volume remain problematic. For normal tissue complication probability, inadequate clinical data on toxicity to normal tissue for different tumor sites continue to make it difficult to use methods that estimate complications, such as dose-volume histograms as proposed by Lyman, to the clinical setting., Conclusion: 3D conformal radiation therapy is a promising new technology that may substantially improve the efficacy of radiation therapy. More clinical research, however, is needed to recognize the costs and benefits of this new technology: 1. Tumor control probability: More information is needed on the accurate definition of the target volume as well as on the amount of radiation necessary to cure different tumor sites. 2. Normal tissue complication probability: Methods for determining toxicity to normal tissue are needed. Current calculations based on various models are insufficient.

Purpose: External beam radiation therapy for carcinoma of the soft palate aims to achieve loco-regional control with normal speech, nasal function, swallowing mechanism, and minimal side effects such as nasal speech and regurgitation of food into the nasopharynx. In this report we present our results of radiotherapy in the treatment of 24 patients with squamous cell carcinoma of the soft palate., Methods and Materials: A total of 24 patients with squamous cell carcinoma of the soft palate were treated at the Veterans Administration Medical Center Minneapolis, MN, between February 1977 and May 1992. Of the 24 patients 2 had T1, 19 T2, 1 T3, and 2 had T4 lesions. Nineteen patients did not have clinical nodal disease, stage (N0), 1 had N1, 2 N2, and 2 N3 disease (Table 1). All the patients were treated by 4 MeV linear accelerator. A 1.75 Gy median dose was administered per fraction to a total of 70 Gy median dose. Bilateral opposed compensated shrinking fields technique was used., Results: The 3-year disease free survival rate after external beam radiation therapy was 100% (1 out of 1), 64.7% (11 out of 17), 100% (1 out of 1), and 0%, for patients with T1, T2, T3, and T4 disease, respectively. Salvage surgery for recurrent disease was successful in 57.1% (4 out of 7 patients (Table 2). The ultimate 3-year disease free survival rate for the entire group, including surgical salvage, was 81% (17 out of 21) (Fig 1)., Conclusion: Radiation therapy alone in our institution resulted in tumor control and survival rates compare favorably to previously published reports in the literature. Surgery can be reserved as salvage procedure.

Purpose: The Purpose of this report is to present the local control rate and survival of patients treated by radiation therapy for T1N0M0 squamous cell carcinoma of the glottic larynx., Methods and Materials: A total of 41 patients with squamous cell carcinoma of the glottis were treated at the Veterans Administration Medical Center Minneapolis, MN, between 1976 and 1990. Of the 41 patients, 40 are available for retrospective analysis with a minimum of a 2-year follow-up and a median follow-up of 5.8 years. Treatment was given to all the patients by a 4 MeV linear accelerator. The vast majority of the patients were treated with bilateral laryngeal opposed wedged 6 x 6 cm fields with a dose of 1.75 Gy per fraction to a total of 70 Gy in 40 fractions over 56 elapsed treatment days., Results: The data indicated local control and survival of 92.3 % at 2 years and 91.8 % at 3 years, post irradiation, with ultimate disease-free survival after surgical salvage of 97.4 % and 97.2 % at 2 years and 3 years, respectively. These local control and survival rates are comparable to those published in the literature when a higher fractional dose was given. No patients developed notable complications with our technique., Conclusions: A dose of 1.75 Gy to 1.8 Gy per fraction to a total of 70 Gy in 56 elapsed treatment days is well tolerated and yields ultimate disease free-survival of 97.2% at 3 years. This time-dose fractionation could be used safely for treating patients who demonstrate low tolerance to irradiation with a risk of laryngitis, laryngeal edema, or difficulty of swallowing, with a higher fractional dose.

Background: In this article the authors report an analysis and long term results of delayed/salvage radiation therapy administered to asymptomatic patients who had an elevated prostate specific antigen (PSA) level, many months to many years after radical prostatectomy., Methods: During 1987 to 1990, 40 asymptomatic patients were found to have an elevated PSA level 9 to 96 months after radical prostatectomy. The patients underwent transrectal needle aspiration biopsy of the urethrovesicle junction anastomosis (uvj); 28 patients had a positive biopsy and 12 patients had a negative biopsy. Delayed/salvage radiation therapy was administered to the pelvis (45 Gray [Gy]) and prostate bed (59.5 Gy), including the uvj., Results: Twenty-four of 37 patients (65%) were free of clinical disease. In 10 patients (27%), the radiation therapy resulted in a durable decrease in the elevated PSA level below a detectable level for a minimum 5-year follow-up. Five patients were alive with clinical disease. Eight died of disease. Three patients were lost to follow-up., Conclusions: This experience shows that delayed/salvage radiation therapy to the pelvis (45 Gy) and prostate bed (59.5 Gy), even many years after radical prostatectomy for pathologic stage pB, pC, and pD1 carcinoma of the prostate, was well tolerated and provided freedom from clinical disease in 24 of 37 patients (65%), and a decrease in elevated PSA level in 10 patients (27%). Delayed/salvage radiation therapy appears to be beneficial for patients who had undergone radical prostatectomy only and then developed rising PSA levels during the follow-up period.

Background: A Bayesian statistical approach was used to examine the effect of local control on survival of patients with early breast carcinoma., Methods: The effect of radiation on overall survival was examined in the four published randomized trials on conservation surgery with or without radiation: the Uppsala-Orebro, Canadian, NSABP-B06, and Milan III trials. Classical and Bayesian statistical approaches were used to evaluate the effect of sample size and follow-up on the results., Results: Combined 5-year survival results of patients with negative lymph nodes and surgical margins in the Uppsala-Orebro, Canadian, and NSABP-B06 trials indicated a 79% probability of a positive benefit with the addition of radiation and a 9.6% relative reduction in the annual mortality rate in favor of the irradiated patients. For the same subgroup of patients in the NSABP-B06 trial, the probability of a positive benefit with radiation increased from 65% at 5 years to 87% at 10 years, and is reflected in the change of the relative reduction in annual mortality from 8.2% at 5 years to 17.5% at 10 years. For all patients who accepted randomized treatment in the NSABP-B06 trial, the probability of a positive survival benefit with radiation was 80%, 98%, and 91% at 5, 10, and 12 years, respectively, with corresponding relative reductions in the annual mortality rates of 12.8%, 20.5%, and 15.2%., Conclusions: The addition of radiation to lumpectomy offers a small but important survival advantage, even in patients with negative surgical margins and lymph nodes. Because locoregional control and breast preservation are significantly improved with radiation, even a small survival advantage substantiates the importance of radiation in the treatment of patients with early breast carcinoma.

The purpose of this study was to examine the long-term outcome of Stage I large-cell non-Hodgkin's lymphoma patients treated with primary radiotherapy and to assess the potential influence of these results on the development of future treatment protocols for non-Hodgkin's lymphoma. Between April 1970 and July 1983, 15 pathological Stage I and four pathological Stage II large cell lymphoma patients were treated with primary radiotherapy at the University of Minnesota Hospital and Clinics. This paper focuses on the long-term outcome of the 15 Stage I patients. As of March 1995, with a median survival of 171 months, five of the 15 Stage I patients are alive: four with no sign of lymphoma and one with recurrence and a secondary malignant neoplasm (SMN). Estimated 5- and 10- year recurrence-free survival rates are 86% and 78%, respectively. Overall survival at 5 years is 80% and at 10 years, 67%. Six patients developed SMNs, all of which were solid tumors. Ten of the 15 patients died: four from SMNs, three from non-Hodgkin's lymphoma, and three from other causes without recurrence (two died of cardiovascular disease and one of a pulmonary embolism). Deaths due to lymphoma in pathologic Stage I patients treated by radiotherapy alone have not changed significantly since our last report in 1985; however, deaths due to SMNs have increased. To provide optimal treatment for early non-Hodgkin's large-cell lymphoma, examination of the long-term treatment risks provides useful information for newer treatment regimens that do not yet have long-term treatment outcomes available.

Strontium-89 chloride (Metastron) is an FDA-approved treatment for palliation of cancer pain. We evaluated blood count changes and pain relief in 28 patients with widespread painful bony metastasis treated with strontium-89 at the University of Minnesota Hospital and Clinics. Eighteen patients had prostate cancer (all hormone-refractory cancer), seven patients had breast cancer, and three patients had lung cancer, all previously treated with either radiation, chemotherapy, or a combination of the two. Serial blood counts were performed weekly up to 8 weeks and at 12 weeks after administering Metastron. Pain scale and blood values were monitored simultaneously. The mean baselines of hemoglobin (Hgb), white blood count (WBC), and platelets (Plts) were 11.4, 5900, and 258,000, respectively. The mean dose of Metastron was 3 mCi (range 2.2-4.4). The median time (range) to nadir was about 6 weeks. The percentage reductions relative to baseline were 32% (range 0-72%) for WBC; 14% (range 0-50%) for Hgb; 15% (range 0-47%) for the red blood cell (RBC) count; and 40% (range 0-85%)for Plts. We did not find a close relationship among the baseline blood count, reduction of subsequent blood counts, or previously irradiated active bone marrow volume. The median time of survival was 23 weeks (range 2-66 weeks). At 12 weeks, 29% of patients had moderate to dramatic improvement of pain, 32% had some relief of pain, and 50% had no improvement in pain. Thirty-two percent of the treated patients required additional palliative external beam radiation to their bony lesions within the study period. Our results show that Metastron for palliation for bony metastases should be used with caution because of moderate to severe bone marrow toxicity, especially in platelets, associated with its use. Careful evaluation of patients given Metastron is needed to assess accurately its full benefit.

Purpose: Since 1985, the University of Minnesota Hospital and Clinic has investigated the efficacy and safety of 8 MHz radiofrequency (RF) capacitive hyperthermia using the Thermotron RF-8. This study reports the thermometric and clinical results of 119 patients treated with RF hyperthermia in combination with radiotherapy (RT)., Methods and Materials: Of 119 patients, 69 received high-dose RT and 50 patients received low-dose RT because of previous irradiation to the treatment site. The most common anatomic sites treated were within the pelvic cavity or head and neck area. Thirty-three percent and 24% of tumors treated were > 7 cm and > 10 cm in largest diameter, respectively. Forty percent of the patients had deep-seated tumors (depth > 6 cm). Hyperthermia was given as soon as possible after RT twice weekly, allowing at least 72 h between treatments. The objective was to raise intratumoral temperatures to 42-43 degrees C or above for 30-50 min while keeping normal tissue temperatures below 40-41 degrees C., Results: Of 119 patients, 40% achieved a Tmax tumor temperature of > 42 degrees C and 40% achieved 40-42 degrees C Tmax. Higher Tmax) tumor temperatures were observed as tumor size increased. Tumors > 10 cm in largest diameter had a Tmax of 42.2 degrees C. Tumor depth was not a significant factor for the tumor temperatures achieved. Of 119 patients, 11% achieved complete response and 38% achieved partial response. Of the no-response patients, 34% had symptomatic palliation and 15% had stable disease for at least 12 months after treatment. We were able to treat tumors of patients with subcutaneous fat as thick as 3 cm by precooling the fat for 20 min with 10-15 degrees C saline-filled boluses prior to the initiation of heating. During treatment, 60% of patients complained of varying degrees of pain and 19% had pain that was a factor in limiting treatment. Vital signs were relatively stable and not a factor in limiting treatment., Conclusion: The Thermotron RF-8 is a useful hyperthermia device that can raise tumor temperatures to a therapeutic level (i.e., 42 degrees C) in a significant proportion of patients with superficial, subsurface, and deep-seated tumors, with minimal adverse effects, complications, and systemic stress. Further clinical studies using improved thermometry systems are warranted.

Purpose: To identify factors associated with the prevalence of radiation proctitis in patients with prostate cancer treated with external radiation therapy and to determine if a dose-response relationship exists., Materials and Methods: The study included 101 prostate cancer patients treated at the University of Minnesota Hospital and Clinics between 1970 and 1987. Radiation therapy at a daily dose of 175-200 cGy was given for 5 consecutive days per week for 7 weeks with a 10-24-MV linear accelerator. Mean dose to the prostate was 6,795 cGy (range, 5,579-7,417 cGy). Simulation radiographs obtained with rectal barium were analyzed in 51 patients. Doses were calculated at specific points in the boost field., Results: Radiation proctitis developed in 19 patients. No pretreatment or treatment factors were associated with a higher prevalence of proctitis. Statistically significant correlation (P < .042) was found between the development of proctitis and dose to the posterior rectum. At chi 2 analysis, proctitis was statistically significantly (P < .005) associated with posterior rectal doses of > 5,000 cGy., Conclusion: A high posterior rectal dose (> 5,000 cGy) is associated with increased prevalence of proctitis after radiation therapy.

The purpose of this study was to examine the meaning of local control, especially on survival, in breast cancer patients treated by lumpectomy with or without radiotherapy. We analyzed the survival results of four major published randomized trials that compare conservation surgery with or without radiation using three different statistical approaches: p-values, confidence intervals, and Bayesian techniques. All four trials report statistically significant increased local control and improved survival for the irradiated patients. Survival based on p-values and confidence intervals shows statistical significance for long-term follow-up of the NSABP-B06 trial, but not for the other trials, probably because of small sample sizes and short follow-up. At 10 years, the overall survival rates for the NSABP-B06 were 65% and 71% for lumpectomy alone or with radiation respectively. Interpreted in a Bayesian framework, the expected advantage in 10-year survival was 6% (the mean of NSABP-B06 10-year survival) with an 83% probability that the 10-year survival difference may lie between 2% and 10%. An 85% probability that 3% of patients will survive at 10 years because of irradiation translates into a 30% reduction in annual odds of death several years after treatment in stage I good prognosis patients and 15% in stage I poor prognosis patients. Analysis of the randomized trials comparing lumpectomy with or without radiation indicate a clear improvement in survival for the irradiated patients associated with increased local control. Combination of improved survival with the reduced psychological and economic costs associated with local recurrence argues well for the inclusion of radiation for many breast cancer patients.

Quality assurance in radiation oncology attempts to prescribe consistent, safe, and optimal delivery of radiation to treat disease. It encompasses three major areas of treatment: clinical, physical, and technical. Although national approaches and guidelines of quality assurance in radiation oncology are available, they usually are not adequate to deal with the particular needs of individual institutions, nor are they adequate to ensure uniform standards of diagnosis and treatment among institutions. Therefore, it is important for individual institutions to develop and implement strict quality assurance standards, based on national guidelines as well as their own strengths and needs, to ensure that patients receive the highest quality of radiotherapy and that the successes and failures of treatment are statistically reliable. This paper addresses the importance of quality assurance in radiation oncology and examines the quality assurance program in the Department of Therapeutic Radiology-Radiation Oncology at the University of Minnesota as an example of a program tailored to the needs of an individual institution.

Background: Different schools of thought regarding the natural history of breast cancer and how it relates to the importance of local control in affecting survival have generated controversy over the optimal treatment of early breast cancer. Parting with traditional thinking that some disease is localized, in which cases local control is important for survival, another view of the natural history of the disease argues that local control is not of value to survival. This commentary will review the evidence and attempt to evaluate the effect of modern adequate local treatment on survival., Methods: A review of the pertinent literature on the treatment of breast cancer and an analysis of recent clinical trials and meta-analysis are presented., Results: Evaluation of the recent literature and meta-analysis demonstrates that adequate local regional treatment, especially radiation therapy in the treatment of breast cancer, does effect survival significantly., Conclusions: Results of modern effective local treatment of breast cancer substantiate the claim that some breast cancer is localized. Data show that tumor size, lymph node involvement, tumor grade, and other prognostic factors are important predictors of whether a tumor is localized and therefore amenable to local treatment. Smaller tumors generally are most likely to be localized. Recent studies on modern irradiation techniques show that adequate effective irradiation of localized disease, including appropriate treatment of all nodal areas when needed and limited radiation to sensitive organs, can significantly improve survival and, in high-risk patients, enhance the effect of systemic treatment in improving survival.

Radiation therapy plays an important role in the treatment of patients with colorectal cancer. Randomized trials show that patients with rectal cancer have an 8% improved local control rate with postoperative radiation and an 11-13% improved local control rate with combined postoperative radiation and chemotherapy. Survival is also improved for these patients. Ongoing randomized trials may clarify the role of postoperative radiation therapy for patients with colon cancer. Although there is little specific information regarding the tolerance and response of the older patient to radiation therapy, there is no reason to believe that cancer in the older patient is more sensitive to ionizing radiation. Therefore, treatment decisions should be based on the available data. The older patient may be at an increased risk for radiation-related small bowel damage, and the clinician should pay particular attention to techniques to limit the amount of small bowel in the irradiated field.