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G E Hanks

Publications and source records attributed to G E Hanks.

At least 37 records · Page 2Linked to original sources

Defining the appropriate radiation dose for pretreatment PSA < or = 10 ng/mL prostate cancer.

PURPOSE: To investigate whether a dose response exists for biochemical no evidence of disease (bNED) control in prostate cancer patients with pretreatment prostate-specific antigen (PSA) < or = 10 ng/mL and to identify the patient subgroups affected. METHODS AND MATERIALS: Between 5/89 and 10/97, 488 T1-T3 NX-0 M0 prostate cancer patients with PSA < or = 10 ng/mL were treated with three-dimensional conformal radiation therapy (3D-CRT) alone. Median and mean pretreatment PSA values were 6.3 and 6.2, respectively. Gleason scores of 2-6 and 7-10 were noted in 386 and 102 men, respectively. AJCC 1992 palpation T1-T2AB tumors were noted in 415 patients. Perineural invasion (PNI) was noted in 60 men. Mean and median age was 67 and 68 years, respectively. Dose to the center of the prostate ranged from 6260 cGy to 8409 cGy with a mean and median of 7423 cGy and 7278 cGy, respectively. Patients were stratified into three groups according to dose: <7250 cGy, 7250-7599 cGy, and > or =7600 cGy. Median dose in these three groups was 7067 cGy, 7278 cGy, and 7734 cGy, respectively. Univariate analysis was performed to determine differences in bNED control (American Society for Therapeutic Radiology and Oncology [ASTRO] Consensus Guidelines definition of failure) by dose group for the entire cohort, for 310 good prognosis patients (T1-T2A, Gleason score 2-6, absence of PNI), and for 178 poor prognosis patients (T2B-T3 or Gleason score 7-10 or presence of PNI) (1). Multivariate analysis (MVA) was performed to determine if dose was an independent predictor of bNED control. Median follow-up was 36 months. RESULTS: A dose response was not demonstrated for the entire group of patients with pretreatment PSA < or =10 ng/mL. Doses of <7250 cGy, 7250-7599 cGy, and > or =7600 cGy were associated with 5-year bNED control rates of 73%, 86%, and 89%, respectively (p = 0.12). MVA demonstrated prognosis group (p = 0. 038) to be the only independent predictor of bNED control. Good prognosis patients had a 5-year bNED of 85% and no dose response was seen. The subgroup of poor prognosis patients demonstrated a 5-year bNED control rate of 81% and a dose response was seen for those receiving > or =7600 cGy, compared to the two lower dose groups (94% vs. 75% vs. 70%; p = 0.0062). MVA for the poor prognosis subset demonstrated dose (p = 0.01) to be the only independent predictor for improved bNED control. CONCLUSIONS: The poor prognosis subset of PSA < or =10 ng/mL prostate cancer patients benefit from dose escalation. A dose response is not demonstrated for prostate cancer patients with pretreatment PSA < or =10 ng/mL and other favorable features.

Adult↗

Socioeconomic characteristics of patients with squamous cell carcinoma of the uterine cervix treated with radiotherapy in the 1992 to 1994 patterns of care study.

PURPOSE: To describe the relationship between socioeconomic variables and the treatment of patients with radiotherapy for cervix cancer.40% minority patients. METHODS AND MATERIALS: Sixty-two institutions werw r andomly selected from a list of all radiotherapy facilities in the Unite d States. From these we randomly selected and reviewed 471 cases of squ amous cell carcinoma treated during 1992 to 1994. To create an addition al minority-rich sample, we randomly selected 215 additional cases from 17 randomly selected institutions that admitted >40% minority patients. The median household income of each patient's neighborhood was determined by matching her zip code to data from the 1990 United States Census. RESULTS: Pati ents who lived in low-income neighborhoods, who had only Medicaid covera ge, or who were treated at large academic or minority-rich institutions tended to have a poorer initial performance status, higher-stage or bulk y central disease, and a lower pretreatment hemoglobin level. Ability t o complete treatment did not correlate with ethnicity or income. Howeve r, noncompliant patients tended to be treated at minority-rich instituti ons and were more often < 40 or > 60 years old. Patients who completed definitive treatment were more likely to have had </= 1 low-dose-rate intracavitary implants if they were black, came from a low-income neighborhood, were covered by Medicaid or Medicare only, or were treated at a minority-rich institution. Patients who were treated in academic institutions received higher mean radiation doses to Point A (83.8 Gy) than those treated in research- or non-research-participating facilities (79.4 and 80.9 Gy, respectively; p = 0.002). Patients who received their radiation therapy in facilities that treated an average of </= 3 patients per year also received lower mean doses to Point A (79.1 vs. 83.0 Gy; p = 0.001). CONCLUSION: The treatment received by patients who belonged to minority groups, came from low-income neighborhoods, or were treated in large, minority-rich institutions differed in several respects from that of white, higher income patients. Larger, more detailed studies will be needed to clarify the reasons for these differences and to define any influence on treatment outcome.

Adult↗

A preliminary outcome analysis of the Patterns of Care Study in Japan for esophageal cancer patients with special reference to age: non surgery group.

BACKGROUND: The Patterns of Care Study (PCS) was imported to Japan from the United States in July 1996. A preliminary outcome analysis of the PCS for esophageal cancer patients in Japan was made with special reference to age, because the elderly population is rapidly increasing in Japan. PATIENTS AND METHODS: From July 1996 to February 1998, external PCS audits were performed for 37 institutions nationwide and detailed information of 561 esophageal cancer patients treated during the period 1992-1994 was collected by using the fifth PCS data format developed in the United States. This format was provided courtesy of the American College of Radiology. For this study, patients who had not undergone surgery (n = 336) were selected. The patients were classified into three age groups: < 65 years old (n = 119), between 65 and 74 years (n = 93), and 75 years or older (n =123). Cox's proportional hazards model was used for the statistical analysis, with survival, acute/subacute complication and late complication of grade 3 or more based on RTOG criteria, as the endpoints. RESULTS: Significant prognostic factors for the entire non-surgery group were Karnofsky Performance Status (KPS) (p = 0.0007), stage (p = 0.0001), and external irradiation dose (p = 0.0001). For the younger group, KPS (p = 0.0004), stage (p = 0.0197), and utilization of brachytherapy (p = 0.0010) were significant, while for the intermediate age group it was KPS (p = 0. 0027), history of pulmonary disease (p = 0.0339), stage (p = 0.0001), and external dose (p = 0.0001), and for the elderly group, stage (p = 0.0001) and external irradiation dose (p = 0.0224) were significant. Significant risk factors for complications for the entire group were stage (p = 0.0411), external dose (p = 0.0163), and stratification of institution (academic vs. nonacademic) (p = 0. 0114). Significant risk factors for the younger group were history of pulmonary disease (p = 0.0495) and external dose (p = 0.0037), and the other age groups showed no significant risk factors. CONCLUSION: Age was not a significant prognostic or risk factor for esophageal cancer patients in the non-surgery group treated with radiation therapy. Therefore, radiation therapy represented an important treatment modality for the elderly as well as for the younger esophageal cancer patients. External dose was a treatment-related prognostic factor for the elderly as well as for the intermediate age group.

Adenocarcinoma↗

Dose selection for prostate cancer patients based on dose comparison and dose response studies.

PURPOSE: To better define the appropriate dose for individual prostate cancer patients treated with three-dimensional conformal radiation therapy (3D CRT). METHODS AND MATERIALS: Six hundred eighteen patients treated with 3D CRT between 4/89 and 4/97 with a median follow-up of 53 months are the subject of this study. The bNED outcomes were assessed by the American Society for Therapeutic Radiology and Oncology (ASTRO) definition. The patients were grouped into three groups by prostate-specific antigen (PSA) level (<10 ng/ml, 10-19.9 ng/ml, and 20+ ng/ml) and further subgrouped into six subgroups by favorable (T1, 2A and Gleason score < or =6 and no perineural invasion) and unfavorable characteristics (one or more of T2B, T3, Gleason 7-10, perineural invasion). Dose comparisons for bNED studies were made for each of the six subgroups by dividing patients at 76 Gy for all subgroups except the favorable <10 ng/ml subgroup, which was divided at 72.5 Gy. Five-year bNED rates were compared for the median dose of each dose comparison subgroup. Dose response functions were plotted based on 5-year bNED rates for the six patient groupings, with the data from each of the six subgroups divided into three dose groups. The 5-year bNED rate was also estimated using the dose response function and compares 73 Gy with 78 Gy. RESULTS: Dose comparisons show a significant difference in 5-year bNED rates for three of the six subgroups but not for the favorable <10 ng/ml, the favorable 10-19.9 ng/ml, or the unfavorable > or =20 ng/ml subgroups. The significant differences ranged from 22% to 40% improvement in 5-year bNED with higher dose. Dose response functions show significant differences in 5-year bNED rates comparing 73 Gy and 78 Gy for four of the six subgroups. Again, no difference was observed for the favorable <10 ng/ml group or the unfavorable > or =20 ng/ml group. The significant differences observed in 5-year bNED ranged from 15% to 43%. CONCLUSIONS: Dose response varies by patient subgroup, and appropriate dose can be estimated for up to six subdivisions of prostate cancer patients. The appropriate use of high dose with 3D CRT results in 5-year cure rates that equal or exceed other treatments. The national practice must be upgraded to allow the safe administration of 75-80 Gy with 3D CRT.

Dose-Response Relationship, Radiation↗

Scrutiny of the ASTRO consensus definition of biochemical failure in irradiated prostate cancer patients demonstrates its usefulness and robustness. American Society for Therapeutic Radiology and Oncology.

PURPOSE: The goals of this study are: (1) to establish the robustness of the Fox Chase Cancer Center (FCCC) and the American Society for Therapeutic Radiology and Oncology (ASTRO) consensus definitions of failure by comparing biochemical estimates under various modifications of the censoring and failure time components to their respective unaltered definitions; (2) to isolate the source of variation between the two definitions of failure; and (3) to describe the hazard of failure over time for each definition. METHODS: Between May 1989 and May 1997, 670 men were treated at Fox Chase Cancer Center for localized prostate cancer using three-dimensional conformal radiation therapy (3DCRT). These men were stratified into three groups for analysis: 111 men treated with adjuvant hormones; 204 men treated with radiation therapy alone and presenting with more favorable prognosis tumor characteristics; 255 men treated with radiation therapy alone and presenting with less favorable prognosis tumor characteristics. For each group, biochemical failure was estimated and compared using the FCCC and ASTRO definitions of failure. The robustness of each definition was evaluated by comparing estimates under the definition as stated to those under various modifications of the censoring and failure components. Analyses were also performed while excluding slow-progressing patients. To isolate the source of variation between the two failure definitions, estimates were compared for patients with agreement in failure status. Estimates of biochemical failure, and thus hazard rates, were made using Kaplan-Meier methodology. RESULTS: ASTRO biochemical failure estimates were higher than the FCCC failure estimates in the first 5 years post-treatment. Beyond 5 years, ASTRO estimates level off, while the FCCC failure estimates continued to increase. These failure patterns were similar in all patient groups; however, patients treated with adjuvant hormones had a much higher risk of failure immediately following treatment under the ASTRO definition. Modifying the censoring pattern had little effect on failure estimates in any patient group, regardless of definition used. The exclusion of patients with slow prostate-specific antigen (PSA) doubling time did not result in biochemical estimates that differed significantly from those for all patients. The analysis of patients with agreement in failure status continued to demonstrate significant differences in estimates between the two definitions, and thus differences may be attributed to the specification of time to failure. For all patient groups, hazard rates were dependent upon failure definition: under the FCCC failure definition, patients were at constant risk of failure over the observation period; under the ASTRO failure definition, patients were at risk of failure during the first 4 years following treatment, and then at low risk of failure beyond 5 years. CONCLUSIONS: Both FCCC and ASTRO failure definitions were robust to modifications in censoring and the inclusion of patients with long doubling times. The ASTRO failure definition was robust to specifying the time to failure at first rise, as opposed to midway between nadir and first rise. Similarities in estimates for all patients versus patients with agreeing failure status suggest that differences in failure definition lie in the specification of time to failure. The ASTRO definition of failure is more appropriate because it does not impose an empirical failure marker but is based on the initiation of biochemical rise. The use of the ASTRO consensus definition demonstrated little risk of biochemical failure 4 years beyond treatment. The ASTRO failure definition should be adopted in all research involving biochemical failure analysis of men treated with radiation therapy.

Aged↗

Preliminary report of toxicity following 3D radiation therapy for prostate cancer on 3DOG/RTOG 9406.

PURPOSE: A prospective Phase I dose escalation study was conducted to determine the maximally-tolerated radiation dose in men treated with three-dimensional conformal radiation therapy (3D CRT) for localized prostate cancer. This is a preliminary report of toxicity encountered on the 3DOG/RTOG 9406 study. METHODS AND MATERIALS: Each participating institution was required to implement data exchange with the RTOG 3D quality assurance (QA) center at Washington University in St. Louis. 3D CRT capabilities were strictly defined within the study protocol. Patients were registered according to three stratification groups: Group 1 patients had clinically organ-confined disease (T1,2) with a calculated risk of seminal vesicle invasion of < 15%. Group 2 patients had clinical T1,2 disease with risk of SV invasion > or = 15%. Group 3 (G3) patients had clinical local extension of tumor beyond the prostate capsule (T3). All patients were treated with 3D techniques with minimum doses prescribed to the planning target volume (PTV). The PTV margins were 5-10 mm around the prostate for patients in Group 1 and 5-10 mm around the prostate and SV for Group 2. After 55.8 Gy, the PTV was reduced in Group 2 patients to 5-10 mm around the prostate only. Minimum prescription dose began at 68.4 Gy (level I) and was escalated to 73.8 Gy (level II) and subsequently to 79.2 Gy (level III). This report describes the acute and late toxicity encountered in Group 1 and 2 patients treated to the first two study dose levels. Data from RTOG 7506 and 7706 allowed calculation of the expected probability of observing a > or = grade 3 late effect more than 120 days after the start of treatment. RTOG toxicity scores were used. RESULTS: Between August 23, 1994 and July 2, 1997, 304 Group 1 and 2 cases were registered; 288 cases were analyzable for toxicity. Acute toxicity was low, with 53-54% of Group 1 patients having either no or grade 1 toxicity at dose levels I and II, respectively. Sixty-two percent of Group 2 patients had either none or grade 1 toxicity at either dose level. Few patients (0-3%) experienced a grade 3 acute bowel or bladder toxicity, and there were no grade 4 or 5 toxicities. Late toxicity was very low in all patient groups. The majority (81-85%) had either no or mild grade 1 late toxicity at dose level I and II, respectively. A single late grade 3 bladder toxicity in a Group 2 patient treated to dose level II was recorded. There were no grade 4 or 5 late effects in any patient. Compared to historical RTOG controls (studies 7506, 7706) at dose level I, no grade 3 or greater late effects were observed in Group 1 and Group 2 patients when 9.1 and 4.8 events were expected (p = 0.003 and p = 0.028), respectively. At dose level II, there were no grade 3 or greater toxicities in Group 1 patients and a single grade 3 toxicity in a Group 2 patient when 12.1 and 13.0 were expected (p = 0.0005 and p = 0.0003), respectively. Multivariate analysis demonstrated that the relative risk of developing acute bladder toxicity was 2.13 if the percentage of the bladder receiving > or = 65 Gy was more than 30% (p = 0.013) and 2.01 if patients received neoadjuvant hormonal therapy (p = 0.018). The relative risk of developing late bladder complications also increased as the percentage of the bladder receiving > or = 65 Gy increased (p = 0.026). Unexpectedly, there was a lower risk of late bladder complications as the mean dose to the bladder and prescription dose level increased. This probably reflects improvement in conformal techniques as the study matured. There was a 2.1 relative risk of developing a late bowel complication if the total rectal volume on the planning CT scan exceeded 100 cc (p = 0.019). CONCLUSION: Tolerance to high-dose 3D CRT has been better than expected in this dose escalation trial for Stage T1,2 prostate cancer compared to low-dose RTOG historical experience. With strict quality assurance standards and review, 3D CRT can be safely studied in a co

Adult↗

Ultrasound-based stereotactic guidance in prostate cancer--quantification of organ motion and set-up errors in external beam radiation therapy.

OBJECTIVE: A mobile transabdominal ultrasound-based targeting system (BAT(R)) has been developed which can stereotactically localize the position of the prostate each treatment day and directly integrate this information into the treatment planning system. Daily target verification facilitates a marked reduction in planning treatment margins by correcting potential organ-motion and set-up errors. Previous studies have been performed to establish the precision of ultrasound localization. This report quantifies the magnitude of the patient isocenter shift parameters encountered during clinical implementation of this system. MATERIAL AND METHODS: After five weeks of conformal external beam radiation therapy, 54 patients underwent a second CT simulation. Prostate-only fields based on this scan were created with no PTV margin beyond the CTV. For each of the final conedown treatments (2-4 fractions), patients underwent ultrasound-based stereotactic prostate localization at the treatment machine. The portable system, which electronically imports the CT simulation target-contour and isocenter information, is situated adjacent to the treatment couch. Transverse and sagittal suprapubic ultrasound images are captured, and the system electronically couples this data to the baseline isocenter. The CT contours are maneuvered in three dimensions by a touch-screen menu to visually overlay the ultrasound images. The system then displays the three-dimensional (3D) couch shifts required to produce field alignment. RESULTS: One hundred and eighty-nine daily ultrasound prostate position shifts were recorded for 54 patients. The isocenter field misalignment between the baseline CT and ultrasound ranged from -26.8 to 33.8 mm in the anterior/posterior (A/P) dimension, -10.2 to 30.9 mm in the lateral dimension, and -24.6 to 9.0 mm in the superior/inferior (S/I) dimension. The corresponding directed average disagreements were -3.0 mm (SD 8.3 mm) A/P, 1.86 mm (SD 5.7 mm) lateral, and -2.6 mm (SD 6.5 mm) S/I. The magnitudes of undirected misalignments were frequently larger than 5 mm (51% of A/P, 31% of lateral, and 35% of superior measurements) and oftentimes larger than 10 mm (21% of A/P, 7% of lateral, and 12% of superior measurements). CONCLUSIONS: Organ motion and set-up uncertainties limit optimization of 3D treatment planning by expanding the width of PTV margins required to ensure target coverage. Transabdominal ultrasound-based stereotactic guidance is a safe and direct method for correcting patient positioning. Our experience with the BAT system in a large cohort of prostate cancer patients revealed that substantial daily isocenter corrections were encountered in a large percentage of cases. This data would suggest that daily clinical isocenter misalignments are greater than would be expected from published data on organ motion and set-up variations encountered in the study setting.

Cohort Studies↗

Ultrasound-based stereotactic guidance of precision conformal external beam radiation therapy in clinically localized prostate cancer.

OBJECTIVES: Use of external beam radiation fields that conform to the shape of the target improves biochemical control in prostate cancer by facilitating dose escalation through increased sparing of normal tissue. By correcting potential organ motion and setup errors, ultrasound-directed stereotactic localization is a method that may improve the accuracy and effectiveness of current conformal technology. The purpose of this study was to quantify the precision of the transabdominal ultrasound-based approach using computed tomography (CT) as a standard. METHODS: Thirty-five consecutive men participated in a prospective comparison of daily CT and ultrasound-guided localization at Fox Chase Cancer Center. Daily CT prostate localization was completed before the delivery of each final boost field. In the CT simulation suite, transabdominal ultrasound-based stereotactic localization was also performed. The main outcome measure was a three-dimensional comparison of prostate position as determined by CT versus ultrasound. RESULTS: Sixty-nine daily CT and ultrasound prostate position shifts were recorded for 35 patients. The magnitude of difference between the CT and ultrasound localization ranged from 0 to 7.0 mm in the anterior/posterior, 0 to 6.4 mm in the lateral, and 0 to 6.7 mm in the superior/inferior dimension. The corresponding directed average disagreements were extremely small: anterior/posterior, -0.09 +/- 2.8 mm SD; lateral, -0.16 +/- 2.4 mm SD; and superior/inferior, -0.03 +/- 2.3 mm SD). Analysis of the paired CT-ultrasound shifts revealed a high correlation between the two modalities in all three dimensions (anterior/ posterior r = 0.88; lateral r = 0.91; and superior/inferior r = 0.87). CONCLUSIONS: Ultrasound-directed stereotactic localization is safe and as accurate as CT scanning in targeting the prostate for conformal external beam radiation therapy. The application of this technology to current conformal techniques will allow the reduction of treatment margins in all dimensions. This should diminish treatment-related morbidity and facilitate further dose escalation, resulting in improved cancer control.

Follow-Up Studies↗

Failure patterns and hazard rates for failure suggest the cure of prostate cancer by external beam radiation.

OBJECTIVES: To present patterns of failure and hazard rates for failure that support the concept of cure for patients with prostate cancer treated with external beam radiation (RT). METHODS: Two patient groups are reported: 408 patients treated with RT alone and 63 patients treated with RT and short-term androgen deprivation (RT+AD). All patients were treated between March 1987 and March 1995 and had at least 4 years of prostate-specific antigen (PSA) follow-up. The median follow-up was 69 months for the RT alone group and 60 months for the RT+AD group. For each treatment group, biochemical control and hazard functions were estimated using the ASTRO consensus definition of failure and the life table method. RESULTS: The 5 and 8-year biochemical control estimates were 60% and 59% for the RT alone group, respectively, with only two failures occurring after 5 years (1% of the total failures observed). Hazard function estimates indicated a maximum risk of failure at 12 to 36 months, tapering to a low rate at 4 years, with no failures observed after 6 years. The differences in the patterns of failure by PSA level revealed a maximum risk of failure at 12 to 24 months (median 28) for a pretreatment PSA level of less than 10 ng/mL, 12 to 36 months (median 25) for a pretreatment PSA level of 10 to 19.9 ng/mL, and 12 to 36 months (median 22) for a pretreatment PSA level of 20 ng/mL or greater. The latter group reached low levels of risk at 6 years in contrast to 4 years for the patients presenting with pretreatment PSA levels of less than 20 ng/mL. Similar patterns were observed when stratifying by stage and Gleason score: patients with a worse prognosis had the highest risk of failure earlier and achieved a low risk of failure later than patients with a more favorable prognosis. The patients in the RT+AD group had a different pattern of risk of failure, with the highest risk immediately after treatment, declining to a low risk of failure at 48 months. CONCLUSIONS: Patients treated with RT alone or RT+AD had little risk of failure after 4 to 6 years. Patients with a favorable prognosis achieved a low risk of failure sooner than high-risk patients when treated with RT alone. These results are consistent with the cure of prostate cancer by RT alone or RT+AD.

Aged↗

Outcome of patients receiving radiation for cancer of the esophagus: results of the 1992-1994 Patterns of Care Study.

PURPOSE: A Patterns of Care Study examined the records of patients with esophageal cancer (EC) treated with radiation in 1992 through 1994 to determine the national practice processes of care and outcomes and to compare the results with those of clinical trials. PATIENTS AND METHODS: A national survey of 63 institutions was conducted using two-stage cluster sampling, and specific information was collected on 400 patients with squamous cell (62%) or adenocarcinoma (37%) of the thoracic esophagus who received radiation therapy (RT) as part of primary or adjuvant treatment. Patients were staged according to a modified 1983 American Joint Committee on Cancer staging system. Fifteen percent of patients had clinical stage (CS) I disease, 40% had CS II disease, and 30% had CS III disease. Twenty-six percent of patients underwent esophagectomy. Seventy-five percent of patients received chemotherapy; 84% of these received concurrent chemotherapy and radiation (CRT). RESULTS: Significant variables for overall survival in multivariate analysis include the use of esophagectomy (risk ratio [RR] = 0.62), the use of chemotherapy (RR = 0.63), Karnofsky performance status (KPS) greater than 80 (RR = 0.61), CS I or II disease (RR = 0.66), and facility type (RR = 0.72). Age, sex, and histology were not significant. Preoperative CRT resulted in a nonsignificantly higher 2-year survival rate compared with definitive CRT alone (63% v 39%; P =.11), whereas 2-year survival by planned treatment rather than treatment given was 47.7% for preoperative CRT and 35.4% for definitive CRT (P =.23). Definitive CRT compared with definitive RT alone resulted in significantly higher 2-year survival (39% v 20.6%; P =.027) and lower 2-year local regional failure (30% v 57.9%; P =. 0031). CONCLUSION: This study confirms the value of CRT in EC treatment. It indicates that the results obtained in practice settings nationwide are similar to those obtained in clinical trials and that KPS and the 1983 clinical staging system are useful prognostic indicators. The suggested value of esophagectomy and superiority of preoperative CRT over CRT alone in this study should be tested in a randomized trial.

Adenocarcinoma↗

Conformal radiotherapy for prostate cancer.

This review presents the contribution conformal treatment has made to the external beam treatment of prostate cancer drawing on 10 years of experience with three-dimensional conformal radiation treatment in 1500 patients with prostate cancer at our institution. Major contributions from other institutions and the Radiation Therapy Oncology Group (RTOG) clinical trials group are also noted. Patient immobilization, computed tomography (CT) scan identification of the target in three dimensions and beams-eye-view conformal treatment portals are critical to the process. Higher doses of radiation are associated with a marked increase in cure rates as the dose-response curve is extremely steep. The advantage given by the high dose depending on prognostic group ranges from 14% to 35% in 5-year cures. Conformal techniques protect normal tissues so that late complications are rare and in fact fewer than those observed with standard radiation technique at standard radiation doses. Educational efforts are underway in the USA to assist practising radiation oncologists to deliver the required radiation doses of 75-80 Gy safely. Conformal therapy cures more prostate cancers causing fewer complications than standard treatment technique and standard dose. It must therefore be disseminated into the practice of radiation oncology worldwide.

Dose-Response Relationship, Radiation↗

Failure pattern implications following external beam irradiation of prostate cancer: long-term follow-up and indications of cure.

The purpose of this study was to present patterns and risk of biochemical failure following external beam irradiation of prostate cancer and to make comparisons to a published modern radical prostatectomy series. Between January 1987 and December 1994, 328 men were treated definitively at Fox Chase Cancer Center for localized prostate cancer using conventional or three-dimensional conformal radiotherapy. The median biochemical follow-up was 6.4 years, with all patients having at least 5 years follow-up. Two prognostic patient groups were established on the basis of proportional hazards modeling that considered treatment and presenting tumor characteristics. For each of the two prognostic groups, biochemical failure and hazard functions were estimated using the ASTRO consensus definition of failure and life table methodology. Failure risk comparisons were made to modern published radical prostatectomy series. Multivariate analysis demonstrated the independent predictive power of pretreatment PSA level, palpation stage, Gleason score, and dose. Thus, the favorable prognosis group, Group I, consisted of 83 patients who were treated with a dose level > or = 74 Gy and who presented with PSA levels < 20 ng/ml, T1/T2A tumors, and Gleason score 2-6. Group II consisted of 245 patients with at least one of the following: pretreatment PSA level > or = 20 ng/ml, T2B/T3 tumor, Gleason score 7-10, dose < 74 Gy. The 5- and 8-year bNED estimates were 76% and 76% for Group I, and 51% and 49% for Group II. Only three failures occurred after 5 years, all from Group II, representing 2% of the total failures observed. Hazard function estimates indicate maximum risk of failure at 24 to 36 months, tapering to a low rate at 4 years with no failures observed after 6 years. Differences in patterns of failure by prognostic group show maximum risk of failure at 24 months (median, 31 months) for Group I, and 12 to 36 months (median, 22 months) for Group II. Group II reaches low levels of risk at 6 years, in contrast to 4 years for the patients with a more favorable prognosis. We concluded that patients treated with external beam radiation alone show little risk of failure after 4 to 6 years. This result suggests that the 5-year bNED control rate approximates the eventual cure rate of prostate cancer.

Aged↗

Three-dimensional conformal radiation therapy: what are the costs and benefits?

Increased attention is being focused on the cost of various medical treatments as limited societal resources are recognized. Three-dimensional conformal radiation therapy is a sophisticated technique that allows high doses of radiation to be focused safely on a target. This technique is more expensive to implement and deliver compared with conventional radiation techniques. A consensus, however, is emerging after reviewing the data that shows three-dimensional conformal radiation therapy to be cost-effective when the clinical benefit is most apparent. More data, sophisticated analyses, and follow-up are necessary before more definitive conclusions can be made.

Cost-Benefit Analysis↗

NCCN Practice Guidelines for Prostate Cancer.

Systemic therapies for prostate cancer are likely to improve, and as they do, they will have enormous impact on the treatment of high-risk and locally advanced cancers. Further technical improvements in radiotherapy and alternative local modalities, such as cryoablation, are also likely, and will bring even more options for local control. It is certain these guidelines will continue to evolve.

Evidence-Based Medicine↗

The cost effectiveness of 3D conformal radiation therapy compared with conventional techniques for patients with clinically localized prostate cancer.

BACKGROUND: We previously demonstrated the advantages of three-dimensional conformal radiation therapy (3DCRT) in improved rates of biochemical (bNED) control in certain subsets of patients with clinically localized prostate cancer. However, in this era of cost consciousness and limited resources, the cost effectiveness of 3DCRT compared with conventional external beam irradiation (CRT) remains unexamined. METHODS AND MATERIALS: Between October 1, 1987 and November 30, 1991, 193 patients with clinically localized prostate cancer received definitive external beam irradiation at Fox Chase Cancer Center. The 1998 Medicare fee schedule was used to determine treatment charges and to provide a reference for a national comparison. Complete charges for pretreatment work-up, treatment, and follow-up were tabulated for each patient. The mean total charges (MTC) using the Lin method of estimating medical costs was used to analyze and compare costs between groups. A matched case/control analysis was performed to further evaluate the effect of cost between techniques. The median follow-up was 72 months (range 3-118). RESULTS: The overall 5-year actuarial rate of bNED control was 41% and 53%, respectively, for the CRT and 3DCRT patients (p = 0.03). The MTC for the CRT patients was $10,544.53. For the 3DCRT patients, the MTC was $8,955.48. The sample mean of the total costs from the observed deaths for the two patient groups by follow-up interval ranged from $9,800.63 to $59,635.01 for the CRT patients to $17,259.00 to $24,250.38 for the 3DCRT patients. No statistically significant difference in cost was observed between groups using the matched case/control analysis. CONCLUSION: Initial work-up and treatment costs were greater for patients treated with 3DCRT compared with patients treated with conventional techniques. However, with longer follow-up, the mean total cost of treatment was not statistically different between the two treatment groups. Because of improved rates of bNED control for these patients and the increased costs associated with the treatment of a greater fraction of patients with recurrent disease following CRT, 3DCRT was cost effective for patients with clinically localized prostate cancer.

Aged↗

Outcomes of patients receiving radiation for carcinoma of the rectum. Results of the 1988-1989 patterns of care study.

BACKGROUND: Clinical trials of surgical adjuvant treatment for patients with rectal carcinoma (RC) indicate that postoperative radiation therapy with concurrent chemotherapy (CRT) is superior to postoperative radiation alone (RT) or surgery alone. Whether preoperative treatment is superior to postoperative treatment is controversial. This Patterns of Care Study (PCS) surveyed patients with RC treated with radiation during the years 1988-1989 to determine the national practice standards and outcomes and to compare these results with those of clinical trials. METHODS: A national survey of 73 institutions was conducted using 2-stage cluster sampling, and specific information on 406 patients with RC who received radiation at 69 facilities was collected. Follow-up information on 215 patients was subsequently collected by mail survey. There were no significant differences between the known prognostic indicators or treatment-related variables for patients for whom follow-up was available compared with the variables for patients for whom follow-up was not available. Follow-up ranged from 0 to 8.44 years with a median of 4 years. One hundred fifty-four patients (71%) received postoperative treatment, either RT (37%) or CRT (34%); and 40 (18%) received preoperative treatment, either RT (15%) or CRT (3%). Ninety-six patients (45%) received chemotherapy, and for 86% of those patients chemotherapy was administered concurrently with radiation. RESULTS: Survival was stage-dependent (85% Stage I, 69% Stage II, and 54% Stage III at 5 years, P = 0.04). Survival was also substage-dependent, and patients with C(1) cancer had significantly higher 5-year survival than those with C(2)/C(3) cancer (89% vs. 48%, P = 0.008). Local failure was similar for Stage II and Stage III patients (10% vs. 11% at 5 years, respectively). In multivariate analyses, only stage and use of chemotherapy were significant to survival (Stage III vs. Stage I and II, relative risk [RR] = 2.52, and chemotherapy vs. no chemotherapy, RR = 0.46). A significantly higher 5-year survival rate was seen with postoperative CRT than with postoperative RT (69% vs. 50%, P = 0. 011). Preoperative radiation resulted in a significantly higher 5-year survival rate than postoperative radiation (85% vs. 50%, P = 0.0006), but not compared with postoperative CRT. Survival and local failure did not differ according to radiation therapy interruption or the interval between surgery and radiation. CONCLUSIONS: Stage is an important prognostic indicator for survival, and among patients with Stage III malignancies survival in the substage C(1) is significantly higher than in the substages C(2) and C(3). As has been demonstrated in randomized trials, adjuvant postoperative CRT is superior to postoperative RT for patients with RC in this national study. These nationwide results of adjuvant treatment are comparable to those reported in randomized trials. The use of CRT was the only treatment-related factor that resulted in a significant reduction in the risk of death.

Adenocarcinoma↗

The evaluation and treatment of patients receiving radiation therapy for carcinoma of the esophagus: results of the 1992-1994 Patterns of Care Study.

BACKGROUND: For the first time, a Patterns of Care Study (PCS) was conducted in 1992-1994 to determine the national practice standards in evaluating and treating patients with esophageal carcinoma and to determine the degree to which clinical trials have been incorporated into national practice. METHODS: A national survey of 61 institutions using 2-stage cluster sampling was conducted, and specific information was collected on 400 patients with squamous cell carcinoma or adenocarcinoma of the thoracic esophagus who received radiation therapy (RT) as part of definitive or adjuvant management of their disease. Patients were staged according to a modified 1983 American Joint Committee on Cancer staging system. Chi-square tests for significant differences between academic and nonacademic institutions for a particular variable were performed. RESULTS: The median age of patients was 66.7 years (range, 26-89 years); 76.5% were male and 23.5% were female. Karnofsky performance status was > or = 80 for 88.3% of patients. Squamous cell carcinoma was diagnosed in 61.5% and adenocarcinoma in 36.8%. Fifteen percent were Clinical Stage (CS) I, 39.5% CS II, and 29.5% CS III. Evaluative procedures included endoscopy (>93%), computed tomography (CT) of the chest (86%), CT of the abdomen (75%), esophagography (68.5%), and endoscopic ultrasound (3.5%). Endoscopic ultrasound and CT of the chest were performed significantly more frequently at academic than nonacademic facilities (6.1% vs. 1.0% and 91.9% vs. 81.3%, respectively). Three-quarters of all patients received chemotherapy and RT and 62.5% received concurrent chemotherapy and RT as part of their treatment. Treatments included chemotherapy plus RT (54.0%), RT alone (20.3%), preoperative chemotherapy + RT (13.3%), postoperative chemotherapy + RT (7.7%), postoperative RT (3.5%), and preoperative RT (1.2%). The chemotherapeutic agents most frequently used were 5-fluorouracil (84%), cisplatin (64%), and mitomycin (9%); academic instututions used cisplatin significantly more often and mitomycin significantly less often than nonacademic institutions. Brachytherapy was used in 8.5% of cases. The median total dose of external beam radiation was 50.4 gray and the median dose per fraction was 1.8 gray. CONCLUSIONS: This study establishes the national benchmarks for the evaluation and treatment of patients with esophageal carcinoma at radiation facilities in the U.S. It also indicates that the majority of patients given RT as a component of treatment for esophageal carcinoma receive chemoradiation rather than RT alone, as supported by clinical trials. Although some differences in the evaluation of esophageal carcinoma were noted between academic and nonacademic facilities, there was no difference in the frequency of use of chemoradiation versus RT by facility type.

Adenocarcinoma↗