Camelina meal and crude glycerin as feed supplements for developing replacement beef heifers.

Angus × Gelbvieh rotationally crossbred yearling heifers (n = 99, yr 1; n = 105, yr 2) were used in a 2-yr randomized complete block design experiment with repeated measures to determine the effect of feeding camelina biodiesel coproducts (meal and crude glycerin) on serum concentrations of triiodothyronine, thyroxine, insulin, ß-hydroxybutyrate, and glucose, as well as on growth and reproductive performance. Heifers were assigned to 1 of 15 pens, and pens were assigned initially to receive 7.03 k·â€¢heifer(-1)·d(-1) of bromegrass hay plus 0.95 kg·heifer(-1)·d(-1) of 1 of 3 supplements for 60 d before breeding: 1) control (50% ground corn and 50% soybean meal, as-fed basis); 2) mechanically extracted camelina meal; or 3) crude glycerin (50% soybean meal, 33% ground corn, 15% crude glycerin, 2% corn gluten meal; as-fed basis). Preprandial blood samples were collected via the jugular vein on d 0, 30, and 60 of the feeding period. A 2-injection PGF(2α) protocol (d 60 and 70 of the study) was used to synchronize estrus. Heifers were artificially inseminated 12 h after estrus was first detected. Heifers not detected in estrus within 66 h received a GnRH injection and were artificially inseminated. Dietary treatment × sampling period interactions were not detected (P = 0.17 to 0.87). Dietary treatment did not affect BW (P = 0.44 to 0.59) or serum concentrations of thyroxine (P = 0.96), ß-hydroxybutyrate (P = 0.46), glucose (P = 0.59), or insulin (P = 0.44). Serum concentrations of triiodothyronine were greater (P = 0.05) in heifers fed camelina meal. Additionally, dietary treatment did not affect the percentage of heifers detected in estrus before timed AI (P = 0.83), first-service pregnancy rates of those heifers detected in estrus (P = 0.97), or overall first-service pregnancy rates (P = 0.58). Heifers fed camelina meal, however, had greater (P = 0.05) first-service pregnancy rates to timed AI than did heifers fed the control and crude glycerin supplements. The cost per pregnancy was similar for heifers fed the crude glycerin or the control supplement, whereas the cost per pregnancy was the least for heifers fed camelina meal. We conclude that camelina coproducts can replace conventional corn-soybean meal supplements in the diets of developing replacement beef heifers.

Dimethylether treatment for condyloma acuminata in women.

OBJECTIVE: Our aim was to test a new cryosurgical wart treatment, dimethylether (Histofreezer), for clinical effi-cacy in newly diagnosed cases of genital warts. METHODS: All patients of the gynecology clinic of a teaching hospital who were at least 12 years of age and who had between one and eight external genital warts were eligible. Treatment occurred at the initial visit and at follow-up visits at 2, 4, 6, and 8 weeks. If all warts were gone at any particular visit, the patient had completed the study and was not required to return. RESULTS: In 14 of 15 patients [93%; 95% confidence interval (Cl), 81-100%], all warts resolved within the 8-week study period. This included 39 of 44 warts (89%; 95% Cl 80-98%). Most warts [35 of 44 (80%)] resolved within 4 weeks. One patient with five warts failed treatment. No known complications were seen. Condusion. Dimethylether (Histofreezer) is an effective cryosurgical treatment for genital warts.

Laparoscopic herniorrhaphy versus traditional open repair at a community hospital.

Over a 2-year period 157 inguinal hernias in 151 patients were consecutively entered in this descriptive, observational study to determine any difference in outcome between a laparoscopic inguinal hernia repair versus an open inguinal hernia repair in a community hospital setting. The laparoscopic transabdominal preperitoneal technique was utilized in 50 cases. A conventional open repair was used in 107 cases. There were statistically significant differences when the laparoscopic and open groups were compared for the number of days until driving a car (p < 0.01), the number of days until getting in and out of bed comfortably (p = 0.01), the number of days until working on a limited basis (p = 0.01), and the number of days until working on a full-time basis (p < 0.05), although these differences may be due to confounding factors in this nonrandomized study. The average length of operating time was 72.2 min laparoscopic versus 51.6 min open (p < 0.001). We have shown that laparoscopic inguinal hernia repairs may have benefits over conventional hernia repairs. This may make its use more widespread than it has already become.

Predicting discharge destination of stroke patients using a mathematical model based on six items from the Functional Independence Measure.

OBJECTIVE: A mathematical model using selected items from the Functional Independence Measure (FIM) was developed to predict disposition of stroke patients from an acute care hospital. DESIGN: Case series of 279 acute stroke patients admitted to the hospital from 4/91 through 12/93. Data collection remains ongoing; a second series of patients will be analyzed to validate results and determine if the same 6 FIM items are significant. SETTING: Tertiary care center, general acute care community hospital. PATIENTS: Diagnosis of acute stroke; 298 patients whose attending physician referred the patient to the rehabilitation team. An 18-item FIM was administered within 3 days of admission and 24 hours of discharge. MAIN OUTCOME MEASURE: FIM scores were analyzed to determine if the initial score could be used to predict disposition. Discriminant analysis identified 6 items as being statistically significant in predicting discharge to home, rehabilitation facility, or nursing home. Patient's actual discharge location was compared with the location predicted by the model developed using the FIM. RESULTS: Bathing, bowel, toileting, social interaction, dressing lower body, and eating were the selected initial FIM items that predicted disposition with 70% accuracy in our patient series. CONCLUSION: The FIM is effective in the acute care setting to help determine appropriate discharge status, with certain variables being more predictive than others.

Influence of a sampling review process for radiation oncology quality assurance in cooperative group clinical trials--results of the Radiation Therapy Oncology Group (RTOG) analysis.

The Radiation Therapy Oncology Group (RTOG) designed a random sampling process and observed its influence upon radiotherapy review mechanisms in cooperative group clinical trials. The method of sampling cases for review was modeled from sampling techniques commonly used in pharmaceutical quality assurance programs, and applied to the initial (on-study) review of protocol cases. 'In control' (IC) status is defined for a given facility as the ability to meet minimum compliance standards. Upon achieving IC status, activation of the sampling process was linked to the rate of continued patient accrual for each participating institution in a given protocol. The sampling design specified that > or = 30% cases not in compliance would be detected with 80% power. A total of 458 cases was analyzed for initial review findings in four RTOG Phase III protocols. Initial review findings were compared with retrospective (final) review results. Of the 458 cases analyzed, 370 underwent initial review at on-study, while 88 did not require review as they were enrolled from institutions that had demonstrated protocol compliance. In the group that had both initial and final review, 345/370 (93%) were found to have followed the protocol or had a minor variation. Of the exempted cases, 79/88 (90%) were found to be per protocol or a minor variant. The sampling process proved itself to be cost-effective and resulted in a noticeable reduction in the workload, thus providing an improved approach to resource allocation for the group. Continued evaluation of the sampling mechanism is appropriate as study designs and participants vary over time, and as more data become available to study.(ABSTRACT TRUNCATED AT 250 WORDS)

Androgen deprivation with radiation therapy compared with radiation therapy alone for locally advanced prostatic carcinoma: a randomized comparative trial of the Radiation Therapy Oncology Group.

OBJECTIVES: Androgen deprivation therapy before and during radiation therapy could, by reducing tumor volume, increase local tumor control, disease-free survival, and overall survival in patients with locally advanced adenocarcinomas of the prostate. METHODS: In a randomized controlled clinical trial, patients with large T2, T3, and T4 prostate tumors, but no evidence of osseous metastasis, were randomized to receive goserelin 3.6 mg subcutaneously every 4 weeks and flutamide 250 mg orally three times daily 2 months before and during the radiation therapy course (Arm I) compared with radiation therapy alone (Arm II). Pelvic irradiation was administered with 1.8 to 2.0 Gy per day to a total dose of 45 +/- 1 Gy followed by a boost to the prostate target volume to a total dose of 65 to 70 Gy. RESULTS: Of 471 randomized patients, 456 were evaluable, 226 on Arm I and 230 on Arm II. With a median potential follow-up of 4.5 years, the cumulative incidence of local progression at 5 years was 46% in Arm I and 71% in Arm II (P < 0.001). The 5-year incidence of distant metastasis on Arms I and II was 34% and 41%, respectively (P = 0.09). Progression-free survival rates including normal prostate-specific antigen (PSA) levels for 396 patients with at least one PSA recorded were 36% in Arm I and 15% in Arm II at 5 years (P < 0.001). At this time, no significant difference in overall survival could be detected (P = 0.7). CONCLUSIONS: Short-term androgen deprivation with radiation therapy results in a marked increase in local control and disease-free survival compared with pelvic irradiation alone in patients with locally advanced carcinoma of the prostate. Long-term surveillance is required to assess effects on overall survival.

Patterns of Care and RTOG studies in prostate cancer: long-term survival, hazard rate observations, and possibilities of cure.

PURPOSE: This study was undertaken to show the long-term survival and probability of cure of prostate cancer patients treated with external beam radiation in USA national surveys and in the prospective clinical trials of the RTOG. METHODS AND MATERIALS: Two national patterns of care surveys of patients treated in 1973 and 1978 are reported along with two RTOG prospective trials (7506 and 7706). Hazard rates represent the risk of death and are compared to the rate expected for a normal population. RESULTS: For patients with Stage A cancers, the survival is not different from the expected survival for any of the reported surveys. The hazard rate for death does not significantly exceed the expected hazard rate out to 15 years. For patients with Stage B cancer, there is a decrease in survival below expected and hazard rates show a continuing excess mortality as long as 15 years after treatment. For patients with Stage C cancers, there is a more rapid decrease in survival that then becomes parallel to the expected survival. Hazard rates indicate there has been a return to expected mortality at 15 years. CONCLUSION: These data make a strong argument for the long-term cure of prostate cancer by external beam radiation, and support the continued use and study of radiation therapy as a curative modality in prostate cancer. No similar national data is available for any other method of management.

Neutron vs. photon radiation therapy for inoperable regional non-small cell lung cancer: results of a multicenter randomized trial.

PURPOSE: To determine, with a prospective, multicenter randomized study, whether fast neutron radiation therapy improves the outcome for patients with non-small cell lung cancer, as compared to conventional photon radiotherapy. METHODS AND MATERIALS: From September 1986 to March 1991, a total of 200 patients with inoperable regional non-small cell lung cancer were randomized to 20.4 Gy in 12 fractions with neutrons versus 66 Gy in 33 fractions with photons. Inoperable patients with Radiation Therapy Oncology Group Stages I, II, III, or IV(M0) disease, Karnofsky Performance Score > or = 70, and who had received no previous therapy for their non-small cell lung cancer were eligible for the study. Of the 200 patients randomized, a total of 193 patients, 99 on the neutron arm and 94 on the photon arm, were eligible for analysis. The two treatment groups were balanced with regards to prognostic factors. At the time of this analysis, the median at-risk follow-up was 33 months, with a minimum follow-up of 16 months. RESULTS: No difference in overall survival was observed; however, there was a statistically significant improvement in survival for patients with squamous cell histology (p = 0.02), and a trend toward improved survival for those with favorable prognostic factors (i.e., patients who were not T4, N3, and had no pleural effusion or weight loss > 5% from baseline) (p = 0.15), favoring the neutron-treated group. With the exception of skin and subcutaneous changes, acute and late toxicity was similar in both arms. CONCLUSION: In selected patients with inoperable regional non-small cell lung cancer (e.g., squamous cell histology, favorable prognostic factors), fast neutron irradiation provides a therapeutic benefit over conventional photon radiotherapy.

Neutron versus photon irradiation for unresectable salivary gland tumors: final report of an RTOG-MRC randomized clinical trial. Radiation Therapy Oncology Group. Medical Research Council.

PURPOSE: To compare the efficacy of fast neutron radiotherapy versus conventional photon and/or electron radiotherapy for unresectable, malignant salivary gland tumors a randomized clinical trial comparing was sponsored by the Radiation Therapy Oncology Group in the United States and the Medical Research Council in Great Britain. METHODS AND MATERIALS: Eligibility criteria included either inoperable primary or recurrent major or minor salivary gland tumors. Patients were stratified by surgical status (primary vs. recurrent), tumor size (less than or greater than 5 cm), and histology (squamous or malignant mixed versus other). After a total of 32 patients were entered onto this study, it appeared that the group receiving fast neutron radiotherapy had a significantly improved local/regional control rate and also a borderline improvement in survival and the study was stopped earlier than planned for ethical reasons. Twenty-five patients were study-eligible and analyzable. RESULTS: Ten-year follow-up data for this study is presented. On an actuarial basis, there continues to be a statistically-significant p = 0.009) but there is no improvement in overall survival (15% vs. 25%, p = n.s.). Patterns of failure are analyzed and it is shown that distant metastases account for the majority of failures on the neutron arm and local/regional failures account for the majority of failures on the photon arm. Long-term, treatment-related morbidity is analyzed and while the incidence of morbidity graded "severe" was greater on the neutron arm, there was no significant difference in "life-threatening" complications. This work is placed in the context of other series of malignant salivary gland tumors treated with definitive radiotherapy. CONCLUSIONS: Fast neutron radiotherapy appears to be the treatment-of-choice for patients with inoperable primary of recurrent malignant salivary gland tumors.

Fast neutron radiotherapy for locally advanced prostate cancer. Final report of Radiation Therapy Oncology Group randomized clinical trial.

Between June 1977 and April 1983 the Radiation Therapy Oncology Group (RTOG) sponsored a Phase III randomized trial investigating the use of fast neutron radiotherapy for patients with locally advanced (Stages C and D1) adenocarcinoma of the prostate gland. Patients were randomized to receive either conventional photon radiation or fast neutron radiation used in a mixed-beam (neutron/photon) treatment schedule. A total of 91 analyzable patients were entered into the study, and the two patient groups were balanced with respect to the major prognostic variables. Actuarial curves are presented for local/regional control and "overall" survival. Ten-year results for clinically assessed local control are 70% for the mixed-beam group versus 58% for the photon group (p = 0.03) and for survival are 46% for the mixed-beam group versus 29% for the photon group (p = 0.04). This study suggests that a regional method of treatment can influence both local tumor control and survival in patients with locally advanced adenocarcinoma of the prostate gland.

Surgical complications of intraoperative radiation therapy: the Radiation Therapy Oncology Group experience.

Intraoperative radiotherapy (IORT) is being used with increasing frequency in many institutions in the United States but little is known about the surgical complication rates. The Radiation Therapy Oncology Group initiated three prospective studies in IORT in 1986 and we report here the experience in advanced malignancies of the stomach, pancreas, and rectum. The incidence and nature of major surgical complications were reviewed and presented with their implications in regard to future IORT trials. Two hundred twenty-seven patients were entered on three studies by 20 participating institutions between 1985 and 1989. One hundred twenty-nine patients received IORT while 98 patients were found to have too advanced disease to be benefited by IORT and underwent palliative surgical procedures only. IORT doses ranged from 12-22 Gy and bowel anastomoses were not irradiated. Wound infection in the IORT group was 6% vs. 2% in the non-IORT patients but this was not significant at the P = 0.05 level. Other complications included anastomotic leak (n = 5), operative bleeding (n = 10), pancreatitis (n = 2), and were not statistically different in the IORT and non-IORT groups. The mortality rate for the IORT and non-IORT groups combined was 1.8%. This large multi-institutional experience in patients with advanced malignancy demonstrates that patients receiving IORT do not have a higher surgical complication rate than those not receiving IORT. Long-term survival data await the implementation of Phase III trials in advanced intra-abdominal malignancy.

Comparison of pathologic and clinical evaluation of lymph nodes in prostate cancer: implications of RTOG data for patient management and trial design and stratification.

RTOG 77-06 and 75-06 were studies of nodal irradiation in prostate cancer, for which the status of nodes was determined by lymph node dissection (LND), lymphangiography (LAG), or computer assisted tomography (CT) based on investigator preference. Actuarial 5 year endpoints of survival, NED survival, local recurrence and distant metastasis have been determined by stage for 805 eligible patients with a comparison of pathologic vs clinical (imaging test) determined nodal status. Patients with pathologically negative lymph nodes show significantly improved 5 year survival (Stage T-2 (B) 84% vs 77%, Stage T-3,4 (C) 82% vs 65%) and NED survival (Stage T-2 (B) 72% vs 63%, Stage T-3,4 (C) 64% vs 44%) compared to patients clinically negative. Free of metastasis rates are increased in Stage T-3,4 (C) pathologic negative patients compared to imaging negative patients (75% vs 60%). A comparison of clinical positive versus clinical negative patients shows no difference in survival, NED survival or rate of metastasis, while a similar comparison of pathologic positive versus pathologic negative shows significant difference for all three endpoints (survival: Stage T-2 (B) 84% vs 61%, Stage T-3,4 (C) 82% vs 66%, NED survival: Stage T-2 (B) 72% vs 32%, Stage T-3,4 (C) 64% vs 32%; free of metastasis: Stage T-2 (B) 82% vs 64%, Stage T-3,4 (C) 75% vs 44%). The clinical determination of nodal status, therefore, has no prognostic value in contrast to pathologic determination and should not be used for stratifying patients in clinical trials. The CT scans often used to evaluate nodal status are more useful if delayed until they can be done as part of the treatment planning process where the CT has value. When imaging tests suggest positive lymph nodes in prostate cancer patients, the imaging finding is confirmed by biopsy.

Intraoperative radiation therapy of pancreatic carcinoma: a report of RTOG-8505. Radiation Therapy Oncology Group.

The Radiation Therapy Oncology Group in 1985 began a study of IORT plus external beam radiation therapy for patients with locally unresected, non-metastatic pancreatic cancer. Patients were treated with a combination of 2000 cGy of IORT and postoperative external beam radiation therapy to 5040 cGy in combination with IV 5-FU (500 mg/m2/day on the first 3 days of the external beam treatment). As patients were registered on study prior to exploration, it was expected that a number of patients would be excluded from further analysis at the time of surgery. Eighty-six patients were entered on study through 6/1/88 and analyzed through 4/90. Fifty-one patients were fully analyzable. Median survival time of the 51 patients was 9 months with an 18-month actuarial survival rate of 9%. Local control could not be adequately evaluated in this multi-institutional study. Major postoperative complications were not excessive and occurred in 12% of patients. Two patients had major late morbidity leading to death, one from duodenal bleeding and the second from biliary obstruction. Although this study does demonstrate the feasibility of IORT in a multi-institutional setting, it does not demonstrate any advantage of IORT over conventional therapy for this disease.

Outcome for lymph node dissection negative T-1b, T-2 (A-2,B) prostate cancer treated with external beam radiation therapy in RTOG 77-06.

One hundred four patients with stage T-1b, T-2 N-O M-O prostate cancer were treated with external beam irradiation as part of RTOG 77-06. Lymph nodes were negative by lymph node dissection in 16 patients with T-1b and 88 patients with T-2 cancers. Survival exceeds age matched expected survival for the 10 years of observation (63% vs 59% at 10 years). Patterns of failure at 10 years show 87% of patients were free of isolated local recurrence, 79% free of metastatic failure, 67% free of any failure, and cause specific survival shows 86% free of cancer death at 10 years. The outcome of this group is equal or superior to reports of radical prostatectomy in similar stage patients.

The effect of overall treatment time on the outcome of definitive radiotherapy for localized prostate carcinoma: the Radiation Therapy Oncology Group 75-06 and 77-06 experience.

From 1976 to 1983, 1091 patients were entered into RTOG protocols 75-06 and 77-06. Of these, 780 patients complied with protocol requirements, received a minimum tumor dose of greater than or equal to 6500 cGy, and received no endocrine therapy. There were 78, 342, and 360 patients with localized prostate carcinoma, Stages T1b(A2), T2(B), and T3,4(C), respectively. The potential follow-up period ranges from 6 years 5 months to 13 years 3 months, with a median follow-up of 9 years. This study examines the influence of overall treatment time on the outcome of definitive radiotherapy for localized prostate carcinoma in this patient population. Within each stage, patients were divided into three groups according to the total number of elapsed days while on treatment: within 49 days (less than or equal to 7 weeks); 50 to 63 days (8 to 9 weeks); and greater than or equal to 64 days (greater than 9 weeks). Based on actuarial analysis, within each stage, the overall treatment time did not have any impact on the following: overall survival, NED survival, or local/regional control. When grouped under different histologic grades, that is, Gleason scores 2-5, 6-7, and 8-10, the actuarial local/regional control showed no statistical difference among the three groups. The actual local/regional failures were analyzed and stratified by stage and Gleason scores, and no statistical difference was noted among the three groups for each stratification. The range of local/regional failure rates among the three groups for T1b(A2), T2(B), and T3,4(C) disease were 0%-8%, 16%-23%, and 24%-27%, respectively. The corresponding range of local/regional failure rates for patients with Gleason scores of 2-5, 6-7, and 8-10 were 13%-14%, 18%-22%, and 22%-33%, respectively. The incidence of late complications was not related to the number of elapsed treatment days. Therefore, the overall treatment time does not have an impact on the outcome of definitive radiotherapy for localized prostate carcinoma. It is hypothesized that prostate carcinoma behaves as late-reacting tissue in which there is little, if any, accelerated repopulation of clonogenic tumor cells during the later half of a protracted course of radiotherapy. This observation is in direct contrast to that suggested for head and neck carcinoma and bears important implications in daily radiotherapeutic management of patients with prostate carcinoma.

Improvements observed in care and outcome in carcinoma of the larynx.

The 1978 Patterns of Care Studies (PCS) survey of carcinoma of the larynx reviewed the process (pre-treatment evaluation and treatment) and outcome of 521 patients. When compared to results from the 1973 PCS survey, several important changes have been observed. The use of surgery in conjunction with radiation therapy (RT) increased in Stage III cases from less than 30% to greater than 60% and in Stage IV cases from 48% to greater than 70%. This change in therapy was associated with a decline in locoregional failure in this patient group. Among Stage I and II supra- and subglottic carcinomas, an improvement in 3-year local tumor control (Stage I: 78 to 100% and Stage II: 54 to 74%) and overall freedom from recurrence (Stage I: 78 to 100% and Stage II: 45 to 73%) was seen over this 5-year period with no identifiable change in process for this subgroup. Also noted was an improvement in the freedom from recurrence rate for Stage III and IV patients receiving treatment at facilities with low process scores. The 1978 PCS survey confirmed the presence of superior patient outcome in several subgroups and the relationship of this improvement to patient process.

Comparison of 1 vs 2 or more intracavitary brachytherapy applications in the management of carcinoma of the cervix, with irradiation alone.

Four hundred ninety-eight patients treated in the USA in 1978 for cancer of the cervix by external beam and intracavitary irradiation have been studied to determine the effect of using a single intracavitary (IC) application versus more than one. Most of the patients (46%) underwent intracavitary (IC) treatment after external radiation therapy (RT), 40% during external RT, and 14% prior to external RT. Five-year actuarial survival for all stages was 66% for greater than or equal to 2 applications versus 59% for 1 application, p less than .01. When survival was analyzed by stage, there was a trend toward improved survival with greater than or equal to 2 applications in Stage II (p .10). The rate of infield recurrence for all stages was higher in the 1 IC group (30% vs 17%, p less than .01). These were more frequent in the 1 IC group (53% vs 34%, p less than .05), in Stage III patients, but no significant difference was noted in the other stages. Distant metastases were more frequent in the 1 IC group (19% vs 11%, p .01). The incidence of major complications was the same in both groups. An analysis of patient characteristics and other variables that would explain the difference in results revealed that older patients (p .03), worse Karnofsky (p .056), and more parametrial involvement (p less than .01) accrued more in the 1 IC group. Higher paracentral point doses were administered when greater than or equal to 2 IC applications were used (p less than 0.01); this group also received higher bladder and rectal doses and lower whole pelvic doses. The use of two or more intracavitary insertions affords an opportunity to administer higher paracentral point doses, which appear to be related to higher pelvic tumor control, lower rate of distant metastasis, and better survival.

Phase II Radiation Therapy Oncology Group study of hormonal cytoreduction with flutamide and Zoladex in locally advanced carcinoma of the prostate treated with definitive radiotherapy.

In patients with locally advanced (bulky) carcinoma of the prostate, definitive radiotherapy is associated with a high rate of local recurrence. The Radiation Therapy Oncology Group (RTOG) has conducted several studies evaluating hormonal cytoreduction (used as an induction regimen) as a means of improving the local control rate. RTOG 85-19 tested an induction regimen consisting of a depot LH-RH agonist (Zoladex) and an antiandrogen (flutamide). Eligible patients were those with bulky primary lesions (stage B2 and C) with disease confined to the pelvis. Zoladex was administered every 29 days via a subcutaneous injection. Flutamide was given by mouth in a dose of 250 mg t.i.d. Administration of the drugs was initiated 2 months prior to start of radiotherapy and was terminated at completion of the radiotherapy course. Radiotherapy consisted of 180-200 rad/day, 4,400-4,500 rad to the regional lymphatics, and 6,500-7,000 rad to the prostate. The primary aim of the study was to evaluate the effectiveness and toxicity of the combined (hormonal cytoreduction plus definitive radiotherapy) regimen. Thirty-one patients were accessioned; 30 are analyzable. The drug-related toxicity appears acceptable. It included appearance of diarrhea before initiation of radiotherapy in two patients, nausea during the 2nd week of drug administration in two patients, and skin rash in three patients. These phenomena appear to be related to flutamide. Hot flashes were recorded in 17 patients. With a minimum follow-up of 2 years, clearance of the primary lesions (by clinical examination) was documented in 28 of 30 patients. During the 1st year, two of 30 patients died (of unrelated causes) with residual palpable tumors. The observed toxicity appears acceptable and the response rate encouraging. A phase III study comparing the tested regimen against radiotherapy alone appears warranted.

Fast neutron radiotherapy in the treatment of locally advanced adenocarcinoma of the prostate. Clinical experience and future directions.

The major clinical experiences using fast neutrons for the treatment of locally advanced prostatic carcinomas are reviewed. In all trials to date, there is evidence that treatment regimens employing a component of fast neutrons achieve results that equal or surpass those obtainable with conventional megavoltage external beam irradiation for comparable groups of patients. Late complications of neutron treatment have not exceeded the complication rate expected by photon irradiation. The structure of the current Radiation Therapy Oncology Group phase III randomized trial comparing neutron and photon treatment of patients with stages B2, C, and D1 disease is discussed.

Fast neutron radiotherapy for locally advanced prostate cancer. Update of a past trial and future research directions.

Between June, 1977, and April, 1983, the Radiation Therapy Oncology Group (RTOG) sponsored a phase III study comparing fast neutron radiotherapy as part of a mixed beam (neutron/photon) regimen with conventional photon (x-ray) radiotherapy for patients with locally advanced (Stages C and D1) adenocarcinoma of the prostate. A total of 91 analyzable patients were entered into the study with the two treatment groups balanced in regard to all major prognostic variables. The current analysis is for a median follow-up of 6.7 years (range 3.4-9.0 yrs.). The results are statistically significant in favor of the mixed-beam group of all parameters mentioned. At five years the freedom from local/regional relapse rate is 81 percent on the mixed-beam arm compared with 60 percent on the photon arm. The actuarial overall survival rate at five years is 70 percent on the mixed beam compared with 56 percent on the conventional photon arm. The determinantal survival at five years (which excluded death due to intercurrent disease in patients clinically free of cancer) was 82 percent on the mixed-beam arm compared with 61 percent on the photon arm. The type of therapy appeared to be the most important predictor of both local tumor control and patient survival in a step-wise Cox analysis. There was no difference in the treatment-related morbidity for the two patient groups. Mixed-beam therapy may be superior to standard photon radiotherapy for treatment of locally advanced prostate cancer.