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W T Sause

Publications and source records attributed to W T Sause.

At least 37 records · Page 2Linked to original sources
PubMed1997

Androgen suppression plus radiation versus radiation alone for patients with D1 (pN+) adenocarcinoma of the prostate (results based on a national prospective randomized trial, RTOG 85-31). Radiation Therapy Oncology Group.

PURPOSE: To evaluate the effect of immediate androgen suppression in conjunction with standard external beam irradiation vs. radiation alone on a group of pathologically staged lymph node-positive patients with adenocarcinoma of the prostate. METHODS AND MATERIALS: A national prospective randomized trial (RTOG 85-31) of standard external beam irradiation plus immediate androgen suppression vs. external beam irradiation alone was initiated in 1985 for patients with locally advanced adenocarcinoma of the prostate. One hundred seventy-three of the patients in this trial had biopsy-proven pathologically involved lymph nodes. Ninety-eight of these patients received radiation plus the immediate androgen suppression (LHRH agonist), while 75 received radiation alone with hormonal manipulation instituted at the time of relapse. RESULTS: With a median followup of 4.9 years, estimated progression-free survival with PSA < 1.5 ng/ml at 5 years was 55% for the patients who received radiation plus immediate LHRH agonist vs. 11% of the patients who received radiation alone with hormonal manipulation at relapse (p = 0.0001). Because all of these patients had locally advanced disease (i.e., pathologically positive lymph nodes), stage does not explain this difference in outcome, and Gleason grade was not statistically different between the two groups. Estimated absolute survival at 5 years for the radiation and LHRH group was 73 vs. 65% for the radiation alone group who received androgen suppression at relapse. Estimated disease-specific survival at 5 years was 82% for the radiation and immediate LHRH agonist group and 77% for the radiation-alone group. CONCLUSION: Patients with adenocarcinoma of the prostate and pathologically involved pelvic lymph nodes (pN+ or clinical stage D1) should be seriously considered for external beam irradiation plus immediate hormonal manipulation over radiation alone with hormonal manipulation at the time of relapse.

Adenocarcinoma↗
PubMed1997

Recursive partitioning analysis of 1592 patients on four Radiation Therapy Oncology Group studies in inoperable non-small cell lung cancer.

Survival outcome of 1592 analyzable patients on four Radiation Therapy Oncology Group (RTOG) studies in inoperable non-small cell lung cancer were studied utilizing a recursive partitioning analysis (RPA). This approach creates a regression tree according to prognostic variables which partitions into homogenous subsets according to survival. Four protocols, RTOG 83-11, 83-21, 84-03 and 84-07 were analyzed. 83-11 and 84-07 were studies utilizing irradiation with alterfractionation; 83-21 and 84-03 were studies evaluating thymocin with irradiation and prophylactic cranial irradiation with thoracic irradiation respectively. Nine pretreatment variables and one treatment variable were analyzed. Adjustment for radiotherapy effect was made in the accelerated treatment protocol (84-07). Overall, median survival for the entire group was 9.0 months with 17% alive at 2 years. Univariate analysis suggests that KPS, < or = 70 vs. 80-100, pleural effusion, weight loss, < or = 5% vs. 5%, age, 60+ vs. < 60, T stage (T1 and T2 vs. T3 and T4) and N stage (N- vs. N+) were important prognastic factors. Radiation dose, sex, race and histology were not univariate prognastic factors. RPA identified KPS as the most significant covariate (median survival 5.9 mos. < or = 70 vs. 9.9 mos. 80-100). Within KPS 80-100 other splits occurred for N stage, age, weight loss and radiation therapy dose. KPS < or = 70 split at pleural effusion only. The best overall RPA tree has four distinct classes with median survival times ranging from 3.3 to 12.6 months. The RPA classes were validated in an independent non-small cell lung cancer dataset. This analysis may allow more intelligent stratification and study-design for future RTOG trials in inoperable non-small cell lung cancer.

Aged↗
PubMed1995

Correlation of survival with quantitative tissue staining of prostate specific acid phosphatase in patients with prostate carcinoma by using microscopic image analysis: a preliminary report of correlative studies on RTOG protocols 75-06, 77-06, and 83-07.

PURPOSE: We have previously shown that the intensity (graded semiquantitatively as 1-4+) of tissue prostate-specific acid phosphatase (PSAP) staining determined immunocytochemically in a cohort of prostate carcinoma patients from Radiation Therapy Oncology Group Protocols (RTOG) protocols 75-06 and 77-06 correlated with survival. The extent of this staining was heterogeneous and was estimated. The extent of staining was not found to be significantly associated with survival. We undertook the present quantitative study to see if the improved precision and reliability of measurement of the intensity and extent of prostate specific acid phosphatase staining would confirm and extend our previous observations. METHODS AND MATERIALS: Patient cohorts representative of the entire group were obtained from RTOG 75-06 plus 77-06 and 83-07. The RTOG 77-06 plus 75-06 patients (No-Hormone population) did not receive preradiation hormonal therapy. RTOG 83-07 patients (Prehormone population) received one of two types of preradiation chemical androgen ablation. In this study, histologic slides of tumors were immunocytochemically stained for PSAP by the peroxidase-antiperoxidase (PAP) technique using diaminobenezidene (DAB) as a substrate and hematoxylin as a nuclear counterstain. The intensity and extent of immunocytochemical PSAP staining (IPSAP stain) was quantified using our dual wavelength and batch mode image process technique. RESULTS: Our study of 151 cases confirmed that overall survival of patients in both populations was positively correlated with the intensity and extent of IPSAP stain. Results of the two studies were similar. The statistical significance of the relationship of both extent and intensity was greater in the cohort from protocol 83-07, which was the patient group receiving pretreatment with hormones. In a Cox multiple regression analysis including clinical stage, Gleason and M. D. Anderson grades, and the cohort of patients (Prehormone or No-Hormone group) as covariables, both the intensity and extent of the IPSAP stain significantly correlated with survival along with M. D. Anderson grade of the tumor. CONCLUSION: Quantitative image analysis of the IPSAP stain predicts survival in patients treated with external beam radiotherapy with and without prior hormonal therapy.

Acid Phosphatase↗
PubMed1995

Radiation Therapy Oncology Group (RTOG) 88-08 and Eastern Cooperative Oncology Group (ECOG) 4588: preliminary results of a phase III trial in regionally advanced, unresectable non-small-cell lung cancer.

BACKGROUND: Regionally advanced, surgically unresectable non-small-cell lung cancer represents a disease with an extremely poor prognosis. External-beam irradiation to the primary tumor and regional lymphatics is generally accepted as standard therapy. The use of more aggressive radiation regimens and the addition of cytotoxic chemotherapy to radiotherapy have yielded conflicting results. Recently, however, results from clinical trials using innovative irradiation delivery techniques or chemotherapy before irradiation have indicated that patients treated with protocols that incorporate these modifications may have higher survival rates than patients receiving standard radiation therapy. PURPOSE: On the basis of these results, the Radiation Therapy Oncology Group (RTOG)-Eastern Cooperative Oncology Group (ECOG) elected to conduct a phase III trial comparing the following regimens: 1) standard radiation therapy, 2) induction chemotherapy followed by standard radiation therapy, and 3) twice-daily radiation therapy. METHODS: Patients with surgically unresectable stage II, IIIA, or IIIB non-small-cell lung cancer were potential candidates. Staging was nonsurgical. Patients were required to have a Karnofsky performance status of 70 or more and weight loss less than 5% for 3 months prior to entry into the trial, to be older than 18 years of age, and to have no metastatic disease. Of the 490 patients registered in the trial, 452 were eligible. The disease in 95% of the patients was stage IIIA or IIIB. More than two thirds of the patients had a Karnofsky performance status of more than 80. Patients were randomly assigned to receive either 60 Gy of radiation therapy delivered at 2 Gy per fraction, 5 days a week, over a 6-week period (standard radiation therapy); induction chemotherapy consisting of cisplatin (100 mg/m2) on days 1 and 29 and 5 mg/m2 vinblastine per week for 5 consecutive weeks beginning on day 1 with cisplatin, followed by standard radiation therapy starting on day 50; or 69.6 Gy delivered at 1.2 Gy per fraction twice daily (hyperfractionated radiation therapy). RESULTS: Toxicity was acceptable, with four treatment-related deaths. Three patients subsequently died of chronic pulmonary complications. Compliance with protocol treatment was acceptable. One-year survival (%) and median survival (months) were as follows: standard radiation therapy--46%, 11.4 months; chemotherapy plus radiotherapy--60%, 13.8 months; and hyperfractionated radiation therapy--51%, 12.3 months. The chemotherapy plus radiotherapy arm was statistically superior to the other two treatment arms (logrank P = .03). CONCLUSIONS: In "good-risk" patients with surgically unresectable non-small-cell lung cancer, induction chemotherapy followed by irradiation was superior to hyperfractionated radiation therapy or standard radiation therapy alone, yielding a statistically significant short-term survival advantage.

Adult↗
PubMed1995

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.

Adenocarcinoma↗
PubMed1994

Surgically staged patients with prostatic carcinoma treated with definitive radiotherapy: fifteen-year results.

OBJECTIVE: To assess the long-term outcome of patients with lymphadenectomy-staged prostate cancer treated with external beam radiotherapy. METHODS: A retrospective analysis was performed on all patients with prostate cancer who underwent staging pelvic lymphadenectomy before treatment with definitive radiotherapy from 1970 to February 1978. This included 71 patients who were evaluated for a minimum of fifteen years. No patients were lost to follow-up. Thirty-five patients were node negative and 36 were node positive. RESULTS: Fifteen-year actuarial overall survival, cause-specific survival, and local control for the 20 patients with clinically organ-confined disease (T1b-T2 N0M0) was 40 percent, 75 percent, and 92 percent, respectively. The results for the 15 T3 N0M0 patients were 15 percent, 22 percent, and 60 percent. Patients with positive nodes did much worse, with rates of 5 percent, 6 percent, and 45 percent. Thirty-four patients received hormonal therapy at the time of first failure. No patient who was clinically free of disease at fifteen years had an elevated level of prostate-specific antigen (PSA). CONCLUSIONS: Our data suggest excellent results in a cohort of patients (T1b-T2 N0M0) treated with primary radiotherapy who would be considered candidates for radical prostatectomy. Outcome is significantly worse in patients with T3 lesions and node-positive disease.

Actuarial Analysis↗
PubMed1994

Dose intensity of radiation therapy in non-small cell carcinoma of the lung: a review of RTOG data and strategies.

Prospective trials exploring questions of dose intensity for control of the local-regional tumor have been conducted by the Radiation Therapy Oncology Group for 20 years. Early studies established radiation therapy with a total dose of 60 Gy in 30 fractions as standard (STD) for unresectable non-small cell carcinomas of the lung (NSCCL). Hyperfractionated radiation therapy (HFX) with 1.2 Gy twice daily permitted higher total doses without increased normal tissue effects and led to comparison of STD vs. HFX (total dose 69.6 Gy in 58 fractions). Induction chemotherapy followed by STD, induction followed by concurrent chemotherapy and STD, and concurrent chemotherapy and HFX, have been explored in successive trials. Preliminary results of STD combined with chemotherapy suggest that increases in dose intensity increase local-regional control and survival. Confirmatory trials of increased dose intensity by combining chemotherapy with STD and HFX have been completed or are progressing.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1994

Evaluation of preoperative radiation therapy in operable colorectal cancer.

MATERIALS AND METHODS: Patients with operable colorectal cancer in the ascending colon, descending colon, and rectum were randomized to 500 cGy before definitive surgery. Patients with stage A and B1 lesions received no further treatment. All patients with stage B2, B3, C1, C2, and C3 received a minimum of 4500 cGy postoperatively. RESULTS: Three hundred fifty-three patients were registered for the study. Three hundred one patients were available for analyses. Follow-up was a minimum of 5 years on all study patients. The majority of patients had rectal cancer. Complications of treatment were acceptable. Two hundred thirty-one patients had stage B2, B3, C1, C2, or C3 tumors. Estimated 5-year rates for no preoperative therapy versus preoperative therapy were as follows: local recurrence 29% versus 26%; metastasis 41% versus 43%; and survival 54% versus 54%. No statistical benefit was observed for preoperative treatment. CONCLUSIONS: In a prospective randomized trial designed to test the value of low-dose preoperative irradiation followed by surgery and postoperative irradiation, the authors were unable to observe any benefit to low-dose preoperative therapy in patients with unfavorable stages.

Adult↗
PubMed1994

Quantitation of prostate-specific acid phosphatase in prostate cancer: reproducibility and correlation with subjective grade.

In this study, we quantitatively evaluated the intensity and extent of prostate-specific acid phosphatase in immunocytochemically stained prostate carcinoma tissue sections by using a dual-wave-length-based image processing technique. Tissue sections were doubly stained in a standard way, i.e., prostate-specific acid phosphatase was immunocytochemically labeled by peroxidase-antiperoxidase (PAP) technique using diaminobenezidene (DAB) as the substrate and hematoxylin as a nuclear counterstain. Statistical analysis in this study indicated that the quantitative measures of the prostate-specific acid phosphatase staining (PAP-DAB) are reproducible. We found that the quantitative intensity was generally proportional to the subjective intensity (graded as 1 to 4+) of PAP-DAB. Although the quantitative extent measurements compared with the subjective estimates of the percentage of tumor showing staining with PAP-DAB had a similar tendency, there were significant overlaps between extent of tumor staining falling in the mid-ranges. Because subjective grading of immunocytochemical prostate-specific acid phosphatase has been thought to be a useful marker of tumor differentiation in patients with prostate carcinoma, we also evaluated the relationship of the quantitative measures of PAP-DAB staining to other predictors of patient outcome, including histologic grades (Gleason score and MD Anderson grading scheme) and clinical stage. We confirmed that quantitative intensity and extent of PAP-DAB staining were independent of histologic grades and stage, just as the subjective measures of intensity and extent were found to be. Possible explanations of this lack of correlation are discussed.

3,3'-Diaminobenzidine↗
PubMed1994

Combination chemotherapy and radiation therapy in lung cancer.

This report outlines the principles and application of chemoirradiation in bronchogenic carcinoma. The emphasis is on the timing of treatment in small cell lung cancer and the Radiation Therapy Oncology Group trial in non-small cell lung cancer. The purpose of this report is to provide a framework for future trials.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1993

Phase I/II trial of accelerated fractionation in brain metastases RTOG 85-28.

PURPOSE: Radiation Therapy Oncology Group 85-28 represents a Phase I/II trial of accelerated fractionation in patients with brain metastases. METHODS AND MATERIALS: Patients entered had controlled or absent primary with metastases other than brain which were stable or only brain metastases with the primary uncontrolled. Karnosfky status was required to be greater than 60. Patients received 1.6 Gy twice daily separated by 4-8 hr delivered 5 days a week. The entire brain was treated to 32.0 Gy and the boost dose escalated from 16.0 Gy to 22.40 Gy and subsequently 32.00 Gy and 42.40 Gy. RESULTS: We observed no undue toxicity with escalating dose of irradiation. An incremental, although not statistically significant improvement in survival was noted with escalating doses. Median survival ranged from 4.2 months to 6.4 months with escalating dose of irradiation. Median survival also increased in patients with controlled primary tumors, non-lung primaries and solitary metastasis. CONCLUSION: The incremental improvement in survival in patients with good prognostic factors appeared encouraging. The Radiation Therapy Oncology Group will test the 54.4 Gy study against 30 Gy in 2 weeks in a Phase III trial based on the results of this trial.

Adult↗
PubMed1993

Improved survival duration in patients with unresected solitary brain metastasis using accelerated hyperfractionated radiation therapy at total doses of 54.4 gray and greater. Results of Radiation Therapy Oncology Group 85-28.

BACKGROUND: Although there have been occasional reports of improved response with greater doses of irradiation for unresected brain metastases, dose escalation has not been systematically studied in a cohort of patients with solitary brain metastasis. The current study examines this group of patients to evaluate dose escalation using accelerated hyperfractionated radiation therapy (XRT) with regard to survival, patterns of failure, and toxicity. METHOD: Radiation Therapy Oncology Group (RTOG) 85-28, a Phase I/II randomized trial of accelerated hyperfractionated XRT for patients with unresected supratentorial brain metastases, enrolled 153 patients with solitary brain metastasis. Whole brain dose was 32 Gray (Gy) administered in 1.6 Gy fractions twice a day with an interfraction interval of 4-8 hours. Boost dose was escalated to total doses of 48.0, 54.4, 64.0, and 70.4 Gy. RESULTS: Acute and late toxicities were acceptable. The median survival time and 1-year survival rates were 4.9 months and 20% at 48 Gy; 5.4 months and 33% at 54.4 Gy; 7.2 months and 28% at 64 Gy; and 8.2 months and 37% at 70.4 Gy, respectively. Comparison of the upper three dose treatment arms to the 48 Gy treatment arm revealed a superior survival time with doses of 54.4 Gy and greater (P = 0.05). Improvement in neurologic function appeared to increase with dose escalation, with 25% of patients experiencing improvement at doses of 48 Gy, 38% at 54.4 Gy, 50% at 64 Gy, and 63% at 70.4 Gy (P = not significant). CONCLUSION: A radiation dose response for survival time appears to exist with the use of accelerated hyperfractionated XRT for patients with unresected solitary brain metastasis.

Adenocarcinoma↗
PubMed1993

Local control following therapeutic nodal dissection for melanoma.

Regional recurrence of melanoma is usually treated with surgical resection alone. Unfortunately sites of failure following surgical resection are poorly documented. Little information exists regarding local failure following surgery. In order to define local control, a retrospective analysis was performed of all patients undergoing a potentially curative lymph node dissection for metastatic melanoma. From 1978 to 1988, 48 patients underwent lymph node dissection with removal of all known disease (15 axillary, 25 groin and 8 radical neck dissections). Seven patients had stage II disease with simultaneous resection of the primary lesion and nodal dissection. The remaining 41 patients had stage I disease with dissection delayed until nodal metastasis became apparent. Of these 48 patients, 25 experienced local failure for an overall local control rate of 48%. Univariate and multivariate analysis showed only age to be a statistically significant prognostic indicator of local failure with a rate of 31% for patients < 50 years of age vs. 66% for patients > 50 years of age (P = 0.02). Nodal size, number of nodes involved, extracapsular extension, initial stage, location, or sex did not influence prognosis. Although not statistically significant, time to recurrence was much shorter in patients with extracapsular extension, 5 months vs. 16 months. With an overall local failure rate of 52% following a potentially curable therapeutic nodal dissection further local treatment should be considered.

Age Factors↗
PubMed1992

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.

Combined Modality Therapy↗
PubMed1992

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.

Humans↗