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Biomedical subjects

Andre Konski

Publications and source records attributed to Andre Konski.

At least 19 recordsLinked to original sources
PubMed2006

Resection of isolated pelvic recurrences after colorectal surgery: long-term results and predictors of improved clinical outcome.

BACKGROUND: Recurrence in the pelvis after resection of a rectal or rectosigmoid cancer presents a dilemma. Resection offers the only reasonable probability for cure, but at the cost of marked perioperative morbidity and potential mortality. Clinical decision making remains difficult. METHODS: Patients who underwent resection with curative intent for isolated pelvic recurrences after curative colorectal surgery from 1988 through 2003 were reviewed retrospectively. Clinical and pathological factors, salvage operations, and complications were recorded. The primary measured outcome was overall survival. Univariate and multivariate analyses were conducted to identify prognostic factors of improved outcome. RESULTS: Ninety patients underwent an attempt at curative resection of a pelvic recurrence; median follow-up was 31 months. Complications occurred in 53% of patients. Operative mortality occurred in 4 (4.4%) of 90 patients. Median overall survival was 38 months, and estimated 5-year survival was 40%. A total of 51 of 86 patients had known recurrences (15 local, 16 distant, 20 both). Multivariate analysis revealed that preoperative carcinoembryonic antigen level and final margin status were statistically significant predictors of outcome. CONCLUSIONS: The resection of pelvic recurrences after colorectal surgery for cancer can be performed with low mortality and good long-term outcome; however, morbidity from such procedures is high. Low preoperative carcinoembryonic antigen and negative margin of resection predict improved survival.

Adult↗
PubMed2006

Using decision analysis to determine the cost-effectiveness of intensity-modulated radiation therapy in the treatment of intermediate risk prostate cancer.

BACKGROUND: The specific aim of this study is to evaluate the cost-effectiveness of intensity-modulated radiation therapy (IMRT) compared with three-dimensional conformal radiation therapy (3D-CRT) in the treatment of a 70-year-old with intermediate-risk prostate cancer. METHODS: A Markov model was designed with the following states; posttreatment, hormone therapy, chemotherapy, and death. Transition probabilities from one state to another were calculated from rates derived from the literature for IMRT and 3D-CRT. Utility values for each health state were obtained from preliminary studies of preferences conducted at Fox Chase Cancer Center. The analysis took a payer's perspective. Expected mean costs, cost-effectiveness scatterplots, and cost acceptability curves were calculated with commercially available software. RESULTS: The expected mean cost of patients undergoing IMRT was $47,931 with a survival of 6.27 quality-adjusted life years (QALYs). The expected mean cost of patients having 3D-CRT was $21,865 with a survival of 5.62 QALYs. The incremental cost-effectiveness comparing IMRT with CRT was $40,101/QALYs. Cost-effectiveness acceptability curve analysis revealed a 55.1% probability of IMRT being cost-effective at a $50,000/QALY willingness to pay. CONCLUSION: Intensity-modulated radiation therapy was found to be cost-effective, however, at the upper limits of acceptability. The results, however, are dependent on the assumptions of improved biochemical disease-free survival with fewer patients undergoing subsequent salvage therapy and improved quality of life after the treatment. In the absence of prospective randomized trials, decision analysis can help inform physicians and health policy experts on the cost-effectiveness of emerging technologies.

Aged↗
PubMed2006

Continuing evidence for poorer treatment outcomes for single male patients: retreatment data from RTOG 97-14.

PURPOSE: The specific aim of this study was to evaluate outcome differences by gender and partner status for patients treated on Radiation Therapy Oncology Group (RTOG) protocol 97-14. METHODS AND MATERIALS: RTOG 97-14 randomized patients with metastatic breast or prostate cancer to bone to receive 8 Gy in 1 fraction or 30 Gy in 10 fractions. Retreatment rates and overall survival were made based upon gender, marital status, and Karnofsky Performance Status (KPS). The cumulative incidence method was used to estimate retreatment time at 36 months from enrollment, and Gray's test was used to test for treatment differences within the same groupings. Marital status, gender, KPS, and treatment were variables tested in a univariate Cox model evaluating the time to retreatment. RESULTS: Married men and women and single women receiving 30 Gy had significantly longer time to retreatment, p = 0.0067, p = 0.0052, and p = 0.0009 respectively. We failed to show a difference in retreatment rates over time in single men receiving either 30 Gy or 8 Gy. Univariate analysis of the entire group determined patients receiving 30 Gy in 10 fractions significantly less likely to receive retreatment, p < 0.0001, with a trend toward single patients less likely to be re-treated, p = 0.07. CONCLUSION: Non-disease-related variables, such as social support, might influence the results of clinical trials with subjective endpoints such as retreatment rates. The statistically nonsignificant difference in the 36-month retreatment rates observed in single male patients receiving 8 Gy may be a result of inadequate social support systems in place to facilitate additional care. Patients receiving 8 Gy in a single fraction had significantly higher retreatment rates compared with patients receiving 30 Gy in 10 fractions.

Adult↗
PubMed2006

Does age matter in the selection of treatment for men with early-stage prostate cancer?

BACKGROUND: The specific aim of the current study was to compare freedom from biochemical failure, distant metastases-free survival, and overall survival in men age < or = 55 years, men ages 60 to 69 years, and men age > or = 70 years presenting with localized prostate cancer. METHODS: A matched pair analysis compared patients age < or = 55 years (Group 1) who were treated with 3-dimension conformal radiation without androgen deprivation to men age > or = 60 years and < 70 years (Group 2), and men age > or = 70 years (Group 3) who were treated at the Fox Chase Cancer Center between November 1989 and October 2001. The groups were matched for disease stage (T1/T2b vs. T2C/T3), Gleason grade (2-6 vs. 7-10), radiation dose (< 70 Gray [Gy] vs. > or = 70-76 Gy vs. > or = 76 Gy), and pretreatment prostate-specific antigen (PSA) level. Estimates of outcome were accomplished using Kaplan-Meier methodology and compared by age group using the log-rank test. RESULTS: Eighty-four men were identified according to the selection criteria. No statistically significant difference was found in the 5-year overall survival rates for Group 1, Group 2, and Group 3 (94%, 95%, and 87%, respectively) or the 5-year rate of freedom from biochemical failure in Group 1, Group 2, and Group 3 (82%, 76%, and 70%, respectively), or freedom from distant metastases (96%, 97%, and 98%, respectively). CONCLUSIONS: Men age < or = 55 years who present with localized prostate cancer do not appear to have a worse prognosis. External beam radiation therapy appears to be a viable treatment alternative and should be offered to men age < or = 55 years who present with organ-confined prostate cancer.

Adult↗
PubMed2006

Induction cisplatin and paclitaxel followed by combination chemoradiotherapy with 5-fluorouracil, cisplatin, and paclitaxel before resection in localized esophageal cancer: a phase II report.

BACKGROUND: Multimodality therapy for esophageal cancer holds promise for improving outcome in this lethal disease. On the basis of encouraging data from a phase I trial, we conducted a phase II study of preoperative chemotherapy, followed by concurrent chemoradiotherapy and surgery. METHODS: Patients with clinically staged resectable esophageal cancer were treated with induction cisplatin and paclitaxel, followed by 45 Gy of external beam radiation with concurrent infusional 5-fluorouracil and weekly cisplatin and paclitaxel. Four to eight weeks after multimodality induction, esophagectomy was performed in suitable patients. Study end points were survival, pathologic complete response, and toxicity. RESULTS: Twenty-one patients were enrolled with a median age of 58 years, and all patients were clinically staged II or III. Sixteen (76.2%) patients completed the trial, of whom four (25%) had a pathologic complete response. One patient died from postoperative complications. Grade 3 or 4 toxicity was observed in 76% of patients, and dose-limiting toxicity was seen in 6 of the first 14 patients, thus necessitating a planned dose reduction of paclitaxel. At a median follow-up of 30 months, 13 patients remain alive. The 2-year disease-specific survival for the study population was 78%. CONCLUSIONS: This regimen of multimodality therapy before resection resulted in an encouraging 2-year survival rate but a disappointing rate of pathologic complete response and was toxic, necessitating a predetermined paclitaxel dose reduction. The incorporation of taxanes into induction strategies for esophageal cancer seems promising, but the optimal schedule remains undefined.

Aged↗
PubMed2006

Long-term hormone therapy and radiation is cost-effective for patients with locally advanced prostate carcinoma.

BACKGROUND: In Radiation Therapy Oncology Group (RTOG) trial 92-02, after men received neoadjuvant hormone cytoreduction and radiotherapy for locally advanced prostate carcinoma, they were randomized to receive either 2 years of long-term androgen-deprivation (LTAD) or no further treatment (short-term androgen-deprivation [STAD]). The specific objective of the current study was to determine whether LTAD was a cost-effective treatment for patients with locally advanced prostate carcinoma. METHODS: The cost-effectiveness of LTAD was tested using a Markov model that was designed using proprietary software. The analysis took a payor's perspective. Unit costs were obtained by estimation using a global Medicare fee schedule. Costs and outcomes were discounted by 3%. Distributions were sampled at random from the treatment utilities, transition probabilities, and costs using a second-order Monte Carlo simulation technique. RESULTS: The expected mean cost was 32,564 dollars for LTAD compared with 33,039 dollars for STAD after accounting for the additional cost of salvage treatment for men who were treated with STAD. The mean number of quality-adjusted life years (QALYs) for men who received LTAD was 4.13 QALYs compared with a mean of 3.68 QALYs for men who received STAD. The cost-effectiveness acceptability curve analysis showed a 91% probability that LTAD was cost-effective compared with STAD. Although overall survival was similar in the LTAD and STAD groups, the patients who received LTAD experienced gains in QALYs and had lower costs, because LTAD prevented biochemical failure and the necessitating salvage hormone therapy. CONCLUSIONS: The current analysis showed that LTAD was cost-effective for the entire population studied in RTOG trial 92-02.

Adenocarcinoma↗
PubMed2006

Phase II trial of preoperative chemoradiation with a hyperfractionated radiation boost in locally advanced rectal cancer.

PURPOSE: The purpose of this phase II study was to prospectively determine the efficacy of preoperative chemoradiation with a hyperfractionated (Hfx) RT boost to 61.8 Gy in locally advanced rectal cancer. METHODS: Eligibility stipulated that the primary lesion had to be either T4; or T3 and >4 cm or 40% of the bowel circumference. Radiation (RT) consisted of 45 Gy to the pelvis (1.8 Gy per fraction) followed by 1.2 Gy twice daily (to the gross tumor volume) to a total RT dose of 61.8 Gy. There was 5-FU infused at 1 g/m2/24 hours for 4 days during the 1st and 6th weeks of RT (concurrent with the Hfx boost). Surgical resection was planned 4 to 6 weeks later. Adjuvant chemotherapy (bolus 5-FU/leucovorin) was scheduled for 4 cycles at 28-day intervals. RESULTS: There were 22 patients, ages 22 to 81 years (median, 64) enrolled in the study. Of the 20 patients evaluable for response, 10 (50%) had evidence of clinical downstaging and 5 patients (25%) had > or =90% fibrosis in the resected specimen. With a median f/u of 40 months (7-158), the 4 years actuarial rate for all patients (n = 22) of OS was 64%, of DFS 62%, and of LC 84%. 3/21 patients (14%) had positive margins, all of whom developed a local failure (P < 0.001). CONCLUSION: This regimen of high dose preoperative chemoRT with a Hfx RT boost (to 61.8 Gy) in patients with bulky, locally advanced rectal cancer results in clinical downstaging in half of the patients with significant fibrosis in the operative specimen.

Adenocarcinoma↗
PubMed2005

Economic analysis of a phase III clinical trial evaluating the addition of total androgen suppression to radiation versus radiation alone for locally advanced prostate cancer (Radiation Therapy Oncology Group protocol 86-10).

PURPOSE: To evaluate the cost-effectiveness of adding hormone therapy to radiation for patients with locally advanced prostate cancer, using a Monte Carlo simulation of a Markov Model. METHODS AND MATERIALS: Radiation Therapy Oncology Group (RTOG) protocol 86-10 randomized patients to receive radiation therapy (RT) alone or RT plus total androgen suppression (RTHormones) 2 months before and during RT for the treatment of locally advanced prostate cancer. A Markov model was designed with Data Pro (TreeAge Software, Williamstown, MA). The analysis took a payer's perspective. Transition probabilities from one state of health (i.e., with no disease progression or with hormone-responsive metastatic disease) to another were calculated from published rates pertaining to RTOG 86-10. Patients remained in one state of health for 1 year. Utility values for each health state and treatment were obtained from the literature. Distributions were sampled at random from the treatment utilities according to a second-order Monte Carlo simulation technique. RESULTS: The mean expected cost for the RT-only treatments was 29,240 dollars (range, 29,138-29,403 dollars). The mean effectiveness for the RT-only treatment was 5.48 quality-adjusted life years (QALYs) (range, 5.47-5.50). The mean expected cost for RTHormones was 31,286 dollars (range, 31,058-31,555 dollars). The mean effectiveness was 6.43 QALYs (range, 6.42-6.44). Incremental cost-effectiveness analysis showed RTHormones to be within the range of cost-effectiveness at 2,153 dollars/QALY. Cost-effectiveness acceptability curve analysis resulted in a >80% probability that RTHormones is cost-effective. CONCLUSIONS: Our analysis shows that adding hormonal treatment to RT improves health outcomes at a cost that is within the acceptable cost-effectiveness range.

Androgen Antagonists↗
PubMed2005

The integration of 18-fluoro-deoxy-glucose positron emission tomography and endoscopic ultrasound in the treatment-planning process for esophageal carcinoma.

PURPOSE: Accurate delineation of the gross tumor volume (GTV) is important in radiation therapy treatment planning. We evaluated the impact of PET and endoscopic ultrasound (EUS) compared with CT simulation in the planning of radiation fields for patients with esophageal carcinoma. MATERIAL AND METHODS: Twenty-five patients presenting with esophageal carcinoma for radiation therapy underwent PET scans in the treatment position after conventional CT simulation. Patients underwent PET/CT scanning after being injected with 10 to 20 mCi of [F-18]-2-deoxy-2-fluro-D-glucose. The length of the abnormality seen on the CT portion of the PET/CT scan vs. the PET scan alone was determined independently by 2 separate investigators. The length of the GTV and detection of regional adenopathy by PET was also correlated with EUS in 18 patients. Of the 18 patients who had EUS, 2 had T2 tumors and 16 had T3 tumors. Eighteen patients had adenocarcinoma and 7 had squamous cell carcinoma. Nine tumors were located at the gastroesophageal junction, 8 at the lower esophagus, 7 in the middle esophagus, and 1 in the cervical esophagus. The PET scans were reviewed to determine the length of the abnormality by use of a standard uptake value (SUV) of 2.5 to delineate the tumor extent. RESULTS: The mean length of the cancer was 5.4 cm (95% CI 4.4-6.4 cm) as determined by PET scan, 6.77 cm (95% CI, 5.6-7.9 cm) as determined by CT scan, and 5.1 cm (95% CI, 4.0-6.1 cm) for the 22 patients who had endoscopy. The length of the tumors was significantly longer as measured by CT scans compared with PET scans (p = 0.0063). EUS detected significantly more patients with periesophageal and celiac lymphadenopathy compared to PET and CT. The SUV of the esophageal tumors was higher in patients with peri-esophageal lymphadenopathy identified on PET scans. CONCLUSION: Endoscopic ultrasound and PET scans can add additional information to aid the radiation oncologist's ability to precisely identify the GTV in patients with esophageal carcinoma.

Adenocarcinoma↗
PubMed2005

Palliative radiation therapy.

Radiation is an effective modality to aid in symptom management of patients with metastatic disease. The type and duration of treatment depends on the Karnofsky performance status (KPS) of the patient and type and status of the cancer. Abbreviated treatment regimens may be favored in this patient population. They provide quick palliation without the patient and family spending significant time traveling back and forth to the treatment center. Hypofractionated regimens have been found effective in relieving pain from metastatic bone disease, relieving obstruction from locally advanced lung cancer, bleeding from gynecologic cancers, and hematuria from advanced bladder cancer. More aggressive regimens such as whole-brain radiation therapy (WBRT) and stereotactic radiosurgery may be appropriate for select patients with a good KPS. Radiation has also been found to be effective in palliating recurrent cancer that has already received definitive radiation.

Clinical Trials as Topic↗
PubMed2005

Morbidity and mortality are not increased after induction chemoradiotherapy followed by esophagectomy in patients with esophageal cancer.

Attempts to improve survival of patients with esophageal cancer have been made using induction chemoradiotherapy (CRT) followed by surgery. This approach may be associated with higher complication rates. A large single-center experience was reviewed to determine whether induction CRT was associated with increased morbidity and mortality among 179 patients undergoing esophagectomy between January 1994 and December 2002. Morbidity was recorded as any complication requiring additional intervention. Mortality was defined as patient death within the first 30 postoperative days or death during the initial hospitalization. In total, 131 patients underwent induction CRT followed by surgery. The most common operation was an Ivor-Lewis esophagogastrectomy (60%). Median survival of the entire group was 33 months and 5-year survival was 26%. Perioperative mortality was 5% and did not differ between induction (4.6%) and non-induction (6.3%) groups. The overall complication rate was 57%, reflecting a very liberal definition of postoperative complications. There were no differences between the two groups in terms of such major complications as anastomotic leak, pneumonia, acute respiratory distress syndrome, respiratory failure, chylothorax, atrial arrhythmia, and wound infections. There were only two complications that occurred more frequently in the induction group--venous thrombosis (8.4% v 0%) and vocal cord paresis (7.6% v 2.1%). The median hospital stay was similar in patients who had complications versus those who did not (12 v 13 days) and in patients who underwent induction CRT versus those that did not (12 days v 13.5 days). Esophagectomy can be performed safely with low mortality and acceptable morbidity following neoadjuvant chemotherapy and radiation with no increase in hospital stay for patients with complications.

Adenocarcinoma↗
PubMed2005

Can molecular imaging predict response to preoperative chemoradiation in patients with rectal cancer? A Fox Chase Cancer Center prospective experience.

This study was undertaken to correlate change in fluorine-18 fluorodeoxyglucose positron emission tomography ((18)FDG-PET) uptake with response to combined-modality neoadjuvant therapy in patients with locally advanced rectal cancer. Twenty patients (13 male; 7 female) underwent (18)FDG-PET scans before and 3 to 4 weeks after completion of chemoradiation before surgery. Staging by endoscopic ultrasound was T3/T4 (17/1); two patients were unable to undergo endorectal ultrasound. Fifteen patients had perirectal lymphadenopathy. Median radiation dose was 5,040 cGy (range, 4,500 to 5,500 cGy). All patients received continuous infusion 5-fluorouracil (or capecitabine) with radiation. Median pre- and post-chemoradiation standard uptake values were 9.4 (range, 3.6 to 37.0) and 3.05 (range, 0.5 to 8.2), respectively. Median percent standard uptake value decrease observed in the postchemoradiation PET scans was 71% (range, 7% to 95%). Six patients (30%) had pathologic complete response. Only two of six patients with postchemoradiation standard uptake values <or=2.5 had a complete pathologic response. The time from the end of radiation to surgery was marginally significant for predicting pathologic complete response (P = .12). Neoadjuvant combined-modality therapy resulted in decreased metabolic activity on PET. Because response to preoperative treatment predicts clinical outcome, the utility of midtreatment PET scans to guide treatment decisions should be further explored in larger clinical studies.

Adenocarcinoma↗
PubMed2005

Clinical and economic outcomes analyses of women developing breast cancer in a managed care organization.

OBJECTIVES: An evaluation was performed linking an administrative database to clinical information to determine the clinical and economic outcomes of women presenting with breast cancer in a managed care organization (MCO). METHODS: Administrative claims records were linked to clinical information obtained from hospital and tumor registry data for women diagnosed with adenocarcinoma or carcinoma in situ of the breast between 1990 and 1997. RESULTS: Only 3 of 53 mammogram-diagnosed women had developed recurrences compared with 12 of 69 self-diagnosed women. Self-diagnosed women with commercial insurance incurred more treatment-related cost, 30,557 dollars, compared with mammogram-diagnosed women, 13,913 dollars (P = 0.005). CONCLUSION: Women with commercial insurance had better clinical outcome at less cost when diagnosed by mammography as compared with women who detected the breast cancer by breast self-examination.

Adult↗
PubMed2004

Radiotherapy is a cost-effective palliative treatment for patients with bone metastasis from prostate cancer.

BACKGROUND: To evaluate the various treatments for patients with hormone-refractory prostate cancer with bone metastases using a Markov model. METHODS AND MATERIALS: The base case to be evaluated was of a man with hormone-refractory prostate cancer. The evaluated palliative treatments were pain medication only, chemotherapy consisting of mitoxantrone and prednisone, and single- and multifraction radiotherapy (RT). A literature search was used to generate the transition probabilities and patient utilities. Modeling was used to generate the cost estimates. Expert opinion was used to generate utilities and cost estimates in the absence of literature data. Second-order Monte Carlo simulation produced incremental cost-effectiveness scatterplots and 95% confidence ellipses. RESULTS: Pain medication had the least expected mean cost of all the treatment options at 11,700 US dollars but also the second lowest quality-adjusted survival at 5.75 quality-adjusted life months. Chemotherapy had the highest expected mean cost, 15,300 US dollars, but the lowest quality-adjusted life months (4.93). Incremental cost-effectiveness analysis revealed that single-fraction RT was the most cost-effective treatment, with a cost of 6,857 US dollars/quality-adjusted life year; multifraction RT had an incremental cost-effectiveness ratio of 36,000 US dollars/quality-adjusted life year. Chemotherapy was dominated by pain medication. CONCLUSION: Within the limits of the established model, single-fraction RT was the most cost-effective palliative treatment compared with pain medication, chemotherapy, and multifraction RT. The use of this model allowed comparison of different treatment regimens that could never be evaluated together in a randomized clinical trial.

Analgesics↗
PubMed2004

Stereotactic IMRT for prostate cancer: setup accuracy of a new stereotactic body localization system.

The purpose of this work is to prospectively assess the setup accuracy that can be achieved with a stereotactic body localizer (SBL) in immobilizing patients for stereotactic intensity-modulated radiotherapy (IMRT) for prostate cancer. By quantifying this important factor and target mobility in the SBL, we expect to provide a guideline for selecting planning target volume margins for stereotactic treatment planning. We analyzed data from 40 computed tomography (CT) studies (with slice thickness of 3 mm) involving 10 patients with prostate cancer. Each patient had four sets of CT scans during the course of radiotherapy. For the purpose of this study, all four sets of CT scans were obtained with the patients immobilized in a customized body pillow formed by vacuum suction. Unlike other immobilization devices, this system consists not only of a customized body pillow, but also of a fixation sheet used to suppress patient respiratory motion, a stereotactic body frame to provide stereotaxy, and a carbon fiber base board to which both the body cushion and the frame are affixed. We identified four bony landmarks and measured their coordinates in the stereotactic body frame on each set of CT scans. The displacements of the bony landmarks from their corresponding positions on the simulation scan (first CT scan) were analyzed in three dimensions in terms of overall, systematic, and random categories. The initial planned isocenter was also marked on the patients' skin with fiducials for each CT study. The distance from each bony landmark to the fiducial-based isocenter was measured and compared among the four sets of CT scans. The deviations in distances were also compared to those measured from the landmarks to the stereotactic frame center, in order to determine the effectiveness of the rigid body frame in positioning patients with prostate cancer. Target inter-fraction motion in this system was also studied for five patients by measuring the deviations in distances from the target geometric center to the bony landmarks. Our results showed that the overall setup accuracy had standard deviations (SDs) of 2.58 mm, 2.41 mm, and 3.51 mm in lateral (LAT), anterior-posterior(AP), and superior-inferior (SI) directions, respectively. The random component had SDs of 1.72 mm, 2.06 mm, and 2.79 mm, and the systematic component showed SDs of 0.92 mm, -0.27 mm, and 0.90 mm in these three directions. In terms of three-dimensional vector, the mean displacement over 116 measurements was 3.0 mm with an SD of 1.29 mm. Compared to the rigid reference, the skin-mark-based reference was less reliable for patient repositioning in terms of reproducing known bony landmark positions. The mean target mobility relative to the bony landmarks was 2.22 +/- 3.45 mm, 0.17 +/- 1.11 mm, and 0.11 +/- 2.69 mm in the AP, LAT, and SI directions, respectively. In conclusion, the body immobilization system has the ability to immobilize prostate cancer patients with satisfactory setup accuracy for fractionated extracranial stereotactic radiotherapy. A rigid frame system serves as a reliable alignment reference in terms of repositioning patients into the planning position, while skin-based reference showed larger deviations in repositioning patients.

Equipment Design↗
PubMed2004

Predictors of preferences and utilities in men treated with 3D-CRT for prostate cancer.

PURPOSE: To assess the preferences and utilities for prostate cancer health state scenarios of men treated with three-dimensional conformal radiotherapy and the predictors of treatment preferences. METHODS AND MATERIALS: The preferences and utilities for probabilistic health states of impotence and incontinence associated with prostate cancer therapies were elicited from prostate cancer registry participants using a modified time trade-off interview. Sociodemographic, disease, and treatment characteristics, as well as quality-of-life scores, were assessed to determine the predictors of preferences. RESULTS: Fifty-seven men treated with three-dimensional conformal radiotherapy completed the time trade-off interview. Of these men, 83% had Stage T1-T2 and 30% were receiving hormonal therapy. The utilities followed a linear trend with declining scores for increasing risk of poorer health states. Men showed an increased preference for health states associated with radiotherapy compared with surgery or hormonal therapy. Univariate predictors of preference included income and marital status. Multivariate predictors of preferences included more aggressive therapy and better prognostic indicators. Current quality-of-life scores in terms of global, sexual, or urinary function were poor predictors of preferences. CONCLUSION: Preference elicitation can assist in decision-making, and understanding the predictors of patient preferences can assist in identifying factors that may increase patient perceptions of poorer outcomes.

Aged↗
PubMed2004

The RTOG Outcomes Model: economic end points and measures.

Recognising the value added by economic evaluations of clinical trials and the interaction of clinical, humanistic and economic end points, the Radiation Therapy Oncology Group (RTOG) has developed an Outcomes Model that guides the comprehensive assessment of this triad of end points. This paper will focus on the economic component of the model. The Economic Impact Committee was founded in 1994 to study the economic impact of clinical trials of cancer care. A steep learning curve ensued with considerable time initially spent understanding the methodology of economic analysis. Since then, economic analyses have been performed on RTOG clinical trials involving treatments for patients with non-small cell lung cancer, locally-advanced head and neck cancer and prostate cancer. As the care of cancer patients evolves with time, so has the economic analyses performed by the Economic Impact Committee. This paper documents the evolution of the cost-effectiveness analyses of RTOG from performing average cost-utility analysis to more technically sophisticated Monte Carlo simulation of Markov models, to incorporating prospective economic analyses as an initial end point. Briefly, results indicated that, accounting for quality-adjusted survival, concurrent chemotherapy and radiation for the treatment of non-small cell lung cancer, more aggressive radiation fractionation schedules for head and neck cancer and the addition of hormone therapy to radiation for prostate cancer are within the range of economically acceptable recommendations. The RTOG economic analyses have provided information that can further inform clinicians and policy makers of the value added of new or improved treatments.

Clinical Trials as Topic↗