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Biomedical subjects

B Emami

Publications and source records attributed to B Emami.

At least 91 records · Page 5Linked to original sources
PubMed1991

RTOG quality assurance guidelines for clinical trials using hyperthermia for deep-seated malignancy.

Quality assurance has been vague or lacking in many previous hyperthermia trials. Recent publications by the Hyperthermia Physics Center, the Center for Devices and Regulatory Health, and the Radiation Therapy Oncology Group have described general guidelines for quality assurance in equipment reliability and reproducibility, superficial applications, and microwave techniques. The present report details quality assurance factors that are believed to be important for hyperthermia of deep clinical sites, defined as extending at least 3 cm beyond the skin surface. This document will discuss patient and physician factors, as well as thermometric accuracy, assessment of specific absorption rates (SAR), assurance of adequate coverage of tumors by the energy deposition pattern of the treatment device, and recommended documentation of the location, quantity, and frequency of treatment, specifically oriented to deep hyperthermia. The recommendations are structured to facilitate compliance in multiinstitutional trials.

Clinical Protocols↗
PubMed1991

RTOG quality assurance guidelines for interstitial hyperthermia.

This document specifies the current recommendations for quality assurance for hyperthermia administration with interstitial techniques as specified by the Radiation Therapy Oncology Group (RTOG). The document begins by providing a brief description of the physical principles behind the use of the three most commonly used methods of interstitial hyperthermia: radiofrequency (RF-LCF), microwave antennas, and ferromagnetic seeds. Emphasis is placed on features that effect quality assurance. Specific recommendations are provided for: a) Pretreatment planning and equipment performance checks, b) Implant considerations and documentation, c) Thermometry, and d) Safety procedures. Specific details regarding quality assurance issues that are common to all local and regional hyperthermia methods are outlined in previous documents sponsored by the RTOG. It is anticipated that technological advances may lead to future modifications of this document.

Documentation↗
PubMed1991

Randomized phase III study comparing irradiation and hyperthermia with irradiation alone in superficial measurable tumors. Final report by the Radiation Therapy Oncology Group.

A total of 307 patients with superficial measurable tumors were registered on a Radiation Therapy Oncology Group (RTOG) protocol involving fractionated radiation therapy, either alone or followed immediately by hyperthermia (42.5 degrees C, 45-60 min). Overall complete response (CR) was observed in 30% of the lesions treated with radiotherapy (RT) and 32% of those receiving RT and heat. Response was found to be significantly related to both maximum tumor diameter (less than 3 or greater than or equal to 3 cm) and site/histology (breast/adenocarcinoma, head and neck/squamous, or other site/histologies). In tumors less than 3 cm in diameter in the breast, trunk, and extremities, a better CR rate was noted with irradiation and heat (62 and 67%) than with irradiation alone (40 and 0%). However, in the head and neck there was only minimal difference in CR with irradiation alone or combined with hyperthermia (50 vs 38%). In lesions less than 3 cm treated with irradiation and heat, there was improved local control. In lesions greater than 3 cm, there was no difference in local control between the two treatment arms. The higher response rate in patients with smaller lesions (less than 3 cm) may be explained by the fact that these tumors are easier to heat. Problems in correlating tumor response with quality of heating include less than optimal heating in larger lesions and the limited ability of current thermometry to map the temperature distribution in a tumor. Acute and late toxicities in both treatment arms were comparable, except for an overall 30% incidence of thermal blisters in the heated tumors.

Adenocarcinoma↗
PubMed1991

Regional hyperthermia in patients with recurrent genitourinary cancer.

During a 6-year period, 53 patients with advanced tumors of the genitourinary tract were treated in Phase I protocols with deep regional hyperthermia in combination with irradiation (83%) or in combination with chemotherapy (11%). Primary tumors included those of bladder in 22 patients (41%), prostate in 20 patients (37%), kidney in 9 patients (17%), and ureter testicle or adrenal in 3 patients (5%). The majority (77%) had prior definitive therapy and had experienced treatment failure, and 11% had clinically important distant metastases. Treatment consisted of deep regional hyperthermia (mean of 4 sessions). In addition, 44 patients (83%) received irradiation (mean dose 39.2 Gy). The 1- and 3-year actuarial survival was 60% and 56%, respectively. Patients with carcinoma of the prostate had a 1- and 3-year survival of 82%. Complete response was observed in 7 patients (13%), partial response in 8 (15%), and nominal response in 13 (25%). Complete and partial response correlated well with histology of the tumor (adenocarcinoma), radiation dose (greater than 50 Gy), primary site (prostate, kidney), and treatment (hyperthermia-radiotherapy combination), (p = 0.02). There was no such correlation between response and thermal dose (p = 0.13). The treatment tolerance was good in 79% of patients. Treatment toxicity was limited to acute side effects, including pain during hyperthermia (47%), tachycardia greater than 140/min (7%), and blister formation in the treated area (4%). Phase II studies in previously untreated patients with locally advanced tumors of bladder, prostate, and kidney are needed for evaluation of the role of deep regional hyperthermia in the management of these cancers.

Actuarial Analysis↗
PubMed1991

Management of soft tissue sarcomas of the extremities.

The management of soft tissue sarcomas has undergone and continues to undergo important changes. The purpose of this report is to review the presentation, diagnosis, and natural history of soft tissue sarcomas. In so doing, the importance of a careful and rigorous method of evaluation will be emphasized. Furthermore, the results of multidisciplinary treatment, with a goal towards limb salvage, will be reviewed. With appropriate and timely intervention, selected patients with pulmonary metastases may still experience long-term survival. Throughout this review, the importance of early and continuing multidisciplinary treatment and evaluation will be emphasized.

Arm↗
PubMed1990

Tumor control in long-term survivors following superficial hyperthermia.

Sixty tumors with a minimum of 1-year follow-up were treated with radiation and superficial microwave hyperthermia (915 MHz). The overall local control rate was 50% (30/60). The most important factor in outcome was appropriateness of the hyperthermia applicator. Tumors covered by at least the 25% iso-SAR contour achieved 65% local control versus 21% local control with less than 25% SAR coverage (p less than 0.01). Several measures of adequate minimum monitored tumor temperature and duration were considered. The measure best correlated with outcome was best single session time at or above 43 degrees C (t43). If each monitored tumor catheter achieved t43 greater than or equal to 30 minutes in at least one session, then tumor control was significantly (p less than 0.01) improved (63% with Min t43 greater than or equal to 30 versus 25% with Min t43 less than 30). Although there was considerable overlap between tumors with SAR greater than or equal to 25% and those achieving Min t43 greater than or equal to 30, a statistically significant (p = 0.02) difference could be demonstrated between the group meeting both the SAR and the minimum tumor time/duration standards as opposed to those meeting only one standard. The actuarial local progression-free survival for tumors most likely to have had adequate hyperthermia (defined as SAR greater than or equal to 25% and Min t43 greater than or equal to 30) and all other tumors did not begin to separate significantly until 8 to 12 months after treatment. Implications for future randomized studies are discussed.

Combined Modality Therapy↗
PubMed1990

A randomized phase I/II trial of hyperfractionated radiation therapy with total doses of 60.0 Gy to 79.2 Gy: possible survival benefit with greater than or equal to 69.6 Gy in favorable patients with Radiation Therapy Oncology Group stage III non-small-cell lung carcinoma: report of Radiation Therapy Oncology Group 83-11.

A phase Ilate/II trial of hyperfractionated (HFX) radiation therapy for non-small-cell carcinoma of the lung (NSCCL) was conducted by the Radiation Therapy Oncology Group (RTOG) between 1983 and 1987. Fractions of 1.2 Gy were administered twice daily with greater than or equal to 4 hours between fractions. Patients were randomized to receive minimum total doses of 60.0, 64.8, and 69.6 Gy. After acceptable risks of acute and late effects were found, 74.4 Gy and 79.2 Gy arms were added, and the lowest total dose arms were closed. No significant differences in the risks of acute or late effects in normal tissues were found among the 848 patients analyzed in the five arms; risks of severe or life-threatening pneumonitis were 2.6% for 60.0 to 64.8 Gy, 5.7% for 69.6 to 74.4 Gy, and 8.1% for 79.2 Gy. Among 350 patients who had the same criteria as Cancer and Leukemia Group B (CALGB) protocol 84-33 (American Joint Committee on Cancer Staging [AJCCS], 1984, stage III; Karnofsky performance status [KPS] 70 to 100; less than 6% weight loss), there was a dose response for survival: survival with 69.6 Gy (median, 13.0 months; 2 years, 29%) was significantly (P = .02) better than the lower total doses. There were no differences in survival among the three highest total-dose arms. Comparisons with results in similar patients treated with 60 Gy in 30 fractions of 2.0 Gy 5 days per week for 6 weeks suggest benefit from HFX radiation therapy with 69.6 Gy. Improvement in survival with HFX radiation therapy at 69.6 Gy total dose without increase in normal tissue effects, justifies phase III comparison with standard fractionation alone and combined with systemic chemotherapy in this common presentation of NSCCL.

Adult↗
PubMed1989

Quality assurance problems in clinical hyperthermia and their impact on therapeutic outcome: a Report by the Radiation Therapy Oncology Group.

Since February 1981, 300 patients with superficial measurable tumors were randomized on an RTOG protocol (81-04) involving fractionated radiation therapy (4.00 Gy twice weekly for a total of 32.00 Gy), either alone or followed immediately by hyperthermia (42.5 degrees C, 60 min). This is a report of 218 eligible patients with single lesions: 107 treated with radiotherapy alone (RT), 111 with radiotherapy plus hyperthermia (RT + HT). Only 56% of the 24 tumors less than 3 cm and 36% of the 53 lesions larger than 3 cm received what was felt to be "adequate" therapy (greater than or equal to 29 Gy and 8 heating sessions). Overall complete response (CR) was observed in 28% of the patients treated with RT, and 32% of the patients receiving RT and heat. Response has been found in previous analyses of this and other RTOG studies to be significantly related to both maximum tumor diameter (less than 3 or greater than or equal to 3 cm) and site/histology (breast/adenocarcinoma, head and neck/squamous, or other site/histologies). In the head and neck tumors less than 3 cm in diameter there was no difference in CR with irradiation alone or combined with hyperthermia (46% vs 43%). However, in the breast, and trunk and extremities a better CR rate was noted with irradiation and heat (55% and 67%) than with irradiation alone (33% and 0). In lesions less than 3 cm treated with irradiation and heat the probability of remaining in response was 80% compared with 15% with irradiation alone. In lesions larger than 3 cm no difference in CR was observed in either treatment group. It has been hypothesized that the response rate is higher in patients with smaller lesions (less than 3 cm) and in breast/chest wall, trunk/extremity lesions because these tumors and anatomical sites are easier to heat adequately. Problems encountered in correlating tumor response with quality of heating include less than optimal heating in larger lesions and the limited ability of current thermometry to accurately represent the temperature distribution in a tumor. Furthermore, differences in equipment and treatment practices among institutions add to the variability in heat administration data collected. In addition, tumor response may be difficult to judge because of short survival of some patients and occasionally rapid tumor regression that may cause necrosis which may be misinterpreted as persistent tumor.(ABSTRACT TRUNCATED AT 400 WORDS)

Adult↗
PubMed1989

Regional hyperthermia for advanced tumors: a clinical study of 353 patients.

A Phase I study using deep regional hyperthermia (HT) with an annular phased array was conducted in 14 U.S. medical centers from 1980 through 1986. There were 353 patients whose average age was 57 years. All patients had advanced recurrent or persistent tumors. Prior frequently complex, multimodality anti-cancer therapy was received by 71% of the patients. Gastrointestinal adenocarcinoma was present in 146 (41%) patients, genitourinary tumors in 86 (24%), soft tissue sarcomas in 46 (13%), malignant melanoma in 21 (6%) and 15% had other tumors. The sites treated included: pelvis 55%, abdomen 21%, liver 14%, thorax 6%, and other sites 3%. All patients received deep regional HT with an average frequency of 55 MHz. A total of 1412 HT treatments was administered to these 353 patients with an aim to increase the temperature in the volume of interest to greater than 42 degrees C for greater than or equal to 30 minutes. Thermal dose (TD in equivalent minutes at 42.5 degrees C) was less than 50 in 104 (29%), greater than or equal to 50 less than 100 in 30 (11%), greater than or equal to 100 in 26 (7%), and greater than 200 in 34 (10%). The remaining 150 (42%) patients had TD = 0. In addition to HT, 260 (74%) received radiotherapy (RT). RT was given at 180 or 200 cGy daily with an average total dose of 33.4 Gy. A total of 42 (12%) patients were given chemotherapy (CT) with HT, and 15 (4%) CT + HT + RT/HT alone was given to 47 (13%) patients. Complete response (CR) was obtained in 35 (10%) and partial response (PR) in 59 (17%) patients. CR was 12% in patients who received RT, vs 2% in those who did not receive it, p = 0.003. Radiation dose was an important factor influencing response, p less than 0.001. Thermal dose was not an important parameter influencing tumor response. A duration of CR ranged from 4 to 73 weeks with an average duration of 31 weeks and the median duration of 28 weeks. The overall 2-year survival was 13% with the median survival of 42 weeks. Patients with CR and PR had a 2 year survival of 41%, and a median survival of 71 weeks. This compared with 8% 2-year survival and 24 weeks median survival in patients who did not have CR or PR, p less than 0.001. Of the patients presenting with significant pain, 62% had complete or partial pain relief.(ABSTRACT TRUNCATED AT 400 WORDS)

Adolescent↗
PubMed1989

Radiation therapy alone or combined with misonidazole in the treatment of locally advanced non-oat cell lung cancer: report of an RTOG prospective randomized trial.

From September 1979 to February 1983, 268 patients with unresectable, locally advanced (RTOG Stage III), non-small cell lung cancer were randomized to receive radiation therapy alone (RT) (50 Gy large field and 10 Gy boost), or combined with misonidazole (400 mg/m2 2-4 hr prior to RT daily for 5-6 weeks to a maximum dose of 12 g/m2 or until tumor progression). One hundred twenty-three patients who received irradiation alone and 116 given RT + misonidazole were evaluable for toxicity, time to tumor progression, and survival as of April 1987. The distribution of patient characteristics was similar in both treatment groups; 59% of the patients had a Karnofsky score of 90 or better, 53% had adenocarcinoma or large cell tumors, and 47% had Stage T3 tumors. Complete tumor regression was reported for 33 (27%) patients treated with radiation therapy alone and 24 (21%) who received misonidazole + RT. Median survival was 8 months with RT alone and 7.4 months with misonidazole + RT. Ninety-five percent of the patients have died. Seventy percent of the patients treated with radiation alone and 77% of those treated with misonidazole + RT died of progressive disease. Three patients treated with radiation alone and two with RT + misonidazole died subsequent to radiotherapy-related pneumonitis or pulmonary fibrosis. There was no significant improvement in response rates, local control, or survival for patients who received daily misonidazole along with irradiation compared with patients treated by irradiation alone.

Adenocarcinoma↗
PubMed1989

Deep regional hyperthermia of the liver. A clinical study of 49 patients.

From 1981 to 1986, six medical centers participated in feasibility studies of radiofrequency deep regional hyperthermia (HT) in the treatment of hepatic metastases. A total of 49 patients, 32 men and 17 women, were treated with an annular phased array. Colon was the primary site in 74% of the patients, and adenocarcinoma was the diagnosis in 80%. More than one half of the patients had been treated previously. This included chemotherapy (CT) in 17 patients and radiotherapy (RT) in 10 patients, with a mean RT dose of 24 Gy. Upper abdominal pain was the dominant presenting symptom in 53% of patients. In the study, treatment was administered as follows: 14 (28%) patients received HT alone, 17 (35%) received HT + RT, 14 (28%) received HT + CT, and 4 (8%) received HT + RT + CT. A total of 157 HT treatments was administered at a mean frequency of 55 MHz and a mean power of 780 watts. The number of HT sessions ranged from 1 to 8, with a mean of 3.2 treatments per patient. Temperature was monitored continuously throughout each treatment session. The treatment aim was to reach and maintain a temperature of 42.5 degrees C for 30 min. In practice, owing to the difficulty in reaching this temperature, an equivalent (lower) temperature from 40 to 42 degrees C was used, extending the duration of treatment sessions to 45-60 min. Thermal dose was defined as the number of minutes at 42.5 degrees C or its equivalent. In 21 (43%) patients, a temperature less than 40 degrees C was obtained and thermal dose = 0. Thermal dose was less than or equal to 50 in 17 (35%) patients, greater than 50 less than or equal to 100 in 7 (14%), and greater than 100 in 4 (8%). RT was given at a daily dose of 1.8 Gy to a total of less than 20 Gy in 14 patients, greater than 20 less than or equal to 30 Gy in 6, and greater than 30 Gy in 1. CT consisted of 5-Fluorouracil by way of Hepatic Artery Infusion (HAI) in 9 patients, i.v. cisplatin in 5, and doxorubicin HAI in 3. Objective tumor regression (CR + PR) was seen in 6 (12%) patients. An additional 10 (20%) patients had less than 50% greater than 25% tumor regression, and 10 (20%) had complete or partial pain relief. The median duration of CR and PR was 26 weeks.(ABSTRACT TRUNCATED AT 400 WORDS)

Adult↗
PubMed1989

Indeterminate mediastinal invasion in bronchogenic carcinoma: CT evaluation.

The computed tomographic (CT) scans of 80 patients with bronchogenic carcinoma classified as indeterminate for direct mediastinal invasion were retrospectively reviewed after the patients had undergone thoracotomy. Forty-eight (60%) of the masses were resectable, without invasion of the mediastinum, 18 (22%) focally invaded the mediastinum but were technically resectable, and 14 (18%) invaded the mediastinum and were not technically resectable. Although in most circumstances in this relatively small subset of patients CT was not helpful in differentiating masses with and without mediastinal invasion, CT was able to separate a large group of masses that were likely to be technically resectable. Thirty-six (97%) of 37 masses with one or more of these CT findings were considered technically resectable: contact of 3 cm or less with mediastinum, less than 90 degrees of contact with aorta, and mediastinal fat between mass and mediastinal structures. Of these 36 masses, 28 were resectable without mediastinal invasion, and eight were resectable with focal limited mediastinal invasion.

Adult↗
PubMed1989

Clinical trials with local (external and interstitial) irradiation and hyperthermia. Current and future perspectives.

There is a growing body of experience in the clinical use of either external or interstitial (local) hyperthermia. A great deal has been learned about the technical and prognostic factors that influence the efficacy of heat combined with irradiation. Despite some technologic advances, substantial limitations remain to the optimal delivery of heat and monitoring of the temperature throughout the treatment volume with localized techniques. Additional efforts to improve present equipment are paramount, and further studies should be encouraged to establish the optimal conditions for the delivery and temperature monitoring of local hyperthermia combined with irradiation or cytotoxic agents. It is possible to induce tumor regression and produce satisfactory palliative results in selected groups of patients with recurrent or advanced tumors. The clinical application of hyperthermia, particularly in previously irradiated patients, should be continued. Adequately designed clinical trials to amplify our understanding of this modality and its optimal clinical applications should be strongly supported.

Brachytherapy↗
PubMed1989

Regional hyperthermia in the treatment of recurrent deep-seated tumors: preliminary analysis of phase I trial.

This is a preliminary report on a phase I pilot study of regional hyperthermia of advanced tumors, using annular phased array system (APAS) in combination with radiation therapy and/or chemotherapy. All patients were treated without anesthesia. In all hyperthermia sessions, physiological parameters such as blood pressure, cardiac rate, respiratory rate, and EKG were monitored throughout the treatment. Tumor temperature was monitored with intratumoral probe with an additional probe either in the esophagus or rectum for monitoring systemic temperature. Present reports are on analysis of the first 30 patients: a total of 139 treatment sessions were analyzed. The results indicate local discomfort, anxiety, systemic temperature elevation, and tachycardia were the predominant factors limiting the number of sessions, the duration of sessions, and the deposition of power, in 18, 6, 6, and 2 patients, respectively. The complications were rare. No injuries to visceral organs clearly attributed to the hyperthermia have been recorded.

Combined Modality Therapy↗
PubMed1988

Analysis of dose fractionation in the palliation of metastases from malignant melanoma.

Sixty-five visceral metastases from malignant melanoma were treated with radiation therapy. A variety of total doses and dose fractions were used. Significant palliation was achieved in 40 of 65 (62%) symptomatic lesions. There was no correlation between total dose or dose fraction size and significant palliation. Brain and bone metastases were separately analyzed. Nineteen of 28 (68%) bone metastases were palliated. Appendicular bony metastases were more likely to be palliated than axial bony metastases (88% versus 60%). The palliation of bone metastases did not depend on total dose given or fraction size. Nine of 23 (39%) symptomatic brain metastases were palliated. There was no difference in the rate of palliation between solitary and multiple brain metastases. Palliation of brain lesions was not dependent on fraction size, although there was a trend to better palliation with higher total doses. These findings suggest that unlike treating cutaneous or nodal melanoma lesions for local control, there is no advantage in large fraction size when treating with palliative intent visceral melanoma lesions.

Bone Neoplasms↗
PubMed1988

Deep microwave hyperthermia for metastatic tumors of the liver.

Between 1981 and 1985, 44 patients with advanced metastatic carcinoma of the liver were treated with deep microwave hyperthermia (HT) in five medical centers in the US. This HT was given with a BSD-1000 Annular Phased Array (BSD Medical Corporation, Salt Lake City, Utah). Of the 44 patients treated, 18 (41%) were in poor general condition and scored less than 60 on the Karnofsky scale. In 50% upper abdominal pain was a major presenting symptom. Prior chemotherapy (CT) had been given in 12 (27%) patients, while 10 (23%) had received prior radiotherapy (RT). Colon (73%) was the most frequent site of the primary tumor, and adenocarcinoma (79%) was the most frequent histological diagnosis. A total of 150 HT treatments were given, with an average of 3.4. HT alone was administered to 12 (27%), HT-RT to 15 (34%), HT-CT to 13 (30%) and HT-RT-CT to four (9%). Therapeutic temperature was reached in 28 (64%) patients. The majority (66%) tolerated treatment well. Due to the poor general condition of over one-third of the patients, prior therapy in 50% and the presence of advanced tumor in all, it is not surprising to see a response rate of only 36%. The response rate was 53% among patients receiving RT in addition to HT and 46% in patients who had therapeutic temperature. Survival ranged from less than 1 to 63 months, with an average of 11 months. Relief of pain was observed in 8 of 22 patients who presented with this symptom. HT can be safely delivered to patients with metastatic tumor to the liver.(ABSTRACT TRUNCATED AT 250 WORDS)

Adenocarcinoma↗