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Biomedical subjects

B Emami

Publications and source records attributed to B Emami.

At least 55 records · Page 3Linked to original sources

Free colon transfer for resurfacing large oral cavity defects.

Ideal reconstruction of the oral cavity includes a durable lining that is thin, supple, and innervated, and that provides a lubricated surface that facilitates deglutition and speech. This paper describes the use of free colon transfer for relining the oral cavity. In three patients, segments of transverse colon, split along the antimesenteric border, were transferred as free flaps on the middle colic vessels for large defects involving the alveolar ridge, buccal mucosa, floor of the mouth, tongue, and pharyngeal walls. All flaps were transferred successfully without adverse vascular events, abdominal complications, or oro-cutaneous fistulas. One flap was re-elevated 2 weeks postoperatively for additional mandibulectomy. Two patients received postoperative radiation therapy and another patient received planned preoperative radiotherapy. The mucosal surface of the colon flattens to provide a thin, smooth, supple oral lining that produces moderate mucus, coapts well to the convoluted surfaces of the defects, and is durable to mastication and denture wear. Mucosal biopsy 2 years postoperatively in the nonradiated flap reveals normal colon mucosa with abundant mucin-producing cells. Free colon transfer is a "functional" reconstruction of the oral lining. The donor tissue is abundant and capable of resurfacing large, convoluted oral cavity surfaces with a thin, supple, mucus-secreting tissue that allows unimpaired tongue mobility, swallowing, speech, and denture wear. Furthermore, the presence of nonirradiated, mucus-secreting cells provides an avenue to further augment mucin production by topical and systemic agents.

Alveoloplasty↗

Squamous cell carcinoma of the pyriform sinus: a nonrandomized comparison of therapeutic modalities and long-term results.

From January 1964 through December 1991, 408 patients with squamous cell carcinomas involving the pyriform sinus were treated at Washington University Medical Center. Their ages ranged from 29 to 83 years (mean, 62.3; median 59) and the male to female ratio was 5:1. The mean duration of symptoms prior to diagnosis was 3.9 months (range 1 to 32 months) and 89% had a smoking or ethanol history. Sixty-seven percent had T3 or T4 lesions and 87% were stage III or IV at presentation. Sixty-nine percent had neck metastases. The treatment strategy varied with respect to radiation and reconstruction. Prior to 1978, preoperative radiation (3.5 to 5000 cGy) was used. Postoperative radiation was given thereafter (600+ Gy). Since 1982, flap reconstruction (usually pectoralis major myocutaneous) has been used to close the partial laryngopharyngectomy (PLP) defect. Almost all N0 necks were treated by radiation or surgery and all N1-N3 lesions were treated by combined therapy. Pyriform tumors were subdivided into three groups: 1. one-wall lesions (n = 48), 2. medial-wall lesions which involved the aryepiglottic fold or supraglottis (N = 267), and 3. two- or three-wall lesions which extended to the pyriform apex or post-cricoid region (N = 93). Ninety-five patients had single-modality therapy and 302 had combined treatment. Two hundred seven patients had conservation surgery (PLP) and 157 had total laryngopharyngectomy alone or in combination with radiation. Thirty-three patients were treated by radiation alone. Eleven patients were excluded from the study because of distant metastases (TxNxM1) at presentation. The cumulative survival (NED) at 5, 10, 15, and 20 years was 56%, 35%, 31%, and 20%, respectively. The cumulative locoregional control rate was 71%. At 5 years (NED), the cure rates for one-wall lesions (73%) were better than for medial-wall lesions (63%) or 2- and 3-wall lesions (49%). One-wall lesions were smaller, medial-wall lesions behaved similar to supraglottic tumors, and two- or three-wall tumors behaved as hypopharyngeal tumors. The cure rates were related to T stage with T1 + T2 > T3 + T4 (28%). Neck metastases reduced the cure rate by 26% and N1 > N2-N3 by an additional 12%. Other factors contributing to therapeutic failure were distant metastases (17.7%), second primary tumors (6.2%; oropharynx and lung were most common), and intercurrent disease fatalities (9.5%). The secondary therapeutic salvage rate was 44% for surgery and 32% for radiation therapy. The therapeutic complication rate was 19% with 3.6% leading to fatality.(ABSTRACT TRUNCATED AT 400 WORDS)

Adult↗

Squamous cell carcinomas of the aryepiglottic fold: therapeutic results and long-term follow-up.

Three hundred fifteen patients with squamous cell carcinomas involving the aryepiglottic (A-E) folds were treated between January 1964 and December 1991. The age ranged from 39 to 87 years (mean, 62.4 years; median, 61.3 years) and the male-to-female ratio was 5:1 (54 women and 261 men). Symptom duration prior to diagnosis was 4.8 months. Eighty percent of patients had T3 and T4 lesions and 56.3% had neck metastases at presentation. Six patients (1.8%) had distant metastases and were excluded from this study. Clinically the tumors presented as either exophytic infiltrating lesions which were confined to the A-E fold (n = 57) or mucosally spreading tumors which extended to the lateral supraglottis or pyriform sinus (n = 258). Prior to 1978 preoperative radiation (3000 to 5000 cGy) was used. Higher doses of postoperative radiation (5000 to 6000+ cGy) were used thereafter. After 1982 the use of myocutaneous flaps for closure of partial laryngopharyngectomy defects was routine. Almost all N0 neck disease was treated by radiation or surgery. Combined therapy was used in N1-N3 disease. One quarter of the patients had single-modality therapy (25.7%; 81 patients) with a cumulative 5-year disease-free survival of 53%. The remainder of the patients (n = 234) had combined therapy with a cumulative 5-year survival of 67.2%. The latter group had 163 conservation surgeries and 121 total laryngectomy resections. The 5-year disease-free survival for preoperative radiation with surgery (68%) and postoperative radiation with surgery (64%) was similar. Those treated by radiation alone had a 34% 5-year disease-free survival and those treated with surgery alone had a 61% 5-year disease-free survival. The cumulative locoregional control rate was 77%. The cumulative disease-free survival at 5, 10, 15, and 20 years is 66%, 57%, 55%, and 55%, respectively. Infiltrating tumors had a better disease-free survival (by more than 10%) than spreading tumors. The 5-year survival rates were separated well by clinical stages of tumors. In patients with T1 tumors the 5-year survival was 87%; in those with T2 tumors, 80%; in those with T3 tumors, 78%; and in those with T4 tumors, 41%. The survival rate was greater in those with N0 tumors than in those with N+ tumors by 25% and greater in those with N1 tumors than in those with N2 + N3 tumors by an additional 18%. The overall complication rate was 26% and in 7.7% these were fatal.(ABSTRACT TRUNCATED AT 400 WORDS)

Adult↗

Design of a fully integrated three-dimensional computed tomography simulator and preliminary clinical evaluation.

PURPOSE: We describe the conceptual structure and process of a fully integrated three-dimensional (3-D) computed tomography (CT) simulator and present a preliminary clinical and financial evaluation of our current system. METHODS AND MATERIALS: This is a preliminary report on 117 patients treated with external beam radiation therapy alone on whom a 3-D simulation and treatment plan and delivery were carried out from July 1, 1992, through June 30, 1993. The elements of a fully integrated 3-D CT simulator were identified: (a) volumetric definition of tumor volume and patient anatomy obtained with a CT scanner, (b) virtual simulation for beam setup and digitally reconstructed radiographs, (c) 3-D treatment planning for volumetric dose computation and plan evaluation, (d) patient-marking device to outline portal on patient's skin, and (e) verification (physical) simulation to verify portal placement on the patient. Actual time-motion (time and effort) recording was made by each professional involved in the various steps of the 3-D simulation and treatment planning on computer-compatible forms. Data were correlated with the anatomic site of the primary tumor being planned. Cost accounting of revenues and operation of the CT simulator and the 3-D planning was carried out, and projected costs per examination, depending on case load, were generated. RESULTS: Average time for CT volumetric simulation was 74 min without or 84 min with contrast material. Average times were 36 min for contouring of tumor/target volume and 44 min for normal anatomy, 78 min for treatment planning, 53 min for plan evaluation/optimization, and 58 min for verification simulation. There were significant variations in time and effort according to the specific anatomic location of the tumor. Portal marking of patient on the CT simulator was not consistently satisfactory, and this procedure was usually carried out on the physical simulator. Based on actual budgetary information, the cost of a volumetric CT simulation (separate from the 3-D treatment planning) showed that 1500 examinations per year (six per day in 250 working days) must be performed to make the operation of the device cost effective. The same financial projections for the entire 3-D planning process and verification yielded five plans per day. Some features were identified that will improve the use of the 3-D simulator, and solutions are offered to incorporate them in existing devices. CONCLUSIONS: Commercially available CT simulators lack some elements that we believe are critical in a fully integrated 3-D CT simulator. Sophisticated 3-D simulation and treatment planning can be carried out in a significant number of patients at a reasonable cost. Time and effort and therefore cost vary according to the anatomic site of the tumor being planned and the number of procedures performed. Further efforts are necessary, with collaboration of radiation oncologists, physicists, and manufacturers, to develop more versatile and efficient 3-D CT simulators, and additional clinical experience is required to make this technology cost effective in standard radiation therapy of patients with cancer.

Adult↗

Integrated software tools for the evaluation of radiotherapy treatment plans.

PURPOSE: This article announces the availability of a convenient and useful software environment for the evaluation of three-dimensional (3D) radiotherapy treatment plans. MATERIALS AND METHODS: Using standards such as American National Standards for Information Systems C and the X Window System allowed us to bring the computation and display of dose-volume histograms, dose statistics, tumor control probabilities, normal tissue complication probabilities, and a figure of merit together under one user interface. These plan evaluation tools are not stand alone, but must interact with a 3D radiation therapy planning system to obtain the required dose matrices and patient anatomical contours. Installation of the software involves a programmer who writes a software bridge between the radiation therapy planning system and the tools, thereby providing access to local data files. This design strategy confines portability issues to one area of the software. RESULTS: Access to the other tools is through the Graphical Plan Evaluation Tool (GPET). GPET coordinates the use of each of the tools and provides graphical facilities for display of their results. Importantly, GPET assures that the displayed results of each tool have been computed with the same input specifications for all treatment plans being compared. For added convenience, the user can rearrange the resultant data to be reviewed in various ways on the video screen. The software design also allows incorporation of customized algorithms and input data for computing tumor control probability and normal tissue complication probabilities, since those currently available are controversial. CONCLUSION: The Graphical Plan Evaluation Tool unifies the simultaneous computation for several analytical tools and graphical display of their results. Within the constraints of the X Window System environment, this assemblage of software tools provides a portable, flexible, and convenient method for the quantitative evaluation of several radiotherapy treatment plans.

Dose-Response Relationship, Radiation↗

Three-dimensional radiation treatment planning study for patients with carcinoma of the lung.

PURPOSE: Several reports in the literature suggest that local-regional control and possibly survival could be improved for inoperable nonsmall cell lung cancer if the radiation dose to the target volume could be increased. Higher doses, however, bring with them the potential for increased side effects and complications of normal tissues. Three-dimensional treatment planning has shown significant potential for improving radiation treatment planning in several sites, both for tumor coverage and for sparing of normal tissue from high doses of radiation and, thus, has the potential of developing radiation therapy techniques that result in uncomplicated local-regional control of lung cancer. We have studied the feasibility of large-scale implementation of true three-dimensional technologies in the treatment of patients with cancers of the thorax. METHODS AND MATERIALS: CT scans were performed on 10 patients with inoperable nonsmall cell lung cancer to obtain full volumetric image data, and therapy was planned on our three-dimensional radiotherapy treatment planning system. Target volumes were determined using the new ICRU nomenclature--Gross Tumor Volume, Clinical Target Volume, and Planning Target Volume. Plans were performed according to our standard treatment policies based on traditional two-dimensional radiotherapy treatment planning methodologies and replanned using noncoplanar three-dimensional beam techniques. The results were quantitatively compared using dose-volume histograms, dose-surface displays, and dose statistics. RESULTS: Target volume delineation remains a difficult problem for lung cancer. Defining Gross Tumor Volume and Clinical Target Volume may depend on window and level settings of the three-dimensional radiotherapy treatment planning system, suggesting that target volume delineation on hard copy film is inadequate. Our study shows that better tumor coverage is possible with three-dimensional plans. Dose to critical structures (e.g., the heart) could often be reduced (or at least remain acceptable) using noncoplanar beams even with dose escalation to 75 to 80 Gy for the planning volume surrounding the Gross Target Volume. CONCLUSION: Commonly used beam arrangements for treatment of lung cancer appear to be inadequate to safely deliver tumor doses of higher than 70 Gy. Although conventional treatment techniques may be adequate for tumor coverage, they are inadequate for sparing of normal tissues when the prescription dose is escalated. The ability to use noncoplanar fields for such patients is a major advantage of three-dimensional planning. This capability led to better tumor coverage and reduced dose to critical normal tissues. However, this advantage was achieved at the expense of a greater time commitment by the treatment planning staff (particularly the radiation oncologist) and a greater complexity of treatment delivery. In summary, three-dimensional radiotherapy treatment planning appears to provide the radiation oncologist with the necessary tools to increase tumor dose, which may lead to increased local-regional control in patients with lung cancer while maintaining normal tissue doses at acceptable tolerance levels.

Carcinoma, Non-Small-Cell Lung↗

Three-dimensional conformal radiotherapy in bronchogenic carcinoma: considerations for implementation.

Lung cancer continues to be a major health problem worldwide. In spite of significant technological and scientific medical progress, the final outcome of this disease is still dismal. Except for a small percentage of patients with early stage who undergo complete surgical resection, local control continues to be disappointingly low. In a recent report by Arriagada et al. (Arriagada R, Le Chevalier T, Quoix E, Rufie P, de Cremoux H, Douillard J-Y, Tarayre M, Pignon, J-P, LaPlanche, A. Effect of chemotherapy on locally advanced non-small cell lung carcinoma: a randomized study of 353 patients. Int J Radiat Oncol Biol Phys 1991; 20:1183-1190), biopsy proven local control by RT alone was only 17%. This team also found that the addition of combination chemotherapy, although it has decreased distant metastasis, has not had any impact on local control. There are some indications in the literature to suggest that higher doses of radiation to the target volume (tumor) may result in improved local control in inoperable non-small cell lung cancer. This temptation for increasing dose to target volume, however, should not result in inappropriate normal tissue side-effects and complications. Three-dimensional (3D) conformal radiation therapy has shown a significant potential for improving radiation treatment planning in several sites, both for tumor coverage and sparing normal tissue. Using this technology, progress in uncomplicated locoregional control of lung cancer may become a reality. The following is a review of literature and analysis of the currently available information on this subject.

Carcinoma, Bronchogenic↗

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↗

Advances in 3-dimensional radiation treatment planning systems: room-view display with real time interactivity.

PURPOSE: We describe our 3-dimensional (3-D) radiation treatment planning system for external photon and electron beam 3-D treatment planning which provides high performance computational speed and a real-time display which we have named "room-view" in which the simulated target volumes, critical structures, skin surfaces, radiation beams and/or dose surfaces can be viewed on the display monitor from any arbitrary viewing position. METHODS AND MATERIALS: We have implemented the 3-D planning system on a graphics superworkstation with parallel processing. Patient's anatomical features are extracted from contiguous computed tomography scan images and are displayed as wireloops or solid surfaces. Radiation beams are displayed as a set of diverging rays plus the polygons formed by the intersection of these rays with planes perpendicular to the beam axis. Controls are provided for each treatment machine motion function. Photon dose calculations are performed using an effective pathlength algorithm modified to accommodate 3-D off-center ratios. Electron dose calculations are performed using a 3-D pencil beam model. RESULTS: Dose distribution information can be displayed as 3-D dose surfaces, dose-volume histograms, or as isodoses superimposed on 2-D gray scale images of the patient's anatomy. Tumor-control-probabilities, normal-tissue-complication probabilities and a figure-of-merit score function are generated to aid in plan evaluation. A split-screen display provides a beam's-eye-view for beam positioning and design of patient shielding block apertures and a concurrent "room-view" display of the patient and beam icon for viewing multiple beam set-ups, beam positioning, and plan evaluation. Both views are simultaneously interactive. CONCLUSION: The development of an interactive 3-D radiation treatment planning system with a real-time room-view display has been accomplished. The concurrent real-time beam's-eye-view and room-view display significantly improves the efficacy of the 3-D planning process.

Computer Systems↗

Interruptions of high-dose radiation therapy decrease long-term survival of favorable patients with unresectable non-small cell carcinoma of the lung: analysis of 1244 cases from 3 Radiation Therapy Oncology Group (RTOG) trials.

PURPOSE: To determine if prolonged treatment time adversely affects survival for patients with inoperable non-small cell carcinoma of the lung. METHODS AND MATERIALS: Patients enrolled on three randomized studies (RTOG 8311, 8321, 8403) between 1983-1989 formed the database. Previous analyses found that the addition of thymosin (8321) or prophylactic cranial irradiation (8403) failed to prolong survival: both studies used thoracic irradiation with standard fractionation to 55-60 Gy in 30 fractions. In 8311, patients were treated by hyperfractionated radiation therapy to randomly assigned total doses of 60.0 Gy, 64.8 Gy, 69.6 Gy, 74.4 Gy or 79.2 Gy, 1.2 Gy twice daily, 5 days per week. Patients analyzed received +/- 4% of the assigned total dose and lived > 90 days (to ensure that all patients would have completed treatment). Completion < 5 days beyond protocol specifications was classified as "per protocol." Elapsed treatment time exceeding specifications by 5-9 days was a minor deviation, 10-13 days was a major deviation-acceptable, and > or = 14 days was a major deviation-unacceptable. Absolute survival was the endpoint to evaluate the effect of delays. The log rank statistic was used to test for survival differences in the univariate setting, the Cox regression model was used in the multivariate setting. RESULTS: Of 293 patients treated with standard fractionation, eight (2.7%) had deviations from the specified treatment time (six minor, two major-acceptable). With hyperfractionation, 90 (15%) patients had deviations (40 minor, 21 major-acceptable, 29 major-unacceptable). As the assigned dose increased, the deviation rate increased (9.7% for 60.0 Gy vs. 20.8% for 79.2 Gy). Survivals for hyperfractionation patients with any deviations in treatment time were significantly shorter than those treated "per protocol" (p = 0.16): estimated 2- and 5-years rates were 24% and 10% versus 13% and 3%, respectively. Multivariate analyses showed the delay effect to be entirely in patients treated with 69.6 Gy or higher; there was also dependence upon the patients' prognosis. In patients with favorable prognosis (KPS 90-100, weight loss < or = 5%, no N3), the difference in survival was pronounced (33% and 15% vs. 14% and 0% at 2- and 5-years, respectively). Such differences were not found in patients with unfavorable prognostic factors. CONCLUSIONS: Interruptions delaying completion of planned radiation therapy were more frequent with higher total doses (> or = 69.6 Gy). Favorable patients (high KPS, little weight loss, < N3 nodal metastasis) had markedly adverse effects on long-term survival associated with delays to completion of the planned total dose.

Adult↗

Radiation therapy alone for stage I non-small cell lung cancer.

PURPOSE: This paper is a retrospective analysis of patients with clinical Stage I non-small cell carcinoma of the lung treated with definitive radiation therapy alone. The results of therapy, patterns of failure and the relationship of technical aspects of the delivery of radiotherapy to outcome are presented. MATERIALS AND METHODS: From 1980 through 1990, 53 patients with Stage I non-small cell lung cancer were treated with definitive radiation therapy alone at the Radiation Oncology Center of the Mallinckrodt Institute of Radiology and its affiliated hospitals. All patients had a pathologic diagnosis of non-small cell lung cancer and were not candidates for surgical resection because of either patient refusal (10 patients), poor performance status (5 patients), or premorbid medical problems (38 patients). The median age was 73 years. Histologic cell type included squamous (32), adenocarcinoma (11), large cell (4), and unclassified non-small cell (6). Initial tumor size was < or = 3 cm in 23 patients, between 3 and 5 cm in 13 patients and > or = 5 cm in 17 patients. Diagnostic staging varied during the study period. All patients had chest X-rays and computed tomography scans of the chest. A majority had liver and bone scans, but only four underwent mediastinoscopy. The radiation therapy was of megavoltage energy in all patients, with a median primary prescription tumor dose of 63.2 Gy. Survival was measured from the date radiation therapy was initiated. RESULTS: The actuarial overall survival rate for the entire group was 19% at 3 years and 6% at 5 years, with a median survival time of 20.9 months. Of the 49 deaths, 35 died of lung cancer; 13 died of intercurrent illness, and one died of pancreatic cancer, which made the actuarial cause-specific survival 33% at 3 years and 13% at 5 years. The actuarial 3-year disease-free survival was 33%. Local primary tumor progression occurred in 22 patients, resulting in a 51% 3-year actuarial freedom from local progression. An additional four patients failed in regional lymph nodes that were included in the original treatment portals. Multivariate analysis found only T stage to be associated with overall survival (p = .02). However multivariate analysis showed age as a prognostic factor to be approaching statistical significance (p = .07). Patients under 70 years of age showed an increased survival rate compared to patients over 70 years. Radiation therapy doses > or = 65 Gy appeared to result in a decreased proportion of patients dying of lung cancer with no apparent increase in either acute or long-term complication rates. CONCLUSION: Results of definitive radiation therapy for inoperable Stage I non-small cell lung remain inferior to surgical therapy. Potential methods to improve local control with radiotherapy are discussed.

Adult↗

The influence of field size and other treatment factors on pulmonary toxicity following hyperfractionated irradiation for inoperable non-small cell lung cancer (NSCLC)--analysis of a Radiation Therapy Oncology Group (RTOG) protocol.

PURPOSE: The risk of pulmonary toxicity, observed in an Radiation Therapy Oncology Group Phase I/II randomized dose escalation trial of hyperfractionated irradiation for nonsmall cell lung cancer, was analyzed with regard to custom vs. hand blocking and compliance to protocol specified treatment field parameters. MATERIALS AND METHODS: There were 832 evaluable cases analyzed. The protocol required field margins 2 cm beyond primary tumor and involved nodes. In 674, the field margins were considered "per protocol" or as having minor protocol variations. In 94, margins exceeded protocol specification ("excessive margin" group). In this group, the area (cm2) of the effective (blocked) field and the portion including lung was measured from simulator films with a computer scanning device. Based on size and location of the primary and nodal disease, "per protocol" fields were constructed and the area (cm2) of lung included beyond these margins was estimated. Patients from both groups who received less than 30 Gy to normal lung were excluded from analysis of pulmonary toxicity. RESULTS: Grade 1 acute lung toxicity was higher (p = .009) in the "excessive margin" group compared to the "per protocol" group, whereas late lung toxicity was not significantly different (p = .94). The risk of Grade 2 or greater acute toxicity increased as area of excess irradiated lung increased. Overall lung toxicity, defined as the greater of either acute or late toxicity, was evaluated by multivariate analysis, in relation to assigned dose, effective treated field area, and type of shielding. Overall maximum lung toxicity (> or = Grade 2) was significantly greater in the "excessive margin" group, when lung treated beyond protocol margins exceeded an area of 35 cm2, than in the "per protocol" group, but only when the effective treated field size was > or = 180 cm2 (68% vs. 37%; p = .02). This effect was independent of assigned total dose or type of shielding. CONCLUSION: For nonsmall cell lung cancer treated with hyperfractionated irradiation, the risk of overall pulmonary toxicity was increased for patients treated with field sizes in excess of protocol specified margins of tumor coverage in comparison to patients treated with protocol specified margins. This effect was seen only when the area of lung treated beyond protocol margins exceeded 35 cm2 and when the overall field size was below 180 cm2.

Carcinoma, Non-Small-Cell Lung↗

A phase I/II study to evaluate accelerated fractionation via concomitant boost for squamous, adeno, and large cell carcinoma of the lung: report of Radiation Therapy Oncology Group 84-07.

PURPOSE: A Phase I/II trial was conducted by the Radiation Therapy Oncology Group from 1984 to 1989 for 355 evaluable patients with non-small-cell lung cancer to assess tolerance to and efficacy of accelerated fractionation irradiation via concomitant boost. METHODS AND MATERIALS: "Large" fields (primary tumor and locoregional lymph nodes) received 1.8 Gy followed after 4 to 6 hr by 1.8 Gy two to three times weekly to reduced "boost" fields (primary and involved nodes only). The total doses escalated during the study and started with 63 Gy in 5 weeks (45 Gy "large" field and 18 Gy "boost") for 61 patients. After follow-up for ongoing toxicity assessment, the total dose was increased to 70.2 Gy in 5.5 weeks (50.4 Gy "large" field and 19.8 Gy "boost") for the next 180 patients. The last 114 patients received 70.2 Gy in 5 weeks (45 Gy "large" field and 25.2 Gy "boost"). RESULTS: Pretreatment patient characteristics were well balanced between the three treatment arms. Grade 3 acute toxicity was 7% for the 63 Gy arm; it was 14% and 17% for the two 70 Gy arms. Grade 4 or greater acute toxicities (esophagitis and pneumonitis) were 2 to 3% for all three arms. Late toxicities ranged between 5 and 9% (> or = Grade 3) and 0 to 2% (> or = Grade 4), not statistically different among the three arms. There was no difference between the three regimens in median survival (9 months) or 1-year survival (39 to 44%). However, the 2-year survivals ranged from 16% (63 Gy) to 21% ("shortened" 70.2 Gy). Among 176 patients who had the same criteria as Cancer and Leukemia Group B protocol 84-33 (American Joint Committee on Cancer Staging, 1984, Stage III; Karnofsky performance status 70 to 100; < 6% weight loss), the 2-year survival rates ranged from 18 to 22%. CONCLUSION: Concomitant boost accelerated fractionation irradiation regimens for non-small cell lung cancer may offer improved long-term survival without enhanced late toxicity. While acute toxicity is somewhat increased, further refinement of the relationship of "large" to "boost" field doses may improve the therapeutic ratio. Further Phase I/II testing seems justified and necessary, before concomitant boost accelerated fractionation irradiation is tested in Phase III trials for NSCLC.

Adenocarcinoma↗

Analysis of early and late deaths on RTOG non-small cell carcinoma of the lung trials: comparison with CALGB 8433.

UNLABELLED: In a major study that showed a treatment advantage for induction chemotherapy followed by radiation therapy (CALGB 8433), there was a significantly (P = 0.02) lower proportion of patients dying within 105 days of registration in the chemotherapy/radiation arm than the radiation therapy arm; without this difference, the overall survival was marginally better (P = 0.059) for the chemotherapy/radiation group. A retrospective analysis of RTOG trials sought explanations for the phenomenon. MATERIALS AND METHODS: Patients who fit the CALGB eligibility criteria and received radiation therapy alone in four prospective trials of the RTOG conducted between 1983 and 1989 were analyzed to determine factors that distinguished patients dying within 105 days from longer survivors. Two were trials of altered fractionation and two used standard fractionation. Of 683 patients identified, 107 (15.7%) died within 105 days after registration. The log linear model was used to evaluate relationships between death within 105 days and known prognostic factors. Karnofsky performance status (KPS), < 90 vs. > or = 90, was the only factor significantly related to death within 105 days (P = 0.0052). A Cox model with the same factors plus fractionation and total dose found KPS and T-stage associated with overall survival (P = 0.0005 and 0.025, respectively). The choice of the hyperfractionation arm (HFX) for Phase III study (69.6 Gy at 1.2 Gy b.i.d.) was based in part on comparison with standard fractionation (STD) from a concurrent RTOG protocol, 8321. Review of early deaths showed that this HFX arm had a lower proportion of patients dying within 105 days (7.9%) than STD in 8321 (21.0%).(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗