Clinical Outcomes of a Team Approach to Thyroidectomy.

OBJECTIVE: The aim of this study is to assess the rates of thyroidectomy complications performed by two attending surgeons operating together. STUDY DESIGN: This is a retrospective chart review. METHODS: This is a retrospective chart review from September 2008 through October 2013 of thyroidectomy cases performed by the head and neck team at Sanford Health. The primary intervention was the presence of two head and neck attendings during each procedure. Outcomes assessed include rates of temporary and permanent recurrent laryngeal nerve paralysis, and of permanent hypocalcemia. RESULTS: There were 282 patients that underwent a thyroid procedure with a total of 449 at-risk nerves. There were five (1.1 percent) cases of transient vocal cord paresis. There was one case (0.22 percent) of permanent vocal cord paresis after planned nerve resection in a patient with anaplastic thyroid carcinoma. There were no other cases of permanent vocal cord paresis. Of 156 total thyroidectomy cases, there was one case of chronic hypocalcemia (0.64 percent). CONCLUSIONS: A two-surgeon approach to thyroidectomy produces excellent functional outcomes. Further investigation into cost-effectiveness is warranted.

Obesity and perioperative complications in head and neck free tissue reconstruction.

BACKGROUND: Free tissue transfer is a mainstay in reconstruction of complex head and neck defects. The purpose of this study was to determine if perioperative complications were more common in patients with body mass index (BMI) >30 kg/m(2) undergoing free flap reconstruction. METHODS: A multi-institutional retrospective cohort was created. Medical complications, surgical complications, and procedural variables were recorded. Logistic regression was used to investigate univariate and multivariate associations between outcomes and predictors. RESULTS: Of 582 cases, 128 patients (22%) had BMI >30. Surgical complications occurred in 153 cases (26.3%), with an adjusted odds ratio (OR) for association of surgical complications with BMI >30 of 0.92 (p = .71). Medical complications occurred in 178 cases (30.6%), with an adjusted OR of 0.78 (p = .26). Age and advanced comorbidity status (Adult Comorbidity Evaluation-27 [ACE-27] 2 or 3) were associated with medical complications (p < .0001). CONCLUSION: BMI >30 does not predict medical or surgical complications in patients undergoing head and neck free flap surgery. © 2015 Wiley Periodicals, Inc. Head Neck 38: E1188-E1191, 2016.

Radiation palliation of cervical cancer.

Radiation is a useful modality for palliation of local-regional disease in patients with cervical cancer who require palliation because of distant metastases, extensive local-regional disease, medical consideration, or patient concerns. Two radiation schedules have been reported on for the treatment of advanced pelvic disease including cervical cancer. The large single-dose schedule consisted of 10-Gy fractions repeated at monthly intervals to a maximum of 30 Gy. This schedule has produced good palliative results with symptomatic improvement in approximately 50% of patients and objective response in 35%-80%. However, severe late toxicity was shown to be as high as 42% (actuarial). The second schedule tested by the Radiation Therapy Oncology Group consisted of 3.7-Gy fractions given twice a day for 2 days (14.8 Gy) repeated after 2-4 weeks for a maximum of 44.4 Gy. There were 284 patients accrued, and the subgroup of 61 cervical cancer patients is analyzed in this article. The subjective response (50%-100% complete response) and objective response (53%) were similar to those observed with the large single-fraction schedule. The late toxicity was significantly lower (7%-actuarial). For patients who may survive 6 months or longer, this second schedule is preferable.

Effect of field shaping on thermal pattern produced by external microwave.

Modification of external microwave heating pattern can be useful clinically to reduce undesired coupling to adjacent bone or soft tissues particularly in the head and neck region. A static phantom was used to measure the effect of symmetric and asymmetric shielding of part of the microwave field from a BSD MA 150 microwave applicator. Thermal patterns were altered in a reliable predictable pattern. This method has been used clinically with improved patient tolerance.

Evaluation of unplanned interruptions in radiotherapy treatment schedules.

One of the major radiobiological interests has been to maximize the effectiveness of the time-dose relationship in the clinical setting. Current explorations include altered fractionation schedules, multiple daily fractions and hypofractionation. Patient compliance to standard radiotherapy treatment schedules is taken for granted. To evaluate the true rate of compliance, the charts of all new patients treated from July 1, 1984 through June 30, 1985 were reviewed. The overall incidence of unplanned interruptions was 54% (361/668). The frequency of interruptions is significantly higher in patients treated to the primary site as compared to those treated for metastasis (59.8% and 35.6% respectively). The duration of the interruptions varied: 12.7% of the patients missed only 1 day, 25% missed 2 to 5 days, 38% had interruptions totalling 6-15 days, and in 24% the total exceeded 15 days. The most frequent cause of the unplanned interruptions was a rest resulting from unusually adverse tissue reactions (46.8%-169/361). Although this study has documented that unplanned interruptions are a major problem, the impact on local control and survival cannot be determined from our data. A retrospective review of multi-institutional studies such as those conducted by the Patterns of Care or RTOG might show that one of the major causes of failure is unplanned interruptions.

Incidence of complications with mini vaginal culpostats in carcinoma of the uterine cervix.

Between 1980 and 1987, 298 patients with carcinoma of the uterine cervix were treated at the University of Louisville Department of Radiation Oncology. Of these, 197 (66.1%) were treated for cure by radiotherapy alone: 36 by external beam alone and 161 by external beam and tandem and ovoid applications. The F.I.G.O. staging of the 161 patients was 82 (50.1%) Stage IB, 9 (5.6%) Stage IIA, 40 (24.9%) Stage IIB, and 30 (18.6%) Stage III. The usual treatment was whole pelvis irradiation followed by two intracavitary applications using the Fletcher Suit Applicators of tandem and ovoids in 79/161 patients (49%), a 3-M Mini Applicator (Fletcher Suit Delcos Applicator) in 52/161 patients (32.3%), and a 3-M Mini Applicator with Caps in 30/161 patients (18.6%). The incidence of grade 3-4 gastrointestinal or genitourinary complications as defined by the RTOG was 19.3% (31/161). Various treatment parameters were analyzed to define possible contributing factors. Grade 3-4 complications were seen in 7.6% (6/79) of patients treated with the standard ovoid Fletcher system, 26.9% (14/52) treated with the mini-ovoid system, and 36.6% (11/30) treated with the mini-ovoid system with caps (p = .0006). Although trends were noted, neither the vaginal surface dose (VSD) from the ovoids nor the addition of the external beam dose to the VSD (total vaginal surface dose = TVSD) were significant independent variables (p = 0.19 and = 0.133, respectively). The TVSD was significant when comparisons were made between different ovoid systems (p = 0.05 for less than 12,000 cGy and p = 0.004 for greater than 12,000 cGy). In this study, the 3-M mini applicator was associated with a significant increase in grade 3-4 complications as compared to the Standard Fletcher Suit Applicator.

Phase II study of multiple daily fractionations in the palliation of advanced pelvic malignancies: preliminary report of RTOG 8502.

This Phase II protocol was designed around the format of a previously reported study for the palliation of advanced pelvic malignancies (RTOG 7905). The large dose per fraction (1000 cGy) of the first study unexpectedly demonstrated frequent late gastrointestinal toxicity and was replaced in the present study by 2 days of twice daily fractionation (370 cGy/fraction totaling 1480 cGy/course) based on linear quadratic consideration of acute and late toxicities. The interval between courses of 4 weeks was retained and the total dose for three courses was 4440 cGy. A total of 152 patients were entered of which 142 have sufficient follow-up information for analysis. Fifty-nine percent of the patients completed all three courses, 20% completed two courses, and 20% received only one course. The primary sites were: gynecological (39.4%); colorectal (32.4%); genitourinary (24.7%); and other (2.8%). The best overall response was: complete remission (10%); partial remission (22%); no change (24%); progression (10%); and unknown (27%). For the patients completing all three courses, the response was: complete remission (14%); partial remission (31%); no change (40%); progression (7%); and unknown (8%). Median survival was 4.5 months and the actuarial survival at 12 months is 19%. In RTOG 7905, 90% of the late toxicities appeared by 12 months. For RTOG 8502, there were 32 patients alive at 9 months and 19 patients alive at 12 months available for evaluation of late toxicity. There has been one late grade 3 GI toxicity reported and only one acute grade 3 gastrointestinal toxicity. Even if the true rate of late toxicity for 8502 were 20%, the chance of seeing none or one toxicity would be 0.007. This toxicity report represents a marked reduction of the grade 3 and 4 late toxicity seen in RTOG 7905 (37% at 9 months and 45% at 12 months) without lowering the tumor response rate. The interval between courses in both protocols allows for potential tumor proliferation. To test for the effect of tumor proliferation, RTOG 8502 is continuing as a Phase III randomization between 4 weeks and 2 weeks separation.

Phase I-II study of multiple daily fractions for palliation of advanced head and neck malignancies.

PURPOSE: To assess palliation of advance head and neck malignancies with the use of rapid hyper fractionation studies similar to the RTOG 85-02. MATERIALS AND METHODS: 37 patients with 39 lesions were entered into the non-randomized Phase I-II protocol, between 1984 and 1991. Previously untreated malignancies were present in 24 lesions, primary recurrent diseases in six patients, metastasis to the head and neck in five patients and skin primaries in the remaining two cases. At presentation 15 of 37 patients (or 17 of 39 lesions) were in operable due to poor medical status, eight patients were considered technically in operable due to extent of disease, 10 patients had distant metastasis and four patients refused surgery. The protocol uses twice a day fraction (370 cGy per fraction) for 2 consecutive days totalling 1,480 cGy per course. Three courses were given at 3-week intervals for a final tumor dose of 4,440 cGy in twelve fraction over 8-9 weeks. RESULTS: Eleven of 39 lesions had complete response; 19 lesions had partial response; 4 lesions had no response; 3 lesions progressed under treatment. Response could not be assessed in two patients. The average survival after completion of therapy was 4.5 months ranging from 2 weeks to 31 months. Palliation was achieved in 33 of 39 lesions. The acute reactions were minimal and no late or long term complications were noted. CONCLUSION: The absence of significant complications with reasonable response in the high rate of palliation suggests that this rapid hyper fractionation palliation study should be studied for further evaluation.

Palliation of advanced pelvic malignant disease with large fraction pelvic radiation and misonidazole: final report of RTOG phase I/II study.

Between October 1979 and June 1982 forty-six patients were entered on a non-randomized Phase I-II protocol for the evaluation of Misonidazole combined with high dose per fraction radiation for the treatment of advanced pelvic malignancies. Pelvic radiation consisted of 1000 cGy in one fraction repeated at 4-week intervals for a total of three treatments. Oral Misonidazole at a dose of 4 gm/m2 was administered 4-6 hr prior to radiation (total dose 12 g/m2). The distribution of histology consisted of 20 gynecologic, 24 bowel, and 2 prostate malignancies. Of the thirty-seven patients completing the three treatments; there were 6 complete responses (14% CR), 10 partial responses (27% PR) 19 minimal or no response (32% NR), and 4 unevaluable. One patient remains NED 5.5 years following radiation. Toxicity directly related to Misonidazole was minimal and consisted primarily of transcient Grade 1, 2 peripheral neuropathy (20% Grade 1, 4% Grade 2) and Grade 2 ototoxicity (4%). Radiation toxicity was significant for late bowel damage. There were 4 (11%) Grade 3 and 7 (19%) Grade 4 gastro-intestinal (GI) toxicities. Kaplan-Meier plot of GI toxicity showed a progressive increase in incidence with time for projected rate of 49% Grade 3, 4 by 12-month. GI toxicity (Grade 3, 4) was also related to tumor response. The complication rate was 80% (4/6) for CR, 30% (3/10) for PR and 26% (5/19) for NR or progression. Because of the GI complication rate, this protocol for palliation of advanced pelvic malignancies has been replaced by a protocol that uses 4 fractions over 2 days (b.i.d.) of 370 cGy per fraction repeated at 3-week intervals for a total of 3 courses.

Treatment of locoregionally advanced breast cancer with surgery, radiotherapy, and combination chemoimmunotherapy.

Fifty-two patients with locally advanced primary breast cancer (T3, T4, N2, N3) but no evidence of distant metastases were treated with three cycles of combination chemotherapy. The regimen consisted of 5-fluorouracil, Adriamycin, cyclophosphamide, and Bacillus Calmette-Guerin (FAC-BCG), followed by local therapy (simple mastectomy and/or radiotherapy to the breast/chest wall and the regional lymphatic system) and adjuvant chemotherapy for two full years. The results were compared with those in an historical control group of 52 patients matched for initial stage of disease who were treated by a simple mastectomy and postoperative radiotherapy only. Forty-nine (94%) of 52 FAC-treated patients and 48 (92%) of the control patients became free of clinically detectable disease. At the median follow-up time of 56 months, 37.5% of the FAC-treated patients and 19.5% of the control patients had remained free of disease. FAC-treated patients who completed 2 years of therapy and in whom adjuvant chemotherapy was started promptly after local treatment had a 48% disease-free survival rate of 4 years. In those in whom the initial manifestation was supraclavicular involvement, the estimated 5-year disease-free survival rate was 42% for patients treated with FAC and 9% for control patients. There were local recurrences in 25% of FAC-treated patients and 23% of control patients (not significant). Distant metastases developed in 50% of FAC-treated patients and 77% of control patients (p less than 0.01). The median disease-free interval was 25 months in the FAC-treated group and 11 months in the control group (p = 0.025). The greatest improvement in prognosis was in patients with supraclavicular involvement; the median disease-free survival was 26 months in FAC-treated patients and 6 months in the control group (p = 0.007). This multimodal approach effectively renders the majority of patients with locoregionally advanced breast cancer free of disease and prolongs the disease-free survival period.

RTOG 96-10: reirradiation with concurrent hydroxyurea and 5-fluorouracil in patients with squamous cell cancer of the head and neck.

PURPOSE: Patients with recurrent squamous cell cancer of the head and neck (SCH&N) are generally treated with systemic chemotherapy. Improvement in survival has not occurred, despite an increased objective response rate. This study was undertaken to explore the feasibility and toxicity, and estimate the therapeutic impact of, reirradiation (RRT) with concurrent hydroxyurea and 5-fluorouracil. METHODS AND MATERIALS: The eligibility requirements included SCH&N presenting as a second primary or recurrence > or =6 months after definitive RT to > or =45 Gy, with > or =75% of the tumor volume within the previous field. The cumulative spinal cord dose was limited to 50 Gy, and measurable disease was required. Four weekly cycles were given, each separated by 1 week of rest. A cycle consisted of 5 days, Monday through Friday, of 1.5-Gy twice-daily repeated RT, with the fractions separated by > or =6 h, with 1.5 g of hydroxyurea given 2 h and 300 mg/m2 of a 5-fluorouracil IV bolus given 30 min before each second daily fraction. RESULTS: Eighty-six patients were entered; 81 patients were assessable. The median prior radiation dose was 61.2 Gy. The 4 planned cycles were delivered in 79% of patients. Grade 3 mucositis occurred in 14% of patients, and Grade 4 in 5%. Grade 3 acute pharyngeal toxicity was seen in 17%. Grade 3 neutropenia occurred in 9%, Grade 4 in 10%, and Grade 5 in 7%. Six patients died of treatment-related toxicity. Two died of hemorrhage from the tumor site without thrombocytopenia. With a median follow-up of 16.3 months for living patients, the estimated median overall survival was 8.2 months and the estimated 1-year survival rate 41.7%. Patients treated >3 years after the previous RT had a 1-year survival rate of 48% compared with 35% for patients treated within 3 years (p = 0.017). The 1-year survival rate for patients with a second primary was 54% compared with 38% for patients with recurrence (p = 0.083). CONCLUSION: Repeated RT with concurrent chemotherapy as given in this study is a feasible approach for selected, previously irradiated patients with SCH&N and may produce increased median and 1-year survival rates compared with systemic chemotherapy trials reported in the literature. A randomized study should be conducted to compare these two different approaches.

Late effect of multiple daily fraction palliation schedule for advanced pelvic malignancies (RTOG 8502).

PURPOSE: Determine late complication incidence for pelvic palliation using accelerated multiple daily fraction radiation [Radiation Therapy Oncology Group (RTOG) 8502]. METHODS AND MATERIALS: Prospective evaluation of a palliative radiation schedule for advanced pelvic malignancies was conducted from 1985 to 1989 by RTOG 8502. The dose was 44.40 Gy in 12 fractions (3.7 Gy BID) with a rest after 14.80 Gy and 29.60 Gy. The pilot part of the study allowed for a variable rest interval of 3-6 weeks. The rest interval was then randomized between 2 and 4 weeks to determine effect on tumor control. No difference in tumor control was identified (p = 0.59). The pilot segment accrued 151 patients and the randomized segment accrued 144 patients. A total of 290 cases were analyzable (four ineligible or canceled) for late effects. To minimize actuarial bias, only patients surviving 90 days (193) were analyzed for late effect risk. The primary site consisted of gynecologic (40%), colorectal (28%), genitourinary (25%), and miscellaneous (7%). The extent of tumor consisted of pelvis only (62%) and additional tumor outside the pelvis (38%). Most of the patients were elderly (76% > 60 years, 47% > 70 years). Karnofsky performance status (KPS) was > or = 80 in 60% of patients and < 80 in 40%. RESULTS: None of the patients with < 30 Gy (less than three courses) developed late toxicity. A total of 11/193 (6%) developed Grade 3+ late toxicity (nine Grade 3, one Grade 4, one Grade 5). Actuarial analysis of complication rate by survival time for Grades 3, 4, and 5 shows a cumulative incidence for complications after 6 months that plateaus at 6.9% by 18 months. The cumulative incidence for Grades 4 and 5 is 2.0% by 12 months. The difference in late effect for the 2-week rest vs. 4-week rest was not statistically different (p = .47). Patient factors evaluated for increased risk of late complications included prior surgeries, age, sex, KPS and primary. None were found to have significant statistical correlations with late effects. CONCLUSION: The crude late complications rate is 6%. Actuarial analysis using cumulative incidence shows 6.9% by 18 months. This represents a significant decrease in late complications from 49% seen with higher dose per fraction (10 Gy x 3) piloted by Radiation Therapy Oncology Group (7905) for a similar group of patients. Long-term analysis of late complication indicates this schedule can be used in the pelvis with relatively low incidence of complication. This schedule has significant logistic benefits and has been shown to produce good tumor regression and excellent palliation of symptoms.

Late injury of cancer therapy on the female reproductive tract.

The purpose of this article is to review the late effects of cancer therapy on the female reproductive tract. The anatomic sites detailed are the vulva, vagina, cervix, uterus, fallopian tubes, and ovaries. The available pathophysiology is discussed. Clinical syndromes are presented. Tolerance doses of irradiation for late effects are rarely presented in the literature and are reviewed where available. Management strategies for surgical, radiotherapeutic, and chemotherapeutic late effects are discussed. Endpoints for evaluation of therapeutic late effects have been formulated utilizing the symptoms, objective, management, and analytic (SOMA) format. Late effects on the female reproductive tract from cancer therapy should be recognized and managed appropriately. A grading system for these effects is presented. Endpoints for late effects and tolls for the evaluation need to be further developed.

Effect of rest interval on tumor and normal tissue response--a report of phase III study of accelerated split course palliative radiation for advanced pelvic malignancies (RTOG-8502)

From August 1985 through September 1989, 284 patients with advanced pelvic malignancies were entered into a trial (RTOG 8502) of palliative split course radiation (4440 cGy in three courses of 1480 cGy/2 days/4 fractions with a rest of 2-4 weeks between courses). The initial 148 patients were part of a Phase II acceptable response rate and minimal acute or late toxicity (IJRBP 17:659-662, 1989). The present analysis is a report of the subsequent 136 patients randomized between rest intervals of 2 weeks versus 4 weeks to determine if length of rest would influence tumor response or patient toxicity. The patients were stratified for performance status (Karnofsky Performance Status) and histology. The patients were evenly matched for age and sex. There was a trend toward increased acute toxicity incidence in patients with shorter rest interval (5/68 versus 0/68; p = .07). Late toxicity was not significantly different between the two groups. Decreasing the interval between courses did not result in a significant improvement in tumor response (CR+PR = 34% vs. 26%, p = n.s.). More patients in the 2 week groups completed all three courses (72% vs. 63%). Not surprisingly, patients completing cell three courses had a significantly higher overall response rate than for patients completing less than three courses (42% vs. 5%) and higher complete response rate (17% vs. 1%). A multivariate analysis indicated performance status as the significant predictor for number of courses completed. For Karnofsky Performance Status greater than or equal to 80, the survival at 12 months was 40% for the 2 week interval and 25% for the 4 week interval. Performance status and histology were the only significant variables in a multivariate analysis of survival.

Endoscopic implantation of iridium wire for treatment of carcinoma of the bile duct.

Primary bile duct carcinoma presents serious challenges in management. These tumors are often not completely resectable. They frequently lead to death by producing obstruction to bile flow and hepatic failure. Initial operations frequently fail because of progression of primary disease. Although bile duct carcinomas respond to radiation, technical constraints limit delivery using an external beam technique. A number of studies have appeared in the literature describing the use of local irradiation delivered by way of catheters placed intraoperatively. In the present study, we have described an alternative method of implantation using a simple endoscopic technique utilizing a choledochojejunocutaneous fistula for access. The advantage of their approach is that the extent of the tumor can be determined visually and biopsy performed, facilitating accurate implant placement. In addition, serial examinations may allow early detection of recurrent disease and fecal retreatment.

Results of irradiation in patients with high-grade gliomas evaluated by magnetic resonance imaging.

Evidence shows that most high-grade gliomas are a diffuse process. Prior studies reported a median survival with surgery and postoperative radiotherapy of 8.6 months for glioblastoma multiforme (GBM) and 36.2 months for anaplastic astrocytoma (AA). Since MRI delineated the glioma better than CT scan, using MRI-based radiotherapy treatment planning allows for more precise treatment volumes. We retrospectively reviewed the records of the first 36 patients with malignant glioma, who had a presurgery MRI-based radiotherapy treatment planning. These patients were diagnosed between January 1986 and February 1991. Minimum follow up was 14 months and median survival was 15.4 months for GBM (7-42 months) and 27.4 months for AA (7-53 months). We feel that the trend for increased median survival in GBM (15.4 vs 8.6 months) is partly due to better definition of the tumor volume by using MRI. Larger studies are needed to confirm this finding.

Radiation therapy for pituitary adenomas. A retrospective study of the University of Louisville experience.

A retrospective analysis of treatment outcome was performed on patients treated with radiation for pituitary adenomas at the University of Louisville from January 1988 to December 1992. The study population included 27 patients. Twenty received radiation as a component of their initial treatment while seven received radiation as part of their treatment for recurrent disease. Nineteen patients were treated with post-operative radiation, and eight were treated with radiation alone. Follow-up interval ranged from 1 month to 109 months, with a median of 28 months. All three patients with stage I disease were controlled with radiation alone (1/3) or combined surgery and postoperative radiation (2/3), whereas six of eight stage II patients had disease control following surgery and postoperative radiation. Both patients with stage III adenomas treated with radiation alone had local control, whereas local control was achieved in six of seven with post-operative radiation. Three of five patients with recurrent disease had local control with radiation alone, whereas both patients undergoing surgery and postoperative radiation had local control. This retrospective analysis supports previous findings that radiation therapy alone or combined with transphenoidal resection is effective in long-term control of pituitary adenomas. It further suggests that immediate radiation therapy may be superior to radiation for surgical or medical failures.

Misonidazole combined with large-fraction pelvic irradiation in the treatment of patients with advanced pelvic malignancies. Preliminary report of an ongoing RTOG phase I-II study.

Between October 1979 and January 1982, a total of 39 cases were entered on a nonrandomized phase I-II protocol for the evaluation of misonidazole combined with radiation in the treatment of patients with advanced pelvic malignancies of multiple gynecological and gastrointestinal origin. Patients were treated with pelvic irradiation using a dose of 1000 rad in one fraction every 4 weeks for a total of three treatments. Oral misonidazole at a dose of 4 g/m2, was administered 4-6 hours prior to the radiation treatment (total dose, 12 g/m2). Of the 39 patients entered, 25 have completed the three doses of radiation and have had at least one follow-up after the third treatment. Eight patients have had insufficient follow-up information for evaluation and five patients did not complete three doses of radiation but have follow-up. One patient was excluded from the study. Among the 30 patients with follow-up, there were four complete responses (13.3%) and seven partial responses (23.3%). Two patients showed no response, and 17 experienced progression of disease. Follow-up time ranged from 2 to 16 months. The most frequent toxicity in the study has been nausea and vomiting. There were eight cases of neurotoxicity reported: ototoxicity grade 1 (one patient), peripheral neuropathy grades 1 and 2 (six patients), and C.N.S. toxicity grade 2 (one patient). Toxicity from radiation was difficult to separate from the presenting symptomatology. In the 30 patients with follow-up information, eight cases of abdominal sequelae were seen with five of them major complications (perforation, obstruction, and abscess). Early information from the study indicates the following: The most frequent morbidity at this point is acute nausea and vomiting. This level of nausea is consistent with the protocol dose of misonidazole. From the evaluable patients, 5/30 (17%) have developed major bowel problems requiring surgery. At the time of this report, this protocol remains open for case accession.

Pediatric astrocytomas. The Louisville experience: 1978-1988.

PURPOSE: The purpose of this study is to retrospectively analyze all pediatric patients with the diagnosis of astrocytoma treated either definitively or postoperatively in our department from 1978 through 1988. Grade, age, T-stage, tumor location, and extent of resection are individually analyzed as prognostic indicators of overall survival. MATERIALS AND METHODS: Pediatric astrocytoma patients (grades I-IV) diagnosed by CT-guided biopsy or surgical resection were assessed. Patients were treated with external beam radiotherapy to involved fields using 4- or 6-MV photons. Daily doses ranged from 1.5 to 2.0 Gy; total doses from 41.4 to 66 Gy. Treatment was given to 17 patients (9 male, 8 female), aged 18 years and younger: 11 patients had low-grade (I & II) astrocytoma with incomplete margins; 3 patients had anaplastic astrocytoma; and 3 patients had glioblastoma multiforme. RESULTS: Overall survival at 140 months was 63%. Median follow-up of patients living NED was 69 months, with a range of 39-140 months. Nine of the eleven (82%) low-grade patients survived NED; 1 of 3 anaplastic patients is NED at 44 months follow-up; 1 died of intercurrent disease at 80 months; the third died of disease at 49 months. All three glioblastomas succumbed to local disease at 9, 15, and 27 months from diagnosis. Univariate analysis showed only grade to be prognostically significant (p < .03) in determining overall survival. CONCLUSION: Postoperative radiotherapy for unresected or partially resected low-grade astrocytomas produces excellent local control. Higher grade astrocytomas require further investigational studies to improve survival and local control. Grade is prognostically significant with respect to overall survival.

Commissioning of a mobile electron accelerator for intraoperative radiotherapy.

Radiation performance characteristics of a dedicated intraoperative accelerator were determined to prepare the unit for clinical use. The linear accelerator uses standing wave X-band technology (wavelength approximately 3 centimeters) in order to minimize the mass of the accelerator. The injector design, smaller accelerator components, and low electron beam currents minimize radiation leakage. The unit may be used in a standard operating room without additional shielding. The mass of the accelerator gantry is 1250 Kg (weight approximately 2750 lbs) and the unit is transportable between operating rooms. Nominal electron energies are 4, 6, 9, and 12 MeV, and operate at selectable dose rates of 2.5 or 10 Gray per minute. D(max) depths in water for a 10 cm applicator are 0.7, 1.3, 1.7, and 2.0 for these energies, respectively. The depths of 80% dose are 1.2, 2.1, 3.1, and 3.9 cm, respectively. Absolute calibration using the American Association of Physicists in Medicine TG-51 protocol was performed for all electron energies using the 10 cm applicator. Applicator sizes ranged from 3 to 10 cm diameter for flat applicators, and 3 to 6 cm diameter for 30 degrees beveled applicators. Output factors were determined for all energies relative to the 10 cm flat applicator. Central axis depth dose profiles and isodose plots were determined for every applicator and energy combination. A quality assurance protocol, performed each day before patient treatment, was developed for output and energy constancy.