Dexamethasone eardrop with grommet placement vs intratympanic steroid injection for sudden sensorineural hearing loss: A randomized prospective clinical trial.

OBJECTIVES: The purpose of this study was to compare different means of intratympanic steroid delivery in the treatment of idiopathic sudden sensorineural hearing loss. DESIGN: Prospective, multicentered, randomized controlled trial. SETTING AND PARTICIPANTS: Fifty-six patients who fulfilled the inclusion criteria for idiopathic sudden sensorineural hearing loss who failed or were contraindicated for oral steroids were included in this study. Patients were randomly divided into 2 groups according to delivery methods: group A received 4 sections of intratympanic dexamethasone injection and group B received grommet placement with dexamethasone delivery followed by 3 sections of dexamethasone ear drop application. Self-administered paper-based questionnaires were filled out to measure subjective pain scores, vertigo, anxiety, and overall satisfaction immediately after each procedure. Hearing threshold was measured with pure tone audiogram in the follow-up. RESULTS: There was no statistical significance detected in hearing threshold improvement between both groups (P = 0.30). Grommet placement followed by dexamethasone eardrop application demonstrated a significant difference in shorter waiting time (24 min in grommet group vs 52 min in injection group; P < 0.01); and better overall satisfaction (1.6 in grommet group vs 2.5 in injection group; P < 0.05). CONCLUSIONS: Grommet placement followed by dexamethasone eardrop application is a good alternative for a patient indicated for intratympanic steroid, with less administrative cost, shorter waiting time, and more satisfaction.

Fingertip Injuries in Mask Factory Workers during the COVID-19 Pandemic.

Background: The COVID-19 pandemic has caused a dramatic increase in the demand of face masks. The aim of this study is to look into the demographics, clinical details, clinical outcome and the risk factors for fingertip injuries in mask manufacturing factory workers. Methods: This is a retrospective review of all patients admitted to a regional hospital following a fingertip injury sustained at a mask making factory over a 6-month period from March 2020 to August 2020. Data with regard to gender, age, hand dominance, job position, injured finger, type of injury, mechanism of injury, treatment, clinical outcome (time to return to work), as well as risk factors for injuries (training before work, duration of work before injury, previous experience on working on similar machines, protective measures and working hours) were collected and analysed. Results: There were seven patients in total (M:F = 6:1) with a mean age of 38.4 years. Four patients had injuries on their dominant hands. The most commonly injured finger was the middle finger (n = 3). The most common injury pattern was fingertip amputation (n = 5). Five patients required operative management. Only four patients received training before work and six patients were injured within the first month of work. No patient had previous experience in operating similar machines. Long working hours is also a related risk factor. Conclusions: Better occupational safety and training should be employed to prevent these injuries. Level of Evidence: Level IV (Therapeutic).

Endosomes and Golgi vesicles in adsorptive and fluid phase endocytosis.

We studied with morphometric methods the endocytosis by pheochromocytoma cells of a conjugate of wheat germ agglutinin with ferritin (WGA-Ft) and of horseradish peroxidase (HRP). Quantitative studies indicated that WGA-Ft was cleared slowly from cell surfaces and that it was not recycled to the surface. Cells labeled with WGA-Ft for 15 min at room temperature were washed and incubated in medium containing HRP for 15 or 30 min at 37 degrees C. The greatest proportion of labeled vesicles and tubules contained only WGA-Ft (83.4% at 15 min and 85.3% at 30 min). A very small fraction of labeled vesicles and tubules contained only HRP (0.2% at 15 min and 0.9% at 30 min). Vesicles and tubules at the Golgi apparatus were labeled almost exclusively with WGA-Ft (97% at 15 min and 30 min); the rest had both labels. Most labeled lysosomes contained both labels (80.1% at 15 min and 80.8% at 30 min). Of the remainder more contained WGA-Ft alone (20% at 15 min and 10.9% at 30 min), then HRP alone (none at 15 min and 8.2% at 30 min). In contrast to the various and varying patterns of labeling with WGA-Ft and HRP of the other organelles studied, the vast majority of endosomes contained both markers (94.1% at 15 min and 100% at 30 min); the rest contained WGA-Ft only. These results demonstrate that endosomes are recipients of both fluid phase and adsorptive endocytosis markers; these findings are consistent with the hypothesis that endosomes mediate the sorting out and subsequent intracellular traffic of membrane bound and fluid phase markers. Cisterns of the Golgi apparatus did not contain WGA-Ft; in sharp contrast, when WGA-HRP was used, the cisterns of the Golgi apparatus consistently contained HRP.

Analysis of complications in patients with endometrial carcinoma receiving adjuvant irradiation.

We analyzed the complications in 310 patients with pathologically documented endometrial carcinoma who received adjuvant radiation therapy (RT) at Fox Chase Cancer Center between 1970 and 1986. Variables included timing of treatment, technique, total dose, age, diabetes, previous abdominal surgery, hypertension, prior bowel pathology, and lymphadenectomy. According to the FIGO (1985) system, 258 patients had Stage I disease, 48 had Stage II, and one had Stage III. One hundred seventy patients received preoperative (preop) RT, 138 received postoperative (postop) RT, and 2 received preop and postop RT. A 4-field technique was used for 212 of 235 patients receiving external-beam (EX) RT, and 75 patients were treated with intracavitary (IC) RT only. Median follow-up was 5.5 years. Actuarial survival of all 310 patients was 78% at 5 years. Thirty-two complications occurred, involving the rectum, small bowel, femur, or lower extremity. Complications were graded according to the ECOG scoring system as grade 2 (mild) and grades 3, 4, or 5 (serious). One of 75 patients treated with IC RT only experienced a grade-2 complication (proctitis). Of 71 patients receiving 4-field EX RT only, 25 preop (16%) and 14 postop (14%) patients had complications. Of 139 patients treated with both EX and IC RT, grade-2 complications were seen in 5% of 87 preop patients and 12% of 52 postop patients (p = 0.17), whereas serious complications were observed in 4% of each group. Univariate analysis of the variables of interest revealed that the incidence of complications was associated with a lymphadenectomy (p = .03), use of external RT (p less than .01), and decreasing age (p = .04). Multivariate analysis confirmed that use of external RT was the most significant predictor for complications. In conclusion, similar complication rates were found in patients treated with either preop or postop 4-field EX RT. While pelvic RT clearly decreases pelvic relapse in patient with endometrial carcinoma, the risk benefit ratio for treatment of these patients should be carefully considered when recommending adjuvant RT for pelvic control.

Should patients with post-resection locoregional recurrence of lung cancer receive aggressive therapy?

The outcome of thirty-seven patients with a post-resection locoregional recurrence of non-small cell lung cancer treated with radiation therapy alone between 1979 and 1989 was compared to that of 759 patients with unresected non-small cell lung cancer also treated with standard radiation during the same period. Each patient's locoregional recurrence was staged using the current American Joint Committee on Cancer staging system. Comparison of pretreatment characteristics between the two groups, including age, sex, extent of weight loss, performance status, stage, and histologic subtype revealed fewer patients with greater than 5% weight loss (35 vs. 47%, p = 0.04) and more cases with squamous histology (54 vs. 28%, p = 0.01) among the patients with locoregional recurrences than those with newly diagnosed lesions. Over 80% of both groups had clinical stage III lesions. The median radiation doses were 56 and 59 Gy for recurrent and newly diagnosed cases (p = NS). For the patients with locoregional recurrences, the median time from resection to recurrence was 13 months (range: 3-118 months), and the recurrences were predominantly nodal in 25 cases, chest wall/pleural in four and at the bronchial stump in eight. When measured from the date of documented recurrence, the median survival time and 2-year actuarial survival rate of the patients with recurrent lesions were 12 months and 22%, as compared to 12 months and 26% for the newly diagnosed patients (p = NS). Freedom from documented locoregional tumor progression at 2 years was 30% for both groups. Patients with bronchial stump lesions had superior survival to those with nodal or chest wall recurrences, with a median survival time of 36 versus 9 months. A therapeutic approach to selected patients with post-resection locoregional recurrence of non-small cell lung cancer equally aggressive to that for newly diagnosed lung cancer patients is justified by these results, especially for patients with bronchial stump recurrences.

Adverse influence of younger age on outcome in patients with non-small cell lung carcinoma (NSCLC) treated with radiation therapy (RT) alone.

Treatment outcome of 63 patients younger than 50 years of age initiated on a course of once-daily definitive radiation therapy without concurrent or preirradiation chemotherapy for clinical Stages I-III unresected non-small cell lung carcinoma from 1978 to 1988 was compared to the outcome of 695 patients over the age of 50. Follow-up ranged from 24-110 months with follow-up until death in 88% of patients. The actuarial overall survival rate for all patients was 22% at 2 years with a median survival time of 11.5 months. Patients less than 50 and greater than or equal to 50 years old were similar in male:female ratio, distribution of histologic subtype, performance status, and extent of weight loss. Poorly differentiated histologic grade was more prevalent among the younger patients (59% vs 41%, p = .005). Ninety-four percent of younger patients and 86% of older patients had clinical stage III disease (p = NS). Survival was significantly worse for patients who were younger than 50 years old (p = .05), with a median survival time of 7.8 months. Median survival time for those patients 50 years of age or older was 12.4 months. Poorer survival outcome among young patients was most pronounced among patients with unfavorable characteristics of poor performance status (greater than or equal to 2) or weight loss (greater than 5%) (p = .002). Distant failure (p = .029) and brain failure (p = .003) as initial site of relapse was more common among younger patients. Among young patients, poor histologic grade was associated with both distant failure (p = .003) and brain metastasis (p = .002). The difference in distribution of histologic grade, incidence of distant failure, particularly in the brain, and poorer survival outcome among patients less than 50 may be indicative of more aggressive tumor behavior in the younger patients. These results indicate that patients less than 50 may require alternate treatment strategies. Age should be considered a stratification variable in non-operative randomized trials of non-small cell lung carcinoma which include patients with non-favorable characteristics.

Management of retroperitoneal sarcomas: does dose escalation impact on locoregional control?

PURPOSE: Only 50% of patients with retroperitoneal sarcomas undergo complete resection and of these, 47% develop local tumor recurrence. To determine whether irradiation with dose escalation improves locoregional control, we reviewed the experience with adjuvant radiotherapy in the treatment of retroperitoneal sarcomas at the Fox Chase Cancer Center and the Hospital of the University of Pennsylvania. METHODS AND MATERIALS: Twenty-one patients with retroperitoneal sarcomas were treated with curative intent with surgical resection and radiation therapy at Fox Chase Cancer Center or the Hospital of the University of Pennsylvania between May 1965 and July 1992. Follow-up ranged from 14-340 months. Nineteen patients were treated postoperatively and 2 preoperatively. Radiation doses were between 36.0 Gy and 90.0 Gy (median 54.0 Gy). RESULTS: The 2-year rates of local control and survival were 72% and 69%, respectively. Tumor size, stage, grade, and histology did not influence local control. Two of eight patients (25%) who received a total dose of > 55.2 Gy experienced local failure compared to 5 of 13 (38%) who received < or = 55.2 Gy. One patient experienced a small bowel obstruction that required surgical intervention. There were no other severe complications. CONCLUSION: Postoperative treatment with radiotherapy using a dose > 55.0 Gy is recommended for patients with retroperitoneal sarcomas following surgical resection due to the significant likelihood of local recurrence. Innovative adjuvant radiation techniques to escalate doses to greater than 55.0 Gy including intraoperative radiation therapy, brachytherapy, or use of small bowel exclusion devices to reduce small bowel toxicity should be considered for retroperitoneal sarcomas.

Decreasing gastrointestinal morbidity with the use of small bowel contrast during treatment planning for pelvic irradiation.

Small bowel tolerance is a major dose-limiting factor in treating the pelvis with radiation therapy (RT). The use of small bowel contrast during RT simulation is one technique used to localize the bowel and identify the treatment plan that would exclude the greatest volume. To determine the influence of treatment planning with oral contrast on gastrointestinal injury, acute and chronic small bowel morbidity was analyzed in 115 patients with endometrial and rectal carcinoma who received postoperative radiation therapy at the Fox Chase Cancer Center. Mean and median time of follow-up were 31 and 27 months, respectively. Acute diarrhea was seen in 82% of the patient population. Ten percent of patients experienced major complications requiring hospitalization. Ninety-three percent of patients simulated without contrast experienced side effects compared to 77% of patients simulated with contrast (p = .026). There was an increased incidence of chronic complications in patients who were not simulated with contrast dye (50% vs 23%, p = .014). Median duration of minor side effects was 4 months for patients planned without oral contrast and 1 month for patients who had contrast at the time of simulation (p = .036). The superior aspect of the treatment field was determined to be at a more inferior location in patients simulated with contrast, thereby excluding small bowel from treatment. Seventy-four percent of patients simulated without contrast had the upper border of the field placed at the superior aspect of the sacroiliac joint or above, compared to only 40% of patients planned with oral contrast (p = .002). This study has demonstrated decreased complications (both overall and chronic) as well as a change in the location of the treatment field with the use of small bowel contrast. Multivariate analysis revealed that both the use of oral contrast (p = .026) and a lower superior border of the treatment field (p = .007) were predictive for fewer sequelae to RT, indicating that planning with contrast leads to changes in the technical delivery of RT other than field placement (e.g., block placement). The reduced incidence and duration of small bowel morbidity may be in part caused by alterations of the treatment plan made when the small bowel is visualized at the time of simulation. It is therefore recommended that oral small bowel contrast be used during treatment planning for pelvic irradiation.

Management of extremity soft tissue sarcomas with limb-sparing surgery and postoperative irradiation: do total dose, overall treatment time, and the surgery-radiotherapy interval impact on local control?

PURPOSE: To evaluate potential prognostic factors in the treatment of extremity soft tissue sarcomas that may influence local control, distant metastases, and overall survival. METHODS AND MATERIALS: Sixty-seven patients with extremity soft tissue sarcomas were treated with curative intent by limb-sparing surgery and postoperative radiation therapy at the Fox Chase Cancer Center or the Hospital of the University of Pennsylvania, between October 1970 and March 1991. Follow-up ranged from 4-218 months. The median external beam dose was 60.4 Gy. In 13 patients, interstitial brachytherapy was used as a component of treatment. RESULTS: The 5-year local control rate for all patients was 87%. The 5-year local control rate for patients who received < or = 62.5 Gy was 78% compared to 95% for patients who received > 62.5 Gy had larger tumors (p = 0.008) and a higher percentage of Grade 3 tumors and positive margins than patients who received < or = 62.5 Gy. The 5-year local control rate for patients with negative or close margins was 100% vs. 56% in patients with positive margins (p = 0.002). Cox proportional hazards regression analysis was performed using the following variables as covariates: tumor dose, overall treatment time, interval from surgery to initiation of radiation therapy, margin status, grade, and tumor size. Total dose (p = 0.04) and margin status (p = 0.02) were found to significantly influence local control. Only tumor size significantly influenced distant metastasis (p = 0.01) or survival (p = 0.03). CONCLUSION: Postoperative radiation therapy doses > 62.5 Gy were noted to significantly improve local control in patients with extremity soft tissue sarcomas. This is the first analysis in the literature to demonstrate the independent influence of total dose on local control of extremity soft tissue sarcomas treated with adjuvant postoperative irradiation.

Volumetric analysis of small bowel displacement from radiation portals with the use of a pelvic tissue expander.

PURPOSE: Many techniques and devices have been used in an attempt to minimize gastrointestinal morbidity of pelvic irradiation. The value of a temporary intrapelvic tissue expander to displace small bowel from pelvic radiotherapy fields was analyzed by comparing volumetric treatment parameters of patients with and without such a device. METHODS AND MATERIALS: Between 1983 and 1991, 77 patients with a diagnosis of endometrial (n = 35), colorectal (n = 41), or anal carcinoma (n = 1) received adjuvant postoperative radiotherapy after undergoing treatment planning simulation with the use of small bowel oral contrast medium. Fourteen of these patients underwent surgical placement of a temporary intrapelvic tissue expander prior to radiotherapy, and 63 patients did not. Small bowel volume within the treatment portals was measured for both initial pelvic and conedown fields for all cases, and compared between the two patient groups. RESULTS: The volume of small bowel within the initial pelvic fields receiving full dose irradiation was significantly less among patients with a tissue expander. For patients with a tissue expander, mean volume receiving full dose irradiation was 25 cm3 (median 0 cm3, range 0-297 cm3), whereas the corresponding volume was 239 cm3 (median 181 cm3, range 0-943 cm3) without a tissue expander (p < .0001). A similar reduction of irradiated small bowel volume was noted in the conedown fields with the use of a tissue expander (p = .07). Volumes receiving less than full dose irradiation were also less within the initial pelvic (p = .0001) and conedown (p = .002) fields with a tissue expander. Multivariate analysis of patient and treatment-related parameters showed the use of a tissue expander to be the only factor correlated with decreased small bowel volume within the treatment field (p = .003). Morbidity related to placement and removal of the tissue expander was acceptable. Acute radiation-related morbidity was significantly less in patients irradiated with a tissue expander in place (p < .001). CONCLUSIONS: Placement of an intrapelvic tissue expander was correlated with decreased small bowel volume within the radiotherapy treatment field. Diminished radiation-induced acute gastrointestinal morbidity was noted with use of a tissue expander.

Comparison of outcome between clinically staged, unresected superior sulcus tumors and other stage III non-small cell lung carcinomas treated with radiation therapy alone.

Several studies suggest that patients with non-small cell lung carcinoma (NSCLC) of the superior sulcus fare better after radiation therapy than those patients with comparable tumors at other thoracic sites. There is limited data on stage-by-stage comparisons between patients with superior sulcus tumors (SST) and non-SST (NSST). Thirty patients had SST among 656 patients with American Joint Committee on Cancer clinically staged IIIA (n = 389) and IIB (n = 267) primary NSCLC who received definitive once-daily radiation therapy. The median patient age, sex ratio, histologic findings, grade, weight loss, and performance status were similar for SST and NSST. Minimum follow-up was 24 months, with 88% of patients followed until death. The survival of patients with SST (median, 10.3 months) was similar to that of patients with tumors at other pulmonary sites (median, 10.8 months; P = 0.39). Survival for favorable patients with performance status 0 to 1 and weight loss of 5% or less was comparable between patients with SST (median, 15.0 months) and NSST were similar for patients with SST and NSST (P = 0.48). The brain was the site of first failure in 20% of patients with SST and 10% of patients with NSCLC at other sites (P = 0.10). The lack of apparent difference in outcome of comparably staged patients with SST and NSST treated with radiation alone may have significant therapeutic implications.

The effect of palliative radiation therapy on epidural compression due to metastatic malignant melanoma.

The efficacy of palliative radiation therapy in the treatment of spinal cord and cauda equina compression due to metastatic malignant melanoma was evaluated in 38 sites in 35 patients treated between 1970 and 1990. All patients had radiographic documentation of epidural compression. The median dose of radiation therapy was 2850 cGy (range, 500 to 4000 cGy), with daily fractions ranging from 200 to 800 cGy. Twenty-eight sites in 26 patients were evaluable 1 month after completion of radiation therapy, and symptoms responded completely in 11 of 28 (39%) sites. Fourteen sites (46%) showed a partial response of symptoms. Response lasting until death was documented in 21 of 26 patients (81%). Patients receiving a total dose of 3000 cGy or greater were more likely to achieve a complete response than those receiving less than 3000 cGy (62% versus 20%) by univariate (P = 0.025) and multivariate (P = 0.048) analyses. A treatment program of radiation therapy and corticosteroids is effective in palliating the symptoms of epidural compression due to metastatic malignant melanoma. It is recommended to deliver an accelerated course of radiation therapy to a dose of 3000 cGy or greater without exceeding spinal cord tolerance (e.g., 3000 cGy in ten fractions at 300 cGy per fraction).

Clinical stage II non-small cell lung cancer treated with radiation therapy alone. The significance of clinically staged ipsilateral hilar adenopathy (N1 disease).

BACKGROUND: The prognosis of patients with clinically staged hilar nodal involvement (Stage N1) or clinical Stage II non-small cell lung cancer (NSCLC, Stage T1-2N1M0) treated with radiation therapy (RT) alone is not well established. METHODS: Records of 758 patients with clinical Stage I-III NSCLC treated with RT were reviewed. Sixty-two patients were identified with clinical Stage II NSCLC, and 126 patients had Stage N1 disease. RESULTS: The median survival time (MST) of the 62 patients with clinical Stage II disease was 17.9 months, with 1-year, 2-year, 3-year, and 5-year overall actuarial survival rates of 70%, 33%, 20%, and 12%, respectively. The survival of patients with clinical Stage II disease was significantly better than that of 389 patients with clinical Stage IIIA disease (MST, 11.3 months; P < 0.008) and 267 patients with clinical Stage IIIB disease (MST, 9.8 months; P = 0.0003), but it was similar to that of 40 patients with clinical Stage I lesions (MST, 15.0 months). Patients with performance statuses of 0-1 lived longer than those with a status of 2 or more (MST, 22.8 versus 6.1 months; P < 0.0001). The median survival for patients with N0, N1, N2, and N3 disease was 13.7, 12.6, 10.9, and 9.1 months, respectively. Patients with Stage N0-1 disease (MST, 13.2 months) had significantly improved MST compared with those with Stage N2-3 disease (MST, 10.3 months). CONCLUSIONS: The survival of patients with clinical Stage II NSCLC treated with RT alone was significantly better than that of those with clinical Stage IIIA or IIIB disease. It was comparable to that of patients with clinical Stage I lesions. The clinical staging of nodal involvement limited to the ipsilateral hilum does not necessarily portend a worse prognosis than that of patients with clinical Stage N0 disease. The absence of clinically evident Stage N2-3 disease is of significant predictive value for patients with NSCLC treated with RT.

Limb-preserving treatment for soft tissue sarcomas of the extremities. The significance of surgical margins.

BACKGROUND AND METHODS: Between 1970 and 1990, 74 patients with extremity soft tissue sarcomas began a regimen of limb-sparing surgery and irradiation. Ninety-two percent received postoperative irradiation, 7% received preoperative irradiation, and one patient was treated with radiation after an incisional biopsy only. Radiation was administered with a shrinking-field technique (median total dose, 63 Gy; range, 39.6-71 Gy), with 14 patients receiving interstitial brachytherapy as a component of treatment. Ten patients received adjuvant chemotherapy. RESULTS: Local control of disease was 82% at 5 years, and 95% after salvage therapy. The actuarial risk of distant disease recurrence was 27%, with an overall survival rate of 70% at 5 years. Histologic subtype, tumor grade, size of tumor, location of tumor, status of the surgical margins, use of chemotherapy, radiation dose, interval until initiation of radiation therapy, and use of a brachytherapy boost were analyzed to determine their effect on survival, local control, and freedom from distant metastasis. Microscopic involvement of the surgical margins predicted for local disease recurrence (P = 0.0002), distant disease recurrence (P = 0.008), and poorer overall survival (P = 0.02). Low histologic grade was favorably correlated with freedom from distant disease recurrence (P = 0.004) and survival (P = 0.002). Patients with liposarcomas had superior local control (P = 0.004) compared with patients with tumors of other histologic subtypes. Five patients experienced a complication of therapy, for an actuarial risk of 10% at 5 years. Only two patients required hospital admittance for treatment-related morbidity. CONCLUSIONS: These findings support the continued use of limb-preserving management for extremity sarcomas and emphasize the importance of the status of the surgical margins.