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Purpose and Objectives: This report presents the analysis of the RTOG 0537 multicenter randomized study that compared acupuncture-like transcutaneous stimulation (ALTENS) with pilocarpine (PC) for relieving radiation-induced xerostomia., Methods and Materials: Eligible patients were randomized to twice-weekly 20-minute ALTENS sessions for 24 sessions during 12 weeks or PC (5 mg 3 times daily for 12 weeks). The primary endpoint was the change in the University of Michigan Xerostomia-Related Quality of Life Scale (XeQOLS) scores from baseline to 9 months from randomization (MFR). Secondary endpoints included basal and citric acid primed whole salivary production (WSP), ratios of positive responders (defined as patients with ≥20% reduction in overall radiation-induced xerostomia symptom burden), and the presence of adverse events based on the Common Terminology Criteria for Adverse Events version 3. An intention-to-treat analysis was conducted., Results: One hundred forty-eight patients were randomized. Only 96 patients completed the required XeQOLS and were evaluable at 9 MFR (representing merely 68.6% statistical power). Seventy-six patients were evaluable at 15 MFR. The median change in the overall XeQOLS in ALTENS and PC groups at 9 and 15 MFR were -0.53 and -0.27 (P=.45) and -0.6 and -0.47 (P=.21). The corresponding percentages of positive responders were 81% and 72% (P=.34) and 83% and 63% (P=.04). Changes in WSP were not significantly different between the groups. Grade 3 or less adverse events, mostly consisting of grade 1, developed in 20.8% of patients in the ALTENS group and in 61.6% of the PC group., Conclusions: The observed effect size was smaller than hypothesized, and statistical power was limited because only 96 of the recruited 148 patients were evaluable. The primary endpoint-the change in radiation-induced xerostomia symptom burden at 9 MFR-was not significantly different between the ALTENS and PC groups. There was significantly less toxicity in patients receiving ALTENS., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Purpose: This paper reports long-term results of RTOG 9903, to determine whether the addition of erythropoietin (EPO) would improve the outcomes of radiation therapy (RT) in mildly to moderately anemic patients with head and neck squamous cell carcinoma (HNSCCa)., Methods and Materials: The trial included HNSCCa patients treated with definitive RT. Patients with stage III or IV disease received concomitant chemoradiation therapy or accelerated fractionation. Pretreatment hemoglobin levels were required to be between 9.0 and 13.5 g/dL (12.5 g/dL for females). EPO, 40,000 U, was administered weekly starting 7 to 10 days before RT was initiated in the RT + EPO arm., Results: A total of 141 of 148 enrolled patients were evaluable. The baseline median hemoglobin level was 12.1 g/dL. In the RT + EPO arm, the mean hemoglobin level at 4 weeks increased by 1.66 g/dL, whereas it decreased by 0.24 g/dL in the RT arm. With a median follow-up of 7.95 years (range: 1.66-10.08 years) for surviving patients and 3.33 years for all patients (range: 0.03-10.08 years), the 5-year estimate of local-regional failure was 46.2% versus 39.4% (P=.42), local-regional progression-free survival was 31.5% versus 37.6% (P=.20), and overall survival was 36.9% versus 38.2% (P=.54) for the RT + EPO and RT arms, respectively. Late toxicity was not different between the 2 arms., Conclusions: This long-term analysis confirmed that despite the ability of EPO to raise hemoglobin levels in anemic patients with HNSCCa, it did not improve outcomes when added to RT. The possibility of a detrimental effect of EPO could not be ruled out., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Purpose: To evaluate the feasibility and usefulness of a three-dimensional ultrasound (3D-US) image-guided system in identifying and tracking the tumor bed (TB) for planning and daily localization before radiation delivery for breast cancer., Methods and Materials: Twenty breast cancer patients underwent two CT scans at the time of simulation and just before their boost. Three-dimensional ultrasound images were acquired immediately after the CT scans, to which the images were automatically fused. Three-dimensional ultrasound images were also acquired immediately before treatment. Spatial and temporal TB differences between CT and US were evaluated., Results: The TB was not visible on US and CT in 1 subject who had and 1 subject who had not received chemotherapy before whole-breast radiotherapy. The mean (SD) TB volume overlap was 78% (14%). The mean centroid position of the TB on CT vs. US differed by 0.1, 0.2, and 0.4 mm in the anterior-posterior, left-right, and superior-inferior directions. The mean (SD) absolute radial displacement of the TB on each fraction from the treatment plan was 10.8 (6.3) mm., Conclusions: The TB was well visualized by US for the majority of patients. Clinically insignificant differences in the displacements calculated by paired CT vs. paired US demonstrate the feasibility of using 3D-US. The present study suggests that a 10-mm planning target volume margin could result in undercoverage of the clinical target volumes in 50% of treatments. Multimodality planning and image-guided radiotherapy with US potentially offers an accurate and non-ionizing solution for the daily definition of the TB position during partial-breast irradiation and boost treatments., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Purpose: To review and describe our institution's outcomes in patients treated with external beam radiotherapy after keloid excision., Methods and Materials: This was a retrospective study. Patients who received radiotherapy between July 1994 and January 2004 after keloid excision were identified. A questionnaire was mailed regarding sociodemographic factors, early and late radiation toxicities, the need for additional therapy, and satisfaction level. All patients had received a total of 15 Gy in three daily 5-Gy fractions. Treatment started within 24 h after surgery and was delivered on a Siemens orthovoltage machine. The data were analyzed using the STATA statistical package., Results: A total of 234 patients were approached. The response rate was 41%, and 75% were female. The mean age was 36.5 years (range, 16-69 years). The patients were mainly of European (53.1%) or African (19.8%) descent. For early toxicity outcomes, 54.2% reported skin redness and 24% reported skin peeling. For late toxicity outcomes, 27% reported telangiectasia and 62% reported permanent skin color changes. No association was found with gender, skin color, or age for the late toxicity outcomes. Of the patients responding, 14.6% required adjuvant treatment. On a visual scale of 1-10 for the satisfaction level, 60% reported a satisfaction level of > or =8. Telangiectasia was the most significant predictor of a low satisfaction level (< or =3, p < 0.005)., Conclusion: The results of our study have shown that orthovoltage-based radiotherapy after surgical excision for keloids is a good method for the prevention of relapse. It is well tolerated, causes little toxicity, and leads to a high patient satisfaction level.

Purpose: To compare the setup accuracy, comfort level, and setup time of two immobilization systems used in head-and-neck radiotherapy., Methods and Materials: Between February 2004 and January 2005, 21 patients undergoing radiotherapy for head-and-neck tumors were assigned to one of two immobilization devices: a standard thermoplastic head-and-shoulder mask fixed to a carbon fiber base (Type S) or a thermoplastic head mask fixed to the Accufix cantilever board equipped with the shoulder depression system. All patients underwent planning computed tomography (CT) followed by repeated control CT under simulation conditions during the course of therapy. The CT images were subsequently co-registered and setup accuracy was examined by recording displacement in the three cartesian planes at six anatomic landmarks and calculating the three-dimensional vector errors. In addition, the setup time and comfort of the two systems were compared., Results: A total of 64 CT data sets were analyzed. No difference was found in the cartesian total displacement errors or total vector displacement errors between the two populations at any landmark considered. A trend was noted toward a smaller mean systemic error for the upper landmarks favoring the Accufix system. No difference was noted in the setup time or comfort level between the two systems., Conclusion: No significant difference in the three-dimensional setup accuracy was identified between the two immobilization systems compared. The data from this study reassure us that our technique provides accurate patient immobilization, allowing us to limit our planning target volume to <4 mm when treating head-and-neck tumors.

Purpose: To compare dose-volume histograms of target volumes and organs at risk in 57 patients with nasopharyngeal carcinoma (NPC) with inverse- (IP) or forward-planned (FP) intensity-modulated radiation treatment (IMRT)., Methods and Materials: The DVHs of 57 patients with NPC with IMRT with or without chemotherapy were reviewed. Thirty-one patients underwent IP IMRT, and 26 patients underwent FP IMRT. Treatment goals were to prescribe a minimum dose of 66-70 Gy for gross tumor volume and 59.4 Gy for planning target volume to greater than 95% of the volume. Multiple selected end points were used to compare dose-volume histograms of the targets, including minimum, mean, and maximum doses; percentage of target volume receiving less than 90% (1-V90%), less than 95% (1-V95%), and greater than 105% (1-V105%). Dose-volume histograms of organs at risk were evaluated with characteristic end points., Results: Both planning methods provided excellent target coverage with no statistically significant differences found, although a trend was suggested in favor of improved target coverage with IP IMRT in patients with T3/T4 NPC (p = 0.10). Overall, IP IMRT statistically decreased the dose to the parotid gland, temporomandibular joint, brain stem, and spinal cord overall, whereas IP led to a dose decrease to the middle/inner ear in only the T1/T2 subgroup., Conclusions: Use of IP and FP IMRT can lead to good target coverage while maintaining critical structures within tolerance. The IP IMRT selectively spared these critical organs to a greater degree and should be considered the standard of treatment in patients with NPC, particularly those with T3/T4. The FP IMRT is an effective second option in centers with limited IP IMRT capacity. As a modification of conformal techniques, the human/departmental resources to incorporate FP-IMRT should be nominal.

Purpose: Adjuvant postoperative para-aortic lymph nodal irradiation is an acceptable alternative to para-aortic and ipsilateral pelvic irradiation postorchiectomy for patients with Stage I seminoma of the testis. In this article, we report the long-term results of our prospective evaluation of para-aortic irradiation only for such patients., Methods and Materials: Between March 1991 and September 2000, 71 patients with Stage I seminoma were treated with adjuvant irradiation to the para-aortic region only after radical inguinal orchiectomy. Radiotherapy was delivered using parallel-opposed fields extending from T11 to L5. A total dose of 25 Gy in 15 fractions was prescribed to midpoint. Follow-up was performed every 3 months for the first year, every 4 months for the second and third years, every 6 months for the fourth and fifth years, and annually thereafter. Chest X-ray, tumor markers, and computed tomography scan of the pelvis were performed routinely as part of the follow-up investigation., Results: At a median follow-up of 75 months, 68 of 71 patients are alive and free of relapse. Only 1 patient (1.4%) experienced failure in the ipsilateral inguinal nodal region. Two patients (2.8%) died of unrelated causes. The actuarial 10-year relapse free survival is 98.5% and the actuarial 10-year overall survival is 92%. No late toxicity has been encountered., Conclusion: Patients with Stage I seminoma of the testis may be safely treated with para-aortic radiotherapy only. Risk of pelvic failure is very low and treatment toxicity minimal.

Purpose: Despite major advances in treatment modalities, the prognosis of patients with glioblastoma multiforme (GBM) remains poor. Exploring hypofractionated regimens to replace the standard 6-week radiotherapy schedule is an attractive strategy as an attempt to prevent accelerated tumor cell repopulation. There is equally interest in dose escalation to the gross tumor volume where the majority of failures occur. We report our preliminary results using hypofractionated intensity-modulated accelerated radiotherapy regimen in the treatment of patients with GBM., Methods and Materials: Between July 1998 and December 2001, 25 patients with histologically proven diagnosis of GBM, Karnofsky performance status > or =60, and a postoperative tumor volume < or =110 cm3 were treated with a hypofractionated accelerated course of radiotherapy. The gross tumor volume (GTV) was defined as the contrast-enhancing lesion on the postoperative MRI T1-weighted images with the latter fused with computed tomography images for treatment planning. The planning target volume was defined as GTV + 1.5-cm margin. Using forward-planning intensity modulation (step-and-shoot technique), 60 Gy in 20 daily fractions of 3 Gy each were given to the GTV, whereas the planning target volume received a minimum of 40 Gy in 20 fractions of 2 Gy each at its periphery. Treatments were delivered over a 4-week period using 5 daily fractions per week. Dose was prescribed at the isocenter (ICRU point). Three beam angles were used in all of the cases., Results: Treatments were well tolerated. Acute toxicity was limited to increased brain edema during radiotherapy in 2 patients who were on tapering doses of corticosteroids. This was corrected by increasing the steroid dose. At a median follow-up of 8.8 months, no late toxicity was observed. One patient experienced visual loss at 9 months after completion of treatment. MRI suggested nonspecific changes to the optic chiasm. On review of the treatment plan, the total dose to the optic chiasm was confirmed to be equal to or less than 40 Gy in 20 fractions. When Radiation Therapy Oncology Group recursive partitioning analysis was used, 10 patients were class III-IV, and 15 patients were class V-VI. To date, 21 patients have had clinical and/or radiologic evidence of disease progression, and 16 patients have died. The median survival was 9.5 months (range: 2.8-22.9 months), the 1-year survival rate was 40%, and the median progression-free survival was 5.2 months (range: 1.9-12.8 months)., Conclusion: This hypofractionated accelerated irradiation schedule using forward planning (step-and-shoot) hypofractionated, intensity-modulated accelerated radiotherapy is feasible and seems to be a safe treatment for patients with GBM. A 2-week reduction in the treatment time may be of valuable benefit for this group of patients. However, despite this accelerated regimen, no survival advantage has been observed.

Purpose: To update our experience with intensity-modulated radiotherapy (IMRT) in the treatment of nasopharyngeal carcinoma (NPC)., Methods and Materials: Between April 1995 and October 2000, 67 patients underwent IMRT for NPC at the University of California-San Francisco (UCSF). There were 20 females and 47 males, with a mean age of 49 (range 17-82). The disease was Stage I in 8 (12%), Stage II in 12 (18%), Stage III in 22 (33%), and Stage IV in 25 (37%). IMRT was delivered using three different techniques: 1) manually cut partial transmission blocks, 2) computer-controlled auto-sequencing segmental multileaf collimator (SMLC), and 3) sequential tomotherapy using a dynamic multivane intensity modulating collimator (MIMiC). Fifty patients received concomitant cisplatinum and adjuvant cisplatinum and 5-FU chemotherapy according to the Intergroup 0099 trial. Twenty-six patients had fractionated high-dose-rate intracavitary brachytherapy boost and 1 patient had gamma knife radiosurgery boost after external beam radiotherapy. The prescribed dose was 65-70 Gy to the gross tumor volume (GTV) and positive neck nodes, 60 Gy to the clinical target volume (CTV), 50-60 Gy to the clinically negative neck, and 5-7 Gy in 2 fractions for the intracavitary brachytherapy boost. Acute and late normal tissue effects were graded according to the Radiation Therapy Oncology Group (RTOG) radiation morbidity scoring criteria. The local progression-free, local-regional progression-free, distant metastasis-free rates, and the overall survival were calculated using the Kaplan-Meier method., Results: With a median follow-up of 31 months (range 7 to 72 months), there has been one local recurrence at the primary site. One patient failed in the neck. Seventeen patients developed distant metastases; 5 of these patients have died. The 4-year estimates of local progression-free, local-regional progression-free, and distant metastases-free rates were 97%, 98%, and 66% respectively. The 4-year estimate of overall survival was 88%. The worst acute toxicity documented was as follows: Grade 1 or 2 in 51 patients, Grade 3 in 15 patients, and Grade 4 in 1 patient. The worst late toxicity was Grade 1 in 20 patients, Grade 2 in 15 patients, Grade 3 in 7 patients, and Grade 4 in 1 patient. At 3 months after IMRT, 64% of the patients had Grade 2, 28% had Grade 1, and 8% had Grade 0 xerostomia. Xerostomia decreased with time. At 24 months, only one of the 41 evaluable patients had Grade 2, 32% had Grade 1, and 66% had Grade 0 or no xerostomia. Analysis of the dose-volume histograms (DVHs) showed that the average maximum, mean, and minimum dose delivered were 79.3 Gy, 74.5 Gy, and 49.4 Gy to the GTV, and 78.9 Gy, 68.7 Gy, and 36.8 Gy to the CTV. An average of only 3% of the GTV and 3% of the CTV received less than 95% of the prescribed dose., Conclusion: Excellent local-regional control for NPC was achieved with IMRT. IMRT provided excellent tumor target coverage and allowed the delivery of a high dose to the target with significant sparing of the salivary glands and other nearby critical normal tissues.