Content Validity of Anatomic Site-Specific Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Item Sets for Assessment of Acute Symptomatic Toxicities in Radiation Oncology

Purpose: To improve assessment of symptomatic toxicity in cancer clinical trials and complement clinician-based toxicity reporting, the US National Cancer Institute developed a measurement system called the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). The objective of this study was to examine the content validity of PRO-CTCAE in patients undergoing radiation therapy and to establish anatomic site-specific item sets for implementation in cancer research. Methods and Materials: Patients receiving radiation to the brain, head and neck, breast, thorax, abdomen, or pelvis were recruited during the final week of radiation. Participants described side effects qualitatively and completed anatomic site-specific checklists indicating the presence or absence of symptomatic toxicities drawn from the PRO-CTCAE library. Items endorsed by ≥20% of participants were selected for inclusion. Symptomatic toxicities described qualitatively were content analyzed and summarized. Symptomatic toxicities not reflected in the PRO-CTCAE item library were tabulated. Results: We conducted 389 interviews of patients receiving radiation to the brain (n = 46), head and neck (n = 69), breast (n = 134), thorax (n = 30), abdomen (n = 27), female pelvis (n = 36), or male pelvis (n = 47). Median age was 62 years; 62% were female. The 53 solicited PRO-CTCAE symptoms reflected all reported radiation-induced toxicities with the exception of phlegm/mucus production and mouth/throat pain with swallowing in patients receiving head and neck radiation, eye dryness/irritation in patients undergoing brain radiation, and obstructive urinary symptoms in men receiving pelvic radiation. The PRO-CTCAE items “skin burns” and “pain” require greater specificity to adequately reflect toxicities experienced during radiation. Conclusions: PRO-CTCAE demonstrates strong content validity as a measure of symptomatic toxicities in patients receiving radiation. These results provide empirical support for the definition of site-specific PRO-CTCAE item sets to assess the symptomatic toxicities of radiation therapy. The site-specific PRO-CTCAE item sets developed herein are currently being deployed in our department via an electronic platform to capture treatment-related toxicity

An endorectal balloon reduces intrafraction prostate motion during radiotherapy.

Item does not contain fulltextPURPOSE: To investigate the effect of endorectal balloons (ERBs) on intrafraction and interfraction prostate motion during radiotherapy. METHODS AND MATERIALS: Thirty patients were treated with intensity-modulated radiotherapy, to a total dose of 80 Gy in 40 fractions. In 15 patients, a daily-inserted air-filled ERB was applied. Prostate motion was tracked, in real-time, using an electromagnetic tracking system. Interfraction displacements, measured before each treatment, were quantified by calculating the systematic and random deviations of the center of mass of the implanted transponders. Intrafraction motion was analyzed in timeframes of 150 s, and displacements >1 mm, >3 mm, >5 mm, and >7 mm were determined in the anteroposterior, left-right, and superoinferior direction, and for the three-dimensional (3D) vector. Manual table corrections, made during treatment sessions, were retrospectively undone. RESULTS: A total of 576 and 567 tracks have been analyzed in the no-ERB group and ERB group, respectively. Interfraction variation was not significantly different between both groups. After 600 s, 95% and 98% of the treatments were completed in the respective groups. Significantly fewer table corrections were performed during treatment fractions with ERB: 88 vs. 207 (p = 0.02). Intrafraction motion was significantly reduced with ERB. During the first 150 s, only negligible deviations were observed, but after 150 s, intrafraction deviations increased with time. This resulted in cumulative percentages of 3D-vector deviations >1 mm, >3 mm, >5 mm, and >7 mm that were 57.7%, 7.0%, 0.7%, and 0.3% in the ERB-group vs. 70.2%, 18.1%, 4.6%, and 1.4% in the no-ERB group after 600 s. The largest reductions in the ERB group were observed in the AP direction. These data suggest that a 5 mm CTV-to-PTV margin is sufficient to correct for intrafraction prostate movements when using an ERB. CONCLUSIONS: ERB significantly reduces intrafraction prostate motion, but not interfraction variation, and may in particular be beneficial for treatment sessions longer than 150 s

IMRT of Prostate Cancer: A Comparison of Fluence Optimization with Sequential Segmentation and Direct-Step-and-Shoot Optimization

BACKGROUND AND PURPOSE: Intensity-modulated radiation therapy (IMRT) has shown its superiority to three-dimensional conformal radiotherapy in the treatment of prostate cancer. Different optimization algorithms are available: algorithms which first optimize the fluence followed by a sequencing (IM), and algorithms which involve the machine parameters directly in the optimization process (DSS). The aim of this treatment-planning study is to compare both of them regarding dose distribution and treatment time. PATIENTS AND METHODS: Ten consecutive patients with localized prostate cancer were enrolled for the planning study. The planning target volume and the rectum volume, urinary bladder and femoral heads as organs at risk were delineated. Average doses, the target dose homogeneity H, D(5), D(95), monitor units per fraction, and the number of segments were evaluated. RESULTS: While there is only a small difference in the mean doses at rectum and bladder, there is a significant advantage for the target dose homogeneity in the DSS-optimized plans compared to the IM-optimized ones. Differences in the monitor units (nearly 10% less for DSS) and the number of segments are also statistically significant and reduce the treatment time. CONCLUSION: Particularly with regard to the tumor control probability, the better homogeneity of the DSS-optimized plans is more profitable. The shorter treatment time is an improvement regarding intrafractional organ motion. The DSS optimizer results in a higher target dose homogeneity and, simultaneously, in a lower number of monitor units. Therefore, it should be preferred for IMRT of prostate cancer