Importance Symptomatic adverse events (AEs) in cancer trials are currently reported by clinicians using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE). To integrate the patient perspective, the NCI developed a patient-reported outcomes version of the CTCAE (PRO-CTCAE) to capture symptomatic AEs directly from patients. Objective To assess the construct validity, test-retest reliability, and responsiveness of PRO-CTCAE items. Design Participants completed PRO-CTCAE items on tablet computers in clinic waiting rooms at two visits 1-6 weeks apart. A subset completed PRO-CTCAE items during an additional visit one business day after the first visit. Setting Nine U.S. cancer centers and community oncology practices. Participants 975 adult cancer patients undergoing outpatient chemotherapy and/or radiation enrolled between January 2011 and February 2012. Eligibility required participants to read English and be without clinically significant cognitive impairment. Main Outcome(s) and Measure(s) Primary comparators were clinician-reported Eastern Cooperative Oncology Group Performance Status (ECOG PS) and the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30). Results 940/975 (96%) and 852/940 (91%) participants completed PRO-CTCAE items at each visit. 938/940 (99.8%) participants (53% female, median age 59, 32% high school education or less, 17% ECOG PS 2-4) reported having at least one symptom. All PRO-CTCAE items had at least one correlation in the expected direction with a QLQ-C30 scale (111/124 P<.05). Stronger correlations were seen between PRO-CTCAE items and conceptually-related QLQ-C30 domains. Scores for 94/124 PRO-CTCAE items were higher in the ECOG PS 2-4 versus 0-1 group (58/124 P<.05). Overall, 119/124 items met at least one construct validity criterion. Test-retest reliability was acceptable for 36/49 pre-specified items (median intra-class correlation coefficient .76; range .53-.96). Correlations between PRO-CTCAE item changes and corresponding QLQ-C30 scale changes reached statistical significance for 27 pre-specified items (median r=.43, range .10-.56; all P≤.006). Conclusions and Relevance Evidence demonstrates favorable validity, reliability, and responsiveness of PRO-CTCAE in a large, heterogeneous U.S. sample of patients undergoing cancer treatment. Studies evaluating other measurement properties of PRO-CTCAE are underway to inform further development of PRO-CTCAE and its inclusion in cancer trials.

Although radical resection is the best treatment for malignant sacral tumors, total sacrectomy for such tumors has been performed in only a few instances. Total sacral resection requires reconstruction of the pelvic ring plus establishment of a bilateral union between the lumbar spine and iliac bone. This technique is illustrated in two patients harboring large, painful, sacral giant-cell tumors that were unresponsive to prior treatment. These patients were treated with complete en bloc resection of the sacrum and complex iliolumbar reconstruction/stabilization and fusion. Surgery was performed in two stages, the first consisting of a midline celiotomy, dissection of visceral/neural structures, and ligation of internal iliac vessels, followed by an anterior L5-S1 discectomy. The second stage consisted of mobilization of an inferiorly based myocutaneous rectus abdominis pedicle flap for wound closure, followed by an L-5 laminectomy, bilateral L-5 foraminotomy, ligation of the thecal sac, division of sacral nerve roots, and transection of the ilia lateral to the tumor and sacroiliac joints. Placement of the instrumentation required segmental fixation of the lumbar spine from L-3 down by means of pedicle screws and the establishment of a bilateral liaison between the lumbar spine and the ilia by using the Galveston L-rod technique. The pelvic ring was then reestablished by means of a threaded rod connecting left and right ilia. Both autologous (posterior iliac crest) and allograft bone were used for fusion, and a tibial allograft strut was placed between the remaining ilia. The patients were immobilized for 8 weeks postoperatively and underwent progressive rehabilitation. At the 1-year follow-up review, one patient could walk unassisted, and the other ambulated independently using a cane. Both patients controlled bowel function satisfactorily with laxatives and diet and could maintain continence but required self-catheterization for bladder emptying. The authors conclude that in selected patients, total sacrectomy represents an acceptable surgical procedure that can offer not only effective local pain control, but also a potential cure, while preserving satisfactory ambulatory capacity and neurological function.

With growing demand on cancer centers to meet new metrics of quality care, the psychosocial matrix can help centers systematically identify and develop steps to address gap areas in their capacity to meet these new standards. The Cancer Psychosocial Care Matrix appears to enable evaluation of psychosocial programs, may promote intentions to improve psychosocial services, and can facilitate communication of 'best practices' among cancer centers.

Symptom control is the goal of palliative irradiation. Approximately 1 month is required before symptomatic relief is accomplished with radiotherapy. However, many patients with cancer-related pain do not receive adequate analgesics, and opioids are often not prescribed until patients fail to respond to palliative irradiation. The presenting symptoms of 108 patients who were referred to a multidisciplinary clinic for bone metastases were evaluated with the Wisconsin Brief Pain Inventory (BPI). This validated instrument evaluates the severity of pain using a 0-10 scale; 10 represents the worst pain imaginable. The population comprised 65 men (60%) and 43 women whose ages ranged from 33 years to 81 years; median age was 55 years, and 69% of patients were less than 65 years of age. Despite the presence of metastatic disease, 21% of patients were working full-time outside the home, and 6% were employed part-time outside the home; 13% were homemakers. Only 17 patients (16%) were unemployed. The time since diagnosis ranged from 2 weeks to 23 years; the median time since diagnosis was 22 months, and 30% of patients had been diagnosed with the past 6 months. Pain was a presenting symptom in 74% (N = 80) of patients at diagnosis. At its worst, the pain was rated as severe (levels 7-10) by 78% and intolerable (level 10) in 22% of the patients in the 24 hr prior to the clinic appointment. On average, the pain was rated moderate to severe (levels 4-10) in 79% and severe in 23% of patients. Only 45% of patients experienced good relief from the prescribed analgesics, and 23% of patients indicated that the prescribed analgesics were ineffective. This survey demonstrates that bone metastases incur significant pain that is often undertreated with analgesics before antineoplastic therapy is administered.

Although radical resection is the best treatment for malignant sacral tumors, total sacrectomy for such tumors has been performed in only a few instances. Total sacral resection requires reconstruction of the pelvic ring plus establishment of a bilateral union between the lumbar spine and iliac bone. This technique is illustrated in two patients harboring large, painful, sacral giant-cell tumors that were unresponsive to prior treatment. These patients were treated with complete en bloc resection of the sacrum and complex iliolumbar reconstruction/stabilization and fusion. Surgery was performed in two stages, the first consisting of a midline celiotomy, dissection of visceral/neural structures, and ligation of internal iliac vessels, followed by an anterior L5-S1 discectomy. The second stage consisted of mobilization of an inferiorly based myocutaneous rectus abdominis pedicle flap for wound closure, followed by an L-5 laminectomy, bilateral L-5 foraminotomy, ligation of the thecal sac, division of sacral nerve roots, and transection of the ilia lateral to the tumor and sacroiliac joints. Placement of the instrumentation required segmental fixation of the lumbar spine from L-3 down by means of pedicle screws and the establishment of a bilateral liaison between the lumbar spine and the ilia by using the Galveston L-rod technique. The pelvic ring was then reestablished by means of a threaded rod connecting left and right ilia. Both autologous (posterior iliac crest) and allograft bone were used for fusion, and a tibial allograft strut was placed between the remaining ilia. The patients were immobilized for 8 weeks postoperatively and underwent progressive rehabilitation. At the 1-year follow-up review, one patient could walk unassisted, and the other ambulated independently using a cane. Both patients controlled bowel function satisfactorily with laxatives and diet and could maintain continence but required self-catheterization for bladder emptying. The authors conclude that in selected patients, total sacrectomy represents an acceptable surgical procedure that can offer not only effective local pain control, but also a potential cure, while preserving satisfactory ambulatory capacity and neurological function.