Prospective study for establishing minimal clinically important differences in patients with surgery for lower extremity metastases.

BACKGROUND: The clinical relevance of patient-reported outcomes score changes is often unclear. Especially in patients undergoing surgery due to lower extremity metastases - where surgery is performed in the palliative setting and the goal is to optimize functional mobility, relieve pain and improve overall quality of life. This study assessed the minimal clinically important difference (MCID) of Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference, Cancer-specific Physical Function, and Global (Physical and Mental Health) in patients treated surgically for impending or completed pathologic fractures. METHODS: Patients undergoing surgery for osseous metastasis of the lower extremity because of an impending or completed pathologic fracture were consecutively enrolled in this tertiary center study. Patients completed the three PROMIS questionnaires preoperatively (n = 56) and at postoperative follow-up (n = 33) assessment one to three months later. Of the 23 patients that did not complete the postoperative survey, 5 patients died within 1-3 months and 18 patients were alive at 3-months but did not respond or show up at their postoperative consult. Thirty-one patients (94%) of the 33 included patients reported at least minimal improvement and two patients (6.1%) no change 1-3 months after the surgery based on an anchor-based approach. RESULTS: The PROMIS MCIDs (95% confidence interval) for Pain Interference was 7.5 (3.4-12), Physical Function 4.1 (0.6-7.6), Global Physical Health 4.2 (2.0-6.6), and Global Mental Health 0.8 (-4.5-2.9). CONCLUSION: This prospective study successfully defined a MCID for PROMIS Pain Interference of 7.5 (3.4-12), PROMIS Physical Function of 4.1 (0.6-7.6), and Global Physical Health of 4.2 (2.0-6.6) in patients with (impending) pathological fractures due to osseous metastases in the lower extremity; no MCID could be established for PROMIS Global Mental Health. Defining a narrower MCID value for each subpopulation requires a large, prospective, multicenter study. Nevertheless, the provided MCID values allow guidance to clinicians to evaluate the impact of surgical treatment on a patient's QoL. LEVEL OF EVIDENCE: Level II Diagnostic study.

Surgical Treatment of Localized-Type Tenosynovial Giant Cell Tumors of Large Joints: A Study Based on a Multicenter-Pooled Database of 31 International Sarcoma Centers.

BACKGROUND: Localized-type tenosynovial giant cell tumor (TGCT) is a rare, neoplastic disease with only limited data supporting treatment protocols. We describe treatment protocols and evaluate their oncological outcome, complications, and functional results in a large multicenter cohort of patients. A secondary study aim was to identify factors associated with local recurrence after surgical treatment. METHODS: Patients with histologically proven localized TGCT of a large joint were included if they had been treated between 1990 and 2017 in 1 of 31 tertiary sarcoma centers. Of 941 patients with localized TGCT, 62% were female. The median age at initial treatment was 39 years, and the median duration of follow-up was 34 months. Sixty-seven percent of the tumors affected the knee, and the primary treatment at the tertiary center was 1-stage open resection in 73% of the patients. Proposed factors for predicting a first local recurrence after treatment in the tertiary center were tested in a univariate analysis, and those that demonstrated significance were subsequently included in a multivariate analysis. RESULTS: The localized TGCT recurred in 12% of all cases, with local-recurrence-free rates at 3, 5, and 10 years of 88%, 83%, and 79%, respectively. The strongest factor for predicting recurrent disease was a prior recurrence (p < 0.001). Surgical treatment decreased pain and swelling in 71% and 85% of the patients, respectively, and such treatment was associated with complications in 4% of the patients. Univariate and multivariate analyses of the patients who had not undergone therapy previously yielded positive associations between local recurrence and a tumor size of ≥5 cm versus <5 cm (hazard ratio [HR] = 2.50; 95% confidence interval [CI] = 1.32 to 4.74; p = 0.005). Arthroscopy (versus open surgery) was significantly associated with tumor recurrence in the univariate analysis (p = 0.04) but not in the multivariate analysis (p = 0.056). CONCLUSIONS: Factors associated with recurrence after resection of localized-type TGCT were larger tumor size and initial treatment with arthroscopy. Relatively low complication rates and good functional outcomes warrant an open approach with complete resection when possible to reduce recurrence rates in high-risk patients. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.