Julia Shelkey

Matched-pair and propensity score comparisons of outcomes of patients with clinical stage i non-small cell lung cancer treated with resection or stereotactic radiosurgery

Stereotactic body radiotherapy (SBRT) is an alternative to surgery for clinical stage I non–small cell lung cancer (NSCLC), but comparing its effectiveness is difficult because of differences in patient selection and staging.

Confirmation of the role of diabetes in the local recurrence of surgically resected non-small cell lung cancer

PURPOSE We recently demonstrated that diabetes mellitus was an independent risk factor for local recurrence (LR) for patients undergoing resection of non-small cell lung cancer (NSCLC). This investigation was performed to confirm or refute this finding in a different patient cohort. MATERIALS AND METHODS Patients were eligible if they did not have a second primary cancer within 5 years of the original diagnosis, had at least 3-month follow-up, and did not receive radiotherapy. There were 373 and 168 patients in the original (P1) and confirmatory (P2) cohorts, respectively, with 66 and 30 patients with diabetes. RESULTS The median follow-up was 33 months (range, 3-98 months). Diabetes was an independent risk factor for LR in a Cox model in both the P2 (p=0.05, hazard ratio [HR] 2.15) and P1 (p=0.008, HR 1.90) cohorts, separately from BMI, glucose control, and the presence of the metabolic syndrome. The rates of LR in the patients with diabetes after combining the cohorts at 2, 3, and 5 years were 23%, 33%, and 56%, respectively; these rates were 15%, 19%, and 26% in non-diabetics. In multivariate Cox regression and competing risk analysis of the combined cohorts, the HRs for LR in patients with diabetes exceeded those of more established risk factors for LR including a 1-cm increase in tumor size and lymphovascular invasion. CONCLUSIONS Diabetes was confirmed to be an independent predictor of the risk of LR following resection of NSCLC.

Case Report: Pelvic Congestion Syndrome as an Unusual Etiology for Chronic Hip Pain in 2 Active, Middle-Age Women

Context: The past 2 decades have shown a dramatic increase in the number of pelvic and hip injuries in female athletes. Accurate diagnosis of hip pain in active women has proven to be a challenge, as there is an extensive differential including both musculoskeletal and visceral problems. While the incidence of pelvic congestion syndrome (PCS) is not known, this condition may manifest as chronic hip pain in this patient population. Evidence Acquisition: A PubMed search was undertaken for articles published in English from 1980 to 2012. Additional references were accrued from reference lists of research articles. Study Design: Case series. Level of Evidence: Level 3. Results: Diagnosis was established using magnetic resonance imaging. Both women were evaluated and treated by interventional radiology with gonadal vein embolization. Initial evaluation and subsequent follow-up was completed in the Sports Medicine Clinic to monitor chronic hip pain symptoms. Both patients experienced significant alleviation of chronic hip pain symptoms within several months after gonadal vein embolization, allowing for a return to the previous level of activity. Conclusion: Although PCS most commonly presents as pelvic pain, it is important to consider this condition in athletes with persistent hip pain. PCS may also present with the primary symptom of hip pain as in the 2 case reports described. With more awareness of this condition and appropriate diagnosis, PCS as an unusual etiology of chronic hip pain may be effectively treated with gonadal vein embolization.

Pretreatment serum biomarkers and clinical outcome in the phase II trial of zibotentan (endothelin A receptor antagonist) in metastatic CRPC.

154 Background: Three angiogenesis-related serum biomarkers [TIMP-1 (tissue inhibitor of metalloproteinase-1), CA IX (carbonic anhydrase 9), and VEGF] and PSA were correlated with outcome in the phase II zibotentan [endothelin A (ETA) receptor inhibitor] trial in metastatic CRPC. METHODS Pretreatment serum samples were available from 206 of 312 patients enrolled in the multicenter phase II trial evaluating zibotentan in patients with metastatic CRPC and bone metastases who were pain free or mildly symptomatic for pain, with a 1:1:1 randomization to zibotentan 10mg, 15mg, or placebo. The CA IX, TIMP-1, and VEGF ELISAs were from WILEX Inc./Oncogene Science, Cambridge, MA. Progression-free survival (PFS) and overall survival (OS) were analyzed using the Kaplan-Meier method and Cox modeling. RESULTS In the final efficacy report, there were no statistical differences in PFS, but a trend for OS improvement was observed in the zibotentan arms compared with placebo: 15 mg (HR 0.76; 80% CI 0.61-0.94; p= 0.103) and 10 mg (HR 0.83; 80% CI 0.67-1.02; p= 0.254) (James et al, BJUI 106L966-973, 2010). In the retrospective serum biomarker analysis (206 patients), there were no apparent differences for PFS with any of the 3 novel biomarkers in the whole population, or within treatment arms. For OS in the whole population, patients with higher serum TIMP (> median) had reduced OS (17.5 mos), compared with patients who had lower serum TIMP-1 (< median) (28.4 mos). Within treatment arms, patients with higher serum CA IX (> median) treated with zibotentan had increased OS in both the 10 mg arm (median 28.4 mos), and the 15 mg arm (median 25.7 mos) compared with those in the placebo arm (median 15.4 mos). In a Cox model, including serum biomarkers and bisphosphonate use, for PFS only PSA was significant (p< 0.0001); for OS only PSA (p< 0.0001) and TIMP-1 (p< 0.002) were significant. CONCLUSIONS Higher pretreatment serum CA IX (a marker of hypoxia) may identify a cohort of metastatic CRPC patients more sensitive to zibotentan treatment, and higher serum TIMP-1 may identify patients at risk for reduced overall survival. These serum biomarkers deserve further study in larger ETA receptor inhibitor trials.