Citations

178 Background: The phase 2 TRITON2 study (NCT02952534) is evaluating the PARP inhibitor rucaparib in pts with mCRPC and a deleterious germline or somatic alteration in BRCA ( BRCA pts) or 1 of 13 other DNA damage repair (DDR) genes. Methods: Eligible pts had progressed on 1–2 lines of androgen receptor-directed therapy and 1 taxane-based chemotherapy. Deleterious DDR gene alterations were identified from central testing of plasma and/or tissue samples by Foundation Medicine or from local testing. Results: As of Jul 2, 2019 (visit cutoff), 98 BRCA pts had received rucaparib; median (range) duration of follow-up was 13.0 (4.1–25.8) mo. Confirmed objective response rate (ORR) in BRCA pts (with investigator-assessed measurable disease) and PSA response rates (in pts with and without measurable disease) are shown in the Table. A biallelic alteration was observed in 81.4% (35/43) of BRCA pts for whom zygosity could be determined, and pts with homozygous BRCA loss (20.4%; 20/98) demonstrated high ORR (66.7% [95% CI, 38.4-88.2]; 10/15) and PSA response rates (75.0% [95% CI, 50.9-91.3]; 15/20). The safety profile in BRCA pts was consistent with the overall TRITON2 pt population. Conclusions: Results from TRITON2 showed antitumor activity with rucaparib in pts with mCRPC and a deleterious BRCA alteration. Responses were observed in patients with germline or somatic alterations in BRCA1 or BRCA2. The activity of rucaparib in these and additional genomic subgroups (e.g., based on zygosity, plasma genomic testing, or co-occurring alterations) will be reported. Clinical trial information: NCT02952534. [Table: see text]

Study Design: Retrospective cohort study. Objective: To evaluate inpatient outcomes in dialysis dependent patients undergoing elective cervical spine surgery. Methods: A total of 1605 dialysis dependent patients undergoing elective primary or revision cervical spine surgery for degenerative conditions were identified from the National Inpatient sample from 2002 to 2012 and compared to 1 450 642 nondialysis-dependent patients undergoing the same procedures. The National Inpatient Sample is a de-identified database; thus, no institutional review board approval was needed. Results: Dialysis dependence was associated with higher inpatient mortality rates (7.5% vs 1.9%; P < .001) as well as both major (17.3% vs 0.6%; P < .001) and minor (36.8% vs 10.5%; P < .001) complication rates as compared with nondialysis-dependent patients. Dialysis-dependent patients had substantially increased mean lengths of stay (9.8 days compared with 2.0 days; P < .001) and total hospital charges ($141 790 compared with $46 562; P < .001). Conclusion: Dialysis-dependence is associated with drastically increased complication rates, risk of mortality, and represent a significant financial and psychosocial burden to patients undergoing elective cervical spine surgery. Both surgeons and patients should be aware of these risks while planning elective surgeries.

The PROSTALAC functional spacer is made of antibiotic-loaded acrylic cement but has a small metal-on-polythene articular surface. We have used it as an interim spacer in two-stage exchange arthroplasty for infected total knee replacement. PROSTALAC allows continuous rehabilitation between stages as it maintains good alignment and stability of the knee and a reasonable range of movement. It also helps to maintain the soft-tissue planes, which facilitates the second-stage procedure. We reviewed 45 consecutive patients, treated over a period of nine years. The mean follow-up was for 48 months (20 to 112). At final review, there was no evidence of infection in 41 patients (91%); only one had a recurrent infection with the same organism. There was improvement in the Hospital for Special Surgery knee score between stages and at final review. The range of movement was maintained between stages. Complications were primarily related to the extensor mechanism and stability of the knee between stages. Both of these problems decreased with refinement of the design of the implant. The rate of cure of the infection in our patients was similar to that using other methods. Movement of the knee does not appear to hinder control of infection.

Study Design. A retrospective cohort study. Objective. The aim of this study was to evaluate the effect of metabolic syndrome (MetS) on 30-day morbidity and mortality following elective lumbar spinal fusion. Summary of Background Data. MetS is a variable combination of hypertension, obesity, elevated fasting plasma glucose, and dyslipidemia. MetS has been associated with an increased risk of postoperative morbidity and mortality in multiple surgical settings. To our knowledge, the effect of MetS on 30-day outcomes following elective lumbar spinal fusion has not been well studied. Methods. An analysis of ACS-NSQIP data was performed between 2006 and 2013. Patients undergoing elective posterior lumbar fusion were identified. Emergency procedures, infections, tumor cases, and revision surgeries were excluded. Patients were defined as having MetS if they had a history of hypertension requiring medication, diabetes, and a body mass index (BMI) ≥30 kg/m2. Results. One thousand five hundred ninety (10.2%) patients with MetS were identified. A mild increase in major (P = 0.040) and minor complications (P = 0.003) in patients with MetS was noted. MetS was associated with increased rates of pulmonary complications (1.9% compared with 1.0%; P = 0.001), sepsis (1.7% compared with 0.9%; P = 0.005), and acute post-op renal failure (0.4% compared with 0%; P < 0.001). Multivariate analysis confirmed MetS to be an independent predictor of pulmonary complications [odds ratio (OR) 1.51; 95% confidence interval (95% CI 1.00–2.27); P = 0.048], sepsis (OR 1.56; 95% CI 1.01–2.42; P = 0.039), and acute postoperative renal failure (OR 6.95; 95% CI 2.23–21.67; P = 0.001). MetS status was associated with a mild increase in total hospital length of stay (4.38 compared with 3.81 days; P < 0.001). Conclusion. While MetS is a predictor of postoperative acute renal failure, it only slightly increases the risk of overall complications and is not associated with increased rates of 30-day reoperations or readmissions following elective lumbar fusion. Level of Evidence: 3