Introduction Tumor growth rate (TGR; percent size change per month [%/m]) is postulated to be an early radiological biomarker to overcome limitations of RECIST. This study aimed to assess the impact of TGR in neuroendocrine tumors (NETs) and potential clinical and therapeutic applications. Materials and Methods Patients (pts) with advanced grade (G) 1/2 NETs from the pancreas or small bowel initiating systemic treatment (ST) or watch and wait (WW) were eligible. Baseline and follow‐up scans were retrospectively reviewed to calculate TGR at pretreatment (TGR0), first follow‐up (TGRfirst), and 3(±1) months of study entry (TGR3m). Results Out of 905 pts screened, 222 were eligible. Best TGRfirst (222 pts) cutoff was 0.8 (area under the curve, 0.74). When applied to TGR3m (103 pts), pts with TGR3m <0.8 (66.9%) versus TGR3m ≥ 0.8 (33.1%) had longer median progression‐free survival (PFS; 26.3 m; 95% confidence interval [CI] 19.5–32.4 vs. 9.3 m; 95% CI, 6.1–22.9) and lower progression rate at 12 months (7.3% vs. 56.8%; p = .001). WW (vs. ST) and TGR3m ≥ 0.8 (hazard ratio [HR], 3.75; 95% CI, 2.21–6.34; p < .001) were retained as factors associated with a shorter PFS in multivariable Cox regression. TGR3m (HR, 3.62; 95% CI, 1.97–6.64; p < .001) was also an independent factor related to shorter PFS when analysis was limited to pts with stable disease (81 pts). Out of the 60 pts with TGR0 data available, 60% of pts had TGR0 < 4%/month. TGR0 ≥ 4 %/month (HR, 2.22; 95% CI, 1.15–4.31; p = .018) was also an independent factor related to shorter PFS. Conclusion TGR is an early radiological biomarker able to predict PFS and to identify patients with advanced NETs who may require closer radiological follow‐up. Implications for Practice Tumor growth rate at 3 months (TGR3m) is an early radiological biomarker able to predict progression‐free survival and to identify patients with advanced neuroendocrine tumors who may require closer radiological follow‐up. It is feasible to calculate TGR3m in clinical practice and it could be a useful tool for guiding patient management. This biomarker could also be implemented in future clinical trials to assess response to therapy.
Purpose: Tumor growth rate (TGR) represents the percentage change in tumor volume per month (%/m). Previous results from the GREPONET study showed that TGR measured after 3 months (TGR 3m ) of starting systemic treatment (ST) or watch and wait (WW) was an early biomarker predicting progression-free survival (PFS) in neuroendocrine tumors (NET).Experimental Design: Patients from 7 centers with advanced grade (G) 1/2 NETs from the pancreas (P)/small bowel (SB) initiating ST/WW were eligible. Computed tomography (CT)/MRI performed at prebaseline, baseline, and 3 (AE1) months of study entry were retrospectively reviewed. Aim-1: explore treatment-induced changes in TGR (DTGR 3m-BL ; paired T test), and Aim-2: validate TGR 3m (<0.8%/m vs. !0.8%/m) as an early biomarker in an independent cohort (Kaplan-Meier/Cox regression).Results: Of 785 patients screened, 127 were eligible. Mean (SD) TGR 0 and TGR 3m were 5.4%/m (14.9) and À1.4%/m (11.8), respectively. Mean (SD) DTGR 3m-BL paired-difference was À6.8%/m (19.3; P < 0.001). Most marked DTGR 3m-BL [mean (SD)] were identified with targeted therapies [À11.3%/m (4.7); P ¼ 0.0237] and chemotherapy [À7.9%/m (3.4); P ¼ 0.0261]. Multivariable analysis confirmed the absence of previous treatment (OR ¼ 4.65; 95% CI, 1.31-16.52; P ¼ 0.018) and low TGR 3m (continuous variable; OR 1.09; 95% CI, 1.01-1.19; P ¼ 0.042) to be independent predictors of radiologic objective response. When the multivariable survival analysis for PFS (Cox regression) was adjusted to grade (P ¼ 0.004) and stage (P ¼ 0.017), TGR 3m ! 0.8 (vs. <0.8) maintained its significance as a prognostic factor (P < 0.001), whereas TGR 0 and DTGR 3m-BL did not. TGR 3m ! 0.8%/m was confirmed as an independent prognostic factor for PFS [external validation; Aim-2; multivariable HR 2.21 (95% CI, 1.21-3.70; P ¼ 0.003)].Conclusions: TGR has a role as a biomarker for monitoring response to therapy for early identification of treatmentinduced changes and for early prediction of PFS and radiologic objective response.
Malignant bowel obstruction (MBO) is a common manifestation in patients with advanced intra-abdominal malignancy. It is especially common with bowel or gynecological cancers and produces distressing symptoms, including nausea, vomiting, and pain. Medical management options are less effective than decompressive strategies for symptom control. Surgery is the gold-standard treatment but is unsuitable for most patients with high complication rates. Consensus guidelines recommend nonsurgical management with a venting gastrostomy in those unsuitable for surgery or for whom medical management is ineffective. The aim of this systematic review is to establish the safety and efficacy of percutaneous venting gastrostomy in relieving symptoms of MBO. Twenty-five studies were included in this review comprising 1194 patients. Gastrostomy insertion was successful at first attempt in 91% of cases and reduction in symptoms of nausea and vomiting was reported in 92% of cases. Mean survival following the procedure ranged from 35 to 147 days. Major complications were rare, with most complications classed as minor wound infections or leakage of fluid around the tube. Studies suggest that the presence of ascites is not an absolute contraindication to the insertion of percutaneous venting gastrostomy in patients with MBO; however, these studies lack longitudinal outcomes and complication rates related to this. However, it is reasonable to suggest that ascitic drainage is performed to reduce potential complications. There is a relative lack of good quality robust data on the utilization of percutaneous venting gastrostomy in MBO, but overall, the combination of being a safe and efficacious procedure alongside the known complication profile suggests that it should be considered a suitable management option.
Introduction: Tumor growth rate (TGR), percentage of change in tumor volume/month, has been previously identified as an early radiological biomarker for treatment monitoring in neuroendocrine tumor (NET) patients. We assessed the performance and reproducibility of TGR at 3 months (TGR 3m ) as a predictor factor of progression-free survival (PFS), including the impact of imaging method and reader variability. Methods: Baseline and 3-month (±1 month) CT/ MRI images from patients with advanced, grade 1-2 NETs were retrospectively reviewed by 2 readers. Influence of number of targets, tumor burden, and location of lesion on the performance of TGR 3m to predict PFS was assessed by uni/multivariable Cox regression analysis. Agreement between readers was assessed by Lin's concordance coefficient (LCC) and kappa coefficient (KC). Results: A total of 790 lesions were measured in 222 patients. Median PFS was 22.9 months. On univariable analysis, number of lesions (≥4), tumor burden, and presence of liver metastases were significantly correlated with PFS. On multivariate analysis, ≥4 lesions (HR: 1.89 [95% CI: 1.01-3.57]), TGR 3m ≥0.8%/month (HR: 4.01 [95% CI: 2.31-6.97]), and watch and wait correlated with shorter PFS. No correlation was found between TGR 3m Dromain et al.
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