Treatment pathways and clinical outcomes in Hodgkin lymphoma outside Europe and North America: results from the international, multicenter, retrospective, B-HOLISTIC study.

Information on Hodgkin lymphoma (HL) is mostly limited to Europe and North America. This real-world, retrospective study assessed treatment pathways and clinical outcomes in adults with stage IIB-IV classical HL receiving frontline treatment (n = 1598) or relapsed/refractory HL (RRHL, n = 426) in regions outside Europe and North America between January 2010 and December 2013. The primary endpoint was progression-free survival (PFS) in the RRHL group. Among patients with RRHL, 89.0% received salvage chemotherapy; most common regimen was etoposide, methylprednisolone, cytarabine, cisplatin (ESHAP; 26.3%). Median PFS in the RRHL group was 13.2 months (95% confidence interval [CI]: 9.9-20.2) and was longer in patients with vs. without stem cell transplantation (SCT; 20.6 vs. 7.5 months; p = 0.0071). This large-scale study identified a lower PFS for RRHL in the rest of the world compared with Europe and North America, highlighting the need for novel targeted therapies and SCT earlier in the treatment continuum.Clinical trial registration: NCT03327571.

Probability of Response as Defined by a Clinical Decision Support Tool Is Associated With Lower Healthcare Resource Utilization in Vedolizumab-Treated Patients With Crohn's Disease.

Background: A previously developed clinical decision support tool (CDST) identified patients with Crohn's disease (CD) most likely to respond to vedolizumab. This study evaluated the ability of the CDST to predict real-world healthcare resource utilization (HRU). Methods: The Optum and Truven healthcare databases were searched for patients with CD treated with vedolizumab (Optum, n = 358; Truven, n = 1445) or an anti-tumor necrosis factor (TNF) agent (Optum, n = 814). Patients were stratified using the 5-variable (prior bowel surgery, prior fistulizing disease, prior anti-TNF exposure, albumin, C-reactive protein) and a new modified 3-variable (without laboratory data) CDST. Annualized expenditures and HRU were compared with both CDSTs across response probability groups for a 12-month period. Results: In the Optum data set, the 5- and 3-variable CDSTs identified lower rates of surgery or hospitalization in CD patients with higher probability of vedolizumab response. Per-patient total costs were 2.5 times lower for CD patients with high versus low probability of vedolizumab response ($12 943 vs $32 931). The 5- and 3-variable CDSTs did not consistently identify anti-TNF-treated CD patients with higher HRU. The 3-variable CDST also identified vedolizumab-treated CD patients with higher probability of response and lower probability for surgery or hospitalization in the Truven data set. Conclusions: The 5-variable CDST identified CD patients treated with vedolizumab, but not an anti-TNF agent, at higher risk for HRU. The 3-variable CDST offers similar performance but more flexibility by removing laboratory data requirements for prediction. These validated CDSTs can be integrated into population health monitoring algorithms using real-world data.

Changes in Vedolizumab Utilization Across US Academic Centers and Community Practice Are Associated With Improved Effectiveness and Disease Outcomes.

BACKGROUND: Vedolizumab effectiveness estimates immediately after Food and Drug Administration (FDA) approval for ulcerative colitis (UC) and Crohn's disease (CD) are limited by use in refractory populations. We aimed to compare treatment patterns and outcomes of vedolizumab in 2 time frames after FDA approval. METHODS: We used 2 data sets for time trend analysis, an academic multicenter vedolizumab consortium (VICTORY) and the Truven MarketScan database, and 2 time periods, May 2014-June 2015 (Era 1) and July 2015-June 2017 (Era 2). VICTORY cumulative 12-month clinical remission, corticosteroid-free remission, and mucosal healing rates, and Truven 12-month hospitalization and surgery rates, were compared between Eras 1 and 2 using time-to-event analyses. RESULTS: A total of 3661 vedolizumab-treated patients were included (n = 1087 VICTORY, n = 2574 Truven). In both cohorts, CD and UC patients treated during Era 2 were more likely to be biologic naïve. Compared with Era 1, Era 2 CD patients in the VICTORY consortium had higher rates of clinical remission (31% vs 40%, P = 0.03) and mucosal healing (42% vs 58%, P < 0.01). These trends were not observed for UC. In the Truven database, UC patients treated during Era 2 had lower rates of inflammatory bowel disease-related hospitalization (22.4% vs 9.6%, P < 0.001) and surgery (17.2% vs 9.4%, P = 0.008), which was not observed for CD. CONCLUSION: Since FDA approval, remission and mucosal healing rates have increased for vedolizumab-treated CD patients, and vedolizumab-treated UC patients have had fewer hospitalizations and surgeries. This is likely due to differences between patient populations treated immediately after drug approval and those treated later.

Polychlorinated biphenyls and organochlorine pesticides in surface sediments from Shantou Bay, China: Sources, seasonal variations and inventories.

Sediments from Shantou Bay, China, were analyzed for polychlorinated biphenyls (PCBs) and organochlorine pesticides (OCPs) for the first time. The concentrations of PCBs and OCPs were 0.54-55.5ngg-1 and 2.19-16.9ngg-1 (dry weight), respectively. Source identification showed that tri-CBs and penta-CBs were manufactured and used in the last century, while usage of antifouling paint might still serve as a significant source of sediment DDT. Concentrations of PCBs and HCHs significantly (p<0.05) increased after wet season, suggesting that atmospheric deposition and surface runoff played an important role in distribution of historical pollutants. Additionally, the adverse biological effects could occasionally occur for DDT in sediments. The mass inventories were preliminarily calculated for PCBs (90.1ngcm-2 and 0.09tons) and OCPs (61.8ngcm-2 and 0.062tons) in Shantou Bay, while as part of the "reservoir" of organochlorine compounds to the global ocean, its role cannot be neglected.

Hydroxyethyl starch resuscitation reduces the risk of intra-abdominal hypertension in severe acute pancreatitis.

OBJECTIVES: This study aimed to address whether hydroxyethyl starch (HES) is beneficial for intra-abdominal pressure (IAP) in severe acute pancreatitis (SAP) in early stages. METHODS: Forty-one patients with SAP were randomized to HES group (n = 20) and the Ringer's lactate (RL) group (n = 21). The groups received 6% HES 130/0.4 for 8 days and RL solution without colloid, respectively. The primary end point was the IAP. The secondary end points were fluid balance, major organ complications, the Acute Physiology and Chronic Heath Evaluation II score, and the serum levels of C-reactive protein, interleukin-6, and interleukin-8. RESULTS: The characteristics of baseline data were similar in the 2 groups. In the HES group, the IAP was significantly lower in 2 to 7 days, and fewer patients received mechanical ventilation (15.0% vs 47.6%). A negative fluid balance was observed earlier in the HES group than in the RL group (2.5 ± 2.2 vs 4.0 ± 2.5 days). CONCLUSIONS: Fluid resuscitation with HES in the early stages of SAP can decrease the risk of intra-abdominal hypertension and reduce the use of mechanical ventilation.

Therapeutic effect of transcatheter arterial chemoembolization and percutaneous injection of acetic acids on primary liver cancer.

BACKGROUND: The resection rate of primary liver tumor in China is only about 20%. A lot of patients with moderate and advanced liver tumor may lose the chance of operation. The objective of present research was to study the efficacy of transcatheter arterial chemoembolization (TACE) combined with percutaneous injection of chemical agents and acetic acids in the treatment of patients with primary liver cancer (PLC). METHODS: Thirty-three patients with middle and advanced stage of PLC were divided into two groups: percutaneous injection of chemical agents and acetic acids (15 patients, group A) and TACE (18 patients, group B). RESULTS: Tumor diameter and serum AFP level reduced to 86.6% and 83.3% in group A, and 55.5% and 40% in group B, respectively. There was significant difference between the two groups (P<0.01). The 1, 2, 3, 4-year survival rates of group A were 96.7%, 86.6%, 51.3%, 33.3%, respectively and in group B were 66.7%, 44.4%, 16.7%, 0%, respectively (P<0.01). CONCLUSION: TACE combined with percutaneous injection of chemical agents and acetic acids is efficacious to increase the survival rate of patients with PLC.