Reduction of nodal micrometastases in patients with histological node-negative esophageal cancer after neoadjuvant treatment.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 73-73
Author(s):  
D. Wang ◽  
J. K. Smit ◽  
H. Hollema ◽  
J. T. Plukker

73 Background: Neoadjuvant chemoradiation (CRT) is important in the treatment ofesophageal cancer. Rationales are tumor-downstaging and elimination of micrometastases improving resectability and curability rate. In this study we evaluated the effect of neo-adjuvant CRT on nodal micrometastases (NMM) in pN0 esophageal cancer patients. Methods: From a prospective database, we selected a matched group of patients on cT-stage, histological type and treatment without (group 1) or with neo-adjuvant CRT (group 2). Patients were staged by EUS, PET-scan, CT-scan and EUS guided cytology. CRT was given in a randomized clinical trial and consisted of paclitaxel 50 mg/m2 and carboplatin AUC = 2 for 5 weeks and concurrent radiotherapy (41.4 Gy/23 frs). All patients (n = 19) underwent a curative intended transthoracic esophagectomy with extended 2-field nodal dissection. After reviewing routine pathological examination all tumors were confirmed as stage pN0. Four sections of every examined lymph node (n = 261) were made at different levels according to a sentinel node protocol and further analyzed immunohistochemically with anti-CK8/18 (CAM 5.2) to detect NMM. Results: Patients characteristics were equally distributed. All patients had a microscopically radical (R0) resection. In group 2 (n = 9) the response rate was 55% which was complete (CR) in 33%. The median number of resected nodes was comparable: 15 ± 6.5 and 15 ± 5.6 in both groups. Thirtheen of the 261 (5%) pN0 nodes in these 19 pts contained NMM. In group 1 (n = 10); 12 of the 136 (9%) examined pN0 lymph nodes were positive and in group 2 only one of the 125 (0.8%) examined pN0 nodes was positive (p = 0.003). NMM were found in 7 pts (70%) in group 1 and in only one patient (11%) in group 2 (p = 0.02). Interestingly, this last patient had responded well to CRT. Conclusions: Neo-adjuvant CRT seems to have a significant impact on the numbers of NMMs in esophageal cancer. Based on the presence of NMM even in patients with good responses, we still advocate a curatively intended nodal dissection. No significant financial relationships to disclose.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. TPS4136-TPS4136
Author(s):  
Neelam Vijay Desai ◽  
Steven Hughes ◽  
Alison Ivey ◽  
Steven N. Hochwald ◽  
Carmen Joseph Allegra ◽  
...  

TPS4136 Background: Pancreatic adenocarcinoma remains a deadly disease with a dismal prognosis. Only 15% of patients present with resectable disease with 5-year survival only 20% despite adjuvant therapy. Neoadjuvant treatment may improve R0 resection rates, allows more patients curative surgery, is cost effective, and may improve overall survival by incorporating earlier systemic therapy. Methods: This is a prospective single arm open-label phase II trial using gemcitabine (G) and nab-paclitaxel (A) in the neoadjuvant treatment of resectable and borderline-resectable pancreatic cancer. Patients are stratified by risk group as defined by a predictive model published by Bao et al and the NCCN expert consensus statement (Table): low-risk resectable (Group 1) and high-risk resectable or borderline-resectable (Group 2). Group 1 receives 3 cycles of G+A then surgical resection. 1 cycle = G 1000mg/m2 +A 100mg/m2 IV on Days 1, 8, 15 Q28 days. Group 2 receives 2 cycles of G+A followed by 2 weeks of hypofractionated IMRT (50.4Gy in 10 fx) with G 400mg/m2 IV weekly, then surgical resection. The primary endpoints are R0 resection rate and overall response rates. Secondary endpoints are PFS, OS, 30-day post-op mortality, toxicity, QOL and molecular analysis including DPC4 and SPARC levels in tumor and stroma. Enrollment has just begun with a total accrual goal of 60 patients. This platform will allow targeted systemic therapy and tailored treatment stratification to optimize outcomes in curable pancreatic cancer. This study is registered with Clinicaltrials.gov (NCT01470417). [Table: see text]


2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 274-274
Author(s):  
M. Palmeri ◽  
J. M. Pipas ◽  
G. H. Ripple ◽  
M. McGowan ◽  
K. D. Smith ◽  
...  

274 Background: Neoadjuvant chemoradiation may play a role in improving the resectability and overall survival (OS) of patients with pancreatic adenocarcinoma. IMRT allows higher radiation doses to regions within a tumor while minimizing the dose to surrounding normal structures. Methods: Eighty-one patients with pancreatic adenocarcinoma completed neoadjuvant IMRT from 2003-2008. All were staged by CT scan, endoscopic ultrasound and laparoscopy. Based on defined resectability criteria, 14 were resectable (R), 38 considered borderline resectable (B) and 29 unresectable (U). Patients were categorized into 3 groups based on their neoadjuvant treatment. All patients received concurrent IMRT with gemcitabine (50mg/m2) twice weekly for 12 doses. IMRT prescription dose was 54 Gy in 28 fractions with a biologically effective dose of 64.47Gy10. All resected patients received intra-operative radiation (mean dose 14 Gy). Group 1 received neoadjuvant chemotherapy involving gemcitabine and docetaxel on days 1, 15, and 29 followed by IMRT. Group 2 received concurrent weekly cetuximab in addition to bi-weekly gemcitabine and IMRT. Group 3 received only concurrent gemcitabine twice weekly and IMRT. Four weeks after treatment completion, patients were evaluated with a CT scan in preparation for surgery. Results: Median OS for all patients was 22 months. The overall resectability rate after neoadjuvant IMRT was 63%. 78% of B and 39% of U patients underwent resection. 80% of all patients had an R0 resection. Median OS was 23 months for R, 28 months for B and 14 months for U patients (P = 0.002). Median OS was 18 months, 27 months and 18 months respectively for patients receiving gemcitabine-IMRT, gemcitabine-cetuximab and neoadjuvant gemcitabine/docetaxel plus concurrent gemcitabine-IMRT (P = 0.20). Median OS for R0 resections were 28 months compared to 24.3 months for patients with positive margins and 11.7 months for unresectable patients (P < 0.001). Conclusions: IMRT as part of a neoadjuvant treatment strategy for pancreatic adenocarcinoma is feasible and well tolerated. Neoadjuvant IMRT rendered a significant percentage of B patients resectable with an OS comparable to patients who were R at presentation. [Table: see text]


2013 ◽  
Vol 31 (3) ◽  
pp. 285-292 ◽  
Author(s):  
Cristina Lika Uezima ◽  
Ariane Moreira Barreto ◽  
Ruth Guinsburg ◽  
Akemi Kuroda Chiba ◽  
José Orlando Bordin ◽  
...  

OBJECTIVE: In preterm newborn infants transfused with erythrocytes stored up to 28 days, to compare the reduction of blood donor exposure in two groups of infants classified according to birth weight. METHODS: A prospective study was conducted with preterm infants with birth weight <1000g (Group 1) and 1000-1499g (Group 2), born between April, 2008 and December, 2009. Neonates submitted to exchange transfusions, emergency erythrocyte transfusion, or those who died in the first 24 hours of life were excluded. Transfusions were indicated according to the local guideline using pediatric transfusion satellite bags. Demographic and clinical data, besides number of transfusions and donors were assessed. . Logistic regression analysis was performed to determine factors associated with multiple transfusions. RESULTS: 30 and 48 neonates were included in Groups 1 and 2, respectively. The percentage of newborns with more than one erythrocyte transfusion (90 versus 11%), the median number of transfusions (3 versus 1) and the median of blood donors (2 versus 1) were higher in Group 1 (p<0.001), compared to Group 2. Among those with multiple transfusions, 14 (82%) and one (50%) presented 50% reduction in the number of blood donors, respectively in Groups 1 and 2. Factors associated with multiple transfusions were: birth weight <1000g (OR 11.91; 95%CI 2.14-66.27) and presence of arterial umbilical catheter (OR 8.59; 95%CI 1.94-38.13), adjusted for confounders. CONCLUSIONS: The efficacy of pediatrics satellites bags on blood donor reduction was higher in preterm infants with birth weight <1000g.


2018 ◽  
Vol 26 (7) ◽  
pp. 552-557 ◽  
Author(s):  
Lieven P Depypere ◽  
Johnny Moons ◽  
Toni E Lerut ◽  
Willy Coosemans ◽  
Hans Van Veer ◽  
...  

Background Despite integrated positron emission tomography and computed tomography screening before and after neoadjuvant treatment in patients with locally advanced esophageal cancer, unexpected metastatic disease is still found in some patients during surgery. Should then esophagectomy be aborted or is there a place for palliative resection? Methods Between 2002 and 2015, 681 patients with potentially resectable esophageal cancer were sheduled for neoadjuvant therapy and subsequent esophagectomy. In 552 patients, a potentially curative esophagectomy was performed. In 12 patients, unexpected disease was discovered during surgery but esophagectomy was performed with synchronous resection of metastases; 10 of them had oligometastatic disease (≤4 single-organ metastases). Esophagectomy was not performed in 117 patients (because of disease progression in 50); 14 were also single-organ oligometastatic. Data of 10 single-organ oligometastatic patients who underwent esophageal resection (group 1) were compared those of 10 non-resected but treated counterparts (group 2) and with 228 patients who underwent potentially curative esophagectomy with persistent pathological lymph nodes (group 3). Results Five oligometastatic esophagectomy patients had lung metastases: 1 peritoneal, 2 adrenal, 1 pleural, and 1 pancreatic. Two oligometastatic non-resected patients had lung, 5 liver, and 3 brain metastases. Median overall survival was 21.4, 12.1, and 20.2 months in the respective groups (group 1 vs. group 2  p = 0.042; group 2 vs. group 3  p = 0.002; group 1 vs. group 3  p = 0.88). Conclusions Survival is longer in patients undergoing palliative esophagectomy with unexpected single-organ oligometastatic disease and comparable to survival in patients with persistent pathological lymph nodes. Palliative resection in these patients seems to be justified.


2000 ◽  
Vol 28 (1) ◽  
pp. 27-30 ◽  
Author(s):  
R. Madan ◽  
T. Perumal ◽  
K. Subramaniam ◽  
D. Shende ◽  
S. Sadashivam ◽  
...  

This prospective, randomized, double-blinded study evaluated the effect of the timing of ondansetron administration on its antiemetic efficacy in children undergoing elective strabismus surgery. One hundred and twenty children aged one to 15 years, ASA physical status 1 or 2, were randomly allocated to receive intravenous ondansetron 100 μg/kg either at induction (Group 1) or at the end of the surgery (Group 2). All patients had general anaesthesia induced and maintained with nitrous oxide and halothane, muscle relaxation with vecuronium, endotracheal intubation, reversal with neostigmine and glycopyrrolate, and pethidine 0.5 mg/kg analgesia. Episodes of nausea and vomiting were evaluated at 0 to 2, 2 to 6 and 6 to 24 hour intervals by a blinded observer. Demographic data, duration of anaesthesia, type of surgery, incidence of previous postoperative nausea or vomiting and motion sickness and number of patients who developed oculocardiac reflex requiring atropine treatment were similar in both groups. The incidence of emesis in the first 24 hours following surgery was similar in both groups (35% Group 1, 33.3% Group 2, P=1.00). Severity of emesis (median number of emetic episodes, rescue antiemetic requirement and mean time to the onset of first episode of emesis) and mean time to discharge from the post anaesthesia care unit were also similar in the two groups. We conclude that the timing of ondansetron administration either before or after the surgical manipulation of extraocular muscles had similar antiemetic efficacy following strabismus surgery in children.


2018 ◽  
Vol 06 (06) ◽  
pp. E745-E750 ◽  
Author(s):  
J. Gonzalez ◽  
D. Lorenzo ◽  
T. Guilbaud ◽  
T. Bège ◽  
M. Barthet

Abstract Background and study aims Management of post-sleeve gastrectomy fistulas (PSGF) recently has evolved, resulting in prioritization of internal endoscopic drainage (IED). We report our experience with the technique in a tertiary center. Patients and methods This was a single-center, retrospective study of 44 patients whose PSGF was managed with IED, comparing two periods: after 2013 (Group 1; n = 22) when IED was used in first line and before 2013 (Group 2; n = 22) when IED was applied in second line. Demographic data, pre-endoscopic management, characteristics of fistulas, therapeutic modalities and outcomes were recorded and compared between the two groups. The primary endpoint was IED efficacy; the secondary endpoint was a comparison of outcomes depending on the timing of IED in the management strategy. Results The groups were matched in gender (16 female, 16 male), mean age (43 years old), severity of fistula, delay before treatment, and exposure to previous endoscopic or surgical treatments. The overall efficacy rate was 84 % (37/44): 86 % in Group 1 and 82 % in Group 2 (NS). There was one death and one patient who underwent surgery. The median time to healing was 226 ± 750 days (Group 1) vs. 305 ± 300 days (Group 2) (NS), with a median number of endoscopies of 3 ± 6 vs. 4.5 ± 2.4 (NS). There were no differences in number of nasocavity drains and double pigtail stents (DPS), but significantly more metallic stents, complications, and secondary strictures were seen in Group 2. Conclusion IED for management of PSGF is effective in more than 80 % of cases whenever it is used during the therapeutic strategy. This approach should be favored when possible.


2019 ◽  
Vol 25 (11) ◽  
pp. 1838-1844 ◽  
Author(s):  
Rishi Bolia ◽  
Jeremy Rajanayagam ◽  
Winita Hardikar ◽  
George Alex

Abstract Background In recent years, treatment strategies for ulcerative colitis have evolved with an early step-up approach, the availability of biologicals, and therapeutic drug monitoring. We carried out this study to evaluate the effect of these changes on disease outcomes. Methods In this retrospective review, 2 time periods were defined: Group 1 (2005–2010) and Group 2 (2011–2016). Baseline demographic, endoscopic parameters, and medication use were compared. Overall colectomy rate, number of disease flares per year, and number of hospital admissions per year were compared between the 2 groups. Results Group 1 had 71 children, and in children in Group 2. The use of 5-ASA increased in Group 2 (Group 2, 99.2% vs. Group 1, 84.5%, P = 0.0007). In addition, infliximab and thiopurines were introduced earlier in the disease course. The 2-year cumulative probability of colectomy decreased from 14% to 3% (P = 0.02) between the 2 periods. No change in median number of flares per year [Group 1, 0.41 (IQR 0.6) vs. Group 2, 0.62 (IQR 0.91), P = 0.28] or median number of hospital admissions per year [Group 1, 0.30 (IQR 0.77) vs. Group 2, 0.21 (IQR 0.75), P = 0.52] was seen. Thereafter, we proceeded to identify the changes in treatment strategies that were responsible for the reduction in colectomy and we found that the use of infliximab OR 3.7 (95% CI 1.1–11.7), P = 0.02, was independently associated with it. Conclusions A reduction in 2-year colectomy rates has been observed in patients with pediatric ulcerative colitis since biologics have become available for its treatment. The numbers of disease-flares rates and hospital admissions remain unchanged.


2016 ◽  
Vol 56 (1-2) ◽  
pp. 76-85
Author(s):  
Saddiq Qazi ◽  
Benedict Kjaergaard ◽  
Fei Yang ◽  
Hong Shen ◽  
Shenguo Wang ◽  
...  

Background: The fusing of the epicardium and sternum due to adhesion is a common problem during repeated cardiac surgery and carries with it an increased risk of bleeding. The use of barriers and patches has been tested to prevent the formation of adhesions, but the very presence of a patch can provoke adhesion formation. The objective of this study was, therefore, to investigate both biodegradable and bioresorbable polylactone patches [(polycaprolactone-poly(ethylene oxide)-polycaprolactone tri-block copolymer (PCE)]. The patches were also tested with a controlled release of rapamycin, which prevents cell migration and extracellular matrix deposition. The clinical effectiveness of rapamycin in pericardial patches has not previously been examined. Materials and Methods: Three groups of 6 female Danish Landrace pigs underwent sternotomy and abrasion of the epicardium, before being randomized to either group 1 - the control group (with no patch), group 2 - PCE patch implanted between the sternum and epicardium, or group 3 - PCE patch and slow-release 1.6-mg rapamycin. After a median time period of 26 days, the pigs were euthanized and their hearts removed en bloc with the sternum, for macroscopic, histological and pathological examination. Results: Upon macroscopic examination, a significantly lower degree of adhesion in group 2, as compared to group 1 (p < 0.05), was found. Histological analysis of the tissues showed significantly more fibrosis, inflammation and foreign body granulomas (p < 0.05) in both group 2 and group 3, when compared to group 1. Conclusion: A PCE patch following sternotomy in animal subjects reduces postoperative macroscopic adhesions without reducing microscopic fibrosis or inflammation. Loading the patch with rapamycin was found not to increase the antifibrotic effect.


Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 2929-2929
Author(s):  
Isabelle A. Bence-Bruckler ◽  
Sheryl McDiarmid ◽  
Harold L. Atkins ◽  
Mitchell Sabloff ◽  
Isabelle Gauthier ◽  
...  

Abstract The optimal dose and schedule of granulocyte colony-stimulating factor (G-CSF) for peripheral blood progenitor cell (PBPC) mobilization is unclear. When PBPC mobilization is performed using chemotherapy and growth factor priming, growth factors are often initiated early (day +1) upon completion of chemotherapy. Several small trials report safe and successful PBPC collection after delayed G-CSF initiation. We evaluated two schedules of G-CSF administration in patients with lymphoma and myeloma undergoing PBPC collection. We compared CD34+ cell yields obtained in each group and number of G-CSF doses required. Secondary end points were post-transplant neutrophil and platelet recovery and duration of febrile neutropenia, IV antibiotic administration and hospitalization. We studied patients with lymphoma and myeloma referred for ASCT. Eligible patients had not received more than two prior chemotherapy regimens or pelvic irradiation. Priming chemotherapy was DHAP (lymphoma) or cyclophosphamide 2.5 gm/m2 (myeloma and lymphoma). Rituximab was combined with chemotherapy for certain lymphoma patients for purposes of in vivo purging. G-CSF was initiated either 24 hours (day +1) post completion of chemotherapy (Group 1), or on the 5th day (day +5) after chemotherapy (Group 2). The dose of G-CSF was 300 ug sc daily for patients weighing 70 kg or less, and 480 ug sc daily if &gt; 70 kg. Leukapheresis was initiated when the WBC count was &gt;2.0 x 109/l and the CD34+ count was &gt;10/microliter. Single or serial daily leukaphereses were performed until a minimum of 2 x 106 CD34+ cells/kg were obtained. There were eighty-one consenting patients: 30 with nonHodgkin’s lymphoma, 37 with myeloma and 14 with Hodgkin’s lymphoma. Priming was done with DHAP in 33 and with cyclophosphamide in 46. Forty-two were randomized to day +1 G-CSF initiation (Group1) and 39 to day +5 (Group 2). Diagnosis, prior chemotherapy or priming regimen did not vary among the study groups. Three patients in Group 1 did not proceed to collection (two due to disease progression, the third withdrew consent). All patients in Group 1 were successfuly mobilized, while in group 2, two were not successfully mobilized (p=0.49). Of these patients, one underwent marrow harvest while the other was transplanted with a suboptimal CD34+ cell count. In Group 1, 32 of 39 were mobilized with a single leukapheresis and 7 required two; in Group 2, 25 of 37 were mobilized in 1 day, 11 in 2 days and one patient required 4 days (p=0.2).The median number of CD34+ cells collected was 10.6 x 106/kg in Group 1 versus 7.9 x 106/kg in Group 2 (p=.04). The median number of doses of G-CSF administered was 9 in Group 1 and 6 in Group 2 (p&lt;.0001). The time to neutrophil and platelet recovery were 11 and 11.5 days respectively and did not differ amoung the groups. There was no difference in the number of platelet transfusions, duration of febrile neutropenia, antibiotic use or length of hospitalization. The number of units of RBC transfused in Group 1 was 4 (range; 0–11) versus 2 in Group 2 (range; 0–21; p=.04). Stem cell mobilization using delayed G-CSF initiation was as effective as early initiation, and required a median of 9 vs 6 doses of drug. Despite lower CD34+ yields in the delayed G-CSF group, the outcome of mobilization was not compromised and post-transplant engraftment, infectious complications and hospitalization were comparable.


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