Cost Effectiveness of Metal Stents in Relieving Obstructive Jaundice in Patients with Pancreatic Cancer

Background

ASGE and ESGE guidelines recommend endoscopic metal stent placement for pancreatic carcinoma patients with biliary obstruction, and whose estimated life expectancy is greater than 6 months. Because median overall survival (OS) of metastatic pancreatic adenocarcinoma until recently has been less than 6 months, plastic biliary stents were preferentially placed rather than metal due to the greater upfront cost of the latter. Recent advances in the treatment of metastatic pancreatic cancer have extended median OS beyond the 6-month range. Given this improvement in OS, we performed a cost-effectiveness analysis of initial metal biliary versus plastic stent placement in metastatic pancreatic cancer patients with biliary obstruction.

Methods

A Markov model was developed to predict lifetime costs, quality-adjusted life years (QALYs), and cost effectiveness of metal compared with plastic stents. Adult patients entered the model with locally advanced cancer and underwent endoscopic retrograde cholangiopancreatography (ERCP) with placement of metal or plastic stents. A targeted literature search was conducted to identify published sources, which were used to estimate clinical, cost, utility, and event rate inputs to the model. Results were estimated from the third-party payer perspective in 2012 US dollars per QALY. One-way and probabilistic sensitivity analyses were conducted to assess the impact on model outcomes resulting from uncertainty among inputs.

Results

Our analysis found that initial placement of metal stents was more cost effective than plastic biliary stents with lower overall costs due to lower restenting rates while at the same time associated with a better quality of life. Based on model projections, placement of metal stents could save approximately $1450 per patient over a lifetime, while simultaneously improving quality of life. These findings were robust in sensitivity analyses.

Conclusions

Placement of metal biliary stents at initial onset of obstructive jaundice in adult patients with metastatic pancreatic carcinoma with an expected OS greater than 6 months was found to be a more cost-effective strategy than plastic stents. These results reinforce guidelines’ suggestions for metal stent placement.

     

Self-expanding metal stents (SEMS) provide superior outcomes compared to plastic stents for pancreatic cancer patients undergoing neoadjuvant therapy

Background

Neoadjuvant therapy is increasingly utilized for pancreatic cancer patients to decrease tumor burden in anticipation of later surgical resection. However, infectious complications such as life threatening cholangitis may occur for those with biliary obstruction. We hypothesized that placement of metal rather than plastic stents in such patients results in lower rates of stent-related complications, leading to improved clinical outcomes.

Methods

Retrospective cohort of pancreatic cancer patients treated by the University of Michigan Multidisciplinary Pancreatic Cancer Destination Program between January 2005 and June 2010. Only patients undergoing neoadjuvant therapy with one or more biliary stents placed for malignant obstruction were studied. Time to stent complication was compared between metal and plastic stents. The complication rate was estimated as the ratio of complications to total stent exposure time and 95% confidence intervals were calculated.

Results

52 patients met inclusion criteria. A total of 113 stents were placed in 52 patients (70 plastic, 43 metal). The complication rate was almost 7 times higher with plastic stents, 0.20 (95% CI, 0.14-0.30), than with metal stents, 0.03 (95% CI, 0.01-0.06). Moreover, the rate of hospitalization for stent-related complications was 3-fold higher in the plastic stent group than the metal stent group. The first quartile estimate of time to stent complication was almost 5 times longer for metal than for plastic stents (44 vs. 200 days) (P<0.0001).

Conclusion

Compelling evidence indicates that self-expanding metal, not plastic stents should be used for malignant biliary obstruction in patients undergoing neoadjuvant therapy for pancreatic cancer.Key Words: Pancreatic cancer, jaundice, chemotherapy, bile duct stents     

Use of Self-expandable Stents for Obstructive Distal and Proximal Large Bowel Cancer: A Retrospective Study in a Single Centre

Aim

The aim of our retrospective study was to determine the effectiveness and safety of self-expandable metal stents in patients presenting with large bowel obstruction secondary to colorectal cancer (regardless of the tumour site), in a district general hospital setting.

Methods

All patients who had endoscopic colonic stents insertion for obstructive colorectal cancer between 2001 and 2005 at our centre were identified retrospectively from patients' discharge database and the unit database. The patients were divided into the 'palliation group' where the stents were inserted to relief symptoms only and the 'bridge group' where patients with resectable cancer underwent colonic stenting as a bridge to improve patient's general condition before definite surgery.

Results

Thirty-eight patients were included in the final analysis. Thirty-three tumours were in the distal colon and five were in more proximal lesions. Stent insertion was successful in 35 patients (92%). Overall clinical success was 71%. All five proximal colonic tumours (13%) had successful stent insertion. Mortality related to procedure was 2%, and the average survival in all patients was 141 days from time of stent insertion.

Conclusion

Colonic stent is a safe and effective method for relief of immediate symptoms of malignant distal and proximal large bowel obstruction.     

Clinical Outcomes of Stenting for Colorectal Obstruction at a Tertiary Centre

Purpose

Self-expandable metal stents (SEMS) have been used to manage large bowel obstruction as a palliative treatment or to initially decompress the colon as a bridge to definitive surgery. Our goal was to review clinical outcomes in patients undergoing placement of a SEMS for colorectal obstruction at a tertiary care hospital.

Methods

A retrospective review was done of patients undergoing placement of a colorectal SEMS at a single centre between August 2005 and March 2011 for obstructing lesions. Outcomes identified included clinical relief of obstruction, successful bridging to surgery or palliation, and stent-related complications.

Results

SEMS were placed in a total of 58 patients. The intent of stenting was to bridge to definitive surgery in 11 patients and palliation in 47 patients. Stent placement was clinically successful in relieving obstruction without early complication in 45 (78 %) patients. Of the patients intended to bridge to surgery, 7/11 (64 %) were successfully bridged to surgery. One patient suffered a perforation, two failed to relieve obstruction, and one re-obstructed. Of the patients stented for palliation, 32/47 (68 %) were successfully palliated at a mean follow-up of 7.5 months. Five patients had perforations, six re-obstructed, two had stent migration, and two failed to relieve obstruction. The overall rates for perforation, re-obstruction, and stent migration were 10, 12, and 7 %, respectively.

Conclusion

SEMS placement as a bridge to surgery and for palliation of colorectal obstruction is associated with moderate rates of clinical success but a high rate of perforation.     

The modified Glasgow Prognostic Score (mGPS) is a good predictor of indication for palliative bypass surgery in patients with unresectable pancreatic and biliary cancers

Background

Patients with unresectable pancreatic and biliary cancers sometimes need decompression due to obstruction of the gastrointestinal tract and/or biliary tract. The aim of this study was to determine the prognostic factors associated with an indication for palliative bypass surgery in patients with unresectable pancreatic and biliary cancers.

Methods

Between April 2005 and September 2011, 37 patients with unresectable pancreatic and biliary cancers underwent palliative bypass surgery. Prognostic factors were searched for among clinical characteristics, operation-related factors, and tumor-related factors using a prospective database.

Results

The median survival time (MST) of these patients was 4.6 months, with a 6-month survival rate of 40.5 %. A multivariate Cox proportional hazards regression analysis revealed that mGPS >2 was the only independent prognostic factor for bypass surgery. Patients with an mGPS of 2 had an MST of 1.7 months, and they had a significantly worse prognosis than mGPS 0–1 patients with an MST of 6.3 months.

Conclusions

The mGPS is useful for predicting survival after surgical decompression due to gastrointestinal obstruction in patients with unresectable pancreatic and biliary cancers. Patients with a poor mGPS may not be indicated for palliative bypass surgery.     

Clinical Outcomes of Using a Conservative Approach of Late Esophageal Stent Placement in Palliation of Malignant Dysphagia

Background

Esophageal stents have been used as first-line treatment for palliation of malignant dysphagia, but this is associated with significant complications. The present study evaluated clinical outcomes and survival in patients with malignant dysphagia with esophageal stent placement who did not respond to prior chemoradiation or endoscopic modalities.

Patients and Methods

Patients with esophageal cancer, who had esophageal stents, were retrospectively reviewed from the electronic medical records. The patient demographics, type of stent placed, dysphagia scores, stent-related complications, and survival were recorded.

Results

Thirty-five patients with esophageal cancer received a total of 41 stents. There were 25 males and 10 females with mean age of 69.8 years. Twenty-two patients had esophageal adenocarcinoma, ten patients had squamous cell carcinoma, and three had poorly differentiated tumor. Esophageal malignancy was early stage (I, II) in 10 patients and advanced (III, IV) in 24 patients. Three patients had upper esophageal involvement, eight patients had mid-esophageal involvement; distal esophageal malignancy was present in 24 patients with 10 patients having gastroesophageal junction involvement. Six patients presented with tracheoesophageal fistula. Nine patients had prior esophagectomy. Thirty-three patients had chemoradiation, and 32 patients had other endoscopic therapies previously. Twelve of the 35 (33%) patients developed stent-related complications; nine patients had dysphagia due to various causes; one patient each developed aspiration, intractable hiccups, and intractable vomiting after stent placement, respectively. Nine patients underwent a repeat esophagogastroduodenoscopy. Development of stent-related complications was not significantly associated with poor survival.

Conclusions

The clinical outcomes for patients with esophageal stent placement for malignant dysphagia after chemoradiation and other endoscopic treatments is not worse than that reported in patients where esophageal stent placement was used as first-line treatment.     

Preoperative biliary drainage-related inflammation is associated with shorter survival in biliary tract cancer patients

Background

An association between inflammation and patient prognosis has been reported in various types of cancer. The aim of this study was to evaluate the influence of preoperative biliary drainage-related inflammation in patients with biliary tract cancer.

Methods

The clinical data of 97 patients who underwent surgery for extrahepatic bile duct cancer between February 2002 and September 2014 were analyzed, and the prognostic significance of tube-obstructive cholangitis after preoperative biliary drainage and pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) was evaluated.

Results

Eighty-four (86.6 %) of the 97 patients underwent ERCP and preoperative biliary drainage. Tube-obstructive cholangitis occurred in 25 cases and post-ERCP pancreatitis in 8 cases. Collectively, 30 patients experienced preoperative biliary drainage-related inflammation consisting of tube-obstructive cholangitis and/or post-ERCP pancreatitis. Drainage-related inflammation was significant risk factor of postoperative complications (P = 0.006), and significant poor predictors of shorter progression-free survival (P = 0.003) and overall survival (OS; P = 0.006) after surgery. In multivariate analysis, drainage-related inflammation was an independent predictor of shorter OS (hazard ratio, 1.924; P = 0.037) after surgery.

Conclusion

Preoperative biliary drainage-related inflammation was an independent prognostic factor for shorter OS in biliary tract cancer patients.

     

Impact of preoperative endoscopic cholangiography and biliary drainage in Ampulla of Vater cancer

Background

Ampulla of Vater (AOV) carcinoma is a rare malignancy but has a relatively good prognosis. The aims of this study were to determine the clinicopathologic factors associated with survival and disease recurrence in patients with AOV cancer, focusing on the impact of preoperative endoscopic retrograde cholangiopancreatography (ERCP) and type of biliary drainage (endoscopic retrograde biliary drainage [ERBD] or percutaneous transhepatic biliary drainage [PTBD]).

Stenting of the Colon in Patients with Malignant Large Bowel Obstruction: a Local Experience

Purpose

There is an increasing evidence base to support the use of self-expanding metallic gastrointestinal stents. In patients with colorectal cancer, they are used as a bridge to surgery and for palliation. The purposes of this study are to assess technical success, clinical outcome, complication rate and patency following colonic stent insertion in patients with colonic cancer at a local level and to compare our results with the current evidence base.

Methods

A retrospective, two-centre study was conducted. Twenty-seven patients were included over a 5-year period. Six patients had undergone stent insertion as a bridge to surgery, and 21 had the procedure for palliation.

Results

Initial technical success was achieved in 26 of 27 patients (96%). Of these 26 patients, clinical success was achieved in 24 patients (92%). Five patients (21%) suffered from stent re-occlusion, and one patient (4%) suffered from stent migration. There was one case (4%) of procedure-related perforation. Of the 19 palliative patients in whom clinical success was achieved, 17 (89%) were alive at 30 days, 13 (68%) at 90 (53%) days and 10 at 180 days. Average stent patency was 195 days.

Conclusion

WallFlex® self-expanding metallic gastrointestinal stents are a safe and effective means of alleviating obstructive symptoms in patients with colonic cancer requiring palliative treatment or as a bridge to surgery. Our data suggest that although a small percentage of patients are affected by stent re-occlusion, this does not contribute to premature mortality. They improve quality of life in palliative care patients as well as reducing premature morbidity and mortality caused by emergency surgery.     

Simple Clinical Score to Predict 24-Week Survival Times in Patients with Inoperable Malignant Distal Biliary Obstruction as a Tool for Selecting Palliative Metallic or Plastic Stents

Background and Aim

Endoscopic biliary drainage (EBD) is the mainstay treatment for inoperable malignant distal biliary obstruction (MDBO). Some authorities suggest that metallic stents are more cost-effective than plastic stents in patients with expected survival of at least 6 months. However, studies attempting to define the predictive factors for such survival times are limited. This study aims to develop a scoring system for predicting a survival time of <24 weeks in these patients.

Method

Patients with MDBO from inoperable periampullary cancers who underwent EBD at Songklanagarind Hospital during 2004–2009 were retrospectively analyzed. Baseline clinical, laboratory, and imaging data were retrieved. The survival time data were retrieved from the medical records and Thailand’s civil registration database. Multivariate Cox regression model coefficients were used in the development of a survival time prediction scoring system.

Results

Ninety-eight patients were included. The overall median survival was 17.6 weeks. Fifty-seven (58.1%) survived <24 weeks. By multivariate analysis, cancer type and liver metastasis were significant predictive factors. The Simple Clinical Score (SCS) was calculated from (2× liver metastasis) + (1× pancreatic cancer) ? (2× ampullary cancer) ? (1× cholangiocarcinoma), when 1 and 0 were used for the presence and absence of each factor, respectively. The cutoff value of the score ≥0 had a sensitivity and specificity of 0.77 and 0.63, respectively, for predicting a survival time of <24 weeks, with AUC of 0.76. The median survival of patients with SCS <0 and ≥0 was 36.6 and 13.1 weeks, respectively.

Conclusion

The scoring system from this study may be beneficial for clinicians to select the appropriate stents in endoscopic biliary drainage in inoperable MDBO patients.

     

Palliative Surgical Bypass for Pancreatic and Peri-ampullary Cancers

Background

The optimal method of palliation for patients with unresectable pancreatic and peri-ampullary cancer (PAC) is controversial with surgical bypass or endoscopic stenting, each having advantages and disadvantages.

Aims

We analysed short term outcomes and survival for all patients undergoing surgical palliative bypass procedures.

Materials and methods

All patients undergoing palliative surgical bypass for unresectable PAC from Aug 1999 to July 2007 were identified from our database. Outcomes analysed were peri-operative morbidity, mortality, and overall survival with comparisons from contemporaneous literature.

Results

One hundred eight patients (median age 65 (range 36–86) years; male = 61) had palliative surgical bypass procedures for unresectable PAC. Patients underwent combined biliary and gastric bypass (n = 81, 75%), gastric bypass alone (n = 24, 22.2%) or biliary bypass alone (n = 3, 2.8%). Overall mortality was 6.5% and the morbidity was 15.7%. Median hospital stay was 11 (range 4–54) days. Median survival was 6 (95% confidence interval (CI) = 4.3–7.6) months. No re-explorations for recurrent biliary or gastric obstruction were required. Contemporaneous literature review showed similar results.

Conclusion

Surgical bypass performed in a specialist pancreatic center can offer effective palliation for unresectable PAC, with satisfactory outcomes.     

Risk Factors of Duodenobiliary Reflux-Related Dysfunction of Covered Biliary Metal Stents after Treatment of Duodenal Stricture in Patients with Malignant Biliary and Duodenal Obstruction

Duodenal obstruction is often accompanied with unresectable malignant distal biliary obstruction in patients who have undergone biliary self-expandable metal stent (SEMS) placement. Duodenobiliary reflux (DBR) is a major cause of recurrent biliary obstruction (RBO) after covered biliary SEMS placement. We analyzed the risk factors for DBR-related SEMS dysfunction following treatment for malignant duodenal obstruction. Sixty-one patients with covered SEMS who underwent treatment for duodenal obstruction were included. We excluded patients with tumor-related stent dysfunction (n = 6) or metal stent migration (n = 1). Fifty-four patients who underwent covered biliary SEMS placement followed by duodenal metal stenting or surgical gastrojejunostomy were included. Eleven patients had DBR-related biliary SEMS dysfunction after treatment of duodenal obstruction. There was no difference between the duodenal metal stenting group and the surgical gastrojejunostomy group. Duodenal obstruction below the papilla of Vater and a score of ≤2 on the Gastric Outlet Obstruction Scoring System after treatment for duodenal obstruction were associated with DBR-related covered biliary SEMS dysfunction. Thus, creating a reliable route for ensuring good oral intake and avoiding DBR in patients with duodenal obstruction below the papilla of Vater are both important factors in preventing DBR-related covered biliary SEMS dysfunction.     

Biliary Obstruction and Pancreatitis Caused by Diffuse Nodular Hyperplasia of Brunner’s Gland

Introduction

Brunner's gland hyperplasia (BGH) of the duodenum is an uncommon finding at endoscopy and is usually asymptomatic. Symptomatic BGH presenting with biliary obstruction and pancreatitis is extremely rare and the literature is limited to a few case reports.

Case

We report an unusual case of diffuse BGH of duodenum involving the ampulla of Vater that led to this clinical presentation. Biopsies revealed BGH and successful endoscopic therapy utilizing sphincterotomy and plastic stent placement led to complete recovery.

Conclusion

Albeit its uncommon clinical presentation, it can become challenging in terms of diagnosis and management. A high index of suspicion is of paramount importance for establishing the correct diagnosis and treatment.     

Percutaneous “Y” biliary stent placement in palliative treatment of type 4 malignant hilar stricture

Background

This study evaluated the technical and clinical efficacy of percutaneous bilateral biliary stent-in-stent (SIS) deployment technique with a “Y” configuration using open-cell-design stents in type 4 Klatskin tumor patients.

Methods

Retrospective evaluation ten patients with type IV Bismuth malignant hilar stricture (MHS) treated with percutaneous bilateral “Y” SIS deployment technique placement followed in our institution between March of 2012 and November of 2014.

Results

Bilateral SIS deployment was technically successful in all patients. One patient (10%) had major complications (episode of cholangitis); one patient (10%) had minor complications, including self-limiting hemobilia. Successful internal drainage was achieved in nine (90%) patients. Stent occlusion by tumor overgrowth and sludge formation occurred in two patient (20%). The median survival and stent patency time were 298 and 315 days respectively.

Conclusions

Percutaneous bilateral metal stenting using a Y-stent is a valid option for the palliative treatment of type 4 Bismuth MHS, improving quality patient’ life.     

高位恶性胆道梗阻胆道双支架植入的疗效

目的 分析胆道双支架植入联合胆道外引流治疗高位恶性胆道梗阻（malignant high biliary obstruction,MHBO）临床疗效及应用价值。方法 MHBO患者96例,胆道双支架植入联合胆道外引流77例、胆道单支架植入并对侧引流11例、单纯胆道外引流8例;观察术后近、远期疗效。结果 胆道双支架植入联合胆道外引流77例,成功率为80.21%。96例MHBO患者术前总胆红素、直接胆红素、谷丙转氨酶、谷草转氨酶与术后第7、14天比较,差异有统计学意义（P<0.05）;术后第21天胆道双支架植入患者总胆红素下降率（92.56%）明显高于胆道单支架植入并对侧引流和单纯胆道外引流患者（61.53%）,差异有统计学意义（P<0.05）。77例胆道双支架植入患者3、6、9、12、15、18、21月生存率分别为98.70%、88.31%、76.62%、46.75%、18.18%、2.6%、1.3%。结论 胆道双支架植入联合胆道外引流治疗MHBO是一种安全有效的方法,不仅能够迅速退黄并恢复肝功能,为肿瘤的进一步治疗赢取了时间,而且能提高患者的生存质量及延长生存期。     

Safety of biliary stent placement followed by definitive chemoradiotherapy in patients with pancreatic cancer with bile duct obstruction

BackgroundAlthough patients with malignant bile duct obstruction due to pancreatic cancer are often initially treated with biliary stent placement, concurrent chemoradiotherapy with stents poses a potential risk of increased toxicity. This retrospective study aimed to evaluate the safety of biliary stent placement followed by definitive concurrent chemoradiotherapy in patients with pancreatic cancer.MethodsPatients with pancreatic cancer who underwent either a plastic stent or a self-expanding metallic stent placement for malignant bile duct obstruction before definitive concurrent chemoradiotherapy were retrospectively reviewed. Radiotherapy was delivered in 1.8 Gy per fraction to a total dose of 50.4 Gy. Gemcitabine, TS-1 plus Gemcitabine, or TS-1 was the concurrent chemotherapy/regimen. The primary endpoint was the rate of biliary stent-related toxicities, defined as biliary bleeding, duodenal perforation, or bile duct perforation.ResultsThirty patients were included. Plastic stents were placed in 23 patients and self-expanding metallic stent in seven patients at the start of irradiation. The median follow-up time was 20 (range, 2–63) months, and 27 patients (90%) completed concurrent chemoradiotherapy. Biliary stent-related toxicity (grade 3 biliary bleeding) was confirmed in one patient (3%) with a plastic stent 9 months after concurrent chemoradiotherapy. The median duration of locoregional control, progression-free survival, and overall survival were 31.1, 7.3, and 10.5 months, respectively.ConclusionsStent placement followed by concurrent chemoradiotherapy was not associated with an apparent increase in toxicity and may be an appropriate treatment for patients with locally advanced pancreatic head cancer with bile duct obstruction.     

Endoscopic dacryocystorhinostomy vs KTP 532 laser-assisted endoscopic dacryocystorhinostomy

Objectives

Advances in endoscopy and lasers have improved surgical management of chronic nasolacrimal duct obstruction. This is a preliminary comparison between standard and laser assisted endoscopic dacryocystorhinostomy (DCR).

Study Design

Combined retrospective and prospective study.

Setting

Tertiary referral hospital.

Patients and Methods

Thirty-eight cases of chronic nasolacrimal duct obstruction underwent endoscopic DCR (26 standard and 12, laser-assisted) and were assessed at 3 and at 6 months postoperatively by nasal endoscopy.

Results

Three months postoperatively (n=38), total relief of epiphora among the nonlaser group was 80.76 vs 75% in the laser group (P=0.982). At 6 months (n=19), the laser group had recorded 100% symptomatic relief compared to 85.71% in the nonlaser group (P=0.964). The laser group suffered fewer complications (33.33 vs 46.15% for nonlaser group).

Conclusion

Lasers show promise in long-term management of duct obstruction and are associated with fewer complications. A larger study is required before and generalization is made.     

A Case of Successful Placement of a Fully Covered Metallic Stent for Hemobilia Secondary to Hepatocellular Carcinoma with Bile Duct Invasion

Hemobilia represents gastrointestinal bleeding that develops as a result of communication between blood vessels and the biliary tract, which causes the blood to reach the duodenal papilla. It is characterized by biliary colic as the initial symptom, and the complications of cholangitis, obstructive jaundice and/or anemia. In general, definitive diagnosis is made by esophagogastroduodenoscopy which confirms bleeding from the duodenal papilla. Abdominal US and abdominal enhanced CT are performed to identify the source of the bleeding, as well as ERCP for biliary drainage to control the comorbid cholangitis. If active hemorrhage accompanied by worsening of the anemia is suspected, abdominal angiography is performed to selectively image the hepatic artery. Then, embolization of the culprit vessel is recommended. In our patients with difficult hemostasis, because of the direct compression hemostasis to the tumor site achieved with the fully covered metallic stent and secondary compression hemostasis due to blood clots, the bleeding could be controlled.Key words: Hemobilia, Hepatocellular carcinoma, Bile duct invasion, Fully covered metallic     

Endobiliary Stent: Marker for Patient Alignment in Image-Guided Radiotherapy in Pancreatic and Periampullary Cancers

Purpose

The aim of this study was to analyse the possibility of using stent in pretreatment megavoltage computed tomography (MVCT) images with respect to that on planning kilovoltage computed tomography as tumour surrogate during matching for daily registration in cases of pancreatic and periampullary cancer treated on a TomoTherapy Hi-Art system.

Methods

Planning CT and pretreatment MVCT of the first and then after every three fractions were transferred to a FocalSim workstation for ten patients. Planning CT of each patient was independently fused with each of the seven MVCT images of that patient. The stent was contoured on all of the eight images for each patient. The difference between the three co-ordinates of centre of mass (CM) of the stent on the planning CT and seven MVCT images was found. The difference between CM of the liver and stents on the planning CT as well as on the MVCT for all seven fractions was also calculated. The mean of these differences across all patients was calculated and analysed.

Results

The mean difference in planning and MVCT CMs for stents in the X, Y and Z directions was 0.13 cm (±0.4), 0.16 cm (±2.2) and 0.35 cm (±0.7), respectively. Average difference between CM of the liver and stent on the planning CT in the X, Y and Z directions was found to be 1.832 cm (±1.64), 5.34 cm (±1.33) and 0.54 cm (±0.26), respectively. Average difference between CM of the liver and CM of stent on the MVCT for that day in the X, Y and Z directions was found to be 1.93 cm (±1.5), 4.6 cm (±1.03) and 0.654 cm (±0.35), respectively.

Conclusions

Endobiliary stents are stable tumour localisation surrogates and can be used to correct for interfraction target motion.     

Pemetrexed and Gemcitabine for Biliary Tract and Gallbladder Carcinomas: a North Central Cancer Treatment Group (NCCTG) Phase I and II Trial, N9943

Purpose

To determine the maximum tolerated dose (MTD) and efficacy of pemetrexed and gemcitabine in patients with either biliary tract or gallbladder carcinoma.

Patients and Methods

Patients with unresectable previously untreated biliary tract cancers were eligible for participation. An initial phase I trial was performed to determine the MTD using an every-2-weeks schedule. The MTD was then used in the phase II portion of the trial. The primary end point for the phase II portion was 6-month survival with a planned accrual of 59 patients.

Results

Overall, 63 eligible patients were enrolled. The MTD was established as pemetrexed 500 mg/m² IV over 10 min and gemcitabine 800 mg/m² IV at 10 mg/m² per minute on days 1 and 15 of an every-4-weeks schedule with vitamin B12 and folate supplementation. Fifty-eight patients were included in the phase II portion. Median age was 61 and median follow-up was 18.2 months. A median of three cycles of treatment was given. Six-month survival was 55% and the median survival was 6.6 months (95% confidence interval 5.4–8.7 months) with a median time to progression of 3.8 months (2.4–5.4). Forty-seven (81%) experienced at least one grade 3+ adverse event, and 28 patients (48%) experienced at least one grade 4 adverse event, most of which were due to grade 4 neutropenia.

Conclusion

The addition of pemetrexed to fixed-dose-rate gemcitabine, in a biweekly schedule, did not enhance the activity of gemcitabine in patients with biliary tract or gallbladder carcinoma.