e15262 Background: Patients receiving gemcitabine-based neoadjuvant chemoradiotherapy for non-metastatic pancreatic cancer often have difficulty tolerating full treatment courses. Providers are thus faced with the difficult decision of holding or reducing chemotherapy. As the effects of chemotherapy dose reduction are not well understood, we evaluated the impact of dose reduction on survival and other outcomes. Methods: We performed a single center retrospective review of patients receiving two gemcitabine-based neoadjuvant chemoradiation protocols for localized pancreatic cancer over a 9 year period. For inclusion, patients were required to have completed at least 95% of their prescribed radiation dose. The dose intensity of completed chemotherapy was stratified into three tiers of 90%-100%, 75%-89%, and <75% of total protocol dose. Our primary outcome was the effect of dose reduction on overall and progression-free survival. Secondary outcomes included completion of surgery, radiologic down staging, R0 resection rate, and nodal status. Results: A total of 113 patients (mean age 62 yr) were included, of which 28 (25%) had resectable disease, 51 (45%) had borderline resectable disease, and 34 (30%) had locally advanced disease. Forty-seven patients (41.6%) received 90-100% of the total protocol dose (dose level I), 36 patients (31.9%) received 75-89% (dose level II), and 30 patients (26.5%) received <75% (dose level III). The most common reasons for dose reduction were thrombocytopenia, neutropenia, or obstruction of the biliary tract. Overall survival and progression free survival at 1, 2, and 5 years were 69.3%, 37.1% and 19.6%, and 43.1%, 26.4%, and 19.5%, respectively. Five year survival in the resectable, borderline and unresectable groups was 39.9%, 22.5% and 3.1%, respectively. Multivariate analysis showed no statistically significant effect of dose reduction at any dose level, on overall survival, progression-free survival, or any secondary outcomes. Conclusions: Mild to moderate dose reduction has no significant impact on outcomes. Providers should feel reassured when reducing gemcitabine doses for patients experiencing treatment side effects.

e15189 Background: The role of neoadjuvant therapy in pancreatic ductal adenocarcinoma (PDAC) remains unclear, but has demonstrated benefit in many studies. CA 19-9 is a commonly used tumor marker in the clinical management of PDAC, but its prognostic role in neoadjuvant therapy is not well defined. The goal of this study was to determine the relationship between CA 19-9 changes after neoadjuvant therapy and subsequent outcomes in patients with non-metastatic PDAC. Methods: We performed a retrospective review of all patients with resectable, borderline resectable, and locally advanced PDAC who received neoadjuvant therapy at our institution between 1996 and 2012. For inclusion, patients needed a serum CA 19-9 >40 U/ml and bilirubin ≤2 mg/dl at the initiation of therapy. We evaluated associations between Ca 19-9 pre- and post- neoadjuvant therapy (NT) and outcome variables including completion of surgery, overall survival, and progression-free survival. Results: Of the 145 patients included, 30 had resectable disease (20%), 56 had borderline resectable disease (39%), and 59 had locally advanced disease (41%). Post-NT CA 19-9 normalized to <40U/ml in 54 patients (37%). Seventy patients (48%) underwent resection. Patients with post-NT CA 19-9 <40U/ml had significantly higher odds of undergoing resection (OR 2.95 p = 0.02). Normalization of post-NT CA19-9 was associated with improved survival (HR=0.58 p=0.006), even after adjusting for successful resection. CA19-9 normalization was predictive of longer OS in patients with borderline disease (HR (0.320, p = 0.001). Completion of resection was also prognostic for overall survival (HR 0.30 p<0.001). Median OS in resected patients who normalized CA 19-9 was 27.3 months, and 20.9 months in those who did not (p = 0.10). Normalization of post-NT CA19-9 in those who did not complete resection was also associated with longer overall survival, with a median OS of 15.1 months, compared to 8.5 months (p=0.032). Conclusions: Normalization of CA 19-9 to <40U/ml with neoadjuvant therapy is highly prognostic for resection and overall survival in patients receiving gemcitabine-based neoadjuvant chemoradiation therapy.

CASE REPORT A 68-year-old man with a history of diabetes and alcohol abuse presented with constitutional symptoms and obstructive jaundice in April 2009. Endoscopic ultrasound (EUS) demonstrated a 3.2 2-cm mass in the head of the pancreas, abutting the portal vein and encasing the common bile duct. A biopsy was positive for adenocarcinoma, and the tumor was judged to be borderline resectable. The patient was treated with neoadjuvant docetaxel and gemcitabine for 3 cycles, followed by twice-weekly gemcitabine 50 mg/m and external beam radiotherapy (total dose, 54 Gy by intensity-modulated radiation therapy [IMRT]), per Pipas et al. Treatment induced a 25% reduction in tumor size at restaging, despite an initial delay and dose reductions related to prolonged elevation in results of liver function studies after biliary stenting. In November 2009, the patient underwent pancreaticoduodenectomy. Pathology revealed an invasive, poorly differentiated pancreatic adenocarcinoma with treatment-related change. Surgical margins and 22 lymph nodes were negative for tumor. The postoperative course was complicated by a 6-week hospital stay for ascites and poor wound healing, due to previously unrecognized alcoholic cirrhosis. The patient eventually made a full recovery and returned to work, but in June 2010, he presented for a surveillance abdominal computed tomographic (CT) scan that showed an irregularity in the pancreatic remnant (Figure 1). A repeat EUS demonstrated a 3-cm pancreatic tail mass that encased splenic vessels, and adenocarcinoma was confirmed by biopsy. Comparison with the prior tumor by light microscopy and immunohistochemistry revealed the specimens to be identical. In addition, massively parallel sequencing of a 50-gene cancer hotspot panel in DNA extracted from both tumors revealed a single PIK3CA polymorphism that was the same in each, thus confirming that the lesion represented recurrent tumor and not a second primary. The patient was not a candidate for completion pancreatectomy because of the cirrhosis. His case was presented at our interdisciplinary GI tumor board, and he was retreated with twice-weekly gemcitabine 50 mg/m, concurrent with radiotherapy in nonoverlapping fields. He received 45 Gy with 3-D conformal planning. The previous radiation plan was fused to avoid overdosing of critical structures. Conformal planning was chosen over IMRT to avoid radiation dose spillage into the previously treated tumor bed (Figure 2). The patient completed chemoradiotherapy (CRT) in September 2010 with a 50% reduction in tumor size and normalization of CA 19-9. Three of 12 planned doses of gemcitabine were cancelled for thrombocytopenia and/or diarrhea. Treatment was well tolerated, except for some weight loss and depression, which was managed with mirtazapine. Re-resection was considered, but the cirrhosis was thought to pose too great a surgical risk. The patient was subsequently followed up for recurrence with twice-yearly CT scans. The most recent scan demonstrated stable 1.5-cm hypodensity in the tail of the pancreas, with no evidence of progression or metastases (Figure 3), and CA 19-9 was 24 U/mL (normal, 34.9 U/mL). The patient remained alive and free of disease progression 48 months from the time of initial diagnosis and 34 months from the time of recurrence.

e14514 Background: This dose escalation study was performed to determine the recommended phase II dose of capecitabine to be delivered concurrently with thoracic radiation therapy and weekly docetaxel in patients with locally advanced esophageal carcinoma. Methods: Patients with operable stage II or III esophageal carcinoma were staged by endoscopic ultrasonography and CT. Two cycles of docetaxel (80 mg/m2) and carboplatin (target AUC of 6) were delivered over 6 weeks, followed by concurrent weekly docetaxel (15 mg/m2), thoracic radiotherapy (50.4 Gy in 28 fractions), and increasing doses of capecitabine (500-3500 mg) given prior to each fraction of radiotherapy. After re-staging, responding patients continued to esophagectomy. Results: Forty-four patients were enrolled and 40 were evaluable for the dose-ranging component of chemoradiotherapy. The median age was 63 (range 47-87), 32 patients (80%) were male, and 36 (90%) had adenocarcinoma while 4 (10%) had squamous cell carcinoma. EUS stages at enrollment were T3N1 (29), T3N0 (4), T2N1 (6), and T4N0 (1). The maximum tolerated dose of capecitabine was 3500 mg. Common non-hematologic grade 3 or 4 toxicities were dysphagia (n=6, 15%) and nausea/vomiting (n=3, 8%). Common grade 3 or 4 hematologic toxicities were ANC and WBC abnormalities (n=10, 25% and n=9, 23% respectively). Overall, 58% of patients had no stage 3 or 4 toxicity. Thirty-six patients had surgery; 83% had R0 (curative) resection and 14% had complete pathological response (pCR). With a median follow-up time of 18.9 months, the median overall survival was 23.5 months, with 34% and 27% alive at three and five years, respectively. The three- and five-year relapse-free survival was 37%. In patients who had pCR or microscopically residual disease, 5-year survival was 74% (n=8). Conclusions: The recommended phase II dose of capecitabine is 3500 mg when given concurrently with 50.4 Gy in 28 fractions of thoracic radiotherapy with weekly docetaxel. This trimodality therapy for locally advanced esophageal carcinoma was well-tolerated and remarkably active. This regimen holds promise for treatment of esophageal carcinoma and warrants further investigation.

L. K. Martin1, X. Li2, B. Kleiber3, E. C. Ellison4, M. Bloomston5, M. Zalupski6 & T. S. Bekaii-Saab1* Department of Internal Medicine, Division of Medical Oncology, The Ohio State University Comprehensive Cancer Center, Columbus; Center for Biostatistics, The Ohio State University, Columbus; Comprehensive Cancer Center, The Ohio State University, Columbus; Department of Surgery, Division of General Surgery, The Ohio State University Medical Center, Columbus; Department of Surgery, Division of Surgical Oncology, The Ohio State University Comprehensive Cancer Center, Columbus; Department of Internal Medicine, Division of Hematology-Oncology, University of Michigan Comprehensive Cancer Center, Ann Arbor, USA

BACKGROUND AND AIM:Groove pancreatitis is a segmental form of chronic pancreatitis that can be treated with pancreaticoduodenectomy (PD), although outcome studies for this approach are lacking. We performed an assessment of pain symptoms, need for opioids, and weight gain following PD for symptomatic groove pancreatitis.METHODS:The study was a retrospective case series describing all patients with groove pancreatitis who underwent PD at our medical center. The primary outcome was the change in pain level and opioid use following PD.RESULTS:Five patients underwent PD for treatment of groove pancreatitis. Patients' perception of pain, using a 10-point visual analog scale, improved after surgery from 5.0 to 0.2. Opioid analgesics, as measured by oral morphine equivalents, dropped from 77.6 to 0 mg daily, with all five patients being completely free of opioids post-operatively. Weight loss ceased in all five patients, with an overall mean weight gain of 15.4 pounds post-operatively.CONCLUSIONS:PD reduces pain and opioid analgesic use in groove pancreatitis. This intervention should be considered for patients with this condition.

BACKGROUND:Neoadjuvant therapy has been investigated for localized and locally advanced pancreatic ductal adenocarcinoma (PDAC) but no standard of care exists. Combination cetuximab/gemcitabine/radiotherapy demonstrates encouraging preclinical activity in PDAC. We investigated cetuximab with twice-weekly gemcitabine and intensity-modulated radiotherapy (IMRT) as neoadjuvant therapy in patients with localized or locally advanced PDAC. EXPERIMENTAL DESIGN:Treatment consisted of cetuximab load at 400 mg/m(2) followed by cetuximab 250 mg/m(2) weekly and gemcitabine 50 mg/m(2) twice-weekly given concurrently with IMRT to 54 Gy. Following therapy, patients were considered for resection. RESULTS:Thirty-seven patients were enrolled with 33 assessable for response. Ten patients (30%) manifested partial response and 20 (61%) manifested stable disease by RECIST. Twenty-five patients (76%) underwent resection, including 18/23 previously borderline and 3/6 previously unresectable tumors. Twenty-three (92%) of these had negative surgical margins. Pathology revealed that 24% of resected tumors had grade III/IV tumor kill, including two pathological complete responses (8%). Median survival was 24.3 months in resected patients. Outcome did not vary by epidermal growth factor receptor status. CONCLUSIONS:Neoadjuvant therapy with cetuximab/gemcitabine/IMRT is tolerable and active in PDAC. Margin-negative resection rates are high and some locally advanced tumors can be downstaged to allow for complete resection with encouraging survival. Pathological complete responses can occur. This combination warrants further investigation.

Groove pancreatitis is an uncommon form of focal chronic pancreatitis that involves the duodenal wall or "groove" area (between the pancreas, common bile duct, and duodenum). It remains largely an unfamiliar entity to most physicians and is often misdiagnosed as pancreatic malignancy or autoimmune pancreatitis because of its "pseudotumor" formation. In this case series, we present 4 cases of groove pancreatitis which highlight important clinical aspects of this disease entity. We then provide a review of the pathophysiology, diagnosis, and treatment of this condition. We hope to clarify the salient aspects of this disease process and make groove pancreatitis a more recognized entity to the clinician.

BACKGROUND: It is unknown whether neoadjuvant chemoradiotherapy, compared with adjuvant chemoradiotherapy, decreases the rate of local recurrence after resection of pancreatic adenocarcinoma.STUDY DESIGN: This is a retrospective case review of 102 patients with pancreatic adenocarcinoma who underwent pancreatic resection between 1993 and 2005.RESULTS: Of 102 patients with pancreatic adenocarcinoma who underwent surgical resection, 19 (19%) had no additional treatment, 41 (40%) underwent adjuvant chemoradiotherapy, and 42 (41%) were treated preoperatively with neoadjuvant chemoradiotherapy. Patients selected to receive neoadjuvant therapy were more likely to have locally advanced tumors. Based on initial CT scan, the percentage of patients with unresectable or borderline resectable tumors in the neoadjuvant group was 67%, compared with 22% in the adjuvant group. Nevertheless, patients receiving neoadjuvant chemoradiotherapy were less likely to have a local recurrence develop than patients receiving adjuvant chemoradiotherapy (5% versus 34%, p=0.02). For those patients with tumors determined to be resectable on initial CT scan, local recurrences were observed in 31% (10 of 32) of patients in the adjuvant therapy group, compared with only 7% (1 of 14) of the neoadjuvant group. Intraoperative radiation therapy, administered to 51% of patients, was not associated with a lower rate of local recurrence.CONCLUSIONS: Neoadjuvant chemoradiotherapy is associated with improved local tumor control in patients undergoing resection for pancreatic carcinoma.

14056 Background: Epidermal growth factor receptor (EGFR) is over expressed in pancreatic cancer. Cetuximab is an EGFR-antagonist which has synergy with gemcitabine (gem) and radiation. Gem is a potent radiosensitizer. We are conducting a Phase II trial of cetuximab with IMRT and twice-weekly gem. Eligibility includes stage I-III adenocarcinoma, with EGFR staining by immunohistochemistry. Pretreatment evaluation includes chest/abdomen CT scan and laparoscopy. Methods: Cetuximab 400 mg/m2 IV load was given over two hours. One week later, treatment continued with weekly cetuximab 250mg/m2 IV over one hour, and gem 50mg/m2 IV twice-weekly for twelve doses, concurrent with IMRT given in 28 daily fractions to 54Gy. Cetuximab/gem was given prior to that day’s IMRT. GI prophylaxis was with a proton pump inhibitor. Patients were considered for resection 4–8 weeks following therapy. Results: Ten patients enrolled to date, median age 70 years (range 54–83). Ninety percent of tumors were EGFR positive (range 1+ to 3+). At presentation, three tumors were unresectable, three borderline resectable and four resectable. One patient was removed from study following cetuximab anaphylaxis. Eight patients experienced grade III-IV hematotoxicity. Two patients had ischemic stroke in the backdrop of infection, one from stent obstruction/cholangitis, the other during neutropenic fever. One of these patients (age 81) died. Autopsy revealed severe atherosclerotic disease and evidence of prior strokes. Eight patients were evaluable for response. No patient had local progression. One patient had liver metastases post treatment. Two patients (25%) exhibited partial response. All others had stable disease. EGFR over expression did not predict response. Six patients went on to margin (−) resection, including one patient each with borderline resectable and unresectable disease prior to therapy. At median follow up of 8.5 months, there were no recurrences. Conclusions: Therapy yields modest efficacy and high resectability rates in patients with pancreatic cancer. Downstaging of tumor can occur in some patients. Toxicity may in part reflect the elderly patient demographic. Planned accrual is 48 patients. [Table: see text]

A 35 y/o female with a history of alcoholic chronic pancreatitis was transferred for open surgical repair of an iatrogenic, proximal jejunal perforation during endoscopic balloon dilatation of a presumed benign duodenal stricture. Three months previously, she had undergone gastrojejunostomy secondary to duodenal obstructive symptoms. The stricture was located in the duodenal c-sweep and perforation occurred just distal to the stricture in the afferent jejunal limb while attempting retrograde dilation. Following primary closure, the patient underwent an MRI to evaluate the stricture and a focal 1.5 cm fluid collection was found in the pancreatic head adjacent to the second portion of the duodenum with associated pancreatic head enlargement. EUS revealed mass-like enlargement of the pancreatic head with a focal 1.5 cm fluid collection and chronic inflammatory changes in the body and tail. EUS-FNA of the fluid collection and surrounding pancreatic parenchyma revealed cell block portions featuring spindle cell proliferation with nuclear atypia, marked cellularity and high mitotic activity. Based on subsequent immunohistochemistry, the pancreatic head lesion appeared to be a malignant spindle cell neoplasm with smooth muscle differentiation. Uneventful pancreaticoduodenectomy was performed three months following her perforation. Pathology revealed fibrosis of the adjacent pancreas, Brunner's gland hyperplasia, and bundles of smooth muscle within the duodenum that were interspersed with dilated ducts containing inspissated secretions. All findings were consistent with a diagnosis of paraduodenal pancreatitis, or groove pancreatitis. Groove pancreatitis is a rare form of segmental chronic pancreatitis that involves the anatomic space between the head of the pancreas, the duodenum, and the common bile duct. It has been associated with alcoholic chronic pancreatitis and its etiology is thought secondary to disruption of normal pancreatic secretory flow via the minor papilla. The differential diagnosis of patients with external duodenal compression, chronic pancreatitis, and pancreatic head fullness should include groove pancreatitis. This is the first reported case of iatrogenic perforation during endoscopic treatment of a duodenal stricture secondary to groove pancreatitis.

BACKGROUND:Pancreatic cancer remains highly lethal. Previous attempts with neoadjuvant therapy in this disease have been inconclusive, but a potential for benefit exists. We conducted a phase II trial of dose-intense docetaxel and gemcitabine followed by twice-weekly gemcitabine and external beam radiotherapy in patients with pancreatic adenocarcinoma.METHODS:Patients with stage I to III disease were eligible. Docetaxel 65 mg/m(2) intravenously over 1 hour and gemcitabine 4000 mg/m(2) given intravenously over 30 minutes were given on days 1, 15, and 29. On day 43, radiotherapy was begun at 50.4 Gy with gemcitabine 50 mg/m(2) intravenously over 30 minutes twice weekly for 12 doses. After treatment, patients were considered for resection.RESULTS:Twenty-four assessable patients were recruited onto the trial. All but one patient completed a full 12 weeks of therapy. Grade 3 and 4 hematological and nonhematological toxicities were common but manageable, and neutropenic fever did not occur. No patient had local tumor progression. Twelve patients (50%) responded by Response Evaluation Criteria in Solid Tumors Group (RECIST) criteria, including one radiographic complete response. Seventeen patients underwent resection after therapy. Margin-negative resections were performed in 13 patients, including 9 patients whose disease was borderline or unresectable before treatment. A treatment effect was seen in all resection specimens. There have been no local recurrences of tumor, and several patients remain alive without evidence of disease.CONCLUSIONS:Docetaxel/gemcitabine followed by gemcitabine/radiotherapy is active in the treatment of pancreatic adenocarcinoma, with manageable toxicity. Tumor downstaging occurs in some patients to allow complete resection. Further investigation of this regimen is warranted.

Background. The effectiveness in improving survival of neoadjuvant chemoradiotherapy (NCRT) in patients undergoing surgery for esophageal carcinoma remains unclear.Methods. MEDLINE, the Cochrane Database of Systematic Reviews, BIOSIS Previews, and other resources were searched from January 1966 through January 2003. Randomized trials were selected on the basis of study design (NCRT followed by surgery vs surgery alone). Of 21 potential studies identified by abstract review, 6 (29%) met the inclusion criteria.Results. Across 6 studies, a total of 374 patients underwent NCRT followed by surgery and 364 underwent surgery alone. In 5 of the 6 studies in our meta-analysis, there was a small, non-statistically significant trend toward improved survival with NCRT Only I study demonstrated a statistically significant benefit to NCRT In our summary measure for all 6 studies, we found a small, non-statistically significant trend toward improved long-term survival in the NCRT followed by surgery group (relative risk of death in the NCRT group [RR], 0.86; 95% confidence interval [CI], 0.74 to 1.01; P = .07).Conclusions. NCRT followed by surgery is associated with a small, non-statistically significant improvement in overall survival. Whether this benefit is sufficient to warrant the considerable expense and risks associated with NCRT should be the subject of future larger randomized trials.

4049 Background: We previously reported promising phase I data using neoadjuvant weekly DTX and 5-fluorouracil (5-FU) with thoracic irradiation followed by surgery in patients with locally advanced esophageal cancer. This trial was modified in an attempt to improve the pathological complete response rate by increasing the 5-FU exposure during thoracic radiation with oral capecitabine (C). Here we report preliminary results from our dose escalation, trimodality trial. Methods: 18 patients with esophageal cancer (16 = adenocarcinoma, 2 = squamous) were consented and enrolled on this study. Patients (Pts) were staged with a CT scan and endoscopic ultrasound (EUS). Neoadjuvant therapy included DTX, 80 mg/M2, and CP, AUC 6, intravenously every three weeks for 2 cycles. Subsequently, concomitant chemoradiotherapy (CXRT) was initiated with DTX, 15 mg/M2, weekly for five doses and C (7 = 500 mg, 3 = 1000 mg, 8 = 1500 mg) orally prior to each fraction of irradiation (50.4 Gy in 28 fractions). Pts were then restaged with CT and EUS. Transhiatal esophagectomy was performed at 4–8 weeks post CXRT. Results: Patient characteristics: EUS stage, 1 = T3N0, 2 = T2N1, 15 = T3N1. Dose limiting toxicity (DLT), grade 3 dysphagia, occurred in 2 pts (1 = 300 mg, 1 = 1000 mg). No other grade 3 and no grade 4 toxicities were encountered. Only 3 pts required a feeding tube; 11 pts had weight gain over the course of therapy. Antitumor response following chemotherapy and CXRT was 78% (95% confidence interval: 52%–94%) by EUS. To date, 16 of 18 patients have had R0 resection. 2 pts had pathologic CR. Conclusions: Response rates are encouraging using this tri-modality approach. Pts have tolerated combined modality therapy well with minimal side effects, thereby allowing for weight gain without the need for a feeding tube in the majority of enrollees. Capecitabine appears to be a safe agent in this combination up to a dose of 1500 mg. Patient accrual continues at 2000 mg dose level. Funded in part by CA23108, Aventis, and Roche. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Aventis Aventis Abbott; Amgen; Aventis; Bristol-Myers Squibb; Genentech; GlaxoSmithKline; Ortho Biotech; Ligand; Merck; Pfizer; OSI; Roche

4109 Background: Docetaxel (DOC) and gemcitabine (GEM) are active against pancreatic cancer. GEM is a potent radiosensitizer. Rigas et al have reported an every-two week schedule of DOC and GEM. We have defined the maximum tolerated dose of GEM twice weekly when given with radiotherapy (XRT) in pancreatic cancer. We are conducting a Phase II trial to evaluate these therapies in combination. Eligibility include biopsy proven, untreated pancreatic adenocarcinoma with stage I-III disease. Pretreatment evaluation includes chest x-ray, abdominal CT scan, serum CA19–9 and laparoscopy. Methods: DOC 65mg/m2 IV over one hour and GEM 4000mg/m2 IV over 30 minutes were given on days 1, 15 and 29. On day 43, therapy continued with XRT given at 1.8 Gy per fraction to a dose of 50.4 Gy, together with GEM 50mg/m2 IV over 30 minutes twice weekly for 12 doses. A proton pump inhibitor was given prophylactically. Following completion of therapy, patients were restaged and considered for resection. Results: Since January 2002, 24 patients were enrolled. The regimen was generally tolerable with grade III vomiting, dehydration, fatigue, hypoalbuminemia and edema seen. Grade III-IV hematotoxicity in several patients, but neutropenic fever did not occur. One patient was treated for pneumocysitis felt secondary to inappropriate use of decadron. Two others developed pneumonitis: one viral in nature, the other ARDS. One patient stopped therapy early due to toxicity. There were no deaths on treatment. Nineteen completed therapy and are evaluable for response. Eleven of 19 patients (57%) have responded by RECIST criteria including one radiographic complete response. No patient had local tumor progression. Fourteen patients underwent resection. Margin (-) resections were performed in 11 patients, including eight patients whose disease was felt to be unresectable or borderline unresectable prior to treatment. Conclusions: This regimen is active and tolerable and can downstage tumors to allow for margin negative resections in some patients. Updated data will be presented at meeting time. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Aventis Oncology

Background: Retrospective analyses have shown that long-term recurrence rates after Lichtenstein mesh and Shouldice herniorrhaphies are low. Therefore differences in short-term outcome may be important determinants of one's choice of repair. Although proponents of the mesh repair claim that their method is less morbid, to our knowledge no prospective comparative studies of short-term morbidity have been reported. Methods: One hundred five adult patients were randomized to undergo either a mesh or Shouldice inguinal hernia repair. Postoperative pain, narcotic use, and time to resumption of usual activities and employment were recorded. Patients were blinded to the type of repair received until all data were collected. Results: There was no difference between the herniorrhaphy methods with respect to postoperative pain, duration of narcotic use, and time to resumption of usual activity and employment. Recovery was rapid for both groups of patients. By 3 days after operation, 50% of patients rated their pain as very mild or less and no longer required narcotic analgesics. Patients in both groups returned to usual activity and work by a median of 9 days after operation. Conclusions: Both of these well-established methods can be used to repair inguinal hernias with local anesthetics in an outpatient setting with minimal morbidity. Despite the “tension-free” design of the mesh repair, short-term outcomes of mesh and Shouldice repairs of inguinal hernias do not differ. (Surgery 1998;123:121-6.)