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Aim: Pancreatic cancer is a near fatal disease. External beam radiotherapy and intraoperative radiation therapy (IORT) has been proposed with the aim to improve clinical outcome in resectable tumors. The aim of this study is to assess the feasibility and outcome in patients with cT1-3 pancreatic cancer, treated with surgery, external beam radiotherapy and IORT.Methods: From 1990 to 1996, 17 patients with clinical stage T1-3N0-1M0 adenocarcinoma of the head of the pancreas were treated with pancreatectomy and pre- (nine patients: 5 Gy), intra- (all patients: 10 Gy) and postoperative (all patients: 80 Gy) radiotherapy. The pathologic T stages were: 4 pT2 and 13 pT3. The pathologic N stages were: 9 pN0 and 8 pN1. Minimum follow-up in living patients was 60 months.Results: No perioperative mortalities were recorded. Two patients showed postoperative morbidity (11.8%) which required a subsequent laparotomy. The disease-free survival at 1, 3 and 5 years was 41, 23 and 18%, respectively (median: 9 months). The overall survival at 1, 3 and 5 years was 70%, 41% and 18%, respectively (median: 17.5 months). Three patients developed local failure (17.6%) and 12 patients showed distant metastases (70.6%). Univariate analysis (logrank) showed: a significant correlation between both N-stage and retroperitoneal involvement (RPI) with local control (N-stage: P = 0.0155; RPI: P = 0.0295), a significant correlation between maximum tumor size and metastases-free survival (P = 0.0167) and overall survival (P = 0.0241); the female gender was another predictor of prolonged survival (P = 0.0465). Multivariate analysis (Cox) showed a significant impact of N-stage and retroperitoneal involvement on local control and also a significant correlation between perineural involvement and tumor diameter with metastases-free survival.Conclusions: These results are similar to those of other published series and suggest that this approach is feasible with acceptable local control and survival, especial

Purpose: To evaluate the impact of tumor response; tumor and nodal downstaging; and cTNM, yTNM (clinical stage after chemoradiation, based on preoperative imaging), and pTNM classifications on long-term outcome in patients with rectal cancer treated with preoperative 5-fluorouracil (5-FU)-based concurrent chemoradiation. Methods and Materials: Between January 1990 and March 1998, 165 consecutive patients with locally advanced extraperitoneal cancer of the rectum were treated with preoperative chemoradiation. Four patients had a cT2 lesion (2.5%), 120 had a cT3 lesion (74.5%), and 41 had a cT4 lesion (23%). The nodal involvement at combined imaging was cN0 in 21%, cN1 in 41%, cN2 in 34%, and cN3 in 4%. Preoperative chemoradiation was delivered according to 1 of 3 schedules: (1) FUMIR-T3 (from 1990 to 1995) for patients with cT3N0-2 or cT2N1-2 rectal carcinoma (82 patients): 37.8 Gy (1.8 Gy/fraction) plus 5-FU, 1 g/m2/d on Days 1-4, continuous infusion, and mitomycin-C, 10 mg/m2/d on Day 1; (2) FUMIR-T4 (from 1990 to 1999) for patients with cT4N0-3 or cT3-4N3 rectal carcinoma (40 patients): 45 Gy (1.8 Gy/fraction) plus 5-FU, 1 g/m2/d on Days 1-4 and 29-32, continuous infusion, and mitomycin-C, 10 mg/m2/d on Days 1 and 29; and (3) PLAFUR-4 (from 1995 to 1998) for patients with cT3N0-2 or cT2N1-2 rectal carcinoma (42 patients): 50.4 Gy (1.8 Gy/fraction) plus 5-FU, 1 g/m2/d on Days 1-4 and 29-32, continuous infusion, and cisplatin, 60 mg/m2/d on Days 1 and 29. Four to five weeks after chemoradiation, patients were reevaluated for clinical response by imaging studies (CT scan, transrectal ultrasonography, barium enema, liver ultrasonography, chest X-rays) and restaged (yTNM). Surgery was performed 6-8 weeks after chemoradiation. Adjuvant chemotherapy (5-FU + l-folinic acid) was delivered to 26 patients in the FUMIR-T4 protocol group. Local control (LC), freedom from distant metastases (FDM), disease-free survival, and overall survival (OS) were evaluated according to the

Hypothesis: Despite aggressive approaches, locoregional tumor control and survival rates for patients with cancer of the pancreatic head remain disappointing. In the present study, we address whether intraoperative and adjuvant radiotherapy may improve the prognosis for these patients.Design: A retrospective study.Setting: University hospital.Patients: From February 1985 to December 1995, 46 patients with an adenocarcinoma of the pancreatic head underwent pancreatic resection. The last 26 patients also received intraoperative radiotherapy (except 5 patients) and adjuvant external beam radiation therapy.Main Outcome Measures: Demographic data, tumor characteristics, surgical procedures, 5-year survival, and local control of disease were analyzed retrospectively.Results: The morbidity rate was not increased by adjuvant radiation therapy; it was 43% in patients treated with surgery alone and 57% in patients treated with surgery and radiotherapy (P=.1); operative mortality was 8% (n=2) and 9% (n=2), respectively (P=.8). Overall 5-year survival and local control were 13% and 48.6%, respectively. The mean+/-SD 5-year survival was 5.5%+/-5.3% (median, 10.8 months) in the surgery-alone group and 15.7%+/-8.6% (median, 14.3 months) in the surgery plus radiotherapy group (P=.06); local control at 5 years was 29.8% +/- 16.9% and 58.4%+/-19.9%, respectively (P<.01). Median metastasis-free survival was 8 and 9 months, respectively (P =.52). Multivariate analysis showed that adjuvant radiotherapy was an independent prognostic factor for survival (P<.01) and local control of the disease (P=.03).Conclusion: The present study supports the role of radiotherapy combined with pancreatoduodenectomy for treatment of cancer of the pancreatic head because even if the improvement in overall survival is moderate, it is effective in improving the local control of the tumor.

Aims and background: The prognosis of pancreatic cancer remains poor. Surgery, when feasible, is rarely curative. Radiation therapy (RT) and concomitant 5-fluorouracil (5-FU) have been shown to improve survival in locally advanced pancreatic cancer. In an attempt to improve resectability and disease control, we used preoperative chemoradiation in a combined modality therapy protocol. The purpose of this study was to evaluate our initial results in terms of acute toxicity and response. Methods: From October 1995 to May 1998, 20 patients (11 males, 9 females; mean age, 60.1 years; median follow-up, 28 months) with unresectable (12 patients) or resectable (8 patients) nonmetastatic pancreatic tumors, received external beam radiation (39.6 Gy) plus 5-FU (96 hours continuous infusion, days 1-4 at 1000 mg/m2/day). After 4 weeks, patients were evaluated for surgical resection. In resected patients, electron-beam intraoperative radiation therapy (10 Gy) was given before reconstruction. Thereafter, in resected patients, adjuvant chemotherapy was prescribed (6 courses: 5-FU, mitomycin C, adriamicine). Results: During chemoradiation, no patients developed grade 3- 4 acute toxicity. Three out of twelve (25%) patients with unresectable tumors had tumor downstaging. No patients showed partial or complete responses. Four out of twenty patients (20%) had minimal tumor response. Three patients showed disease progression after chemoradiation (liver or peritoneal metastases). Nine patients underwent surgical resection and IORT, with 1 postoperative death. The median survival time for the 20 patients was 9.4 (18.5 and 8.3 months in resected and unresected patients, respectively). Conclusion: Our preliminary results suggest that preoperative 5-FU chemoradiation was well tolerated and may result in tumor downstaging but the response-rate is still low. Based on the impact of surgical resection on survival, an improvement in local response rate is necessary.

BACKGROUND. Rectal carcinoma patients with local recurrence are reported to have a dismal prognosis. The purpose of this study was to evaluate the effect of combined modality therapy on clinical outcome and to determine the prognostic impact of a 'presurgical' staging system. METHODS. Between September 1989 and June 1997, 47 patients (with a median follow-up of 80 months) with locally recurrent, nonmetastatic rectal carcinoma were classified according to the extent of pelvic sidewall involvement as determined by pretreatment computed tomography (CT) scan. They received preoperative external beam radiation (45-47 grays [Gy] in 34 patients; 23.4 Gy in 13 preirradiated patients) plus concomitant 5-fluorouracil (1000 mg/m2/day as a 96-hour continuous infusion on Days 1-4 + 29-32) and mitomycin C (10 mg/m2 as a bolus intravenously on Day 1 + 29). After 4-6 weeks, the patients were evaluated for surgical resection and intraoperative radiation therapy (IORT) procedure (10-15 Gy) or, in unresectable patients, a boost dose was planned by chemoradiation (23.4 Gy) or brachytherapy. Thereafter, adjuvant chemotherapy (5-fluorouracil and leucovorin for a total of six to nine courses) was prescribed. RESULTS. During chemoradiation, 2 patients (4.3%) developed Radiation Therapy Oncology Group Grade 3-4 acute toxicity. Twenty-five patients (53.2%) had an objective response after chemoradiation. Twenty-one patients (45%) underwent radical surgical resection. The overall 5-year survival and local control rates were 22% and 32%, respectively. The classification system significantly predicted survival (P = 0.008). Radically resected patients had better local control and survival (P < 0.0001); in patients treated with IORT, the 5-year local control and survival rates were 79% and 41%, respectively. CONCLUSIONS. The data from the current study suggest that combined modality therapy was well tolerated and improved resectability, local control, and survival. The classification system app

Aim of this study was to evaluate the preliminary outcomes of a multidisciplinary treatment of carcinoma of the head of the pancreas. Fourteen patients were treated with 39.8 Gy of preoperative radiotherapy combined with continuous infusion of 5FU (1000 mg/m2, days 1-4), followed by radical surgery if feasible. No patients had grade 3-4 acute toxicity during chemoradiation. Two out 14 patients showed minor response and 3 patients a disease progression. Four patients were suitable for radical surgery. Median survival of the whole group is 12 months. The treatment was feasible but new drugs should be tested to intensity the combined preoperative approach.

Local recurrence affects approximately 50% of patients undergoing surgery for pancreatic adenocarcinoma. To lower the incidence of locoregional recurrence, the combination with surgery of adjuvant radiotherapy has been proposed. The latter is based on external radiotherapy (ERT), intraoperative radiotherapy (IORT) or their combination. To evaluate the impact on local control and survival, results achieved in a a group of patients undergoing surgical resection and combined adjuvant radiotherapy, are analyzed. 17 patients with adenocarcinoma of the exocrine pancreas were treated with a therapeutic protocol based on pancreatectomy and intraoperative radiotherapy (IORT) to the tumor bed (10 Gy) followed by postoperative radiotherapy (50 Gy); 9 patients underwent also preoperative radiotherapy (5 Gy) to the pancreas and liver. With a median follow-up of 45 months, in 3 patients (17.6%) local recurrence was observed while 12 patients (70.6%) showed liver metastases or peritoneal spread. Median survival was 17.5 months and actuarial survival at 2 and 5 years was 41.2% and 11.2%, respectively. As compared to a moderate local control, the prognosis of patients undergoing surgical resection remained disappointing. Thus, the effort of improving results with new therapeutic modalities as preoperative radiochemotherapy and adjuvant chemotherapy, seems justified.