Background: The most accepted treatment for locally advanced pancreatic cancer is chemoradiotherapy. However, indications to and results of pancreatic resections after chemoradiation are not yet defined.Methods: From June 1999 to December 2003, 28 patients with locally advanced pancreatic cancer (group 1) were enrolled for institutional trials of gemcitabine-based chemoradiotherapy. Tumors were stratified as unresectable or borderline resectable according to the pattern of vascular involvement at pretreatment computed tomographic scan. Patients with partial response or stable disease and in-range Ca19-9 were surgically explored. Perioperative outcome and survival of group 1 were compared with 44 patients primary resected for localized cancer with or without adjuvant treatment in the same time period (group 2).Results: Only one unresectable tumor was successfully resected compared to 7 out of 18 (39%) that were borderline resectable. Operations after chemoradiation were 1 hour longer and postoperative stays 5 days longer, but transfusion rate, morbidity, and mortality were not significantly different. Median survival was 15.4 months for group 1 (>21 for resected vs. 10 for not resected, P < 0.01) and 14 months for group 2. In both groups, a disease-free survival beyond 24 months was recorded only among patients resected with negative margins.Conclusions: The conversion of an unresectable cancer to a resectable one is a rare event. On the contrary, the resection of a borderline resectable tumor was successfully accomplished in one-third of cases. Chemoradiotherapy did not increase the operative risk, but the interventions were more technically demanding and required a longer postoperative stay. Patients resected after chemoradiation for a locally advanced tumor had at least the same survival as those primary resected for a localized one. Only R0 resections in both groups gave the chance of disease-free survival longer than 24 months.

Objectives: Primary chemoradiotherapy for locally advanced pancreatic cancer (LAPC) may improve local control, curative resection rate and long-term survival. We performed a phase II study to evaluate toxicity and activity of primary radiation therapy and concurrent chemotherapy with gemcitabine (GEM) twice weekly in patients (pts) with LAPC. Methods: From 6/1999 to 6/2003, 23 LAPC pts received GEM 100 mg/m² twice weekly in the first 15 pts and 50 mg/m² in the last 8 pts, concurrently with radiotherapy (1.8 Gy/day for a total dose of 45 Gy). Results: The treatment was completed in 19/23 pts. Toxicities: G3–4 hematological toxicity occurred in 35 and 4% respectively; G3 nausea and vomiting and gastrointestinal toxicity in 30%. Clinical benefit was found in 10/18 pts (55%). Overall response: partial response rate 4/18 (22%); stable disease 13/18 (72%); progressive disease 1/18 (6%). Six pts underwent pancreaticoduodenectomy with extended lymphadenectomy (5/6 pts pT3, 1/6 pts microscopic cancer foci, 1/6 N+, 5/6 negative retroperitoneal margin). Median survival: 14 months for the entire group, 12 months for unresected pts, 20 months for resected pts. Conclusions: The treatment with GEM twice weekly at 50 mg/m² associated with radiotherapy (45 Gy) is feasible and permits to obtain clinical benefit in a good percentage of pts. Objective response, median survival, and local and systemic control are similar to other studies and need further improvement.

Neoadjuvant therapy may prolong overall survival in a subset of patients with multiple hepatic metastases. The global impact on progression-free survival is low; less than one-half of the patients resected after chemotherapy are disease-free at three years. However, patients resected after chemotherapy obtained overall survival similar to that of primary surgery, suggesting a positive role for integrated approaches.

The purpose of the study was to evaluate the influence of baseline haemoglobin level in predicting response to 5-fluorouracil (5FU)-based first-line chemotherapy in advanced colorectal cancer patients. Data from 631 patients were collected from three different institutions. Globally, overall response rate was 35.8% (226 out of 631). Factors influencing response rate were 5FU dose intensity (high: 43.1%, low: 34.0%, P=0.03); oxaliplatin (yes: 45.8%, no: 22.9%, P<0.0001), performance status (PS 0: 46.1%, 1: 28.8%, 2: 26.7%, P<0.0001), and haemoglobin levels (⩾12 g dl−1: 40.4%, <12 g dl−1: 29.2%, P=0.004). In subgroup analysis significant differences in response rate between anaemic and nonanaemic patients were recorded in those patients treated with infusional chemotherapies (45.7 vs 25.5%, P<0.0001), with high 5FU dose intensity (50.3 vs 32.7%, P=0.005), with PS=0 (49.8 vs 37.9%, P=0.03), and with liver metastases (44.8 vs 33.8%, P=0.002), whereas no difference was evident in those subjects treated with bolus schedules or according to gender. Anaemia was a strong predictor for activity of first-line 5FU-based chemotherapy especially in those groups that showed the best responses, for example high performance status, infusionally treated, higher 5FU dose and those with liver secondaries. Patients with higher haemoglobin levels recorded a greater response rate and a longer time to progression and survival than anaemic subjects. Prospective evaluation of role of correcting anaemia on response to therapy is justified by these results.

14019 Background: Combined chemo-radiation therapy may render curative resection feasible in pancreatic cancer deemed unresectable for vascular invasion. We previously demonstrated that primary radiotherapy with concurrent gemcitabine is feasible and allows clinical benefit. However, the percentage of resected patients was low. Methods: Patients with locally advanced pancreatic adenocarcinoma, received induction with 4 cycle GEMOX (gemcitabine 1000 mg/mq, day 1 and oxaliplatin 100 mg/mq, day 2) each 2-week cycle. Patients without disease progression received gemcitabine twice weekly (50 mg/mq/day) for 5 weeks concurrent with upper abdominal radiation (50.4 Gy over 5.5 weeks) and were re-evaluated for resectability. Results: From 7/2003 to 11/2005, 20 patients entered this study, of whom 17 are evaluable for toxicity and 15 for treatment response. Twelve men and 8 women (median age 63 years; range 43–71) received a median of 3.5 cycles GEMOX (range 2–4). Fourteen patients completed the treatment with external beam radiation and received a median of 7 cycles with gemcitabine (range 3–10). In two patients chemotherapy during radiotherapy was omitted for previous toxicity, and one stopped also radiotherapy for gastrointestinal toxicity. No grade IV toxicities or deaths due to therapy were observed. Gastrointestinal grade III toxicities were observed in 3/17 patients (17.6%) after GEMOX and 6/16 patients (37.5%) during radiotherapy. Grades III hematologic toxicity and fatigue occurred in 4/16 (25%) and 2/16 (12.5%) respectively during radiotherapy. A disease control was obtained in 10/15 evaluable patients. One patient progressed after GEMOX and 4 after chemoradiotherapy. Eight patients (53%) appeared to be resectable: 1 patient is planned for surgery, 2 patients were found unresectable at lapaproscopy for peritoneal carcinomatosis or local extension; 5 patients underwent resection and in 4 of them (26%) margins were negative. Conclusions: Induction GEMOX followed by twice-weekly gemcitabine and upper abdominal radiation is feasible in patients with locally advanced pancreatic cancer and seems to induce a high resectability rate. This protocol warrants further evaluation. No significant financial relationships to disclose.