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616 poster Preoperative neoadjuvant radiochemotherapy for gastric cancer
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resections were identified. Patients who had palliative surgery, gallbladder cancer or intrahepatic cholangiocarcinoma were excluded. Median follow up was 21 months. Patient's tumor T-stage, according to 2002 AJCC criteria, was T2, T3 and T4 in 50, 14 and 4.5 percent, respectively. In general, patients who were found to have positive resection margin or positive nodes postoperatively were offered adjuvant chemoradiation. Twenty-six patients had adjuvant concurrent chemoradiation and the remaining patients received no further treatment (n=20). The rate of positive nodes and/or positive margins was 88% and 27% for patients who did and did not received adjuvant chemoradiotherapy, respectively (p--0.001). All patients received protracted venous infusion of 5-fluorouracil concurrently with radiotherapy. The median total radiotherapy dose Results: The actuarial local control rate at 3 years for patients who did and did not received adjuvant concurrent chemoradiation XRT was 72% and 38%, respectively (p=0.01). The median disease specific survival for patients who were and were not treated with chemoradiotherapy was 43 and 35 months, respectively p. The overall distant metastasis rate for patients who did and did not receive adjuvant concurrent chemoradiation was 42 and 5 percent, respectively (p=0.056). AJCC tumour stage, tumour size or Conclusion: The use of adjuvant chemoradiation significantly improved local control in patients with resected extrahepatic cholangiocarcimoma with high-risk pathologic features. However, this did not translate to a significant disease specific survival benefit likely due to the competing risk of distant metastasis and small patient numbers. Even with the use of chemoradiation, local control remains a significant problem. 616 poster Preoperative neoadjuvant radiochemotherapy for gastric cancer
J. Dvorak 1, J. Petera 1, B. Melicha/, K. Kabelac 2, R. Voborif, Z. Zou/, M. Vosmik ~, P. Vesel/, V. Spacek 2, P. Jandik2 1Charles University Hospital, Oncology and Radiotherapy, Hradec Kralove, Czech Republic 2Charles University Hospital, Surgery, Hradec Kralove, Czech Republic Purpose: To evaluate toxicities, effect on achievement of radical resection with microscopically negative margins (R0 resection) and prognostic factors in gastric cancer treated with preoperative neoadjuvant radiochemotherapy. Patients and methods: Between April 1999 and March 2004, 33 patients (pts), 21 males and 12 females, mean age 62 (range 28-80) years, with gastric cancer were treated. All pts had histology of adenocarcinoma: 1 pts grade 1, 11 pts grade 2, 17 pts grade 3 and 4 pts grade 4. Pretreatment stage were as follow: 3 pts AJCC stage I.B, 9 pts stage II, 17 pts stage IlI.A and 4 pts stage IV. Anatomic sublocalization: 7 pts cardia, 1 pts fundus, 17 pts body, 5 pts antrum and 3 pts pylorus. Neoadjuvant radiochemotherapy consisted of radiotherapy of stomach and regional nodes 30 Gy in 15 fractions (2 Gy daily) in 16 pts and 40 Gy in 20 fractions (2 Gy daily)in 17 pts, with concurrent chemotherapy: 5fluorouracil 200 mg/m 2 continuously and weekly cisplatin 25 mg/m 2. Weekly paclitaxel 60 mg/m 2 was added in 16 pts. The surgery was performed in 5 weeks after completion of radiochemotherapy. Results: Leucopenia grade 3-4 occurred in 6/33 (18%) pts, thrombocytopenia grade 3 in 3/33 (9%) pts, nausea and vomitus grade 3 in 5/33 (15%) pts. Neoadjuvant regimen was completed in planned extension in 23/33 (70%) pts, in the rest of pts the intensity of chemotherapy had to be reduced
Posters
due to haematological and gastrointestinal toxicities. Neoadjuvant radiochemotherapy did not increase surgical mortality and morbidity. Surgical stage were as follow: 2 pts pathologic CR, 4 pts AJCC stage I.B, 6 pts stage II, 11 pts stage Ill.A, 9 pts stage IV. R0 resection was achieved in 20/33 (61%) pts, R1 (microscopic residual tumor) in 3 pts and R2 (macroscopic residual tumor) in 10 pts. From 20 pts after R0 resection 16 pts are without recurrence an 4 pts have a recurrence: 2 pts in retroperitoneal nodes, 1 pts in omentum and 1 pts in left ovary. The mean of survival was 971 days (range 67-1483). Prognostic influence showed histologic grade 1,2 vs. 3,4: p=0,02. No prognostic influence showed Tstage, N-stage, anatomic sublocalization, hemoglobin level or toxicities. Conclusion: Preoperative neoadjuvant radiochemotherapy has acceptable toxicities, can lead to achievement of high rate of R0 resections. An optimal regimen has to be found in new studies. Only prognostic factor was histologic grade of adenocarcinoma. 617 poster Hyperfractionated radiotherapy, Uraful and selective inhibitor of cox-2 enzyme for locally advanced/ unresectable pancreatic cancer
S.M. Youn Eulji University Hospital, Radiation Oncology, Daejeon, South Korea Purpose: To determine prospectively the maximal tolerated dose and potential antitumour activity of concurrent hyperfractionated radiotherapy, Uraful and selective inhibitor of cyclooxgenase-2 enzyme (Celecoxib) in patients with locally advanced and/or unresectable pancreatic cancer. Methods and Materials: We investigated on Phase I-II study of hyperfractionated radiotherapy using daily bid fractionation to a total dose of 66 Gy in 6 weeks at 1.1 Gy/fraction combined with Uraful and selective inhibitor of COX-2 enzyme, Celecoxib, as radiosensitizer. Uraful is a combination of tegafur (a prodrug of 5-flouorouracil) and uracil that can be given orally. The administration of Uraful for several weeks may simulate the effects of a continuous infusion of 5-fluorouracil. A dose of 300 mg/m2/day of Uraful was administered orally until the appearance of disease progression or unacceptable toxicity. Celecoxib was administered by per oral from first days to last days during radiotherapy and during 3 months follow-up period after completion of radiotherapy. Daily dose of Celecoxib was 200400mg/day. Twenty one patients were studied, 15 women and 6 men (mean age 64 years). Some patients presented with one or more symptoms. Obstructive jaundice was the main presenting symptom in 10 patients and epigastric pain in 14. All patients had unresectable histologically proven adenocarcinoma of the pancreas (14 head, 6 body, and 1 tail). Reasons for unresectability were involvement of the portal vein, and/or superior mesenteric artery (16 pts), paraaortic nodes (9 pts), and medically inoperable (1 pt). Fourteen patients underwent a biliary bypass procedure before treatment (nine endoscopic stenting, two choledochojejunostomy, and three cholecystojejunostomy). The follow-up period ranged from 14 to 66 months, and median follow-up period was 44 months. Results: Grade IV NCI common toxicity criteria was not seen. Grade I gastrointestinal adverse effects occurred in 9 patients, Grade II in 8 patient and Grade III in 4 patients. No neurologic morbidity was encountered. No demonstrable report for Grade II and Ill neutropenia. The treatment course
resections were identified. Patients who had palliative surgery, gallbladder cancer or intrahepatic cholangiocarcinoma were excluded. Median follow up was 21 months. Patient's tumor T-stage, according to 2002 AJCC criteria, was T2, T3 and T4 in 50, 14 and 4.5 percent, respectively. In general, patients who were found to have positive resection margin or positive nodes postoperatively were offered adjuvant chemoradiation. Twenty-six patients had adjuvant concurrent chemoradiation and the remaining patients received no further treatment (n=20). The rate of positive nodes and/or positive margins was 88% and 27% for patients who did and did not received adjuvant chemoradiotherapy, respectively (p--0.001). All patients received protracted venous infusion of 5-fluorouracil concurrently with radiotherapy. The median total radiotherapy dose Results: The actuarial local control rate at 3 years for patients who did and did not received adjuvant concurrent chemoradiation XRT was 72% and 38%, respectively (p=0.01). The median disease specific survival for patients who were and were not treated with chemoradiotherapy was 43 and 35 months, respectively p. The overall distant metastasis rate for patients who did and did not receive adjuvant concurrent chemoradiation was 42 and 5 percent, respectively (p=0.056). AJCC tumour stage, tumour size or Conclusion: The use of adjuvant chemoradiation significantly improved local control in patients with resected extrahepatic cholangiocarcimoma with high-risk pathologic features. However, this did not translate to a significant disease specific survival benefit likely due to the competing risk of distant metastasis and small patient numbers. Even with the use of chemoradiation, local control remains a significant problem. 616 poster Preoperative neoadjuvant radiochemotherapy for gastric cancer
J. Dvorak 1, J. Petera 1, B. Melicha/, K. Kabelac 2, R. Voborif, Z. Zou/, M. Vosmik ~, P. Vesel/, V. Spacek 2, P. Jandik2 1Charles University Hospital, Oncology and Radiotherapy, Hradec Kralove, Czech Republic 2Charles University Hospital, Surgery, Hradec Kralove, Czech Republic Purpose: To evaluate toxicities, effect on achievement of radical resection with microscopically negative margins (R0 resection) and prognostic factors in gastric cancer treated with preoperative neoadjuvant radiochemotherapy. Patients and methods: Between April 1999 and March 2004, 33 patients (pts), 21 males and 12 females, mean age 62 (range 28-80) years, with gastric cancer were treated. All pts had histology of adenocarcinoma: 1 pts grade 1, 11 pts grade 2, 17 pts grade 3 and 4 pts grade 4. Pretreatment stage were as follow: 3 pts AJCC stage I.B, 9 pts stage II, 17 pts stage IlI.A and 4 pts stage IV. Anatomic sublocalization: 7 pts cardia, 1 pts fundus, 17 pts body, 5 pts antrum and 3 pts pylorus. Neoadjuvant radiochemotherapy consisted of radiotherapy of stomach and regional nodes 30 Gy in 15 fractions (2 Gy daily) in 16 pts and 40 Gy in 20 fractions (2 Gy daily)in 17 pts, with concurrent chemotherapy: 5fluorouracil 200 mg/m 2 continuously and weekly cisplatin 25 mg/m 2. Weekly paclitaxel 60 mg/m 2 was added in 16 pts. The surgery was performed in 5 weeks after completion of radiochemotherapy. Results: Leucopenia grade 3-4 occurred in 6/33 (18%) pts, thrombocytopenia grade 3 in 3/33 (9%) pts, nausea and vomitus grade 3 in 5/33 (15%) pts. Neoadjuvant regimen was completed in planned extension in 23/33 (70%) pts, in the rest of pts the intensity of chemotherapy had to be reduced
Posters
due to haematological and gastrointestinal toxicities. Neoadjuvant radiochemotherapy did not increase surgical mortality and morbidity. Surgical stage were as follow: 2 pts pathologic CR, 4 pts AJCC stage I.B, 6 pts stage II, 11 pts stage Ill.A, 9 pts stage IV. R0 resection was achieved in 20/33 (61%) pts, R1 (microscopic residual tumor) in 3 pts and R2 (macroscopic residual tumor) in 10 pts. From 20 pts after R0 resection 16 pts are without recurrence an 4 pts have a recurrence: 2 pts in retroperitoneal nodes, 1 pts in omentum and 1 pts in left ovary. The mean of survival was 971 days (range 67-1483). Prognostic influence showed histologic grade 1,2 vs. 3,4: p=0,02. No prognostic influence showed Tstage, N-stage, anatomic sublocalization, hemoglobin level or toxicities. Conclusion: Preoperative neoadjuvant radiochemotherapy has acceptable toxicities, can lead to achievement of high rate of R0 resections. An optimal regimen has to be found in new studies. Only prognostic factor was histologic grade of adenocarcinoma. 617 poster Hyperfractionated radiotherapy, Uraful and selective inhibitor of cox-2 enzyme for locally advanced/ unresectable pancreatic cancer
S.M. Youn Eulji University Hospital, Radiation Oncology, Daejeon, South Korea Purpose: To determine prospectively the maximal tolerated dose and potential antitumour activity of concurrent hyperfractionated radiotherapy, Uraful and selective inhibitor of cyclooxgenase-2 enzyme (Celecoxib) in patients with locally advanced and/or unresectable pancreatic cancer. Methods and Materials: We investigated on Phase I-II study of hyperfractionated radiotherapy using daily bid fractionation to a total dose of 66 Gy in 6 weeks at 1.1 Gy/fraction combined with Uraful and selective inhibitor of COX-2 enzyme, Celecoxib, as radiosensitizer. Uraful is a combination of tegafur (a prodrug of 5-flouorouracil) and uracil that can be given orally. The administration of Uraful for several weeks may simulate the effects of a continuous infusion of 5-fluorouracil. A dose of 300 mg/m2/day of Uraful was administered orally until the appearance of disease progression or unacceptable toxicity. Celecoxib was administered by per oral from first days to last days during radiotherapy and during 3 months follow-up period after completion of radiotherapy. Daily dose of Celecoxib was 200400mg/day. Twenty one patients were studied, 15 women and 6 men (mean age 64 years). Some patients presented with one or more symptoms. Obstructive jaundice was the main presenting symptom in 10 patients and epigastric pain in 14. All patients had unresectable histologically proven adenocarcinoma of the pancreas (14 head, 6 body, and 1 tail). Reasons for unresectability were involvement of the portal vein, and/or superior mesenteric artery (16 pts), paraaortic nodes (9 pts), and medically inoperable (1 pt). Fourteen patients underwent a biliary bypass procedure before treatment (nine endoscopic stenting, two choledochojejunostomy, and three cholecystojejunostomy). The follow-up period ranged from 14 to 66 months, and median follow-up period was 44 months. Results: Grade IV NCI common toxicity criteria was not seen. Grade I gastrointestinal adverse effects occurred in 9 patients, Grade II in 8 patient and Grade III in 4 patients. No neurologic morbidity was encountered. No demonstrable report for Grade II and Ill neutropenia. The treatment course