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Introduction: The prognostic outlook for patients suffering from pancreatic cancer is generally poor. Particularly in cases of advanced and metastatic disease, long-term relapse-free survival may be achieved only in a few cases. Case Report: A 45-year-old patient presented with metastatic pancreatic cancer. Liver metastases had been intra-operatively confirmed by histology. Prior to initiating treatment, a portacath was surgically implanted. Subsequently, the patient received a weekly dose of 1,000 mg/m2 gemcitabine combined with 2,000 mg/m2 high-dose 5- fluorouracil as a 24-hour infusion for palliative treatment. As the patient was suffering from a stenosis of the ductus hepaticus communis, an endoprosthesis was primarily implanted. After 18 applications of chemotherapy during which only low toxic side effects such as nausea, vomiting and alopecia (NCI-CTC grade 1) presented, a partial remission of the primary tumor was observed. In the course of chemotherapy treatment, the carbohydrate antigen 19-9 tumor marker value normalized. Thus, the interdisciplinary tumor board of the University of Erlangen decided to perform a laparoscopy to evaluate the status of liver metastases after palliative chemotherapy treatment. Subsequently, the primary tumor could be completely resected (pT2, pN0, pM0, L0, V0, G2, R0); liver metastases were not observed. Eight years after the initial diagnosis, the patient is relapse-free, professionally fully integrated and presents with an excellent performance status. Conclusion: Patients suffering from metastatic pancreatic cancer may benefit from treatment combinations with palliative intent. In singular cases, patients may even have a curative treatment option, provided a close interdisciplinary collaboration exists.

13528 Background: During the last years due to the application of Irinotecan, Oxaliplatin and “biologicals” for the first- and secondline treatment of CRC in palliative situation the efficacy of palliative treatment has considerably improved with an acceptable toxicity. The achievements of secondary metastatic resection after downsizing by palliative treatment have increasingly become the focus of interest in palliative patients and opened up new ways in terms of curative options (Folprecht et al. 2005; Wein et al. 2001). Here, we analyse the influence of different departments on the resection rate after palliative treatment. Methods: A prospective phase III trial in metastatic CRC with systemic treatment by 5-FU/sodium FA as a 24h-infusion (AIO) versus AIO plus Oxaliplatin followed by secondary metastatic resection. Trial start: 2000; end of trial: 2005. Randomized patients: n = 240 by 5 centers experienced in clinical trials. In order to achieve a homogeneous patient group, non-resectability of distant metastases was required according to pre-defined criteria. Stratification characteristics: In accordance to the participating departments; ECOG index 0.1 vs 2. Involvement of the hepatic tumour extension 25% vs other localisation; organ manifestation 1 vs > 1. Inclusion criteria: Definitively non-resectable metastases. Palliative first-line treatment: Histologically proven adenocarcinoma of the colon or rectum, unambiguous enlargement of metastatic masses in objective imaging procedures. At least one bidimensionally measurable tumour lesion. Age: > 18, < 75 years. Exclusion criteria: Concomitant treatment with other anti-neoplastic substances. Sensoric neuropathy. Results: Resected/randomized patients of 176 currently evaluable patients, both treatment groups combined: department (dep.) 01: 0/26 (0%), dep. 02: 10/27 (37.0%), dep. 03: 21/68 (30.9%), dep. 04: 8/43 (18.6%), dep. 05: 1/12 (8.3%), total: 40/176 (22.7%). Although in the total population, a remarkable resection rate could be achieved, the variation between the departments is high (p=.0043 for differences between departments). Conclusions: The resection rate after palliative CRC treatment essentially depends on the department. No significant financial relationships to disclose.

14109 Background: At the moment of establishing the diagnosis, in approximately 50–60% of the patients with esophageal carcinoma only palliative treatment is possible due to either a locally advanced tumour growth or due to distant metastases. While adenocarcinomas of the esophagogastric junction are increasingly treated like gastric carcinomas, no palliative standard regimen is established for advanced squamous carcinomas of the oesophagus. The question should be answered whether the AIO regimen plus Irinotecan may achieve similarly positive results in esophageal carcinomas as in gastric carcinomas. Methods: Prospective phase II trial, patients: n=20, trial start: 03/2003, chemotherapeutic regimen: Irinotecan (80 mg/m2 i.v. as 1h-infusion; d 1, 8, 15, 22, 29, 36, qd 57) as well as folinic acid (500 mg/m2 i.v.) together with 5-Fluorouracil (2000 mg/m2 i.v.; d 1, 8, 15, 22, 29, 36, qd 57) as 24h-infusion via port catheter. Results: n=16 (adenocarcinomas: n=8, squamous epithelial carcinomas: n=8); median age: 59,3 (44–72) years; men/women: 13/3; ECOG 0/1/2: 4/11/1; chemotherapeutic applications: 314. Evaluable in terms of toxicity: n=16. Higher grade toxicity: grade III diarrhea: n=2, grade III hyponatremia: n=1, thrombosis of the vena subclavia: n=1, grade III stomatitis: n=1, ischemic lesion of the brain stem: n=1. Two patients died after 2 chemotherapeutic applications with known peritoneal carcinomatosis and high tumour burden. Evaluable in terms of response: n=13. PR: n=7 (54%), SD: n=4 (31%), PD: n=2 (15%). Conclusion: The AIO regimen plus Irinotecan is excellently manageable on an outpatient basis in a multimorbid patient group and shows high efficacy in both adenocarcinomas and squamous epithelial carcinomas of the oesophagus. Final results, however, particularly in terms of median survival, still remain to be seen. No significant financial relationships to disclose.

3561 Background: The FOLFIRI followed by FOLFOX6 (or vice versa) schedule has been considered as the gold standard of sequential treatment in CRC (Tournigand C. JCO 2004). In contrast to those bi-weekly schedules, the wide-spread weekly chemotherapy administration (e.g. AIO regimen), has not been investigated as yet for second-line treatment. The AIO + IRI schedule has provided promising results in the first-line treatment of CRC (Köhne C.-H. JCO 2005). Therefore, we now investigated the efficacy and toxicity of this schedule in second-line treatment in a phase II study. Methods: From 5/02 to 6/10, 60 palliative patients (pts.) with histologically proven CRC were enrolled in an oligocentric phase II study based on the following regimen: weekly IRI (80 mg/m2 i.v.) as 1h-infusion (inf.): d1, 8, 15, 22, 29, 36, qd 57 followed by 5-FU (2000 mg/m2 i.v.) combined with sodium folinic acid (500 mg/m2, d1, 8, 15, 22, 29, 36, qd 57) as a 24h-inf. via port-a-cath. This study focused on the efficacy and toxicity of second-line treatment with AIO + IRI. Results: Last date of evaluation: November 30, 2012; evaluable for efficacy: n = 58 pts., evaluable for toxicity: n = 59 pts.; men/women: 28/72%; median age: 65y; primary tumor location: rectum/colon: 45/55%.; toxicity data: higher grade toxicity (grade 3-4): leukocytopenia: 5.1%; thrombocytopenia: 1.7%; vomiting: 3.4%; diarrhea: 13.5%; hand-foot-syndrome: 1.7%; alopecia (grade 2) 3.4%; efficacy data: PFS: 4.2 m; median OS 14.2 m, RR: 10%; AIO + IRI following AIO + L-OHP achieved a median OS of 25.0 months. Conclusions: In the field of second-linetreatment of CRC the AIO plus IRI regimen offers both a favorable toxicity profile and promising results in terms of efficacy compared with the FOLFIRI regimen.

e15585 Background: Due to the positive experience with combined AIO plus irinotecan (iri.) in a phase II trial (Möhler M et al, Br J Cancer 2005), this combination has been applied as first-line treatment in our department since 1999. Methods: 76 chemonaive patients (pts.) with histologically proven metastatic adenocarcinomas of the stomach or AEG tumours (tum.) (UICC IV), deemed to be non-resectable by the Interdisciplinary Tumour Board (ITB), were enrolled from 08/99 to 12/08. Chemotherapy (chemoth.) schedule: iri. (80 mg/m2 i.v. as 1h-infusion (inf.); d1, 8, 15, 22, 29, 36, qd 57) followed by 5-FU (2000 mg/m2 i.v.) with sodium folinic acid (500 mg/m2; d1, 8, 15, 22, 29, 36, qd 57) as 24h-inf. via port-a-cath. After downsizing the patients were again presented at the ITB. In 16 out of 76 pts. (21%) a secondary (sec.) metastatic resection (res.) with curative intent was taken into account. This collective is presented here evidencing the efficacy of this interdisciplinary procedure in palliative (pall.) treatment of gastric cancer. Results: Last date of evaluation: Dec/31/2008; median age: 58,7 years; men/women: n=12/4; res. of the primary tum. prior to pall. chemoth.: yes/no: n=2/14, ECOG 0/1: n=5/11; primary tum. localisation: AEG tum.: n=7; gastric carcinoma: n=9, elevated CEA yes/no: n=5/11, elevated CA19–9 yes/no: n=5/11. Number of metastatic localisations: 1/2/3: 69%/19%/12%, chemoth. application: total number:267; average value/patient:17 cycles altogether: 46, median cycles/pt.: 3, higher grade tox. (grade 3–4): anaemia 4%; diarrhea 2%, vomitus 2%, fever/infection 2%; response: PR 32%; SD 56 %; PD 6%; not evaluable 6 %; tum. control (PR, SD) 88 %; sec. res.: R0: 82 %; R1: 6 %, R2: 6 %; RX: 6%; gastrectomy with peritonectomy (R0): n=4 (25%), gastrectomy with lymph node dissection (D4,R0): n=6 (38%); HIPEC: n=4 (25%); 1-year survival:81%, 2-year survival: 44%, 3-year survival: 25%; deceased pts.: n=9 (56%), NED 19% (n=3). Conclusions: In our trial curative resections could be achieved in 82 % of the pts. During a follow-up of 20 months a NED status could be documented in 19% of the patients. No significant financial relationships to disclose.

e15633 Background: Due to the late diagnosis of biliary tract carcinomas in an advanced tumor stage, the application of palliative chemotherapy frequently remains as a possible treatment option. The aim of this study is to evaluate the efficacy and toxic side effects of a chemotherapy schedule consisting of GEM combined with 5-FU in patients (pts.) with metastatic biliary tract cancer. Methods: Evaluation of 35 pts. based on our prospective tumor registry data; essential inclusion criteria: histologically proven adeno-carcinoma, UICC stage IV, chemonaivity; all the pts. were presented in the interdisciplinary tumorboard of Erlangen University and were primarily non-curatively-resectable (n = 35); evaluation period: 11/1998 - 09/2008; treatment schedule: 1.000 mg/m2 of GEM as a 0.5h-infusion (inf.) combined with 2.000 mg/m2 of 5-FU as a 24h-inf. via port catheter on day 1, 8, 15 qd 22. Results: Median age: 64 years; men/women: n=18/17; ECOG 0/1/2: n=10/21/4; localisation: intrahepatic bile ducts: n=19, extrahepatic bile ducts: n=11; gall bladder: n=4; metastases: liver: 91.4%, lymph nodes: 51.4%, peritoneum: 28.8%, bones: 8.6%, intestine: 8.6%, skin: 2.9%, lungs: 2.9%; chemotherapy applications: total number: 486, average value/patient: 13.9; CA 19–9 elevated yes/no: n=13/22 (37.1%/62.9%); CEA elevated yes/no: n=15/9 (42.9%/25.7%, not evaluable: 11); higher grade toxicity (III or IV): leukocytopenia III: 14.3%, thrombocytopenia III: 2.9%, weariness III: 2.9%, diarrhea III: 5.7%, diarrhea IV: 2.9%, vomiting IV: 2.9%, pain III: 5.7%, ascites III: 5.7%, infections III: 2.9%, thromboembolia IV: 2.9%, elevated bilirubin value III: 1.7%, grade IV: 8.3%; deep leg vein thrombosis: 15%; median TTP: 5.1 months (95% CI: 2.9 - 7.2); median overall survival: 10.4 months (95% CI: 7.9 - 12.9); 6-months-/1-year-/2-year-survival rate: 65.7%/45.7%/17.1%; response rate: PR: n=5 (14.3%), SD: n=18 (51.4%), PD: n=7 (20%), not evaluable: n=5 (14.3%); tumor control (PR/SD): n=23 (65.7%); median follow-up: 10.4 months. Conclusions: Combination chemotherapy with weekly GEM as a 0.5h-inf. and 5-FU as a 24h-inf. on an out-patient basis is an effective palliative treatment schedule with solely low grade toxicity. No significant financial relationships to disclose.

e15073 Background: In an interdisciplinary phase II trial performed from 1995 to 1997 and based on a 5-FU monotherapy it was possible to achieve both a sec. metastatic resection after downsizing in 9 patients (17%) and a R0 resection offering curative option in 6 patients (11%) out of a total collective of 53 treated patients (Wein et al, Ann Oncol 2001). The objective of this phase II trial is to verify whether a combination therapy based on ox may improve the curative option in terms of a sec. metastatic resection in a patient cohort with identical inclusion - and exclusion criteria. Methods: Prospective evaluation of 50 patients.; palliative chemotherapy: ox (oxaliplatin, 85 mg/m2 i.v. as a 2h-infusion (inf.); d 1, 15, 29 qd 57) followed by 5-FU (2000 mg/m2 i.v. as a 24h- inf.; d 1, 8, 15, 22, 29, 36 qd 57) together with s-FA (Oncofolic, 500 mg/m2 i.v. as a 24h-inf.; d 1, 8, 15, 22, 29, 36 qd 57) via a miniature pump system. Results: Last date of evaluation: Sep/30/2008; median age: 63 years; chemoth. appl.: total number: 935; higher grade toxicity (grade 3+4): diarrhea 20,0 %, nausea 4,0 %; vomitus 6,0 %; hand-foot-syndrome 2,0 %; fever/infection 2,0 %; response: CR: 2,0 %; PR: 52,0 %; SD: 32,0 %; PD: 12,0 %; not evaluable: 2,0 %; tumor control (CR, PR, SD): 86,0 %; sec. metastatic resection: R0: 28,0 %; R1: 2,0 %; R2 8,0 %; TTP (n = 50): 9,8 months. Conclusion: Combination chemotherapy with weekly 5-FU and s-FA (AIO) plus bi-weekly ox on an outpatient basis is an effective palliative treatment schedule offering a high rate of curative metastatic resection with solely low grade toxicity and no higher grade neurotoxic side effects. Final results in terms of median survival remain to be seen whereas they are certainly influenced by the second line therapy. No significant financial relationships to disclose.

15083 Background: Only 15–20% of all patients (pts.) with colorectal liver metastases are suitable for primary surgical resection. Liver resection offers the only chance of cure for these pts. In 2003 Wein et al. (Oncology) published the first data of neoadjuvant therapy following curative resection of liver metastases after a short median follow up (23 months) within a phase II trial. Here we report on the long-term results (median follow up: 45,5 months). Methods: Prospective phase II trial; pts.: n=20; start: 1/1998; end of recruitment: 2/2000; neoadjuvant chemotherapy: oxaliplatin (Eloxatin, 85 mg/m2 i.v. as a 2h-infusion (inf.); d 1, 15, 29 qd 57) and FA (Rescuvolin, 500 mg/m2 i.v. as a 1h- to 2h-inf.; d 1, 8, 15, 22, 29, 36 qd 57) followed by 5-FU (2600 mg/m2 i.v. as a 24h-inf.; d 1, 8, 15, 22, 29, 36 qd 57). Results: Last date of evaluation: 31/5/2007; localisation of the primary tumor: colon: n=40%, rectum: n=60%; histology: adenocarcinoma: n=20; G1/G2/G3/G4: 0/17/3/0; median age: 62,5 years; men/...

15644 Background: Due to the late diagnosis of pancreatic carcinomas in an advanced tumor stage, the application of palliative chemotherapy is frequently left as the only indicated treatment option...

15051 Background: In the majority of patients with esophageal carcinoma curative treatment proves to be impossible when establishing the diagnosis. While adenocarcinomas (ac) of the oesophago-gastric junction are increasingly treated in the same way as gastric carcinomas, the most frequently applied palliative chemotherapy regimen for both advanced squamous epithelial carcinomas (sec) of the oesophagus and gastric carcinomas is a combination of 5-FU and cisplatin. The question should be answered whether the AIO regimen plus irinotecan may achieve similarly positive results in esophageal carcinomas such as in gastric carcinomas (median survival (ms) up to 11 months). Methods: Prospective phase II trial, patients: n=25, trial start: 11/2002, chemotherapy: Irinotecan (80 mg/m2 i.v. as 1h-infusion; d 1, 8, 15, 22, 29, 36, qd 57) as well as sodium folinic acid (500 mg/m2 i.v.) together with 5-FU (2000 mg/m2 i.v.; d 1, 8, 15, 22, 29, 36, qd 57) as 24h-infusion via a miniature pump system. Results: Last date of evaluation: 31/12/2006: n=25; ac: n=13, sec: n=12; UICC III: n=3, UICC IV: n =22; grading G1/G2/G3/G4: 0/10/10/5; median age: 58 (44- 77) years; men/women: 20/5; ECOG 0/1/2/3: 3/17/4/1; chemotherapeutic applications: 429. Evaluable in terms of toxicity: n=25. Higher grade toxicity: grade (g) III diarrhea: n=2, g III hyponatremia: n=1, g III stomatitis: n=1, g III fatigue: n=1, g III vomiting: n=1, g IV nausea: n=1, g IV elevation of creatinine: n=1, thrombosis of the vena subclavia: n=1, ischemic lesion of the brain stem: n=1. 4 patients died after 2 chemotherapeutic applications due to known peritoneal carcinomatosis and high tumour burden. Evaluable in terms of response: n=25. PR: n=7 (28%), SD: n=10 (40%), PD: n=2 (8%), not evaluable: n=6 (24%). Cases of death: n=18. Total ms: 13 months (95% CI 3,9–22,1). ms of ac: 20 months (95% CI 8,6–31,4). ms of sec: 8 months (95% CI 0,0–17). Secondary resection (R0): n=2. Conclusion: In oesophageal carcinomas the AIO regimen plus irinotecan is excellently manageable on an outpatient basis and shows high efficacy in both adenocarcinomas and squamous epithelial carcinomas of the oesophagus. No significant financial relationships to disclose.