J. Fahlke

Outpatient Therapy with Gemcitabine and Docetaxel for Gallbladder, Biliary, and Cholangio-Carcinomas

AbstractPurpose. The prognosis of patients withbiliary tree carcinomas is very poor. Thediagnosis often occurs at an advancedstage, when curative resection is notpossible. We combined gemcitabine anddocetaxel to optimize the palliativetherapy for patients with gallbladder,biliary, and cholangio-carcinomas on anoutpatient basis. Patients and methods. Patients withhistologically proven biliary treecarcinomas and a WHO performance status<2 received gemcitabine 1000 mg/m2followed by docetaxel 35 mg/m2 weekly for 3weeks followed by 1 week of rest. Results. Forty-three patients, 14males/29 females, with an average age of63.3 years (range, 41 to 78) have beenenrolled since 1998; 37 have completedtreatment. So far, 168 cycles (range, 1 to16) have been administered. All 43 patientswere included in the response and toxicityassessments. There are no completeremissions; however, 4 (9.3%) patientsachieved partial remission, 1 (2.3%) had aminimal remission, and 24 (55.8%)reached disease stabilization for a medianperiod of 5.2 months. Fourteen (32.6%)patients progressed. The median overallsurvival rate is currently 11.0 months. Grade 3 hematologic toxicities wereinfrequent, and there were no grade 4hematologic toxicities. Grade 3 leukopeniawas reported in 4 (9.3%) patients, grade 3thrombozytopenia in 1 (2.3%) patient, andgrade 3 anemia in 1 (2.3%) patient.Twenty-eight (65.1%) patients had grade3/4 alopecia, 8 (18.6%) hadnausea/vomiting, and 2 (4.6%) hadmucositis. Conclusion. The combination ofgemcitabine/docetaxel is an effective andwell tolerated therapy for patients withadvanced or metastatic gallbladder,biliary, and cholangio-carcinomas.

Surgical treatment of gastric cancer: Oncologic outcome of neoadjuvant treatment in the German multicenter observational study II.

139 Background: Neoadjuvant chemotherapy is broadly established in European centers when treating locally advanced gastric cancer. However, there still remain questions as to the benefit of this extended form of treatment in regards to tumor location and stage. Methods: Data obtained in the ongoing prospective, multicenter observational study (German Gastric Cancer Study II) on quality assurance in surgical therapy of gastric cancer containing a total of 2897 patients treated from 01/01/2007 through 31/12/2009 in 145 surgical departments to evaluate. Results: Overall, 506 patients (18.4%) received neoadjuvant treatment in regards to all tumor stages. Of the 530 patients with adenocarcinoma of the gastroesophageal junction (GEJ) 34.5% (n=183) received chemotherapy. In detail, 30.1% (n=873) of the patients were found to be in stage I. In regards to the mean time of survival for advanced stages (III/IV 6th editiion) a survival benefit for patients receiving neoadjuvant treatment (n=356) of 12.0 months was de...

Analysis of response to chemotherapy with subsequently emerging surgical potential in the initially locally advanced and/or metastasized gastric carcinoma.

e14587 Background: Multimodal treatment of the advanced gastric carcinoma is associated with an improved oncological outcome. There is a chance for improved time of survival for a selected group of patients even in a palliative setting by achieving secondary resectability. METHODS Within the setting of multicentered phase II studies on chemotherapy of the advanced gastric carcinoma we analyzed patients (pts) with secondary resectability treated in our centre. In an initially purely palliative setting 84 (53.8%) pts were treated with cisplatin/docetaxel (C/D), 45 (28.8%) pts received cisplatin/5-FU/leucovorin (PLF), while 17 (10.9%) pts underwent a therapy combining C/D and cetuximab. A further 10 pts were treated according to differing chemotherapeutic protocols. A total of 45 out of 156 pts responded well to treatment and thus were treated surgically. After neoadjuvant therapy pts underwent D2 lymphadenectomy along with gastrectomy. A R0 situation was achieved in 35 pts (77.8%). RESULTS A significant advantage of 23.8 months (95% CI 16.85-30.75) was shown for pts receiving neoadjuvant therapy in regards to the overall survival (OS) versus 13.13. months (CI 9.99-16.28) in merely palliatively treated pts. Time to progression (TTP) showed significant improvement in the neoadjuvant setting with a median of 16.3 months versus 8.6 months. There was no significant difference in the overall survival or time to progression in regards to the chemotherapy administered (OS: C/D 23.8 vs PLF 19.77, TTP: C/D 18.9 vs PLF 16.3), however secondary resectability was not achieved in pts treated with a combination of C/D and cetuximab. Male gender and the histologically intestinal type were found to be initial positive prognostic factors. CONCLUSIONS Results show that application of active chemotherapy in a multimodal concept of treatment can improve prognosis dramatically even in palliative settings for selected pts. In addition to the choice of therapy, excellent response evaluation and ambitious surgery are pivotal criteria. Developing valid predictive and prognostic parameters, like molecular signatures for instance, is a future necessity.