scholarly journals PD-0030 2-Year Follow-Up of A Phase II Study on Catumaxomab as Part of a Multimodal Approach in Primarily Resectable Gastric Cancer

2012 ◽  
Vol 23 ◽  
pp. iv29-iv30
Author(s):  
Carsten Bokemeyer ◽  
Karsten Ridwelski ◽  
G. Ramadori ◽  
Djordje Atanackovic ◽  
Dirk Arnold ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Multimodal Approach ◽  
Resectable Gastric Cancer

scholarly journals 2-Year Follow-up of a Phase II Study on Catumaxomab as Part of a Multimodal Approach in Primarily Resectable Gastric Cancer

2012 ◽  
Vol 23 ◽  
pp. ix228
Author(s):  
C. Bokemeyer ◽  
K. Ridwelski ◽  
D. Atanackovic ◽  
D. Arnold ◽  
E. Wöll ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Multimodal Approach ◽  
Resectable Gastric Cancer

Two-year follow-up of a phase II study on catumaxomab as part of a multimodal approach in primarily resectable gastric cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4095-4095 ◽  
Author(s):  
Carsten Bokemeyer ◽  
Karsten Ridwelski ◽  
Djordje Atanackovic ◽  
Dirk Arnold ◽  
Ewald Woell ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Multimodal Approach ◽  
En Bloc ◽  
Locally Advanced Gastric Cancer ◽  
Number Of Patients

4095^ Background: Perioperative chemotherapy (CT) has demonstrated as survival benefit in locally advanced gastric cancer (GC) in randomized trials. However, the overall cure rate is 30-40% and a significant number of patients are not able to receive the postoperative part of their CT regimen. In Europe, the trifunctional antibody catumaxomab is approved for the treatment of malignant ascites based on a pivotal trial which also included GC patients. A new multimodal approach combining neoadjuvant CT, followed by gastrectomy and intraperitoneal (i.p.) immunotherapy with catumaxomab was assessed in a single-arm multicenter phase II study. We here report 2-year follow-up data. Methods: GC pts (T2/T3/T4, N+/–, M0) received 3 cycles of neoadjuvant fluoropyrimidin/platinum-based CT followed by ’en-bloc’ R0-gastrectomy. Catumaxomab was administered i.p. as intraoperative bolus (10 µg) followed by 4 consecutive 3-hour infusions of 10-150 µg. Primary safety endpoint was the rate of predefined postoperative complications observed during 30 days after surgery. Key efficacy endpoints included disease-free (DFS) and overall survival (OS). Results: The original study data presented at the WCGC in 2011 (Schuhmacher et al.,Ann Oncol (2011) 22(suppl. 5)) showed that the primary endpoint was met and the described application regimen is safe. At time of surgery, 27.8% of patients were stage I, 27,8% of patients were stage II, 22,3% of patients were stage III and 14,8% of patients were stage IV as assessed according to pTNM measures. At 24 months 39/54 (safety analysis set) patients were still alife,14/54 were dead, (one patient lost to follow-up), 24/37 had no progression, only 13/37 patients relapsed (for 2 patients disease status was not recorded). At the 2 year cut off DFS was 56.4% (95% CI: 41–69%), OS was 75% (95% CI: 60–85%). Conclusions: Catumaxomab as part of a multimodal therapy in primarily resectable GC is a feasible option. The 2-year follow up efficacy results show promising data for DFS and OS in a cohort of locally advanced gastric cancer pts.

Long-Term Follow-Up of a Pilot Phase II Study with Neoadjuvant Epidoxorubicin, Etoposide and Cisplatin in Gastric Cancer

Oncology ◽  
2004 ◽  
Vol 67 (1) ◽  
pp. 48-53 ◽  
Author(s):  
C. Barone ◽  
A. Cassano ◽  
C. Pozzo ◽  
D. D’Ugo ◽  
G. Schinzari ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Pilot Phase ◽  
Long Term Follow Up

Follow-up data from a phase II study of adjuvant S-1/cisplatin chemotherapy followed by S-1 based chemoradiotherapy for advanced gastric cancer.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 116-116
Author(s):  
Hyun-Jeong Shim ◽  
Woo Kyun Bae ◽  
Jun-Eul Hwang ◽  
Young-Kyu Park ◽  
Seong-Yeop Ryu ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Phase Ii ◽  
Adjuvant Treatment ◽  
Phase Ii Study ◽  
Survival Rates ◽  
Disease Free Survival ◽  
Disease Recurrence ◽  
High Recurrence Rate ◽  
Stage Ib

116 Background: Surgery is the only possible curative treatment for gastric cancer. However, the high recurrence rate makes gastric cancer difficult to cure by surgery alone. The present study was conducted to evaluate the clinical outcomes and toxicity of adjuvant treatment, including S-1/cisplatin chemotherapy followed by radiotherapy with concurrent S-1. Methods: Patients with radically D2-resected adenocarcinoma of the stomach of stage IB–IV (M0) were eligible. Patients were treated with S-1 (40–60 mg depending on the patient’s body surface area) twice daily for 3 weeks and cisplatin (60 mg/m²) intravenously on day 1 every 5 weeks. Patients received CRT (45 Gy of radiation at 1.8 Gy/day, 5 days per week, for 5 weeks with the same dose of S-1 during radiation) followed by two additional cycles of S-1/cisplatin. The primary endpoint was the 3-year disease-free survival (DFS) rate; the secondary endpoints were the 3-year overall survival rate and toxicities. Results: Until May 2012, 46 patients were enrolled, and 34 (73.9%) completed the planned treatment. The median age was 53 years (range: 31–69 years), and the numbers of patients with stage IB, II, III and IV disease were 0, 17, 25 and 4, respectively. Grade 3–4 toxicities were as follows: neutropenia (28.2%), nausea (17.4%), vomiting (8.7%) and anorexia (15.2%). At the time of analysis, after a median follow-up period of 56.5 months (3.03–74.0 months), 16 recurrence events and 15 deaths were reported. The estimated 3-year DFS and survival rates were 65.2% and 76.1%, respectively. The most common site of recurrence was the peritoneum (n = 12). Conclusions: The results of this phase II study show that intensified adjuvant treatment with S-1/cisplatin chemotherapy and S-1-based chemoradiotherapy was effective in reducing disease recurrence. A randomized trial is needed to evaluate the role of the addition of radiation to chemotherapy in adjuvant treatment for gastric cancer. Clinical trial information: NCT01824004.

Phase II Study of Docetaxel and S-1 (DS) as Neoadjuvant Chemotherapy for Clinical Stage III Resectable Gastric Cancer

2014 ◽  
Vol 21 (7) ◽  
pp. 2340-2346 ◽  
Author(s):  
Eiji Oki ◽  
Yasunori Emi ◽  
Tetsuya Kusumoto ◽  
Yoshihisa Sakaguchi ◽  
Manabu Yamamoto ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Clinical Stage ◽  
Stage Iii ◽  
Resectable Gastric Cancer

scholarly journals Phase II study of docetaxel, cisplatin and capecitabine as preoperative chemotherapy in resectable gastric cancer

2016 ◽  
Vol 8 (10) ◽  
pp. 706
Author(s):  
Anneriet E Dassen ◽  
Nienke Bernards ◽  
Valery EPP Lemmens ◽  
Yes AJ van de Wouw ◽  
Koop Bosscha ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Phase Ii ◽  
Preoperative Chemotherapy ◽  
Phase Ii Study ◽  
Resectable Gastric Cancer
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