A Phase II Feasibility Study of Weekly Paclitaxel in Heavily Pretreated Advanced Gastric Cancer Patients with Poor Performance Status

Oncology ◽  
2009 ◽  
Vol 77 (6) ◽  
pp. 349-357 ◽  
Author(s):  
Chong Kun Im ◽  
Sun Young Rha ◽  
Hei-Cheul Jeung ◽  
Jaeheon Jeong ◽  
Soo Hyeon Lee ◽  
...  
2010 ◽  
Vol 2 ◽  
pp. CMT.S5191
Author(s):  
Alessandro Inno ◽  
Michele Basso ◽  
Alessandra Cassano ◽  
Carlo Barone

Docetaxel, a member of the taxane family, promotes cell death by binding β-tubulin and has demonstrated activity against several human malignancies, both as a single agent and in combination therapy. It has been approved in Europe and the US as front-line treatment for advanced gastric cancer in combination with cisplatin and fluorouracil (DCF regimen). This approval was based on the results of a pivotal study (V325) which demonstrated that the addition of docetaxel to the reference regimen of cisplatin and fluorouracil improves overall survival and progression-free survival with a better quality of life despite increased toxicity (mainly haematological). Modifications of DCF regimen have been successfully investigated as a means of making the treatment more tolerable and suitable also for elderly patients or patients with poor performance status. Emerging data from several phase II studies suggest that other docetaxel-based combination regimens with anthracyclines or irinotecan have interesting activity with acceptable toxicity profiles, but the true efficacy of these regimens needs to be assessed in large randomized phase III studies. Thus, the best docetaxel-containing regimen has yet to be identified. Docetaxel also represents a good candidate for combination with novel molecular target agents. In light of the high response rates observed in phase II-III studies, a docetaxel-based chemotherapy regimen might also be considered a treatment option as perioperative or adjuvant therapy in potentially curable gastric cancer and further studies with or without biological agents are eagerly awaited in this setting.


1986 ◽  
Vol 4 (9) ◽  
pp. 1348-1355 ◽  
Author(s):  
J A Levi ◽  
R M Fox ◽  
M H Tattersall ◽  
R L Woods ◽  
D Thomson ◽  
...  

A multi-institutional cooperative study of patients with locally advanced, recurrent, or metastatic gastric adenocarcinoma who had not previously received chemotherapy was conducted, prospectively randomizing patients to receive either doxorubicin or the three-drug combination, 5-fluorouracil (5-FU), doxorubicin (Adriamycin; Adria Laboratories, Columbus, Ohio), and BCNU (FAB). The 187 evaluable patients were initially stratified according to the presence of measurable or evaluable disease and performance status. There was a significantly higher response rate observed for FAB (40%) compared with doxorubicin (13%) among the 145 measurable-disease patients. Duration of response and survival were significantly longer for FAB in the measurable-disease group, but for the total patient population an early advantage for FAB in time to disease progression and survival was lost with continued follow-up. Median survival was 33 weeks for patients receiving FAB and 19 weeks for those receiving doxorubicin. Significant pretreatment factors adversely affecting survival included poor performance status, weight loss of greater than 10%, and more than two sites of metastases. Toxicity was not severe in either treatment arm, and only thrombocytopenia occurred significantly more often with FAB. It is contended that in the treatment of advanced gastric cancer, chemotherapy only exerts a relatively short-term and modest beneficial effect, most apparent in patients with intermediate tumor bulk. 5-FU remains the most active single agent, and combination chemotherapy has not yet proven its overall worth. Further studies are indicated comparing the most active combinations with 5-FU using optimal doses and schedules, and consideration must be given to the incorporation of no-treatment controls.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e15047-e15047 ◽  
Author(s):  
Yu-hong Li ◽  
Xin An ◽  
Fang Wang ◽  
Qiong Shao ◽  
Feng-Hua Wang ◽  
...  

e15047 Background: Several large studies have reported an extremely low incidence of MET gene amplification (GA) in patients with radically resected gastric cancer. The aim of our study was to evaluate the prevalence and prognostic role of MET GA and protein expression in recurrent/metastatic gastric cancer patients who received chemotherapy. Methods: This retrospective study included 232 recurrent/metastatic gastric cancer patients. MET GA and protein expression were evaluated by fluorescent in-situ hybridization (FISH) and immunohistochemistry (IHC), respectively.Results: MET GA and strong protein expression were observed in 8.3% and 9.6% of patients, respectively. MET IHC 3+ was significantly correlated with GA. Patients with MET GA more frequently had a poor performance status (P < 0.001) and poorly differentiate tumors (P = 0.015) than those without MET GA. Both MET GA and IHC 3+ expression were associated with substantially shorter median progression free survival (PFS) and overall survival (OS). The median OS and PFS for patients with MET GA positive vs. MET GA negative were 5.7 vs. 15.5 months (P < 0.001) and 3.6 vs. 6.9 months (P < 0.001), respectively.The median OS and PFS for patients with MET IHC 3+ vs. IHC (0 to 2+) were 6.3 vs. 15.1 months (P < 0.001) and 3.6 vs. 7.0 months (P < 0.001), respectively. Conclusions: In recurrent/metastatic gastric cancer, MET amplification and strong protein expression are not rare and significantly associated with unfavorable clinical outcomes.


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