رژﻳﻢ ﺷﻴﻤﻲ درﻣﺎﻧﻲ ﻣﺆﺛﺮ ﺑﺮاي ﻛﺎﻧﺴﺮﻫﺎي ﻣﻌﺪه ﭘﻴﺸﺮﻓﺘﻪ ﻏﻴﺮ ﻗﺎﺑﻞ ﺟﺮاﺣﻲ

The Effective Chemotherapy Regimen for Advanced Unresectable Gastric Cancer

ﺯﻣﻴﻨﻪ ﻭ ﻫﺪﻑ: ﺩﺭ ﻳﻚ ﻣﻄﺎﻟﻌﺔ ﺁﻳﻨﺪﻩ ﻧﮕﺮ ﻣﻮﻟﺘﻲ ﺳﻨﺘﺮ ﻓﺎﺯ II ﺍﺛﺮﮔﺬﺍﺭﻱ ﻭ ﺗﻮﻛﺴﻴﺴﻴﺘﻲ ﺭﮊﻳﻢ )DCF (Docetaxel, Cisplatin, 5–FU ﺭﻭﻱ ﺑﻴﻤـﺎﺭﺍﻥ ﺑﺎ ﻛﺎﻧﺴﺮ ﻣﻌـﺪﻩ ﭘﻴﺸﺮﻓﺘﻪ ﻭ ﻣﺘﺎﺳﺘﺎﺗﻴﻚ ﻏﻴـﺮ ﻗﺎﺑﻞ ﺟﺮﺍﺣﻲ ﻛﻪ ﻗﺒﻼﹰ ﻫﻴﭽﮕـﻮﻧﻪ ﺷﻴﻤﻲ ﺩﺭﻣﺎﻧﻲ ﺩﺭﻳﺎﻓﺖ ﻧﻜـﺮﺩﻩ ﺑﻮﺩﻧﺪ ﺗﺴﺖ ﺷﺪ. ﻣﻮﺍﺩ ﻭ ﺭﻭﺵ ﻫﺎ: ﺩﺭ ﺍﻳﻦ ﻣﻄﺎﻟﻌﻪ ﺑﻴﻦ ﺳﺎﻝ ﻫﺎﻱ 1382 ﺗﺎ ﺍﻭﺍﻳﻞ 1385 ﺗﻌـﺪﺍﺩ 56 ﺑﻴﻤـﺎﺭ ﺑﻪ ﻛﺎﻧﺴﺮ ﻣﻌـﺪﻩ ﺩﺭ ﻭﺿﻌﻴﺖ ﻣﻮﺿﻌﻲ ﭘﻴﺸﺮﻓﺘﻪ ﻭ ﻳﺎ ﻣﺘﺎﺳﺘﺎﺗﻴﻚ ﺭﻭﻱ رزيم Docetaxel 75mg/m2 ﺑﻪ ﻣﻘﺪﺍﺭ Cisplatin ﻳﻚ ﺭﻭﺯ ﻭ 750mg/m به طور مداوم براي 3 ﺭﻭﺯ ﺑﺎ ﺣﻤـﺎﻳﺖ ﻓـﻮﻟﻴﻨﻴﻚ ﺍﺳﻴﺪ ﻗـﺮﺍﺭ ﮔﺮﻓﺘﻨﺪ ﻛﻪ ﭘﺮﻭﺗـﻮﻛﻞ ﻫﺮ 3 ﻫﻔﺘﻪ ﻭ ﺑـﺮﺍﻱ ﺷﺶ ﺩﻭﺭﺓ ﺯﻣـﺎﻧﻲ ﺍﺩﺍﻣﻪ ﻳﺎﻓﺖ. ﻫﺪﻑ ﺍﻭﻟﻴﻪ )Primary end Point( ﻋﺒﺎﺭﺕ ﺑﻮﺩ ﺍﺯ Time to Progression (TTP), Response Rate (RR), Overall Survival (OS). ﻳﺎﻓﺘﻪ ﻫﺎ: ﺍﺯ 56 ﺑﻴﻤﺎﺭ ﻛﻪ ﻭﺍﺭﺩ ﻣﻄﺎﻟﻌﻪ ﺷﺪﻧﺪ 36 ﻣﺮﺩ ﻭ 20 ﺯﻥ ﺑﻮﺩﻧﺪ ﻭ ﺑﺎ ﺳﻦ ﻣﺘﻮﺳﻂ 56 ﺳﺎﻝ ﻫﻤﮕﻲ ﻋﻤﻠﻜﺮﺩ ﺑﺎﻻﺗﺮ ﺍﺯ 70 ﺑﺮ ﺍﺳﺎﺱ ﻛﺎﺭﻧﻮﻓﺴﻜﻲ ﺩﺍﺷﺘﻨﺪ. 40% ﻗﺒﻼﹰ ﻻﭘﺎﺭﺍﺗـﻮﻣﻲ ﺷﺪﻩ ﺑﻮﺩﻧﺪ. ﻛﻼﹰ 274 ﺳﻴﻜﻞ ﺩﺍﺭﻭ ﺗﺰﺭﻳﻖ ﺷﺪ ﻛﻪ ﻣﺘﻮﺳﻂ ﺩﺭﻳﺎﻓﺖ ﺳﻴﻜﻞ ﻫﺎ 5 ﺑﺎﺭ ﺑﻮﺩ ﺩﺭ ﻳﻚ ﭘﻴﮕﻴﺮﻱ 16 ﻣﺎﻫـﻪ 75 ﺑﻴﻤﺎﺭﺍﻥ ﭘﻴﺸﺮﻓﺖ ﺑﻴﻤـﺎﺭﻱ ﺭﺍ ﻧﺸﺎﻥ ﺩﺍﺩﻧﺪ. ﺩﺭ ﺑﺮﺭﺳﻲ 19 ﻣﺎﻫﻪ 65 ﺑﻴﻤﺎﺭﺍﻥ ﻓـﻮﺕ ﻛﺮﺩﻧﺪ ﻭ ﻣﺘﻮﺳﻂ OS ﺣﺪﻭﺩ 10 ﻣﺎﻩ ﺑﻮﺩ. ﺗﺎ ﺯﻣﺎﻥ ﮔـﺰﺍﺭﺵ ﺩﺭﺻﺪ ﺑﻴﻤﺎﺭﺍﻧﻲ ﻛﻪ ﺑﻴﺶ ﺍﺯ ﻳﻚ ﺳﺎﻝ ﺯﻧﺪﻩ ﺑﻮﺩﻧﺪ 35 ﻳﺎ 19 ﺍﺯ 56 ﺑﻮﺩ. ﻛﻼﹰ TTP ﺑﺎ ﺭﮊﻳﻢ DCF ﺣﺪﻭﺩ ﺩﻭ ﺑﺮﺍﺑﺮ ﻧﺴﺒﺖ ﺑﻪ ﺭﮊﻳﻢ ﻫﺎﻱ ﻗﺒﻠﻲ ﺑﻮﺩ. ﻣﻬﻤﺘﺮﻳﻦ ﻋـﻮﺍﺭﺽ ﻧﻮﺗﺮﻭﭘﻨﻲ ﻭ ﺗﺐ ﺩﺭ 12%، ﻋـﻮﺍﺭﺽ ﮔﻮﺍﺭﺷﻲ ﻭ ﻧﻮﺭﻭﭘﺎﺗﻲ ﺑﻮﺩ. ﻧﺘﻴﺠﻪ ﮔﻴـﺮﻱ: ﺍﺿـﺎﻓﻪ ﻛــﺮﺩﻥ ﺩﺍﺭﻭﻱDocetaxel ﺑـﻪ ﺭﮊﻳـﻢ ﻗﺒﻠـﻲ CF ﺳﺒـﺐ ﺑﻬﺒـﻮﺩ ﻧﺴﺒـﻲ ﺩﺭ ﻣﻌﻴـﺎﺭﻫـﺎﻱ ﭘـﺎﺳــﺦ ﻣﺜـﻞRR, OS ﻭ TTP ﺩﺭ ﺑﻴﻤـﺎﺭﺍﻥ ﺷﺪ. ﮔﺮ ﭼﻪ ﻧﺘﺎﻳﺞ ﺑﺎ ﺍﻓﺰﺍﻳﺶ ﻣﺨﺘﺼﺮ ﺗﻮﻛﺴﻴﺴﻴﺘﻲ ﻫﻤﺮﺍﻩ ﺑﻮﺩ ﻭﻟﻲ ﻣﺎﻧﻊ ﺑﻬﺒﻮﺩﻱ ﺩﺭ ﻛﻴﻔﻴﺖ ﺯﻧﺪﮔﻲ ﻧﺸﺪ ﻭ ﺭﮊﻳﻢ DCF ﻣﻲ ﺗﻮﺍﻧﺪ ﺑﻪ ﻋﻨﻮﺍﻥ ﻳﻜﻲ ﺍﺯ ﺭﮊﻳﻢ ﻫﺎﻱ ﺍﺳﺘﺎﻧﺪﺍﺭﺩ ﺩﺭ ﺩﺭﻣﺎﻥ ﻛﺎﻧﺴﺮﻫﺎﻱ ﻣﻌﺪﻩ ﭘﻴﺸﺮﻓﺘﻪ ﺍﺳﺘﻔﺎﺩﻩ ﺷﻮﺩ.

Introduction & Objective: In a prospective multicentric phase II trial, we evaluated the efficacy and toxicity of combination of docetaxel, cisplatin and 5fu/lv (DCF) in a group of untreated patients with unresectable advanced and metastatic Gastric Cancer. Materials & Methods: Fifty six patients with locally advanced and metastatic Gastric cancer were enrolled in this study. Docetaxel, 75mg/m2 in day 1, Cisplatin 75mg/m2 in day 1, 5-fu 750mg/m2/ for day 1 –3 with continuous infusion with folinic acid support were administered. The above regimen were given every 3 weeks for total of 6 cycles. The primary end points were time to progression (TTP) and overall survival (OS). Results: In 56 assigned patients (Male = 36, Female = 20) with median age of 56 year, 40% had already undergone unsuccessful laparatomy, a total of 274 cycles of above regimen were given. The average of received cycles were 5 cycles. In a 16 months of follow up 75% of patients showed progression, in evaluation after 19 months 65% of patients died and overall survival was 10 months. Until this report 19 out of 56 (35%) were alive for more than a year. Time to progression with DCF was almost two times compared to prior chemotherapy regimen. The most important toxicity of this regimen were neutropenic fever in 12% of patients, gastrointestinal toxicity and neuropathy. Conclusions: Adding Docetaxel to CF significantly improved RR, TTP, and OS. The above results have associated with brief increase in toxicity, the overall quality of life was better, therefore, DCF regimen could be one of the standard options for patients with untreated advanced gastric cancers