Asian Pacific Journal of Cancer Prevention

Asian Pacific Journal of Cancer Prevention (아시아태평양암예방학회)
권호 표지
DOI QR코드

DOI QR Code

Low-Dose Docetaxel/Cisplatin - Leucovorin and 46 Hour Infusional Fluorouracil in Metastatic Gastric Carcinoma

  • Alici, Suleyman (Oncology of Department of Goztepe Medical park Hospital, Medical School of Bahcesehir University) ;
  • Buyukberber, Suleyman (Oncology of Department, Medical School of Gazi University) ;
  • Alkis, Necati (Oncology of Department, Ankara Oncology Hospital) ;
  • Benekli, Mustafa (Oncology of Department, Medical School of Gazi University) ;
  • Ozkan, Metin (Oncology of Department, Medical School of Erciyes University) ;
  • Bilici, Ahmet (Oncology of Department, Kartal Training-Research Hospital) ;
  • Demirci, Umut (Oncology of Department, Medical School of Gazi University) ;
  • Karaca, Halit (Oncology of Department, Medical School of Erciyes University) ;
  • Arpaci, Erkan ;
  • Gumus, Mahmut (Oncology of Department, Kartal Training-Research Hospital) ;
  • Altunbas, Mustafa (Oncology of Department, Medical School of Yildirim Beyazit University) ;
  • Dane, Faysal (Oncology of Department, Medical School of Marmara University) ;
  • Turk, H. Mehmet (Oncology of Department of Goztepe Medical park Hospital, Medical School of Bahcesehir University) ;
  • Anatolian Society of Medical Oncology (Anatolian Society of Medical Oncology)
  • Published : 2013.01.31
Download PDF
⟨ Previous Next ⟩

Abstract

Background: Phase II and III trials of docetaxel, cisplatin and fluorouracil (DCF) have shown superior efficacy versus cisplatin and fluorouracil alone but with high rates of hematologic toxicity in metastatic gastric cancer cases. To reduce toxicity while maintaining the efficacy of DCF, we investigated low dose docetaxel (D), cispatin (C) - leucovorin and fluorouracil (De Gramont regimen). Patient and methods: Chemotherapy-naïve patients with metastatic gastric cancer (MGC) received D 60 mg/$m^2$ on day 1 and cisplatin 30 mg/$m^2$ on day 1-2 and the De Gramont regimen (Folinic acid 400 mg/m2 on day 1 and 5-FU 2400 mg/$m^2$/46h continuous infusion) every 3 weeks. The primary endpoint was response rate. Results: One hundred twenty patients with a median age of 52.5 years (range, 32-78) received a median of 6 cycles (range, 2-12 cycles). Of the 120 evaluable patients, 4 showed complete remission and 36 achieved a partial response. The overall response rate was 56.6%. Twenty eight patients (23.3%) showed stable disease and 52 (43.3%) progression. The median time to progression was 7 months (95%CI 6-7.9). The median overall survival was 15 months (95%CI 13.7-16.2). The most frequent hematological toxicity was leucopenia, which occurred at grade 3/4 intensity in 24 patients (20%). Conclusions: Low-dose DC-De Gramont regimen is active in MGC with a tolerable toxicity profile.

Keywords

References

  1. Ajani JA, Fodor MB, Tjulandin SA, et al (2005). Phase II multi-institutional randomized trial of docetaxel plus cisplatin with or without fluorouracil in patients with untreated, advanced gastric, or gastroesophageal adenocarcinomas. J Clin Oncol, 23, 5660-7. https://doi.org/10.1200/JCO.2005.17.376
  2. Ajani JA, Van Cutsem E, Moiseyenko V, et al (2003). Docetaxel, cisplatin, 5-fluorouracil compared to cisplatin and 5- fluorouracil for chemotherapy-naı¨ve patients with metastatic or locally recurrent, unresectable gastric carcinoma: interim results of a randomized phase III trial (V325). Proc Am Soc Clin Oncol, 22, 249.
  3. Bang YJ, Kang WK, Kang YK, et al (2002). Docetaxel $75 mg/m^{2}$ is active and well tolerated in patients with metastatic or recurrent gastric cancer: a phase II trial. Jpn J Clin Oncol, 32, 248-54. https://doi.org/10.1093/jjco/hyf057
  4. Colevas AD, Busse PM, Norris CM, et al (1998). Induction chemotherapy with docetaxel, cisplatin, fluorouracil, and leucovorin for squamous cell carcinoma of the head and neck: a phase I/II trial. J Clin Oncol, 16, 1331-9.
  5. Colevas AD, Norris CM, Tishler RB, et al (1999). Phase II trial of docetaxel, cisplatin, fluorouracil, and leucovorin as induction for squamous cell carcinoma of the head and neck. J Clin Oncol, 17, 3503-11.
  6. Glimelius B, Ekstrom K, Hoffman K, et al (1997). Randomized comparison between chemotherapy plus best supportive care with best supportive care in advanced gastric cancer. Ann Oncol, 8, 163-8. https://doi.org/10.1023/A:1008243606668
  7. Geen S, weiss GR (1992). Southwest oncology group standard response criteria, endpoint definitions and tocicity criteria. Invest New Drugs, 10, 239-53. https://doi.org/10.1007/BF00944177
  8. Fleming TR(1982). One-sample multiple testing procedure for phase II clinical trials. Biometrics, 38, 143-51. https://doi.org/10.2307/2530297
  9. Janinis J, Papadakou M, Panagos G, et al (2001). Sequential chemoradiotherapy with docetaxel, cisplatin, and 5-fluorouracil in patients with locally advanced head and neck cancer. Am J Clin Oncol, 24, 227-31. https://doi.org/10.1097/00000421-200106000-00003
  10. Janinis J, Panagos G (2000). Docetaxel, cisplatin, fluorouracil, and leucovorin in locally advanced head and neck cancer. J Clin Oncol, 18, 1393-5.
  11. Kim NK, Park YS, Heo DS, et al (1993). A phase III randomized study of 5-fluorouracil and cisplatin versus 5- fluorouracil, doxorubicin, and mitomycin C versus 5-fluorouracil alone in the treatment of advanced gastric cancer. Cancer, 71, 3813-8. https://doi.org/10.1002/1097-0142(19930615)71:12<3813::AID-CNCR2820711205>3.0.CO;2-5
  12. Mavroudis D, Kourousis C, Androulakis N, et al (2000). Frontline treatment of advanced gastric cancer with docetaxel and granulocyte colony-stimulating factor (G-CSF): a phase II trial. Am J Clin Oncol, 23, 341-4. https://doi.org/10.1097/00000421-200008000-00005
  13. Posner MR, Glisson B, Frenette G, et al (2001). Multicenter phase I–II trial of docetaxel, cisplatin, and fluorouracil induction chemotherapy for patients with locally advanced squamous cell cancer of the head and neck. J Clin Oncol, 19, 1096-104.
  14. Preusser P, Achterrath W, Wilke H, et al (1988). Chemotherapy of gastric cancer. Cancer Treat Rev, 15, 57-77.
  15. Pyrhonen S, Kuitunen T, Nsyandoto P, et al (1995). Randomized comparison of fluorouracil, epidoxorubicin and methotrexate (FEMTX) plus supportive care with supportive care alone in patients with non-resectable gastric cancer. Br J Cancer, 71, 587-91. https://doi.org/10.1038/bjc.1995.114
  16. Ridwelski K, Gebauer T, Fahlke J, et al (2001). Combination chemotherapy with docetaxel and cisplatin for locally advanced and metastatic gastric cancer. Ann Oncol, 12, 47-51.
  17. Roth AD, Maibach R, Falk S, et al (2004). Docetaxel–cisplatin–5FU versus docetaxel–cisplatin versus epirubicin–cisplatin–5FU as systemic treatment for advanced gastric cancer: a randomized phase III trial of the Swiss Group for Clinical Cancer Research (SAKK). J Clin Oncol, 22, 14.
  18. Roth AS, Maibach R, Martinelli G, et al (2000). Docetaxel (Taxotere)-cisplatin (TC): an effective drug combination in gastric carcinoma. Swiss group for clinical cancer research (SAKK), and the European institute of oncology (EIO). Ann Oncol, 11, 301-6. https://doi.org/10.1023/A:1008342013224
  19. Sulkes A, Smyth J, Sessa C, et al (1994). Docetaxel in advanced gastric cancer: results of a phase II clinical trial. Br J Cancer, 70, 380-3. https://doi.org/10.1038/bjc.1994.310
  20. Tanaka M, Obata T, Sasaki T (1996). Evaluation of antitumor effects of docetaxel (Taxotere) on human gastric cancer in vitro and in vivo. Eur J Cancer, 32, 226-30. https://doi.org/10.1016/0959-8049(95)00500-5
  21. Thuss-Patience PC, Kretschmar A, Repp M, et al (2005). Docetaxel and continuous-infusion fluorouracil versus epirubicin, cisplatin and fluorouracil for advanced gastric adenocarcinoma: a randomized phase II study. J Clin Oncol, 23, 494-501.
  22. Vanhoefer U, Rougier P, Wilke HJ, et al (2002). Author update. Classi Papers and Current Comments. J Clin Oncol, 6, 770.
  23. Wilke H, Vanhoefer U, Harstrick A, et al (1998). Phase II study of docetaxel as salvage chemotherapy in patients with advanced gastric cancer. Proc Am Soc Clin Oncol, 17, 305.
  24. Wilke HJ, Korn M, Vanhoefer U, et al (1996). Weekly infusional 5-fluorouracil plus/minus other drugs for the treatment of advanced gastric cancer. J Infus Chemother, 6, 123-6.
  25. Van Cutsem E, Moiseyenko VM, Tjulandin S, et al (2006). Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as firstline therapy for advanced gastric cancer: A report of the V325 study group. J Clin Oncol, 24, 4991-7. https://doi.org/10.1200/JCO.2006.06.8429

Cited by

  1. Modified Docetaxel and Cisplatin in Combination with Capecitabine (DCX) as a First-Line Treatment in HER2-Negative Advanced Gastric Cancer vol.15, pp.20, 2014, https://doi.org/10.7314/APJCP.2014.15.20.8661
  2. Efficacy and Tolerability of Weekly Docetaxel, Cisplatin, and 5-Fluorouracil for Locally Advanced or Metastatic Gastric Cancer Patients with ECOG Performance Scores of 1 and 2 vol.16, pp.3, 2015, https://doi.org/10.7314/APJCP.2015.16.3.985
  3. Experimental design and statistical analysis for three-drug combination studies vol.26, pp.3, 2017, https://doi.org/10.1177/0962280215574320
  4. Modified schedules of DCF chemotherapy for advanced gastric cancer vol.28, pp.2, 2017, https://doi.org/10.1097/CAD.0000000000000436