Skip to main content

Advertisement

SpringerLink
Log in

Phase II study of first-line biweekly docetaxel and cisplatin combination chemotherapy in advanced gastric cancer

  • Original Article
  • Published:
Cancer Chemotherapy and Pharmacology Aims and scope Submit manuscript

Abstract

Purpose

Previous studies have shown that docetaxel and cisplatin, as single agents, are effective and relatively well tolerated in patients with advanced gastric cancer. The aim of this study was to assess efficacy and toxicity of a biweekly regimen of docetaxel plus cisplatin in patients with advanced gastric cancer.

Patients/methods

Fifty-five patients with histologically proven advanced gastric cancer with at least 1 measurable lesion and ECOG PS ≤ 2 were enrolled. Patients received docetaxel 50 mg/m2 and cisplatin 50 mg/m2 every 2 weeks until progression disease, unbearable toxicity or a maximum of 12 cycles.

Results

In total, 426 cycles were administered (median 8.5 cycles) to 52 evaluable patients. One patient (1.9 %) showed a complete response, while 21 (40.4 %) had partial responses. The objective response rate was 42.3 % (95 % CI 28.9–55.7), the median time to progression was 5.5 months (95 % CI 4.0–7.0), and the median overall survival was 8.9 months (95 % CI 6.0–11.9). The most common grade 3–4 toxicities per cycle were haematological [neutropenia (5.9 %)].

Conclusions

Biweekly administration of docetaxel and cisplatin in advanced gastric cancer has a manageable toxicity profile and shows a promising antitumour activity as a first-line therapy.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2

Similar content being viewed by others

References

  1. Garcia M, Jemal A, Ward EM et al (2007) Global cancer facts and figures 2007. American Cancer Society, Atlanta

    Google Scholar 

  2. Wagner AD, Unverzagt S, Grothe W et al (2010) Chemotherapy for advanced gastric cancer. Cochrane Database Syst Rev 3:CD004064

    PubMed  Google Scholar 

  3. Power DG, Kelsen DP, Shah MA (2010) Advanced gastric cancer—slow but steady progress. Cancer Treat Rev 36(5):384–392

    Article  PubMed  Google Scholar 

  4. Koizumi W, Narahara H, Hara T et al (2008) S-1 plus cisplatin versus S-1 alone for first-line treatment of advanced gastric cancer (SPIRITS trial): a phase III trial. Lancet Oncol 3:215–221

    Article  Google Scholar 

  5. Cunningham D, Starling N, Rao S et al (2008) Upper gastrointestinal clinical studies group of the National Cancer Research Institute of the United Kingdom. Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med 358(1):36–46

    Article  CAS  PubMed  Google Scholar 

  6. Ross P, Nicolson M, Cunningham D et al (2002) Prospective randomized trial comparing mitomycin, cisplatin, and protracted venous-infusion fluorouracil (PVI 5-FU) with epirubicin, cisplatin, and PVI 5-FU in advanced esophagogastric cancer. J Clin Oncol 20:1996–2004

    Article  CAS  PubMed  Google Scholar 

  7. Webb A, Cunningham D, Scarffe JH et al (1997) Randomized trial comparing epirubicin, cisplatin, and fluorouracil versus fluorouracil, doxorubicin, and methotrexate in advanced esophagogastric cancer. J Clin Oncol 15:261–267

    Article  CAS  PubMed  Google Scholar 

  8. Yun J, Lee J, Park SH et al (2010) A randomised phase 2 study of combination chemotherapy with epirubicin, cisplatin and capecitabine (ECX) or cisplatin and capecitabine (CX) in advanced gastric cancer. Eur J Cancer 46(5):885–891

    Article  CAS  PubMed  Google Scholar 

  9. Hohenberger P, Gretschel S (2003) Gastric cancer. Lancet 362:305–315

    Article  PubMed  Google Scholar 

  10. Kim T, Choi SJ, Ahn JH et al (2001) A prospective randomised Phase 3 trial of 5-fluorouracil and cisplatin versus epirubicin, cisplatin and 5FU in the treatment of patients with previously untreated advanced gastric cancer. Eur J Cancer 37(Suppl. 6):1160a

    Google Scholar 

  11. Bleiberg H, Sargent DJ (2011) GASTRIC meta-analyses of 22 randomized trials assessing the influence of chemotherapy in advanced/recurrent gastric cancer. J Clin Oncol 29 (Abstract 4109)

  12. Van Cutsem E, Moiseyenko VM, Tjulandin S et al (2006) V325 study group. Phase 3 study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 Study Group. J Clin Oncol 24(31):4991–4997

    Article  PubMed  Google Scholar 

  13. Park YS, Lee J, Kang JH et al (2007) Phase II study of docetaxel and cisplatin combination chemotherapy in metastatic gastric cancer. Cancer Chemother Pharmacol 59(1):17–21

    Article  CAS  PubMed  Google Scholar 

  14. Al-Batran SE, Hartmann JT, Hofheinz R et al (2008) Biweekly fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) for patients with metastatic adenocarcinoma of the stomach or esophagogastric junction: a phase II trial of the Arbeitsgemeinschaft Internistische Onkologie. Ann Oncol 19(11):1882–1887

    Article  PubMed  Google Scholar 

  15. Shah MA, Stoller R, Shibata S et al (2010) Random assignment multicenter phase 2 study of modified docetaxel, cisplatin, fluorouracil (mDCF) versus DCF with growth factor support (GCSF) in metastatic gastroesophageal adenocarcinoma (GE). Presented at: Gastrointestinal Cancers Symposium 170a. Orlando, FL, USA, 22–24

  16. Tebbutt NC, Cummins MM, Sourjina T et al (2010) Randomised, non-comparative Phase 2 study of weekly docetaxel with cisplatin and 5-fluorouracil or with capecitabine in oesophagogastric cancer: the AGITG ATTAX trial. Br J Cancer 102(3):475–481

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  17. Pronk L, Schellens J, Planting A et al (1997) Phase I and pharmacologic study of decetaxel and cisplatin in patients with advanced solid tumors. J Clin Oncol 15(3):1071–1079

    CAS  PubMed  Google Scholar 

  18. Maeda Shingo, Sugiura T et al (2004) Docetaxel enhances the cytotoxicity of cisplatin to gastric cancer cells by modification of intracellular platinum metabolism. Cancer Sci 8:679–684

    Article  Google Scholar 

  19. Roth AD, 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 11:301–306

    Article  CAS  PubMed  Google Scholar 

  20. Schull B, Kornek G, Schmid K et al (2003) Effective combination chemotherapy with bimonthly docetaxel and cisplatin with or without hematopoietic growth factor support in patients with advanced grastroesophageal cancer. Oncology 65:211–217

    Article  PubMed  Google Scholar 

  21. 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

    Article  CAS  PubMed  Google Scholar 

  22. Ajani JA, Fodor M, Van Cutsem E et al (2000) Multinational randomized phase II trial of docetaxel (T) and cisplatin (C) with or without 5-fluorouracil (FU) in patients (pts) with advanced gastric or GE junction adenocarcinoma (AGC-AGEJC). Proc Am Soc Clin Oncol 19:247a

    Google Scholar 

  23. Page DL, Flemming ID, Fritz AG et al (2002) The AJCC cancer staging manual, 6th edn. Springer, New York

    Google Scholar 

  24. Ajani JA, Fodor MB, Tjulandin SA, Moiseyenko VM, Chao Y, Cabral Filho S, Majlis A, Assadourian S, Van Cutsem E (2005) Phase II multiinstitutional randomized trial of docetaxel plus cisplatin with or without fluorouracil in patients with untreated, advanced gastric, or gastroesophageal adenocarcinoma. J Clin Oncol 23:5660–5667

    Article  CAS  PubMed  Google Scholar 

  25. Roth AD, Fazio N, Stupp R et al (2007) Docetaxel-cisplatin-5FU (TCF) versus docetaxel-cisplatin (TC) versus epirubicin-cisplatin-5FU (ECF) as systemic treatment for advanced gastric carcinoma (AGC): a randomized phase II trial of the Swiss Group for Clinical Cancer Research (SAKK). J Clin Oncol 25:3217–3223

    Article  CAS  PubMed  Google Scholar 

  26. Cocconi G, Carlini P, Gamboni A et al (2003) Cisplatin, epirubicin, leucovorin and 5-fluorouracil (PELF) is more active than 5-fluorouracil, doxorubicin and methotrexate (FAMTX) in advanced gastric carcinoma. Ann Oncol 14(8):1258–1263

    Article  CAS  PubMed  Google Scholar 

  27. Cullinan SA, Moertel CG, Wieand HS et al (1994) Controlled evaluation of three drug combination regimens versus fluorouracil alone for the therapy of advanced gastric cancer. North Central Cancer Treatment Group. J Clin Oncol 12:412–416

    CAS  PubMed  Google Scholar 

  28. Cascinu S, Labianca R, Alessandroni P et al (1997) Intensive weekly chemotherapy for advanced gastric cancer using fluorouracil, cisplatin, epi-doxorubicin, 6S-leucovorin, glutathione, and filgrastim: a report from the Italian Group for the Study of Digestive Tract Cancer. J Clin Oncol 15:3313–3319

    CAS  PubMed  Google Scholar 

  29. Di Lauro L, Belli F, Arena MG et al (2005) Epirubicin, cisplatin and docetaxel combination therapy for metastatic gastric cancer. Ann Oncol 16(9):1498–1502

    Article  PubMed  Google Scholar 

  30. Nitti D, Wils J, Dos Santos JG et al (2006) Randomized phase III trials of adjuvant FAMTX or FEMTX compared with surgery alone in resected gastric cancer. A combined analysis of the EORTC GI Group and the ICCG. Ann Oncol 17(2):262–269

    Article  CAS  PubMed  Google Scholar 

  31. Popov IP, Jelić SB, Krivokapić ZV et al (2008) Bimonthly 24 h infusion of high-dose 5-fluorouracil vs EAP regimen in patients with advanced gastric cancer. A randomized phase II study. Med Oncol 25(1):73–80

    Article  CAS  PubMed  Google Scholar 

Download references

Acknowledgments

The authors thank Sanofi-Aventis Spain for providing financial support.

Author information

Authors and Affiliations

  1. Hospital Universitario Lucus, Augusti, Lugo, Spain

    G. Quintero-Aldana, S. Varela, E. Alvarez & B. Campos Balea

  2. Complejo Hospitalario Universitario de Vigo, CHUVI, Vigo, Spain

    M. Jorge, C. Grande, C. López, M. J. Villanueva, P. González, J. Castellanos & J. Casal

  3. Complejo Hospitalario de Ourense, CHOU, Ourense, Spain

    M. Salgado & A. Fernández

  4. Complejo Hospitalario Universitario de Santiago, CHUS, Santiago de Compostela, Spain

    E. Gallardo & R. López

Authors
  1. G. Quintero-Aldana
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. M. Jorge
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. C. Grande
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. M. Salgado
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. E. Gallardo
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. S. Varela
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. C. López
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. M. J. Villanueva
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. A. Fernández
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. E. Alvarez
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. P. González
    View author publications

    You can also search for this author in PubMed Google Scholar

  12. J. Castellanos
    View author publications

    You can also search for this author in PubMed Google Scholar

  13. J. Casal
    View author publications

    You can also search for this author in PubMed Google Scholar

  14. R. López
    View author publications

    You can also search for this author in PubMed Google Scholar

  15. B. Campos Balea
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to A. Fernández.

Ethics declarations

Conflict of interest

The authors declare that they have no conflict of interest.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Quintero-Aldana, G., Jorge, M., Grande, C. et al. Phase II study of first-line biweekly docetaxel and cisplatin combination chemotherapy in advanced gastric cancer. Cancer Chemother Pharmacol 76, 731–737 (2015). https://doi.org/10.1007/s00280-015-2839-z

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00280-015-2839-z

Keywords

Search

Navigation