Skip to main content

Advertisement

SpringerLink
Log in

A phase II study of docetaxel as salvage chemotherapy in advanced gastric cancer after failure of fluoropyrimidine and platinum combination chemotherapy

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

Abstract

Purpose

Fluoropyrimidine (F) and platinum (P) combination chemotherapy has been widely used as a first-line treatment of advanced gastric cancer (AGC). Docetaxel has shown promising activity against this disease. In this study, we explored the efficacy and safety of docetaxel monotherapy as salvage chemotherapy in AGC after F and P combination chemotherapy failed.

Materials and methods

From October 2004 to October 2005, 49 eligible patients were enrolled in this study. The median treatment-free interval was 28.0 days, and 81.6% of patients had suffered cancer progression within 4 months after the withdrawal of first-line chemotherapy. Docetaxel was given IV at a dose of 75 mg/m2 every 3 weeks, together with dexamethasone prophylaxis.

Results

A total of 182 cycles of docetaxel were administered with a median of 3 (range 1–9) cycles. From an intention-to-treat analysis, eight patients achieved objective response with a response rate of 16.3% (95% CI, 6.0–26.6). The median response duration was 4.7 months. A total of 20 patients showed stable disease, but 17 patients suffered disease progression. At a median follow-up duration of 11.3 months for surviving patients (range 6.3–18.8 months), the median time to disease progression was 2.5 months (95% CI, 2.3–2.7) and the median overall survival time since the start of docetaxel monotherapy was 8.3 months (95% CI, 6.7–9.8). Grade 3/4 neutropenia and febrile neutropenia occurred in 18.4% of patients and in 5.4% of cycles. The incidence of non-hematologic toxicities of grade 3 or worse was asthenia 32.7%, diarrhea 10.2% and peripheral sensory neuropathy 8.2%.

Conclusion

Docetaxel at 75 mg/m2 is active against AGC as second-line chemotherapy after prior exposure to F and P combination chemotherapy. The toxicity profile is moderate.

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. Andre T, Louvet C, Ychou M, Gamelin E, Mousseau M, Carola E, Assadourian S, Gramont A (1999) Docetaxel-epirubicin as second-line treatment for patients with advanced gastric cancer. Proc Am Soc Clin Oncol 18:1062 [Abstract]

    Google Scholar 

  2. Assersohn L, Brown G, Cunningham D, Ward C, Oates J, Waters JS, Hill ME, Norman AR (2004) Phase II study of irinotecan and 5-fluorouracil/leucovorin in patients with primary refractory or relapsed advanced oesophageal and gastric carcinoma. Ann Oncol 15:64–69

    Article  PubMed  CAS  Google Scholar 

  3. Bang Y-J, Kang WK, Kang Y-K, Kim HC, Jacques C, Zuber E, Daglish B, Boudraa Y, Kim WS, Heo DS, Kim NK (2002) Docetaxel 75 mg/m2 is active and well tolerated in patients with metastatic or recurrent gastric cancer: a phase II trial. Jpn J Clin Oncol 32:248–254

    Article  PubMed  Google Scholar 

  4. Chun JH, Kim HK, Lee JS, Choi JY, Lee HG, Yoon SM, Choi IJ, Ryu KW, Kim YW, Bae JM (2004) Weekly irinotecan in patients with metastatic gastric cancer failing cisplatin-based chemotherapy. Jpn J Clin Oncol 34:8–13

    Article  PubMed  Google Scholar 

  5. Einzig AI, Neuberg D, Remick SC, Karp DD, O’Dwyer PJ, Stewart JA, Benson AB III (1996) Phase II trial of docetaxel (Taxotere) in patients with adenocarcinoma of the upper gastrointestinal tract previously untreated with cytotoxic chemotherapy: the eastern cooperative oncology group (ECOG) results of protocol E1293. Med Oncol 13:87–93

    PubMed  CAS  Google Scholar 

  6. Giuliani F, Gebbia V, De Vita F, Maiello E, Di Bisceglie M, Catalano G, Gebbia N, Colucci G (2003) Docetaxel as salvage therapy in advanced gastric cancer: a phase II study of the gruppo oncologico Italia meridionale (G.O.I.M.). Anticancer Res 23:4219–4222

    PubMed  CAS  Google Scholar 

  7. Glimelius B, Ekstrom K, Hoffman K, Graf W, Sjoden PO, Haglund U, Svensson C, Enander LK, Linne T, Sellstrom H, Heuman R (1997) Randomized comparison between chemotherapy plus best supportive care with best supportive care in advanced gastric cancer. Ann Oncol 8:163–168

    Article  PubMed  CAS  Google Scholar 

  8. Kang Y-K, Kim TW, Chang HM, Ryu M-H, Yook JH, Oh ST, Kim BS, Lee JS (2004) A phase I/II trial of docetaxel, capecitabine, and cisplatin as a first line chemotherapy for advanced gastric cancer. Proc Am Soc Clin Oncol 22:4066 [Abstract]

    Google Scholar 

  9. Kang Y, Kang WK, Shin DB, Chen J, Xiong J, Wang J, Lichinitser M, Philco M, Suarez T, Santamaria J (2006) Randomized phase III trial of capecitabine/cisplatin (XP) vs. continuous infusion of 5-FU/cisplatin (FP) as first-line therapy in patients (pts) with advanced gastric cancer (AGC): efficacy and safety results. Proc Am Soc Clin Oncol 24:LBA4018 [Abstract]

    Google Scholar 

  10. Kim DY, Kim JH, Lee SH, Kim TY, Heo DS, Bang YJ, Kim NK (2003) Phase II study of oxaliplatin, 5-fluorouracil and leucovorin in previously platinum-treated patients with advanced gastric cancer. Ann Oncol 14:383–387

    Article  PubMed  CAS  Google Scholar 

  11. Kim NK, Park YS, Heo DS, Suh C, Kim SY, Park KC, Kang YK, Shin DB, Kim HT, Kim HJ, 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 71:3813–3818

    Article  PubMed  CAS  Google Scholar 

  12. Kim ST, Kang WK, Kang JH, Park KW, Lee J, Lee SH, Park JO, Kim K, Kim WS, Jung CW, Park YS, Im YH, Park K (2005) Salvage chemotherapy with irinotecan, 5-fluorouracil and leucovorin for taxane- and cisplatin-refractory, metastatic gastric cancer. Br J Cancer 92:1850–1854

    Article  PubMed  CAS  Google Scholar 

  13. Kim TW, Kang YK, Ahn JH, Chang HM, Yook JH, Oh ST, Kim BS, Lee JS (2002) Phase II study of capecitabine plus cisplatin as first-line chemotherapy in advanced gastric cancer. Ann Oncol 13:1893–1898

    Article  PubMed  CAS  Google Scholar 

  14. Koizumi W, Tanabe S, Saigenji K, Ohtsu A, Boku N, Nagashima F, Shirao K, Matsumura Y, Gotoh M (2003) Phase I/II study of S-1 combined with cisplatin in patients with advanced gastric cancer. Br J Cancer 89:2207–2212

    Article  PubMed  CAS  Google Scholar 

  15. Lee JL, Ryu MH, Chang HM, Kim TW, Yook JH, Oh ST, Kim BS, Lee JS, Kang YK (2005) Efficacy and safety study of docetaxel as salvage chemotherapy in metastatic gastric cancer failing fluoropyrimidine and platinum combination chemotherapy. Cancer Res Treat 37:201–207

    Article  PubMed  Google Scholar 

  16. Lee JL, Ryu MH, Kang HJ, Chang HM, Kim TW, Lee JS, Kang YK (2005) Efficacy and safety study of docetaxel as salvage chemotherapy in metastatic gastric cancer failing fluoropyrimidine and platinum combination chemotherapy. Proc Am Soc Clin Oncol 23:4220 [Abstract]

    Google Scholar 

  17. Lee SS, Lee J-L, Ryu M-H, Chang HM, Kim TW, Kang H-J, Kim WK, Lee JS, Kang Y-K (2007) Combination chemotherapy with capecitabine (X) and cisplatin (P) as first line treatment in advanced gastric cancer: experience of 223 patients with prognostic factor analysis. Jpn J Clin Oncol 37:30–37

    Article  PubMed  Google Scholar 

  18. Murad AM, Santiago FF, Petroianu A, Rocha PR, Rodrigues MA, Rausch M (1993) Modified therapy with 5-fluorouracil, doxorubicin, and methotrexate in advanced gastric cancer. Cancer 72:37–41

    Article  PubMed  CAS  Google Scholar 

  19. Parkin DM, Bray F, Ferlay J, Pisani P (2005) Global cancer statistics, 2002. CA Cancer J Clin 55:74–108

    Article  PubMed  Google Scholar 

  20. Pyrhonen S, Kuitunen T, Nyandoto P, Kouri M (1995) Randomised comparison of fluorouracil, epidoxorubicin and methotrexate (FEMTX) plus supportive care with supportive care alone in patients with non-resectable gastric cancer. Br J Cancer 71:587–591

    PubMed  CAS  Google Scholar 

  21. Shepherd FA, Dancey J, Ramlau R, Mattson K, Gralla R, O’Rourke M, Levitan N, Gressot L, Vincent M, Burkes R, Coughlin S, Kim Y, Berille J (2000) Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol 18:2095–2103

    PubMed  CAS  Google Scholar 

  22. Shin H-R, Jung K-W, Won Y-J, Park J-G (2004) 2002 annual report of the Korea central cancer registry: based on registered data from 139 hospitals. Cancer Res Treat 36:103–114

    Article  PubMed  Google Scholar 

  23. Sulkes A, Smyth J, Sessa C, Dirix LY, Vermorken JB, Kaye S, Wanders J, Franklin H, LeBail N, Verweij J (1994) Docetaxel (Taxotere) in advanced gastric cancer: results of a phase II clinical trial. EORTC early clinical trials group. Br J Cancer 70:380–383

    PubMed  CAS  Google Scholar 

  24. Taguchi T, Sakata Y, Kanamaru R, Kurihara M, Suminaga M, Ota J, Hirabayashi N (1998) Late phase II clinical study of RP56976 (docetaxel) in patients with advanced/recurrent gastric cancer: a Japanese cooperative study group trial (group A). Gan To Kagaku Ryoho 25:1915–1924

    PubMed  CAS  Google Scholar 

  25. Van Cutsem E, Moiseyenko VM, Tjulandin S, Majlis A, Constenla M, Boni C, Rodrigues A, Fodor M, Chao Y, Voznyi E, Risse M-L, Ajani JA (2006) Phase III 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 24:4991–4997

    Article  PubMed  CAS  Google Scholar 

  26. Vanhoefer U, Rougier P, Wilke H, Ducreux MP, Lacave AJ, Van Cutsem E, Planker M, Santos JGD, Piedbois P, Paillot B, Bodenstein H, Schmoll H-J, Bleiberg H, Nordlinger B, Couvreur M-L, Baron B, Wils JA (2000) Final results of a randomized phase III trial of sequential high-dose methotrexate, fluorouracil, and doxorubicin versus etoposide, leucovorin, and fluorouracil versus infusional fluorouracil and cisplatin in advanced gastric cancer: a trial of the European organization for research and treatment of cancer gastrointestinal tract cancer cooperative group. J Clin Oncol 18:2648–2657

    PubMed  CAS  Google Scholar 

  27. Vanhoefer U, Wilke H, Harstrick A, Achterrath W, Preusser P, Stahl M, Clemens M, Thiel E, Flasshove M, Fink U, Trenn G, Seeber S (1999) Phase II study of docetaxel as second line chemotherapy in metastatic gastric cancer. Proc Am Soc Clin Oncol 18:303 [Abstract]

    Google Scholar 

  28. Waters JS, Norman A, Cunningham D, Scarffe JH, Webb A, Harper P, Joffe JK, Mackean M, Mansi J, Leahy M, Hill A, Oates J, Rao S, Nicolson M, Hickish T (1999) Long-term survival after epirubicin, cisplatin and fluorouracil for gastric cancer: results of a randomized trial. Br J Cancer 80:269–272

    Article  PubMed  CAS  Google Scholar 

  29. Webb A, Cunningham D, Scarffe JH, Harper P, Norman A, Joffe JK, Hughes M, Mansi J, Findlay M, Hill A, Oates J, Nicolson M, Hickish T, O’Brien M, Iveson T, Watson M, Underhill C, Wardley A, Meehan M (1997) Randomized trial comparing epirubicin, cisplatin, and fluorouracil versus fluorouracil, doxorubicin, and methotrexate in advanced esophagogastric cancer. J Clin Oncol 15:261–267

    PubMed  CAS  Google Scholar 

Download references

Acknowledgments

This study was supported by a grant from the Korea Health 21 R&D Project, Ministry of Health and Welfare, Republic of Korea (A060775).

Author information

Authors and Affiliations

  1. Division of Oncology, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, 388-1 Poongnap-dong, Songpa-gu, Seoul, 138-736, South Korea

    Jae-Lyun Lee, Min-Hee Ryu, Heung Moon Chang, Tae-Won Kim, Jung Shin Lee & Yoon-Koo Kang

  2. Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea

    Jeong Hwan Yook, Sung Tae Oh & Byung Sik Kim

  3. Department of Pharmacy, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea

    Minsun Kim & Young Joo Chun

Authors
  1. Jae-Lyun Lee
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Min-Hee Ryu
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Heung Moon Chang
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Tae-Won Kim
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Jeong Hwan Yook
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Sung Tae Oh
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Byung Sik Kim
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Minsun Kim
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Young Joo Chun
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Jung Shin Lee
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. Yoon-Koo Kang
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Yoon-Koo Kang.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Lee, JL., Ryu, MH., Chang, H.M. et al. A phase II study of docetaxel as salvage chemotherapy in advanced gastric cancer after failure of fluoropyrimidine and platinum combination chemotherapy. Cancer Chemother Pharmacol 61, 631–637 (2008). https://doi.org/10.1007/s00280-007-0516-6

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00280-007-0516-6

Keywords

Search

Navigation