Abstract
In advanced gastric cancer, we investigated feasibility and activity of sequential chemotherapy with docetaxel after an intensive weekly regimen consisting of cisplatin, epidoxorubicin, fluorouracil, leucovorin (PELF) plus filgrastim. Chemotherapy-naive patients with relapsed or metastatic gastric cancer received 8 weekly administrations of chemotherapy with cisplatin 40 mg/m2, fluorouracil 500 mg/m2,epi-doxorubicin 35 mg/m2, 6S-steroisomer of leucovorin 250 mg/m2and glutathione 1.5 g/m2. On the other days filgrastim 5 μg kg–1was administered by subcutanous injection. Subsequently, patients with partial response or stable disease received 3 cycles of docetaxel 100 mg/m2every 3 weeks. 40 patients have been enrolled and they are evaluable for response and toxicity. After the PELF regimen, 3 patients achieved complete response, 13 patients showed partial response, 21 patients had stable disease and 3 patients progressed (40% response rate; 95% CI 25% to 55%). After docetaxel, 9 out 34 patients improved the outcome (26.5%); 7 patients with stable disease achieved partial response and 2 patients with partial response achieved complete response. The overall response rate in the 40 patients was 57.5% (95% CI, 42.5% to 72.5%). The PELF regimen did not cause any grade IV toxicity, the most frequent grade III acute side-effects were thrombocytopenia and vomiting which occurred in the 10% of 320 PELF cycles. Docetaxel caused grade III–IV neutropenia and thrombocytopenia in the 10% and the 19% of cycles respectively. Fatigue was a frequent side-effect during both PELF and docetaxel chemotherapy. The sequential application of docetaxel after PELF chemotherapy gained major objective responses with manageable toxicity. This strategy is worth of further investigation in the setting of palliative or neoadjuvant chemotherapy. © 2001 Cancer Research Campaign
Similar content being viewed by others
Article PDF
Change history
16 November 2011
This paper was modified 12 months after initial publication to switch to Creative Commons licence terms, as noted at publication
References
Ajani JA, Fodor M, Van Cutsem E, Tjulandin S, Moiseyenko V, Cabral F, Majilis A, Chao Y, Zuber A, Blattmann C, Garay C and Jacques C (2000) Multinational randomized phase II trial of docetaxel and cisplatin with or without 5-fluorouracil in patients with advanced gastric cancer or GE junction adenocarcinoma. Proc Am Soc Clin Oncol 19: 247
Andrè T, Louvet C, Ychou M, Gamelin E, Mousseau E, Carola S, Assadourian S and De Gramont A (1999) Docetaxel-epirubicin as second-line treatment for patients with advanced gastric cancer. Proc Am Soc Clin Oncol 18: 277
Antoine EC, Chollet P, Monfardini S, Sorio R, Ambrosini G, Benhammouda A, Mazen MF, Ramazeilles C, Azli N and Khayat D (1998) Sequential administration of docetaxel followed by AC in first-line metastatic breast cancer patients: final results. Ann Oncol 9(4): 19
Cascinu S, Labianca R, Alessandroni P, Marcellini M, Silva RR, Pancera G, Testa E, Martignoni G, Barni S, Frontini L, Zaniboni A, Luporini G, Cellerino R and Catalano G (1997) Intensive weekly chemotherapy for advanced gastric cancer using fluorouracil, cisplatin, epidoxorubicin, 6S-leucovorin, gluthatione and filgrastim: a report of the Italian Group for the Study of the Digestive Tract Cancer. J Clin Oncol 15: 3313–3319
Cascinu S, Labianca R, Graziano F, Pancera G, Barni S, Frontini L, Luporini G, Cellerino R and Catalano G (1998) Intensive weekly chemotherapy for locally advanced gastric cancer using 5-fluorouracil, cisplatin, epidoxorubicin, 6S-leucovorin, gluthatione and filgrastim: a report from the Italian Group for the Study of Digestive Tract Cancer (GISCAD). Br J Cancer 78: 390–393
Cortes JE and Pazdur R (1995) Docetaxel. J Clin Oncol 13: 2643–2655
Day RS (1986) Treatment sequencing, asymmetry and uncertainty: protocol strategies for combination chemotherapy. Cancer Res 46: 3876–3885
Findlay M, Cunningham D, Norman A, Mansi J, Nicolson M, Hickish T, Nicolson V, Nash A, Sacks N and Ford H (1994) A phase II study in advanced gastro-esophageal cancer using epirubicin and cisplatin in combination with continuous infusion 5-fluorouracil (ECF). Ann Oncol 5: 609–616
Fizazi K and Zelek L (2000) Is one cycle every three or four weeks obsolete? A critical review of dose-dense chemotherapy in solid neoplasms. Ann Oncol 11: 133–149
Furue H and Taguchi T (1998) A late phase II study of RP56976 (docetaxel) in patients with advanced or recurrent gastric cancer. Ann Oncol 9(supp.4): 49
Hill ME and Cunningham D (1998) Medical management of advanced gastric cancer. Cancer Treat Rev 24: 113–118
Kelsen DP (1996) Adjuvant and neoadjuvant therapy for gastric cancer. Semin Oncol 23: 379–389
Mavroudis D, Kakolyris S, Kouroussis CH, Androulakis N, Agelaki S, Kalbakis K, Sarra E, Vardakis N, Souglakos J, Hatzidaki D, Malliotakis P, Samonis G and Geogoulias G (1999) First line treatment of advanced gastric cancer with docetaxel monotherapy and granulocyte colony-stimulating factor (G-CSF). Proc Am Soc Clin Oncol 18: 254
Melcher AA, Mort D and Maughan TS (1996) Epirubicin, cisplatin and continuous infusion 5-fluorouracil (ECF) as neoadjuvant chemotherapy in gastro-oesophageal cancer. Br J Cancer 74: 1651–1654
Miller AB, Hoogstraten B Staquet M and Winkler V Reporting results of cancer treatment (1981). Cancer 47: 207–214
Pronk LC, Stoter G and Verweij J (1995) Docetaxel (Taxotere): single agent activity, development of combination treatment and reducing side-effects. Cancer Treat Rev 21: 463–478
Reichle A, Jauch K, Hofstaedter F, Bataille F, Erdmann A, Kreuser E and Andreesen R (2000) Preoperative chemotherapy and consecutive gastrectomy in chemosensitive gastric cancer. Testing a new strategy. Proc Am Soc Clin Oncol 19: 298
Roth AD, Maibach R, Martinelli G, Fazio N, Aapro MS, Pagani O, Morant R, Borner MM, Herrmann R, Honegger H, Cavalli F, Alberto P, Castiglione M and Goldhirsch A (2000) Docetaxel (Taxotere)-cisplatin (TC): an effective drug combination in gastric carcinoma. Ann Oncol 11: 301–306
Simon R (1989) Optimal two-stage designs for phase II clinical trials. Controlled Clin Trials 10: 1–10
Sulkes A, Smyth J, Sessa C, Dirix LY, Vermorken JB, Kaye S, Wanders J, Franklin H, LeBail N and Verweij J (1994) Docetaxel (Taxotere) in advanced gastric cancer: results of a phase II clinical trial. Br J Cancer 70: 380–383
Vanhoefer U, Wilke H, Harstrick A, Achterrath W, Preusser P, Sthal M, Clemens MR, Thiel E, Flasshove M, Fink U, Trenn G and Seeber S (1999) Phase II study of docetaxel as second line chemotherapy in metastatic gastric cancer. Proc Am Soc Clin Oncol 18: 303
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 and 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
Author information
Authors and Affiliations
Rights and permissions
From twelve months after its original publication, this work is licensed under the Creative Commons Attribution-NonCommercial-Share Alike 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-sa/3.0/
About this article
Cite this article
Cascinu, S., Graziano, F., Barni, S. et al. A phase II study of sequential chemotherapy with docetaxel after the weekly PELF regimen in advanced gastric cancer. A report from the Italian group for the study of digestive tract cancer. Br J Cancer 84, 470–474 (2001). https://doi.org/10.1054/bjoc.2000.1631
Received:
Revised:
Accepted:
Published:
Issue date:
DOI: https://doi.org/10.1054/bjoc.2000.1631
Keywords
This article is cited by
-
Assessment of Ramucirumab plus paclitaxel as switch maintenance versus continuation of first-line chemotherapy in patients with advanced HER-2 negative gastric or gastroesophageal junction cancers: the ARMANI phase III trial
BMC Cancer (2019)
-
Sequential treatment with epirubicin, oxaliplatin and 5FU (EOF) followed by docetaxel, oxaliplatin and 5FU (DOF) in patients with advanced gastric or gastroesophageal cancer: a single-institution experience
Cancer Chemotherapy and Pharmacology (2015)
-
Impact of neoadjuvant chemotherapy with PELF-protocoll versus surgery alone in the treatment of advanced gastric carcinoma
BMC Surgery (2014)
-
Comparison of efficacy of different route of administration of chemotherapy on unresectable, advanced gastric cancer
World Journal of Surgical Oncology (2012)
-
Sequential chemotherapy with cisplatin, leucovorin, and 5-fluorouracil followed by docetaxel in previously untreated patients with metastatic gastric cancer: a phase II study
Gastric Cancer (2012)
