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

作者: Avi I. Einzig , DOnna Neuberg , Scot C. Remick , Daniel D. Karp , Peter J. O’Dwyer

DOI: 10.1007/BF02993858

关键词: VomitingMedicineStomatitisDocetaxelGastroenterologyChemotherapyInternal medicineAdenocarcinomaSurvival rateSurgeryNauseaNeutropenia

摘要: The aim of this study was to evaluate the clinical efficacy and safety docetaxel (Taxotere) in patients with adenocarcinoma upper gastrointestinal tract previously untreated cytotoxic chemotherapy. Docetaxe1100 mg m−2 administered as a 1 hour intravenous (IV) infusion every 3 weeks 41 patients. Patients were premedicated prior each course dexamethasone, diphenhydramine cimetidine. Clinical response toxicity determined. Objective responses seen seven eligible (two complete [CRs] five partial [PRs], for an objective rate 17% (90% confidence interval [CI], 8% 30%). most common grade 4 neutropenia, which occurred 88% patients; 46% required dose reduction following episode neutropenic fever requiring antibiotic therapy. Additional have had reversible 3–4 toxicities including nausea, vomiting, stomatitis, diarrhea, fatigue peripheral neuropathy. Ten 1–3 hypersensitivity reactions. Alopecia has been majority Fluid retention observed Docetaxel on schedule is active agent adenocarcinomas tract. Further investigation drug should be conducted multi-drug combination programs.

参考文章(38)
A. Setanoians, P. Wilson, M. A. Graham, V. Auzannet, G. A. Chadwick, D. J. Kerr, N. Le Bail, S. B. Kaye, D. Bissett, J. Cassidy, Phase I and Pharmacokinetic Study of Taxotere (RP 56976) Administered as a 24-Hour Infusion Cancer Research. ,vol. 53, pp. 523- 527 ,(1993)
P A Francis, J R Rigas, M G Kris, K M Pisters, J P Orazem, K J Woolley, R T Heelan, Phase II trial of docetaxel in patients with stage III and IV non-small-cell lung cancer. Journal of Clinical Oncology. ,vol. 12, pp. 1232- 1237 ,(1994) , 10.1200/JCO.1994.12.6.1232
W.W. ten Bokkel Huinink, A.M. Prove, M. Piccart, W. Steward, T. Tursz, J. Wanders, H. Franklin, M. Clavel, J. Verweij, M. Alakl, M. Bayssas, S.B. Kaye, A phase II trial with docetaxel (Taxotere) in second line treatment with chemotherapy for advanced breast cancer. A study of the EORTC Early Clinical Trials Group. Annals of Oncology. ,vol. 5, pp. 527- 532 ,(1994) , 10.1093/OXFORDJOURNALS.ANNONC.A058907
Frank V Fossella, Jin Soo Lee, Dong M Shin, Maria Calayag, Martin Huber, Roman Perez-Soler, William K Murphy, Scott Lippman, Steven Benner, Bonnie Glisson, None, Phase II study of docetaxel for advanced or metastatic platinum-refractory non-small-cell lung cancer. Journal of Clinical Oncology. ,vol. 13, pp. 645- 651 ,(1995) , 10.1200/JCO.1995.13.3.645
P Preusser, H Wilke, W Achterrath, U Fink, L Lenaz, A Heinicke, J Meyer, H J Meyer, H Buente, Phase II study with the combination etoposide, doxorubicin, and cisplatin in advanced measurable gastric cancer. Journal of Clinical Oncology. ,vol. 7, pp. 1310- 1317 ,(1989) , 10.1200/JCO.1989.7.9.1310
Françoise Guéritte-Voegelein, François Lavelle, Daniel Guénard, Marie-Christine Bissery, Experimental Antitumor Activity of Taxotere (RP 56976, NSC 628503), a Taxol Analogue Cancer Research. ,vol. 51, pp. 4845- 4852 ,(1991)
D Kelsen, O T Atiq, L Saltz, D Niedzwiecki, D Ginn, D Chapman, R Heelan, C Lightdale, V Vinciguerra, M Brennan, FAMTX versus etoposide, doxorubicin, and cisplatin: a random assignment trial in gastric cancer. Journal of Clinical Oncology. ,vol. 10, pp. 541- 548 ,(1992) , 10.1200/JCO.1992.10.4.541
B Chevallier, P Fumoleau, P Kerbrat, V Dieras, H Roche, I Krakowski, N Azli, M Bayssas, M A Lentz, M Van Glabbeke, Docetaxel is a major cytotoxic drug for the treatment of advanced breast cancer: a phase II trial of the Clinical Screening Cooperative Group of the European Organization for Research and Treatment of Cancer. Journal of Clinical Oncology. ,vol. 13, pp. 314- 322 ,(1995) , 10.1200/JCO.1995.13.2.314
S A Cullinan, C G Moertel, H S Wieand, M J O'Connell, M A Poon, J E Krook, J A Mailliard, L K Tschetter, Controlled evaluation of three drug combination regimens versus fluorouracil alone for the therapy of advanced gastric cancer. North Central Cancer Treatment Group. Journal of Clinical Oncology. ,vol. 12, pp. 412- 416 ,(1994) , 10.1200/JCO.1994.12.2.412