Academic Journal
S-1 in combination with docetaxel and oxaliplatin in patients with advanced gastro-esophageal adenocarcinoma: two parallel phase 1/2a studies.
| Τίτλος: | S-1 in combination with docetaxel and oxaliplatin in patients with advanced gastro-esophageal adenocarcinoma: two parallel phase 1/2a studies. |
|---|---|
| Συγγραφείς: | Pfeiffer P; a Department of Oncology , Odense University Hospital , Odense , Denmark.; b Institute of Clinical Research, University of Southern Denmark , Odense , Denmark., Qvortrup C; a Department of Oncology , Odense University Hospital , Odense , Denmark., Krogh M; a Department of Oncology , Odense University Hospital , Odense , Denmark., Schoennemann K; a Department of Oncology , Odense University Hospital , Odense , Denmark., Vestermark LW; a Department of Oncology , Odense University Hospital , Odense , Denmark., Jensen HA; a Department of Oncology , Odense University Hospital , Odense , Denmark., Bjerregaard JK; a Department of Oncology , Odense University Hospital , Odense , Denmark. |
| Πηγή: | Acta oncologica (Stockholm, Sweden) [Acta Oncol] 2017 Jan; Vol. 56 (1), pp. 46-51. Date of Electronic Publication: 2016 Dec 02. |
| Τύπος έκδοσης: | Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: Medical Journals Sweden AB Country of Publication: Sweden NLM ID: 8709065 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1651-226X (Electronic) Linking ISSN: 0284186X NLM ISO Abbreviation: Acta Oncol Subsets: MEDLINE |
| Imprint Name(s): | Publication: 2024- : [Uppsala, Sweden] : Medical Journals Sweden AB Original Publication: Stockholm, Sweden : Acta Oncologica, [1987- |
| Ιατρικοί όροι (MeSH): | Adenocarcinoma/*drug therapy , Antineoplastic Combined Chemotherapy Protocols/*therapeutic use , Esophageal Neoplasms/*drug therapy , Stomach Neoplasms/*drug therapy, Adenocarcinoma/pathology ; Esophageal Neoplasms/pathology ; Organoplatinum Compounds/administration & dosage ; Oxonic Acid/administration & dosage ; Stomach Neoplasms/pathology ; Taxoids/administration & dosage ; Tegafur/administration & dosage ; Aged ; Docetaxel ; Drug Combinations ; Female ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Neoplasm Staging ; Oxaliplatin ; Prognosis ; Survival Rate |
| Περίληψη: | Background: Docetaxel in combination with cisplatin and 5-fluorouracil (5-FU) is one of several standard chemotherapy regimens for patients with advanced gastro-esophageal adenocarcinoma (aGEA) in Europe. To enable outpatient treatment, we evaluated the maximum tolerated dose (MTD), recommended dose (RD), dose limiting toxicity (DLT) and safety of docetaxel in combination with oxaliplatin (O) and S-1 (DOS) in Caucasian patients with aGEA. Methods: We present final results of two parallel phase 1/2a studies (3 + 3 design). Escalating doses of docetaxel and S-1 with fixed dose O were given for 18 weeks every second week (DOS2w) or every third week (DOS3w) followed by S-1 maintenance therapy. Results: Thirty-four patients (18 in DOS2w and 16 in DOS3w) were enrolled between October 2013 and June 2015. Median age was 65 years (range 49-78). DLT was most often febrile neutropenia. Most common severe non-hematological adverse events were diarrhea (9%) and fatigue (6%). The RD of DOS3w was: docetaxel 50 mg/m2, O 100 mg/m2 and S-1 25 mg/m2 twice daily and of DOS2w was: docetaxel 40 mg/m2, O 70 mg/m2 and S-1 35 mg/m2 twice daily. Overall, response rate was 56%; median progression-free survival was 9.1 months; and median overall survival was 13.2 months in 34 patients. Conclusions: At the RD, DOS2w and DOS3w showed an acceptable safety profile in patients with aGEA. Clinical trials ID: NCT-01928524 and EudraCT 2012-005187-10. |
| Molecular Sequence: | ClinicalTrials.gov NCT01928524 |
| Substance Nomenclature: | 0 (Drug Combinations) 0 (Organoplatinum Compounds) 0 (Taxoids) 04ZR38536J (Oxaliplatin) 150863-82-4 (S 1 (combination)) 1548R74NSZ (Tegafur) 15H5577CQD (Docetaxel) 5VT6420TIG (Oxonic Acid) |
| Entry Date(s): | Date Created: 20161203 Date Completed: 20170117 Latest Revision: 20181202 |
| Update Code: | 20260130 |
| DOI: | 10.1080/0284186X.2016.1257865 |
| PMID: | 27911128 |
| Βάση Δεδομένων: | MEDLINE |
| ISSN: | 1651-226X |
|---|---|
| DOI: | 10.1080/0284186X.2016.1257865 |