In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 35, No. 15_suppl ( 2017-05-20), p. 4070-4070
Abstract:
4070 Background: Docetaxel has shown antitumor activity in the treatment of MGC as a single or combination chemotherapy. This study was designed to compare the clinical outcome of docetaxel based and platinum based doublet regimen as first-line treatment in MGC patients. Methods: In an open, randomized, single center phase II trial, 134 pts were randomly assigned and treated with either TX (capecitabine 1g/m2/twice daily/ 1-14 days and docetaxel 75mg/m2 in 1st day) or XELOX (capecitabine 1g/m2/twice daily/ 1-14 days and oxaliplatin 130 mg/m2 in 1st day) as first-line chemotherapy. The primary endpoint is finding potential predictive factors, secondary endpoint is ORR, PFS, OS and safety. After progression, patients were switched into the other group. Results: Now, the potential predictive factors are testing in genomics and proteomics. In 134 randomly assigned and treated pts (TX = 69; XELOX = 65). Most pts were male (87pts).Overall survival was longer with TX versus XELOX (13.1m vs. 9.6m, p = 0.173), but no statistical differences. Progression free survival was similar with TX versus XELOX (4.57m vs. 5.27m, p = 0.297). Overall response rate was equal with TX versus XELOX (50.8% vs. 47.6%, p = 0.72). G3-4 treatment-related AE occurred in 60.6% (TX) v 55.4% (XELOX) of patients. Frequent G3-4 toxicities for TX v XELOX were: neutropenia (60.6% v 15.4%), febrile granulocyte deficiency (17.4% v 1.5%), anemia (10.1% v 10.8%), thrombocytopenia (1.4% v 15.4%), and all grade peripheral neurotoxicity (11.6% v 38.5%).After first-line treatment failure, 35 patients in the TX group switched to XELOX, and 27 patients in the XELOX group switched to TX, and there is also no significant difference in survival time from the first-line treatment between the two groups (p = 0.129). Conclusions: Although TX led to more neutropenia, first-line palliative chemotherapy with docetaxel based doublet regimens provides a new choice and can gain almost the same response rate and survival time as frequently-used fluorouracil and platinum based regimen. And potential predictive factors will indicate who will get more benefit from taxanes or platinums. Clinical trial information: NCT01963702.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/JCO.2017.35.15_suppl.4070
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2017
detail.hit.zdb_id:
2005181-5