In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. 4034-4034
Abstract:
4034 Background: In Europe and the USA, pancreatic ductal adenocarcinoma (PDAC) is the fifth most common cause of cancer-related death. For patients with metastatic disease, palliative cytostatic systemic treatment is the only option. There is no established standard for 2 nd -line treatment. Fluoropyrimidines either alone or in combination with Oxaliplatin or other chemotherapeutic agents are increasingly used. There are interesting data regarding the combination of Gemcitabine with Oxaliplatin or Docetaxel with respect to progression free survival (PFS) and tumor response in 1 st -line. For the first time, the DocOx-trial investigates the combination of Oxaliplatin with Docetaxel as 2 nd -line treatment after progression under palliative first-line systemic treatment with Gemcitabine. Methods: Prospective, single arm, non-randomized, multicenter, Simon´s two stage phase II trial using Docetaxel (75 mg/m 2 , 60 min, d 1) plus Oxaliplatin (80 mg/m 2 , 120 min, d 2, qd 22). Duration of the trial is scheduled up to 8 cycles. Primary endpoint: tumor response (RR) according to RECIST 1.0. Secondary endpoints: PFS, OS, safety/toxicity, QoL/clinical benefit. Results: Here we present the data on response rate (RR), median progression free survival (mPFS) and median overall survival (mOS) as of February 4th, 2013. Data represents the Intention to treat-analysis of the 44 patients included between 2009 and 2012. 5 patients did not obtain any treatment. RR was 16% (7 partial remissions, no complete remission) with a disease control rate (DCR) of 48% after the first two treatment cycles. Median PFS was 7 weeks ( 95%-CI: 6-16 w.) and median OS after start of 2 nd -line therapy was 36 weeks ( 95%-CI: 19-55 w.). Conclusions: In this single-arm 2 nd -line trial for the treatment of PDAC, the combination of Doxcetaxel and Oxaliplatin shows very promising results compared to other 2 nd -line-protocols such as OFF. Some patients seem to benefit particularly as indicated by long periods of treatment in this setting. Even after 8 cycles of treatment with DocOx, partial response was observed in 2 patients and stable disease in another 6 patients corresponding a disease control rate of 18%. Clinical trial information: NCT00690300.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2013.31.15_suppl.4034
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2013
detail.hit.zdb_id:
2005181-5
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