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Docetaxel, cisplatin, and fluorouracil combination in neoadjuvant setting in the treatment of locally advanced gastric adenocarcinoma: Phase II NEOTAX study

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An Erratum to this article was published on 12 June 2015

Abstract

Purpose

This phase II trial aimed to evaluate the efficacy and safety of docetaxel, cisplatin, and fluorouracil (DCF) combination in neoadjuvant setting in patients with locally advanced gastric adenocarcinoma.

Methods

Fifty-nine patients with resectable or unresectable locally advanced gastric and gastroesophageal cancer were recruited in this multicenter, single-arm, open-label, local clinical phase II study conducted at three centers from Turkey between June 2006 and March 2012. Patients had T3–4 or lymph node-positive disease. After staging with imaging and laparotomy or laparoscopy, they received three cycles of DCF with lenograstim. Imaging studies were repeated after the last two cycles. Patients who underwent surgery were followed up for at least 1 year after the surgery. Toxicity and response were evaluated in accordance with NCI-CTC version3.0 and RECIST 1.0.

Results

At baseline, 66.1 % of patients were considered resectable. In 47 patients evaluable, partial response in 16 (34.0 %), stable disease in 27 (57.5 %), and progressive disease in four (8.5 %) were observed. Forty-six patients underwent surgery. In 38 (64.4 %; 95 % confidence interval (CI) 52.2–76.6 %) out of 59 patients, complete resection (R0) was achieved. Median overall and disease-free survival were 19.1 months (95 % CI 13.5–24.7) and 11.6 months (95 % CI 5.9–17.4), respectively. The most frequent grade 3–4 adverse events were neutropenia (52.5 %), febrile neutropenia (11.9 %), leukopenia (39.0 %), and diarrhea (10.5 %). One patient died from an unknown cause.

Conclusions

Classical DCF triplet with lenograstim showed a good clinical response with acceptable safety profile in the treatment of locally advanced gastric and gastroesophageal cancer with a significant R0 rate and manageable toxicity.

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Acknowledgments

Authors would like to thank to Dr. Semra Yoruk from Sanofi Turkey for her valuable contributions by reviewing the manuscript. Prof. Sule Oktay, MD, PhD and Cagla Ayhan, MD from KAPPA Consultancy Training Research Ltd (Istanbul, Turkey) provided technical support in the manuscript preparation, and Oguz Akbas, MD, Ph.D. and Arzu Calisgan from Monitor Medical Research and Consulting (Istanbul, Turkey) conducted the statistical analyses. Monitor Contract Research Organization (Istanbul, Turkey) was responsible for the conduct of the study operations. This work was fully supported by Sanofi Turkey [DOCET-L-00072].

Conflict of interest

None.

Author information

Authors and Affiliations

  1. Department of Medical Oncology, Ankara Numune Training and Research Hospital, Ankara, Turkey

    Nuriye Ozdemir, Burak Civelek & Nurullah Zengin

  2. Department of Medical Oncology, Adana Teaching and Research Center, Adana Hospital, Kisla Medical Campus, Baskent University Faculty of Medicine, Kazim Karabekir M. 4227 Sk No: 27, 01120, Yuregir, Adana, Turkey

    Huseyin Abali

  3. Department of Radiology, Ankara Numune Training and Research Hospital, Ankara, Turkey

    Murat Vural

  4. Department of Medical Oncology, Hacettepe University Faculty of Medicine, Ankara, Turkey

    Suayib Yalcin

  5. Department of Medical Oncology, Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital, Ankara, Turkey

    Berna Oksuzoglu

  6. Department of Gastroenterology, Turkiye Yuksek Ihtisas Training and Research Hospital, Ankara, Turkey

    Dilek Oguz

  7. Department of Gastroenterological Surgery, Turkiye Yuksek Ihtisas Training and Research Hospital, Ankara, Turkey

    Birol Bostanci

  8. Department of Medical Oncology, Ankara University Faculty of Medicine, Ankara, Turkey

    Bulent Yalcin

Authors
  1. Nuriye Ozdemir
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  2. Huseyin Abali
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Corresponding author

Correspondence to Huseyin Abali.

Electronic supplementary material

Below is the link to the electronic supplementary material.

Supplementary Figure 1

Overall survival curves according to age groups based on the median age of 59 years in ITT-population (n = 59) (TIFF 137 kb)

Supplementary Figure 2

Overall survival curves according to operation status in ITT-population (n = 59) (TIFF 133 kb)

Supplementary Figure 3

Overall survival in patients with R0 resection in comparison with all other remaining patients (TIFF 119 kb)

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Ozdemir, N., Abali, H., Vural, M. et al. Docetaxel, cisplatin, and fluorouracil combination in neoadjuvant setting in the treatment of locally advanced gastric adenocarcinoma: Phase II NEOTAX study. Cancer Chemother Pharmacol 74, 1139–1147 (2014). https://doi.org/10.1007/s00280-014-2586-6

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  • DOI: https://doi.org/10.1007/s00280-014-2586-6

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