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Impact of treatment duration of neoadjuvant FIRINOX in patients with borderline resectable pancreatic cancer: a pilot trial

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Abstract

Purpose

The aim of this pilot study is to confirm the safety and efficacy of neoadjuvant therapy and also treatment duration efficacy using modified FOLFIRINOX for patients with borderline resectable pancreatic cancer (BRPC).

Methods

The study is a prospective multicenter pilot trial conducted on patients with BRPC. Intervention for clinical trials: Modified FOLFIRINOX (without bolus 5-FU and LV, also decreased the dose of irinotecan; FIRINOX) was given to the first five patients in the 4-cycle group of the regimen and next five patients in the 8-cycle group. The primary end point was the toxicity of the therapy and one of the secondary end points were the optimal duration.

Results

The overall rate of grade 3 and 4 events was 80 %: 3 patients (60 %) in the four-cycle group and five patients (100 %) in the eight-cycle group had grade 3 or 4 adverse events. There was no incidence of serious adverse effect such as febrile neutropenia, sepsis, liver abscess or uncontrollable diarrhea. There was no clinically relevant morbidity presented in patients who underwent surgery. R0 rates by intention to treat were 60.0 % in the four-cycle group and 40 % in the eight-cycle group (P = 0.999). The histopathologic treatment effect based on the Evans grade revealed grade I (n = 1), IIa (n = 3) in the four-cycle group and grade I (n = 2), IIa (n = 1) in the eight-cycle group.

Conclusions

FIRINOX therapy was feasible and safe for strictly selected patients with BRPC. Four cycles of FIRINOX would be sufficient for patients with BRPC as neoadjuvant therapy.

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Acknowledgments

Hiroki Yamaue, MD, and Tatsuya Ioka, MD, participated in the design of the study, and Ken-ichi Okada, MD, performed statistical analysis and drafted the manuscript. Manabu Kawai, MD, and Sohei Satoi, MD, participated in its design and coordination. Manabu Kawai, MD, Tatsuya Ioka, MD, and Sohei Satoi, MD, helped to draft the manuscript. Hiroki Yamaue helped to draft the manuscript. Hiroki Yamaue, MD, helped in the revision of the article. Seiko Hirono, MD, performed the surgery. Motoki Miyazawa, MD, performed the surgery. Hiroaki Yanagimoto, MD, and Atsushi Shimizu, MD, performed data collection. Yuji Kitahata, MD, performed the surgery. Hiroki Yamaue, MD, helped in the revision of the article and gave approval for the final write up. All authors read and approved the final manuscript. We would like to thank Shenli Hew from the Department of Clinical Research Center, Wakayama Medical University, for proofreading and editing the manuscript. The study was carried out in accordance with the Declaration of Helsinki. The protocol was approved by the ethics committees of all participating institutions, and informed consent was obtained.

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Authors and Affiliations

  1. Second Department of Surgery, Wakayama Medical University, Wakayama, 641-8510, Japan

    Ken-ichi Okada, Manabu Kawai, Seiko Hirono, Motoki Miyazawa, Atsushi Shimizu, Yuji Kitahata & Hiroki Yamaue

  2. Department of Surgery, Kansai Medical University, Hirakata, Japan

    Sohei Satoi & Hiroaki Yanagimoto

  3. Department of Hepatobiliary and Pancreatic Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan

    Tatsuya Ioka

Authors
  1. Ken-ichi Okada
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  2. Manabu Kawai
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  3. Seiko Hirono
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  6. Tatsuya Ioka
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  7. Motoki Miyazawa
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  8. Atsushi Shimizu
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  9. Yuji Kitahata
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  10. Hiroki Yamaue
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Correspondence to Hiroki Yamaue.

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All other authors declare that they have no conflict of interest.

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Okada, Ki., Kawai, M., Hirono, S. et al. Impact of treatment duration of neoadjuvant FIRINOX in patients with borderline resectable pancreatic cancer: a pilot trial. Cancer Chemother Pharmacol 78, 719–726 (2016). https://doi.org/10.1007/s00280-016-3121-8

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  • DOI: https://doi.org/10.1007/s00280-016-3121-8

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