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The influence of prior ramucirumab treatment on the clinical activity of FOLFIRI as third-line therapy in patients with metastatic gastric Cancer

  • Giandomenico RovielloEmail author
  • Roberto Petrioli
  • Pietro Rosellini
  • Andrea Giovanni Multari
  • Raffaele Conca
  • Giovanni Paganini
  • Giorgio Chiriacò
  • Michele Aieta
PHASE II STUDIES
  • 31 Downloads

Summary

Purpose Few data described the activity of chemotherapy after ramucirumab plus paclitaxel progression in metastatic gastric cancer patients. The aim of this phase II study is to assess the efficacy and safety of the FOLFIRI regimen as a third-line of treatment. Methods The study enrolled patients with histologically proven metastatic gastric cancer or gastroesophageal junction carcinoma whose disease had progressed after ramucirumab-based second line of treatment. Treatment consisted of biweekly irinotecan 150 mg/m2 as a 1-h infusion on day 1, folinic acid 100 mg/m2 intravenously on days 1–2, and 5-fluorouracil as a 400 mg/m2 bolus and then 600 mg/m2 continuous infusion over 22 h on days 1–2. Primary end-point was tumor response rate (confirmed complete and partial response). Results Twenty-six patients were enrolled. Overall response rate and disease control rate were 11.5% and 38.5%. The median progression free survival (PFS) was 52 days (95% CI:42–74), and the median overall survival was 117 days (95% CI: 94–154). no unexpected adverse events have been observed. A longer PFS and OS were observed in patients who had achieved PFS ≥ 3 months during prior ramucirumab treatment. Conclusions Our findings suggest a poor efficacy of the FOLFIRI regimen in metastatic gastric or gastroesophageal junction cancer patients whose disease progressed during a ramucirumab-based second line of treatment. However, FOLFIRI could be an option for patients who responded to prior ramucirumab.

Keywords

Gastric cancer Irinotecan Ramucirumab Third line 

Notes

Compliance with ethical standards

Conflict of interest

Roviello G declares that he has no conflict of interest. Petrioli R declares that he has no conflict of interest. Multari AG declares that he has no conflict of interest. Conca R declares that he has no conflict of interest. Paganini G declares that he has no conflict of interest. Chiariacò G declares that he has no conflict of interest. Aieta M declares that he has no conflict of interest.

Ethical approval

Ethical approval: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Division of Medical Oncology, Department of Onco-Hematology, IRCCS-CROB, Referral Cancer Center of BasilicataRioneroItaly
  2. 2.Medical Oncology Unit, Department of Medicine, Surgery and NeurosciencesUniversity of SienaSienaItaly
  3. 3.Unit of Medical Oncology, Department of OncologyOspedale San DonatoArezzoItaly
  4. 4.Unit of General Medicine, Azienda Ospedaliera ″C. Poma ″ Presidio ospedaliero di Pieve di Coriano, ASST MantovaMantovaItaly
  5. 5.Medical Oncology Unit, Department of Oncology, ASST del GardaDesenzano del GardaItaly

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