A Phase II Study of Modified FOLFOX6 for Advanced Gastric Cancer Refractory to Standard Therapies.

Abstract

INTRODUCTION:

In patients with advanced gastric cancer refractory to chemotherapy, the treatment options are limited. Via this phase II study, we aimed to assess the efficacy and safety of oxaliplatin in combination with 5-fluorouracil and l-leucovorin (modified FOLFOX6).

METHODS:

Patients who had histologically confirmed metastatic gastric cancer refractory to ≥ two previous chemotherapy regimens were included. The primary endpoint was the overall response rate (ORR) by an independent central review. According to an assumption of a threshold ORR of 10% and expected ORR of 25%, with α = 0.05 and β = 0.20, at least 33 patients were required. The secondary endpoints included overall survival (OS), progression-free survival (PFS), quality of life measured by EQ-5D, and safety.

RESULTS:

Among the 35 enrolled patients, 33 were included in the primary analysis. All patients previously received fluoropyrimidines, cisplatin, and taxanes, and 24 (73%) were pretreated with irinotecan. The confirmed ORR was 27% [95% confidence interval (CI) 13-46]. The median PFS and OS were 2.2 (95% CI 1.2-3.2) and 5.6 (95% CI 4.1-7.0) months, respectively. In the multivariate analyses, immunotherapy within 90 days and a Glasgow Prognostic Score of 0 were associated with better treatment outcomes. The most common grade ≥ 3 adverse event was neutropenia (36%), and no febrile neutropenia was observed. The median EQ-5D scores did not change from baseline at 2, 4, and 8 weeks (p value = 0.38, 0.79, and 0.98, respectively).

CONCLUSION:

Modified FOLFOX6 (mFOLFOX6) showed substantial activity and acceptable toxicity for chemotherapy-refractory advanced gastric cancer.

TRIAL REGISTRATION:

UMIN Clinical Trial Registry (UMIN000016416).

• Authors: Seiichiro Mitani, Shigenori Kadowaki, Azusa Komori, Chihiro Kondoh, Isao Oze, Kyoko Kato, Toshiki Masuishi, Kazunori Honda, Yukiya Narita, Hiroya Taniguchi, Masashi Ando, Tsutomu Tanaka, Masahiro Tajika, Kei Muro
• Journal: Advances in therapy (Adv Ther) Vol. 37 Issue 6 Pg. 2853-2864 (06 2020) ISSN: 1865-8652 [Electronic] United States
• PMID: 32378071 (Publication Type: Clinical Trial, Phase II, Comparative Study, Journal Article, Randomized Controlled Trial)

Chemical References

• Organoplatinum Compounds
• Oxaliplatin
• Leucovorin
• Fluorouracil

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Female
• Fluorouracil (therapeutic use)
• Humans
• Leucovorin (therapeutic use)
• Male
• Middle Aged
• Organoplatinum Compounds (therapeutic use)
• Oxaliplatin (therapeutic use)
• Progression-Free Survival
• Stomach Neoplasms (drug therapy)
• Treatment Outcome