Phase II clinical trial of S-1 plus oral leucovorin in previously treated patients with non-small-cell lung cancer

T. Naito, T. Seto, K. Takeda, K. Goto, I. Okamoto, K. Nakagawa, T. Ohba, H. Murakami, T. Takahashi, T. Yamanaka, N. Yamamoto

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Abstract

Background: S-1, a novel oral fluoropyrimidine, has potent antitumor activity against non-small-cell lung cancer (NSCLC). Meanwhile, leucovorin enhances the efficacy of 5-fluorouracil by inhibiting thymidylate synthase. Therefore, this phase II clinical trial evaluated the safety and efficacy of S-1 plus leucovorin combination therapy for previously treated patients with NSCLC. Patients and methods: Patients with stage IIIB or IV NSCLC were prospectively enrolled if they received 1 or 2 prior chemotherapy regimens. S-1 (40-60. mg) and leucovorin (25. mg) were administered together orally twice per day for 7 consecutive days followed by 7 days of rest. This 2-week cycle was repeated for a maximum of 25 cycles until the onset of disease progression or unacceptable adverse events. Endpoints included objective tumor response, progression-free survival, overall survival, and safety. Results: Among 33 patients, 6 (18.2%), 14 (42.4%), and 11 (33.3%) had partial response, stable disease, and progressive disease, respectively. Median progression-free and overall survival times were 3.5 and 11.7 months, respectively. The common grade 3 toxicities included stomatitis (18.2%), anorexia (12.1%), and neutropenia (9.1%). One patient had pneumatosis cystoides intestinalis, and another experienced paralytic ileus. There were no treatment-related deaths. Conclusions: S-1 plus leucovorin combination therapy demonstrated promising efficacy and an acceptable toxicity profile in previously treated patients with NSCLC.

Original languageEnglish
Pages (from-to)339-343
Number of pages5
JournalLung Cancer
Volume86
Issue number3
DOIs
Publication statusPublished - Dec 1 2014

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

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    Naito, T., Seto, T., Takeda, K., Goto, K., Okamoto, I., Nakagawa, K., Ohba, T., Murakami, H., Takahashi, T., Yamanaka, T., & Yamamoto, N. (2014). Phase II clinical trial of S-1 plus oral leucovorin in previously treated patients with non-small-cell lung cancer. Lung Cancer, 86(3), 339-343. https://doi.org/10.1016/j.lungcan.2014.10.010