Cancer Res Treat.  2021 Jan;53(1):87-92. 10.4143/crt.2020.741.

Phase II Study of Pemetrexed as a Salvage Chemotherapy for Thymidylate Synthase–Low Squamous Cell Lung Cancer

Affiliations
  • 1Department of Internal Medicine, The Catholic University of Korea Incheon St. Mary’s Hospital, Incheon, Korea
  • 2Division of Hematology and Oncology, Department of Internal Medicine, National Cancer Center, Goyang, Korea
  • 3Center for Lung Cancer, National Cancer Center, Goyang, Korea
  • 4Department of Pathology, National Cancer Center, Goyang, Korea
  • 5Department of Radiology, National Cancer Center, Goyang, Korea
  • 6Office of Biostatistics Research, National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, USA

Abstract

Purpose
Squamous cell carcinomas (SqCC) of the lung often express high levels of thymidylate synthase (TS), which is associated with primary resistance to pemetrexed. We explored the efficacy of pemetrexed in a selected population of patients with lung SqCC with low TS expression.
Materials and Methods
In this single-arm phase II trial, we enrolled 32 previously-treated patients with advanced lung SqCC exhibiting low immunohistochemical staining for TS (i.e., in 10% or less of tumor cells). The primary endpoint was 12-week progression-free survival (PFS) rate.
Results
Of 32 patients, eight patients (25%) had an Eastern Cooperative Oncology Group performance status of 2, and seven patients (22%) had previously received three or more lines of chemotherapy. The disease control rate from pemetrexed treatment was 30%, and no objective response was observed. The 12-week PFS rate was 24.5% (95% confidence interval [CI], 13.0 to 46.1). Median PFS was 1.3 months (95% CI, 1.3 to 2.7), and median overall survival was 11.8 months (95% CI, 8.1 to not applicable). Most of adverse events were grade 1 or 2.
Conclusion
Pemetrexed demonstrated modest activity as a salvage chemotherapy in patients with advanced lung SqCC with low TS expression, although its toxicity was generally manageable.

Keyword

Pemetrexed; Thymidylate synthase; Squamous cell lung cancer

Figure

  • Fig. 1 Selection of study population.


Reference

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