Phase II trial of S-1 monotherapy in elderly or frail patients with metastatic colorectal cancer

Sang Joon Shin, Jae Heon Jeong, Young Suk Park, Kyung Hee Lee, Byoung Yong Shim, Tae Won Kim, Do Youn Oh, Myung Ah Lee, Yong Tai Kim, Yeul Hong Kim, Dae Young Zang, Jae Kyung Roh, Joong Bae Ahn

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8 Citations (Scopus)

Abstract

A phase II study was conducted to evaluate S-1 monotherapy in previously untreated elderly or frail metastatic colorectal cancer patients. A total of 48 elderly (70-85 years old) and frail [Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 and 65-69 years old] patients were eligible for first-line S-1 of 35 mg/m 2 given twice daily for 2 weeks followed by 1 week of rest. The overall response rate (ORR) for all patients was 19%. Similarly, the ORR for frail and elderly patients was 22% and 18%, respectively. Median progression-free survival (PFS) and overall survival (OS) for all patients were 3.9 months (95% CI, 3.0-4.8) and 11.3 months (95% CI, 7.4-15.2), respectively. For frail patients, PFS was 1.4 (95% CI, 0.8-2.0) vs. 4.3 months (95% CI, 3.0-5.4) for the elderly (P=0.016). OS was significantly longer for elderly patients than for frail patients (13.1 months, 95% CI, 9.5-16.7) vs. (4.1 months, 95% CI, 3.2-5.0; P=0.01). Toxicity was mild to moderate, as only 29% of patients experienced grade 3 toxicity. Grade 4 toxicity and febrile neutropenia did not occur; however, two frail patients died from grade 5 treatment-related infections. Generally, S-1 monotherapy was well-tolerated and efficacious in the elderly patient group, but not in the frail patient group. Considering performance status and co-morbidities in patients >70 years old, S-1 monotherapy may be a first-line therapeutic option for elderly mCRC patients.

Original languageEnglish
Pages (from-to)1073-1080
Number of pages8
JournalInvestigational New Drugs
Volume29
Issue number5
DOIs
Publication statusPublished - 2011 Oct

Keywords

  • Colorectal cancer
  • Elderly
  • Frail
  • S-1

ASJC Scopus subject areas

  • Oncology
  • Pharmacology
  • Pharmacology (medical)

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    Shin, S. J., Jeong, J. H., Park, Y. S., Lee, K. H., Shim, B. Y., Kim, T. W., Oh, D. Y., Lee, M. A., Kim, Y. T., Kim, Y. H., Zang, D. Y., Roh, J. K., & Ahn, J. B. (2011). Phase II trial of S-1 monotherapy in elderly or frail patients with metastatic colorectal cancer. Investigational New Drugs, 29(5), 1073-1080. https://doi.org/10.1007/s10637-010-9418-2