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

Investigational New Drugs volume 29, pages 1073–1080 (2011)Cite this article

Summary

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/m2 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.

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Acknowledgement

The authors are indebted to Professor J. Patrick Barron of the International Medical Communication Center of Tokyo Medical University for his review of this manuscript. This study was supported by Grant No. 0412-CR01-0704-0001 of the Korea Health 21 R & D Project, Ministry of Health & Welfare, Republic of Korea.

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Affiliations

  1. Yonsei Cancer Center, Yonsei University College of Medicine, 250 Seongsanno, Seodaemun-gu, 120-752, Seoul, Korea

    Sang Joon Shin, Jae Heon Jeong, Jae Kyung Roh & Joong Bae Ahn

  2. Samsung Medical Center, Seoul, Korea

    Young Suk Park

  3. Yeungnam University College of Medicine, Daegu, Korea

    Kyung Hee Lee

  4. St. Vincent’s Hospital, Suwon, Korea

    Byoung Yong Shim

  5. Asan Medical Center, Seoul, Korea

    Tae Won Kim

  6. Seoul National University Hospital, Seoul, Korea

    Do Youn Oh

  7. St. Mary’s Hospital, Seoul, Korea

    Myung Ah Lee

  8. National Health Insurance Corporation Ilsan Hospital, Kyonggi-do, Korea

    Yong Tai Kim

  9. Korea University Anam Hospital, Seoul, Korea

    Yeul Hong Kim

  10. Hallym University College of Medicine, Seoul, Korea

    Dae Young Zang

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  1. Sang Joon Shin
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Shin, S.J., Jeong, J.H., Park, Y.S. et al. Phase II trial of S-1 monotherapy in elderly or frail patients with metastatic colorectal cancer. Invest New Drugs 29, 1073–1080 (2011). https://doi.org/10.1007/s10637-010-9418-2

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  • DOI: https://doi.org/10.1007/s10637-010-9418-2

Keywords

  • S-1
  • Elderly
  • Frail
  • Colorectal cancer