Skip to main content
Top
Published in: Cancer Chemotherapy and Pharmacology 6/2014

01-12-2014 | Short Communication

Safety and pharmacokinetics of S-1 in a recurrent colon cancer patient with chronic myeloid leukemia treated with dasatinib: a case report

Authors: Toshinori Sueda, Toshihiro Kudo, Daisuke Sakai, Mamoru Uemura, Junichi Nishimura, Taishi Hata, Ichiro Takemasa, Tsunekazu Mizushima, Hirofumi Yamamoto, Sachiko Ezoe, Kana Matsumoto, Yuichiro Doki, Masaki Mori, Taroh Satoh

Published in: Cancer Chemotherapy and Pharmacology | Issue 6/2014

Login to get access

Abstract

Purpose

The safety of S-1 in recurrent colorectal cancer patients with chronic myeloid leukemia (CML) treated with dasatinib has not been established. We evaluated the safety and pharmacokinetics of S-1 in a recurrent colon cancer patient with CML treated with dasatinib.

Patient

A 70-year-old man had undergone surgery three times for sigmoid colon cancer and recurrence. Systemic chemotherapy with S-1 plus oxaliplatin plus bevacizumab as a clinical trial had already been administered because of metastatic colon cancer. The patient’s medical history was CML, and he had been receiving dasatinib treatment (100 mg once daily). Based on the diagnosis of unresectable and multiple metastases, S-1 monotherapy was started. S-1 (120 mg/day) was taken for 28 consecutive days, followed by a 14-day rest. Blood samples were obtained before and after the first administration of S-1. The plasma pharmacokinetics of S-1 were comparable to a pharmacokinetics study of S-1.

Results

The area under the plasma concentration–time curve (AUC0–8) of tegafur (FT), 5-chloro-2, 4-dihydroxypyridine (CDHP), oxonate (Oxo), and 5-fluorouracil (5-FU) was 4,309.2, 716.3, 86.8, and 492.75 ng h/mL, respectively, after S-1 administration. The pharmacokinetics of FT, CDHP, Oxo, and 5-FU after treatment with S-1 were not significantly different from a phase I pharmacokinetics study of S-1. During treatment with S-1 and dasatinib, CML relapse and serious myelosuppression were not observed.

Conclusions

Our report suggests that S-1 is an important treatment option for recurrent colorectal cancer in patients with CML treated with dasatinib.
Literature
2.
go back to reference Edwards BK, Ward E, Kohler BA et al (2010) Report to the nation on the status of cancer, 1975–2006, featuring colorectal cancer trends and impact of interventions (risk factors, screening, and treatment) to reduce future rates. Cancer 116:544–573PubMedCentralPubMedCrossRef Edwards BK, Ward E, Kohler BA et al (2010) Report to the nation on the status of cancer, 1975–2006, featuring colorectal cancer trends and impact of interventions (risk factors, screening, and treatment) to reduce future rates. Cancer 116:544–573PubMedCentralPubMedCrossRef
3.
go back to reference Goldberg RM, Sargent DJ, Morton RF et al (2004) A randomized controlled trial of fl uorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer. J Clin Oncol 22:23–30PubMedCrossRef Goldberg RM, Sargent DJ, Morton RF et al (2004) A randomized controlled trial of fl uorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer. J Clin Oncol 22:23–30PubMedCrossRef
4.
go back to reference Tournigand C, Andre T, Achille E et al (2004) FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J Clin Oncol 22:229–237PubMedCrossRef Tournigand C, Andre T, Achille E et al (2004) FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J Clin Oncol 22:229–237PubMedCrossRef
5.
go back to reference Shirasaka T (2009) Development history and concept of an oral anticancer agent S-1 (TS-1): its clinical usefulness and future vistas. Jpn J Clin Oncol 39:2–15PubMedCentralPubMedCrossRef Shirasaka T (2009) Development history and concept of an oral anticancer agent S-1 (TS-1): its clinical usefulness and future vistas. Jpn J Clin Oncol 39:2–15PubMedCentralPubMedCrossRef
6.
go back to reference Muro K, Boku N, Shimada Y et al (2010) Irinotecan plus S-1 (IRIS) versus fluorouracil and folinic acid plus irinotecan (FOLFIRI) as second-line chemotherapy for metastatic colorectal cancer: a randomised phase 2/3 non-inferiority study (FIRIS study). Lancet Oncol 11:853–860PubMedCrossRef Muro K, Boku N, Shimada Y et al (2010) Irinotecan plus S-1 (IRIS) versus fluorouracil and folinic acid plus irinotecan (FOLFIRI) as second-line chemotherapy for metastatic colorectal cancer: a randomised phase 2/3 non-inferiority study (FIRIS study). Lancet Oncol 11:853–860PubMedCrossRef
7.
go back to reference Yamada Y, Takahari D, Matsumoto H et al (2013) Leucovorin, fluorouracil, and oxaliplatin plus bevacizumab versus S-1 and oxaliplatin plus bevacizumab in patients with metastatic colorectal cancer (SOFT): an open-label, non-inferiority, randomised phase 3 trial. Lancet Oncol 14:1278–1286PubMedCrossRef Yamada Y, Takahari D, Matsumoto H et al (2013) Leucovorin, fluorouracil, and oxaliplatin plus bevacizumab versus S-1 and oxaliplatin plus bevacizumab in patients with metastatic colorectal cancer (SOFT): an open-label, non-inferiority, randomised phase 3 trial. Lancet Oncol 14:1278–1286PubMedCrossRef
8.
go back to reference Yamada Y, Tahara M, Miya T et al (2008) Phase I/II study of oxaliplatin with oral S-1 as first-line therapy for patients with metastatic colorectal cancer. Br J Cancer 98:1034–1038PubMedCentralPubMedCrossRef Yamada Y, Tahara M, Miya T et al (2008) Phase I/II study of oxaliplatin with oral S-1 as first-line therapy for patients with metastatic colorectal cancer. Br J Cancer 98:1034–1038PubMedCentralPubMedCrossRef
9.
go back to reference Schmoll HJ, Van Cutsem E, Stein A et al (2012) ESMO Consensus guidelines for management of patients with colon and rectal cancer. A personalized approach to clinical decision making. Ann Oncol 23:2479–2516PubMedCrossRef Schmoll HJ, Van Cutsem E, Stein A et al (2012) ESMO Consensus guidelines for management of patients with colon and rectal cancer. A personalized approach to clinical decision making. Ann Oncol 23:2479–2516PubMedCrossRef
10.
go back to reference Benson AB, Venook AP, Bekaii-Saab T et al (2014) Colon cancer, version 3.2014: featured updates to the NCCN guidelines. J Natl Compr Canc Netw 12(7):1028–1059 Benson AB, Venook AP, Bekaii-Saab T et al (2014) Colon cancer, version 3.2014: featured updates to the NCCN guidelines. J Natl Compr Canc Netw 12(7):1028–1059
11.
go back to reference Hirata K, Horikoshi N, Aiba K et al (1999) Pharmacokinetic study of S-1, a novel oral fluorouracil antitumor drug. Clin Cancer Res 5:2000–2005PubMed Hirata K, Horikoshi N, Aiba K et al (1999) Pharmacokinetic study of S-1, a novel oral fluorouracil antitumor drug. Clin Cancer Res 5:2000–2005PubMed
12.
go back to reference Van Groeningen CJ, Pinedo HM, Heddrs J et al (1988) Pharmaco-kinetics of 5-fluorouracil assessed with a sensitive mass spectrometric method in patients on a dose escalation schedule. Cancer Res 48:6956–6961PubMed Van Groeningen CJ, Pinedo HM, Heddrs J et al (1988) Pharmaco-kinetics of 5-fluorouracil assessed with a sensitive mass spectrometric method in patients on a dose escalation schedule. Cancer Res 48:6956–6961PubMed
13.
go back to reference Rousselot P, Boucher S, Etienne G et al (2010) Pharmacokinetics of dasatinib as a first line therapy in newly diagnosed CML patients (OPTIM dasatinib trial): correlation with safety and response. Blood 116(21):3432 Rousselot P, Boucher S, Etienne G et al (2010) Pharmacokinetics of dasatinib as a first line therapy in newly diagnosed CML patients (OPTIM dasatinib trial): correlation with safety and response. Blood 116(21):3432
14.
go back to reference Takahashi S, Miyazaki M, Okamoto I et al (2011) Phase I study of dasatinib (BMS- 354825) in Japanese patients with solid tumors. Cancer Sci 102:205–2064 Takahashi S, Miyazaki M, Okamoto I et al (2011) Phase I study of dasatinib (BMS- 354825) in Japanese patients with solid tumors. Cancer Sci 102:205–2064
15.
go back to reference Ohtsu A, Baba H, Sakata Y et al (2000) Phase II study of S-1, a novel oral fluoropyrimidine derivative, in patients with metastatic colorectal carcinoma. Br J Cancer 83(2):141–145PubMedCentralPubMedCrossRef Ohtsu A, Baba H, Sakata Y et al (2000) Phase II study of S-1, a novel oral fluoropyrimidine derivative, in patients with metastatic colorectal carcinoma. Br J Cancer 83(2):141–145PubMedCentralPubMedCrossRef
Metadata
Title
Safety and pharmacokinetics of S-1 in a recurrent colon cancer patient with chronic myeloid leukemia treated with dasatinib: a case report
Authors
Toshinori Sueda
Toshihiro Kudo
Daisuke Sakai
Mamoru Uemura
Junichi Nishimura
Taishi Hata
Ichiro Takemasa
Tsunekazu Mizushima
Hirofumi Yamamoto
Sachiko Ezoe
Kana Matsumoto
Yuichiro Doki
Masaki Mori
Taroh Satoh
Publication date
01-12-2014
Publisher
Springer Berlin Heidelberg
Published in
Cancer Chemotherapy and Pharmacology / Issue 6/2014
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI
https://doi.org/10.1007/s00280-014-2620-8

Other articles of this Issue 6/2014

Cancer Chemotherapy and Pharmacology 6/2014 Go to the issue
Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras
Prof. Fabrice Barlesi
Developed by: Springer Medicine