A phase II study of S-1 plus oral leucovorin in heavily treated metastatic colorectal cancer patients

Hung Chih Hsu, Wen Chi Chou, Feng Che Kuan, Kuan Der Lee, Kun Ming Rau, Jen Seng Huang, Tsai Sheng Yang

研究成果: 雜誌貢獻文章

摘要

Purpose: Fewer treatment options are available for refractory metastatic colorectal cancer (mCRC). In early trials, S-1 monotherapy was effective for mCRC patients after chemotherapy failure and its combination with oral leucovorin therapy offers promising results in untreated mCRC. Hence, we conduct a Phase II trial to assess the efficacy of S-1 plus oral leucovorin (SL) in refractory mCRC that progressed after multiple prior standard therapies. Methods: In this open-label, single-arm study, we enrolled the refractory mCRC patients who received fluoropyrimidine, oxaliplatin, and irinotecan treatment and at least one targeted therapy previously. The doses of SL were 40–60 and 30 mg twice daily separately. They were administered for 7 days in a 2-week cycle. Treatment was continued until disease progression. Results: Of the 41 enrolled patients, 36 patients were evaluable with 61.1% disease control rate. The median progression-free survival and overall survival were 2.55 and 7.63 months, respectively. Regression change in tumor size stayed 10%–20% in five patients (13.9%) through 18 weeks after treatment, and two patients continued free from tumor progression at 30 and 42 weeks. Compared with moderate heavily pretreated mCRC patient subgroup (≤4 prior regimens), the severe heavily pretreated subgroup (≥5 prior regimens) showed similar disease control rate and survival benefit. Grade 3 or higher toxicities were documented only in 11 patients (26.8%). Conclusion: SL shows potential as a salvage regimen in refractory mCRC patients especially in the severe heavily pretreated setting and is well tolerated in these patients.
原文英語
頁(從 - 到)6061-6070
頁數10
期刊Cancer Management and Research
10
DOIs
出版狀態已發佈 - 一月 1 2018

指紋

Leucovorin
Colorectal Neoplasms
oxaliplatin
irinotecan
Therapeutics
Disease-Free Survival
Disease Progression
Neoplasms
Survival Rate
Drug Therapy
Survival

ASJC Scopus subject areas

  • Oncology

引用此文

A phase II study of S-1 plus oral leucovorin in heavily treated metastatic colorectal cancer patients. / Hsu, Hung Chih; Chou, Wen Chi; Kuan, Feng Che; Lee, Kuan Der; Rau, Kun Ming; Huang, Jen Seng; Yang, Tsai Sheng.

於: Cancer Management and Research, 卷 10, 01.01.2018, p. 6061-6070.

研究成果: 雜誌貢獻文章

Hsu, Hung Chih ; Chou, Wen Chi ; Kuan, Feng Che ; Lee, Kuan Der ; Rau, Kun Ming ; Huang, Jen Seng ; Yang, Tsai Sheng. / A phase II study of S-1 plus oral leucovorin in heavily treated metastatic colorectal cancer patients. 於: Cancer Management and Research. 2018 ; 卷 10. 頁 6061-6070.
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title = "A phase II study of S-1 plus oral leucovorin in heavily treated metastatic colorectal cancer patients",
abstract = "Purpose: Fewer treatment options are available for refractory metastatic colorectal cancer (mCRC). In early trials, S-1 monotherapy was effective for mCRC patients after chemotherapy failure and its combination with oral leucovorin therapy offers promising results in untreated mCRC. Hence, we conduct a Phase II trial to assess the efficacy of S-1 plus oral leucovorin (SL) in refractory mCRC that progressed after multiple prior standard therapies. Methods: In this open-label, single-arm study, we enrolled the refractory mCRC patients who received fluoropyrimidine, oxaliplatin, and irinotecan treatment and at least one targeted therapy previously. The doses of SL were 40–60 and 30 mg twice daily separately. They were administered for 7 days in a 2-week cycle. Treatment was continued until disease progression. Results: Of the 41 enrolled patients, 36 patients were evaluable with 61.1{\%} disease control rate. The median progression-free survival and overall survival were 2.55 and 7.63 months, respectively. Regression change in tumor size stayed 10{\%}–20{\%} in five patients (13.9{\%}) through 18 weeks after treatment, and two patients continued free from tumor progression at 30 and 42 weeks. Compared with moderate heavily pretreated mCRC patient subgroup (≤4 prior regimens), the severe heavily pretreated subgroup (≥5 prior regimens) showed similar disease control rate and survival benefit. Grade 3 or higher toxicities were documented only in 11 patients (26.8{\%}). Conclusion: SL shows potential as a salvage regimen in refractory mCRC patients especially in the severe heavily pretreated setting and is well tolerated in these patients.",
keywords = "Oral leucovorin, Phase II, Refractory metastatic colorectal cancer, S-1, Survival and safety",
author = "Hsu, {Hung Chih} and Chou, {Wen Chi} and Kuan, {Feng Che} and Lee, {Kuan Der} and Rau, {Kun Ming} and Huang, {Jen Seng} and Yang, {Tsai Sheng}",
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AU - Hsu, Hung Chih

AU - Chou, Wen Chi

AU - Kuan, Feng Che

AU - Lee, Kuan Der

AU - Rau, Kun Ming

AU - Huang, Jen Seng

AU - Yang, Tsai Sheng

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N2 - Purpose: Fewer treatment options are available for refractory metastatic colorectal cancer (mCRC). In early trials, S-1 monotherapy was effective for mCRC patients after chemotherapy failure and its combination with oral leucovorin therapy offers promising results in untreated mCRC. Hence, we conduct a Phase II trial to assess the efficacy of S-1 plus oral leucovorin (SL) in refractory mCRC that progressed after multiple prior standard therapies. Methods: In this open-label, single-arm study, we enrolled the refractory mCRC patients who received fluoropyrimidine, oxaliplatin, and irinotecan treatment and at least one targeted therapy previously. The doses of SL were 40–60 and 30 mg twice daily separately. They were administered for 7 days in a 2-week cycle. Treatment was continued until disease progression. Results: Of the 41 enrolled patients, 36 patients were evaluable with 61.1% disease control rate. The median progression-free survival and overall survival were 2.55 and 7.63 months, respectively. Regression change in tumor size stayed 10%–20% in five patients (13.9%) through 18 weeks after treatment, and two patients continued free from tumor progression at 30 and 42 weeks. Compared with moderate heavily pretreated mCRC patient subgroup (≤4 prior regimens), the severe heavily pretreated subgroup (≥5 prior regimens) showed similar disease control rate and survival benefit. Grade 3 or higher toxicities were documented only in 11 patients (26.8%). Conclusion: SL shows potential as a salvage regimen in refractory mCRC patients especially in the severe heavily pretreated setting and is well tolerated in these patients.

AB - Purpose: Fewer treatment options are available for refractory metastatic colorectal cancer (mCRC). In early trials, S-1 monotherapy was effective for mCRC patients after chemotherapy failure and its combination with oral leucovorin therapy offers promising results in untreated mCRC. Hence, we conduct a Phase II trial to assess the efficacy of S-1 plus oral leucovorin (SL) in refractory mCRC that progressed after multiple prior standard therapies. Methods: In this open-label, single-arm study, we enrolled the refractory mCRC patients who received fluoropyrimidine, oxaliplatin, and irinotecan treatment and at least one targeted therapy previously. The doses of SL were 40–60 and 30 mg twice daily separately. They were administered for 7 days in a 2-week cycle. Treatment was continued until disease progression. Results: Of the 41 enrolled patients, 36 patients were evaluable with 61.1% disease control rate. The median progression-free survival and overall survival were 2.55 and 7.63 months, respectively. Regression change in tumor size stayed 10%–20% in five patients (13.9%) through 18 weeks after treatment, and two patients continued free from tumor progression at 30 and 42 weeks. Compared with moderate heavily pretreated mCRC patient subgroup (≤4 prior regimens), the severe heavily pretreated subgroup (≥5 prior regimens) showed similar disease control rate and survival benefit. Grade 3 or higher toxicities were documented only in 11 patients (26.8%). Conclusion: SL shows potential as a salvage regimen in refractory mCRC patients especially in the severe heavily pretreated setting and is well tolerated in these patients.

KW - Oral leucovorin

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KW - Refractory metastatic colorectal cancer

KW - S-1

KW - Survival and safety

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