Dataset Information

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.

SUBMITTER: Hsu HC

PROVIDER: S-EPMC6252780 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Publications

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

Hsu Hung-Chih HC Chou Wen-Chi WC Kuan Feng-Che FC Lee Kuan-Der KD Rau Kun-Ming KM Huang Jen-Seng JS Yang Tsai-Sheng TS

Cancer management and research 20181121

<h4>Purpose</h4>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.<h4>Methods</h4>In this open-label, single- ...[more]

PMID: 30538555

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Dataset Information

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

Purpose

Methods

Results

Conclusion

Publications

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

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