{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T22:03:33Z","timestamp":1790633013746,"version":"4.1.0"},"reference-count":24,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"2","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO Oncology Advances"],"published-print":{"date-parts":[[2025,1]]},"abstract":"<jats:sec>\n            <jats:title>PURPOSE<\/jats:title>\n            <jats:p>\n              In metastatic breast cancer (MBC), oral capecitabine prescribed at the US Food and Drug Administration (FDA)\u2013approved dose of 1,250 mg\/m\n              <jats:sup>2<\/jats:sup>\n              twice daily, 14 days on, 7 days off, is associated with poor tolerance. Mathematical models suggest that a fixed-dose (FD), dose-dense schedule may optimize efficacy. We conducted a randomized, open-label trial to compare the efficacy and tolerability of FD capecitabine, 1,500 mg twice daily, 7 days on, 7 days off (FD-7\/7), with the FDA-approved dose and schedule (standard-dose [SD]-14\/7).\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>METHODS<\/jats:title>\n            <jats:p>Females with MBC and any previous lines of therapy were included. Patients were randomly assigned 1:1 to either FD-7\/7 or SD-14\/7. The primary end point was 3-month progression-free survival (PFS). Capecitabine-related toxicities were graded at each visit.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>RESULTS<\/jats:title>\n            <jats:p>\n              Between October 2015 and April 2021, 153 patients were enrolled (n = 80 FD-7\/7, n = 73 SD-14\/7). The 3-month PFS was 63.1% (95% CI, 52.0 to 74.2) in the FD-7\/7 arm and 67.2% (95% CI, 54.5 to 79.9) in the SD-14\/7 arm. Restricted mean survival time was used to report estimates of effect. The PFS (restricted mean) at 33 months was 10.1 months (95% CI, 7.6 to 12.6) in the FD-7\/7 arm compared with 9.1 months (95% CI, 6.6 to 11.7) in the SD-14\/7 arm. The overall survival (restricted mean) at 80 months was 30.6 months (95% CI, 23.6 to 37.6) in the FD-7\/7 arm versus 24.5 months (95% CI, 18 to 31.1) in the SD-14\/7 arm. Toxicity-related treatment discontinuation occurred in 24 patients (32.9%) in the SD-14\/7 arm compared with seven patients (8.8%) in the FD-7\/7 arm (\n              <jats:italic>P<\/jats:italic>\n              = .0002). Grade 2 to 4 toxicities occurred in 79.5% in the SD-14\/7 arm compared with 37.5% in the FD-7\/7 arm (\n              <jats:italic>P<\/jats:italic>\n              &lt; .0001).\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>CONCLUSION<\/jats:title>\n            <jats:p>In MBC, FD capecitabine 1,500 mg twice daily on a 7\/7 schedule has less toxicity and similar efficacy when compared with body surface area-based dosing on a 14\/7 schedule.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1200\/oa-24-00068","type":"journal-article","created":{"date-parts":[[2025,1,30]],"date-time":"2025-01-30T20:59:10Z","timestamp":1738270750000},"source":"Crossref","is-referenced-by-count":9,"title":["Randomized Trial of Fixed-Dose Capecitabine Compared With Standard-Dose Capecitabine in Metastatic Breast Cancer: X-7\/7 Trial"],"prefix":"10.1200","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6287-020X","authenticated-orcid":true,"given":"Qamar 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CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne","family":"O'Dea","sequence":"additional","affiliation":[{"name":"University of Kansas Cancer Center, Westwood, KS"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark R.","family":"Fesen","sequence":"additional","affiliation":[{"name":"Central Care Cancer Center, Great Bend, KS"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gregory J.","family":"Crane","sequence":"additional","affiliation":[{"name":"University of Kansas Cancer Center, Westwood, KS"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6921-0987","authenticated-orcid":true,"given":"Lauren E.","family":"Nye","sequence":"additional","affiliation":[{"name":"University of Kansas Cancer Center, Westwood, KS"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0917-6307","authenticated-orcid":true,"given":"Joaquina 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