{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Woodward WA"],"funding":["NCI NIH HHS"],"pagination":["777-783"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC6072264"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["99(4)"],"pubmed_abstract":["<h4>Purpose</h4>To examine the response rate of gross chemo-refractory breast cancer treated with concurrent capecitabine (CAP) and radiation therapy in a prospective Phase II study.<h4>Methods and materials</h4>Breast cancer patients with inoperable disease after chemotherapy, residual nodal disease after definitive surgical resection, unresectable chest wall or nodal recurrence after a prior mastectomy, or oligometastatic disease were eligible. Response by RECIST criteria was assessed after 45 Gy. Conversion to operable, locoregional control, and grade ≥3 toxicities were assessed. The first 9 patients received CAP 825 mg/m<sup>2</sup> twice daily continuously. Because of toxicity, subsequent patients received CAP only on radiation days. Kaplan-Meier analysis was used to estimate overall survival (OS) and locoregional recurrence-free survival.<h4>Results</h4>From 2009 to 2012, 32 patients were accrued; 26 received protocol-specified treatment. Median follow-up was 12.9 months (interquartile range, 7.10-42.9 months). Nineteen patients (73%) had partial or complete response. Fourteen patients (53.9%) experienced grade 3 non-dermatitis toxicity (7 of 9 continuous dosing). Three of four inoperable patients converted to operable. One-year actuarial OS in the treated cohort was 54%. The trial was stopped early after interim analysis suggested futility independent of response. Treatment was deemed futile (ie, conversion to operable but M1 disease immediately postoperatively) in 9 of 10 patients with triple-negative (TN) versus 6 of 16 with non-TN disease (P=.014). Median OS and 1-year locoregional recurrence-free survival among non-TN versus TN patients was 22.8 versus 5.1 months, and 63% versus 20% (P=.007).<h4>Conclusions</h4>Capecitabine can be safely administered on radiation days with careful clinical monitoring and was associated with encouraging response in this chemo-refractory cohort. However, patients with TN breast cancer had poor outcomes even when response was achieved. Further study in non-TN patients may be warranted."],"journal":["International journal of radiation oncology, biology, physics"],"pubmed_title":["A phase 2 study of capecitabine and concomitant radiation in women with advanced breast cancer."],"pmcid":["PMC6072264"],"funding_grant_id":["R01 CA138239","P30 CA016672"],"pubmed_authors":["Tereffe W","Reuben JM","Perkins GH","Valero V","Strom EA","Hoffman K","Babiera GV","Gao H","Woodward WA","Buchholz TA","Le-Petross H","Smith BD","Cohen EN","Fang P","Middleton LP","Arriaga L"],"additional_accession":[]},"is_claimable":false,"name":"A phase 2 study of capecitabine and concomitant radiation in women with advanced breast cancer.","description":"<h4>Purpose</h4>To examine the response rate of gross chemo-refractory breast cancer treated with concurrent capecitabine (CAP) and radiation therapy in a prospective Phase II study.<h4>Methods and materials</h4>Breast cancer patients with inoperable disease after chemotherapy, residual nodal disease after definitive surgical resection, unresectable chest wall or nodal recurrence after a prior mastectomy, or oligometastatic disease were eligible. Response by RECIST criteria was assessed after 45 Gy. Conversion to operable, locoregional control, and grade ≥3 toxicities were assessed. The first 9 patients received CAP 825 mg/m<sup>2</sup> twice daily continuously. Because of toxicity, subsequent patients received CAP only on radiation days. Kaplan-Meier analysis was used to estimate overall survival (OS) and locoregional recurrence-free survival.<h4>Results</h4>From 2009 to 2012, 32 patients were accrued; 26 received protocol-specified treatment. Median follow-up was 12.9 months (interquartile range, 7.10-42.9 months). Nineteen patients (73%) had partial or complete response. Fourteen patients (53.9%) experienced grade 3 non-dermatitis toxicity (7 of 9 continuous dosing). Three of four inoperable patients converted to operable. One-year actuarial OS in the treated cohort was 54%. The trial was stopped early after interim analysis suggested futility independent of response. Treatment was deemed futile (ie, conversion to operable but M1 disease immediately postoperatively) in 9 of 10 patients with triple-negative (TN) versus 6 of 16 with non-TN disease (P=.014). Median OS and 1-year locoregional recurrence-free survival among non-TN versus TN patients was 22.8 versus 5.1 months, and 63% versus 20% (P=.007).<h4>Conclusions</h4>Capecitabine can be safely administered on radiation days with careful clinical monitoring and was associated with encouraging response in this chemo-refractory cohort. However, patients with TN breast cancer had poor outcomes even when response was achieved. Further study in non-TN patients may be warranted.","dates":{"release":"2017-01-01T00:00:00Z","publication":"2017 Nov","modification":"2024-11-20T23:45:58.137Z","creation":"2019-03-27T00:07:04Z"},"accession":"S-EPMC6072264","cross_references":{"pubmed":["28843370"],"doi":["10.1016/j.ijrobp.2017.04.030"]}}