Wendy A Woodward1, Penny Fang2, Lisa Arriaga2, Hui Gao3, Evan N Cohen3, James M Reuben3, Vicente Valero4, Huong Le-Petross5, Lavinia P Middleton3, Gildy V Babiera6, Eric A Strom2, Welela Tereffe2, Karen Hoffman2, Benjamin D Smith2, Thomas A Buchholz2, George H Perkins2. 1. Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas. Electronic address: wwoodward@mdanderson.org. 2. Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas. 3. Department of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, Texas. 4. Department of Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas. 5. Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas; Department of Radiology, The University of Texas MD Anderson Cancer Center, Houston, Texas. 6. Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Abstract
PURPOSE: 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. METHODS AND MATERIALS: 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/m2 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. RESULTS: 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). CONCLUSIONS: 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.
PURPOSE: 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. METHODS AND MATERIALS: 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/m2 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. RESULTS: 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). CONCLUSIONS: 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.
Authors: Eugene Huang; Marsha D McNeese; Eric A Strom; George H Perkins; Angela Katz; Gabriel N Hortobagyi; Vicente Valero; Henry M Kuerer; S Eva Singletary; Kelly K Hunt; Aman U Buzdar; Thomas A Buchholz Journal: Int J Radiat Oncol Biol Phys Date: 2002-08-01 Impact factor: 7.038
Authors: Sunil Krishnan; Nora A Janjan; John M Skibber; Miguel A Rodriguez-Bigas; Robert A Wolff; Prajnan Das; Marc E Delclos; George J Chang; Paulo M Hoff; Cathy Eng; Thomas D Brown; Christopher H Crane; Barry W Feig; Jeffrey Morris; Saroj Vadhan-Raj; Stanley R Hamilton; Edward H Lin Journal: Int J Radiat Oncol Biol Phys Date: 2006-11-01 Impact factor: 7.038
Authors: Joseph N Shaughnessy; Richard A Meena; Neal E Dunlap; Dharamvir Jain; Elizabeth C Riley; Amy R Quillo; Anthony E Dragun Journal: Clin Breast Cancer Date: 2014-10-22 Impact factor: 3.225
Authors: Sayeh Fattahi; Safia K Ahmed; Sean S Park; Ivy A Petersen; Dean A Shumway; Bradley J Stish; Elizabeth S Yan; Nicholas B Remmes; Robert W Mutter; Kimberly S Corbin Journal: Adv Radiat Oncol Date: 2020-12-17
Authors: Marc D Piroth; David Krug; Felix Sedlmayer; Marciana-Nona Duma; René Baumann; Wilfried Budach; Jürgen Dunst; Petra Feyer; Rainer Fietkau; Wulf Haase; Wolfgang Harms; Thomas Hehr; Rainer Souchon; Vratislav Strnad; Rolf Sauer Journal: Strahlenther Onkol Date: 2020-07-31 Impact factor: 3.621