卡培他滨联合放疗用于晚期乳腺癌女性的2期研究。
A phase 2 study of capecitabine and concomitant radiation in women with advanced breast cancer.
作者信息
Woodward Wendy A, Fang Penny, Arriaga Lisa, Gao Hui, Cohen Evan N, Reuben James M, Valero Vicente, Le-Petross Huong, Middleton Lavinia P, Babiera Gildy V, Strom Eric A, Tereffe Welela, Hoffman Karen, Smith Benjamin D, Buchholz Thomas A, Perkins George H
机构信息
Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
出版信息
Int J Radiat Oncol Biol Phys. 2017 Nov 15;99(4):777-783. doi: 10.1016/j.ijrobp.2017.04.030. Epub 2017 May 3.
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/m 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.
目的
在一项前瞻性II期研究中，检测同步使用卡培他滨（CAP）和放射治疗对大体化疗难治性乳腺癌的缓解率。
方法和材料
符合条件的乳腺癌患者包括化疗后无法手术的疾病、根治性手术切除后残留淋巴结疾病、先前乳房切除术后不可切除的胸壁或淋巴结复发，或寡转移疾病。45 Gy后根据RECIST标准评估缓解情况。评估转为可手术状态、局部区域控制情况以及≥3级毒性反应。前9例患者连续每日两次接受825 mg/m的CAP治疗。由于毒性反应，后续患者仅在放疗日接受CAP治疗。采用Kaplan-Meier分析来估计总生存期（OS）和局部区域无复发生存期。
结果
2009年至2012年，共纳入32例患者；26例接受了方案规定的治疗。中位随访时间为12.9个月（四分位间距，7.10 - 42.9个月）。19例患者（73%）有部分或完全缓解。14例患者（53.9%）出现3级非皮肤毒性反应（9例连续给药患者中有7例）。4例无法手术的患者中有3例转为可手术状态。治疗队列中1年精算OS为54%。中期分析表明无效且与缓解无关后，试验提前终止。三阴性（TN）的10例患者中有9例治疗被认为无效（即转为可手术但术后立即为M1期疾病），而非TN疾病的16例患者中有6例（P = 0.014）。非TN患者与TN患者的中位OS以及1年局部区域无复发生存率分别为22.8个月对5.1个月，以及63%对20%（P = 0.007）。
结论
卡培他滨在放疗日可通过仔细的临床监测安全给药，并且在这个化疗难治性队列中与令人鼓舞的缓解相关。然而，即使实现缓解，TN乳腺癌患者的预后也较差。可能有必要对非TN患者进行进一步研究。
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