Nardone Luigia, Valentini Vincenzo, Marino Lorenza, De Santis Maria Carmen, Terribile Daniela, Franceschini Gianluca, Balducci Mario, Mantini Giovanna, Mattiucci Giancarlo, Mulè Antonino, Belli Paolo, Masetti Riccardo
Radiotherapy Department, Policlinico Universitario A. Gemelli, Catholic University, Rome, Italy.
Tumori. 2012 Jan-Feb;98(1):79-85. doi: 10.1177/030089161209800110.
The aim of the study was to evaluate the feasibility of neoadjuvant low-dose fractionated radiotherapy, in combination with two anthracycline-docetaxel regimens, in breast cancer treatment.
Women with stage IIA/B-IIIA breast cancer were assigned to receive the treatment of low-dose fractionated radiotherapy (0.4 Gy/per fraction, 2 fractions per day, for 2 days, every 21 days for 8-6 cycles) with concomitant neoadjuvant chemotherapy with non-pegylated liposomal doxorubicin and docetaxel. Two chemotherapy schedules were planned to be combined with low-dose fractionated radiotherapy. The first schedule consisted of four cycles of non-pegylated liposomal doxorubicin sequentially followed by four cycles of docetaxel, and the second schedule consisted of six cycles of non-pegylated liposomal doxorubicin plus concomitant docetaxel. Acute toxicity was evaluated according to the Radiation Therapy Oncology Group score system. Pathological response was evaluated by the Mandard score and expressed as tumor regression grade.
Between March 2008 and February 2009, 10 patients underwent low-dose fractionated radiotherapy and concomitant chemotherapy. No grade 3-4 breast toxicity was observed. Five patients had a clinical complete response. Seven patients underwent conservative surgery. Overall, tumor regression grade 1 (absence of residual cancer) was achieved in one patient (10%) and grade 2 (residual isolated cells scattered through the fibrosis) in 4 patients (40%). The pathologic major response rate (tumor regression grade 1 + 2) was 20% in patients receiving low-dose fractionated radiotherapy and sequential non-pegylated liposomal doxorubicin and docetaxel and 80% in the group receiving low-dose fractionated radiotherapy and concurrent non-pegylated liposomal doxorubicin and docetaxel treatment.
Concomitant low-dose fractionated radiotherapy combined with anthracycline and docetaxel is feasible. The toxicity profile of radio-chemotherapy was similar to that of chemotherapy alone: there was no acute skin or cardiac toxicity. The concurrent application of liposomal doxorubicin and docetaxel with low-dose fractionated radiation led to higher histological response rates compared to the sequential application of the same two drugs.
本研究旨在评估新辅助低分割放疗联合两种蒽环类-多西他赛方案治疗乳腺癌的可行性。
IIA/B-IIIA期乳腺癌女性患者被分配接受低分割放疗（每次0.4 Gy，每天2次，共2天，每21天重复，共8 - 6个周期），同时联合非聚乙二醇化脂质体阿霉素和多西他赛进行新辅助化疗。计划将两种化疗方案与低分割放疗联合使用。第一种方案为四个周期的非聚乙二醇化脂质体阿霉素序贯四个周期的多西他赛，第二种方案为六个周期的非聚乙二醇化脂质体阿霉素加同期多西他赛。根据放射肿瘤学组评分系统评估急性毒性。通过Mandard评分评估病理反应，并以肿瘤退缩分级表示。
2008年3月至2009年2月，10例患者接受了低分割放疗及同期化疗。未观察到3 - 4级乳腺毒性。5例患者获得临床完全缓解。7例患者接受了保乳手术。总体而言，1例患者（10%）达到肿瘤退缩1级（无残留癌），4例患者（40%）达到2级（残留孤立细胞散布于纤维化组织中）。接受低分割放疗及序贯非聚乙二醇化脂质体阿霉素和多西他赛治疗的患者中，病理主要反应率（肿瘤退缩分级1 + 2）为20%，而接受低分割放疗及同期非聚乙二醇化脂质体阿霉素和多西他赛治疗的组中该反应率为80%。
低分割放疗联合蒽环类和多西他赛是可行的。放化疗的毒性特征与单纯化疗相似：无急性皮肤或心脏毒性。与两种药物序贯应用相比，脂质体阿霉素和多西他赛与低分割放疗同期应用导致更高的组织学反应率。
