Medical Division of Urogenital and Head and Neck Cancer.
Department of Statistics and Quantitative Methods, University of Milano-Bicocca.
Am J Clin Oncol. 2020 Jun;43(6):381-387. doi: 10.1097/COC.0000000000000679.
Bleomycin, etoposide, and cisplatin (BEP) is the most common and successful chemotherapy regimen for germ-cell tumor (GCT) patients, accompanied by a bleomycin-induced dose-dependent lung toxicity in certain patients. In an attempt to reduce bleomycin-toxicity, we developed a modified-BEP (mBEP) regimen.
Between August 2008 and February 2018, 182 unselected mainly testicular GCT patients (39 with adjuvant purpose and 143 with curative purpose) received a tri-weekly 5-day hospitalization schedule with bleomycin 15 U intravenous (IV) push on day 1 and 10 U IV continuous infusion over 12 hours on days 1 to 3, cisplatin 20 mg/m IV, and etoposide 100 mg/m IV on days 1 to 5. Pulmonary toxicity was assessed through chest computed tomography scan and clinical monitoring.
Median number of mBEP cycles was 3 (range: 1 to 4). In the curative setting, according to the International Germ Cell Cancer Collaborative Group (IGCCCG) prognostic system, 112, 21, and 9 patients had good-risk, intermediate-risk, and poor-risk class, respectively; 66 (46%) patients had complete response (CR), 67 (47%) had partial response (52 of whom became CR afterwards), 6 (4%) had stable disease (that in 3 became CR afterwards), 3 (2%) progressed, and 1 (1%) died of brain stroke. At a median follow-up of 2.67 years (interquartile range: 1.23-5.00 y), 1 and 5-year overall survival and progression-free survival were 99% and 95%, and 90% and 88%, respectively. In the entire patient population, there was grade 3/4 neutropenia in 92 patients (51%), febrile neutropenia in 11 patients (6%), grade 1/2 nausea in 74 patients (41%), and no death due to pulmonary toxicity.
In GCT patients, our mBEP-schedule would suggest an effective treatment modality without suffering meaningful pulmonary toxicity.
博来霉素、依托泊苷和顺铂（BEP）是生殖细胞肿瘤（GCT）患者最常用和最成功的化疗方案，某些患者会出现博来霉素剂量依赖性的肺毒性。为了降低博来霉素的毒性，我们开发了改良 BEP（mBEP）方案。
2008 年 8 月至 2018 年 2 月，182 例未经选择的主要睾丸 GCT 患者（39 例为辅助治疗目的，143 例为根治性治疗目的）接受了每周 3 天 5 天的住院治疗方案，第 1 天静脉注射（IV）推注博来霉素 15U，第 1 至 3 天 IV 持续输注 10U/12 小时，第 1 至 5 天 IV 注射顺铂 20mg/m2和依托泊苷 100mg/m2。通过胸部计算机断层扫描（CT）扫描和临床监测评估肺毒性。
mBEP 周期的中位数为 3 个（范围：1 至 4 个）。在根治性治疗中，根据国际生殖细胞癌协作组（IGCCCG）预后系统，112 例、21 例和 9 例患者分别为低危、中危和高危；66 例（46%）患者获得完全缓解（CR），67 例（47%）患者获得部分缓解（其中 52 例随后获得 CR），6 例（4%）患者疾病稳定（其中 3 例随后获得 CR），3 例（2%）患者进展，1 例（1%）患者死于脑卒。在中位随访 2.67 年（四分位距：1.23-5.00 年）时，1 年和 5 年的总生存率和无进展生存率分别为 99%和 95%，90%和 88%。在整个患者群体中，92 例（51%）患者出现 3/4 级中性粒细胞减少症，11 例（6%）患者出现发热性中性粒细胞减少症，74 例（41%）患者出现 1/2 级恶心，无因肺毒性导致的死亡。
在 GCT 患者中，我们的 mBEP 方案是一种有效的治疗方法，不会导致明显的肺毒性。
