The recommended cumulative doxorubicin dose in soft tissue sarcoma (STS) treatment was based on cardiotoxicity data from retrospective studies of breast cancer patients. However, the treatment and prognosis of STS and breast cancer are quite different, and reference to breast cancer data alone may not reflect the efficacy of doxorubicin treatment in STS. This study, thus, aimed to review and analyze clinical data of STS patients treated with a high cumulative doxorubicin dose, to provide a reference for treatment selection and clinical trial design. We retrospectively collected and analyzed clinical data of patients with advanced STS who received doxorubicin-based chemotherapy from January 2016 to January 2020. The patients were divided into a standard-dose group (who received ≤6 cycles of doxorubicin after the initial diagnosis) and an over-dose group (who were re-administered doxorubicin [doxorubicin-rechallenge] after receiving 6 cycles of doxorubicin therapy discontinuously). Patient characteristics, cumulative doxorubicin dose, objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), cardiotoxicity incidence, and treatment effectiveness were evaluated in both groups. A total of 170 patients with advanced STS were recruited (146 in the standard-dose group and 24 in the over-dose group). The average cumulative doxorubicin dose was 364.04 ± 63.81 mg/m2 in the standard-dose group and 714.38 ± 210.09 mg/m2 in the over-dose group. The ORR, DCR, and median PFS were 15.07, 58.9%, and 6 (95% confidence interval [CI]: 5.8–6.5) months in the standard-dose group and 16.67, 66.67%, and 4 (95%CI: 2.0–5.8) months in the over-dose group, respectively. Symptomatic heart failure occurred in five patients (3.42%) of the standard-dose group and in one patient (4.17%) of the over-dose group. In these patients with cardiotoxicity, doxorubicin was discontinued, and all of them died of uncontrolled tumor growth. No drug-related deaths occurred. The continuation of or rechallenge with doxorubicin beyond the recommended cumulative dose could be a promising therapeutic option in the treatment of chemotherapy-sensitive advanced sarcomas. Further evaluation is necessary in prospective trials.

中文翻译：

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高累积阿霉素剂量治疗晚期软组织肉瘤

软组织肉瘤（STS）治疗中推荐的阿霉素累积剂量基于乳腺癌患者回顾性研究的心脏毒性数据。但是，STS和乳腺癌的治疗和预后完全不同，仅参考乳腺癌数据可能无法反映阿霉素治疗STS的疗效。因此，本研究旨在回顾和分析接受高累积阿霉素剂量治疗的STS患者的临床数据，为治疗选择和临床试验设计提供参考。我们回顾性收集并分析了2016年1月至2020年1月接受基于阿霉素化疗的晚期STS患者的临床数据。将患者分为标准剂量组（初诊后接受≤6个周期的阿霉素）和超剂量组（不连续接受6个周期的阿霉素治疗后重新给予阿霉素[doxorubicin-rechallenge]的患者） 。两组均评估了患者特征，阿霉素累积剂量，客观缓解率（ORR），疾病控制率（DCR），无进展生存期（PFS），心脏毒性发生率和治疗效果。总共招募了170名晚期STS患者（标准剂量组为146名，超剂量组为24名）。标准剂量组的平均阿霉素累积累积剂量为364.04±63.81 mg / m2，超剂量组为714.38±210.09 mg / m2。ORR，DCR和中位数PFS分别为15.07、58.9％和6（95％置信区间[CI]：5.8-6。在标准剂量组中分别为5个月和在过量组中分别为16.67、66.67％和4（95％CI：2.0-5.8）个月。有症状的心力衰竭发生在标准剂量组的5名患者（3.42％）和过量组的1名患者（4.17％）中。在这些具有心脏毒性的患者中，停用阿霉素，所有患者均因肿瘤生长不受控制而死亡。没有发生与毒品有关的死亡。在推荐的化疗累积性肉瘤治疗中，阿霉素继续或再挑战超过推荐的累积剂量可能是有希望的治疗选择。在前瞻性试验中需要进一步评估。标准剂量组为42％），超剂量组中一名患者（4.17％）。在这些具有心脏毒性的患者中，停用阿霉素，所有患者均因肿瘤生长不受控制而死亡。没有发生与毒品有关的死亡。在推荐的化疗累积性肉瘤治疗中，阿霉素继续或再挑战超过推荐的累积剂量可能是有希望的治疗选择。在前瞻性试验中需要进一步评估。标准剂量组为42％），超剂量组中一名患者（4.17％）。在这些具有心脏毒性的患者中，停用阿霉素，所有患者均因肿瘤生长不受控制而死亡。没有发生与毒品有关的死亡。在推荐的化疗累积性肉瘤治疗中，阿霉素继续或再挑战超过推荐的累积剂量可能是有希望的治疗选择。在前瞻性试验中需要进一步评估。在推荐的化疗累积性肉瘤治疗中，阿霉素继续或再挑战超过推荐的累积剂量可能是有希望的治疗选择。在前瞻性试验中需要进一步评估。在推荐的化疗累积性肉瘤治疗中，阿霉素继续或再挑战超过推荐的累积剂量可能是有希望的治疗选择。在前瞻性试验中需要进一步评估。