Rivera Edgardo, Valero Vicente, Esteva Francisco J, Syrewicz Laura, Cristofanilli Massimo, Rahman Zia, Booser Daniel J, Hortobagyi Gabriel N
Department of Breast Medical Oncology, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX 77030-4009, USA.
Cancer Chemother Pharmacol. 2002 Apr;49(4):299-302. doi: 10.1007/s00280-001-0405-3. Epub 2001 Dec 18.
We conducted a single-institution phase II clinical trial to determine the objective response rate, duration of response, time to progression, and overall survival in patients with anthracycline-resistant breast cancer treated with Doxil.
Patients with metastatic breast cancer were eligible if they had disease progression while receiving an anthracycline-containing regimen or developed evidence of metastatic disease during or within 6 months after the last cycle of an anthracycline-containing adjuvant regimen. Prior treatment with liposomal doxorubicin was not allowed. Patients received a dose of 50 mg/m(2) infused every 4 weeks via a peripheral vein or central line. Doxil was administered for a total of six cycles or until disease progression.
We treated 11 patients with stage IV breast cancer of whom two had never received chemotherapy for their metastatic disease. Most had a performance status of 1 and had visceral involvement as their dominant site of disease. All patients had received prior therapy with doxorubicin. No clinical evidence of congestive heart failure or cardiac toxicity was observed. The most common toxicities were nonhematologic and were mostly grade 1/2. These included fatigue, nausea, vomiting, and stomatitis. Significant myelosuppression was only observed in one patient. No complete or partial response was observed. There were two patients who had a minimal response and two other patients who had evidence of stable disease.
Doxil was well tolerated with minimal toxicity. However, the lack of antitumor activity in anthracycline-resistant breast cancer patients indicates that further evaluation in this patient population is not warranted.
我们开展了一项单机构II期临床试验，以确定接受多柔比星脂质体（Doxil）治疗的蒽环类耐药乳腺癌患者的客观缓解率、缓解持续时间、疾病进展时间和总生存期。
转移性乳腺癌患者若在接受含蒽环类方案治疗期间出现疾病进展，或在含蒽环类辅助方案的最后一个周期期间或之后6个月内出现转移性疾病证据，则符合入组条件。不允许先前接受过脂质体阿霉素治疗。患者通过外周静脉或中心静脉导管每4周接受一次50 mg/m²的剂量输注。多柔比星脂质体总共给药六个周期或直至疾病进展。
我们治疗了11例IV期乳腺癌患者，其中2例转移性疾病从未接受过化疗。大多数患者的体能状态为1，主要疾病部位为内脏受累。所有患者均接受过阿霉素的先前治疗。未观察到充血性心力衰竭或心脏毒性的临床证据。最常见的毒性为非血液学毒性，大多为1/2级。这些毒性包括疲劳、恶心、呕吐和口腔炎。仅1例患者观察到显著的骨髓抑制。未观察到完全缓解或部分缓解。有2例患者有轻微缓解，另有2例患者有疾病稳定的证据。
多柔比星脂质体耐受性良好，毒性极小。然而，蒽环类耐药乳腺癌患者缺乏抗肿瘤活性表明，该患者群体无需进一步评估。
