Martín M, Lluch A, Casado A, Santabárbara P, Adrover E, Valverde J J, López-Martín J A, Rodriguez-Lescure A, Azagra P, García-Conde J
University Hospital of Madrid, Spain.
J Clin Oncol. 1994 May;12(5):986-91. doi: 10.1200/JCO.1994.12.5.986.
This study was undertaken to assess the antitumor activity and tolerance of chronic oral etoposide (50 mg/m2/d for 21 days every 4 weeks) in metastatic breast cancer (MBC).
Forty-three consecutive metastatic breast cancer patients with at least one site of measurable disease entered the study. All patients had received prior chemotherapy (adjuvant, three patients; adjuvant plus chemotherapy for metastases, 21; chemotherapy for metastases, 19). Twenty-two and 21 patients had also received prior hormonal and radiation therapy, respectively.
Thirty-five percent of patients (15 of 43; 95% confidence interval, 21% to 51%) had objective responses, according to an intention-to-treat analysis. Responses were seen in lymph nodes (six of 14), skin and soft tissues (eight of 16), lung (six of 14), lytic lesions of the bone (two of six), liver (four of 23), and peritoneum (one of one). The median duration of response was 7 months (range, 3+ to 12). The main toxic side effects were leukopenia (overall, 65% of patients; World Health Organization [WHO] grade 4, 21%), thrombocytopenia (21%; WHO grade 4, 5%) and anemia (51%; WHO grade 4, 5%). Nine patients (21%) required a 25% dose reduction because of myelosuppression, and one patient abandoned treatment because of gastrointestinal toxicity and severe asthenia. Ninety-one percent of patients developed alopecia, 39.5% had mucositis (WHO grade 3, 9.5%) and 60.5% had some degree of emesis (11.5% nausea, 46.5% transient vomiting, 2.5% intractable vomiting). No toxic deaths occurred.
Chronic oral etoposide appears to be an active and well-tolerated regimen in MBC patients previously exposed to chemotherapy. This schedule of etoposide administration warrants further studies, alone or in combination, in MBC.
本研究旨在评估慢性口服依托泊苷（每4周，50mg/m²/天，共21天）对转移性乳腺癌（MBC）的抗肿瘤活性及耐受性。
43例连续性转移性乳腺癌患者进入本研究，这些患者至少有一处可测量病灶。所有患者均接受过先前的化疗（辅助化疗，3例；辅助化疗加转移灶化疗，21例；转移灶化疗，19例）。分别有22例和21例患者还接受过先前的激素治疗和放疗。
根据意向性分析，35%的患者（43例中的15例；95%置信区间，21%至51%）有客观缓解。在淋巴结（14例中的6例）、皮肤和软组织（16例中的8例）、肺（14例中的6例）、溶骨性骨病变（6例中的2例）、肝（23例中的4例）和腹膜（1例中的1例）中观察到缓解。缓解的中位持续时间为7个月（范围，3+至12个月）。主要的毒副作用为白细胞减少（总体，65%的患者；世界卫生组织[WHO]4级，21%）、血小板减少（21%；WHO 4级，5%）和贫血（51%；WHO 4级，5%）。9例患者（21%）因骨髓抑制需要降低25%的剂量，1例患者因胃肠道毒性和严重乏力而放弃治疗。91%的患者出现脱发，39.5%有黏膜炎（WHO 3级，9.5%），60.5%有一定程度的呕吐（11.5%恶心，46.5%短暂呕吐，2.5%顽固性呕吐）。未发生毒性死亡。
慢性口服依托泊苷似乎是一种对先前接受过化疗的MBC患者有效且耐受性良好的方案。这种依托泊苷给药方案值得在MBC中单独或联合进行进一步研究。
