Mattioli R, Lippe P, Massacesi C, Cappelletti C, Nacciarriti D, Bisonni R, Graziano F, Menichetti E T, Imperatori L, Testa E, Laici G, Balletra A, Silva R R
S Croce Hospital, Fano, Italy.
Anticancer Res. 2004 Sep-Oct;24(5B):3257-61.
The doxorubicin-docetaxel combination is active in breast cancer; the aim of the present study was to evaluate the complete response rate and safety profile of the doxorubicin and docetaxel regimen as first-line chemotherapy in metastatic breast cancer patients.
Forty-three patients entered the study. Treatment plan was: doxorubicin (50 mg/m2, i.v. bolus) followed 1 hour later by docetaxel (75 mg/m2 i.v. infusion over 1 hour), q 3 weeks, for up to six courses. The patients achieving a response or a stabilisation of disease after 6 courses were allowed to intensify the treatment with docetaxel (100 mg/m2, q 3 weeks) for up to 2 courses. G-CSF (or GM-CSF) was administered if clinically indicated.
Patients' median age was 57years (range 32-75) and 72% of them had visceral disease. A total of 217 doxorubicin-docetaxel courses were delivered, with 70% of patients receiving all the 6 planned cycles. Among the 40 patients assessable for response (WHO criteria), 7 (16%) achieved a complete remission and 22 (51%) a partial remission, for an overall response rate (intent-to-treat) of 67% (95% C.I. =53% to 81%). In 19 patients, the treatment was intensified with two more single-agent docetaxel cycles, without ameliorating the response. Twenty-seven patients with oestrogen receptor-positive received hormonal therapy as 'maintenance' after completing chemotherapy treatment. NCIC G3-G4 neutropenia was recorded in 58% of patients, with G/GM-CSF used in 23 (53%) patients and 91 (38%) cycles. No patients experienced severe cardiac or neurological toxicity. No toxic death occurred. With a median follow-up of 41 months among alive patients, we observed in responder patients an overall median time to progression and survival of 18 and 33 months respectively, with ten long-survivors still alive.
This study confirmed the combination doxorubicin-docetaxel as a very active regimen for metastatic breast cancer. Remarkably long survival times were observed not only in complete responders, but also in those patients who responded partially. This might be equally attributed to first-line treatment and sequential maintenance hormonal therapy.
阿霉素与多西他赛联合用药对乳腺癌有效；本研究旨在评估阿霉素和多西他赛方案作为转移性乳腺癌患者一线化疗的完全缓解率和安全性。
43例患者进入本研究。治疗方案为：阿霉素（50mg/m²，静脉推注），1小时后给予多西他赛（75mg/m²，静脉滴注1小时），每3周1次，最多6个疗程。6个疗程后病情缓解或稳定的患者可强化使用多西他赛（100mg/m²，每3周1次），最多2个疗程。如有临床指征则给予粒细胞集落刺激因子（G-CSF）或粒细胞-巨噬细胞集落刺激因子（GM-CSF）。
患者中位年龄为57岁（范围32 - 75岁），72%患者有内脏转移。共进行了217个阿霉素-多西他赛疗程，70%患者接受了全部6个计划周期的治疗。在40例可评估疗效（按WHO标准）的患者中，7例（16%）达到完全缓解，22例（51%）达到部分缓解，总缓解率（意向性分析）为67%（95%可信区间=53%至81%）。19例患者增加了2个多西他赛单药周期进行强化治疗，但疗效未改善。27例雌激素受体阳性患者在完成化疗后接受激素治疗作为“维持治疗”。58%患者记录到NCIC 3 - 4级中性粒细胞减少，23例（53%）患者及91个疗程（38%）使用了G/GM-CSF。无患者出现严重心脏或神经毒性。无治疗相关死亡。存活患者中位随访41个月，缓解患者的中位疾病进展时间和总生存时间分别为18个月和33个月，10例长期存活者仍存活。
本研究证实阿霉素-多西他赛联合方案对转移性乳腺癌是一种非常有效的治疗方案。不仅完全缓解患者，部分缓解患者也观察到显著延长的生存时间。这可能同样归因于一线治疗和序贯维持激素治疗。
