Ribas A, Albanell J, Bellmunt J, Solé-Calvo L A, Bermejo B, Gallardo E, Vidal R, Vera R, Eres N, Carulla J, Baselga J
Medical Oncology Section, Hospital General Universitari Vall d'Hebron, Barcelona, Spain.
J Clin Oncol. 1996 May;14(5):1573-80. doi: 10.1200/JCO.1996.14.5.1573.
To analyze the safety and efficacy of a short course of granulocyte colony-stimulating factor (G-CSF) to maintain dose-intensity of subsequent cycles of chemotherapy after a prior episode of prolonged neutropenia, without febrile complications, in patients receiving adjuvant treatment for breast cancer.
Thirty-two patients undergoing adjuvant cyclophosphamide, methotrexate, and fluorouracil (CMF) or doxorubicin-CMF for stages I to II breast cancer were included after having chemotherapy delays due to neutropenia (absolute neutrophil count [ANC] < 1.5 x 10(9)/L) on day 22. G-CSF was administered subcutaneously on days 15 to 19 of each subsequent cycle.
None of the patients included in this study had to be admitted to the hospital for fever and neutropenia. The median percentage of the projected dose-intensity for CMF or doxorubicin-CMF on an intent-to-treat basis was 0.994, which was significantly higher than the delivered dose-intensity before the start of G-CSF treatment (P < .0001). Patients who received concomitant G-CSF and radiotherapy achieved a similar dose-intensity as patients who did not undergo radiotherapy. Seven patients discontinued G-CSF treatment due to musculoskeletal pain. These patients had more subsequent cycle delays because of day 22 neutropenia than the 25 patients who followed the G-CSF schedule (P = .0028).
A 5-day course of G-CSF in patients with prior chemotherapy delays due to prolonged neutropenia seems to be a safe and cost-effective schedule to maintain CMF or doxorubicin-CMF dose-intensity in the adjuvant treatment of breast cancer.
分析短期应用粒细胞集落刺激因子(G-CSF)在既往发生过无发热并发症的长时间中性粒细胞减少后维持后续化疗周期剂量强度的安全性和有效性,这些患者正在接受乳腺癌辅助治疗。
纳入32例接受I至II期乳腺癌辅助环磷酰胺、甲氨蝶呤和氟尿嘧啶(CMF)或多柔比星-CMF治疗的患者,这些患者在第22天因中性粒细胞减少(绝对中性粒细胞计数[ANC]<1.5×10⁹/L)导致化疗延迟。在每个后续周期的第15至19天皮下注射G-CSF。
本研究纳入的患者中无一例因发热和中性粒细胞减少而住院。在意向性治疗基础上,CMF或多柔比星-CMF预计剂量强度的中位数为0.994,显著高于G-CSF治疗开始前的实际剂量强度(P<.0001)。接受G-CSF与放疗联合治疗的患者达到的剂量强度与未接受放疗的患者相似。7例患者因肌肉骨骼疼痛停止G-CSF治疗。与遵循G-CSF治疗方案的25例患者相比,这些患者因第22天中性粒细胞减少导致更多后续周期延迟(P = .0028)。
对于既往因长时间中性粒细胞减少导致化疗延迟的患者,5天疗程的G-CSF似乎是在乳腺癌辅助治疗中维持CMF或多柔比星-CMF剂量强度的一种安全且具有成本效益的方案。