Chollet P, Charrier S, Brain E, Curé H, van Praagh I, Feillel V, de Latour M, Dauplat J, Misset J L, Ferrière J P
Centre Jean Perrin, Clermont-Ferrand, France.
Eur J Cancer. 1997 May;33(6):862-6. doi: 10.1016/s0959-8049(97)00038-5.
Neoadjuvant chemotherapy is used to improve patients' survival in locally-advanced and inflammatory breast cancer and to increase conservative surgical procedures in bulky tumours. Pathological complete responses are unusual. The aim of this pilot study was to assess the clinical and pathological response rates and to evaluate toxicity with a new protocol of primary chemotherapy in 50 high-risk breast cancer patients. All tumours were > 3 cm and had at least one other adverse prognostic factor: lymph node involvement (32 N1, 6 N2), SBR grade III (20), aneuploidy (29), negative hormonal receptors (19). Patients were treated by 3-week cycles of THP-doxorubicin 20 mg/m2 D1 to 3, vinorelbine 25 mg/m2 D1 and 4, cyclophosphamide 300 mg/m2 and 5-fluorouracil 400 mg/m2 D1 to 4 (TNCF). 38 patients received G-CSF or GM-CSF support. After 4-6 cycles, all underwent surgery (39 conservative, 11 modified radical). Tumour response was assessed clinically, by mammography and echography and on pathological specimens. An objective clinical response was observed for 43 patients: 26 complete (51%) and 18 partial (37%). After pathological review, 11 patients (22%) were devoid of any tumour cells, 4 others (8%) had only in situ carcinoma. From 253 evaluated cycles, grade III-IV toxicity occurred, 81% with neutropenia, 25% with anaemia, and 20% with thrombocytopenia. All patients recovered. This regimen induced a severe but not life-threatening haematological toxicity and resulted in a high pathological response rate (30%).
新辅助化疗用于提高局部晚期和炎性乳腺癌患者的生存率，并增加对体积较大肿瘤的保乳手术率。病理完全缓解并不常见。本前瞻性研究的目的是评估50例高危乳腺癌患者采用新的原发性化疗方案后的临床和病理缓解率，并评估毒性。所有肿瘤均大于3cm，且至少有一个其他不良预后因素：淋巴结受累（32例N1，6例N2）、SBR III级（20例）、非整倍体（29例）、激素受体阴性（19例）。患者接受为期3周的化疗周期，具体方案为：吡柔比星20mg/m²，第1至3天；长春瑞滨25mg/m²，第1天和第4天；环磷酰胺300mg/m²，5-氟尿嘧啶400mg/m²，第1至4天（TNCF）。38例患者接受了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）支持。4至6个周期后，所有患者均接受了手术（39例保乳手术，11例改良根治术）。通过乳腺X线摄影、超声检查及病理标本评估肿瘤反应。43例患者观察到客观临床反应：26例完全缓解（51%），18例部分缓解（37%）。病理检查后，11例患者（22%）未见任何肿瘤细胞，另外4例（8%）仅存在原位癌。在253个评估周期中，发生了III-IV级毒性反应，81%为中性粒细胞减少，25%为贫血，20%为血小板减少。所有患者均康复。该方案引起了严重但不危及生命的血液学毒性，并导致了较高的病理缓解率（30%）。
