Lakshmaiah K C, Rudresha A H, Suresh T M, Lokanatha D, Babu G K, Jacob L A
Department of Medical Oncology, Kidwai Memorial Institute of Oncology, Bangalore, Karnataka, India.
Indian J Cancer. 2015 Jan-Mar;52(1):65-8. doi: 10.4103/0019-509X.175601.
The aim of this study is to assess the efficacy and toxicity of 5-flurouracil (5-FU) and cisplatin (PF) versus taxane and cisplatin (TP) as induction chemotherapy in locally advanced head and neck squamous cell cancer.
There were 50 patients in each arm, matched for age, performance state, site and stage of disease. PF arm (cisplatin - 100 mg/m2 D1, 5-FU - 1000 mg/m2 D1-D5) TP arm (docetaxel - 75 mg/m2 or paclitaxel - 175 mg/m2 on D1, cisplatin 75 mg/m2 on D2), received once in 3 weeks for 3 cycles. Patients without progressive disease underwent either surgery or chemoradiation. The primary end point was overall response rate (ORR) and secondary endpoint was toxicity.
In a total of 100 patients in our study, 44 in PF and 47 in TP arm were evaluable. ORR was 86.6% in PF arm and 82.9% in TP arm (P = 0.71).There were more Grade 3 or 4 events of neutropenia, mucositis (P ≤ 0.05) and myelosuppression diarrhea, febrile neutropenia (P ≥ 0.05) in PF arm compared with TP arm. Post-chemotherapy hospital admissions due to toxicity were more frequent in PF arm (38.6% vs. 19%), dropout rate due to toxicity (9% vs. 0%) and deaths (6.8% vs. 2.1%) were more common in PF arm compared with TP arm.
TP induction chemotherapy better tolerated than PF, which has similar efficacy, further multicenter randomized controlled studies; involving a large sample size is needed to confirm our data.
本研究旨在评估5-氟尿嘧啶(5-FU)和顺铂(PF)与紫杉烷和顺铂(TP)作为局部晚期头颈部鳞状细胞癌诱导化疗的疗效和毒性。
每组有50例患者,根据年龄、体能状态、疾病部位和分期进行匹配。PF组(顺铂-100mg/m²第1天,5-FU-1000mg/m²第1 - 5天),TP组(多西他赛-75mg/m²或紫杉醇-175mg/m²第1天,顺铂75mg/m²第2天),每3周给药1次,共3个周期。无疾病进展的患者接受手术或放化疗。主要终点是总缓解率(ORR),次要终点是毒性。
在我们研究的总共100例患者中,PF组44例和TP组47例可评估。PF组的ORR为86.6%,TP组为82.9%(P = 0.71)。与TP组相比,PF组3/4级中性粒细胞减少、粘膜炎(P≤0.05)以及骨髓抑制性腹泻、发热性中性粒细胞减少(P≥0.05)的事件更多。由于毒性导致的化疗后住院在PF组更频繁(38.6%对19%),与TP组相比,PF组因毒性导致的退出率(9%对0%)和死亡率(6.8%对2.1%)更常见。
TP诱导化疗的耐受性优于PF,二者疗效相似,需要进一步开展多中心随机对照研究,纳入大样本量以证实我们的数据。