CAJ | 학술논문

目的观察尼妥珠单抗联合顺铂和氟尿嘧啶(fluorouracil,5-Fu)方案作为诱导化疗治疗可切除的头颈部鳞癌患者的肿瘤缓解率、病理完全缓解率及化疗相关毒性.方法 2009年3月至2011年9月对初治的40例可切除的头颈部鳞癌患者以尼妥珠单抗(400 mg第1天)联合顺铂(75 mg/m2第1天)和5-Fu(750 mg/m2第1～5天)3周方案作为诱导化疗.两个周期后予以保留器官功能的根治性手术或根治性放化疗.主要研究终点为肿瘤缓解率、病理完全缓解率及化疗相关毒性.40例患者年龄中位数54岁.口咽癌9例(22.5％)、下咽癌16例(40.0％)、喉癌10例(25.0％)、口腔癌5例(12.5％).结果两个周期诱导化疗后肿瘤缓解率为85.0％(34/40).24例(60.0％)影像学降期,其中21例次(52.5％)达T降期,8例次(20.0％)达N降期.27例患者行诱导化疗后手术治疗,其中20例(74.1％)为保留器官功能的局部切除手术.4例术后原发灶病理完全缓解,占总入组患者数的10.0％ (4/40),占总手术患者的14.8％(4/27).2例(5.0％)出现Ⅲ～Ⅳ度中性粒细胞减少,Ⅲ～Ⅳ度恶心呕吐、口腔炎、血小板减少各1例(2.5％),1例患者出现Ⅱ度肾功能不全,1例患者出现Ⅰ度皮疹.结论尼妥珠单抗联合顺铂和5-Fu方案作为诱导化疗可提高头颈部鳞癌患者的肿瘤缓解率,且对其毒性耐受良好,多数患者通过诱导化疗保留了器官功能.
목적 관찰니타주단항연합순박화불뇨밀정(fluorouracil,5-Fu)방안작위유도화료치료가절제적두경부린암환자적종류완해솔、병리완전완해솔급화료상관독성.방법 2009년3월지2011년9월대초치적40례가절제적두경부린암환자이니타주단항(400 mg제1천)연합순박(75 mg/m2제1천)화5-Fu(750 mg/m2제1～5천)3주방안작위유도화료.량개주기후여이보류기관공능적근치성수술혹근치성방화료.주요연구종점위종류완해솔、병리완전완해솔급화료상관독성.40례환자년령중위수54세.구인암9례(22.5％)、하인암16례(40.0％)、후암10례(25.0％)、구강암5례(12.5％).결과 량개주기유도화료후종류완해솔위85.0％(34/40).24례(60.0％)영상학강기,기중21례차(52.5％)체T강기,8례차(20.0％)체N강기.27례환자행유도화료후수술치료,기중20례(74.1％)위보류기관공능적국부절제수술.4례술후원발조병리완전완해,점총입조환자수적10.0％ (4/40),점총수술환자적14.8％(4/27).2례(5.0％)출현Ⅲ～Ⅳ도중성립세포감소,Ⅲ～Ⅳ도악심구토、구강염、혈소판감소각1례(2.5％),1례환자출현Ⅱ도신공능불전,1례환자출현Ⅰ도피진.결론 니타주단항연합순박화5-Fu방안작위유도화료가제고두경부린암환자적종류완해솔,차대기독성내수량호,다수환자통과유도화료보류료기관공능.
Objective A phase Ⅱ study was conducted to test the efficacy and toxicity of the combination of cisplatin,5-Fu and nimotuzumab,as induction treatment of resectable head and neck squamous cell carcinoma (HNSCC).Methods Forty cases of resectable HNSCC were treated with nimotuzumab (400 mg on day 1 ) combined with PF regimens ( cisplatin 75 mg/m2 on days 1 and 5-Fu 750 mg/m2 on days 1 -5 q3wks ). After 2 cycles,an organ-preservation local therapy (surgery or radiotherapy) was recommended.The primary endpoints of this study were overall response rate,pathologic complete response and safety of the induction treatment.Mean age of 40 patients was 54 years old,of them 9 patients with oropharyngeal cancer (22.5％ ),16 hypopharyngeal cancer (40.0％ ),10 laryngeal cancer (25.0％),and 5 oral cancer (12.5％ ).Results With a 2-cycle induction treatment,34 (85.0％)patients achieved complete or partial response. Twenty-four patients (60.0％) got downstage,with T downstage in 21 (52.5％ ) patients and N downstage in 8(20.0％) patients.Totally 27 patients got surgery after the induction treatment,of them 20 patients (74.1％ ) preserved organ functions. Four patients' primary tumors ( 10.0％ in all 40 patients and 14.8％ in operated 27 patients) showed pathologically complete responses.The toxicity was mild and manageable.The most common grade 3/4 toxicities were neutropenia ( 5.0％ ),nausea/vomiting ( 2.5％ ),stomatitis ( 2.5％ ) and thrombocytopenia ( 2.5％ ).One patient got grade 2 renal insufficiency and one patient got grade 1 skin rash. Conclusion For resectable HNSCC,nimotuzumab plus PF regimen as induction treatment is highly effective for preserving the organ function and the toxicities are well tolerable.