CAJ | 학술논문

目的初步探讨洛铂联合5-氟尿嘧啶(5-Fu)诱导化疗加洛铂同期放化疗治疗局部区域中晚期鼻咽癌的安全性、有效性以及同期洛铂放化疗的适宜剂量.方法未行抗肿瘤治疗的初治局部区域中晚期鼻咽癌患者签署知情同意书.诱导化疗方案为洛铂30 mg/m2+5-Fu 4 g/m2持续静脉滴注120 h,每21d为1个疗程,共2个疗程；同期化疗起始剂量为洛铂50 mg/m2,每21 d重复.每剂量组至少入组患者3例.3例患者中出现2例剂量限制性毒性(DLT)则化疗剂量降5 mg/m2,直至达到最大耐受剂量(MTD).2个疗程诱导化疗后、放疗结束、放疗后3个月及放疗后6个月评价疗效.结果 2011年12月至2012年4月,共11例患者入组.2个疗程诱导化疗后完全缓解1例,部分缓解8例,稳定2例.放化疗结束及放疗后3个月评价疗效显示完全缓解10例,部分缓解1例.放疗结束6个月,所有患者均显示为完全缓解.洛铂50 mg/m2同期化放疗组的3例患者中2例出现DLT;45 mg/m2组的3例患者出现2例DLT;40 mg/m2组5例均未出现DLT,因此推荐洛铂联合5-Fu诱导化疗后的洛铂同期放化疗MTD为40 mg/m2.主要DLT为血小板抑制.结论洛铂联合5-Fu诱导化疗加洛铂同期放化疗治疗局部区域中晚期鼻咽癌安全性好,可以取得较满意的疗效,诱导化疗后洛铂同期放化疗MTD为40 mg/m2,进一步扩大样本量的临床研究值得期待.
목적 초보탐토락박연합5-불뇨밀정(5-Fu)유도화료가락박동기방화료치료국부구역중만기비인암적안전성、유효성이급동기락박방화료적괄의제량.방법 미행항종류치료적초치국부구역중만기비인암환자첨서지정동의서.유도화료방안위락박30 mg/m2+5-Fu 4 g/m2지속정맥적주120 h,매21d위1개료정,공2개료정；동기화료기시제량위락박50 mg/m2,매21 d중복.매제량조지소입조환자3례.3례환자중출현2례제량한제성독성(DLT)칙화료제량강5 mg/m2,직지체도최대내수제량(MTD).2개료정유도화료후、방료결속、방료후3개월급방료후6개월평개료효.결과 2011년12월지2012년4월,공11례환자입조.2개료정유도화료후완전완해1례,부분완해8례,은정2례.방화료결속급방료후3개월평개료효현시완전완해10례,부분완해1례.방료결속6개월,소유환자균현시위완전완해.락박50 mg/m2동기화방료조적3례환자중2례출현DLT;45 mg/m2조적3례환자출현2례DLT;40 mg/m2조5례균미출현DLT,인차추천락박연합5-Fu유도화료후적락박동기방화료MTD위40 mg/m2.주요DLT위혈소판억제.결론 락박연합5-Fu유도화료가락박동기방화료치료국부구역중만기비인암안전성호,가이취득교만의적료효,유도화료후락박동기방화료MTD위40 mg/m2,진일보확대양본량적림상연구치득기대.
Objective To observe the safety and effectiveness of inductive chemotheray with lobaplatin plus 5-Fu (LF regimen) and concurrent chemoradiotherapy with lobaplatin for local-regionally advanced nasopharyngeal carcinoma (NPC) patients,and investigate the appropriate lobaplatin dose for the concurrent chemoradiotherapy.Methods Newly diagnosed local-regionally advanced NPC patients signed informed consent.The inductive chemotherapy was lobaplatin 30 mg/m2 + 5-Fu 4 g/m2 civ 120 h for 2 cycles every 21 days,then concurrent lobaplatin chemoradiotherapy was conducted.The initial lobaplatin dose for concurrent chemoradiotherapy was 50 mg/m2 with at least 3 cases in every dose level.If 2 of 3 patients presented dose-limiting toxicity (DLT),5 mg/m2 dose decreased for the next level until maximal tolerant dose (MTD) reached.The tumor response was evaluated after inductive chemotherapy,at the end of the chemoradiotherapy,3 months after chemoradiotherapy and 6 months after chemoradiotherapy.Results From Dec 2011 to Apr 2012,11 patients were enrolled in this study.After 2 courses of inductive chemoradiotherapy,CR,PR and SD were observed in 1,8 and 2 patients,respectively.At the end of the chemoradiotherapy and 3 months after chemoradiotherapy,CR and PR were observed in 10 and 1 patients,respectively.Six months after the chemoradiotherapy,all patients were CR.For the patients(3 in each arm) received 50 mg/m2 or 45 mg/m2 lobapaltin concurrent chemoradiotherapy,2 patients in each arm presented DLT.For the 5 patients received 40 mg/m2 lobapaltin concurrent chemoradiotherapy,no patients presented DLT.40 mg/m2 was suggested as the MTD.Inhibition of platelet was the major DLT.Conclusion Inductive chemotherapy with LF regimen and concurrent chemoradiotherapy with lobaplatin is safe and effective for local-regionally advanced NPC patients and the MTD of lobaplatin for the concurrent chemoradiotherapy is 40 mg/m2.Further clinical trial with large sample is expected.