CAJ | 학술논문

背景与目的：恶性肿瘤一线化疗后多出现复发或转移，需要二线及以上治疗。本研究旨在确定洛铂联合固定剂量多西紫杉醇治疗化疗后进展的实体肿瘤时洛铂的最大耐受剂量(maximum-tolerated dose，MTD)，并评价其不良反应。方法：应用改良的Fibonacci法进行洛铂剂量递增，固定多西紫杉醇剂量为60 mg/m2，洛铂初始剂量为30 mg/m2，组间递增剂量为5 mg/m2，每21天重复。每组至少3例，如1个剂量组中3例均无剂量限制性毒性(dose-limiting toxicity，DLT)出现，则进入下1个剂量组，直至出现DLT，DLT的低一剂量水平即为MTD。结果：17例患者共完成58个周期化疗，进行3个剂量组的研究(洛铂分别为30、35、40 mg/m2)，完全缓解(complete response，CR)0例，部分缓解(partial response，PR)1例，疾病稳定(stable disease，SD)10例，疾病进展(progression disease，PD)3例；有效率(response rate，RR，CR+PR)为7.1%(1/14)，疾病控制率(disease control rate，DCR，CR+PR+SD)为78.6%(11/14)。主要不良反应为白细胞下降，3例出现DLT，其中2例发生在洛铂40 mg/m2组。确定洛铂35 mg/m2组为MTD。结论：本组洛铂联合固定剂量多西紫杉醇的MTD为35 mg/m2，其不良反应可耐受。
배경여목적：악성종류일선화료후다출현복발혹전이，수요이선급이상치료。본연구지재학정락박연합고정제량다서자삼순치료화료후진전적실체종류시락박적최대내수제량(maximum-tolerated dose，MTD)，병평개기불량반응。방법：응용개량적Fibonacci법진행락박제량체증，고정다서자삼순제량위60 mg/m2，락박초시제량위30 mg/m2，조간체증제량위5 mg/m2，매21천중복。매조지소3례，여1개제량조중3례균무제량한제성독성(dose-limiting toxicity，DLT)출현，칙진입하1개제량조，직지출현DLT，DLT적저일제량수평즉위MTD。결과：17례환자공완성58개주기화료，진행3개제량조적연구(락박분별위30、35、40 mg/m2)，완전완해(complete response，CR)0례，부분완해(partial response，PR)1례，질병은정(stable disease，SD)10례，질병진전(progression disease，PD)3례；유효솔(response rate，RR，CR+PR)위7.1%(1/14)，질병공제솔(disease control rate，DCR，CR+PR+SD)위78.6%(11/14)。주요불량반응위백세포하강，3례출현DLT，기중2례발생재락박40 mg/m2조。학정락박35 mg/m2조위MTD。결론：본조락박연합고정제량다서자삼순적MTD위35 mg/m2，기불량반응가내수。
Background and purpose: Malignant tumors often relapsed or metastasized after first-line chemotherapy and needed second-line or above treatment. We conducted this study to deifne the maximum-tolerated dose (MTD) of lobaplatin with ifxed docetaxel for Chinese patients in previously treated solid tumors. Methods:Escalating doses of lobaplatin with fixed docetaxel were administered in a modified Fibonacci sequence. The initial doses were lobapla-tin 30 mg/m2 and docetaxel 60 mg/m2, respectively. Escalating doses was 5 mg/m2. The regimen was repeated every 21 days. If no dose-limiting toxicity (DLT) was observed, the next dose level was applied. The procedures were repeated until DLT appeared. The MTD was declared to be one dose level below the level at which DLT appeared. Results:Seventeen patients received fifty-eight cycles chemotherapy at lobaplatin of levelⅠ(30mg/m2), levelⅡ(35 mg/m2)and levelⅢ(40 mg/m2). Cases of complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) for the whole group were 0, 1, 10 and 3, respectively. Response rate (RR, CR+PR) and disease control rate (DCR, CR+PR+SD) were 7.1%(1/14) and 78.6%(11/14), respectively. The most common toxicity was leukopenia. Three DLTs occurred in 3 patients in the whole group, including 2 DLTs in dose levelⅢ. We declared thus levelⅡwas MTD. Conclusion:MTD of lobaplatin in our re-search was 35 mg/m2 combined with fixed dose of docetaxel. This combination regimen was well tolerated.