한국형 자궁경부 촬영진 ( New Cervicography ) , 세포검사 그리고 HPV-DNA 검사를 이용한 새로운 자궁경부암 검진 모델 ( Model ) 개발

김승조(SJ Kim),박찬규(CK Park),이효표(HP Lee),남궁성은(SE Namkoong),강순범(SB Kang),서호석(HS Saw),이재관(JK Lee),김수녕(SN Kim),김재원(JW Kim),배석년(SN Bae),김찬주(CJ Kim),이근호(KH Lee),이선영(SY Lee),김인호(IH Kim),이찬(C Lee),이정노(JN Lee) 대한산부인과학회 2001 Obstetrics & Gynecology Science Vol.44 No.5

N/A Objective : The false negative rate of conventional cytology is reported to range from 18 to 45%. It is necessary to develop more effective screening strategies that would ideally be more accurate than conventional cytology. This study is designed to investigate the potential of conventional cytology, cervicography, HPV-DNA testing and their combinations as primary screening techniques for cervical neoplasia. The purpose of this project is to develop the models and guidelines for screening tools of cervical cancer of the uterus by evaluating sensitivity, specificity and cost-effectiveness of all the screening methods. Study design : We conducted a screening of random sample of women who visited the department of OB-Gyn. of five different major university hospitals such as Catholic University Hospital, Korea University Hospital, Seoul National University Hospital, Yeonsei University Hospital and Pochon CHA University Bundang CHA Hospital, from May 1, 1996 to April 30, 1999. In a cohort women with an age range of 20 to 70 who underwent routine cytologic screening at Catholic University, Hospital Bundang CHA General Hospital and local clinics from April 1, 1996 to Decomber 31, 2000. cervicography (n=417,125) and testing for HPV-DNA (n=1,347) by the hybrid capture assay were studied for the ability of the cervical cancer screeuing. A new cervicography system with Kim's classification which was developed by Prof. Kim Seung Jo as an adjunctive method for the cervical cancer screening was applied in this cohort study. And then, accuracy, effectivencess, cost-effectiveness of the single or combined screening method were analysed. Result : Sensitivity and specificity of Pap smear were ranged from 55.6% to 83.1% and 72.8% to 88.3% respectively. The combination of Pap smear and cervicography had sensitivity from 89.7% to 98.6%, specificity from 68.2% to 93.2%. With combination of Pap smear, HPV DNA test and cervicography, sensitivity became also highest accuracy among all screening methods from 92.8% to 98.8%. Considering medical charges for diagnosis and social cost occurred by false positive and false negative results, the most cost-effective diagnostic modality was thought to be the combination of Pap smear and cervicography(91,433 won). In patients who were diagnosed as LSIL, colposcopic examination confirmed progression to high grade intraepithelial lesion(HSIL) in 10.7% patients, persistence of LSIL in 55% patients during the 3 year follow-up period. Accuracy of the screening for cervical cancer and CIN can significantly be improved by cytology with new cervicography rather than cytology alone. We concluded that cervicography can be important adjunctive tests for cervical cytology, improving the effectiveness of cervical screening by allowing a more sensitive detection of cervical neoplasia.

조산아 호흡부전증후군 발생의 예측에 있어서 Lecithin-Shpingomyelin Ratio , Phosphatidylglycerol , Shake test, Stable Microbubble test의 유용성

김재원,김승욱,신희철,윤보현,전종관,구승엽 대한산부인과학회 1995 Obstetrics & Gynecology Science Vol.38 No.7

양수천자하여 얻은 검체로 폐성숙 여부에 대한 검사를 시행한 예중 양수천자와 분만간 간격 이 72시간이내이고 임신 37주 이전에 분만한 136건의 양수검체와 48건의 위흡인물을 대상으로 L/S ratio, PG측정, shake test, SM test를 시행하고 신생아 호흡 부전증후군의 예측능을 비교하여 다음과 같은 결과를 얻었다. 1. 136명 중 16명 (11.8%)에서 호흡부전증후군이 발생하였다. L/S ratio가 2.0 이상이었던 129 예 중 10예(7.8%)에서 2.0미만이었던 7예 중 6예(85.7%)에서 신생아 호흡부전증후군이 발생하였다. 2. 민감도는 SM test가 78%로 가장 높았고 특이도는 L/S ratio가 기준치를 2.0미만으로 할 경우 99%로 가장 높았다. 양성예측율은 L/S ratio기준치를 2.0미만으로 할 경우 86%로 가장 높았고 음성예측율은 모두 90% 이상이었다. 전체적인 정확도는 네 지표간 통계적 유의성이 없었다. 3. ROC curve를 이용한 L/S ratio 분석에서 기준치를 2.0미만으로 할 경우 민감도는 38% 특 이도는 99%, 정확도는 92%이다. 2.6미만일 경우 각각 56%, 89%, 85% 3.3미만일 경우 81%, 71% 72%이다. 4. 호흡부전증후군이 발생한 16명중 10명의 태아에서 L/S ratio가 (2.0미만 기준) 가음성이었 고, PG검사 가음성은 1명, shake test 검사 가음성은 3명, SM test 가음성은 2명이었다. 6명 은 두가지 검사에서 가음성을 나타냈다. 네가지 지표중 어느 것도 호흡부전증후군 발생을 예측하지 못한 경우는 2명이었다. OBJECTIVE : To ascetain the usefulness of the amniotic fluid lecithin-shpingomyelin(L/S) ratio, phosphatidlglyecrol(PG) determination, shake test and gastric aspirate stable microbubble test in the identification of neonates with respiratory distress syndrome delivered before 37 weeks` gestation. METHODS : Amniotic fluid samples of 136 women delivered before 37 gestational weeks and gastric aspirates of 48 preterm neonates requiring assessment of fetal lung maturity and delivering within 72 hours of amniocentesis were analyzed by the four lung matrutity tests accordingly. The accuracy in predicting respiratory distress syndrome(RDS) was assessed by conventional statistical techniques. Receiver operating characteristic(ROC) analysis was used to examine the L/S ratio and its performance as a diagnostic test in prediction RDS. RESULTS : Among 136 neonates, 16 neonates showed RDS on delivery within 3 days of testing. The stable microbubbles(SM) test had the best sensitivity(78%, 95% confidence limit [CL] 40.0-97.2) than any other and L/S ratio showed highest specificity(99%, 95% CL 95.4-99.9). All tests showed similarly low positive predictive values and high negative predictive values. However there was no significant difference in the overall accuracy between the four tests. When the cut-off L/S ratio value for the assessment of lung immaturity was set at below 2.0, the sensitivity, specificity and accuracy were 38%, 99%, 92% respectively. when set at below 2.6 and 3.3 the result were 56% 89% 85% and 81% 71% 72% respectively. Conclusions : ROC curve analysis of L/S ratio showed that it is a useful test in the indentification of RDS. And the other three indices also seem to be effective methods to identify RDS(sensitivity over 67% and specificity over 75%).

E6 , E7 , E1 유전자에 기초한 다중 중합효소 연쇄반응법에 의한 인유두종 바이러스 16 , 18형의 검출에 관한 연구

이효표,김재원 대한산부인과학회 1997 Obstetrics & Gynecology Science Vol.40 No.9

Epidemiological and experimental studies have established that specific human papillo- mavirus(HPV) types are strongly associated with cervical cancer. In understanding the role of HPV in the development of cervical cancer, more accurate and efficient detection method of various HPV types is warranted. Currently polymerase chain reaction(PCR)-based methods are the most commonly used one. Recently developed PCR systems, mainly, amplify a region of the L1 or E1 genes of HPVs which may not be integrated into host chromosome and more likely to produce false negative results. In this paper we describe the design and use of a simplified PCR system with high sensitivity in which all primers are multiplexed in the same PCR mixture. The full genomic sequence of HPV types were obtained from the HPV Sequence Data- base(http : //hpv-web.lanl.gov). Matrix, homology and alignment analyses were carried out by using computer programs such as CLUSTAL V, DNASIS^(TM) and Amplify. To determine the detection sensitivity of our PCR system, we have performed experiments using cloned HPV DNAs of type 16 and 18 serially diluted(10-fold dilutions from 10 picogram to 0.01 femtogram per assay) and in a cocktail. By alignment and comparing the sequences we located regions of outer and inner primer sequences based on the E6, E7 and E1 open reading frames which is usually integrated into host chromosome. Amplimer size were determined in order to be below than 400 base pair. The sensitivity of our PCR system ranged from the 1 copy per cell for HPV 16 and 10 copies per cell for HPV 18. This sensitivity was maintained when cloned HPV 16 and 18 DNAs were applied both indi- vidually and in a cocktail with variable mixing ratio. Our PCR system shows high sensitivity and specificity with minimal competitive inhibition between primers. This multiplex nested PCR system may be efficiently used for simultaneous detection and typing of HPV 16 and 18 in paraffin-embedded sections or rapid prepared samples.

만삭전 조기 양막파열 산모에서 양수내 감염의 발생양상 및 임상적 의의

이유미,김재원,김승욱,신희철,윤보현,전종관,양순하,채희동 대한산부인과학회 1994 Obstetrics & Gynecology Science Vol.37 No.9

분만진통이 선행되지 않은 만삭전 조기 양막파열을 주소로 서울대학교병원 산부인과에 입원한 산모 51명을 대상을 하여 경복부 천자를 시행하여 얻은 양수로 배양검사를 실시하고 임신의 경과와 분만된 신생아의 예후를 조사하여 다음과 같은 결과를 얻었다. 1. 양수 배양 결과 세균이 분리된 산모는 9명(17.6%)이었다. 2. 양수 배양양성군의 모든 산모가 조기 분만하였고 양수배양 양성군은 음성군에 비해 양수 천자에서 분만까지의 시간간격이 유의하게 짧았다. 3. 양수 배양양성군은 음성군에 비해 임상적 융모양막염의 발생률이 유으하게 높았으며 조직학적 융모양막염의 발생도 높은 경향을 보였다. 4. 양수 배양양성군의 신생아는 출생시 배양음성군의 신생아에 비해 임신주수 및 체중이 낮은 경향을 보였다. 5. 양수 배양양성군의 신생아 패혈증, 호흡부전증후군, 뇌실내 출혈, 기관지폐이형성증, 폐렴, 괴사성 장염 등의 신생아 이환율도 배양양성군에서 더 높았다. Objective: To determine the prevalence and microbiology of intraamniotic infection and to compare maternal and neonatal outcomes according to amniotic fluid culture results in patients with preterm premature rupture of membrances. Methods: Amniotic fluid was obtained by transabdominal amniocentesis in 51 patients with preterm premature rupture of membranes. Amniotic fluid was cultured for aerobic and anaerobic bacteria as well as for mycoplasmas. Fisheres exact test, Students t-test, and generalized Wilcoxon test for survival analysis were used for statistical comparisons. Results: 1) The prevalence of positive amniotic fluid cultures was 17.6%(9/51) and the most frequently isolated microorganism was Ureplasma urealyticum (n=7). 2) All patients with positive amniotic fluid culture delivered at preterm and the amniocetesis-to-delivery interval of patients with positive amniotic fluid cultures was significantly shorter than that of patients with negative amniotic fluid cultures (median 41.6 hr, range 7.5-295.0 hr vs. median 91.4 hr, range 2.5-3146.5 hr, respectively, p$lt;0.05:generalized Wilcoxon test for survival analysis). 3) The prevalence of clinical chorioamnionitis of the patients with positive amniotic fluid culture was significantly higher than that of patients with negative amniotic fluid culture. 4) The newborn infants born to mothers with positive amniotic fluid cultures had lower gestational ages and birth weights than those born to mothers with negative amniotic fluid cultures. 5) neonates of patients with positive amniotic fluid cultures had higher rate of perinatal complications than those with negative cultures. Conclusion : Microbial invasion of amniotic cavity is a risk factor for spontineous preterm delivery, perinatal morbidity and mortality in patients with preterm premature repture of membranes.

일측 질폐쇄와 신장 무발생을 동반한 중복자궁 3 례

이효표,김재원,박노현,이진용,오성일,이배훈,김문홍 대한산부인과학회 1997 Obstetrics & Gynecology Science Vol.40 No.7

Associated congenital anomalies of both reproductive and urinary tracts are frequent, because wolffian and mullerian developments are closely related. The combination of uterus didelphys, obstructive hemivagina, ana ipsilateral renal agenesis is a rare but specific syndrome. The most common clinical presentation is pelvic pain and/or dysmenorrhea shortly after menarche, in association with the finding of a vaginal or pelvic mass. An accurate and prompt diagnosis is of importance to permit treatment and to assure the future fertility of the patients. The simple and curative treatment of the condition is incision of the obstructing vaginal septum providing adequate drainage of the retained blood. We report three cases of uterus didelphys with an obstructed bemivagina and ipsilateral renal agenesis with a brief review of concerned literatures.

난소기형종에서 유래한 편평상피세포암 3 예

강순범,이효표,송용상,김재원,박노현,유상영,김은경,김수연,박인애 대한산부인과학회 1998 Obstetrics & Gynecology Science Vol.41 No.6

저자들은 1988년 1월부터 1997년 12월까지 서울대학병원 산부인과에서 조직학적으로 확진된 난소의 기형종에서 발생한 편평상피세포암 3예를 경험하였기에 임상 병리학적 소견 및 p53 면역조직화학염색 결과와 함께 보고하는 바이다. Squamous cell carcinoma of the ovary is very rare malignant tumor usually originating from the malignant transformation of mature cystic teratoma. Because of its rarity, the clinico-pathologic characteristics are not well established. We have experienced three cases of squamous cell carcinoma of the ovary arising in mature cystic teratoma. We investigated the clinical profiles and histopathologic features of these patients, and examined the presence of p53 mutations with immunohistochemical method. First, a 54-year-old woman with FIGO stage Ia survived for 124 months without adjunctive chemotherapy after total hysterectomy and bilateral salpingo-oophorectomy. Second, a 75-year-old woman with FIGO stage IIIc who had rejected adjunctive chemotherapy after total hysterectomy and bilateral salpingo-oophorectomy expired 3 months later. Third, a 39-year-old premenopausal woman with FIGO stage IIIb recurred after 7 months in spite of surgery and adjunctive chemotherapy. We report these three cases of squamous cell carcinoma arising in mature cystic teratoma of the ovary with brief review of literature.

원발성 침윤성 질암의 임상 양상과 인유두종 바이러스 감염 및 p53 상태

강순범,이효표,송용상,김재원,박노현,유상영,김미화,박인애 대한산부인과학회 1998 Obstetrics & Gynecology Science Vol.41 No.3

1984년 1월부터 1997년 5월까지 13년 동안 서울대학교병원 산부인과에 입원하였던 원발성 침윤성 질암 환자 19예를 대상으로 후향적 임상적 고찰을 하였으며, 12예의 파라핀 포매 조직에서 인유두종 바이러스 감염 및 p53 변이 여부를 검색하여 아래와 같은 결과를 얻었다. 1. 연령별 분포는 39세부터 77세까지 였으며, 중 간 나이는 56세였다. 51∼60세 사이가 7예[36.8%]로 가장 많았고, 41세부터 60세까지가 13예로 전체의 68.4%를 차지하였다. 2. 월경력 및 과거력상 14예[73.7%]가 폐경 후 상태였으며, 이전에 전자궁 절제술을 받은 경우가 5예[26.3%] 있었다. 증상 및 징후는 질출혈이 12예[63.2 %]로 가장 흔하였고, 질분비물이 4예[21.%], 질내 종괴 2예[10.5%]의 순이었다. 3. 병리조직학적 분류상 편평상피암이 10예[52.6 %], 선암이 4예[21.1%], 악성 흑색종이 4예[21.1%], 미분화암이 1예[5.3%]이었다. 4. FIGO 병기는 Ⅰ기 7예, Ⅱ기 8예, Ⅲ기는 없었 으며, Ⅳ기 4예였다. 5. 병변의 위치는 상부 1/3에 우세하였으며, 전· 후·측벽은 비슷한 정도로 분포하였다. 6. 일차적 치료 방법으로 7예에서 수술적 치료를, 12예에서 방사선 치료를 시행하였으며, 수술을 받은 3예에서 수술 후 보조적 방사선 치료를, 1예에서 보조적 항암제 치료를 시행하였다. 7. 치료 자체로 인한 사망예는 없었으며, 합병증 으로 직장-회음루, 염증을 동반한 림프낭종, 방사선 대장염, 질협착, 피부 괴사가 각각 1예씩 있었다. 8. 추적 관찰 가능했던 16예 중 동기간 중 무병 생존한 예는 6예[37.5%]였으며, 나머지 10예 중 3예에서는 지속성 암이 있었고, 2예에서는 국소적 재발암이, 5예에서는 원격장기 전이가 있었다. 이 중 6예는 사망하였고 치료 후 재발이나 사망까지의 평균 기간은 7.9개월이었다. 9. 중합효소연쇄반응 및 면역조직화학검사를 이용하여 HPV 감염 여부와 p53 변이를 확인한 결과, 12예 중 2예[16.7%]에서 HPV 감염이 있었으며, 1예는 16형과 18형, 1예는 18형 HPV DNA 양성이었다. P53 단백은 12예 중 8예[66.7%]에서 양성이었으며, 7예에서 HPV DNA 음성이었고, 1예에서 18형 HPV DNA 양성이었다. 이상의 결과는 HPV 감염이 원발성 침윤성 질암의 발생에 있어서 중요한 인자[major factor]가 아닐 가능성을 시사하며, p53 변이는 원발성 침윤성 질암의 발생에 중요한 기전으로 생각된다. Primary invasive carcinoma of the vagina is one of the rarest malignant tumors of the female genital tract, so the clinicopathologic characteristics are too difficult to be identified. Association with HPV as an etiologic factor and p53 status were not clearly demonstrated until now. Nineteen patients with primary invasive carcinoma of the vagina were treated at Seoul National University Hospital from 1984 to 1997. We reviewed their clinical records retrospectively and investigated the presence of HPV DNA by PCR and altered expression of p53 by immunohistochemistry[IHC] in paraffin-embedded tissue specimens. The median age of the patients was 56 years[range: 39∼77 years]. Five out of 19 patients had a history of previous hysterectomy. The most frequent presenting symptom was a vaginal spotting in 12 patients[63.2%]. Squamous cell carcinoma was the most common histologic type, followed by adenocarcinoma, malignant melanoma and undifferentiated carcinoma in order. Seven were FIGO clinical stage I[37%]; 8, stage II[42%]; 4, stage IV[21%]. Upper one third of vagina was the most commonly involved site[42.1%]. Among 7 surgically treated patients, 3 were managed with adjuvant radiotherapy and one with chemotherapy. Twelve patients were treated primarily with radiotherapy. Among 16 patients followed consistently [median follow-up 37 months], 10 had persistent or recurrent disease, and only six out of 16 followed were disease-free. Out of 12 patients investigated for HPV 16/18 and p53 status, two cases of SCCA were HPV DNA-positive. p53 was detected in 8 tumors. These findings suggest that multicenter cooperative studies are needed to identify the clinopathologic characteristics of this rare malignancy. Oncogenic HPVs may not be a major factor in the development of carcinoma of vagina and the detection of p53 probably is not related to poorer prognosis.

자궁경부암에서 선행보조 항암화학요법의 효과

강순범,이효표,송용상,김재원,박노현,고창원 대한산부인과학회 1997 Obstetrics & Gynecology Science Vol.40 No.2

Neoadjuvant chemotherapy is used as a new therapeutic modality in the treatment of locally advanced cervical cancer, but limited information is available regarding the effectiveness and survival. The aim of this study is to identify the factors concerning chemoresponsiveness and survival, and to evaluate the efficacy of neoadjuvant combination chemotherapy(NAC) for the patients with locally advanced cervical cancer in terms of 2-year disease-free survival (DFS). Between June 1987 and May 1992, 77 patients with bulky or locally advanced cervical cancer(FIGO Stage IB-III) received two or three courses of NAC. Sixty patients were treated with FP chemotherapy regimen consisting of 5-FU 1000mg/m²(day 1~day 5), CDDP 60mg/m²(day 1) and remaining 17 patients received EP chemotherapy consisting of Epirubicin 110mg/m²(day 1), CDDP 60mg/m²(day 1). After chemotherapy, patients were treated with surgery or radiotherapy according to feasibility. The effectiveness of NAC was evaluated for response by using World Health Organization criteria. Factors related to chemores ponse and survival were analyzed. The overall clinical response rate was 61%, which included a complete response(CR) in 16 patients(20.8%) and a partial response(PR) in 27 patients (40.2%). Mass size but none of the other parameters studied(age, stage, histologic type, chemotherapy regimen) was related to chemoresponsiveness. This therapy rendered radical surgery feasible in 58 evaluable cases(75.3%). Pretereatment characteristics were analyzed for response to NAC. Significantly lower response rates(38.2%) and lower 2-year DFS rates(48.7%) were found in stage II or III patients with tumor size more than 4 cm in diameter. Patients achieving CR or PR had a significantly improved 2-year DFS rate compared with those who did not respond. Lymph-node metastases were found after chemotherapy in 34.5%(20/58) of the surgically treated patients and less than 3 lymph node were involved in 10 patients. Pathologic parametrial involvement was found to be the most significant prognostic factor for recurrence. A 2-year DFS of 72% and 48.7% for stage IB-IIA, I IB-III, respectively, was found. According to chemoresponsiveness, these rate was 78% for responders and 31.6% for nonresponders, respectively. Poor chemoresponsiveness and uncertain survival benifits in stage II, III with bulky mass necessitate more effective therapeutic modalities in this group of patients.

자궁경부암 환자에서 융합단백 ELISA를 이용한 혈청내 인유두종 바이러스 16형 E7 항체검사

강순범,이효표,송용상,김재원,박노현,기선호 대한산부인과학회 1997 Obstetrics & Gynecology Science Vol.40 No.9

Background : Human papillomavirus(HPV) 16 is the most frequently found oncogenic HPV type in cervical cancer and the early protein E7 is considered to be one of the two major proteins involved in malignant transformation and maintenance of the transformed phenotype of the cells. It is suggested that serologic detection of anti-HPV antibody in serum can be used as a marker for HPV-associated cervical cancer. We evaluated the efficacy of enzyme-linked immunosorbent assay(ELISA) method for detecting antibodies circulating in human sera against E7 proteins of HPV 16 in patients with cervical cancer/cervical intraepithelial neoplasia(CIN) and in normal controls. Materials & Methods : We have developed a ELISA method using fusion proteins of HPV 16 E7, expressed in E. coli, as antigen to detect the anti-E7 antibody in human sera. Sera from 276 women(90 patients with invasive cervical cancers, 8 patients with CIN III and 178 healthy women) were tested for the presence of antibodies to E7 proteins. The results were compared with that of polymerase chain reaction(PCR) method. Results : Fifteen(16.7 %) of the 90 cervical cancer sera, one(12.5 %) of the 8 CIN sera and twelve (6.7 %) of the 178 normal sera were reactive with E7 proteins(cut-off value : absorbance (A) = 0.079, x + 3 SD). The detection rate of HPV 16 DNA by PCR were 45.5 %(41/90) in cervical cancer patients, 37.5 %(3/8) in CIN III patients, and 11.8 %(21/178) in normal controls Twelve(29.3 %) of 41 cervical cancer patients harboring HPV 16 DNA showed positive for the anti-E7 antobody. Although the positivity with ELISA was rather lower that of PCR. A statistically significant trend of increasing seropositivity was obtained( 2=6.48 ; df=1 ; p=0.011). The concordance rate between the results of ELISA and PCR was 64.4 %. Conclusion : The increasing seropositivity for HPV 16 E7 antibodies in association with malignant progression suggest that these antibodies may be a useful marker for HPV 16-associated cervical cancer. But the facts that in only about one-fifth portion of patients with cervical cancer showed the positive results in ELISA restricts the direct clinical applications. A search for more sensitive and specific serologic method for the detection of antibodies to HPV 16 E7 is needed.

Platinum제제를 기본으로 한 화학요법 후 재발한 난소암 환자에서 Taxol 포함 항암요법의 효용성

강순범,이효표,송용상,김재원,박노현,김용범,이철민,김미하 대한산부인과학회 1998 Obstetrics & Gynecology Science Vol.41 No.9

난소암은 조기진단이 어려워 진단 당시 이미 진행된 경우가 많으며, 일반적으로 종양감축술 후 platinum 제제를 기본으로 한 항암화학요법이 표준치료법으로 사용되고 있다. 그러나 치료 후 재발된 난소암과 치료 중에 나타나는 약제에 대한 저항성이 난소암의 치료에 있어서 가장 중요한 문제로 대두되고 있으며, 이를 극복하려는 노력의 일환으로 Taxol등을 비롯한 새로운 약제의 개발이 이루어지고 있다. 저자들은 platinum 제제를 기본으로 한 화학요법 후 재발하거나 저항성이 있는 난소암 환자들을 대상으로, Taxol을 포함한 항암요법의 치료 효과 및 부작용을 연구함으로써 임상적 유용성을 평가하고자 하였다. 1994년 4월부터 1997년 10월까지 서울대학교병원에서 진행성 난소암으로 platinum 제제를 기본으로 한 화학요법 치료 후 재발하거나 저항성이 있는 환자 31명을 대상으로 하였으며, 이 중 platinum 반응군은 11명, platinum 저항군은 20명이었다. Taxol은 cisplatin 혹은 carboplatin과 병합한 경우는 135 mg/m2를, Taxol 단독요법을 시행한 경우는 175 mg/m2를 24시간 동안 정맥 주사하였으며 매 3주마다 반복하였다. 치료 결과의 평가는 매 cycle마다 종양 표지 물질로서 CA-125 및 CEA를 측정하여 변화 추이를 관찰하였으며, CT나 MRI는 화학요법 시작 전과 끝난 후에 시행하였고, 치료에 대한 반응 및 부작용은 GOG 기준을 적용하였다. 평균 7.4회(3∼12회)의 항암화학요법 후, 9명이 완전관해, 2명이 부분관해를 보여 전체 반응률은 35.5%(11/31)이었으며, Platinum 반응군은 54.5%(6/11), platinum 저항군은 25%(5/20)의 반응률을 보였다. 전체 환자의 추적검사 기간은 13.4개월(3∼40개월)이었고 치료반응 기간은 10.1개월(1∼22개월)이었으며, platinum 반응군은 15.5개월(11∼22개월)이었고 platinum 저항군은 8.3개월(1∼16개월)이었다. Grade 3 이상의 과립구 감소증이 20%에서 나타났고, 이 중 1예에서는 감염에 의한 고열 증상이 있었다. Grade 3 이상의 간독성은 8%, Grade 3 이상의 소화기계 부작용은 8%이었으며 기타 다른 Grade 3, 4 독성은 발생하지 않았다. Taxol을 포함한 항암요법은 진행성 난소암에서 platinum 제제를 기본으로 한 화학요법 후 재발하거나 치료에 실패한 환자들의 일부에서 유용한 치료법이다. 그러나 cisplatin 저항군에서는 반응군에 비해 효과가 낮았으며, 이러한 제한점을 극복하기 위한 연구가 필요하다. Second-line Salvage chemotherapy with Taxol Containing Regimen in Recurrent or Refractory Ovarian Carcinoma after Platinum-Based Chemotherapy. Objectives: This study is to investigate the efficacy and toxicity of Taxol containing regimen used as a salvage therapy. Methods: Between April 1994 and October 1997, 31 patients aged 20∼70 years (median 53) with recurrent or refractory ovarian carcinoma were given Taxol-containing regimen. Taxol was administered at a dose of 135 mg/m2 intravenously with cisplatin or carboplatin every 3 weeks. The patients who treated with Taxol only were received 175 mg/m2 intravenously with same interval. The median treatment cycle was 7.4 cycles (range, 3 to 12 cycles). Patient`s response were evaluated with tumor marker (CA-125) and CT or MRI before and after chemotherapy. Responses and toxicities were defined according to the Gynecologic Oncology Group criteria. Result: The overall clinical response rate was 35.5% (11/31), including 9 complete response (CR) and 2 partial response (PR). Better response was observed in patients who had response with prior platinum based chemotherapy (6/11, 54.5%) than who did not (5/20, 25%). The median duration of follow up was 13.4 months (range, 3 to 40 months) and the median progression free interval was 10.1 months (range, 1 to 22 months); 15.5 months (range, 11 to 22 months) in platinum sensitive group and 8.3 months (range, 1∼16 months) in platinum resistant group. The most common and dose limiting toxicity was neutropenia, and grade 4 toxicity occurred in 10% of courses. Conclusion: Taxol containing regimen is useful combination chemotherapy in patients with previously platinum-sensitive patients with acceptable toxicity, but has limited role in chemo-refractory cases. Further prospective randomized trials are required to assess the optimal role of this drug in the management of ovarian cancer.