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II study of the arbeitsgemeinschaft Gynäkologische Onkologie (AGO) study group
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diagnoses of metastases were established by surgery (n=15) or clinical follow-up for at least 6 months (n=15) after the PET scan. Results: Twenty-one patients were confirmed of the metastasis or recurrence in 30 patients. The sensitivities of PET/CT/MRI/US/Markers for the detection of the intraperitoneal metastases were 91%/68%/75%/58%/45%, respectively. The sensitivities of PET/CT/MRI/US/Markers for retroperitoneal recurrence were 100%/63%/50%/55%/44%, respectively. The specificities of PET/CT/MRI/US/Markers for the detection or recurrence were 89%/83%/71%/78%/71%, respectively. Conclusion: FDG PET had a higher sensitivity for detecting both intraperitoneal and/or retroperitoneal metastases.
FC4.27.08 A TEN YEAR ANALYSIS OF 600 CASES OF OVARIAN CANCER SK Baneriee, K.Gupta, N.R. Mondol. Dept. of Gynecology, Cancer Center Welfare Home & Research Institute, Calcutta, India. Objectives: The aim of the study is to find the ideal method of treatment of ovarian cancer during a ten-year period in a referral oncology institute in India. Study Methods: 600 cases of ovarian cancer admitted to this institute have been analyzed from January 1990 to December 1999. Results: Ovarian carcinoma was found to be the second most common gynecological cancer at this institution, following cancer of the cervix. Most ovarian cancer was of epilithelial origin and present themselves in the advanced stage (Stage III & IV). Follow-up has been found to be unsatisfactory, and a five-year survival rate was dismal (6%). Conclusions: Effective screening to detect ovarian cancer early enough is unfortunately not economically viable in India. Though surgery is regarded as the gold standard, better results have been achieved with concomitant chemotherapy, particularly with regimes containing cisplatin, carboplatin and paclitaxel. Radiotherapy has been found to be of very limited use in the management of ovarian cancer.
FC4.27.09 GEMCITABINE (G) + CARBOPLATIN (C) AS 2”d LINE THERAPY IN GYNAECOLOGIC CANCER PATIENTS: A PHASE I/II STUDY OF THE ARBEITSGEMEINSCHAF-I GYN.&KOLOGISCHE ONKOLOGIE (AGO) STUDY GROUP .I. Ouaas, (Dept. OBIGYN, University Hospital, Greifswald, Germany), H.J. Liick, W. SchrGder, .I. Blohmer, R. Kimmig, V. MGbus, J. Pfisterer, A. du Bois for the Arbeitsgemeinschaft Gyn&ologische Onkologie (AGO) Study Group Objectives: Platinum (P) sensitive malignant tumors of the ovary (relapsing > 6 month after P and paclitaxel [T]) are usually treated with P monotherapy. An advantage for monotherapy vs. a combination therapy is not yet established. Due to a persisting neuropathy at the time of relapsing (caused by the primary Pn therapy), non-neurotoxic substances for a P combination are wanted. G is an improved active substance in ovarian cancer (OC). To establish a study arm for a randomized phase III trial we performed a phase I/II trial with G/C. Study Methods: 26 previously P and T treated patients (mostly OC) with a relapse > 6 months were treated on day 1 with C (dose: AUC 5 according to the Calvert formula); G (doses escalating 800-1000-1200 mg/mz) was given on day 1 and 8. Maximum tolerable dose (MTD) was considered to be reached if 216 pts. experience dose-limiting toxicity (DLT) defined as: Neutropenia grade 4 > 7 days, febrile neutropenia, grade 4 thrombocytopenia or major organ toxicity grade 3 or higher. Results: Neutropenia grade 314 in level I (12 p&./48 courses) and level II (6 p&./31 courses) was observed in 26% vs. 30%. Due to a grade 314 thrombocytopenia of 28% vs. 29% level 3 was cancelled and a Level IIa (G 1000 mg/mz day 1 and 8/C AUC 4 day 1) was established. There were no grade 4 hematologic and non-hematologic toxicity’s to observe (7 pts.) Conclusions :The combination of G (1000 mg/mz day 1 and 8) with C (AUC 4 day 1) q21x6 is safe to be recommended for phase III trials. A prospective randomized trial, comparing G/C with standard C in relapsed OC, has been initiated by the AGO OC Study Group in September 1999.
THURSDAY,
FC4.28 PREGNANCY
SEPTEMBER 7
COMPLICATIONS
FC4.28.01 RESISTANCE TO ACTIVATED PROTEIN C DURING PREGNANCY: LOW MOLECULAR WEIGm HEPARIN FOR OBSTETRIC THROMBO PROPHYLAXIS P. Bariot, G. Beucher, Y. Lindet, M. Herlicoviez, Dept. OBIGYB, University of Caen, Caen, France. Objective: Utilization, during pregnancy, of low molecular weight heparins for obstetric thromboprophylaxis for patients with activated protein C resistance, following Factor V Leiden mutation. Study Design: Prospective study enrolling 16 pregnant patients heterozygote or homozygote for Factor V Leiden mutation. They all have familial or personal history of severe thrombotic disease and received 40 mg per day of enoxaparine. Results: No thrombosis or hemorrhage was recorded during pregnancies or deliveries. All the infants were doing well. After birth, low molecular weight heparin were continued for 6 to 12 weeks, accordingly allelic status and history and no complications during post-partum were recorded. We reviewed literature on this subject. Conclusion: This series confirms the efficacy, safety and tolerance of low molecular weight heparins which will probably become next gold standard for obstetric thromboprophylaxis.
FC4.28.02 THE PREVALENCE OF THE FACTOR V LEIDEN MUTATION IN PREECLAMPSIA AND SUPERIMPOSED PREECLAMPSIA: IMPLICATIONS FOR CLINICAL OUTCOMES J., B. Nagy, Z. Ban, Z. Papp, Semmelweis University, Budapest, Hungary Objectives: The higher prevalence of Factor V Leiden mutation among women diagnosed with preeclampsia has been well-documented but among those with superimposed preeclampsia its role remains unclear. The aim of the study is to compare the prevalence of Factor V Leiden mutation in both severe and superimposed preeclampsia in order to investigate perinatal outcome in both Leiden positive and negative groups. Study Methods: One hundred and fifty-four pregnant Caucasian women diagnosed with hypertension and proteinuria were recruited to participate in the study and classified according to ACOG (American College of Obstetrics and Gynecology) guidelines. DNA was extracted from whole blood of ninety-nine preeclamptic and fifty-five superimposed preeclamptic patients. Factor V Leiden mutation was detected using Bertina’s PCR-RFLP methods modified with silver staining. Perinatial outcome (mean gestational age at deliver, mean birth weight, intrauterine growth retardation, HELLP syndrome, eclampsia) was then evaluated in the two groups. Statistical analysis was performed using SPSS (Windows Version 6.0). Intergroup comparisons were conducted using Mantel-Haenszel Chi square 01’) test while intragroup comparison were performed using unpaired Student’s t-test (~~0.05, CI 95%). Results: In the preeclamptic study group series (n=99), 16 (16.2%) were determined to be positive for Factor V Leiden mutation versus 13 (23.6%) in the superimposed preeclamptic group (n=55); all Leiden positive patients were heterozygous. We found no significant difference in perinatal outcome (birth weight, gestational age at delivery, rate of intrauterine growth retardation, HELLP syndrome and eclampsia) between Leiden positive preeclamptic and superimposed preeclamptic groups. Conclusions: As has been reported with respect to the prevalence of Factor V Leiden mutation among preeclamptic women, Factor V Leiden mutation also appears to play a role in superimposed preeclamptic populations. These results suggest that Factor V Leiden mutation may play a significant pathyophysiologic role and should be among the factors taken it into consideration when superimposed preeclampsia is diagnosed.
diagnoses of metastases were established by surgery (n=15) or clinical follow-up for at least 6 months (n=15) after the PET scan. Results: Twenty-one patients were confirmed of the metastasis or recurrence in 30 patients. The sensitivities of PET/CT/MRI/US/Markers for the detection of the intraperitoneal metastases were 91%/68%/75%/58%/45%, respectively. The sensitivities of PET/CT/MRI/US/Markers for retroperitoneal recurrence were 100%/63%/50%/55%/44%, respectively. The specificities of PET/CT/MRI/US/Markers for the detection or recurrence were 89%/83%/71%/78%/71%, respectively. Conclusion: FDG PET had a higher sensitivity for detecting both intraperitoneal and/or retroperitoneal metastases.
FC4.27.08 A TEN YEAR ANALYSIS OF 600 CASES OF OVARIAN CANCER SK Baneriee, K.Gupta, N.R. Mondol. Dept. of Gynecology, Cancer Center Welfare Home & Research Institute, Calcutta, India. Objectives: The aim of the study is to find the ideal method of treatment of ovarian cancer during a ten-year period in a referral oncology institute in India. Study Methods: 600 cases of ovarian cancer admitted to this institute have been analyzed from January 1990 to December 1999. Results: Ovarian carcinoma was found to be the second most common gynecological cancer at this institution, following cancer of the cervix. Most ovarian cancer was of epilithelial origin and present themselves in the advanced stage (Stage III & IV). Follow-up has been found to be unsatisfactory, and a five-year survival rate was dismal (6%). Conclusions: Effective screening to detect ovarian cancer early enough is unfortunately not economically viable in India. Though surgery is regarded as the gold standard, better results have been achieved with concomitant chemotherapy, particularly with regimes containing cisplatin, carboplatin and paclitaxel. Radiotherapy has been found to be of very limited use in the management of ovarian cancer.
FC4.27.09 GEMCITABINE (G) + CARBOPLATIN (C) AS 2”d LINE THERAPY IN GYNAECOLOGIC CANCER PATIENTS: A PHASE I/II STUDY OF THE ARBEITSGEMEINSCHAF-I GYN.&KOLOGISCHE ONKOLOGIE (AGO) STUDY GROUP .I. Ouaas, (Dept. OBIGYN, University Hospital, Greifswald, Germany), H.J. Liick, W. SchrGder, .I. Blohmer, R. Kimmig, V. MGbus, J. Pfisterer, A. du Bois for the Arbeitsgemeinschaft Gyn&ologische Onkologie (AGO) Study Group Objectives: Platinum (P) sensitive malignant tumors of the ovary (relapsing > 6 month after P and paclitaxel [T]) are usually treated with P monotherapy. An advantage for monotherapy vs. a combination therapy is not yet established. Due to a persisting neuropathy at the time of relapsing (caused by the primary Pn therapy), non-neurotoxic substances for a P combination are wanted. G is an improved active substance in ovarian cancer (OC). To establish a study arm for a randomized phase III trial we performed a phase I/II trial with G/C. Study Methods: 26 previously P and T treated patients (mostly OC) with a relapse > 6 months were treated on day 1 with C (dose: AUC 5 according to the Calvert formula); G (doses escalating 800-1000-1200 mg/mz) was given on day 1 and 8. Maximum tolerable dose (MTD) was considered to be reached if 216 pts. experience dose-limiting toxicity (DLT) defined as: Neutropenia grade 4 > 7 days, febrile neutropenia, grade 4 thrombocytopenia or major organ toxicity grade 3 or higher. Results: Neutropenia grade 314 in level I (12 p&./48 courses) and level II (6 p&./31 courses) was observed in 26% vs. 30%. Due to a grade 314 thrombocytopenia of 28% vs. 29% level 3 was cancelled and a Level IIa (G 1000 mg/mz day 1 and 8/C AUC 4 day 1) was established. There were no grade 4 hematologic and non-hematologic toxicity’s to observe (7 pts.) Conclusions :The combination of G (1000 mg/mz day 1 and 8) with C (AUC 4 day 1) q21x6 is safe to be recommended for phase III trials. A prospective randomized trial, comparing G/C with standard C in relapsed OC, has been initiated by the AGO OC Study Group in September 1999.
THURSDAY,
FC4.28 PREGNANCY
SEPTEMBER 7
COMPLICATIONS
FC4.28.01 RESISTANCE TO ACTIVATED PROTEIN C DURING PREGNANCY: LOW MOLECULAR WEIGm HEPARIN FOR OBSTETRIC THROMBO PROPHYLAXIS P. Bariot, G. Beucher, Y. Lindet, M. Herlicoviez, Dept. OBIGYB, University of Caen, Caen, France. Objective: Utilization, during pregnancy, of low molecular weight heparins for obstetric thromboprophylaxis for patients with activated protein C resistance, following Factor V Leiden mutation. Study Design: Prospective study enrolling 16 pregnant patients heterozygote or homozygote for Factor V Leiden mutation. They all have familial or personal history of severe thrombotic disease and received 40 mg per day of enoxaparine. Results: No thrombosis or hemorrhage was recorded during pregnancies or deliveries. All the infants were doing well. After birth, low molecular weight heparin were continued for 6 to 12 weeks, accordingly allelic status and history and no complications during post-partum were recorded. We reviewed literature on this subject. Conclusion: This series confirms the efficacy, safety and tolerance of low molecular weight heparins which will probably become next gold standard for obstetric thromboprophylaxis.
FC4.28.02 THE PREVALENCE OF THE FACTOR V LEIDEN MUTATION IN PREECLAMPSIA AND SUPERIMPOSED PREECLAMPSIA: IMPLICATIONS FOR CLINICAL OUTCOMES J., B. Nagy, Z. Ban, Z. Papp, Semmelweis University, Budapest, Hungary Objectives: The higher prevalence of Factor V Leiden mutation among women diagnosed with preeclampsia has been well-documented but among those with superimposed preeclampsia its role remains unclear. The aim of the study is to compare the prevalence of Factor V Leiden mutation in both severe and superimposed preeclampsia in order to investigate perinatal outcome in both Leiden positive and negative groups. Study Methods: One hundred and fifty-four pregnant Caucasian women diagnosed with hypertension and proteinuria were recruited to participate in the study and classified according to ACOG (American College of Obstetrics and Gynecology) guidelines. DNA was extracted from whole blood of ninety-nine preeclamptic and fifty-five superimposed preeclamptic patients. Factor V Leiden mutation was detected using Bertina’s PCR-RFLP methods modified with silver staining. Perinatial outcome (mean gestational age at deliver, mean birth weight, intrauterine growth retardation, HELLP syndrome, eclampsia) was then evaluated in the two groups. Statistical analysis was performed using SPSS (Windows Version 6.0). Intergroup comparisons were conducted using Mantel-Haenszel Chi square 01’) test while intragroup comparison were performed using unpaired Student’s t-test (~~0.05, CI 95%). Results: In the preeclamptic study group series (n=99), 16 (16.2%) were determined to be positive for Factor V Leiden mutation versus 13 (23.6%) in the superimposed preeclamptic group (n=55); all Leiden positive patients were heterozygous. We found no significant difference in perinatal outcome (birth weight, gestational age at delivery, rate of intrauterine growth retardation, HELLP syndrome and eclampsia) between Leiden positive preeclamptic and superimposed preeclamptic groups. Conclusions: As has been reported with respect to the prevalence of Factor V Leiden mutation among preeclamptic women, Factor V Leiden mutation also appears to play a role in superimposed preeclamptic populations. These results suggest that Factor V Leiden mutation may play a significant pathyophysiologic role and should be among the factors taken it into consideration when superimposed preeclampsia is diagnosed.