Therapeutische und prognostische Ergebnisse einer prospektiven multizentrischen Ovarialkarzinomstudie der FIGO-Stadien I und II

Abstract

Between April 1980 and December 1985 a prospective controlled and randomized multicenter study of 124 assessable patients with stage I and II epithelial ovarian carcinomas was carried out. The aims of this study were first to verify the value of adjuvant irradiation therapy or combined chemo-irradiation therapy, and second to evaluate the importance of different prognostic factors such as age, histology, tumor grading, and tumor stage. Patients with well-differentiated stage IA tumors did not receive any therapy; patients with undifferentiated stage IA tumors were randomized to "no therapy" or irradiation therapy; patients with stage IB, IIA, and IIB tumors were treated by either irradiation or a combined chemo-irradiation therapy consisting of Adriamycin/Cyclophosphamide. In patients with stage IC and IIC ovarian carcinomas a combined irradiation-polychemotherapy was instituted, consisting either of Adriamycin/Cyclophosphamide or of Adriamycin/Cisplatin. Because of the low number of patients and the relatively good prognosis no definite evaluation of the individual therapeutic modalities could be done. An analysis of all patients showed that differentiation between stage I and stage II ovarian carcinomas is the single most important prognostic factor. After a mean observation time of 42 months (8-71 months) for stage I tumors a 91% probability of three-year survival was attained, in comparison with 57% for stage II tumors. It has not been definitely established that there is a need for adjuvant therapy for stage I tumors and this should be confirmed by further studies. Because of the unfavorable prognosis for patients with stage II ovarian cancer, these patients should be given the same polychemotherapy, including Cisplatin, as patients with advanced ovarian carcinomas.

Adjuvant (post-surgery) chemotherapy for early stage epithelial ovarian cancer

“…Trial also known as GOG 175 Sell 1990 In this trial whole abdominal radiotherapy was compared to a combination of pelvic radiotherapy and cyclophosphamide. Additionally the block randomisation method did not achieve prognostic balance between the 2 trial arms Sevelda 1987 This was a trial of adjuvant radiotherapy versus adjuvant chemo-irradiation in early stage ovarian cancer Sigurdsson 1982 In this trial melphalan chemotherapy was compared to observation for mucinous stage Ia and Ib tumours, chemotherapy versus radiotherapy compared for non-mucinous stage Ia and Ib and radiotherapy versus chemoradiotherapy were compared in stage Ic-IIc. There was a stratified quasi-randomisation which did not achieve prognostic balance between the various trial arms Smith 1975 This trial compared melphalan chemotherapy versus whole abdominal radiotherapy; the method of randomisation was unspecified and more patients with stage 1 disease were in the chemotherapy arm Vergote 1992 This was a methodologically good trial with central computerised randomisation; it compared chemotherapy with intraperitoneal radio-isotope therapy Young 2000 The comparison was between 3 and 6 cycles of platinum-based adjuvant chemotherapy Young 2003 This was a trial comparing intraperitoneal radio-isotope therapy with cyclophosphamide and cisplatin chemotherapy after surgery in early stage disease; there was no control arm on observation only CAP = cyclophosphamide, adriamycin and cisplatin; CT = chemotherapy; RCT = randomised controlled trial; RT = radiotherapy …”