Treosulfan in the treatment of advanced ovarian cancer: a randomised co-operative multicentre phase III-study.

BACKGROUND: In August 1988 a randomised phase III multicenter trial was started in order to compare cisplatinum/treosulfan (PT) with standard cisplatinum/cyclophosphamide (PC) in advanced ovarian carcinoma, aiming at lower toxicity and maintained efficiency. PATIENTS AND METHODS: Five hundred and nineteen patients were enrolled into the protocol. Final evaluation after a median observation time of more than five years was made in July 1996 and included 398 eligible patients, of whom 366 were evaluable regarding efficiency and 290 in respect of toxicity. The tumour stages were classified as FIGO II in 53, FIGO III in 244 and FIGO IV in 68 patients. The patients were stratified regarding post-operative tumour burden. RESULTS: Hematological and gastrointestinal toxicity WHO > = 3 were comparable between the two study arms though a significant difference could be demonstrated regarding alopecia (PT 8% vs. PC 47% after six cycles). The median time to progression as the main efficiency item was in favour of the study schedule (PT 20.6 vs. PC 15.1 months) while significant differences were neither observed in the whole study group nor in the analysed subgroups (R0, < 2 cm, > = 2 cm). The same held true for overall survival. CONCLUSION: PT may be recommended as a less toxic substitute for the former standard PC. After the acceptance of paclitaxel/cisplatin as a new standard, the role of treosulfan should be investigated regarding adjuvant therapy in patients without residual tumor, as a potential partner in triple or sequential treatment and in second-line treatment.

[Acute phase proteins (C-reactive protein, orosomucoid, haptoglobin)--specific markers in the diagnosis of inflammatory adnexal diseases]. / Akute-Phase-Proteine (C-reaktives Protein, Orosomucoid, Haptoglobin)--Spezifische Marker bei der Diagnostik entzündlicher Adnex-erkrankungen.

The group of patients discussed here comprises 51 women admitted to hospital with diagnosed adnexitis. Twenty-seven patients whose diagnosis was confirmed by the correlation of pathologic laboratory parameters with examination findings or by laparoscopy or laparatomy were defined as adnexitis-positive. Apart from clinical examination findings, the evaluation analysis also included blood sedimentation rate, leukocytes and body temperature, as well as the acute-phase proteins C-reactive protein, orosomucoid, and haptoglobin. It was found that both clinical examination findings and normal laboratory parameters, as they have been set up to the present in normal clinical routine, were only partially useful in the diagnosis of an inflammatory adnexal lesion. Ultrasonic examination findings resulted in unequivocally positive or negative findings in roughly one-half of the cases. In contrast, the 27 inpatients receiving treatment for adnexitis had pathologically increased levels of C-reactive protein. In all 24 cases in which an inflammatory adnexal lesion was ruled out, a normal concentration (less than 0.6 mg/dl) of the same protein was found. Similarly good results were arrived at in the analysis of orosomucoid and haptoglobin. By means of follow-up controls of the acute-phase proteins, as opposed to measurement of BSR and leukocyte count, the success of treatment could also be determined unequivocally. For routine clinical procedures analysis of the inflammation marker C-reactive protein seems to be sufficient, since no additional information about the inflammatory lesion was obtained by assay of the other acute-phase proteins.(ABSTRACT TRUNCATED AT 250 WORDS)