513 Trial of oral hexalen for relapsed ovarian carcinoma [OV/CA]: Comparison of CA125 and EORTC response definitions

Between 11/91 and 11/94 71 patients (pt) with recurrent ov ca were entered into a trial of oral Hexalen 260 mg/m 2 in divided doses daily for 14 days per month [mo]. Eligibility criteria included a treatment free interval of >6 mo, complete clinical remission and serum CA125 75% (Rustin G, Ann Oncol suppl 4, 71–77:1993). Toxicity was assessed according to NCI criteria & is available on 65 pts. 13 pts were withdrawn because of toxicity which was mainly nausea [G 2 or 3 in 25], vomiting [G 2 or 3 in 18] and tiredness [G 2 or 3 in 17]. With increasing experience it was found that a combination of domperidone, dexamethasone & chlorpromazine at night controlled this toxicity in most pts. G 2 anaemia but not G 3 or 4 was seen in 5, G 2 or 3 neutropenia in 2 and G 1 & 3 thrombocytopenia in 2 pts. G 1 neurotoxicity was seen in 5 and G 2 in 6. Median treatment free interval was 12 mo. Responses [CR + PR] were seen in 15 (39%) [95% CI 24–55] of those evaluated according to EORTC & in 16 [36%] [95% CI 21–50) of those evaluated according to CA125. Overall response rate was 22 of 53 [42%] & was related to treatment free interval, 6 to 12 mo 32%, > 12 to 24 mo 60% and >24 mo 57%. Median duration of response was 8 mo. Oral Hexalen is a highly efficient & well tolerated agent in pts relapsing after previously responsive ov ca. Response evaluation by a strict CA125 definition gives similar conclusions regarding efficacy of Hexalen to the EORTC criteria.