Abstract
Recombinant interleukin 2 (rIL-2) and flavone acetic acid (FAA) were used to treat 34 patients with progressing metastatic melanoma. Five patients had solely non-visceral disease and the median number of organ sites involved was two. Five doses of rIL-2 were given, the first dose intrasplenically via a femoral artery catheter with a further dose 4 h later i.v. and the other doses i.v. on alternate days. The rIL-2 dose was 11 x 10(6) Cetus units m-2; the day before rIL-2, FAA (4.8 G m-2) was given as a 6 h i.v. infusion, in order to enhance further killer cell activity. A total of three courses at 21-day intervals was planned and 74 courses in all were given. Despite the high dose of rIL-2 and the potential overlapping toxicity affecting blood pressure with the addition of FAA, side-effects were generally mild. There were only five episodes of grade 4 toxicity: one of ventricular tachycardia and four other episodes of transient biochemical or haematological disturbance. Grade 3 hypotension or hypertension occurred on 22 courses but again was transient. No patient required intensive care facilities. Five patients had tumour response, one being complete. Responses occurred in pulmonary and hepatic metastases, but mainly in non-visceral sites. Eleven patients remain alive at 6-17 months and in five there is no relapse or progression of disease. Despite the impressive results in animal tumour models, the addition of FAA to rIL-2 in the present study has not markedly improved results over rIL-2 alone.
Highlights
We report on the results of a phase II study using flavone acetic acid (FAA) and IL-2 in advanced malignant melanoma
Patient population Thirty-four patients with metastatic, progressing melanoma were entered into this study which commenced in January 1988 and was completed in March 1989
The median cumulative dose of Recombinant interleukin 2 (rIL-2) in the present study with FAA was 12.0 x 107 U m-2 with 9% of doses being omitted because of toxicity. These values are very similar to the preceding phase II, rIL-2 alone study, with a cumulative dose of 14.0 x 107 U m2 and 11% of doses omitted, these data were only from 16 patients
Summary
Patient population Thirty-four patients with metastatic, progressing melanoma were entered into this study which commenced in January 1988 and was completed in March 1989. All patients had clinically evaluable disease and none had received antitumour treatment within 4 weeks before study entry. Nine patients had received previous DTIC melphalan with or without local radiotherapy. To be eligible all patients had to have a Karnofsky score >,50, be without major cardio respiratory disease of nononcological nature and have no obvious CNS metastases, routine CT brain scans were not performed. Pretreatment investigations included routine haematology and biochemistry with isotope and other scans as necessary to measure and evaluate disease. The metastatic pattern in the 34 patients is shown in Table I; only five patients had solely non-visceral disease ie metastases limited to skin, superficial soft tissues and peripheral lymph nodes
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