Concomitant chemotherapy and IFN-alpha for small cell lung cancer: a randomized multicenter phase III study.
Patients with any stage of small cell lung cancer were given low-dose interferon-alpha (IFN-alpha) from the first day of treatment as long as possible irrespective of changes in treatment dictated by disease progression. All patients received 6 cycles of the chemotherapy (CT): cisplatin 70 mg/m2 i.v. day 1 and etoposide 100 mg/m2 i.v. days 1, 2, 3 every 28 days. Seventy-eight patients were assigned to arm 1: CT alone, 75 patients to arm 2: CT + natural IFN-alpha (3 MU three times a week i.m.), and 66 patients to arm 3: CT + recombinant IFN alpha-2a (3 MU three times a week i.m.). There was no difference in median survival between the arms (10.2 months, 10.0 months, 10.1 months, respectively), p = 0.32. The 2-year survival rates were 15%, 3%, and 11%, respectively. Grade 3 and 4 leukopenia occurred more frequently in the IFN arms than in the CT alone arm and resulted in dose reductions. Antibodies occasionally developed to recombinant IFN. We conclude that IFN-alpha can be administered concomitantly with chemotherapy but is probably better kept for maintenance therapy so that optimal full doses of induction CT can be given.
Ruotsalainen
T M
TM
Department of Medicine, Helsinki University Central Hospital, Finland.
Halme
M
M
Tamminen
K
K
Szopinski
J
J
Niiranen
A
A
Pyrhönen
S
S
Riska
H
H
Maasilta
P
P
Jekunen
A
A
Mäntylä
M
M
Kajanti
M
M
Joensuu
H
H
Sarna
S
S
Cantell
K
K
Mattson
K
K
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D018288:Carcinoma, Small Cell / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007370:Interferon Type I / Q000008:administration & dosage; D016898:Interferon-alpha / Q000008:administration & dosage; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins; D016896:Treatment Outcome
D007370:Interferon Type I; D016898:Interferon-alpha; D011994:Recombinant Proteins