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A phase II study of days 1 and 8 cisplatin and recombinant alpha‐2B interferon in advanced non‐small cell lung cancer
Author(s) -
Rosell R.,
Carles J.,
Moreno I.,
Ribelles N.,
Solano V.,
Barnadas A.,
Abad A.,
Ariza A.,
Pellicer I.
Publication year - 1991
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/1097-0142(19910515)67:10<2448::aid-cncr2820671009>3.0.co;2-2
Subject(s) - medicine , cisplatin , alpha interferon , lung cancer , toxicity , interferon alfa , chemotherapy , gastroenterology , interferon , alpha (finance) , phases of clinical research , stage (stratigraphy) , oncology , urology , surgery , immunology , paleontology , construct validity , biology , patient satisfaction
Preclinical data from studies of human lung cancer xenografts suggest that the cytotoxic effects of cisplatin are enhanced by alpha‐interferon. To verify the above observations, the authors initiated a Phase II trial in advanced non‐small cell lung cancer (NSCLC). Cisplatin was given at 100 mg/m 2 during a 28‐day cycle in a divided day 1 and day 8 schedule. Starting on day 1, alpha‐2B interferon was administered intramuscularly at a dose of 5 million units three times a week continuously for a minimum of 2 months. Between January 1989 and September 1989, 30 patients were evaluated for response and toxicity. According to the staging system proposed by Mountain, 20 patients had Stage IV disease, 7 had Stage IIIB disease, and 3 had Stage IIIA disease. Expression of neuron‐specific enolase (NSE) and Leu‐7 was immunohistochemically investigated to evaluate possible relationship to treatment response. The response rate was 13.3% (95% confidence interval [CI]: 1.2% to 25%). The four responders showed positivity for NSE, and two of them were positive for Leu‐7. An average of three cycles was given. The mean dose intensity administered was 83% of the projected dose for cisplatin and 92% of the projected dose for alpha‐2B interferon. A standard scale was used to assess interferon toxicity. Hematologic, renal, and systemic side effects were not significant. In advanced NSCLC the addition of alpha‐2B interferon did not increase the cisplatin‐induced response rate. Further studies should be performed to determine the real value of chemotherapy response in tumors showing positive immunoreactivity for neural markers such as NSE and Leu‐7.