S. Mcdonald et al., COMBINED BETASERON-R (RECOMBINANT HUMAN INTERFERON-BETA) AND RADIATION FOR INOPERABLE NON-SMALL-CELL LUNG-CANCER, International journal of radiation oncology, biology, physics, 27(3), 1993, pp. 613-619
Citations number
31
Categorie Soggetti
Oncology,"Radiology,Nuclear Medicine & Medical Imaging
Purpose: Based on in vitro evidence of radiosensitization by Betaseron
(R) (beta-IFN), a Phase I/II study was undertaken to determine toxicit
y and response using combined radiation (RT) and B-IFN in patients wit
h unresectable Stage III and nonsmall cell lung cancer. Methods and Ma
terials: Varying doses of beta-IFN(10 to 90 X 10(6) IU) were administe
red IV immediately preceding RT on the first three days of weeks 1, 3,
and 5. The RT dose was 1.8 Gy/day, 5 days/week for a total of 54 or 5
9.4 Gy. Results: Thirty-nine patients were entered, 32 of whom were ev
aluable. The median follow-up time at time of analysis was 60 months.
Responses were based on CT scan. The response rate for the total group
was 81% with 44% achieving complete response. Seventy-eight percent o
f patients with complete response survived a minimum of 21 months. Twe
nty-six patients had Stage III A/B disease with a median tumor size of
6.5 cm. and median survival was 19.7 months. The 5-year actuarial sur
vival for this group was 31%, with a plateau persisting after 3 years.
There were no treatment related deaths nor any event of life threaten
ing toxicity. Of eight patients surviving 3-5 years, no long-term toxi
city has been observed. Karnofsky indices were 90-100 and respiratory
symptoms were minimal. Conclusion: Beta-IFN is well-tolerated. Respons
e and survival rates are sufficiently encouraging to warrant further i
nvestigation in a randomized trial which has been accepted as an RTOG
study awaiting drug availability.