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Combined Betaseron R (recombinant human interferon beta) and radiation for inoperable non-small cell lung cancer.

AbstractPURPOSE:
Based on in vitro evidence of radiosensitization by Betaseron (beta-IFN), a Phase I/II study was undertaken to determine toxicity and response using combined radiation (RT) and B-IFN in patients with unresectable Stage III and nonsmall cell lung cancer.
METHODS AND MATERIALS:
Varying doses of beta-IFN(10 to 90 x 10(6) IU) were administered 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 59.4 Gy.
RESULTS:
Thirty-nine patients were entered, 32 of whom were evaluable. 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 of patients with complete response survived a minimum of 21 months. Twenty-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 survival for this group was 31%, with a plateau persisting after 3 years. There were no treatment related deaths nor any event of life threatening toxicity. Of eight patients surviving 3-5 years, no long-term toxicity has been observed. Karnofsky indices were 90-100 and respiratory symptoms were minimal.
CONCLUSION:
beta-IFN is well-tolerated. Response and survival rates are sufficiently encouraging to warrant further investigation in a randomized trial which has been accepted as an RTOG study awaiting drug availability.
AuthorsS McDonald, A Y Chang, P Rubin, J Wallenberg, I S Kim, S Sobel, J Smith, P Keng, A Muhs
JournalInternational journal of radiation oncology, biology, physics (Int J Radiat Oncol Biol Phys) Vol. 27 Issue 3 Pg. 613-9 (Oct 20 1993) ISSN: 0360-3016 [Print] UNITED STATES
PMID8226156 (Publication Type: Clinical Trial, Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)
Chemical References
  • Recombinant Proteins
  • Interferon beta-1b
  • Interferon-beta
  • Interferon beta-1a
Topics
  • Adult
  • Aged
  • Aged, 80 and over
  • Carcinoma, Non-Small-Cell Lung (mortality, physiopathology, radiotherapy, therapy)
  • Combined Modality Therapy
  • Female
  • Humans
  • Interferon beta-1a
  • Interferon beta-1b
  • Interferon-beta (adverse effects, therapeutic use)
  • Lung (physiopathology)
  • Lung Neoplasms (mortality, physiopathology, radiotherapy, therapy)
  • Male
  • Middle Aged
  • Radiotherapy Dosage
  • Recombinant Proteins (adverse effects, therapeutic use)
  • Survival Rate

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