Immunotherapy with subcutaneous low-dose interleukin-2 and the pineal indole melatonin as a new effective therapy in advanced cancers of the digestive tract
1993

Immunotherapy with IL-2 and Melatonin for Advanced Digestive Cancers

Sample size: 35 publication Evidence: moderate

Author Information

Author(s): P. Lissonil, S. Barnil, G. Tancinil, A. Ardizzoia, F. Rovellil, M. Cazzaniga, F. Brivio, A. Piperno, R. Aldeghi, D. Fossati, D. Characiejus, L. Kothari, A. Conti, G.J.M. Maestroni

Primary Institution: San Gerardo Hospital, Monza, Milan, Italy

Hypothesis

Can low-dose interleukin-2 combined with melatonin improve treatment outcomes in patients with advanced digestive tract cancers?

Conclusion

The combination of low-dose IL-2 and melatonin is a well-tolerated and effective therapy for advanced digestive tract tumors, particularly in gastric cancer and hepatocarcinoma.

Supporting Evidence

  • The overall response rate was 23%, with two complete responses and six partial responses.
  • Stable disease was observed in 31% of patients.
  • Toxicity was low, with only mild side effects reported.

Takeaway

This study tested a new treatment for serious stomach and liver cancers using two medicines together, and it worked for some patients.

Methodology

The study involved 35 patients with advanced digestive tract tumors receiving low-dose IL-2 and melatonin, with responses evaluated through clinical assessments and imaging.

Potential Biases

Potential bias due to lack of randomization and the small sample size.

Limitations

The study did not include a control group, and the long-term effects of the treatment remain unclear.

Participant Demographics

35 patients (22 males, 13 females; median age 55 years, range 38-70) with advanced digestive tract cancers.

Statistical Information

P-Value

p<0.01

Statistical Significance

p<0.01

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