Chemoneuroendocrine therapy of metastatic breast cancer with persistent thrombocytopenia with weekly low-dose epirubicin plus melatonin: a phase II study.
Level 4 - case-series / case-control
Uncontrolled single-arm phase II clinical study (case series).
PubMed 10231730 · doi:10.1111/j.1600-079x.1999.tb00579.x
What was done
Fourteen women with metastatic breast cancer and persistent thrombocytopenia were treated with weekly low-dose epirubicin (25 mg/m2 i.v.) combined with oral melatonin (20 mg/day in the evening every day), starting 7 days before chemotherapy. Patients were considered evaluable if they completed at least four cycles of chemotherapy.
What was found
Twelve of the 14 patients were evaluable. Melatonin induction normalized platelet counts in 9/12 patients, and no further platelet decline occurred during chemotherapy. Objective tumor regression occurred in 5/12 (41%) patients. Exact numerical platelet counts were not reported in the abstract.
Why it matters
This preliminary study suggests melatonin may mitigate cancer-related thrombocytopenia, potentially allowing patients with persistent cytopenias to undergo chemotherapy.
Limits
The study is a very small, non-randomized, single-arm trial without a control group. The abstract does not report baseline or post-treatment platelet values, confidence intervals, or toxicity data.
Cited by
- context In clinical trials of breast cancer patients, high doses of supplemental melatonin combined with traditional therapies increased one-year survival rates from 36% to approximately 65%.