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Phase I Trial of Intravenous Mistletoe Extract in Advanced Cancer.
Channing J Paller1, Lin Wang2, Wei Fu1
1The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Cancer Research Communications
|March 2, 2023
Summary
Intravenous mistletoe extract (ME) showed manageable side effects and improved quality of life in cancer patients. Further trials are needed to confirm its efficacy in solid tumors.
Area of Science:
- Oncology
- Pharmacology
- Complementary and Alternative Medicine
Background:
- Mistletoe extract (ME) is a popular complementary therapy for cancer patients, aiming to improve quality of life (QoL).
- However, clinical evidence supporting its efficacy and safety, particularly for intravenous administration, remains limited and controversial due to suboptimal trials.
Purpose of the Study:
- To determine the recommended phase II dosing and evaluate the safety of intravenous mistletoe (Helixor M) in patients with advanced solid tumors.
- To assess tumor marker kinetics and QoL changes during treatment with intravenous mistletoe.
Main Methods:
- A phase I clinical trial involving 21 patients with solid tumors progressing on chemotherapy.
- Escalating doses of intravenous Helixor M were administered three times weekly.
- Safety assessments included adverse events (AEs), and efficacy was evaluated through tumor marker kinetics, objective responses, disease control rate, and QoL questionnaires.
Main Results:
- The maximum tolerated dose (MTD) of intravenous mistletoe was determined to be 600 mg.
- Treatment-related adverse events (AEs) were manageable, with fatigue, nausea, and chills being the most common. Grade 3+ AEs occurred in 14.8% of patients.
- Disease control was observed in 23.8% of heavily pretreated patients, with a median stable disease duration of 15 weeks. Quality of life significantly improved from baseline.
Conclusions:
- Intravenous mistletoe (Helixor M) demonstrates manageable toxicity and potential for disease control and QoL improvement in patients with advanced solid tumors.
- The findings support further investigation in phase II trials to explore its therapeutic potential and impact on survival and chemotherapy tolerability.
