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Phase II study with lonidamine in the treatment of hormone-refractory prostatic cancer patients
F Boccardo1, D Guarneri, M Pace
1Servizio di Oncologia Medica II, Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy.
Abstract:
Twenty-one patients with metastatic prostate cancer who had become refractory to hormonal therapies received lonidamine (150 mg tid and 600 mg daily dose in 17 and 4 patients, respectively). In all but 4 patients, treatment was continued until disease progression or the development of severe toxicity. Toxicity was minimal and reversible (score 1 or 2) and included myalgia (8 cases), arthralgia (6 cases), gastrointestinal toxicity (11 cases), fatigue (14 cases) and testicular pain (9 cases). The response was evaluated after at least one month of therapy with lonidamine, according to NPCP-USA recommendations. Of 21 patients who entered the study, only 15 were evaluable for response; 2 died (1 for severe toxicity and 1 for drug-unrelated reasons). No objective response was obtained in the series. In fact, only 6 patients achieved stable disease and 9 progressed. Median survival time from the beginning of treatment was no longer than that of patients in a similar condition who were treated with standard palliative maneuvers. We conclude that this therapeutic approach with lonidamine is not active in hormone-refractory prostatic cancer patients with distant metastasis.
Insights
Lonidamine showed minimal toxicity in patients with metastatic prostate cancer refractory to hormonal therapies. However, it did not improve outcomes, with no objective responses observed and survival similar to standard palliative care.
Area of Science:
- Oncology
- Pharmacology
Background:
- Metastatic prostate cancer often becomes refractory to hormonal therapies, necessitating alternative treatment strategies.
- Hormone-refractory prostate cancer (HRPC) presents a significant clinical challenge with limited effective therapeutic options.
Purpose of the Study:
- To evaluate the efficacy and safety of lonidamine in patients with metastatic prostate cancer resistant to hormonal therapies.
- To determine if lonidamine can induce objective responses or improve survival in this patient population.
Main Methods:
- A phase II study involving 21 patients with hormone-refractory metastatic prostate cancer.
- Patients received lonidamine at doses of 150 mg tid or 600 mg daily until disease progression or toxicity.
- Treatment response was assessed using National Prostatic Cancer Project (NPCP-USA) recommendations.
Main Results:
- Lonidamine exhibited minimal and reversible toxicity, with common side effects including fatigue, gastrointestinal issues, myalgia, arthralgia, and testicular pain.
- No objective responses were observed in the 15 evaluable patients; 6 achieved stable disease, and 9 progressed.
- Median survival time was not improved compared to standard palliative care.
Conclusions:
- Lonidamine is not an active therapeutic agent for patients with hormone-refractory metastatic prostate cancer.
- Further investigation into lonidamine for this indication is not warranted based on these findings.