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Taxol in malignant melanoma
1Albert Einstein Cancer Center, New York, NY 10467.
Abstract:
Taxol is a major new antitumor agent with significant activity against a number of human cancers. Preclinical investigation demonstrated significant activity against B16 melanoma and against cells derived from melanoma in a human stem cell assay. To determine whether there are sufficient clinical phase II data for Taxol activity against melanoma to warrant phase III clinical trials, data from the three published trials of Taxol in patients with metastatic malignant melanoma plus data from an ongoing Albert Einstein Cancer Center study of Taxol plus granulocyte-colony stimulating factor were analyzed for response rate and quality. Of 73 evaluable patients, complete plus partial responses occurred in 12 (16.4%). An additional nine patients had objective responses not qualifying for partial response, and 10 others had stabilization of previously progressive disease. Two complete responders remain disease free at 33+ and 46+ months. Patients with stable disease, minimal response, or partial response had a median duration of response of approximately 5 months (range 1-17 months). Responses occurred in liver, lung, skin, and other tissues. Taxol as a single agent has activity comparable with that of dacarbazine, cisplatin, or interleukin-2 in metastatic malignant melanoma. Pilot studies of Taxol combinations are warranted.
Insights
Taxol shows significant antitumor activity in metastatic malignant melanoma patients. This analysis of clinical trials suggests Taxol warrants further investigation in combination therapies for melanoma.
Area of Science:
- Oncology
- Cancer Research
- Pharmacology
Background:
- Taxol (paclitaxel) is an established antitumor agent with demonstrated efficacy across various human cancers.
- Preclinical studies indicated Taxol's potential against melanoma, including B16 melanoma models and human stem cell assays.
Purpose of the Study:
- To evaluate the clinical efficacy of Taxol in patients with metastatic malignant melanoma.
- To determine if existing Phase II data supports advancing Taxol into Phase III trials for melanoma treatment.
Main Methods:
- Analysis of data from three published Phase II trials of Taxol in metastatic malignant melanoma patients.
- Inclusion of data from an ongoing study combining Taxol with granulocyte-colony stimulating factor.
- Assessment of response rate and quality in 73 evaluable patients.
Main Results:
- A combined 16.4% complete or partial response rate was observed in evaluable patients.
- Additional objective responses and disease stabilization were noted in a significant proportion of patients.
- Responses were documented in various metastatic sites, including liver, lung, and skin.
Conclusions:
- Taxol demonstrates comparable activity to other agents like dacarbazine and cisplatin in metastatic malignant melanoma.
- The findings support the potential of Taxol as a monotherapy and warrant pilot studies for combination therapies in melanoma treatment.