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A phase II study of dacarbazine, cisplatin, interferon-alpha and high-dose interleukin-2 in 'poor-risk' metastatic
T M Proebstle1, C Scheibenbogen, W Sterry
1Department of Dermatology, University of Ulm, Germany.
Abstract:
Melanoma patients with very advanced disease have usually not been included in chemo-immunotherapy trials. We report on 22 melanoma patients, including 5 with reduced performance status (Karnofsky PS < 70), 8 with metastatic ocular melanoma, 6 with brain metastases, and 4 who had pretreatment with interleukin-2. These were treated with a combination regimen of dacarbazine (250 mg/m2, days 1-3), cisplatin (30 mg/m2, days 1-3), interferon-alpha 2a (IFN-alpha, 10 Mio IU/m2 s.c., days 1-5) and IL-2 (i.v., 18 Mio IU/m2 for 6, 12, 24 h, followed by 13.5 Mio IU/m2 in 72 h). In the case of brain metastases radiotherapy was added. No grade IV toxicity occurred and no dose reductions were necessary. 21 patients were evaluable for response. 6 (29%) had disease progression, 5 (24%) had partial response and 10 (48%), had stable disease. Sites of response included skin, lymph nodes, muscle, lung, pleura, liver, pancreas, adrenal gland and brain. The described treatment schedule is safe and active even in patients with metastatic melanoma and poor prognosis.
Insights
This study shows a combination chemo-immunotherapy regimen is safe and effective for advanced melanoma patients, including those with poor prognosis. The treatment demonstrated activity across various metastatic sites.
Area of Science:
- Oncology
- Immunotherapy
- Melanoma Research
Background:
- Advanced melanoma patients are often excluded from clinical trials.
- Limited treatment options exist for patients with poor prognosis, brain metastases, or ocular melanoma.
Purpose of the Study:
- To evaluate the safety and efficacy of a novel chemo-immunotherapy regimen in advanced melanoma patients.
- To assess treatment response in a cohort including patients with reduced performance status and specific metastatic sites.
Main Methods:
- A combination regimen of dacarbazine, cisplatin, interferon-alpha 2a (IFN-alpha), and interleukin-2 (IL-2) was administered.
- Radiotherapy was added for patients with brain metastases.
- Patient response and toxicity were monitored.
Main Results:
- The treatment regimen was safe, with no grade IV toxicity observed.
- Of 21 evaluable patients, 48% had stable disease and 24% had a partial response.
- Responses were observed in skin, lymph nodes, lung, liver, brain, and other sites.
Conclusions:
- The chemo-immunotherapy schedule is safe and active in metastatic melanoma patients, even those with poor prognosis.
- This regimen offers a viable treatment option for a heavily pretreated and advanced melanoma population.
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