Therapy Regimens for Malignant Melanoma

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The usual therapy regimen for treatment of malignant melanomas is shown in Table 45. For more information the reader is also referred to Chapter 25.

In recent years, the adjuvant therapy regimen using Interferon (IFN)-a2b has been tested in many investigations, its efficacy has been confirmed in some (Agarwala and Kirkwood 2002; Wheatley et al. 2002; Molife and Hancock 2002; Pawlik and Sondak 2003; Mohr et al. 2003). However, the biological profile of melanoma cases in which the therapy is efficient is still not clear, and controversies persist (Sabel and Sondak 2003).

In Kefford's cumulative studies (2003) high-dose IFN-a (HDI) treatment did not prolong overall survival. In the specific investigations of Schachter et al. (2003) patients treated for stage II B disease fared better than those treated for stage III, regardless of whether the patients had regional microme-tastases or palpable metastases. CNS relapses obviously could not be significantly prevented by adjuvant IFN treatment.

In recent randomized studies performed by Hauschild et al. (2003), adjuvant combination therapy using IFN-a2b (3 million IU/m2, days 1-7 in week 1; then three times weekly in weeks 3-6, repeated every 6 weeks) plus IL-2 (IMU/m2 per day on days 1-4 in week 2 of each cycle) for 48 weeks, did not improve disease-free or overall survival.

In their analysis, Kleeberg et al. (2004) combined the data from EORTC studies and from the DKG-80-1 trial. No advantage of adjuvant melanoma treatment with rIFN-a2 or rIFN-y was found in the treatment of high-risk melanoma patients. Hancock et al. (2004) treated 674 patients with thick melanomas (>4 mm), some of whom had lo-coregional metastases. Low-dose IFN-a2a (3 mega units) three times per week for 2 years or until recurrence showed no benefit in these high-risk melanoma cases.

Hakansson et al. (2003) used cisplatin (30 mg/ m2 i.v., days 1-3), dacarbazine (250 mg/m2 i.v. days 1-3, IFN-a2b (10 million IU s.c.) on 3 days a week. Their results demonstrated the occurrence of some antitumor reactivity in the majority of cases. Patients with extensive regressive changes in 75-100% of the biopsies analyzed were also found to have a longer overall survival (P = 0.019).

In recent years phase I and II studies of treatment with dendritic cell vaccines in patients with disseminated melanomas have been started. Hershey et al.'s (2004) experience has shown that as a source of antigen for DC vaccines autologous ly-sates of melanomas may be more effective than melanoma peptides. The negative results of chemotherapy efforts in the 1980s, when dacarba-zine (DTIC), vincristine, 5-FU, and hydroxyurea were used, have lately been reconfirmed by Kretschmer et al. (2002).

In addition, tamoxifen has been found not to inhibit metastasis of malignant melanoma (Lens et al. 2003); nor has HER/neu evaluation of malignant melanomas with a view to trastuzumab (Hercep-tin) therapy proved successful (Potti et al. 2003).

Medalie and Ackerman (2003) recently demanded that the search for the sentinel node be abandoned, having found no advantage of it in terms of survival. However, their argumentation is diffuse and in important points inadequate. Because of changes in and deviations from treatment protocols and the wide variation in initial biological behavior, it is very difficult to establish cumulative judgments from a purely statistical point of view.

In locally advanced cancers surgical clearance aimed at R0 resection is essential, because in individual cases survival is absolutely dependent on the surgical intervention alone and this is optimized by the search for the sentinel node(s) and the determination of the local basins that this allows.

Table 45. Interferon as single-agent chemotherapy for malignant melanoma

Agent Dose Route Frequency

Interferon-a 5-10 million s.c. 3 x weekly

IU for 1-2 years

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