eMedicine Specialties > Oncology > Carcinomas of the Skin

Malignant Melanoma: Treatment & Medication

Author: Winston W Tan, MD, Assistant Professor of Medicine, Mayo Medical School; Consulting Staff, Mayo Group Practices
Contributor Information and Disclosures

Updated: Nov 23, 2009

Treatment

Medical Care

  • Adjuvant therapy
    • Because the definitive treatment of cutaneous melanoma is surgery, medical management is reserved for adjuvant therapy of patients with advanced melanoma.
    • Because fewer than one half of patients with deep primaries (>4 mm) or regional lymph node involvement have long-term disease-free survival, these patients are classified as high risk and should be considered for adjuvant therapy.
    • A large multicenter study, Eastern Cooperative Group (ECOG) 1684, showed improvement in disease-free survival using high-dose interferon-alfa-2b (IFN) and survival benefit (time to progression improvement of 8 months, with a 1-year survival benefit (P=0.0297).9 On the basis of ECOG-1684, the Food and Drug Administration (FDA) approved IFN as adjuvant treatment after excision in patients who are free of disease but are at high risk for recurrence.
      • A pooled analysis of 1016 patients and 716 observational controls from all ECOG trials showed a significant increase in relapse-free survival (P=0.006) but not overall survival (P=0.42).10
      • Concerns about toxicity associated with high-dose adjuvant interferon alfa have prompted several investigators to test lower doses of the drug. Lower-dose adjuvant interferon alfa has demonstrated less toxicity than high-dose interferon alfa but also less efficacy in delaying progression, with no survival advantage.
      • To investigate the possibility that the survival benefit seen in ECOG-1684 had to do with its incorporation of an induction phase of maximally tolerated dosages of IFN given intravenously for the initial 4 weeks, Pectasides et al conducted a prospective randomized study in 364 patients with stage IIB, IIC, or III melanoma who had undergone curative surgery. Patients were randomly assigned to receive IFN-alpha-2b IV for 5/7 days weekly for 4 weeks (arm A) versus the same induction regimen followed by IFN-alpha-2b administered subcutaneously 3 times a week for 48 weeks (arm B). At a median follow-up of 63 months, there were no significant differences in overall survival and relapse-free survival between the 2 arms, and patients in arm B had more grade 1 to 2 hepatotoxicity, nausea/vomiting, alopecia, and neurologic toxicity.11
      • On the other hand, Hauschild et al found that the addition of a 4-week modified high-dose IFN-alpha induction phase to a 2-year low-dose adjuvant IFN-alpha-2b treatment schedule did not improve the clinical outcome. In their prospective randomized multicenter trial in 674 lymph node–negative patients with resected primary malignant melanoma of more than 1.5-mm tumor thickness, there was no significant difference in 5-year relapse-free survival and overall survival between patients who received an induction phase (IFN-alpha-2b 5 times weekly IV for 2 weeks and 5 times weekly subcutaneously for another 2 weeks) followed by 23 months of low-dose IFN-alpha-2b, and patients who received low-dose subcutaneous treatment 3 times a week for 24 months.12
    • Granulocyte-macrophage colony-stimulating factor (GM-CSF) has been used in the adjuvant setting to treat high risk melanoma. Spitler et al treated 46 patients with resected stage III or IV melanoma with a subcutaneous dose of 125 mg/m2  for 2 weeks on and 2 weeks off for a year. The improvement in progression-free survival over historical controls was 37 vs 12 months (P<.001).13 Based on this promising result, a trial was done to test the efficacy of this regimen compared to placebo and a vaccine  (ECOG-4697). The results of the trial are still pending at this time.
    • Advanced-stage melanoma (stage IV)
      • Treatment of patients with advanced-stage melanoma (stage IV) has not improved significantly in recent years. At this time, no combination chemotherapy regimen has proven to be significantly better than single-agent dacarbazine (DTIC), which yields only a 10-15% response rate.14
      • Two combination regimens commonly are used in the treatment of patients with advanced-stage melanoma. The first regimen is the cisplatin, vinblastine, and DTIC (CVD) regimen. The second commonly used regimen is the Dartmouth regimen, which is a combination of cisplatin, DTIC, carmustine, and tamoxifen. However, a meta-analysis found that the strength of evidence does not support the addition of tamoxifen to combined chemotherapy regimens.15
      • Dacarbazine was the first drug approved for the treatment of metastatic melanoma. In the initial studies with dacarbazine, the overall response rate was 22% with no impact on survival. In a phase III study of dacarbazine compared with temozolomide, the response rate was 12% versus 13%.16 On the basis of this trial, and the greater ease of administration of temozolomide versus dacarbazine (oral versus intravenous), most oncologists currently use temozolomide as their first-line drug for melanoma.
    • Biological therapies now are being used alone and with chemotherapy regimens in the treatment of patients with advanced-stage melanoma. To date, studies do not show that IFN and interleukin-2 added to DTIC is better than DTIC alone.
    • The second drug approved by the Food and Drug administration (FDA) was interleukin-2 (IL-2), a recombinant hormone of the immune system originally described as a T-cell derived growth factor and used as a lymphokine-activated cell killer therapy. 
      • A pooled analysis of 270 patients treated with a high-dose IL-2 bolus (600,000-720,000 units/kg administered every 8 hours for 5 days) resulted in an objective response rate of 16% (complete response of 6%) with the best response in patient with soft tissue and lung metastases. The overall median survival was 11.4 months.17
      • The treatment was quite toxic, with some patients requiring intensive care unit support. The more common toxicities included hypotension (45%), vomiting (37%), diarrhea (32%), and oliguria (39%). Consequently, this therapy is offered only in centers that have adequately trained staff and facilities. To qualify for this type of treatment, patients must have normal results on pulmonary function testing, brain MRI, and cardiac stress testing, plus adequate renal and hepatic function.
    • Carboplatin and paclitaxel have been tested in 2 small phase II studies, and when used in combination with sorafenib, the response rate was 11-17%. This sometimes is being used by clinicians in clinical practice because of lesser toxicity than dacarbazine and also as a second- or third-line regimen. However, a randomized, placebo-controlled phase III study by Hauschild et al found that the addition of sorafenib to carboplatin and paclitaxel did not improve outcome in patients with unresectable stage III or IV melanoma; these investigators recommend against this combination in the second-line setting for patients with advanced melanoma.18 A trial of similar design for the first-line treatment of patients with advanced melanoma is currently ongoing.
    • Anti–cytotoxic T-lymphocyte associated protein 4 (CTLA-4) is a humanized antibody directed at a down-regulatory receptor on activated T-cells.19 This is not yet approved by the FDA. The proposed mechanism of action is inhibition of T-cell inactivation, allowing expansion of naturally developed melanoma-specific cytotoxic T-cells. Several phase III studies are being done to test its efficacy.
    • Melanoma vaccines and gene therapy are 2 additional treatment options that may become available.20 A 2007 review found no clear evidence that the addition of immunotherapy to chemotherapy increases survival in metastatic melanoma and recommended that combined immunotherapy and chemotherapy be limited to clinical trials.21 Because numerous protocols for patients with advanced-stage melanoma exist, eligible patients should be referred to an oncology center participating in these studies. Vaccines have not been successful as a treatment for metastatic melanoma but is still a reasonable area of research in the adjuvant setting.
    • Currently, there are no standard systemic therapeutic regimens that offer significant prolongation of survival for most patients with metastatic melanoma without significant risk of toxicities.
    • The brain is a common site of metastasis in malignant melanoma. Brain metastases are associated with a poor prognosis. Management of brain metastases can be difficult due to rapid progression of disease and resistance to conventional therapies. Stereotactic radiosurgery is used increasingly in patients with a limited number of metastases; it is less invasive than craniotomy. External-beam radiation alone appears effective in palliating symptoms. Chemotherapy alone is relatively ineffective, though the combination of chemotherapy with external-beam radiation is being investigated.22

Surgical Care

  • Surgery is the definitive treatment for early stage melanoma. A wide local excision with sentinel lymph node biopsy and/or elective LND is considered the mainstay of treatment for patients with primary melanoma.
  • In patients with solitary or acutely symptomatic brain metastases, surgical management may alleviate symptoms and provide local control of disease.22

Consultations

  • A patient with a suggestive lesion should be referred to a dermatologist or surgical oncologist for excisional biopsy.
  • If diagnosis of melanoma is made, the patient should be referred to an oncologist after definitive surgery is performed.

Medication

Factors predicting the likelihood of response to treatment include the following:

  • Good performance status
  • Soft tissue disease or only a few visceral metastases
  • Age younger than 65 years
  • No prior chemotherapy
  • Normal hepatic and renal function
  • Normal CBC count
  • Absence of CNS metastases

Antineoplastics

Chemotherapeutic agents used to treat melanoma include dacarbazine, cisplatin, vinblastine, carmustine, and tamoxifen.


Dacarbazine (DTIC)

Although mechanism of action unknown, possible actions include alkylating agent, purine metabolite, or interaction with sulfhydryl groups. End result is inhibition of DNA, RNA, and protein synthesis.

Adult

Monotherapy: 2-4.5 mg/kg IV for 10 d, repeat q4wk; or 250 mg/m2 IV qd for 5 d, repeat q3wk
Combination therapy: 150 mg/m2 IV qd for 5 d, repeat q4wk; or 375 mg/m2 IV on day 1, repeat q15d; or 800 mg/m2 IV on day 1, repeat q21-28d; or 220 mg/m2 IV days 1-3 and 22-24

Pediatric

Not established

Pregnancy

C - Fetal risk revealed in studies in animals but not established or not studied in humans; may use if benefits outweigh risk to fetus

Precautions

Site reactions can occur with IV route; tissue damage and severe pain may result


Cisplatin (Platinol)

Alkylating agent that inhibits DNA synthesis and, thus, cell proliferation by causing DNA cross-links and denaturation of double helix.

Adult

CVD regimen: 20 mg/m2/d IV days 2-5
Dartmouth regimen: 25 mg/m2/d IV days 1-3 and 22-24

Pediatric

Not established

Increases toxicity of bleomycin and ethacrynic acid

Documented hypersensitivity; preexisting renal insufficiency; myelosuppression; hearing impairment

Pregnancy

D - Fetal risk shown in humans; use only if benefits outweigh risk to fetus

Precautions

Administer adequate hydration before and for 24 h after dosing to reduce risk of nephrotoxicity; myelosuppression, ototoxicity, nausea, and vomiting may occur; pretreatment with antiemetics encouraged


Vinblastine (Velban)

Inhibits microtubule formation, which disrupts formation of mitotic spindle, causing cell proliferation to arrest at metaphase. Component of CVD regimen.

Adult

1.6 mg/m2/d IV days 1-5, repeat q21-28d

Pediatric

Not established

May reduce phenytoin plasma levels; mitomycin-C may increase toxicity significantly

Documented hypersensitivity; bone marrow suppression

Pregnancy

D - Fetal risk shown in humans; use only if benefits outweigh risk to fetus

Precautions

Caution in patients diagnosed with impaired liver function and neurotoxicity; when patient is receiving mitomycin-C, monitor closely for shortness of breath and bronchospasm; extravasation may lead to severe pain, inflammation, and tissue damage


Carmustine (BiCNU)

Alkylates and cross-links DNA strands, inhibiting cell proliferation. Used in Dartmouth regimen.

Adult

150 mg/m2 IV day 1 q6wk

Pediatric

Not established

Cimetidine may increase toxicity; etoposide may cause severe hepatic dysfunction (hyperbilirubinemia, ascites, thrombocytopenia)

Documented hypersensitivity; myelosuppression from previous chemotherapy

Pregnancy

D - Fetal risk shown in humans; use only if benefits outweigh risk to fetus

Precautions

Caution in patients with depressed platelet, leukocyte, or erythrocyte counts or hepatic or renal impairment; perform baseline pulmonary function tests; delayed myelosuppression (3-6 wk) may occur, do not administer more frequently than every 6 wk; amphotericin may enhance toxicity; secondary leukemia has been reported


Tamoxifen (Nolvadex)

Competitively binds to estrogen receptor, producing nuclear complex that decreases DNA synthesis and inhibits estrogen effects. Used in Dartmouth regimen to possibly abrogate multidrug resistance phenotype.

Adult

10 mg PO bid starting day 4 or 20 mg qd PO

Pediatric

Not established

May exacerbate hepatotoxic effects of allopurinol; may increase cyclosporine serum levels; increases anticoagulant effects of warfarin; aminoglutethimide reduces serum concentration; cyclophosphamide, methotrexate, and 5-FU increase thrombotic risk

Pregnancy

D - Fetal risk shown in humans; use only if benefits outweigh risk to fetus

Precautions

Caution in leukopenia, thrombocytopenia, and hyperlipidemia; decreased visual acuity, corneal changes, and retinopathy may occur with > 1 y of use; may induce ovulation

Recombinant cytokines

Immunotherapy (biotherapy) currently used to treat patients with melanoma includes IFN and IL-2. An oncologist should administer these treatments.


Interferon-alfa-2b (Intron)

Protein product manufactured by recombinant DNA technology. Mechanism of antitumor activity not clearly understood; however, direct antiproliferative effects against malignant cells and modulation of host immune response may play important roles. DOC for adjuvant therapy in patients with high-risk melanoma. Immunomodulatory effects include suppression of tumor cell proliferation, enhancement of macrophage phagocytic activity, and augmentation of lymphocyte cytotoxicity.

Adult

20 million U/m2 IV for 5 consecutive d/wk for 4 wk; then, 10 million U/m2 SC 3 times/wk for 48 wk

Pediatric

Not established

Potential risk of renal failure when administered concurrently with IL-2; cimetidine may increase antitumor effects; zidovudine, theophylline, and vinblastine may increase toxicity

Pregnancy

C - Fetal risk revealed in studies in animals but not established or not studied in humans; may use if benefits outweigh risk to fetus

Precautions

Depression and suicidal ideation may be adverse effects of treatment


Interleukin-2 (Proleukin)

IL-2 is only therapy known to cure advanced-stage melanoma. Activates T cells and amplifies their responses. Enhances NK cell antitumor activity.

Adult

600,000 -720,000 units/kg IV q8h for up to 14 doses in 5 days; repeat 7-9 days later for 28 doses total; retreat if necessary 8-12 wk after initial course

Pediatric

Not established

Antihypertensives may potentiate hypotension seen with IL-2; glucocorticoids may reduce antitumor effectiveness; protease inhibitors increase concentrations and risk of toxicity

Pregnancy

C - Fetal risk revealed in studies in animals but not established or not studied in humans; may use if benefits outweigh risk to fetus

Precautions

Associated with hypotension, requiring IV fluid replacement and, occasionally, pressor support; vascular leak syndrome and cardiorespiratory insufficiency often observed in patients treated with high doses

More on Malignant Melanoma

Overview: Malignant Melanoma
Differential Diagnoses & Workup: Malignant Melanoma
Treatment & Medication: Malignant Melanoma
Follow-up: Malignant Melanoma
Multimedia: Malignant Melanoma
References
Further Reading
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Keywords

malignant melanoma, melanoma skin cancer, lentigo maligna melanoma, atypical nevus, atypical nevi, dysplastic nevus, dysplastic nevi, ultraviolet radiation, sentinel lymph node dissection, sentinel node dissection

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Contributor Information and Disclosures

Author

Winston W Tan, MD, Assistant Professor of Medicine, Mayo Medical School; Consulting Staff, Mayo Group Practices
Winston W Tan, MD is a member of the following medical societies: American College of Physicians, American Society of Clinical Oncology, American Society of Hematology, Philippine Medical Association, and Texas Medical Association
Disclosure: Roche Grant/research funds Other; Sanofi Aventis Grant/research funds Other; Genentech Grant/research funds Other; Bristol Myers Squibb Grant/research funds Other

Medical Editor

Philip Schulman, MD, Chief, Medical Oncology, Department of Medicine, Memorial Sloan-Kettering Cancer Center; Clinical Professor, Department of Medicine, New York University School of Medicine
Philip Schulman, MD is a member of the following medical societies: American Association for Cancer Research, American College of Physicians, American Society of Hematology, and Medical Society of the State of New York
Disclosure: celgene Honoraria Speaking and teaching; Amgen Honoraria Speaking and teaching; genetech/idec Honoraria Speaking and teaching

Pharmacy Editor

Francisco Talavera, PharmD, PhD, Senior Pharmacy Editor, eMedicine
Disclosure: eMedicine Salary Employment

Managing Editor

Wendy Hu, MD, Consulting Staff, Department of Hematology/Oncology and Bone Marrow Transplantation, Huntington Memorial Medical Center
Wendy Hu, MD is a member of the following medical societies: American Association for the Advancement of Science, American College of Physicians, American Society for Blood and Marrow Transplantation, American Society of Hematology, and Physicians for Social Responsibility
Disclosure: Nothing to disclose.

CME Editor

Rajalaxmi McKenna, MD, FACP, Southwest Medical Consultants, SC, Department of Medicine, Good Samaritan Hospital, Advocate Health Systems
Rajalaxmi McKenna, MD, FACP is a member of the following medical societies: American Society of Clinical Oncology, American Society of Hematology, and International Society on Thrombosis and Haemostasis
Disclosure: Nothing to disclose.

Chief Editor

Jules E Harris, MD, Clinical Professor of Medicine, Division of Hematology/Medical Oncology, Department of Internal Medicine, University of Arizona College of Medicine at Tucson; Consulting Staff, Arizona Cancer Center
Jules E Harris, MD is a member of the following medical societies: American Association for Cancer Research, American Association for the Advancement of Science, American Association of Immunologists, American Society of Hematology, and Central Society for Clinical Research
Disclosure: GlobeImmune Salary Consulting; Amplimed Consulting fee Consulting; FibroGen Consulting fee Consulting

 
 
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