Skip to content

Melanoma/Skin Cancer Health Center

Font Size

Melanoma Treatment (PDQ®): Treatment - Health Professional Information [NCI] - Stage IV and Recurrent Melanoma

continued...

Previously untreated patients. A multicenter, international trial randomly assigned 502 patients untreated for metastatic disease (adjuvant treatment was allowed) in a 1:1 ratio to ipilimumab (10 mg/kg) plus dacarbazine (850 mg/m2) or placebo plus dacarbazine (850 mg/m2) at weeks 1, 4, 7, and 10 followed by dacarbazine alone every 3 weeks through week 22.[6] Patients with stable disease or an objective response and no dose-limiting toxic effects received ipilimumab or placebo every 12 weeks thereafter as maintenance therapy. The primary endpoint was survival.

Patients were stratified according to Eastern Cooperative Oncology Group (ECOG) performance status (PS) and metastatic stage. Approximately 70% of the patients had an ECOG PS of 0, and the remainder of the patients had an ECOG PS of 1. Approximately 55% of the patients had stage M1c disease. The median OS was 11.2 months (95% confidence interval [CI], 9.4–13.6) versus 9.1 months (95% CI, 7.8–10.5). Estimated survival rates in the two groups respectively were 47.3% and 36.3% at 1 year; 28.5% and 17.9% at 2 years; and 20.9% and 12.2% at 3 years (HR for death with ipilimumab-dacarbazine, 0.72; P < .001). The most common study-drug–related AEs were those classified as immune related. Grade 3 to 4, immune-related AEs were seen in 38.1% of patients treated with ipilimumab plus dacarbazine versus 4.4% in patients treated with placebo plus dacarbazine, the most common being hepatitis and enterocolitis. No drug-related deaths occurred.[6][Level of evidence: 1iA]

Clinicians and patients should be aware that immune-mediated adverse reactions may be severe and fatal. Early identification and treatment, including potential administration of systemic glucocorticoids or other immunosuppressants according to the immune-mediated–adverse reaction management guide provided by the manufacturer, is necessary.[20]

Anti-PD-1 and PD-L1

Anti-PD-1 and PD-L1 are immune checkpoint inhibitors; however, they inhibit different targets than ipilimumab. Promising early data have supported testing anti-PD-1 against DTIC in a phase III trial (NCT01721772).[21]

IL-2

Response to high-dose IL-2 regimens generally ranges from 10% to 20%.[12,13,22] Approximately 4% to 6% of patients may obtain a durable complete remission and be long-term survivors; these results were the basis for approval by the FDA in 1998. Phase III confirmatory trials have not been conducted, and there are currently no predictive biomarkers to select who is likely to respond to treatment.

1|2|3|4|5|6|7|8|9
Next Article:

Today on WebMD

Malignant melanoma
About 40-50 percent of those who live to be 65 may get it. Here’s how to spot early.
Woman checking out tan lines
There’s a dark side to that strive for beauty. See them here.
 
sauteed cherry tomatoes
Fight cancer one plate at a time.
Lung cancer xray
See it in pictures, plus read the facts.
 
12 Ways to Protect Your Skin from Melanoma
ARTICLE
precancerous lesions slideshow
SLIDESHOW
 
Do You Know Your Melanoma ABCs
VIDEO
15 Cancer Symptoms Men Ignore
ARTICLE
 
screening tests for men
SLIDESHOW
Vitamin D
SLIDESHOW
 
Is That Mole Skin Cancer
VIDEO
Brilliant sun rays
Quiz
 

WebMD Special Sections