HDI Versus Chemotherapy as Systemic Adjuvant Therapy for Resected Mucosal Melanoma

Inclusion Criteria:

1. Age more than 18 years;
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
3. Pathologically confirmed diagnosis of mucosal melanoma;
4. Completely resected primary tumor (once regional lymph nodes were involved, diagnosed by clinical or imaging examinations, lymphadenectomy was conducted);
5. No prior systemic adjuvant therapy or regional radiotherapy;
6. No evidence of distant metastatic disease evaluated by means of lymph nodes ultrasound, endoscopy, and ultrasound of anorectum and genitourinary tract, single-photon emission computed tomography (CT) of bone, and whole-body spiral CT or positron emission tomography-CT (PET-CT);
7. Normal bone marrow function; and adequate liver and renal function [including white blood cell (WBC) count > 3,000/mm^3;absolute neutrophil count > 1,500/mm^3; platelets >100,000/mm^3; serum creatinine less than two times of the upper limit of normal (ULN); bilirubin less than 1.5 times of ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5 times of ULN; international normalized ratio less than 1.5 times of ULN; and partial thromboplastin time less than ULN].

Exclusion Criteria:

1. Cutaneous melanoma or ocular melanoma or melanoma of unknown primary site;
2. Incomplete resection or primary tumor unable to be resected;
3. A second cancer diagnosis;
4. Definite medical history of cirrhoses of the liver or autoimmune diseases;
5. Severe depression; and pregnant or lactating female.