Melanoma is a highly malignant tumor that can occur in multiple parts of the body, such as the palms and soles, under the nails, or in the nasal cavity and digestive tract mucosa. In its early stages, it is often mistaken for a common mole or ulcer. If not detected in time, it can rapidly metastasize and threaten life. Recently, the anti-PD-1 monoclonal antibody drug toripalimab has been added to the list of first-line treatments for unresectable or metastatic melanoma and has been included in the National Basic Medical Insurance Program .This drug is listed in the National Medical Insurance Drug Catalog (2025), specifically the "Drug Catalog for Maternity and Work Injury Insurance ," and is the only anti-PD-1 monoclonal antibody drug in the catalog used for melanoma. Professor Luo Zhiguo, Deputy Director of the Department of Medical Oncology at Fudan University Cancer Hospital, pointed out that understanding the characteristics of melanoma and early diagnosis and treatment are crucial.

The pathogenesis of melanoma in my country differs significantly from that abroad. Abroad, cutaneous melanoma is predominant and closely related to sun exposure. In my country, however, cutaneous melanoma accounts for a low percentage; acral and mucosal melanomas together make up 75%, while cutaneous, melanomas of unknown origin, and ocular melanomas account for only 25%. Due to these subtype differences, the causes also vary. Acral melanoma may be related to prolonged non-healing of wounds after trauma, while no clear cause has yet been identified for mucosal melanomas (such as those in the nasal cavity, esophagus, vagina, and rectal mucosa).

Early detection of melanoma is difficult and relies mainly on regular checkups. The nasal cavity can be examined by an ENT specialist, the esophagus by a gastroscopy, the female reproductive tract by a gynecological examination, and the rectum by a colonoscopy. Any mole on the body that enlarges rapidly, changes color, ulcerates and bleeds, or fails to heal should raise a high level of suspicion. While primary melanoma lesions can sometimes disappear spontaneously, the risk of metastasis remains. Once lymph node or distant metastasis (such as to the lungs or bones) occurs, it is often in an advanced stage, making treatment extremely difficult. Therefore, patients with a history of mole removal should promptly inform their doctor of their past pathological findings if metastasis is discovered.

Treatment pathways after diagnosis vary depending on the condition. First, the feasibility of resection is assessed in patients who meet surgical indications. After surgery, the need for adjuvant therapy, including chemotherapy, targeted therapy, or immunotherapy, is determined based on the pathological stage.Patients with advanced disease who are not eligible for surgery or have already experienced distant metastases will be directly admitted to first-line treatment.

Treatment methods have made significant progress compared to the past. Early treatments often relied on chemotherapy such as interferon, interleukin, or dacarbazine, with limited effectiveness. Now, targeted therapies combined with PD-1 immunotherapy have significantly changed the treatment landscape. In particular, PD-1 immunotherapy has gradually been approved as first-line treatment from a later-line approach. The national approval of toripalimab as a first-line treatment for advanced or unresectable melanoma and its inclusion in the national medical insurance catalog will greatly reduce the financial burden on patients. Previously, first-line immunotherapy was out-of-pocket and reimbursed only after failure of standard treatment. Now, patients with relapsed, metastatic, or inoperable melanoma can directly use it and enjoy medical insurance benefits. Clinically, it is often combined with anti-angiogenic targeted drugs or chemotherapy to further improve efficacy.

Patient survival has also improved. Previously, the median progression-free survival (PFS) for recurrent and metastatic patients was only four to five months, and overall survival (OS) was less than one year. Now, data for different subtypes show improvement, especially for acral melanoma, where the combined use of PD-1 inhibitors, anti-angiogenic drugs, and oral chemotherapy yields better results. Traditional chemotherapy such as dacarbazine and platinum-based drugs are reimbursable, but many combination therapies still require out-of-pocket payment. Including immunotherapy in medical insurance will significantly reduce the overall burden. Neoadjuvant therapy (preoperative medication) has been successfully studied extensively in the international field of cutaneous melanoma and may rewrite clinical guidelines in the future.

Because mucosal melanomas are distributed across multiple disciplines—for example, rectal melanomas are initially treated by colorectal surgeons, esophageal melanomas by thoracic surgeons, and female reproductive tract melanomas by gynecologists—some surgeons may lack a systematic understanding of melanomas, easily misdiagnosing them as ordinary tumors. This leads to inadequate treatment standards, and patients' treatment and benefits often vary by region. In response, relevant specialized committees are promoting standardized diagnosis and treatment and disseminating professional knowledge on early detection.

The future expansion of indications for combination therapies requires rigorous Phase III clinical data. Currently, many combination therapies are based on investigator-initiated trials or small sample data. Professor Luo Zhiguo stated that patients should choose professional medical institutions and receive individualized treatment from professional doctors, avoiding self-diagnosis based solely on information from the internet or patient support groups. Although treatment methods have improved compared to the past, they have not yet reached the level of other solid tumors. Regardless of whether surgery is performed or not, patients after surgery or systemic treatment still require long-term, standardized follow-up, as recurrence and metastasis are still possible even years later; therefore, regular monitoring should not be neglected.

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