JSCO2016: International Session 17 Skin Cancer (Malignant Melanoma)

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The 54th Annual Meeting of Japan Society of Clinical Oncology (JSCO2016)

"Renovation of Cancer Medicine in the Mature Society"



International Session 1: Lung Cancer
International Session 2: Colorectal Cancer
International Session 3: Gastric Cancer
International Session 4: Urological Cancer (Prostate and Renal Cancer)
International Session 5: Supportive Care for Adverse Events
International Session 6: Gynecological Cancer (Uterine Body Cancer and Ovarian Cancer)
International Session 7: Central Nervous System Tumor
International Session 8: New Development of Particle Beam Therapy for Cancer
International Session 9: International Cooperation in Radiation Medicine
International Session 10: Recent Advances In Cancer Immunotherapy
International Session 11: Breast Cancer
International Session 12: Pharmacology of Antitumor Agents: New Drug Application (NDA)
International Session 13: Malignant Lymphoma
International Session 14: Palliative Care
International Session 15: Radiation Therapy
International Session 16: Head and Neck Cancer
International Session 17: Skin Cancer (Malignant Melanoma)
International Session 18: Hepato-Biliary and Pancreas Cancers
International Session 19: Leukemia
International Session 20: Ethics for Clinical Research
International Session 21: Esophageal Cancer
International Session 22: Bone and Soft Tissue Tumor
FACO/JSCO Joint Symposium

Abstract Archives (in Japanese)


International Session 17: Skin Cancer (Malignant Melanoma)


Treatment guideline in Japan
Hisashi Uhara (Dermatology, Shinshu University School of Medicine)
The number of skin cancer patients in Japan is rapidly increasing due to the aging of the population. The recent number of skin cancer patients nationwide is 20,000, with 1,600 deaths from skin cancer; the corresponding numbers for melanoma are 1,500-2,000 and 600. The first evidenced-based guideline for skin cancer in Japan was published in 2007, covering melanoma, squamous cell carcinoma, basal cell carcinoma and extramammary Paget's disease. Lymphoma was added in 2010. Although the guideline was revised in 2015, the contents cannot fully reflect the recent dramatic advance in melanoma treatment.

In Japan, the advance of systemic therapy for melanoma began in 2014. The first approval was for nivolumab in July 2014 (the world's first as an anti-PD-1 antibody), followed by vemurafenib in December 2014, ipilimumab in June 2015 and dabrafenib/trametinib in March 2016. The application for pembrolizumab is undergoing review. The following clinical trials are ongoing: the combination of ipilimumab and nivolumab, nibolumab (2 mg/every 3 weeks) vs. (3 mg/every 2 weeks), LGX818 +/- MEK 162 for advanced melanoma and, in an adjuvant setting, ipilimumab vs. nivolumab, pembrolizumab vs. observation, and interferon beta vs. observation, among others.

There is scant evidence regarding whether ethnic differences affect the efficacy and toxicity of immune checkpoint inhibitors and molecular targeted drugs. In Japan, there is a unique system of post-approval surveillance performed after a product's launch to collect adverse drug reaction data. The situation and issues regarding melanoma treatment in Japan will also be discussed.


Management of advanced melanoma in the United States: Year in review
Gregory Pennock (Hematology/Oncology, Baptist MD Anderson Cancer Center, USA)
The approval of several agents in the United States has made the management of patients with metastatic melanoma increasingly complex. The choice of first line therapy often hinges on the presence or absence of a BRAF mutation. In patients with BRAF-mutated tumors, particularly those with a high tumor burden, data clearly support the use of combined BRAF and MEK inhibition rather than a single agent BRAF inhibitor. In patients with metastatic BRAF wild type melanoma, immunotherapy has become the treatment modality of choice. Trials such as CheckMate 067 demonstrate improved progression-free survival with combined immunotherapy (nivolumab + ipilimumab) compared to either drug as a single agent. However, the incidence of immune-mediated toxicities is certainly higher with the combination immunotherapy approach. Awareness of these potential toxicities is key for both patients and physicians. In patients who are not candidates for combined immunotherapy, anti-PD1 therapies such as nivolumab or pembrolizumab appear superior to anti-CTLA4 therapy (ipilimumab) in terms of response rate and survival. Patients with brain metastases remain a challenge. The optimal treatment of patients with brain metastases has yet to be determined, even with the approval of both targeted agents and immunotherapy.
In patients with stage III (node positive) melanoma, ipilimumab has been approved and adjuvant treatment, but based on European demonstrating superiority over observation. We anxiously await the results of the ECOG 1609 trial, comparing the efficiacy of ipilimumab versus high-dose interferon alfa 2b, which has long been the standard in the United States.


Treatment for malignant melanoma in Japan: Updates in the last year
Yasuhiro Nakamura (Skin Oncology/Dermatology, Saitama Medical University International Medical Center)
The recent development of immune checkpoint inhibitors, which enhance anti-tumor immunity by blocking negative regulators of immunity, and molecular targeted agents, which inhibit the oncogenes that drive the aberrant tumor growth, have dramatically improved the tumor response and prognosis in patients with advanced melanoma. However, there seems to be several differences between Japan and the USA in the treatment situation for patients with melanoma.
In Japan, the PD-1 antibody nivolumab was approved in June 2014, its first approval worldwide, followed by the approval of vemurafenib in December 2014 and ipilimumab in June 2015. Recently, in March 2016, combination therapy targeting BRAF + MEK by using dabrafenib and trametinib was approved. Pembrolizumab, which was the first approved PD-1 antibody in the USA, and combination immunotherapy using ipilimumab and nivolumab have not been approved in Japan.
The incidence of each clinical type of melanoma shows huge differences between ethnic Japanese and Caucasian individuals. For example, there are fewer patients with melanoma harboring BRAF mutations in Japan than in the USA. In addition to the different sequence of approval of new drugs between two countries, differences in racial characteristics between Japanese and Caucasian individuals also influence the treatment selection for advanced melanoma in Japan.
Although there have been few advances in surgical treatment and adjuvant therapy for melanoma, in Japan, we have several clinical trials that will be initiated or are ongoing regarding surgery for subungual melanoma and adjuvant therapy with interferon beta (JCOG 1602 and JCOG1309).
The goals of this presentation are to describe the latest updates on the treatment for advanced melanoma worldwide and to review the treatment of patients with melanoma and the characteristics of our clinical practice in Japan over the last year.


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