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Study: Ipilimumab Shows Durable Responses But Low Overall Response Rate In Patients With Unresectable Or Metastatic Mucosal Melanoma

Durham, NC (PRWEB) May 28, 2013

Treatment with ipilimumab can result in durable antitumor effects despite a low overall response rate in patients with advanced mucosal melanoma (MM). Richard D. Carvajal, MD, Medical Oncologist at the Memorial Sloan-Kettering Cancer Center in New York, led the multicenter, retrospective study, recently published in The Oncologist, in collaboration with researchers from the Dana-Farber Cancer Institute and Massachusetts General Hospital in Boston.

Melanoma arising from the mucosal surfaces is a rare form of melanoma that differs clinically and biologically from cutaneous melanoma and is associated with a poor prognosis. To date, no prospective trials for patients with MM have been published, and the most effective systemic therapy has not been defined. Ipilimumab is currently a standard of care for patients with unresectable or metastatic melanoma, but its potential role in the treatment of patients with MM is unknown.

In the current study, researchers examined radiographic tumor response at 12 weeks, overall survival, and toxicity in 33 patients who received treatment with single-agent ipilimumab at one of the three participating institutions. All patients had unresectable or metastatic melanoma of primary mucosal origin, and 76% had received prior systemic therapy for metastatic disease. Twenty-five patients (76%) received a median of 4 doses of ipilimumab 3 mg/kg (range, 2 to 8 doses), and 24% received a median of 4 doses of ipilimumab 10 mg/kg (range, 2 to 17 doses). The most common immune-related adverse events were rash in 6 patients, diarrhea in 3 patients, and 1 case each of thyroiditis, hepatitis, and hypophysitis.

Among 30 evaluable patients, radiographic assessment at 12 weeks showed 1 complete response (CR), 1 partial response (PR), and 6 cases of stable disease. The overall response rate was 6.7%. The patient who achieved CR was aged 87 years at the time of ipilimumab treatment, had metastatic MM arising from the urinary bladder, and received ipilimumab as first-line treatment for metastatic disease. The CR after ipilimumab 3 mg/kg has been durable, currently ongoing at 22 weeks. The patient who achieved a PR had a history of sunitinib treatment, started ipilimumab at age 79 years, and achieved a durable response that lasted 56 weeks. The median overall survival for all patients was 6.4 months.

“It is clear now that immunological-checkpoint blockade can result in durable clinical benefit in a number of different tumor types, however, the benefit rates may differ. As mucosal melanoma is clinically and biologically distinct from cutaneous melanoma, therapeutic studies such as ours specifically assessing efficacy in this melanoma subset are critical, and prospective trials should be performed,” said Dr. Carvajal.

“Ipilimumab shows durable responses but low overall response rate in patients with unresectable or metastatic mucosal melanoma,” Walter J. Urba, M.D., Ph.D., Director of Cancer Research, Robert W. Franz Cancer Research Center at Providence Cancer Center and the Melanoma and Cutaneous Malignancies Section Editor for The Oncologist.

Additional research into the unique biology of MM may reveal novel immunotherapeutic approaches. Given that ipilimumab appears to show durable activity in a subset of patients with MM, however, this targeted agent should not be excluded from future immunotherapy trials. The potential role of this treatment strategy will be further clarified in the ongoing prospective study of ipilimumab in patients with MM (NCT 01355120).

The full article, titled “Ipilimumab for Patients with Mucosal Melanoma,” can be accessed at

About The Oncologist
Established by oncologists to help physicians better manage their practices in an ever-changing environment, The Oncologist® is the official journal of the Society for Translational Oncology (STO). Now in its 18th year, this internationally peer-reviewed journal focuses on clear and concise interpretation addressing the multimodality diagnosis, treatment, and quality of life of the cancer patient. Each issue is meant to impact the practice of oncology and to facilitate significant communication in the introduction of new medical treatments and technologies. For more information, visit

About AlphaMed Press: Established in 1983, AlphaMed Press, with offices in Durham, NC, San Francisco, CA, and Belfast, Northern Ireland, publishes three internationally renowned peer-reviewed journals with globally recognized editorial boards dedicated to advancing knowledge and education in their focused disciplines. STEM CELLS® (, which celebrated its 31st year in 2013, is the world's first journal devoted to this fast paced field of research. THE ONCOLOGIST® (, entering its 18th year, is devoted to community and hospital-based oncologists and physicians entrusted with cancer patient care. STEM CELLS TRANSLATIONAL MEDICINE® (, in its second year, is dedicated to significantly advancing the clinical utilization of stem cell molecular and cellular biology. By bridging stem cell research and clinical trials, SCTM will help move applications of these critical investigations closer to accepted best practices.

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