Skin cancers

Unmet need for advanced cSCC treatment options, Australian study shows


Australian research has highlighted a high burden of disease in advanced cutaneous squamous cell carcinoma (cSCC) and significant gaps in access to therapies.

A study by Sir Charles Gairdner Hospital Medical Oncologist Dr Piyush Grover and colleagues assessed clinicopathological features, morbidity and mortality of 129 high-risk head and neck cSCC patients treated with surgery, chemo- and/or radiotherapy. Dr Grover said the trial was conducted after clinicians noted a lack of high-quality Australian data about the disease’s natural history, burden and outcomes.

They found most patients were older (mean age 72), had multiple comorbidities and had a history of non-melanoma skin cancer with advanced disease (57% stage IV without distant metastasis).

Patients also often had high-risk features, such as nodal extracapsular extension (47%) and cranial nerve involvement (16%) and faced a heavy clinical burden — requiring median two lesion excisions and up to 21 (median two) cSCC-related hospitalisations over the 43.9-month follow-up period, the authors wrote.

Despite the excisions, primary index lesions recurred at least once in 60% of patients and twice in 20%.

Forty-four patients died from cSCC during the study while 25 died due to other relevant comorbidities, including other cancers and pneumonia.

Perhaps expectedly, median overall survival was far longer in patients with non-malignant versus malignant disease (39.8 [25.9–53.7] versus 16.1 [0.2–32.0] months respectively), with increased comorbidities, advanced nodal stage and multiple recurrences increasing risk of overall mortality. Nodal extracapsular extension and any recurrences were associated with a greater risk of disease-specific mortality.

Australia’s data on cSCC remains sparse, the authors noted, partly because “most cancer registries do not mandate data collection on keratinocyte cancers”.

However, Australia apparently has the highest incidence of cSCC worldwide and, though it’s “plateauing or falling . . . the number of hospitalisations and deaths each year from non-melanoma skin cancers appear to be increasing from 109,000 hospitalisations and 600 deaths in 2014 to 115,000 hospitalisations and 679 deaths in 2016,” they said.

“This calls for public health measures to further reduce the incidence of cSCC, develop better therapeutic interventions to treat advanced disease and routinely capture data on these patients to better guide management,” they suggested.

Immunotherapies would be prime candidates, as far as therapeutic interventions go, “with [an] approximately 50% response rate, excellent tolerability and durable disease control”, the authors said, noting however, that these are not easily accessible in Australia.

Last year, the PBAC rejected Sanofi’s application to PBS-list cemiplimab for patients with metastatic or locally advanced cSCC “who are not candidates for curative surgery or curative radiation”, citing “insufficient” data to “adequately determine the magnitude of improvement in effectiveness and safety of cemiplimab compared to best supporting care ± chemotherapy, with the single arm studies highly uncertain”. The estimated financial impact was “uncertain and potentially very high”.

This, along with the presence of other clinical trials investigating immunotherapy use in earlier clinical settings highlighted “the urgent unmet need to comprehensively define the current epidemiology and morbidity of cSCC to understand how such treatments have and will revolutionise patient outcomes,” the authors concluded.

The full study is available in the Internal Medicine Journal.

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