Improving the standard treatment for vulvar cancer patients.

Treatment of vulvar cancer causes significant morbidity. Despite being a rare cancer, at least 2500 survivors of vulvar cancer live in Australia. Most survivors live with the detrimental, life-long impacts resulting from their cancer treatment because currently there are no alternatives available. Standard treatment of vulvar cancer involves surgery to remove both the primary tumour and groin lymph nodes.

While this is often curative, groin lymph node removal results in debilitating long-term outcomes (i.e. painful and disfiguring leg swelling, impaired mobility and greater susceptibility to infection). This one-size-fits-all approach results in unnecessary surgeries for low-risk patients, causing debilitating side effects, while high-risk patients may be undertreated, leaving undetected cancer in the lymph nodes, which can be fatal.

In a recently published article, women with vulvar cancer describe life after groin lymph node removal as traumatic. The following quotes were taken from this article

• “I thought I’d be back to my normal life within a very short time. And I’m still struggling past the 12-month mark”. Participant 2
• “I’ve been uncomfortable for years. To sit down, it’s still sore”. Participant 4

The aim of this study is to assess the accuracy of using high-resolution groin ultrasound as a non-invasive alternative for identifying vulvar cancer spread to lymph nodes. Groin lymph nodes will then only be removed if cancer is present, sparing up to 70% of women from having to undergo this debilitating procedure. This is the only vulvar cancer study in Australia that focuses on reducing surgery-related morbidity and the only vulvar cancer study in Queensland.

An initial feasibility pilot cohort study was run in Queensland in 2022 and is now complete. Because of its success, the aim is to recruit a total of 100 patients from Queensland, Northern Territory, New South Wales, Victoria, South Australia, Western Australia, Tasmania and two (2) international sites located in Belgium and Uruguay. Once deemed feasible and safe, we plan to achieve better short and long-term patient outcomes through evidence from the Australian National Vulvar Cancer trial.

NODE

The NODE (groiN ultrasOunD cancEr) study will run concurrently to pre-ANVU. NODE will determine the feasibility of randomising 20 women with vulvar cancer into either surgical removal of groin lymph nodes (standard care) or groin node ultrasound (groin lymph nodes are not removed) at sites in Queensland. This study will road-test operating procedures and patient information materials in preparation for a subsequent large randomised controlled clinical trial.

Patient recruitment is underway in Brisbane at the Royal Brisbane and Women’s Hospital and St Andrew’s War Memorial Hospital.

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Cherish Women’s Cancer Foundation | Registered as Gynaecological Cancer Foundation Ltd | ABN 86 158 553 229