Vulvar cancer affects the external genitalia of women. This type of cancer is uncommon, arising mostly in older women and has been neglected in research and clinical trials. Over the recent years, investigators have learned that the most common type of vulvar cancer; vulvar squamous cell carcinoma (VSCC) develops from pre-cancerous lesions via different pathways. One pathway is associated with human papillomavirus (HPV) infection, and another is related to chronic inflammatory skin conditions (and not HPV). The VSCCs arising from these two principal pathways; HPV- associated (HPV A) and HPV-independent (HPV I), behave differently with different risks of recurrence, and different response to treatments. HPV-I VSCC are further defined by mutations in TP53 (Tumor Protein 53), which identify a group of patients with aggressive disease. Currently treatment is the same for all women with vulvar cancer, and consequently many women may be overtreated, and many women are not treated enough. Given evolving knowledge of this disease, this 'one size fits all' approach may no longer be appropriate. The investigators aim in this study is to see if personalizing surgical therapy for patients with vulvar cancer based on HPV and TP53 status will improve outcomes.
Histologically confirmed primary diagnosis of vulvar squamous cell carcinoma
Surgically staged FIGO (International Federation of Gynaecology and Obstetrics) I-II disease
HPV-I VSCC: margins are negative for cancer but <8mm, and/or positive for dVIN, and/or positive for p53 abnormality on IHC
HPV-A VSCC: margins are negative for cancer but <8mm (regardless of in-situ (HSIL) margin status)
Recurrent vulvar squamous cell carcinoma
Non-squamous cell carcinoma histotypes
FIGO stage III- IV disease
Patients referred for adjuvant radiation for close margins
Single group
Re-excision
Procedure/SurgeryRe-excise (one take back only) Excise scar aiming for 1-2cm margin
Local Vulvar Disease Recurrence - Local vulvar disease recurrence rate (within 3 years) in HPV-I and HPV-A vulvar squamous cell carcinoma
Duration of time from registration to time of recurrent disease in the vulvar
Health Economic Impact of implementation of HPV and p53 stratified treatment algorithms - Measure the delta in surgical parameters (surgical take backs, longer hospital stay for more extensive surgery)
Health utility scores will be obtained through multi-attribute quality of life instruments such as the EQ-5D-5L. Outcome measure will be the incremental cost-effectiveness ratio, which is defined as the difference in cost divided by the difference in effectiveness between the 2 treatment strategies.
Patient Reported Outcome EORTC QLQ-C30 - Measures subject's physical, psychological and social functions.
Assess the quality of life of cancer patients
Patient Reported Outcome EORTC QLQ-VU34 vulva-specific module - Measures symptoms or problems related to the genital area
Assess issues related to the genital area
Patient Decisional Conflict Scale - Change in level of patient decisional conflict is defined as the change in the Decisional Conflict Scale or subscale prior to and after treatment
a validated tool reflecting patient decision making prior to intervention
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British Columbia Cancer Agency
Lead sponsor
Gynecologic Cancer Initiative
Collaborator
Australia New Zealand Gynaecological Oncology Group
Collaborator
Canadian Cancer Trials Group
Collaborator
