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13 Systemic treatment

13.1 Summary of available scientific evidence

Neoadjuvant chemotherapy: no studies enrolling at least 50 patients were identified. Results from the LoE 3
8 identified studies257-264 are limited notably by the heterogeneity and the number of patients
evaluated (only 3 studies258,262,263 have accrued in excess of 20 patients), and by the heterogeneity in

the chemotherapy regimens. Although studies are very small, agents showing response include
bleomycin, cisplatin, and most notably infusional 5-FU (Table 13). It should be noted that response
rates differ quite extensively among the studies. But, the identified trials have not shown significant
evidence of improved survival. Additionally, some effective agents produce high toxicity, such as
Bleomycin, that is a significant issue.

Adjuvant chemotherapy: only one very small study265 was identified. To assess the use of LoE 3
chemotherapy alone in the adjuvant setting, Bellaty et al.265 included 14 patients with inguinal node
metastases after radical surgery. Cisplatin (100 mg/m²) was administered every 21 days for 4 cycles.
Four of 14 patients recurred (29%) at a median of 57 months of follow-up, including two recurrences
in the groin. Three-year OS and PFS were 86% and 71%, respectively.

Targeted therapy: only one small study was identified. Horowitz et al.266 evaluated the efficacy and LoE 3
toxicity of erlotinib (150 mg daily), a selective epidermal growth factor receptor tyrosine kinase
inhibitor, among 41 patients with locally advanced, primary, recurrent or metastatic vulvar squamous
cell carcinoma. In this first phase II trial, overall clinical benefit rate was 67.5% including partial
response (27.5%) and stable disease (40%). No complete response has been observed. It should to be
noted that 1) responses were of relatively short duration and toxities were significant, and 2) quality
of life evaluation was not assessed in this study.

13.2 Previous initiatives

Three previous initiatives1,3,39 presenting guidelines on systemic treatment were identified.

13.3 Development group comments

None.

13.4 Guidelines

D Data in vulvar cancer are insufficient to recommend a preferred schedule in a palliative setting.

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