Page 19 - ESGO - Vulvar cancer - Complete report_fxd2

9 Surgical management

9.1 Summary of available scientific evidence LoE 2+

Radical/wide local excision versus radical vulvectomy : none of the five identified studies40-44
reported statistically significant differences in overall survival, disease-free survival, local or distant
recurrence rates between patients treated by radical/wide local excision and patients treated by
radical vulvectomy:

 In a retrospective study enrolling 74 patients (T1-2N0-1M0), Farias-Eisner et al.40 compared the
effectiveness and safety of a radical local excision (N = 56) versus radical vulvectomy (N = 18).
Of women with stage I disease, the 5-year survival was similar for those patients who underwent
the more conservative operation (97%) compared with those who underwent a radical
vulvectomy (100%). The difference in the overall survival of stage II patients undergoing radical
local excision versus radical vulvectomy did not reach statistical significance (90% versus 75%,
p > 0.05). Operative morbidity was less in those undergoing a conservative operation. Serious
infection, necrosis, or major breakdown of the primary wound occurred in 2 (11%) and 14
(25%) patients undergoing radical local excision and radical vulvectomy, respectively.

 Similar overall survival, local control and 5-year disease-free survival rates were reported by
Balat et al.41 between 25 patients treated by wide local excision and 24 patients treated by

radical vulvectomy (73% versus 67%, 83% versus 80%, and 75% versus 67%, respectively). In
this retrospective study, all patients received irradiation combined with surgery. There were
fewer complications (eg lymphedema, wound infection, lymphocyst, vulvar dystrophy) in the
patients treated by wide local excision than in those treated with radical vulvectomy. Similar
local recurrence rates were reported by de Hullu et al.42 between patients treated by wide local

excision and patients treated by radical vulvectomy (11.4% (9/79) versus 7.5% (12/159), p =
0.32). An analysis of the exact tumour free margins among 39 patients treated by wide local
excision showed that no patient with histologic tumour free margins measuring > 8 mm
developed a local recurrence, whereas 9 of 40 patients with at least one tumour free margin
measuring ≤ 8 mm developed local recurrences within 2 years (p = 0.002). As Balat et al.41,
there was no difference in overall survival between two groups of patients. Rutledge et al.43
undertook an analysis of 179 stage I and II lesions treated with a curative aim to see if there was
a difference in survival or in disease-free interval between those patients treated with radical
vulvectomy and those treated with radical wide local excision. No survival advantage from the

radical vulvectomy procedure has been reported (data not shown).

 No statistical correlation between the type of primary surgery performed and the frequency of
recurrence to any site were described by DeSimone et al.44 in a retrospective study enrolling 122
patients with lateral T1 (N = 61) and T2 (N = 61) vulvar cancer confined to the labium majus
and labium minus (local: 13% versus 8%, p = 0.33, groin: 0% versus 3%, p = 0.50, distant
(pulmonary): 2% versus 3%, p = 1.0, total: 15% versus 15%, p = 1.0). It should be noted that
lymphoedema occurred more commonly in patients undergoing radical vulvectomy than in
patients undergoing radical wide excision (26% versus 7.5%, p = 0.007). Likewise, both wound
separation (23% versus 7.5%) and lymphocyst formation (6.7% versus 3.2%) were more
common in patients undergoing radical vulvectomy.

As part of Cochrane systematic review, van der Velden45 also assessed the effectiveness and safety LoE 2-
of a radical local excision. Two observational studies46,47 enrolling 94 patients (TIN0M0: N = 51,

T2N0M0: N = 43) have been included in this systematic review. No pooled analysis is described and

it should be noted that details regarding radiotherapy interventions were not addressed and the grade

of complications was not defined in any study. Furthermore, an adequate description of common
complications was not stated in one study47. Authors reported a recurrence rate of 0%47 and 12%46.

 VULVAR CANCER - GUIDELINES 
19