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11 Radiation therapy

11.1 Summary of available scientific evidence LoE 1-

Primary radiotherapy of the groin: as part of Cochrane systematic review, van der Velden et al.204
compared the effectiveness and safety of this therapeutic approach to the inguino-femoral lymph
nodes with primary groin surgery. One randomised controlled trial205, one case-control206 and two
observational186,207 studies have been included in this review. No pooled analysis is described and it
should be noted that two studies also included patients with non-squamous histology206,207. The
tumour recurrence rate in the groin after primary groin radiation ranged from 0% to 18.5% (Table 7).
However, only the randomised controlled trial205 directly compared radiotherapy towards the groin
versus surgery. In this trial, there is a difference in groin recurrence, favouring the primary groin
surgery (0% versus 18.5%). Overall survival and progression-free survival were significantly lower
in the radiation group compared with the surgery group (p = 0.04 and p = 0.03, respectively). But,
the patients treated with groin radiation had substantially shorter hospitalizations than those who
underwent groin surgery (p = 0.0001). It should be noted that this trial was closed prematurely when
interim monitoring revealed an excessive number of groin relapses on the groin radiation regimen.
Criticisms could be made of the technique of radiotherapy applied in this trial (potential
insufficiency to sterilise subclinical lymph node metastases in the groin). Maximum dose was
prescribed at 3 cm in this trial. It is likely, therefore, that the deeper groin nodes were relatively
undertreated.

Neoadjuvant radiotherapy: no studies enrolling at least 50 patients were identified. Interpretation of LoE 3
the results from the 8 identified trials208-215 are limited notably by the small number of patients
evaluated (only 3 trials208-210 have accrued in excess of 10 patients) and by the heterogeneity in the

radiotherapy regimens (external beam radiation and/or intracavitary brachytherapy). Although

studies are very small, authors reported low severe complications and high proportions of patients

alive with no evidence of disease and no recurrence (Table 8). Furthermore, this combined therapeutic

approach showed a good probability of bladder and/or rectal preservation.

Adjuvant radiotherapy (close surgical margins or positive margins): Faul et al.216 reported a LoE 2+
reduction of local recurrence from 58% to 16% in these patients treated with adjuvant radiation
therapy. On multivariate analysis, adjuvant radiation was a significant prognostic predictor for local
control (p = 0.009). However, it did not reach statistical significance for overall survival. On
subgroup analysis, adjuvant radiation therapy significantly improved actuarial 5-year survival for
patients with positive margins (p = 0.001), but not for those with close margins (p = 0.63).

Adjuvant radiotherapy (no suspicious groin nodes): Stehman et al.205 randomised 58 patients patients LoE 1-
with lesions clinically confined to the vulva and no suspicious groin nodes to either radical
vulvectomy followed by either groin radiation or inguinal lymphadenectomy (plus groin radiation if
nodes were involved) to compare efficacy and morbidity of the two treatment approaches. The groins
were treated daily to a dose of 50 Gy over 5 weeks (200 cGy/d). Patients randomised to the groin
dissection arm who where found to have metastatic carcinoma in the resected nodes received post-
operative radiation therapy to the ipsilateral groin and hemipelvis. A total dose of 50 Gy was
administered through anterior portals to the groin and through anterior and posterior portals to the
iliac nodes. The study was closed prematurely when interim monitoring revealed an excessive
number of groin relapses on the groin radiation regimen (see above).

Adjuvant radiotherapy (single positive node): the benefit of adjuvant radiation in patients with a LoE 2+
single lymph node metastasis and micrometastatic disease to the lymph nodes is controversial. Fons
et al.217 could not demonstrate a significant benefit of adjuvant radiotherapy in these patients on both
disease-free and disease-specific survival (HR = 0.98, 95% CI = 0.45-2.14, p = 0.97 and HR = 1.02,
95% CI = 0.42-2.47, p = 0.96). Recurrence rates appeared quite similar between the radiotherapy

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