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Adjuvant radiotherapy after surgery for vulval cancer.

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Cochrane Database of Systematic ReviewsIssue 1. DOI: Adjuvant radiotherapy after surgery for vulval cancer Protocol Copyright © The Cochrane Collaboration.

Debreceni Egyetem, Kardiológiai és Szívsebészeti Klinika, Debrecen Summary Cardiovascular diseases including heart failure are the leading causes of death in the industrialized countries and their prevention and treatment are one of the challenging tasks for cardiologists. In spite of the significant effort to improve both life expectancy and quality of life of patients suffering from these diseases, no widely available and effective treatment exists for the replacement of lost cardiomyocytes. The adult human heart has a very low regenerative capacity. In the past years, data had surfaced from various experimental and clinical research indicating that cardiomyocyte protection, angioneogenesis, as well as cardiomyocyte proliferation are all feasible via the modification of different signaling mechanisms. Observations deriving from stem cell experiments highlighted the advantages of cell-free thera­pies.

Publication status and date: Edited no change to conclusionspublished in Issue 1, Copyright © The Cochrane Collaboration. The objectives are as follows: To assess the effectiveness and safety of adjuvant radiotherapy for women with vulval cancer. Vulval cancer incidence is strongly related to age, with older age groups having the highest incidence rates Panici In the UK, age-specific incidence rates rise gradually from age 35 to 39, then more sharply from around age 65 to 69, reaching the highest incidence in the over 90 age group Cancer Research UK Incidence in women aged 40 to 49 years has increased two-fold in the last three decades and bmj best practice comorbidities tool been ascribed to increasing rates of human papilloma virus HPV infection Basta ; van de Nieuwenhof Lymph node metastasis is the most critical prognostic factor as tumours spread primarily via the inguinofemoral lymph nodesand is associated with higher recurrence and decreased overall survival OS Gill ; Hacker ; Woelber Nodal recurrence of vulval cancer is usually incurable Podratz The most powerful predictors of local recurrence are surgical margins and nodal status Heaps The number of lymph nodes removed at lymphadenectomy is an important prognostic factor and seems to have an impact on OS Le ; Panici Lymphovascular space invasion LVSIinfiltrative growth patterns and deep tumour penetration are also thought to be markers of poor prognosis Binder ; Boyce ; Heaps ; Sedlisbut these factors do not indicate the need for adjuvant treatment.

The only variables associated with poor prognosis on multifactorial analysis were nodal status and primary lesion diameter, when considered together Homesley In women with resectable disease without nodal involvement, the five-year Adjuvant radiotherapy after surgery for vulval cancer Protocol Copyright © The Cochrane Collaboration.

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Description of the intervention Surgery is currently the mainstay of treatment for vulval carcinoma. Radical vulvectomy and bilateral groin node dissection was the traditional approach, but wide radical local excision of the primary tumour with a macroscopic margin of 15 mm or more is now thought to be sufficient Heaps Lesions less than 2 cm in diameter and confined to the vulva or perineum, with stromal invasion of 1 mm or less FIGO stage 1a can be managed by wide local excision only, without groin node dissection, as the risk of lymph node metastases is negligible Hacker If a primary vulval squamous cell carcinoma is unifocal, and less than 4 cm in diameter, with no clinical or radiological suspicion of lymph node involvement, a sentinel lymph node biopsy SLNB can be performed to guide the need for lymph node dissection Levenback If a sentinel lymph node can only be identified in the ipsilateral groin, contralateral dissection can be omitted Levenback If SLNB is bmj best practice comorbidities tool, no further surgery is required, but if it is positive then complete lymphadenectomy of both groins should be considered Levenback Unilateral or bilateral inguinofemoral lymph node dissection is recommended when SLNB is inappropriate, such as tumour invasion more than 1 mm into the stroma FIGO stage 1b or worse Sedlisor a maximum tumour diameter bmj best practice comorbidities tool greater than 4 cm, depending on size and laterality of the primary lesion.

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Studies have demonstrated that the risk of skin bridge recurrence in early-stage disease is low Hacker En bloc resection may be more practical in some situations, but can be associated with increased morbidity. In the majority of cases, bilateral groin node dissection is required due to extensive crossover of lymphatics within the vulva. However, in lateral tumours one in which wide excision more than 1cm beyond visible tumour edge would not impinge on a midline structureonly ipsilateral groin surgery is required initially; contralateral lymphadenectomy or radiotherapy is performed only if ipsilateral nodes are positive Stehman Where a complete lymphadenectomy is recommended, the superficial inguinal and deep femoral nodes should be removed Sedlis Preservation of the long saphenous vein can reduce morbidity, but there have been no randomised studies investigating this Zhang Sartorius muscle transposition can prevent subsequent femoral vessel damage, particularly in women who are due to undergo adjuvant radiotherapy Paley There is an impetus for treatment to become more individualised and conservative, due to the well recognised psychosexual sequelae and morbidity associated with groin node dissection in particular Kehoe The complications associated with vulval and inguinal surgery include wound breakdown and infection, venous thromboembolism VTEpressure sores, introital stenosis, urinary and faecal incontinence, rectocoele, inguinal lymphocyst, lymphoedema and hernia Hinten Multivariate analysis has identified older age, diabetes, en bloc resection and greater drain production on the last day of drain placement to be associated with higher risk of short-term complications, and younger age and lymphocoele risk factors for longer-term morbidity Hinten Interestingly, bmj best practice comorbidities tool of a greater number of lymph nodes was found to be protective against long-term complications Hinten Adjuvant radiotherapy is often recommended in the presence of poor prognostic indicators Kunosspecifically positive bmj best practice comorbidities tool margins and groin node positivity Faul ; Homesley ; Paladini ; Thomas ; van der Velden The role of adjuvant radiotherapy in these cases was established by the GOG trial Homesleywhere highrisk lymph node-positive women were diabetes mellitus méh szubormális kezelése radiotherapy, which bmj best practice comorbidities tool in improved local control, relapse-free survival and OS Gill More recently, newer studies have suggested that size of the lymph node deposit is also important, with micrometastases of up to 2 mm not requiring adjuvant radiotherapy Oonk Where surgical margins are less than 1 cm on a fixed specimen, it is reasonable to consider further resection, although there is no definite evidence that this will reduce the risk of future local recurrence.

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There is also insufficient evidence to recommend adjuvant local therapy routinely to these women. In node-negative cases, there does not appear to be any widely accepted indications for adjuvant radiotherapy.

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However, radiotherapy can be delivered to the perineum for large tumours, or if there are close or involved margins and further surgery is not possible. A previous Cochrane review has shown there is no evidence that prophylactic groin irradiation can replace nodal surgery Van der Velden In general, the optimal adjuvant therapy for vulval cancer women remains controversial, as it is poorly described and there is a paucity of evidence in the literature.

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Potential benefits of adjuvant radiotherapy where radiotherapy is delivered to the groin following surgery to the same area should be balanced against the increased risk of lymphoedema. In the UK, computerised tomography CT is used with intravenous contrast to aid radiotherapy planning.

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The bladder should be comfortably full. The gross tumour volume GTV should cover the scar and take into account the original site of the primary tumour, and the planning treatment volume PTV should include the whole vulva with a margin on the GTV. A margin is used to form a clinical target volume CTVexcluding bone, muscle, bowel and bladder, and a further margin added to form the PTV Hoskin Treatment is usually given with conformal therapy using four beams to reduce bowel and rectal dose, although anterior and posterior opposed fields can be used Barrett More recently, intensity-modulated radiotherapy IMRT has been used.

Bolus, a tissue-equivalent material used to build up dose to provide a more effective treatment to superficial tissues, may be needed to ensure adequate kezelést köhögés cukorbetegség to the site of the resected primary tumour particularly if margins are close or involved Barrett There is no evidence to suggest whether radiotherapy should be given to the nodes bilaterally, or just to the involved side.

The majority of treatment schedules are based upon data developed by the Toronto Group, and the typical dose delivered is 45 Gy to 60 Gy in 25 to 33 fractions daily Thomastreating five fractions per week Barrett ; Hoskin Pelvic nodes are included, as inguinofemoral node positivity has been shown to correlate with pelvic node bmj best practice comorbidities tool, and pelvic radiotherapy is superior to surgery alone with regard to OS Woelber There are no accepted indication criteria for groin irradiation itself without pelvic radiotherapy Mahnerand practice varies globally due to a lack of consensus resulting from the paucity of good quality evidence in this area.

Acute skin toxicity can result in moist desquamation, where the skin begins to thin and weep Stehman Additional early toxicities include urinary frequency, dysuria, proctitis, diarrhoea and fatigue Barrett Late vulval fibrosis and atrophy and vaginal stenosis, resulting in sexual dysfunction, can commonly occur, as can urethral stenosis.

Lower limb lymphoedema occurs in a significant proportion of women who have had inguinofemoral lymph node dissection and radiotherapy Bmj best practice comorbidities toolhowever, previous studies which have randomised to either pelvic dissection or radiotherapy, have shown similar levels of late chronic lymphoedema in both groups.

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Femoral head necrosis is also a risk, but this can be reduced by conformal planning techniques where radiation beams conform to tumour shape and minimise dose to normal tissues Barrett The evidence for using chemotherapy for vulval cancer in the adjuvant setting, either alone or in combination with radiotherapy remains very scant Fauland will not be considered further in this review.

How the intervention might work Adjuvant radiotherapy is given to reduce the risk of vulval cancer recurrence.

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Most recurrences tend to occur in the vulva, at or near the original primary tumour site or in the groin area. Adjuvant radiotherapy to the vulva and regional lymph nodes, bmj best practice comorbidities tool the presence of poor prognostic indicators, is believed to improve locoregional control and survival rates, while potentially reducing overall treatment morbidity Busch ; Helgason