18. Primary vaginal cancer and vaginal recurrences - The GEC-ESTRO Handbook of Brachytherapy

Primary vaginal cancer and vaginal recurrences

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THE GEC ESTRO HANDBOOK OF BRACHYTHERAPY | Part II Clinical Practice Version 1 - 01/09/2023

TABLE 3 SUMMARY OF ONCOLOGICAL OUTCOMES OF IMAGE-GUIDED BRACHYTHERAPY IN PRIMARY VAGINAL CANCER STUDIES. Author (year of publication) (ref n o ) Years of inclusion Number of patients Median FU (months) Median D90 CTV (Gy) LC at 2 years (%) DFS at 2 years (%) OS at 2 years (%) Severe toxicity (%)

Dimopoulos (2012) [46] 1999-2006 13

43

86

92*

NA

85*

23

Fokdal (2011) [39]

2005-2010 9

18

82

92†

59†

74†

4

Huertas(2018) [47]

2004-2016 27

40

73

82

75

91

15

Gebhardt (2018) [40]

2011-2016 16

39

77

93‡

64‡

67‡

3

Manuel (2016) [28]

2002-2014 47

24

81

93

86

82

2

Lee (2013) [41]

2005-2011 10

17

74

86

60

62

13

Westerveld (2021) [24]

2001-2016 148

29

80

86

73

79

17

Goodman (2021) [32]

2002-2017 67

32

74

87

74

86

10

FU=follow-up; D90=minimal dose to 90% of the volume; CTV=clinical target volume; LC=local control; DFS=disease free survival; OS=overall survival; NA=not available. *Outcome at 3 years. †Outcome at 4 years. ‡Outcome for the entire group, including recurrences. Updated table with permission adopted from Westerveld et al [7].

Differentiation between necrosis and local tumour recurrence can be difficult. Limited use of biopsies is recommended as necrosis usually worsens after invasive procedures. In the recent retrospective multicentre study on IGABT in primary vaginal cancer “RetroEMBRAVE” the crude incidence of severe (grade 3 and higher) adverse effects was 17%. Vesico-vaginal fistula and complete vaginal obliteration were the most frequent severe events [24]. However, as prospective data is lacking, under reporting of adverse effects, in particular with regard to vaginal morbidity, has to be assumed. Necrosis and chronic ulceration often require intensive treatment such as anti-inflammatory treatment, wound management including regular local washings with suitable solutions (e.g., benzydaminhydrochlorid), antibiotics for superinfection and hyperbaric oxygen therapy, and even may necessitate reconstructive surgery. Sexual and vaginal rehabilitation (e.g., psycho-oncological support, regular dilation, lubrication, hormonal replacement therapy) should be considered as patients may be able to regain satisfactory sexual life. Means to minimize or prevent vaginal side effects impacting on function in a similar way as reported after brachytherapy for cervical cancer [44, 45] are essential such as careful target selection and dose prescription balancing tumour and vaginal dose and volume.

adaptive brachytherapy are very limited. Older reports from the 2D brachytherapy era with patients treated with an IC/IS approach and in most cases LDR, showed a wide range of 5-years local control rates, namely from 29-100% [38]. In contrast, the results from the IGBT era including patient treated with IC-only and IC/ IS approach with PDR or HDR, showed more consistent results with local control rates ranging from 75-93% which appears to be comparable to the local control rates in primary vaginal cancer patients [39-42]. Although studies are small, some prognostic factors for oncological outcome are suggested, namely tumour volume at diagnosis and brachytherapy, time to first relapse, prescribed dose, and primary prognostic factors (e.g., FIGO stage)[38, 42]. Results from the prospective EMBRAVE study will provide evidence to confirm these results. Reported acute and late side effects after definitive chemoradiation are similar to those reported for cervical cancer. Brachytherapy specific severe adverse effects concern mainly the vagina, urinary bladder, rectum and depending on the location of the tumour also the urethra, clitoris, bowel and anal canal [24]. The vagina has a special role as it is both the target volume and organ at risk at the same time and the optimal balance between target dose and avoidance of side effects is challenging. Typical vaginal side effects range from mucosal atrophy and dryness to more severe conditions such as progressive fibrosis with stenosis and shortening, chronic ulceration and necrosis, which substantially impact quality of life. Low seated tumours combined with high dose radiation to the lower vagina carry an increased risk for complete obliteration, necrosis and painful ulceration [43], also for the adjacent vulvar region. 13. ADVERSE EVENTS