Clinical Results

Between 1993 and 2001, 199 patients were treated at William Beaumont Hospital with interstitial brachytherapy alone (120 with LDR and 79 with HDR). With a median follow-up of 6.4 years, the 5-year local acturial recurrence rate was 1.2% with an elsewhere breast failure rate of 0.6% (Chen et al. 2006). To compare potential outcome differences based upon the volume of breast irradiated, the patients treated with interstitial brachytherapy alone were matched with 199 patients treated with whole-breast RT. The match criteria included tumor size, lymph node status, patient age, margins of excision, estro-

Table 8.1 Toxicities with resolution or stabilization over time

Toxicity

Interval

<6 months (n-

= 165)

2 years(

n=128)

>5 years (n=79)

Grade

Grade

Grade

I

II

III

I

II

III

I

II

III

Breast pain (%)

27

0

0

13

1

0

8

1

0

Breast edema (%)

50

1

0

12

0

0

6

1

0

Erythema (%)

35

1

0

11

0

0

11

0

tation (%)

67

2

0

39

2

0

37

0

0

Fibrosis (%)

22

1

0

48

2

1

46

5

1

Hypopigmen-tation (%)

18

0

0

34

0

0

38

0

0

gen receptor status and use of tamoxifen. The rate of local recurrence was not significantly different between the two groups: those receiving whole-breast RT demonstrated a 1% recurrence rate and those receiving partial breast irradiation a similar 1% risk of local recurrence (P=0.65). Furthermore, no statistically significant differences were seen in the 5-year actuarial cause-specific survival (97% versus 97%, P=0.34) and overall survival (93% versus 87%, P=0.23) between those receiving whole-breast RT and those receiving accelerated partial breast irradiation alone (Vicini et al. 2003a).

In terms of toxicities and cosmetic outcome, the toxicity parameters examined in our cohort of patients included breast edema, erythema, fibrosis, hyperpigmentation, hy-popigmentation, breast pain, breast infection, telangiectasia, and fat necrosis. Toxicities were graded using the Radiation Therapy Oncology Group (RTOG)/Eastern Cooperative Oncology Group (ECOG) late radiation morbidity scoring scheme (Cox et al. 1995) for skin, subcutaneous tissues, pain, radiation dermatitis, and dermatology/skin from the Common Toxicity Criteria (CTC) version 2.0 (Trotti et al. 2000). As per the guidelines of CTC version 2, toxicities were graded using the acute/chronic radiation morbidity scale: grade 0 = no observable radiation effects, grade I = mild radiation effects, grade II = moderate radiation effects, and grade III = severe radiation effects. Cosmetic evaluation was based on standards as set out by the Harvard criteria (Rose et al. 1989). An excellent score was given when the treated breast looked essentially the same as the contralateral untreated breast. A good score was assigned for minimal but identifiable radiation effects on the treated breast. Scoring a fair result meant significant radiation effects readily observable. A poor score was used for severe sequelae of normal tissue.

Breast toxicities including pain, edema, erythema, and hyperpigmentation were nearly all mild and diminished over time (Table 8.1). Breast pain diminished from 27% at 6 months to 8% at 5 years. Breast edema decreased from 50% at 6 months to 12% at 2 years and 6% at 5 years. Similarly, erythema demonstrated the following pattern: 35% at 6 months to 11% at 2 years with stabilization thereafter. Hyperpigmentation followed a similar downward trend in frequency: 67% at 6 months to 37% at 5 years. All of these were statistically analyzed using Pearson's chi squared test and were found not to be chance occurrences (Chen et al. 2006)

Breast sequelae which increased until the 2-year mark and then stabilized included breast fibrosis (22%, 48% and 46% at 6 months, 2 years and 5 years, respectively) and hypopigmentation (18%, 34% and 38% at 6 months, 2 years and 5 years). Of note, any slight degree of periscar induration was scored as mild fibrosis regardless of whether or not post surgical changes may have contributed. Nearly all the pigmentary changes, whether hyper- or hypopigmentation were mild and pinpoint rather than diffuse, and corresponded to the sites where the LDR catheters or HDR needles had been placed. Likewise, the chi squared analysis verified these trends. The time-course trend of hy-popigmentation followed that of fibrosis with an increase in frequency out to 2 years with a subsequent plateau occurring with further passage of time.

The frequency of fat necrosis and telangiectasia increased with time; the time course of fat necrosis was 9% at 2 years and 11% at 5 years. The median time to occurrence of fat necrosis was 5.5 years (range of 0.25 to 8.2 years; Table 8.2). Telangiectasias, nearly all of which were grade I, were evenly distributed between the LDR and HDR treatment modalities at 5 years being 34% for both LDR and HDR (P=0.983).

Good to excellent cosmetic outcomes were noted in 95% to 99% of patients depending on the time of assessment (Table 8.3). At 6 months the percentage of good scores

Table 8.2 Toxicities with increased incidence over time

Toxicity

Interval

<6 months (n-

= 165)

2 years (n=128)

>5 years (n=79)

Grade

Grade

Grade

I II

III

I II III

I II III

Telangiectasia (%)

5 0

0

21 2 0

34 1 0

of all patients)"

of all patients)"

a Fat necrosis is not graded. Median time to occurrence: 5.5 years (0.25-8.2 years).

was 85%. However, between 6 months and 2 years, the percentage of excellent scores increased from 10% to 29%. Comparison of cosmetic results at 2 and 5 years demonstrated stabilization of scores with the percentage of excellent scores increasing out to 5 years. The percentage of good to excellent cosmetic outcome scores never fell below 95%.

Table 8.3 Cosmetic outcome over time with APBI

<6 months (n=165)"

2 years (n=129)ยป

>5 years (n=134)"

Excellent Good Fair

Excellent Good

Fair

Excellent Good

Fair

10% 85% 1%

29% 68%

2%

33% 66%

1%

95%

97%

99%

a Four percent and 1% of cosmetic outcomes were unreported for < 6 months and 2 years, respectively.

a Four percent and 1% of cosmetic outcomes were unreported for < 6 months and 2 years, respectively.

No statistically significant difference was noted in the incidence/severity of any toxicity or cosmetic outcome with the following parameters: tamoxifen, type of brachyther-apy (LDR versus HDR), and tumor size (T1 versus T2) (Pearson's chi squared analysis). However, the incidence of breast erythema at 2 and 5 years and the incidence of delayed infections were higher for those patients receiving chemotherapy (P=0.015, 0.016, and 0.003, respectively). Cosmetic assessment at 6 months was better in those patients not receiving chemotherapy than in those who received chemotherapy (100% versus 94%, P=0.005) (Chen et al. 2006).

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