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document
Fifteen-year results of a randomized prospective trial of hyperfractionated chest wall irradiation versus once-daily chest wall irradiation after chemotherapy and mastectomy for patients with locally advanced noninflammatory breast cancer . PURPOSE To analyze the results of a Phase III clinical trial that investigated whether a hyperfractionated radiotherapy ( RT ) schedule could reduce the risk of locoregional recurrence in patients with locally advanced breast cancer treated with chemotherapy and mastectomy . METHODS AND MATERIALS Between 1985 and 1989 , 200 patients with clinical Stage III noninflammatory breast cancer were enrolled in a prospective study investigating neoadjuvant and adjuvant chemotherapy . Of the 179 patients treated with mastectomy after neoadjuvant chemotherapy , 108 participated in a randomized component of the trial that compared a dose-escalated , hyperfractionated ( twice-daily , b.i.d . ) chest wall RT schedule ( 72 Gy in 1.2-Gy b.i.d . fractions ) with a once-daily ( q.d . ) schedule ( 60 Gy in 2-Gy q.d . fractions ) . In both arms of the study , the supraclavicular fossa and axillary apex were treated once daily to 50 Gy . The median follow-up period was 15 years . RESULTS The 15-year actuarial locoregional recurrence rate was 7 % for the q.d . arm and 12 % for the b.i.d . arm ( p=0.36 ) . The rates of severe acute toxicity were similar ( 4 % for q.d . vs. 5 % for b.i.d . ) , but moist desquamation developed in 42 % of patients in the b.i.d . arm compared with 28 % of the patients in the q.d . arm ( p=0.16 ) . The 15-year actuarial rate of severe late RT complications did not differ between the two arms ( 6 % for q.d . vs. 11 % for b.i.d. , p=0.54 ) . CONCLUSION Although the sample size of this study was small , we found no evidence that this hyperfractionation schedule of postmastectomy RT offered a clinical advantage . Therefore , we have concluded that it should not be further studied in this cohort of patients .
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Intervention_Physical
hyperfractionated chest wall irradiation
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Intervention_Physical
once-daily chest wall irradiation after
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Intervention_Pharmacological
chemotherapy
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Intervention_Physical
hyperfractionated radiotherapy ( RT )
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Intervention_Surgical
mastectomy after
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Intervention_Physical
neoadjuvant chemotherapy
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Intervention_Physical
hyperfractionated ( twice-daily , b.i.d . ) chest wall RT
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Intervention_Physical
q.d . arm
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Intervention_Physical
b.i.d . arm
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Intervention_Physical
b.i.d . arm
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Intervention_Physical
q.d . arm
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Intervention_Physical
postmastectomy RT
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Outcome_Physical
15-year actuarial locoregional recurrence rate
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Outcome_Adverse-effects
rates of severe acute toxicity
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Outcome_Adverse-effects
15-year actuarial rate of severe late RT complications
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Participant_Condition
locally advanced noninflammatory breast cancer
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Participant_Condition
locally advanced breast cancer
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Participant_Sample-size
200
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Participant_Condition
Stage III noninflammatory breast cancer
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Participant_Sample-size
179
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Participant_Sample-size
108