A phase III randomized trial comparing adjuvant concomitant chemoradiotherapy versus standard adjuvant chemotherapy followed by radiotherapy in operable node-positive breast cancer: Final results

Journal Article · Wed Mar 15 04:00:00 EST 2006 · International Journal of Radiation Oncology, Biology and Physics

DOI:https://doi.org/10.1016/J.IJROBP.2005.1· OSTI ID:20793385

Rouesse, Jacques ^[1]; Lande, Brigitte de la ^[1]; Bertheault-Cvitkovic, Frederique ^[1]; Serin, Daniel ^[2]; Graic, Yvon ^[3]; Combe, Martin ^[4]; Leduc, Bernard ^[5]; Lucas, Virginie ^[6]; Demange, Liliane ^[7]; Nguyen, Tan Dat ^[7]; Castera, Daniel ^[8]; Krzisch, Claude ^[9]; Villet, Richard ^[10]; Mouret-Fourme, Emmanuelle ^[1]; Garbay, Jean-Remy ^[1]; Nogues, Catherine ^[1]

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1. Centre Rene Huguenin, Saint-Cloud (France)
2. Institut Sainte-Catherine, Avignon (France)
3. Centre H. Becquerel, Rouen (France)
4. Centre Hospitalier, Le Mans (France)
5. Centre Hospitalier, Brive (France)
6. Hopital de la Source, Orleans (France)
7. Institut J. Godinot, Reims (France)
8. Clinique Saint-Pierre, Perpignan (France)
9. Centre Hospitalier Universitaire, Amiens (France)
10. Hopital des Diaconesses, Paris (France)

Purpose: To compare concomitant and sequential adjuvant chemoradiotherapy regimens in node-positive, operable breast cancer patients. Methods and Materials: This was a randomized, French, multicenter, phase III trial enrolling 638 eligible women with prior breast surgery and positive axillary dissection. Patients in Arm A received 500 mg/m{sup 2} 5-fluorouracil, 12 mg/m{sup 2} mitoxantrone, and 500 mg/m{sup 2} cyclophosphamide, with concomitant radiotherapy (50 Gy {+-} 10-20-Gy boost). Patients in Arm B received 500 mg/m{sup 2} 5-fluorouracil, 60 mg/m{sup 2} epirubicin, and 500 mg/m{sup 2} cyclophosphamide, with subsequent radiotherapy. Chemotherapy was administered on Day 1 every 21 days for 4 cycles. Results: Median treatment durations were 64 and 126 days (Arms A and B, respectively), with no significant difference in overall or disease-free survival. Five-year locoregional relapse-free survival favored patients with conservative surgery (two thirds of the population), with less local and/or regional recurrence in Arm A than in Arm B (3% vs. 9%; p 0.01). Multivariate analysis in this subgroup showed a 2.8-fold increased risk of locoregional recurrence with sequential chemoradiotherapy, independent of other prognostic factors (p = 0.027). Febrile neutropenia and Grade 3-4 leukopenia were significantly more frequent in Arm A. Subclinical left ventricular ejection fraction events at 1 year were more frequent with concomitant radiotherapy (p = 0.02). Conclusions: Concomitant radiotherapy with adjuvant fluorouracil, mitoxantrone, and cyclophosphamide has significantly better locoregional control in node-positive breast cancer after conservative surgery and 50% shorter treatment, albeit with slightly more acute toxicity. With mitoxantrone no longer available for adjuvant breast cancer treatment, alternative concomitant chemoradiotherapy studies are needed.

• OSTI ID: 20793385
• Journal Information: International Journal of Radiation Oncology, Biology and Physics, Journal Name: International Journal of Radiation Oncology, Biology and Physics Journal Issue: 4 Vol. 64; ISSN IOBPD3; ISSN 0360-3016
• Country of Publication: United States
• Language: English

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