title: Results of a phase I-II study of adjuvant concurrent carboplatin and accelerated radiotherapy for triple negative breast cancer.
abstract: Purpose: To determine feasibility and explore the clinical efficacy of concurrent radiotherapy and carboplatin as adjuvant treatment of triple negative breast cancer (TNBC).Patients and Methods: Women with Stage I-II TNBC were treated after surgery in a phase I-II prospective trial [NCT01289353]. Weekly carboplatin (AUC = 2.0) was delivered for 6 weeks. Concurrent radiotherapy was delivered in the prone position during weeks 2-4, for a total dose of 40.5 Gy in 15 fractions to the breast, and 46.5 Gy in 17 fractions to the tumor bed. Adverse events (AE) were assessed weekly during treatment, once at 45-60 d, and every 6 mo thereafter, using the Common Terminology Criteria for AE (CTCAE) v3.0.Results: A total of 39 patients accrued and 36 received treatment. Eight patients (22%, exact 95% CI: 10%, 39%) developed grade 2 or greater acute radiation dermatitis. Overall, grade 2 AE were seen in nine and grade 3 in two patients. Twenty-three patients (64%) received additional adjuvant chemotherapy. With a median follow-up of 48 mo, 34/36 (94%) are alive and disease free. One patient died of pulmonary failure with possible but unproven breast cancer recurrence, and one patient died of pelvic malignancy. One patient recurred locally and is alive and disease free after surgical management. Brisk lymphocytic infiltrate was present pre-treatment in 39% of 18 patients with evaluable tumor.Conclusions: Adjuvant concurrent carboplatin and prone accelerated radiotherapy is a well-tolerated and promising treatment of early stage TNBC. The observed 3% compares favorably with the expected 30% recurrence rate within 1-4 y from treatment, warranting further studies.
authors.affiliation: Department of Radiation Oncology, Weill Cornell Medicine , New York, NY, USA.
authors.forename: Silvia C
authors.initials: SC
authors.lastname: Formenti
authors.affiliation: Department of Radiation Oncology, Weill Cornell Medicine , New York, NY, USA.
authors.forename: Encouse B
authors.initials: EB
authors.lastname: Golden
authors.affiliation: Departments of Population Health and Environmental Medicine, New York University School of Medicine , New York, NY, USA.
authors.forename: Judith D
authors.initials: JD
authors.lastname: Goldberg
authors.affiliation: Departments of Population Health and Environmental Medicine, New York University School of Medicine , New York, NY, USA.
authors.forename: Xiaochun
authors.initials: X
authors.lastname: Li
authors.affiliation: Department of Medicine, New York University School of Medicine , New York, NY, USA.
authors.forename: Jessica
authors.initials: J
authors.lastname: Taff
authors.affiliation: Department of Radiation Oncology, Weill Cornell Medicine , New York, NY, USA.
authors.forename: Maria B
authors.initials: MB
authors.lastname: Fenton-Kerimian
authors.affiliation: Department of Radiation Oncology, Weill Cornell Medicine , New York, NY, USA.
authors.forename: Sharanya
authors.initials: S
authors.lastname: Chandrasekhar
authors.affiliation: Department of Radiation Oncology, Weill Cornell Medicine , New York, NY, USA.
authors.forename: Sandra
authors.initials: S
authors.lastname: Demaria
authors.affiliation: Department of Medicine, New York University School of Medicine , New York, NY, USA.
authors.forename: Yelena
authors.initials: Y
authors.lastname: Novik
keywords: Adjuvant treatment; chemo-radiation; clinical trial; immunogenic cell death; triple negative breast cancer; tumor-infiltrating lymphocytes