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Randomized Trial of Dose-Dense Versus Conventionally Scheduled and Sequential Versus Concurrent Combination Chemotherapy as Postoperative Adjuvant Treatment of Node-Positive Primary Breast Cancer: First Report of Intergroup Trial C9741/Cancer and Leukemia Group B Trial 9741
- Source :
- Journal of Clinical Oncology. 21:1431-1439
- Publication Year :
- 2003
- Publisher :
- American Society of Clinical Oncology (ASCO), 2003.
-
Abstract
- Purpose: Using a 2 × 2 factorial design, we studied the adjuvant chemotherapy of women with axillary node–positive breast cancer to compare sequential doxorubicin (A), paclitaxel (T), and cyclophosphamide (C) with concurrent doxorubicin and cyclophosphamide (AC) followed by paclitaxel (T) for disease-free (DFS) and overall survival (OS); to determine whether the dose density of the agents improves DFS and OS; and to compare toxicities. Patients and Methods: A total of 2,005 female patients were randomly assigned to receive one of the following regimens: (I) sequential A × 4 (doses) → T × 4 → C × 4 with doses every 3 weeks, (II) sequential A × 4 → T × 4 → C × 4 every 2 weeks with filgrastim, (III) concurrent AC × 4 → T × 4 every 3 weeks, or (IV) concurrent AC × 4 → T × 4 every 2 weeks with filgrastim. Results: A protocol-specified analysis was performed at a median follow-up of 36 months: 315 patients had experienced relapse or died, compared with 515 expected treatment failures. Dose-dense treatment improved the primary end point, DFS (risk ratio [RR] = 0.74; P = .010), and OS (RR = 0.69; P = .013). Four-year DFS was 82% for the dose-dense regimens and 75% for the others. There was no difference in either DFS or OS between the concurrent and sequential schedules. There was no interaction between density and sequence. Severe neutropenia was less frequent in patients who received the dose-dense regimens. Conclusion: Dose density improves clinical outcomes significantly, despite the lower than expected number of events at this time. Sequential chemotherapy is as effective as concurrent chemotherapy.
- Subjects :
- Adult
Cancer Research
medicine.medical_specialty
Filgrastim
Paclitaxel
Dose-dense chemotherapy
Cyclophosphamide
medicine.medical_treatment
Urology
Breast Neoplasms
Drug Administration Schedule
chemistry.chemical_compound
Breast cancer
Antineoplastic Combined Chemotherapy Protocols
Granulocyte Colony-Stimulating Factor
Humans
Medicine
Aged
Proportional Hazards Models
Chemotherapy
business.industry
Combination chemotherapy
Middle Aged
medicine.disease
Survival Analysis
Recombinant Proteins
Nitrogen mustard
Surgery
Granulocyte colony-stimulating factor
Treatment Outcome
Oncology
chemistry
Chemotherapy, Adjuvant
Doxorubicin
Multivariate Analysis
Female
business
medicine.drug
Subjects
Details
- ISSN :
- 15277755 and 0732183X
- Volume :
- 21
- Database :
- OpenAIRE
- Journal :
- Journal of Clinical Oncology
- Accession number :
- edsair.doi.dedup.....0c792b6f69ce415af5100ae77f406de5
- Full Text :
- https://doi.org/10.1200/jco.2003.09.081