Annals of Oncology 12:997-1003, 2001
© 2001 European Society for Medical Oncology
research-article |
Radiotherapy after breast-conserving surgery in small breast carcinoma: Long-term results of a randomized trial
1Departments of Senology, European Institute Oncology Milano, Italy
2Department of Biometrics, Istuto Nazonale per lo Studio la Cura dei Tumor Milano, Italy
3Department of Oncology, Policinico San Marco Zingonia, Bergamo
4Department of Radiotherapy, Ospedale Clinicizzato Milano, Italy
Prof. U. Veronesi European Institute of Oncology Via G. Ripamonti. 435 20141 Milan Italy E-mail: umberto.veronesi{at}leo.it
BackgroundThalidomide is effective in approximately 30% of patients with refractory multiple myeloma. Dexarnethasone is active in 25%of patients with disease resistant to alkylating agents. We investigated the combination of thalidomide with dexarneth treatment for heavily pretreated patients with multiple myeloma, in order to assess its efficacy and toxicity.
Patients and methods: Forty-four patients with refractory myelorna were treated with thalidomide, 200 mg p.o. daily at bededtime, with dose escalation to 400 rng after 14 days, and dexarnethasone, which was administered intermittently at a dose of 20 mg/m2 p.o. daily for four days on day 1–4, 9–12, 17–20, followed by monthly dexamethasone for four days. Patients' median age was 67 years. All patients were resistant to standard chemotherapy, 77% were resistant to dexamethasone based regimens and 32% had previously received high-dose therapy.
Results: On an intention-to-treat basis twenty-four patients (55%) achieved a partial response with a median time to response of 1.3 months. The thalidomide and dexamethasone combination was equally effective in patients with or without prior resistance to dexamethasone-based regimens and in patients with or without prior high-dose therapy. Toxicities were mild or moderate and consisted primarily of constipation, morning somnolence, tremor, xerostomia and peripheral neuro pathy. The median time to progression for responding patients is expected to exceed 10 months and the median survival for all patients is 12.6 months.
Conclusion: The combination of thalidomide with dexa methasone appears active in patients with refractory multiple myeloma. If this activity is confirmed, further studies of this combination as second-line treatment for patients resistant to conventional chemotherapy, and as primary treatment for patients with active rnyeloma. should be considered.
breast-conserving surgery, radiotherapy, small breast carcinooma
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