The combination of paclitaxel at low dose and epirubicin followed by CMF is a feasible regimen, which seems to be effective in high-risk node positive breast cancer patients and requires further investigations.
BackgroundSchedules with anthracyclines and taxanes are one of the best options for primary chemotherapy. The addition of trastuzumab showed an impressive percentage of pathological complete responses in Buzdar trial (66.7%). Recently, nonpegylated liposome-encapsulated doxorubicin (NLD) has been widely used in advanced breast cancer with high response rates (98.1 % in Cortes study). The aims of our study were to assess pathological responses and toxicity of NLD plus paclitaxel (and trastuzumab in patients with HER2 overexpression).MethodsThirty patients entered the study: 9 locally advanced and 21 operable. Median age was 58.5 years (range: 31-73). 23 patients without HER2 overexpression (or FISH not amplified) were treated with NLD 50 mg/m2 every three weeks for 3 courses and weekly paclitaxel 80 mg/m2 for 8 courses. 7 patients with HER2 overexpression or FISH amplified were treated with the same schedules plus trastuzumab (Herceptin) 4 mg/kg for the first administration and 2 mg/kg for the following 7 weekly administrations.ResultsPathological complete response (pCR) was documented in 1 patient (treated with trastuzumab); no residual tumor (infiltrating or “in situ”) on breast was documented in other 2 patients. Objective clinical responses were documented in 22 patients (73.3%): 8 complete, 10 partial and 4 “minimal” responses. 7 patients have shown stable and 1 progressive disease. Clinical response in patients with HER2 overexpression treated with trastuzumab was 100% (4 complete and 3 partial responses). Conservative surgery was performed in 8 (38%) and mastectomy in 13 (62%) out of 21 operable patients; however, 7 out of 14 responding patients with operable disease underwent quadrantectomy (50%). Main toxicity was neutropenia: febrile in 2 patients (7%) and gr. 3-4 in 13 (43%). Other grade 3 toxicities were as follows: vomiting in 1 patient, asthenia in 1 patient, joint symptom in 1 patient. 3 patients were withdrawn from the study. No episodes of left ventricular ejection fraction (LVEF) < 50% were recorded (with a median reduction of 8%).ConclusionsA “short course” of paclitaxel and NLD is active in terms of clinical response and conservative surgery for patients with potentially operable and locally advanced breast cancer; toxicity was manageable. High activity of the combination with trastuzumab has been confirmed. However, with this “short course” schedule, the result in term of clinical responses didn't turn into complete pathological responses.
Scopo del presente lavoro è mostrare che il metodo è anche facilmente implementabile con dati di real life, cogliendo così l'occasione per riflettere su alcuni rilevanti aspetti che emergono con l'uso dei nuovi farmaci in Oncologia. Per comodità del Lettore nella sezione 2 sono riepilogati i punti essenziali del metodo. Nella sezione 3 sono esposte le procedure seguite per la sua applicazione, nella sezione 4 sono presentati i risultati, discussi infine nella sezione 5. Aspetti salienti del nuovo metodo di payment-by-results Il metodo (1) è applicabile solo se esiste uno studio in cui si dimostri che il nuovo trattamento è più efficace della terapia standard. Il cuore del metodo è la trasformazione della misura di efficacia espressa in termini di tempo in una misura di efficacia espressa in forma di probabilità. Sia PFS 0 la PFS osservata in un determinato paziente (si osservi che quanto segue conserva la sua validità anche se, anziché la PFS, si considera la OS). Per una migliore comprensione, riportiamo nella Figura 1 un esempio (in cui PFS 0 è posto uguale a 10 mesi) con il grafico delle ipotetiche funzioni di densità della PFS per il nuovo trattamento (N) e per la terapia standard (S), indicate, rispettivamente, con f(N) e f(S). Consideriamo la funzione di densità relativa al nuovo trattamento, f(N). L'area a sinistra di PFS 0 (nell'esempio, 10 mesi), che indichiamo con P1, è la probabilità di osservare con la nuova terapia un risultato non migliore di quello osservato.
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