Survival outcomes of the NeoALTTO study (BIG 1-06): updated results of a randomised multicenter phase III neoadjuvant clinical trial in patients with HER2-positive primary breast cancer.

BACKGROUND: Lapatinib (L) plus trastuzumab (T) with weekly paclitaxel significantly increased the pathologic complete response (pCR) rate compared with the anti-human epidermal growth factor receptor 2 (HER2) agent alone plus paclitaxel. The event-free survival (EFS) and overall survival (OS) by the treatment arms L + T vs. T and L vs. T and the relationship between pCR and EFS/OS both in the whole study population and according to hormone receptor-negative and hormone receptor-positive cohorts after a median follow-up of 6.7 years were assessed. PATIENTS AND METHODS: Four hundred fifty-five patients with HER2-positive early breast cancer randomly received L 1500 mg/day (n = 154), T (common dose, n = 149) or L 1000 mg/day plus T (n = 152) for 6 weeks, followed by the assigned anti-HER2 treatment combined with paclitaxel weekly × 12. After surgery, patients received 3 cycles of fluorouracil, epirubicin and cyclophosphamide. The primary end-point was pCR (ypT0/is; for current analysis, it is ypT0/is ypN0), and the secondary end-points were EFS and OS. RESULTS: Six-year EFS rates were 67%, 67% and 74% with L, T and L + T, respectively (L vs T: hazard ratio [HR], 0.98 [95% confidence interval {CI}, 0.64-1.51; P = .93]; L + T vs T: HR, 0.81 [95% CI, 0.52-1.26; P = .35]). Six-Year OS rates were 82%, 79% and 85% for L, T and L + T, respectively (L vs T: HR, 0.85 [95% CI, 0.49-1.46; P = .56]; L + T vs T: HR, 0.72 [95% CI, 0.41-1.27; P = .26]). In landmark analyses, patients with a pCR had a significantly higher 6-year EFS (77% and 65%) and OS (89% and 77%) compared with those without a pCR for both overall and the hormone receptor-negative cohort. CONCLUSION: Achieving a pCR is important in HER2-positive disease and translates into better long-term outcome with regard to EFS and OS.

Circulating tumor cells and response to neoadjuvant paclitaxel and HER2-targeted therapy: a sub-study from the NeoALTTO phase III trial.

BACKGROUND: The role of circulating tumor cells (CTCs) in HER2-positive breast cancer patients receiving neoadjuvant therapy is unclear. PATIENTS & METHODS: We describe the CTC detection rate, HER2 phenotyping and pathological complete response (pCR) in patients enrolled in the NeoALTTO phase III trial. Participation in the CTC sub-study was optional. CTC evaluation was performed centrally using CellSearch at baseline, week 2 and week 18 (prior to surgery) of neoadjuvant therapy. RESULTS: Samples for CTC analysis were available for 51/455 patients randomized. At baseline, week 2 and week 18, we detected ≥1 CTC/22.5 ml in 5/46 (11%), 4/41 (10%), and 5/31 (16%) patients and ≥1 HER2-positive CTC/22.5 ml in 2/46 (4%), 2/41 (5%), and 3/31 (10%) patients with evaluable samples, respectively. 11/51 patients (21%) had ≥1 CTC/22.5 ml in at least one time point. pCR was observed in 3/11 (27.3%) versus 17/40 (42.5%) patients with detectable and no detectable CTCs, respectively (p = 0.36). No pCR was observed in the three patients with detectable HER2-positive CTCs prior to surgery. CONCLUSION: Numerically lower pCR rates were observed in patients with detectable CTCs, yet the study remains underpowered. A meta-analysis of CTC studies in this setting is warranted.

[Bladder leiomyosarcoma. Partial cystectomy and adjuvant treatment]. / Leiomiosarcoma de vejiga: cistectomía parcial y tratamiento complementario.

OBJECTIVE: We report a new case of bladder leiomyosarcoma in an old patient. METHODS: We present the case of a 75-year-old man with bladder leiomyosarcoma treated by partial surgery followed by adjuvant treatment. RESULTS: Partial surgery of the primary tumor followed by concomitant chemoradiotherapy was the approach for this patient. Nowadays, patient is free of tumor and living without any problems. CONCLUSIONS: Bladder leiomyosarcoma is an uncommon tumor (only about 1% of all bladder cancers) treated basically with radical surgery. Nowadays, partial surgery is a usual approach in other tumors and there is a trend toward less aggressive surgery with preservation of function (such as head and neck cancer, bladder cancer).

Leiomiosarcoma de vejiga: cistectomía parcial y tratamiento complementario / Bladder leiomyosarcoma. Partial cystectomy and adjuvant treatment

OBJETIVO: realizar una revisón de las posibilidades terapéuticas del leiomiosarcoma vesical.MÉTODO: Presentamos el caso de un varón de 75 años con leiomiosarcoma vesical tratado mediante cirugía parcial y un tratamiento complementario tras la cirugía.RESULTADOS: El paciente fue sometido a cirugía parcial seguido de radioterapia locorregional así como quimioterapia complementaria en régimen ifosfamida-adriamicina.CONCLUSIONES: El leiomiosarcoma de vejiga es un tumor poco frecuente (únicamente 1% de todos los tumores vesicales) en el que la piedra angular del tratamiento es la cirugía. Hoy en día, las cirugías parciales son una alternative terapéutica en otros tumores, observando cada vez más un mayor número de cirugías conservadoras para conservar función(AU)

OBJECTIVE: We report a new case of bladder leiomyosarcoma in an old patient.METHODS: We present the case of a 75-year-old man with bladder leiomyosarcoma treated by partial surgery followed by adjuvant treatment.RESULTS: Partial surgery of the primary tumor followed by concomitant chemo-radiotherapy was the approach for this patient. Nowadays, patient is free of tumor and living without any problems.CONCLUSIONS: Bladder leiomyosarcoma is an uncom-mon tumor (only about 1% of all bladder cancers) treated ba-sically with radical surgery. Nowadays, partial surgery is a usual approach in other tumors and there is a trend toward less aggressive surgery with preservation of function (such as head and neck cancer, bladder cancer)(AU)