Phase II study on paclitaxel in patients with recurrent, metastatic or locally advanced vulvar cancer not amenable to surgery or radiotherapy: a study of the EORTC-GCG (European Organisation for Research and Treatment of Cancer--Gynaecological Cancer Group).

BACKGROUND: No standard treatment options are available for patients with advanced, recurrent or metastatic vulvar carcinoma not amenable for locoregional treatment. PATIENTS AND METHODS: In this phase II study, patients with advanced vulvar cancer received paclitaxel (Taxol) every 3 weeks for up to 10 cycles. Primary objective was response rate. Secondary objectives were response duration and toxicity. Response evaluation was assessed by World Health Organisation criteria, toxicity according to Common Toxicity Criteria. RESULTS: Thirty-one women from 10 institutions were included, with a median age of 64 (range 47-84), of which 29 were assessable for response. On study patients received a median of four cycles (range 1-10). SAFETY: Grade 3 and 4 neutropenia was seen in eight patients (8/29 = 27.6%), which in one patient resulted in neutropenic fever and treatment-related death. Further treatment-related grade 3/4 toxicity includes fatigue in three patients (10.3%) and neuropathy in one patient (3.4%). EFFICACY: Overall response was 13.8% (n = 4; two complete responses + two partial responses). With a median follow-up of 24 months, median PFS was 2.6 months (95%confidence interval 2.04-4.21). CONCLUSION: Paclitaxel shows moderate activity for local control in advanced vulvar cancer.

Adjuvant chemotherapy in 2005: standards and beyond.

The 2003 St. Gallen consensus panel divided the many available adjuvant chemotherapy (CT) regimens into those with "standard efficacy" (ACx4, CMFx6) and those with "superior efficacy" (FA(E)Cx6, CA(E)Fx6, A(E)-->CMF, TACx6, ACx4--> paclitaxel (P)x4 or docetaxel (D)x4) but also greater complexity, toxicity and cost. This paper will summarize the latest information on long-term side effects of the "superior" regimens and 5-year benefits reported in taxane trials, including those of a "new" sequential regimen, FECx3--> docetaxelx3. Rapidly expanding evidence of marked heterogeneity in the magnitude of CT benefits according to the tumour oestrogen receptor (ER) status, a claim made for many years by IBCSG investigators, will be reviewed; it will lead to the conclusion that a revolution needs to take place in the way oncologists think about the CT added value and design adjuvant clinical trials. The conclusions proposed to the 2005 St. Gallen consensus panel are that: adequately dosed anthracycline-based CT regimens remain an acceptable standard for many women; a lower threshold for using taxanes in sequence or combination with anthracyclines (A) is justified in the presence of an ER-negative or low-ER tumour status, other aggressive biologic features (such as HER-2 overexpression), fear about A-induced cardiotoxicity; no recommendation can yet be made as far as the optimal taxane-A regimen, the best taxane or the best taxane schedule.

'Pure' invasive apocrine carcinoma of the breast: a new clinicopathological entity?

Invasive apocrine carcinoma (IAC) of the breast has a similar prognosis to infiltrating ductal carcinoma not otherwise specified (IDC-NOS). The existence of a pure IAC subtype (PIAC) and its possible prognostic implications have not been fully investigated. To this end, pathological inclusion criteria for the diagnosis of PIAC were defined and three pathologists reviewed their slides blind to identify it. To assess its clinical behavior, a case-control evaluation was performed, for which 122 cases were selected. There was 100% agreement among the pathologists on the diagnosis: PIAC was identified in 37 cases and IDC-NOS, in 68, while 17 cases were categorized as complex IAC. The probability of 6-year survival was 0.72 for PIAC and 0.52 for IDC-NOS (P=0.02), and was still better after adjustment for tumor grade and axillary status. PIAC may be a distinct clinicopathological entity with a less aggressive behavior than high-grade IDC-NOS and might be regarded as an independent prognostic factor in early breast cancer.