gms | German Medical Science

In the context of the quality assurance project of the gynaecological clinics of Lower Saxony female patients with an adjuvant therapy for breast cancer were reviewed since October 2002 with regard to the compliance with quality standards. The following evaluation contains patients who had been administered EC (90/600 mg/m²), FEC (500/100/500 mg/m²), EC-Taxol (90/600-175 mg/m²), or TEC (75/75/500 mg/m²). 876 patients were reported within 33 months. 694 of them are already documented and 693 evaluated. 27 gynaecological clinics and 4 medical practices were involved.

Patient characteristics: median age 56 years; median AZ 0 (ECOG); 211 (30.4%) premenopausal, 29 (4.2%) perimenopausal, 453 (65.4%) postmenopausal; 445 patients (64.2%) had undergone a breast-preserving surgery and 246 a mastectomy (35.5%), two patients had only a lymphonodectomy.

Therapy (Table 1 [Tab. 1]): A cycle delay for at least one week took place with 47 (7%) patients (5%/10%/4%/4%) due to hematological toxicity, a dose reduction with 20 (3%) patients (1%/4%/3%/6%). 51 (8%) patients were required to be in-patients.

There was no evidence for a tumor (NED) in 676 (97.5%) patients after completion of the therapy. 9 patients could not be evaluated. In 6 of the 14 patients with remaining tumor cells a complete response could be diagnosed. A progression of the disease occurred in two patients (local relapse after ablatio, scar with BET).

Side effects: Hematological side effects NCI grade 3/4: leucocytopenia 40%/64%/46%/79%, febrile neutropenia 1/3/1/7, anemia 22%/30%/30%/26%

Non-hematological side effects NCI grade 1-3: peripheral neurotoxicity 5%/9%/29%/11%, myalgia/arthralgia 2%/12%/23%/9%

Intervention or prophylaxis: Leucocytopenia 21%/32%/22%/64%, primarily prophylactic n=13 (6%), secondarily prophylactic n=8 (4%), therapeutic-interventional n=181 (90%)

Anemia 3%/14%/6%/15%

Conclusion: The adjuvant therapy could be completed according to plan in 629 (90.8%.) patients. Therapy delays due to hematological side effects occurred between 3.8% - 9.7%. The occurrence of anemia (CTC grade 2-4: 22.0% 30.2 %) is faced with a too low intervention rate (3.2% - 15.1%). The intervention rate in case of leucocytopenia is considerably better though rarely prophylactic. The management of thescheme with the highest toxicity rate (TEC) seems to be better than that of the olderschemes which are being regarded as sure manageable.

Taxane is mainly applied to patients with an affection of lymph nodes.