DOCETAXEL NOT MORE EFFECTIVE THAN CMF IN BREAST CANCER

Ann Oncol. 2014 Dec 8. pii: mdu564. [Epub ahead of print]

Weekly docetaxel vs CMF as adjuvant chemotherapy for older women with early breast cancer: final results of the randomised phase 3 ELDA trial.

Perrone F1, Nuzzo F1, Di Rella F1, Gravina A1, Iodice G1, Labonia V1, Landi G1, Pacilio C1, Rossi E1, De Laurentiis M1, D'Aiuto M1, Botti G1, Forestieri V2, Lauria R2, De Placido S2, Tinessa V3, Daniele B3, Gori S4, Colantuoni G5, Barni S6, Riccardi F7, De Maio E1, Montanino A1, Morabito A1, Daniele G1, Di Maio M1, Piccirillo MC1, Signoriello S8, Gallo C8, de Matteis A1.

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Abstract

BACKGROUND: 

Evidence on adjuvant chemotherapy in older women with breast cancer is poor. We tested whether weekly docetaxel is more effective than standard chemotherapy.

PATIENTS AND METHODS: 

We performed a multicentre, randomised phase 3 study. Women aged 65 to 79, operated for breast cancer, with average to high risk of recurrence, were allocated 1:1 to CMF (cyclophosphamide 600mg/m², methotrexate 40mg/m², fluorouracil 600mg/m², days 1, 8) or docetaxel (35mg/m2 days 1, 8, 15) every 4 weeks, for 4 or 6 cycles according to hormone-receptor status. Primary end-point was disease-free survival (DFS). A geriatric assessment was performed. Quality of life was assessed with EORTC C-30 and BR-23 questionnaires.

RESULTS: 

From July 2003 to April 2011, 302 pts were randomized and 299 (152 allocated CMF and 147 docetaxel) were eligible. After 70 months median follow-up, 109 DFS events were observed. Unadjusted hazard ratio (HR) of DFS for docetaxel vs CMF was 1.21 (95%CI: 0.83-1.76, p=0.32); DFS estimate at 5 years was 0.69 with CMF and 0.65 with docetaxel. HR of death was 1.34 (95% CI: 0.80-2.22, p=0.26). There was no interaction between treatment arms and geriatric scales measuring patients' ability or comorbidities. Haematological toxicity, mucositis and nausea were worse with CMF; allergy, fatigue, hair loss, onychopathy, dysgeusia, diarrhoea, abdominal pain, neuropathy, cardiac and skin toxicity were worse with docetaxel. One death was attributed to CMF and two to docetaxel. Increasing age, impairment in instrumental daily living activities, number of comorbidities and docetaxel treatment were independently associated with severe non-haematological toxicity. Quality of life was worse with docetaxel for nausea-vomiting, appetite loss, diarrhoea, body image, future perspective, treatment side effects and hair loss items.

CONCLUSIONS: 

Weekly docetaxel is not more effective than standard CMF as adjuvant treatment for older women with breast cancer, and worsens QoL and toxicity.