BACKGROUND: The aim of the study was to analyse the toxicity and health related quality of life (HRQoL) of breast cancer patients treated withFAC (5-fluorouracil, doxorubicin, cyclophosphamide) and TAC (docetaxel, doxorubicin, cyclophosphamide) with and without primary prophylactic G-CSF (PPG). PATIENTS AND METHODS: This was a phase III study to compare FAC and TAC as adjuvant treatment of high-risk node-negative breast cancer patients. After the entry of the first 237 patients, the protocol was amended to include PPG in the TAC arm due to the high incidence of febrile neutropenia. A total of 1047 evaluable patients from 49 centres in Spain, two in Poland and four in Germany were included in the trial. Side-effects and the scores of the EORTC QLQ-C30 and QLQ BR-23 questionnaires were compared in the three groups (FAC, TAC pre-amendment and TAC post-amendment). RESULTS: The addition of PPG to TAC significantly reduced the incidence of neutropenic fever, grade 2-4 anaemia, asthenia, anorexia, nail disorders, stomatitis, myalgia and dysgeusia. Patient QoL decreased during chemotherapy, more with TAC than FAC, but returned to baseline values afterwards. The addition of PPG to TAC significantly reduced the percentage of patients with clinically relevant Global Health Status deterioration (10 or more points over baseline value) at the end of chemotherapy (64% versus 46%, P<0.03). CONCLUSIONS: The addition of PPG significantly reduces the incidence of neutropenic fever associated with TAC chemotherapy as well as that of some TAC-induced haematological and extrahaematological side-effects. The HRQoL of patients treated with TAC is worse than that of those treated with FAC but improves with the addition of PPG, particularly in the final part of chemotherapy treatment.
RCT Entities:
BACKGROUND: The aim of the study was to analyse the toxicity and health related quality of life (HRQoL) of breast cancerpatients treated with FAC (5-fluorouracil, doxorubicin, cyclophosphamide) and TAC (docetaxel, doxorubicin, cyclophosphamide) with and without primary prophylactic G-CSF (PPG). PATIENTS AND METHODS: This was a phase III study to compare FAC and TAC as adjuvant treatment of high-risk node-negative breast cancerpatients. After the entry of the first 237 patients, the protocol was amended to include PPG in the TAC arm due to the high incidence of febrile neutropenia. A total of 1047 evaluable patients from 49 centres in Spain, two in Poland and four in Germany were included in the trial. Side-effects and the scores of the EORTC QLQ-C30 and QLQ BR-23 questionnaires were compared in the three groups (FAC, TAC pre-amendment and TAC post-amendment). RESULTS: The addition of PPG to TAC significantly reduced the incidence of neutropenic fever, grade 2-4 anaemia, asthenia, anorexia, nail disorders, stomatitis, myalgia and dysgeusia. Patient QoL decreased during chemotherapy, more with TAC than FAC, but returned to baseline values afterwards. The addition of PPG to TAC significantly reduced the percentage of patients with clinically relevant Global Health Status deterioration (10 or more points over baseline value) at the end of chemotherapy (64% versus 46%, P<0.03). CONCLUSIONS: The addition of PPG significantly reduces the incidence of neutropenic fever associated with TAC chemotherapy as well as that of some TAC-induced haematological and extrahaematological side-effects. The HRQoL of patients treated with TAC is worse than that of those treated with FAC but improves with the addition of PPG, particularly in the final part of chemotherapy treatment.
Authors: Allan J Hovan; P Michele Williams; Peter Stevenson-Moore; Yula B Wahlin; Kirsten E O Ohrn; Linda S Elting; Fred K L Spijkervet; Michael T Brennan Journal: Support Care Cancer Date: 2010-05-22 Impact factor: 3.603
Authors: Helen V Worthington; Jan E Clarkson; Gemma Bryan; Susan Furness; Anne-Marie Glenny; Anne Littlewood; Martin G McCabe; Stefan Meyer; Tasneem Khalid Journal: Cochrane Database Syst Rev Date: 2011-04-13
Authors: Heather-Jane Au; Wolfgang Eiermann; Nicholas J Robert; Tadeusz Pienkowski; John Crown; Miguel Martin; Marek Pawlicki; Arlene Chan; John Mackey; John Glaspy; Tamás Pintér; Mei-Ching Liu; Tommy Fornander; Sandeep Sehdev; Jean-Marc Ferrero; Valerie Bée; Maria J Santana; Dave P Miller; Deepa Lalla; Dennis J Slamon Journal: Oncologist Date: 2013-06-28
Authors: María Concepción Delgado-Sanz; María José García-Mendizábal; Marina Pollán; Maria João Forjaz; Gonzalo López-Abente; Nuria Aragonés; Beatriz Pérez-Gómez Journal: Health Qual Life Outcomes Date: 2011-01-14 Impact factor: 3.186
Authors: Wendy J Langeberg; Conchitina C Siozon; John H Page; P K Morrow; Victoria M Chia Journal: Support Care Cancer Date: 2014-03-21 Impact factor: 3.603