Multicenter Randomized Trial Comparing Sequential With Concomitant Administration of Doxorubicin and Docetaxel As First-Line Treatment of Metastatic Breast Cancer: A Spanish Breast Cancer Research Group (GEICAM-9903) Phase III Study

Abstract

A-->T significantly reduced febrile neutropenia compared with AT in MBC patients and maintains comparable antitumoral efficacy. A-->T represents a valid option for the treatment of MBC.

Maintenance treatment with Pegylated liposomal doxorubicin versus observation following induction chemotherapy for metastatic breast cancer: GEICAM 2001-01 study

“…Based on our previous experience, a median TTP of 10.5 months in the observation arm was selected [18]. Assuming that TTP would conform to an exponential distribution, at least 77 patients per group were required to provide 80% power using a significance level (alpha) of 0.01 (one-sided).…”

“…In a previous phase III trial conducted by our group (GEICAM 9903), sequential versus concomitant administration of doxorubicin and docetaxel were compared as first-line therapy for MBC [18]. Both arms demonstrated similar antitumor efficacy.…”

Risk of Treatment Related Death and Febrile Neutropaenia with First Line Palliative Chemotherapy for De Novo Metastatic Breast Cancer in Clinical Practice in a Middle Resource Country

“…While in the adjuvant setting, clinicians and patients expect a low risk of FN and TRD, in the metastatic setting the expected rates should be higher as patients are either symptomatic or without further treatment can expect to become symptomatic soon and eventually die of metastatic disease. Reported FN rates in the literature from clinical trials for first line chemotherapy in MBC range from 4.9% to as high as 47.8% (Biganzoli et al, 2002;Alba et al, 2004;Conte et al, 2004;Cresta et al, 2004;Park et al, 2010;Tomova et al, 2010, Chan A et al, 2011. These rates differed according to different regimens and were the highest for regimens using combination chemotherapy rather than sequential treatment.…”

“…These rates differed according to different regimens and were the highest for regimens using combination chemotherapy rather than sequential treatment. Combination of adriamycin and taxane ,both of which are the standard chemotherapy backbone for breast cancer, is especially toxic, with FN rates of 32% (adriamycin plus paclitaxel) and 47.8% (adriamycin plus docetaxel) in two phase III clinical trials (Biganzoli et al, 2002;Alba et al, 2004). Interestingly, a recent Cochrane meta-analysis has shown no improvement of overall survival (OS) when comparing combination therapy over sequential therapy for MBC.…”

“…In fact, combination chemotherapy was shown to have a detrimental effect on progression free survival and increased rates of FN (Dear et al, 2013). The available data on TRD from clinical trials with chemotherapy for MBC range from 0.4% to 5.3% (Baker et al, 1974;Chlebowski et al, 1989;FESG, 2000;Biganzoli et al, 2002;Alba et al, 2004;Conte et al, 2004;Cresta et al, 2004;Park et al, 2010;Tomova et al, 2010, Chan A et al, 2011. Due to the paucity of data regarding the FN and TRD rates for de novo MBC especially in the clinical practice setting where we can expect a higher rate compared to clinical trial setting.…”