Report in English with a Dutch summary (KCE reports 63A)

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108 Breast Cancer KCE reports 63 Study ID Ref Search date Verma S 2003 [241] Anthracyclinepretreated women with metastatic breast Population Intervention Ouctomes Results Comments Study type cancer Parnes HL 2003 [242] NA Women with metastatic breast cancer Nooij MA 2003 [243] NA Women with nonprogressive metastatic breast cancer after induction chemotherapy with CMF Single-agent docetaxel (n = 255) vs. docetaxel + capecitabine (n = 251) Cyclophosphamide + doxorubicin + fluorouracil with (n = 120) or without leucovorin (n = 121) as firstline Continue CMF (n = 97) or not (n = 107) complications of treatment occurred in 47% (IT) vs 6% (non-IT) (P = 0.0072). Projected survival gain of 136 life-years with combination therapy. Small incremental cost of Can$ 3.691 per lifeyear gained. The overall response rate was 29% for CAF versus 28% for CAF plus LV. The median time to treatment failure (9 months) and median survival (1.7 years) did not differ by treatment arm. The two study arms were similar with regard to serious adverse events. Continuation of CMF had a significantly longer time to treatment failure (TTF) 5.2 versus 3.5 months (P=0.011). There was no overall survival (OS) difference 14.0 versus 14.4 months (P=0.77). Mean qualityadjusted survival time was equal to 8.4 months for no further treatment and decreased to 7.9 months for continuation of CMF (95%CI of difference equals 0.5-2.5 months). Randomization procedure? Randomization procedure? RCT High Level of evidence RCT Moderate RCT Moderate
KCE reports 63 Breast Cancer 109 Study ID Ref Search date Elomaa I 2003 [244] NA Women with metastatic breast cancer Sequencing of chemotherapy Cresta S 2004 [245] NA Women with metastatic breast cancer Population Intervention Ouctomes Results Comments Study type Dose-finding study of Vinorelbine (VMF): 20 + 20 mg/m² vs. 30 + 10 mg/m² vs. 40 + 0 mg/m² (first line) Doxorubicin and DOC either in combination (60 mg/m² of each drug) (n = 42), or by alternated (n = 42) or sequential schedule (100 mg/m2 DOC and 75 mg/m² doxorubicin) (n = 39) every 3 weeks World Health Organization (WHO) grade 3 hematological toxicity occurred in 23%, 36% and 50% of patients and grade 4 in 39%, 32% and 50% of patients in groups 1, 2 and 3, respectively; grade 3 infections were observed in 15%, 9% and 10% of patients in groups 1, 2 and 3, and grade 4 infections in 5% and 10% of patients in groups 2 and 3, respectively. Nonhematological toxicity included a mild to moderate neurotoxicity manifesting as constipation, abdominal colics and myalgia in the majority of patients. One patient in group 3 had serious convulsions after vinorelbine administration; she also developed neutropenic sepsis; all symptoms were reversible. No patient died from side-effects. The objective response rates were 50%, 55% and 44% for groups 1, 2 and 3, respectively. Median time to progression was 7, 10 and 8 months and median survival time was 26, 23 and 16 months in groups 1, 2 and 3, respectively. The overall response was 63%, 52% and 61% in the combination, alternating and sequential schedules, respectively. Corresponding rates of complete response were 15%, 14% and 11%. Grade 4 neutropenia was common in all arms (81%) and, together with febrile neutropenia, was significantly more frequent with the combination. RCT in 2 phases (second phase: expansion of 2 least toxic groups) Randomization procedure? Level of evidence RCT Moderate RCT Moderate
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