Helsinki University, Helsinki, Finland (E-mail: carl.blomqvist@helsinki.fi)
Drs Isik and Altundag argue that differences in patient characteristics may be responsible for the somewhat poorer response rate noted in the third arm of our study, where vinorelbine was given in an undivided dose of 40 mg/m2 on day one in contrast to the two other study arms where the dose was divided between days one and eight. While this may be correct we do not think that any firm conclusions on treatment efficacy should be drawn from our study, which was of a randomised phase II design, where tolerability is the primary endpoint and statistical power for the assessment of efficacy is low.
They also point out that heavier pretreatment may be responsible for differences in tolerance between the three study arms. We do not believe this to be the case. Actually, fewer patients in the more toxic arm 3 had received previous adjuvant chemotherapy with the more myelosuppressive FEC regimen than in the two other study arms. There was no significant difference between the groups regarding the time elapsed between the dates of initiation of adjuvant chemotherapy and chemotherapy for overtly metastatic disease.
C. Blomqvist
Helsinki University, Helsinki, Finland (E-mail: carl.blomqvist@helsinki.fi)