Trial Information

Long Term Follow-up of Ph+ CML Patients Achieving Complete Cytogenetic Remission With Interferon Based Therapy

Study rational

- IFN, either alone or in combination with AC, prolonged survival of Ph+ CML patients, in
early chronic phase, mainly in those patients achieving the CCgR

- CCgR became the surrogate marker for survival duration and the main target of IFN
therapy

- CCgR were rare events accounting for less than 10% of the cytogenetic responsive
patients

- These cases can be considered as a fascinating elite of patients who have the highest
sensitivity to IFN and are the most likely candidates for prolonged survival and
possibly cure

- From 1986 to 2001, more than 1200 CML patients either enrolled in different national
trials or referred in single Institutions have been treated frontline with IFN based
therapy

- In 2001, data on 317 CCgRs were reported by the EICML group

- They included 214 cases treated with IFN alone collected from the database of 9
national study groups in Austria, Belgium, Netherlands, France, Germany, Italy, Spain,
Sweden and United Kingdom and 103 cases treated with IFN alone collected from single
Institutions in Italy, France, and United Kingdom.

- The study did not include the patients achieving CCgR with IFN + LDAC

- The contribution of Italy was of 119 cases: 59 from national studies and 60 from single
Institutions

- The follow-up of these patients is stopped at 2000 and from 2000 thereafter almost CML
patients were treated with IM

- We don't know if the patients who had achieved a CCgR with IFN based therapy continued
or discontinued IFN, or crossed to IM therapy

- We don't know if they maintained a CCgR with or without therapy

- We don't know if the patients who achieved a CCgR with IFN and crossed to IM had the
same cytogenetic and molecular response, PFS and OS as the majority of the patients
unresponsive to IFN who were treated with IM

- We don't know the clinical and biological features of these selected cohort of
patients