Comparison of 2 Chemotherapy Regimens in Non-small-cell Lung Cancer (NSCLC) Patients Relapsing After Surgery and Peri-operative Chemotherapy. A Randomized Phase III Study.
As chemotherapy gains wider acceptance for the treatment of earlier stages of NSCLC,
particularly in the adjuvant and neoadjuvant setting, physicians face a growing population
of high performance status patients who have relapsed after their first-line chemotherapy.
The type of second-line chemotherapy after initial adjuvant or neoadjuvant treatment with a
platinum-based regimen remains largely undefined. Some might consider rechallenging patients
with a platinum based doublet whereas others might treat these patients with a
monochemotherapy (pemetrexed or docetaxel).
Most relapses occurring after perioperative chemotherapy and surgery are non surgical
locally advanced relapses or metastatic diseases.
Some differences exist between these post surgical relapses and the progressions occurring
after the first line non surgical treatment of a stage III/IV.
- Patients are most often in a good condition (performance status 0-1).
- Progression is often asymptomatic and diagnosed in the post surgical follow up.
- The dose of chemotherapy previously administered is lower than that administered in
first line of a stage III/IV.
- The time between the first line of treatment and the treatment of the relapse is
These differences might be associated with a more chemosensitive disease and thus might be
the rationale of using a platinum containing doublet instead of the classical mono
chemotherapy docetaxel or pemetrexed.
Thus, the current study has been designed to answer these questions.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
progression-free survival (PFS)
Denis Moro-Sibilot, Pr
University Hospital, Grenoble
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)