Multicenter Phase II Study evaluating Docetaxel and Cisplatin as Neoadjuvant Induction Regimen prior to Surgery or Radiochemotherapy with Docetaxel, followed by adjuvant Docetaxel Therapy in chemonaive Patients with NSCLC Stage II, IIIA and IIIB (TAX-AT 1.203 Trial)
Mené sur 78 patients atteints d'un cancer du poumon non à petites cellules de stade II, IIIA ou IIIB, cet essai multicentrique de phase II évalue, du point de vue de la survie sans progression et de la survie globale à 5 et 10 ans, l'intérêt d'une chimiothérapie néoadjuvante d'induction à base de docétaxel et de cisplatine avant un protocole thérapeutique comportant une intervention chirurgicale ou une chimioradiothérapie par docétaxel puis une chimiothérapie adjuvante avec ce même agent anticancéreux
Objectives : Neoadjuvant therapy with a platinum based doublet is an option in NSCLC patients with upfront resectable disease. However, the role of neoadjuvant induction in stages IIIA and IIIB and in initially not resectable patients is unclear. Patients and Methods : In this phase II trial, 78 patients with locally advanced NSCLC, of whom 56 were considered not resectable at initial diagnosis, were treated with three neoadjuvant cycles of docetaxel and cisplatin and subjected to radical surgery if resectable. Definitive radiochemotherapy (RCT) using weekly docetaxel was the prespecified alternative if patients were not resectable at restaging. The primary objective was response to neoadjuvant induction. Results : After induction, 36 (46%) were radically operated and 24 (31%) were treated with RCT. Overall, 32 patients (41%) completed the entire study plan. Partial response to induction therapy was observed in 43 patients (55%); furthermore, 19 of 56 initially not resectable cases (34%) became resectable upon induction. Median progression-free (PFS) and overall survival (OS) were 8.5 and 16.4 months for the whole cohort. Encouragingly, conversion to resectability was predictive for favourable outcome. On the other hand, patients who were not resectable at restaging and received RCT were characterized by a rather unfavourable prognosis (5-year and 10-year OS, whole cohort: 20% and 12%; RCT: 8% and 0%; surgery: 37% and 24%, respectively). Conclusion : Neoadjuvant induction with the doublet docetaxel/cisplatin and subsequent radical resection resulted in favorable survival. Of note, conversion to resectability was mandatory for the chance of cure in patients considered initially not resectable.
Lung Cancer 2014