A randomized phase III trial of stereotactic radiosurgery (SRS) versus observation for patients with asymptomatic cerebral oligo-metastases in non-small cell lung cancer
Mené sur 105 patients atteints d'un cancer du poumon non à petites cellules et présentant au plus 4 oligo-métastases asymptomatiques du cerveau (âge médian : 58 ans), cet essai de phase III évalue l'intérêt d'une radiochirurgie stéréotaxique cérébrale avant une chimiothérapie pour améliorer la survie globale des patients
Background : It is unclear whether treating brain metastasis before starting systemic chemotherapy can improve survival compared to upfront chemotherapy in non-small cell lung cancer (NSCLC) with asymptomatic cerebral oligo-metastases. Patients and methods : We undertook a randomized controlled trial of 105 patients with one to four brain metastases, admitted to Samsung Medical Center between 2008 and 2013. Patients were randomly assigned to receive stereotactic radiosurgery (SRS) (49 patients) followed by chemotherapy or upfront chemotherapy (49 patients). The primary end point was overall survival and secondary end points included central nervous system (CNS) progression-free survival, progression to symptomatic brain metastasis, and brain functional outcome. Results : The median age was 58 years (range, 29-85) with ECOG 0-1 performance status, and 40% of patients were never smokers. Most patients had adenocarcinoma, and about half of patients had only one brain metastasis while, the rest had multiple cerebral metastases. The median overall survival time was 14.6 months (95% CI, 9.2-20.0) in SRS group and 15.3 months (95% CI, 7.2-23.4) for upfront chemotherapy group (P=.418). There was no significant difference in time to CNS disease progression (median, 9.4 months (SRS) vs. 6.6 months (upfront chemotherapy), P=.248). Symptomatic progression of brain metastases was observed more frequently in upfront chemotherapy group (26.5%) than SRS group (18.4%) but without statistical significance. Conclusions : Although this study included smaller sample size than initially anticipated due to early termination, SRS followed by chemotherapy did not improve overall survival in oligo-brain metastases NSCLC patients compared with upfront chemotherapy. Further study with large number of patients should be needed to confirm the use of upfront chemotherapy alone in this subgroup of patients.