Induction chemotherapy plus bevacizumab or radiotherapy in N2 non-squamous non-small cell lung cancer: 5-year results of a randomized phase 2 trial.

OBJECTIVES

The Personalized Induction Therapy-1 (PIT-1) trial is a multicenter, randomized, phase 2 selection design study in which patients with stage IIIA (N2) non-squamous non-small cell lung cancer received pemetrexed plus cisplatin with bevacizumab or concurrent thoracic radiotherapy, both followed by surgery. Herein, we report the 5-year survival outcomes.

METHODS

Eighty-two patients (42 in the bevacizumab arm and 40 in the radiotherapy arm) received induction therapy, and 75 patients (38 and 37, respectively) underwent surgery. Five-year overall survival and progression-free survival were compared between arms in the 82 eligible patients. In addition, overall survival, relapse-free survival, and patterns of postoperative relapse were analyzed in the 75 patients who underwent surgery.

RESULTS

Among the 82 treated patients, the 5-year overall survival rate was 63.5% (95% CI, 46.9-76.1) in the bevacizumab arm and 57.2% (95% CI, 40.5-70.8) in the radiotherapy arm (P = .57). The 5-year progression-free survival rate was 26.2% (95% CI, 14.1-40.0) and 27.5% (95% CI, 14.9-41.7), respectively (P = .36). Recurrence of ipsilateral hilar or mediastinal lymph nodes (within the irradiation field) was significantly lower in the radiotherapy arm (n = 1, 3%) than in the bevacizumab arm (n = 7, 18%, P = .01). All patients with relapse in the PIT-1 trial (except 1 patient in the radiotherapy arm) received at least 1 subsequent therapy.

CONCLUSIONS

Five-year survival outcomes did not differ between treatment arms. The radiotherapy arm exhibited sufficient local control within the irradiated field.