The ABOUND.sqm trial is currently investigating treatment outcomes of 4 cycles of nab-P/C followed by nab-P maintenance therapy in patients (pts) with SCC NSCLC. Given that tolerability is an important consideration for treatment decisions, this analysis evaluated the safety of nab-P/C during induction.
Chemotherapy-naive pts with stage IIIB/IV SCC NSCLC received 4 cycles of induction therapy with nab-P 100 mg/m2 d1, 8, and 15 + C area under the curve 6 d 1 (21-d cycles). Pts not progressing after induction received (2:1) maintenance nab-P 100 mg/m2 d1 and 8 (21-d cycles) + best supportive care (BSC) or BSC alone until progression/unacceptable toxicity. The primary endpoint is progression-free survival (randomization to maintenance). Secondary endpoints include safety analyzed as treatment-emergent adverse events (TEAEs), overall survival, overall response rate, and disease control rate.
A total of 334 pts were included in this analysis. Median age was 68 yrs; 90% were white, 68% male, and 68% had ECOG PS 1. During induction, 145/334 pts (43%) discontinued treatment. Of these, 51/145 (35%) discontinued due to progressive disease, 39/145 (27%) due to adverse events, 16/145 (11%) each due to death and pt withdrawal, 13/145 (9%) due to symptomatic deterioration, 9/145 (6%) due to other, and 1/145 (< 1%) due to protocol violation. The median percentage of per-protocol dose of nab-P was 74%; median nab-P dose intensity and cumulative dose were 74.08 mg/m2/week and 900 mg/m2, respectively. nab-P dose modifications included ≥ 1 reduction, missed dose, or dose delay in 55%, 60%, and 60% of pts, respectively. Grade ≥ 3 TEAEs were mainly hematologic and included neutropenia (148/334 [44%]), anemia (92/334 [28%]), and thrombocytopenia (48/334 [14%]). Grade ≥ 3 peripheral neuropathy was observed in 14/334 pts (4%).
This interim analysis demonstrates the safety and tolerability of nab-P/C induction therapy in pts with SCC histology. The findings are consistent with those reported in subset analysis of the phase III study and provide additional support for the use of this regimen in this pt population. NCT02027428.
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Legal entity responsible for the study
C. Gridelli: Honoraria: Celgene. D. Morgensztern: Advisory role: Celgene; Speaker bureau: Boehringer. O. Juan: Advisory or Speaker role: Roche, Astra, MSD, Boehringer, BMS, Lilly, Pfizer, Pierre-Fabre. B. Levy: Honoraria: Eli Lilly, Genetech, Astra-Zeneca, Celgene; Consulting or Advisory Role: Eli Lilly, Genetech, Astra-Zeneca, Celgene; Speakers\' Bureau: Eli Lilly, Genetech. A. Ardizzoni: Honoraria: Eli Lilly, BMS, MSD, Boehringer; Consulting Role: Eli Lilly, BMS, MSD, Boehringer. T. Berry: Employment and Stock Ownership: Celgene. T. Chen, N. Trunova: Employment and stock ownership: Celgene. All other authors have declared no conflicts of interest.