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nab-paclitaxel (nab-P) + carboplatin (C) induction therapy in patients (Pts) with squamous (SCC) NSCLC: Interim safety results from the phase 3 ABOUND.sqm study

Date

08 Oct 2016

Session

Poster Display

Presenters

Oscar Juan Vidal

Citation

Annals of Oncology (2016) 27 (6): 416-454. 10.1093/annonc/mdw383

Authors

O.J. Vidal1, D. Daniel2, M. Johnson3, J. Knoble4, T. Chen5, M. McCleod6, T.J. Ong5, N. Trunova5, E. Kim7

Author affiliations

  • 1 Oncology, Hospital Universitari i Politècnic La Fe, 46026 - Valencia/ES
  • 2 Oncology, Tennessee Oncology, Chattanooga/US
  • 3 Oncology, Sarah Cannon Research Institute, Nashville/US
  • 4 Hematology/oncology, The Mark H. Zangmeister Center, Columbus/US
  • 5 Medical Affairs, Celgene Corporation, Summit/US
  • 6 Oncology, Florida Cancer Specialists, Ft. Myers/US
  • 7 Oncology, Levine Cancer Institute, Carolinas Healthcare System, Charlotte/US
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Resources

Background

Safe and effective chemotherapy options in the maintenance setting are limited for pts with SCC NSCLC. The ongoing phase 3 ABOUND.sqm study is evaluating nab-P as maintenance therapy after nab-P/C induction in pts with SCC NSCLC. Interim safety outcomes from the induction part of the study are reported here.

Methods

Chemotherapy-naive pts with advanced SCC NSCLC received nab-P 100 mg/m2 d 1, 8, 15 + C area under the curve 6 d 1 (21-d cycles) for 4 cycles intravenously (induction). Pts without progression after 4 cycles were randomized 2:1 to maintenance nab-P 100 mg/m2 d 1 and 8 of each 21-d cycle + best supportive care (BSC) or BSC alone until progression or unacceptable toxicity. The primary endpoint of the study is progression-free survival from randomization into the maintenance part of the study. The secondary endpoints include safety (analyzed as treatment-emergent adverse events [TEAEs]) and efficacy.

Results

212 pts were treated in the induction period. The median age of these pts was 68 years, 66% were male, 87% were white, and 99% had an Eastern Cooperative Oncology Group performance status of 0-1. Overall, 44% of pts (94/212) discontinued induction treatment; of these, 37% discontinued due to progression, 24% due to adverse events, 12% due to other reasons, 11% due to death, 10% due to pt decision, and 6% due to symptomatic deterioration. The median percentage of per protocol dose of nab-P was 75%. Dose adjustments included at least 1 nab-P dose reduction, dose missed, or dose delay, in 41%, 51%, and 58% of treated pts, respectively. The median dose intensity for nab-P was 74.87 mg/m2/week. Grade 3/4 TEAEs included neutropenia (41%), anemia (25%), and thrombocytopenia (16%), and 8 pts (4%) experienced grade 3/4 peripheral sensory neuropathy.

Conclusions

These interim results of the ABOUND.sqm study indicate no new safety signals in pts with SCC NSCLC receiving nab-P/C induction therapy. Updated results will be presented at the meeting. NCT02027428

Clinical trial identification

NCT02027428

Legal entity responsible for the study

N/A

Funding

Celgene Corporation

Disclosure

O.J. Vidal: Dr Juan Vidal: Advisory role or speaker: Roche, Astra, MSD, Boehringer, Bristol-Myers, Lilly, Pfizer, Pierre-Fabre. M. Johnson: Ad Board/Consultant/Honorarium from Celgene. J. Knoble: Consultant to Cardinal Health; is a member of the following Speakers' Bureau: Novartis, Celgene, Alexion. T. Chen, T.J. Ong, N. Trunova: Employee of Celgene, owns stock. All other authors have declared no conflicts of interest.

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