Efficacy of octreotide LAR (OCT) in patients (pts) with advanced neuroendocrine tumors (NET): A post hoc analysis of the placebo (PBO) arm of the phase III RADIANT-2 study with updated survival data.

Authors

null

Jonathan R. Strosberg

Department of Gastrointestinal Oncology, Moffitt Cancer Center, Tampa, FL

Jonathan R. Strosberg , James C. Yao , Emilio Bajetta , Mounir Aout , Bert Bakker , John D. Hainsworth , Philippe B. Ruszniewski , Eric Van Cutsem , Kjell E. Oberg , Marianne E. Pavel

Organizations

Department of Gastrointestinal Oncology, Moffitt Cancer Center, Tampa, FL, Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, Istituto di Oncologia, Policlinico di Monza, Monza, Italy, Novartis Pharma AG, Basel, Switzerland, Novartis Pharmaceuticals Corporation, East Hanover, NJ, Sarah Cannon Research Institute, Nashville, TN, University of Paris VII and Hopital Beaujon, Paris, France, Digestive Oncology Unit, University Hospital Gasthuisberg/Leuven, Leuven, Belgium, Uppsala University Hospital, Uppsala, Sweden, Charité-Universitätsmedizin Berlin, Berlin, Germany

Research Funding

Pharmaceutical/Biotech Company

Background: In pts with metastatic midgut NET, OCT showed antitumor activity and significantly extended time to tumor progression (TTP) vs PBO (PROMID trial, Rinke et al. 2009). We present a post hoc analysis assessing efficacy of OCT (30 mg q28d) in the PBO+ OCT arm of the phase III RADIANT-2 study. Methods: For this post hoc analysis, progression-free survival (PFS by central review, cutoff Apr 2, 2010) and overall survival (OS, cutoff Jun 13, 2013) in the PBO + OCT arm were estimated by prior somatostatin analogue (SSA) use and primary tumor location subgroups using the Kaplan-Meier (KM) method. Results: 213 pts were randomized to PBO + OCT (median age, 60 yrs; male, 58%; WHO PS: 0/1/2 in 66%/29%/5% pts; >80% had well-differentiated disease). Of these, 47 (22%) were SSA naïve (foregut, 32%; midgut, 51%; hindgut, 4%; not classified or missing, 13%) and 166 (78%) had received SSA (foregut, 10%; midgut, 72%; hindgut, 11%; not classified or missing, 7%) prior to study entry. Median PFS (95% CI) for pts who were SSA naïve vs who had received SSA was 13.6 (8.2-22.7) mos vs 11.1 (8.4-14.2) mos. By primary tumor location, median PFS (95% CI) in SSA naïve pts vs who received SSA was 5.7 (2.8-27.8) mos vs 8.7 (2.8-13.9) mos for foregut, 22.2 (8.3-29.5) mos vs 12.0 (8.4-17.7) mos for midgut, and not-reached (NR; 4.7-NR) vs 6.6 (3.0-13.0) mos for hindgut. OS analysis is in table. Conclusions: This post hoc analysis of the PBO + OCT arm of the RADIANT-2 study showed a PFS of 13.6 mos in SSA naïve pts treated with OCT. While the RADIANT-2 study PBO arm differs from PROMID in patient population and method of assessment of tumor progression, the data from this post hoc analysis provide additional evidence of the antiproliferative effect of OCT in NET. Clinical trial information: NCT00412061.

No-prior SSA Prior SSA All pts
No. of events, n (%) 22 (46.8) 106 (63.9) 128 (60.1)
No. censored, n (%) 25 (53.2) 60 (36.1) 85 (39.9)
Median OS (95% CI), mos 50.6 (36.4-NR) 33.0 (24.5-43.7) 35.2 (30.7-44.7)

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Abstract Details

Meeting

2014 Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

General Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract

Track

Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract

Sub Track

Multidisciplinary Treatment

Clinical Trial Registration Number

NCT00412061

Citation

J Clin Oncol 32, 2014 (suppl 3; abstr 265)

DOI

10.1200/jco.2014.32.3_suppl.265

Abstract #

265

Poster Bd #

B38

Abstract Disclosures