Survival outcomes from CALGB 80803 (Alliance): A randomized phase II trial of PET scan-directed combined modality therapy for esophageal cancer.

Authors

null

Karyn A. Goodman

University of Colorado, Denver, CO

Karyn A. Goodman , Nathan Hall , Tanios S. Bekaii-Saab , Fang-Shu Ou , Erin Twohy , Michael O. Meyers , Daniel J. Boffa , Kisha Mitchell , Kyle Perry , Wendy L Frankel , Alan P. Venook , Eileen Mary O'Reilly , David H. Ilson

Organizations

University of Colorado, Denver, CO, University of Pennsylvania, Philadelphia, PA, Mayo Clinic, Phoenix, AZ, Mayo Clinic, Rochester, MN, Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, University of North Carolina at Chapel Hill, Chapel Hill, NC, Section of Thoracic Surgery, Department of Surgery, Yale School of Medicine, New Haven, CT, Yale University School of Medicine, New Haven, CT, The Ohio State University Comprehensive Cancer Center, James Cancer Hospital, Solove Research Institute, Columbus, OH, The Ohio State University Comprehensive Cancer Center, Arthur G. James Cancer Hospital, Columbus, OH, University of California San Francisco, San Francisco, CA, Memorial Sloan Kettering Cancer Center, New York, NY

Research Funding

NIH

Background: We evaluated use of early PET response after induction chemotherapy (CT) to direct changing to alternative CT during preoperative chemoradiation (CRT) among patients (pts) with resectable esophageal and gastroesophageal junction (GEJ) adenocarcinomas who are PET nonresponders. We previously reported the primary endpoint of improving pathologic complete response (pCR) in PET nonresponders; pre-specified efficacy criteria were met for improvement in pCR rates with changing CT during CRT. We now report survival outcomes by PET response status. Methods: 257 pts enrolled, underwent baseline PET and were randomized to 1 of 2 induction CT arms: modified FOLFOX-6 (oxaliplatin, leucovorin, 5-FU) days 1, 15, 29 or carboplatin/paclitaxel (CP) days 1, 8, 22, 29. Repeat PET was performed days 36-42; change in maximum standardized uptake value (SUV) from baseline was assessed. PET nonresponders ( < 35% decrease in SUV: PET-NR) crossed over to alternative CT regimen during CRT (50.4 Gy/28 fractions). PET responders (≥35% decrease in SUV: PET-R) continued on same CT during CRT. Pts underwent surgery at 6 weeks post-CRT. Overall survival (OS) was measured from randomization to death from any cause; 2-year (yr) OS rates were estimated using the Kaplan-Meier method. Results: 240 eligible pts received protocol treatment and 222 had an evaluable repeat PET. With median follow-up of 35.9 months (mo) (95% CI: 33.1-41.2), median OS was 34.4 mo (95%CI: 28.4-49.7) and 2-yr OS was 61.8% (95%CI: 55.7-68.5%). Median OS for PET-R was 40.2 mo (95% CI:31.0, not estimable [NE]) and for PET-NR was 27.4 mo (95% CI: 20.3, NE). Median and 2-yr OS by induction CT and PET response appear below. Clinical trial information: NCT01333033Conclusions: PET response after induction CT is prognostic for outcome in pts with esophageal and GEJ adenocarcinomas. Outcomes for PET-R pts receiving induction and concurrent FOLFOX are encouraging. Support: U10CA180821, U10CA180882

Response GroupEvents/NMedian OS (mo)95% CI (mo)2-yr OS (%)95% CI (%)
CP N = 111
PET-R31/6331.0(20.4, NE)57.4(46.2, 71.3)
PET-NR28/4826.4(16.0, NE)52.4(39.8, 69.0)
FOLFOX N = 111
PET-R29/7248.7(33.1, NE)73.3(63.4, 84.7)
PET-NR20/3930.9(25.4, NE)64.0(50.0. 82.0)

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Abstract Details

Meeting

2018 ASCO Annual Meeting

Session Type

Poster Discussion Session

Session Title

Gastrointestinal (Noncolorectal) Cancer

Track

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Sub Track

Esophageal or Gastric Cancer

Clinical Trial Registration Number

NCT01333033

Citation

J Clin Oncol 36, 2018 (suppl; abstr 4012)

DOI

10.1200/JCO.2018.36.15_suppl.4012

Abstract #

4012

Poster Bd #

201

Abstract Disclosures