Randomized Phase II Study of PET Response-Adapted Combined Modality Therapy for Esophageal Cancer: Mature Results of the CALGB 80803 (Alliance) Trial

Goodman KA 1 , Ou FS 2 , Hall NC 3 , Bekaii-Saab T 4 , Fruth B 2 , Twohy E 2 Show all authors , Meyers MO 5 , Boffa DJ 6 , Mitchell K 7 , Frankel WL 8 , Niedzwiecki D 9 , Noonan A 8 , Janjigian YY 10 , Thurmes PJ 11 , Venook AP 12 , Meyerhardt JA 13 , O'Reilly EM 10 , Ilson DH 10

Affiliations 

  • 1 Icahn School of Medicine at Mount Sinai, New York, NY
  • 2 Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN
  • 3 Hospital of the University of Pennsylvania, Philadelphia, PA
  • 4 Mayo Clinic Cancer Center, Scottsdale, AZ
  • 5 University of North Carolina at Chapel Hill, Chapel Hill, NC
  • 6 Yale University, New Haven, CT
  • 7 Greenwich Hospital, Greenwich, CT
  • 8 The Ohio State University Wexner Medical Center, Columbus, OH
  • 9 Duke University, Durham, NC
  • 10 Memorial Sloan Kettering Cancer Center, New York, NY
  • 11 Metro Minnesota Community Oncology Research Consortium, Minneapolis, MN
  • 12 Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA
  • 13 Dana Farber/Partners CancerCare, Boston, MA
J Clin Oncol, 2021 09 01;39(25):2803-2815.
PMID: 34077237 DOI: 10.1200/JCO.20.03611

Abstract

PURPOSE: To evaluate the use of early assessment of chemotherapy responsiveness by positron emission tomography (PET) imaging to tailor therapy in patients with esophageal and esophagogastric junction adenocarcinoma.

METHODS: After baseline PET, patients were randomly assigned to an induction chemotherapy regimen: modified oxaliplatin, leucovorin, and fluorouracil (FOLFOX) or carboplatin-paclitaxel (CP). Repeat PET was performed after induction; change in maximum standardized uptake value (SUV) from baseline was assessed. PET nonresponders (< 35% decrease in SUV) crossed over to the alternative chemotherapy during chemoradiation (50.4 Gy/28 fractions). PET responders (≥ 35% decrease in SUV) continued on the same chemotherapy during chemoradiation. Patients underwent surgery at 6 weeks postchemoradiation. Primary end point was pathologic complete response (pCR) rate in nonresponders after switching chemotherapy.

RESULTS: Two hundred forty-one eligible patients received Protocol treatment, of whom 225 had an evaluable repeat PET. The pCR rates for PET nonresponders after induction FOLFOX who crossed over to CP (n = 39) or after induction CP who changed to FOLFOX (n = 50) was 18.0% (95% CI, 7.5 to 33.5) and 20% (95% CI, 10 to 33.7), respectively. The pCR rate in responders who received induction FOLFOX was 40.3% (95% CI, 28.9 to 52.5) and 14.1% (95% CI, 6.6 to 25.0) in responders to CP. With a median follow-up of 5.2 years, median overall survival was 48.8 months (95% CI, 33.2 months to not estimable) for PET responders and 27.4 months (95% CI, 19.4 months to not estimable) for nonresponders. For induction FOLFOX patients who were PET responders, median survival was not reached.

CONCLUSION: Early response assessment using PET imaging as a biomarker to individualize therapy for patients with esophageal and esophagogastric junction adenocarcinoma was effective, improving pCR rates in PET nonresponders. PET responders to induction FOLFOX who continued on FOLFOX during chemoradiation achieved a promising 5-year overall survival of 53%.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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