Meeting
2022 ASCO Annual Meeting
Outcomes by tobacco history in E3311, a phase II trial of transoral surgery (TOS) followed by pathology-based adjuvant treatment in HPV-associated (HPV+) oropharynx cancer (OPC): A trial of the ECOG-ACRIN Cancer Research Group.
Authors
Ranee Mehra
Greenebaum Comprehensive Cancer Center, University of Maryland, Baltimore, MD
Ranee Mehra , Yael Flamand , Harry Quon , Joaquin J. Garcia , Gregory S. Weinstein , Umamaheswar Duvvuri , Bert W. O'Malley , Enver Ozer , Giovana R. Thomas , Wayne Koch , Neil D. Gross , Richard Bryan Bell , Nabil F. Saba , Miriam Lango , Rodrigo Bayon , Barbara Burtness , Robert L. Ferris
Organizations
Greenebaum Comprehensive Cancer Center, University of Maryland, Baltimore, MD, Dana Farber Cancer Institute – ECOG-ACRIN Biostatistics Center, Boston, MA, Johns Hopkins University, Baltimore, MD, Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, University of Pennsylvania, Philadelphia, PA, University of Pittsburgh School of Medicine, Pittsburgh, PA, University of Maryland, Baltimore, MD, The James Cancer Hospital and Solove Research Institute, Columbus, OH, Univ of Miami/Miller School of Medcn, Aventura, FL, The Johns Hopkins University School of Medicine, Baltimore, MD, The University of Texas MD Anderson Cancer Center, Department of Head and Neck Surgery, Houston, TX, Earle A. Chiles Research Institute at Robert W. Franz Cancer Center, Providence Cancer Institute, Portland, OR, Winship Cancer Institute Emory University School of Medicine, Atlanta, GA, MD Anderson, Houston, TX, University of Iowa, Iowa City, IA, Yale School of Medicine and Yale Cancer Center, New Haven, CT, University of Pittsburgh Medical Center and University of Pittsburgh Cancer Institute, Pittsburgh, PA
Research Funding
U.S. National Institutes of Health
Background: E3311 is a phase II randomized study which showed favorable outcomes among intermediate (INT) risk HPV+ OPC patients (pts) who underwent TOS followed by pathology-guided or adapted, deintensified adjuvant treatment. Among HPV+ pts treated with definitive chemoradiation, survival outcomes are worse among those who smoked > 10 pack years (pk-yrs). Methods: We retrospectively analyzed demographics, pathologic results, and efficacy outcomes from E3311 by smoking group (current (C) vs. former (F) and > 10 vs. ≤10 pk-yrs ? the latter a pre-specified stratification factor for INT patients). Binary and categorical variables were compared using a chi-square test (or Fisher?s exact test for small sample sizes). Ordinal variables were compared using a Wilcoxon rank sum test. Progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan-Meier method and compared using a log-rank test. Results: Among 359 evaluable pts, performance status (PS) was significantly worse for pts with > 10 pk-yrs vs. ≤10 pk-yrs (15.4% vs. 7.9% with PS of 1, p = 0.034). Primary site, margin status, histologic grade, stage, and extranodal extension were not significantly different between the groups of > 10 vs. ≤10 pk-yrs. Smoking status (F vs. C) was available for 182 pts with a history of smoking. Slightly more C vs. F smokers had tonsil as primary site (79.5% vs. 65.0%, p = 0.09). Positive margins were significantly more frequent among C smokers (10.3% vs. 2.1%; p = 0.029). Overall, there were no significant differences in PFS (p = 0.55) or OS (p = 0.94), comparing those with > 10 vs. ≤10 pk-yrs, or comparing C vs. F smokers (p = 0.76, p = 0.82, respectively). Similarly, no significant differences were observed within the treatment arms. (Table 1) Conclusions: In this analysis of smoking status in E3311, INT risk HPV+ OPC pts who are C smokers or have a history of > 10 pk-yrs had favorable 3-yr PFS and OS rates that were not significantly worse than those with < 10 pk-yrs history. This data represents the first treatment approach for HPV+ OPC in which outcomes were not influenced by smoking status. Clinical trial information: NCT01898494.
| Smoking History(pk-yrs) | N (pts) | 3-yr PFS (%), 90% CI | 3-yr OS (%), 90% CI | |
|---|---|---|---|---|
| All evaluable pts, N = 356* | > 10 < 10 | 104 252 | 95.5, (91.9%, 99.2%) 92.5, (89.7%, 95.3%) | 96.8, (93.8%, 99.8%) 95.4, (93.1%, 97.6%) |
| Arm A | > 10 | 7 | 100% | 100% |
| ≤ 10 | 30 | 96, (90%, 100%) | 96, (91%, 100%) | |
| Arm B | > 10 | 33 | 97 (92%, 100%) | 100 |
| ≤ 10 | 67 | 94 (89%, 99%) | 99, (96%, 100%) | |
| Arm C | > 10 | 30 | 95, (88%, 100%) | 96, (90%, 100%) |
| ≤ 10 | 78 | 93, (88%, 98%) | 95, (90%, 99%) | |
| Arm D | > 10 | 34 | 93, (86%, 100%) | 93, (85%, 100%) |
| ≤ 10 | 77 | 90, (84%, 96%) | 93, (89%, 98%) | |
| Known Smoking status, N = 182 | Current (C) Former (F) | 39 143 | 93.8, (87.2%, 100%) 94.7, (91.6%, 98.0%) | 94.3, (88.0%, 100%) 95.6, (92.7%, 98.5%) |
*3 pts missing smoking history data.
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Abstract Details
Session Type
Poster Session
Session Title
Head and Neck Cancer
Track
Head and Neck Cancer
Sub Track
Local-Regional Disease
Clinical Trial Registration Number
NCT01898494
Citation
J Clin Oncol 40, 2022 (suppl 16; abstr 6077)
DOI
10.1200/JCO.2022.40.16_suppl.6077
Abstract #
6077
Poster Bd #
69
Abstract Disclosures
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