Confidentia

Mature Outcomes of 61.2 Gy Concomitant Boost (CB) Thoracic Radiotherapy (TRT) in Limited Stage Small
Cell Lung Cancer (LSCLC): CALGB 30610 (Alliance) / RTOG 0538
J. A. Bogart1, X. Wang2, G. Masters3, J. Gao2, R. U. Komaki-Cox4, L. E. Gaspar5, J. Heymach6, M. C.
Dobelbower7, C. Kuzma8, S. Waqar9, W. Petty10, T. E. Stinchcombe11, J. D. Bradley12, and E. E. Vokes13;
1
SUNY Upstate Medical Center, Syracuse, NY, 2Duke University Department of Biostatistics and Bioinformatics,
Durham, NC, 3Christiana Care/Helen F. Graham Cancer Center, Newark, DE, 4Baylor College of Medicine,
Houston, TX, 5Department of Radiation Oncology, University of Colorado Denver, Aurora, CO, 6Department of
Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX,
7
University of Alabama at Birmingham, Birmingham, AL, 8First Health of the Carolinas-Moore Regional Hospital,
Pinehurst, NC, 9Washington University School of Medicine, St. Louis, MO, 10Wake Forest University Health
Sciences, Salem, NC, 11Duke University Hospitals, Durham, NC, 12Department of Radiation Oncology, Winship
Cancer Institute of Emory University, Atlanta, GA, 13Department of Medicine, Section of Hematology/Oncology,
University of Chicago Medical Center, Chicago, IL
Purpose/Objective(s): We report mature outcomes of LSCLC patients randomized to the 61.2 Gy CB TRT arm of
CALGB 30610/RTOG 0538. The study initially included 2 experimental arms, 61.2 Gy CB TRT over 5 weeks and
70 Gy daily (QD) over 7 weeks, both with higher predicted biologic efficacy than standard 45 Gy twice-daily
(BID)TRT. The CB arm was discontinued after planned early interim analysis comparing toxicity in the
experimental arms, but the study provides the largest prospective dataset assessing 61.2 Gy CB TRT in LSCLC
Materials/Methods: Eligible patients had LSCLC with regional lymph node involvement, excluding contralateral
hilar and supraclavicular nodes, and ECOG PS 0-2. TRT began with either the first or 2nd (of 4 total) cycle of
cisplatin-based chemotherapy, and prophylactic cranial radiotherapy was recommended in cases of complete (or
near complete) response. In the initial phase of the trial, patients were randomized with a 1:1:1 allocation to 45 Gy
BID, 70 Gy QD and 61.2 Gy CB TRT. A decision to drop an experimental arm was mandated after toxicity data was
available for approximately 70 patients in each cohort. Although toxicity was similar in both experimental arms, a
decision was made to discontinue the 61.2 Gy cohort after discussion with the DSMB.
Results: From March 2008 until March 2013 (when the cohort was discontinued), 93 patients were assigned to
receive 61.2 Gy CB TRT. The median age was 62 years (range 41 to 77), the majority of patients were Caucasian
(86%), male (51%), ECOG PS 0-1 (95%). Most patients started TRT with the first chemotherapy cycle (65%) and
had 3D planning (63%). After median follow up of 7 years for surviving patients, median overall survival (OS) and
progression free survival were 32.3 months (95% CI: 21.1-44.8) and 15.6 months (95% CI: 10.0-27.5), respectively.
Two-year OS was 57% (95% CI: 0.47-0.68), with 28% OS (95% CI: 0.2-0.4) at 5 years. Rates of grade 3 and 4
hematologic adverse events (AEs) were 20.5% and 59.1%, with 40.9% and 25% Grade 3 and 4 non-hematologic
AEs. Grade 3+ dysphagia and dyspnea were 16% and 7%, respectively. There were 4 Grade 5 AEs, including one
patient with febrile neutropenia.
Conclusion: Outcomes are similar to the contemporaneous CONVERT trial, and compare favorably to the prior
phase II trial examining 61.2 Gy CB TRT (RTOG 0239) in LSCLC, despite the allowance of early stage (N0)
disease in those studies. The improvement in OS compared with RTOG 0239 is likely attributed to improved staging
and advances in radiotherapy planning and delivery, though additional factors may have contributed. Support:
U10CA180821, U10CA180882; U10CA180868 (NRG), U10CA180888 (SWOG);
https://acknowledgments.alliancefound.org Clinicaltrials.gov Id: NCT00632853
Author Disclosure: J.A. Bogart: Partner; Upstate University Radiation Oncology. Travel Expenses; Alliance Clinical
Trials. Chair, radiation oncology committee; Alliance. X. Wang: None. G. Masters: None. J. Gao: None. R.U.
Komaki-Cox: None. L.E. Gaspar: Speaker's Bureau; Cancer Expert Now. other relationship; NCI. J. Heymach:
None. M.C. Dobelbower: None. C. Kuzma: None. S. Waqar: Research Grant; Spectrum Pharmaceuticals, Lilly,
Pfizer, Genentech/Roche, Daiichi Sankyo, Newlink Genetics, EMD Serono, Puma Biotechnology, Novartis,
Xcovery, Synermore Biologics, Celgene, Vertex, Bristol-Myers Squibb, Stem CentRx, Hengrui Therapeutics,
Checkpoint Therapeutics, Ignyta, AstraZeneca, ARIAD, Roche, Merck. W. Petty: Research Grant; Merck Sharp &
Dohme, Abbvie. Consultant; Jazz Pharmaceuticals. Travel Expenses; Dava Oncology. T.E. Stinchcombe: Research
Grant; Genentech/Roche, Blueprint Medicines, AstraZeneca, Takeda, Advaxis, Regeneron. Consultant; Takeda,
AstraZeneca, Geentech/Roche, Foundation Medicine, Pfizer, EMD Serono, Novartis, Daiichi Sankyo, Lilly,
Medtronic, Puma Biotechnology, Janssen Oncology, Regeneron. J.D. Bradley: Honoraria; Genentech, Inc, Mevion
Medical Systems. Consultant; AstraZeneca, Inc, Varian Medical Systems, Inc. Advisory Board; Genentech, Inc,
Mevion Medical Systems. ; American Radium Society Executive Committee. Organize NRG Oncology research
Confidentia
agenda on lung cancer; American College of Radiology. E.E. Vokes: Research Grant; Abbvie, Bristol-Myers
Squibb, Celegene, Novartis, Lilly. Honoraria; Abbvie, Amgen, AstraZeneca, Bristol-Myers Squibb, Celgene, Lilly,
EMD Serono, Genentech, GlaxoSmithKline, Merck, Novartis, Regeneron, Takeda, Radius Health, Ascendis
Pharma. Consultant; Abbvie, Amgen, Astrazeneca, Bristol-Myers Squibb, Celegene, Lilly, Merc.