Kenneth L Kehl1, David Zahrieh2, Ping Yang2, Shauna L Hillman2, Angelina D Tan2, Jacob M Sands1, Geoffrey R Oxnard1, Erin A Gillaspie3, Dennis Wigle2, Shakun Malik4, Thomas E Stinchcombe5, Suresh S Ramalingam6, Karen Kelly7, Ramaswamy Govindan8, Sumithra J Mandrekar2, Raymond U Osarogiagbon9, David Kozono1. 1. Dana-Farber/Partners CancerCare, Brigham and Women's Hospital, and Harvard Medical School, Boston, Massachusetts. 2. Alliance Statistics and Data Management Center, Mayo Clinic, Rochester, Minnesota. 3. Department of Thoracic Surgery, Vanderbilt University Medical Center, Nashville, Tennessee. 4. National Cancer Institute Cancer Therapy Evaluation Program, Bethesda, Maryland. 5. Duke Cancer Institute, Duke University Medical Center, Durham, North Carolina. 6. The Winship Cancer Institute of Emory University, Atlanta, Georgia. 7. University of California at Davis Comprehensive Cancer Center, Sacramento. 8. Alvin J Siteman Cancer Center and Washington University School of Medicine, St Louis, Missouri. 9. Baptist Cancer Center, Memphis, Tennessee.
Abstract
Importance: Standard treatment for resectable non-small cell lung cancer (NSCLC) includes anatomic resection with adequate lymph node dissection and adjuvant chemotherapy for appropriate patients. Historically, many patients with early-stage NSCLC have not received such treatment, which may affect the interpretation of the results of adjuvant therapy trials. Objective: To ascertain patterns of guideline-concordant treatment among patients enrolled in a US-wide screening protocol for adjuvant treatment trials for resected NSCLC. Design, Setting, and Participants: This retrospective cohort study included 2833 patients with stage IB to IIIA NSCLC (per American Joint Committee on Cancer 7th edition criteria) who enrolled in the Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST) screening study (Alliance for Clinical Trials in Oncology A151216) from August 18, 2014, to April 1, 2019, and who did not enroll in a therapeutic adjuvant clinical trial; patients had tumors of at least 4 cm and/or with positive lymph nodes. Statistical analysis was conducted from June 1, 2020, through October 1, 2021. Exposures: Care patterns were ascertained overall and by sociodemographic and clinical factors, including age, sex, race and ethnicity, educational level, marital status, geography, histologic characteristics, stage, genomic variant status, smoking history, and comorbidities. Main Outcomes and Measures: Five outcomes are reported: whether patients (1) had anatomic surgical resection, (2) had adequate lymph node dissection (≥1 N1 nodal station plus ≥3 N2 nodal stations), (3) received any adjuvant chemotherapy, (4) received any cisplatin-based adjuvant chemotherapy, and (5) received at least 4 cycles of adjuvant chemotherapy. Results: Of the 2833 patients (1505 women [53%]; mean [SD] age, 66.5 [9.2] years) included in this analysis, 2697 (95%) had anatomic surgical resection, 1513 (53%) had adequate lymph node dissection, 1617 (57%) received any adjuvant chemotherapy, 1237 (44%) received at least 4 cycles of adjuvant platinum-based chemotherapy, and 965 (34%) received any cisplatin-based adjuvant chemotherapy. Rates were similar across race and ethnicity. Conclusions and Relevance: This cohort study found that among participants in a screening protocol for adjuvant clinical trials for resected early-stage NSCLC, just 53% underwent adequate lymph node dissection, and 57% received adjuvant chemotherapy, despite indications for such treatment. These results may affect the interpretation of adjuvant trials. Efforts are needed to optimize the use of proven therapies for early-stage NSCLC. Trial Registration: ClinicalTrials.gov Identifier: NCT02194738.
Importance: Standard treatment for resectable non-small cell lung cancer (NSCLC) includes anatomic resection with adequate lymph node dissection and adjuvant chemotherapy for appropriate patients. Historically, many patients with early-stage NSCLC have not received such treatment, which may affect the interpretation of the results of adjuvant therapy trials. Objective: To ascertain patterns of guideline-concordant treatment among patients enrolled in a US-wide screening protocol for adjuvant treatment trials for resected NSCLC. Design, Setting, and Participants: This retrospective cohort study included 2833 patients with stage IB to IIIA NSCLC (per American Joint Committee on Cancer 7th edition criteria) who enrolled in the Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST) screening study (Alliance for Clinical Trials in Oncology A151216) from August 18, 2014, to April 1, 2019, and who did not enroll in a therapeutic adjuvant clinical trial; patients had tumors of at least 4 cm and/or with positive lymph nodes. Statistical analysis was conducted from June 1, 2020, through October 1, 2021. Exposures: Care patterns were ascertained overall and by sociodemographic and clinical factors, including age, sex, race and ethnicity, educational level, marital status, geography, histologic characteristics, stage, genomic variant status, smoking history, and comorbidities. Main Outcomes and Measures: Five outcomes are reported: whether patients (1) had anatomic surgical resection, (2) had adequate lymph node dissection (≥1 N1 nodal station plus ≥3 N2 nodal stations), (3) received any adjuvant chemotherapy, (4) received any cisplatin-based adjuvant chemotherapy, and (5) received at least 4 cycles of adjuvant chemotherapy. Results: Of the 2833 patients (1505 women [53%]; mean [SD] age, 66.5 [9.2] years) included in this analysis, 2697 (95%) had anatomic surgical resection, 1513 (53%) had adequate lymph node dissection, 1617 (57%) received any adjuvant chemotherapy, 1237 (44%) received at least 4 cycles of adjuvant platinum-based chemotherapy, and 965 (34%) received any cisplatin-based adjuvant chemotherapy. Rates were similar across race and ethnicity. Conclusions and Relevance: This cohort study found that among participants in a screening protocol for adjuvant clinical trials for resected early-stage NSCLC, just 53% underwent adequate lymph node dissection, and 57% received adjuvant chemotherapy, despite indications for such treatment. These results may affect the interpretation of adjuvant trials. Efforts are needed to optimize the use of proven therapies for early-stage NSCLC. Trial Registration: ClinicalTrials.gov Identifier: NCT02194738.
Authors: Amy J H Kind; Steve Jencks; Jane Brock; Menggang Yu; Christie Bartels; William Ehlenbach; Caprice Greenberg; Maureen Smith Journal: Ann Intern Med Date: 2014-12-02 Impact factor: 25.391
Authors: Solange Peters; D Ross Camidge; Alice T Shaw; Shirish Gadgeel; Jin S Ahn; Dong-Wan Kim; Sai-Hong I Ou; Maurice Pérol; Rafal Dziadziuszko; Rafael Rosell; Ali Zeaiter; Emmanuel Mitry; Sophie Golding; Bogdana Balas; Johannes Noe; Peter N Morcos; Tony Mok Journal: N Engl J Med Date: 2017-06-06 Impact factor: 91.245
Authors: Yi-Long Wu; Thomas John; Christian Grohe; Margarita Majem; Jonathan W Goldman; Sang-We Kim; Terufumi Kato; Konstantin Laktionov; Huu Vinh Vu; Zhijie Wang; Shun Lu; Kye Young Lee; Charuwan Akewanlop; Chong-Jen Yu; Filippo de Marinis; Laura Bonanno; Manuel Domine; Frances A Shepherd; Lingmin Zeng; Ajlan Atasoy; Roy S Herbst; Masahiro Tsuboi Journal: J Thorac Oncol Date: 2021-11-02 Impact factor: 15.609
Authors: Luis Paz-Ares; Alexander Luft; David Vicente; Ali Tafreshi; Mahmut Gümüş; Julien Mazières; Barbara Hermes; Filiz Çay Şenler; Tibor Csőszi; Andrea Fülöp; Jerónimo Rodríguez-Cid; Jonathan Wilson; Shunichi Sugawara; Terufumi Kato; Ki Hyeong Lee; Ying Cheng; Silvia Novello; Balazs Halmos; Xiaodong Li; Gregory M Lubiniecki; Bilal Piperdi; Dariusz M Kowalski Journal: N Engl J Med Date: 2018-09-25 Impact factor: 91.245
Authors: Joseph M Unger; Charles D Blanke; Michael LeBlanc; William E Barlow; Riha Vaidya; Scott D Ramsey; Dawn L Hershman Journal: JAMA Netw Open Date: 2020-04-01
Authors: Filippo de Marinis; Ilaria Attili; Cesare Gridelli; Fabiana Cecere; Carlo Curcio; Francesco Facciolo; Lorenzo Spaggiari Journal: Front Oncol Date: 2022-07-22 Impact factor: 5.738