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. 2020 Mar 2;3(3):e200452.
doi: 10.1001/jamanetworkopen.2020.0452.

Estimates of Overall Survival in Patients With Cancer Receiving Different Treatment Regimens: Emulating Hypothetical Target Trials in the Surveillance, Epidemiology, and End Results (SEER)-Medicare Linked Database

Lucia C Petito  1   2 , Xabier García-Albéniz  1   3   4 , Roger W Logan  1 , Nadia Howlader  5 , Angela B Mariotto  5 , Issa J Dahabreh  1   6   7   8 , Miguel A Hernán  1   9   10
Affiliations

Estimates of Overall Survival in Patients With Cancer Receiving Different Treatment Regimens: Emulating Hypothetical Target Trials in the Surveillance, Epidemiology, and End Results (SEER)-Medicare Linked Database

Lucia C Petito et al. JAMA Netw Open. .

Erratum in

  • Errors in Results and Supplement.
    [No authors listed] [No authors listed] JAMA Netw Open. 2020 Apr 1;3(4):e204966. doi: 10.1001/jamanetworkopen.2020.4966. JAMA Netw Open. 2020. PMID: 32250428 Free PMC article. No abstract available.

Abstract

Importance: The Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database may provide insights into the comparative effectiveness of oncological treatments for elderly individuals who are underrepresented in clinical trials.

Objective: To evaluate the suitability of SEER-Medicare data for assessing the effectiveness of adding a drug to an existing treatment regimen on the overall survival of elderly patients with cancer.

Design, setting, and participants: This comparative effectiveness study analyzed SEER-Medicare data from 9549 individuals who received a new diagnosis of stage II colorectal cancer (2008-2012) and 940 patients who received a new diagnosis of advanced pancreatic adenocarcinoma (2007-2012), with follow-up to December 31, 2013 (SEER-Medicare data released in 2015). Two (hypothetical) target trials were designed and emulated based on 2 existing randomized clinical trials: (1) adjuvant fluorouracil after curative surgery for individuals with stage II colorectal cancer and (2) erlotinib added to gemcitabine for individuals with advanced pancreatic adenocarcinoma. Data were analyzed January 2018 to March 2019.

Exposures: The following treatment strategies were compared: (1) fluorouracil initiation vs no initiation within 3 months of tumor resection and (2) erlotinib initiation vs no initiation within 12 weeks of gemcitabine initiation.

Main outcomes and measures: All-cause mortality within 60 months of baseline for the fluorouracil trial and within 72 weeks for the erlotinib trial.

Results: Compared with 3293 individuals in the existing fluorouracil trial, 9549 eligible individuals included in the present analyses were more likely to have colon cancer (8565 [90%] vs 2291 [71%]) and were older (median [interquartile range], 79 [73-84] vs 63 [56-68] years). The 5-year risk difference for initiation vs noninitiation of fluorouracil after surgery was -3.8% (95% CI, -14.8% to 12.6%), and the mortality hazard ratio (HR) was 0.95 (95% CI, 0.85-1.04). Compared with 569 individuals in the existing erlotinib trial, 940 eligible patients included in the present analysis were older (median [range], 74 [66-93] vs 64 [36-92] years) and more likely to be male (547 [58%] vs 298 [52%]). The 1-year risk difference for initiation vs noninitiation of erlotinib was 4.7% (95% CI, -9.4% to 18.0%), and the corresponding mortality HR was 1.04 (95% CI, 0.86-1.42). In naive analyses, the mortality HR estimate was 1.14 (95% CI, 0.95-1.36) for the fluorouracil emulation and 0.68 (95% CI, 0.54-0.87) for the erlotinib emulation.

Conclusions and relevance: The present estimates were similar to those from randomized clinical trials that studied adding the same cancer drugs to existing regimens. The published HR was 1.02 (95% CI, 0.70-1.48) in the fluorouracil trial for individuals aged 70 or older and 0.96 (95% CI, 0.74-1.24) in the erlotinib trial for individuals aged 65 years or older. The SEER-Medicare database may be adequate for studying the real-world effectiveness of adding a drug to treatment regimens used for elderly individuals with cancer.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Petito reported that she is currently funded by the following National Institutes of Health grants as a coinvestigator: 5R01HL133860-04 (National Heart, Lung, and Blood Institute [NHLBI]), 5R01HL096875-08 (NHLBI), 4R33AG057383-03 (National Institute on Aging [NIA]), 5R01MD012236-02 (National Institute on Minority Health and Health Disparities), 1R01AG059291-01A1 (NIA), 1R01HL141881-01A1 (NHLBI), 2UL1TR001422-05A1 (National Center for Advancing Translational Sciences). Drs Logan and Hernán reported receiving grants from the National Institutes of Health during the conduct of the study. Dr Dahabreh reported receiving personal fees from Sanofi Pasteur outside the submitted work.

Figures

Figure 1.
Figure 1.. Survival Curves From the Emulated Target Trial of Adjuvant Fluorouracil-Based Chemotherapy in Stage II Colorectal Cancer Using Surveillance, Epidemiology, and End Results–Medicare Data From 2008 to 2013
Figure 2.
Figure 2.. Survival Curves From the Emulated Target Trial of the Addition of Erlotinib to a Regimen of Gemcitabine in Locally Advanced or Metastatic Pancreatic Cancer Using Surveillance, Epidemiology, and End Results–Medicare Data From 2007 to 2013
See this image and copyright information in PMC

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