title: Generalizability of trial results to elderly Medicare patients with advanced solid tumors (Alliance 70802).
abstract: BACKGROUND
  In the United States, patients who enroll in chemotherapy trials seldom reflect the attributes of the general population with cancer, as they are often younger, more functional, and have less comorbidity. We compared survival following three chemotherapy regimens according to the setting in which care was delivered (ie, clinical trial vs usual care) to determine the generalizability of clinical trial results to unselected elderly Medicare patients.
  
  
  METHODS
  Using SEER-Medicare data, we estimated survival for elderly patients (ie, age 65 years or older, n = 14097) with advanced pancreatic or lung cancer following receipt of one of three guideline-recommended first-line chemotherapy regimens. We compared their survival to that of similarly treated clinical trial enrollees, without age restrictions, with the same diagnosis and stage (n = 937). All statistical tests were two-sided.
  
  
  RESULTS
  Trial patients were 9.5 years younger than elderly Medicare patients. Medicare patients were more often white and tended to live in areas of greater educational attainment than trial enrollees. For each tumor type, Medicare patients who were 75 years or older had median survivals that were six to eight weeks shorter than those of trial patients (4.3 vs 5.8 months following treatment with single agent gemcitabine for advanced pancreatic cancer, P = .03; 7.3 vs 8.9 months following treatment with carboplatin and paclitaxel for stage IV non-small cell lung cancer, P = .91; 8.2 vs 10.2 months following treatment with CDDP/ VP16 for extensive stage small cell lung cancer, P ≤ .01), whereas younger Medicare patients had survival times that were similar to those of trial patients.
  
  
  CONCLUSIONS
  Results of clinical trials for advanced pancreatic cancer and lung cancers tended to correctly estimate survival for Medicare patients aged 65 to 74 years, but to overestimate survival for older Medicare patients by six to eight weeks. These estimates of Medicare patients' survival may aid subsequent patients and their oncologists in treatment decision-making.
authors.affiliation: Massachusetts General Hospital Cancer Center, Boston, MA (EL); Departments of Medicine, and Health Care Policy, Harvard Medical School, Boston, MA (EL, YH, AM); American Society of Clinical Oncology, Alexandria, VA (RLS); Department of Medicine, University of North Carolina, Chapel Hill, NC (HM); Department of Medicine, Duke University, Durham, NC (HJC); City of Hope, Duarte, CA (AH); Department of Medicine, University of Chicago, Chicago, IL (HLK); Department of Medicine, University of California San Francisco, San Francisco, CA (AV); Yale Cancer Center, New Haven, CT (RL); Department of Medicine, the University of Tennessee, Memphis, TN (HN); Department of Medicine, Ohio State University, Columbus, OH (RMG); Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA (SJ). lamont@hcp.med.harvard.edu.
authors.forename: Elizabeth B
authors.initials: EB
authors.lastname: Lamont
authors.affiliation: Massachusetts General Hospital Cancer Center, Boston, MA (EL); Departments of Medicine, and Health Care Policy, Harvard Medical School, Boston, MA (EL, YH, AM); American Society of Clinical Oncology, Alexandria, VA (RLS); Department of Medicine, University of North Carolina, Chapel Hill, NC (HM); Department of Medicine, Duke University, Durham, NC (HJC); City of Hope, Duarte, CA (AH); Department of Medicine, University of Chicago, Chicago, IL (HLK); Department of Medicine, University of California San Francisco, San Francisco, CA (AV); Yale Cancer Center, New Haven, CT (RL); Department of Medicine, the University of Tennessee, Memphis, TN (HN); Department of Medicine, Ohio State University, Columbus, OH (RMG); Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA (SJ).
authors.forename: Richard L
authors.initials: RL
authors.lastname: Schilsky
authors.affiliation: Massachusetts General Hospital Cancer Center, Boston, MA (EL); Departments of Medicine, and Health Care Policy, Harvard Medical School, Boston, MA (EL, YH, AM); American Society of Clinical Oncology, Alexandria, VA (RLS); Department of Medicine, University of North Carolina, Chapel Hill, NC (HM); Department of Medicine, Duke University, Durham, NC (HJC); City of Hope, Duarte, CA (AH); Department of Medicine, University of Chicago, Chicago, IL (HLK); Department of Medicine, University of California San Francisco, San Francisco, CA (AV); Yale Cancer Center, New Haven, CT (RL); Department of Medicine, the University of Tennessee, Memphis, TN (HN); Department of Medicine, Ohio State University, Columbus, OH (RMG); Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA (SJ).
authors.forename: Yulei
authors.initials: Y
authors.lastname: He
authors.affiliation: Massachusetts General Hospital Cancer Center, Boston, MA (EL); Departments of Medicine, and Health Care Policy, Harvard Medical School, Boston, MA (EL, YH, AM); American Society of Clinical Oncology, Alexandria, VA (RLS); Department of Medicine, University of North Carolina, Chapel Hill, NC (HM); Department of Medicine, Duke University, Durham, NC (HJC); City of Hope, Duarte, CA (AH); Department of Medicine, University of Chicago, Chicago, IL (HLK); Department of Medicine, University of California San Francisco, San Francisco, CA (AV); Yale Cancer Center, New Haven, CT (RL); Department of Medicine, the University of Tennessee, Memphis, TN (HN); Department of Medicine, Ohio State University, Columbus, OH (RMG); Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA (SJ).
authors.forename: Hyman
authors.initials: H
authors.lastname: Muss
authors.affiliation: Massachusetts General Hospital Cancer Center, Boston, MA (EL); Departments of Medicine, and Health Care Policy, Harvard Medical School, Boston, MA (EL, YH, AM); American Society of Clinical Oncology, Alexandria, VA (RLS); Department of Medicine, University of North Carolina, Chapel Hill, NC (HM); Department of Medicine, Duke University, Durham, NC (HJC); City of Hope, Duarte, CA (AH); Department of Medicine, University of Chicago, Chicago, IL (HLK); Department of Medicine, University of California San Francisco, San Francisco, CA (AV); Yale Cancer Center, New Haven, CT (RL); Department of Medicine, the University of Tennessee, Memphis, TN (HN); Department of Medicine, Ohio State University, Columbus, OH (RMG); Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA (SJ).
authors.forename: Harvey Jay
authors.initials: HJ
authors.lastname: Cohen
authors.affiliation: Massachusetts General Hospital Cancer Center, Boston, MA (EL); Departments of Medicine, and Health Care Policy, Harvard Medical School, Boston, MA (EL, YH, AM); American Society of Clinical Oncology, Alexandria, VA (RLS); Department of Medicine, University of North Carolina, Chapel Hill, NC (HM); Department of Medicine, Duke University, Durham, NC (HJC); City of Hope, Duarte, CA (AH); Department of Medicine, University of Chicago, Chicago, IL (HLK); Department of Medicine, University of California San Francisco, San Francisco, CA (AV); Yale Cancer Center, New Haven, CT (RL); Department of Medicine, the University of Tennessee, Memphis, TN (HN); Department of Medicine, Ohio State University, Columbus, OH (RMG); Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA (SJ).
authors.forename: Arti
authors.initials: A
authors.lastname: Hurria
authors.affiliation: Massachusetts General Hospital Cancer Center, Boston, MA (EL); Departments of Medicine, and Health Care Policy, Harvard Medical School, Boston, MA (EL, YH, AM); American Society of Clinical Oncology, Alexandria, VA (RLS); Department of Medicine, University of North Carolina, Chapel Hill, NC (HM); Department of Medicine, Duke University, Durham, NC (HJC); City of Hope, Duarte, CA (AH); Department of Medicine, University of Chicago, Chicago, IL (HLK); Department of Medicine, University of California San Francisco, San Francisco, CA (AV); Yale Cancer Center, New Haven, CT (RL); Department of Medicine, the University of Tennessee, Memphis, TN (HN); Department of Medicine, Ohio State University, Columbus, OH (RMG); Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA (SJ).
authors.forename: Ashley
authors.initials: A
authors.lastname: Meilleur
authors.affiliation: Massachusetts General Hospital Cancer Center, Boston, MA (EL); Departments of Medicine, and Health Care Policy, Harvard Medical School, Boston, MA (EL, YH, AM); American Society of Clinical Oncology, Alexandria, VA (RLS); Department of Medicine, University of North Carolina, Chapel Hill, NC (HM); Department of Medicine, Duke University, Durham, NC (HJC); City of Hope, Duarte, CA (AH); Department of Medicine, University of Chicago, Chicago, IL (HLK); Department of Medicine, University of California San Francisco, San Francisco, CA (AV); Yale Cancer Center, New Haven, CT (RL); Department of Medicine, the University of Tennessee, Memphis, TN (HN); Department of Medicine, Ohio State University, Columbus, OH (RMG); Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA (SJ).
authors.forename: Hedy L
authors.initials: HL
authors.lastname: Kindler
authors.affiliation: Massachusetts General Hospital Cancer Center, Boston, MA (EL); Departments of Medicine, and Health Care Policy, Harvard Medical School, Boston, MA (EL, YH, AM); American Society of Clinical Oncology, Alexandria, VA (RLS); Department of Medicine, University of North Carolina, Chapel Hill, NC (HM); Department of Medicine, Duke University, Durham, NC (HJC); City of Hope, Duarte, CA (AH); Department of Medicine, University of Chicago, Chicago, IL (HLK); Department of Medicine, University of California San Francisco, San Francisco, CA (AV); Yale Cancer Center, New Haven, CT (RL); Department of Medicine, the University of Tennessee, Memphis, TN (HN); Department of Medicine, Ohio State University, Columbus, OH (RMG); Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA (SJ).
authors.forename: Alan
authors.initials: A
authors.lastname: Venook
authors.affiliation: Massachusetts General Hospital Cancer Center, Boston, MA (EL); Departments of Medicine, and Health Care Policy, Harvard Medical School, Boston, MA (EL, YH, AM); American Society of Clinical Oncology, Alexandria, VA (RLS); Department of Medicine, University of North Carolina, Chapel Hill, NC (HM); Department of Medicine, Duke University, Durham, NC (HJC); City of Hope, Duarte, CA (AH); Department of Medicine, University of Chicago, Chicago, IL (HLK); Department of Medicine, University of California San Francisco, San Francisco, CA (AV); Yale Cancer Center, New Haven, CT (RL); Department of Medicine, the University of Tennessee, Memphis, TN (HN); Department of Medicine, Ohio State University, Columbus, OH (RMG); Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA (SJ).
authors.forename: Rogerio
authors.initials: R
authors.lastname: Lilenbaum
authors.affiliation: Massachusetts General Hospital Cancer Center, Boston, MA (EL); Departments of Medicine, and Health Care Policy, Harvard Medical School, Boston, MA (EL, YH, AM); American Society of Clinical Oncology, Alexandria, VA (RLS); Department of Medicine, University of North Carolina, Chapel Hill, NC (HM); Department of Medicine, Duke University, Durham, NC (HJC); City of Hope, Duarte, CA (AH); Department of Medicine, University of Chicago, Chicago, IL (HLK); Department of Medicine, University of California San Francisco, San Francisco, CA (AV); Yale Cancer Center, New Haven, CT (RL); Department of Medicine, the University of Tennessee, Memphis, TN (HN); Department of Medicine, Ohio State University, Columbus, OH (RMG); Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA (SJ).
authors.forename: Harvey
authors.initials: H
authors.lastname: Niell
authors.affiliation: Massachusetts General Hospital Cancer Center, Boston, MA (EL); Departments of Medicine, and Health Care Policy, Harvard Medical School, Boston, MA (EL, YH, AM); American Society of Clinical Oncology, Alexandria, VA (RLS); Department of Medicine, University of North Carolina, Chapel Hill, NC (HM); Department of Medicine, Duke University, Durham, NC (HJC); City of Hope, Duarte, CA (AH); Department of Medicine, University of Chicago, Chicago, IL (HLK); Department of Medicine, University of California San Francisco, San Francisco, CA (AV); Yale Cancer Center, New Haven, CT (RL); Department of Medicine, the University of Tennessee, Memphis, TN (HN); Department of Medicine, Ohio State University, Columbus, OH (RMG); Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA (SJ).
authors.forename: Richard M
authors.initials: RM
authors.lastname: Goldberg
authors.affiliation: Massachusetts General Hospital Cancer Center, Boston, MA (EL); Departments of Medicine, and Health Care Policy, Harvard Medical School, Boston, MA (EL, YH, AM); American Society of Clinical Oncology, Alexandria, VA (RLS); Department of Medicine, University of North Carolina, Chapel Hill, NC (HM); Department of Medicine, Duke University, Durham, NC (HJC); City of Hope, Duarte, CA (AH); Department of Medicine, University of Chicago, Chicago, IL (HLK); Department of Medicine, University of California San Francisco, San Francisco, CA (AV); Yale Cancer Center, New Haven, CT (RL); Department of Medicine, the University of Tennessee, Memphis, TN (HN); Department of Medicine, Ohio State University, Columbus, OH (RMG); Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA (SJ).
authors.forename: Steven
authors.initials: S
authors.lastname: Joffe
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004522:Educational Status; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D008297:Male; D006278:Medicare; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D011379:Prognosis; D018426:SEER Program; D014481:United States