title: Contribution of age to clinical trial enrollment and tolerance with ovarian cancer.
abstract: Increasing age has been correlated with shorter survival in ovarian cancer patients, a finding attributed to diminished tolerance of standard therapy. Elderly patients, however, are less likely to enroll on clinical trials; thus, limited data exists to evaluate their response to front line treatment. This study describes how elderly patients on trial fared, with respect to toxicity and response, compared to younger women.
  
  
  
  A retrospective cohort study was performed of ovarian cancer patients enrolled in front line chemotherapy trials at our institution between 2000 and 2013. Patients were dichotomized by age: <70 and ≥70years. Clinical, pathologic, and treatment characteristics were recorded and analyzed using SAS version 9.3.
  
  
  
  336 patients were enrolled. Of these, 79 (23.5%) were ≥70yrs. Demographics were similar between the two groups. Compared to patients <70, those ≥70 completed a comparable number of chemotherapy cycles (p=0.16) and had similar numbers of dose modifications (p=0.40) and delays (p=0.26). Both hematologic and non-hematologic toxicities occurred at similar rates as well. Age≥70 (HR 1.8, 95% CI 1.27-2.54, p=0.0009), stage III/IV (HR 3.44, 95% CI 1.08-10.95, p=0.036), and residual disease (HR 2.63, 95% CI 1.82-3.78, p<0.0001) were independently predictive of shorter overall survival.
  
  
  
  Our data continues to support reports of shorter survival for older women with ovarian cancer. With physician bias removed and similar chemotherapy tolerance noted, our study suggests that inherent tumor biology may be a significant contributor. Further research is needed to identify the mechanisms which contribute to the inequality that age imposes on outcomes.
authors.affiliation: Section of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States. Electronic address: Jessica-gillen@ouhsc.edu.
authors.forename: Jessica
authors.initials: J
authors.lastname: Gillen
authors.affiliation: Section of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States. Electronic address: Camille-gunderson@ouhsc.edu.
authors.forename: Camille
authors.initials: C
authors.lastname: Gunderson
authors.affiliation: Section of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States. Electronic address: molly-greenwade@ouhsc.edu.
authors.forename: Molly
authors.initials: M
authors.lastname: Greenwade
authors.affiliation: Section of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States. Electronic address: michelle-rowland@ouhsc.edu.
authors.forename: Michelle
authors.initials: M
authors.lastname: Rowland
authors.affiliation: Section of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States. Electronic address: Rachel-ruskin@ouhsc.edu.
authors.forename: Rachel
authors.initials: R
authors.lastname: Ruskin
authors.affiliation: Department of Biostatistics and Epidemiology, University of Oklahoma, Oklahoma City, OK, United States. Electronic address: kai-ding@ouhsc.edu.
authors.forename: Kai
authors.initials: K
authors.lastname: Ding
authors.affiliation: Section of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States. Electronic address: alia-crim@ouhsc.edu.
authors.forename: Aleia
authors.initials: A
authors.lastname: Crim
authors.affiliation: Section of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States. Electronic address: adam.waltermd@promedica.org.
authors.forename: Adam
authors.initials: A
authors.lastname: Walter
authors.affiliation: Section of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States. Electronic address: Emily-white@ouhsc.edu.
authors.forename: Emily
authors.initials: E
authors.lastname: White
authors.affiliation: Section of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States. Electronic address: Kathleen-moore@ouhsc.edu.
authors.forename: Kathleen
authors.initials: K
authors.lastname: Moore
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D018269:Carcinoma, Endometrioid / Q000188:drug therapy*; D000077216:Carcinoma, Ovarian Epithelial; D017024:Chemotherapy, Adjuvant; D002986:Clinical Trials as Topic; D015331:Cohort Studies; D065426:Cytoreduction Surgical Procedures; D005260:Female; D006801:Humans; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D018365:Neoplasm, Residual; D018297:Neoplasms, Cystic, Mucinous, and Serous / Q000188:drug therapy*; D009375:Neoplasms, Glandular and Epithelial / Q000188:drug therapy*; D009503:Neutropenia / Q000139:chemically induced; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D018579:Patient Selection; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced; D017671:Platinum Compounds / Q000008:administration & dosage; D012189:Retrospective Studies; D043823:Taxoids / Q000008:administration & dosage; D013921:Thrombocytopenia / Q000139:chemically induced; D055815:Young Adult
chemical_list: D017671:Platinum Compounds; D043823:Taxoids
keywords: Chemotherapy tolerance; Older women; Ovarian cancer