title: Clinical outcome and prognostic markers for patients with gynecologic malignancies in phase 1 clinical trials: a single institution experience from 1999 to 2010.
abstract: OBJECTIVE
  There is a scarcity of outcome data regarding phase 1 trials for patients with gynecologic malignancy. The objective of this study was to assess toxicity, clinical benefit and prognosticators in gynecologic oncology patients participating in phase 1 trials.
  
  
  METHODS
  All phase 1 oncology trials conducted at Albert Einstein Cancer Center from 1999 to 2010 were reviewed and extracted for relevant demographic and clinical data concerning patients with gynecologic malignancy. Cox-proportional and logistic regression modeling were used for multivariate analysis.
  
  
  RESULTS
  120 distinct patients with gynecologic malignancy participated in 41 trials, constituting 30.6% of all phase 1 patients enrolled in the same time period. The median age is 59 years. Out of the 184 patients enrolled, 160 individual responses were evaluable. Seventeen DLT events (9.2%) occurred, including 1 (0.5%) treatment-related mortality. There were 27.2%≥ grade 3 hematologic and 24.4% non-hematologic toxicity. Eighty patients had stable disease (SD, 50%), including 21.9% with SD ≥ 4 months, 11 (6.3%) with partial response (PR), and 3 (1.9%) achieving complete response (CR). The clinical benefit rate (CBR=SD+CR+PR) was 58.1%. Albumin (Alb)≤ 3.5 g/dL and abnormal ANC were independent negative prognosticators of survival. We also found a continuous correlation between changes in Albumin (p=0.02) and LDH (p=0.02) and odds of achieving CBR≥4month.
  
  
  CONCLUSIONS
  Our clinical outcome and safety data suggested that phase 1 trials may be a reasonable option for patients with advanced and recurrent gynecologic cancer. The potential prognosticators identified should be further validated in larger trials.
authors.affiliation: Montefiore Medical Center, Bronx, NY, USA; Albert Einstein College of Medicine, Bronx, NY, USA; Department of Obstetrics & Gynecology, & Women's Health, Division of Gynecology Oncology, Albert Einstein College of Medicine, Bronx, NY, USA.
authors.forename: June Y
authors.initials: JY
authors.lastname: Hou
authors.forename: Santiago
authors.initials: S
authors.lastname: Aparo
authors.forename: Mohammad
authors.initials: M
authors.lastname: Ghalib
authors.forename: Imran
authors.initials: I
authors.lastname: Chaudhary
authors.forename: Umang
authors.initials: U
authors.lastname: Shah
authors.forename: Umang
authors.initials: U
authors.lastname: Swami
authors.forename: Mark
authors.initials: M
authors.lastname: Einstein
authors.forename: Gary L
authors.initials: GL
authors.lastname: Goldberg
authors.forename: Sridhar
authors.initials: S
authors.lastname: Mani
authors.forename: Sanjay
authors.initials: S
authors.lastname: Goel
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use*; D018572:Disease-Free Survival; D005260:Female; D005833:Genital Neoplasms, Female / Q000188:drug therapy*; D006801:Humans; D053208:Kaplan-Meier Estimate; D007958:Leukocyte Count; D008875:Middle Aged; D009504:Neutrophils; D016016:Proportional Hazards Models; D012709:Serum Albumin / Q000378:metabolism; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D012709:Serum Albumin
keywords: Clinical trials; Gynecologic cancer; Phase 1; Prognosticator; Survival; Toxicity