Outcomes of patients with metastatic cervical cancer in a phase I clinical trials program.
BACKGROUND
We evaluated clinical outcomes of patients with metastatic cervical cancer referred to a Phase I Clinical Trials Program.


METHODS
We reviewed the electronic medical records of 54 consecutive phase I patients with metastatic cervical cancer over 6.5 years and analyzed the correlation between clinical outcome and potential predictors.


RESULTS
All patients had received at least one systemic therapy for metastatic disease before referral. Only two patients declined phase I trial therapy. The median progression-free (PFS) and overall (OS) survivals were 3.6 and 10.6 months, respectively. Patients harboring phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PIK3CA) mutations or phosphatase and tensin homolog loss, and those with more than two sites of metastasis who received more than one prior systemic chemotherapy before the referral had median PFS of 6.7 and 1.8 months, and median OS of 12.6 and 2.9 months, respectively.


CONCLUSIONS
Patients with more than two metastatic sites who had received more than one prior system therapy had dismal outcomes. An aberrant PI3K pathway was frequently identified and associated with favorable outcome, providing a promising target.
Department of Investigational Cancer Therapeutics, Unit 0455, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX 77030, U.S.A. siqingfu@mdanderson.org.
Ming-Mo
MM
Hou
Xiaochun
X
Liu
Jennifer
J
Wheler
Aung
A
Naing
David
D
Hong
Diane
D
Bodurka
Kathleen
K
Schmeler
Apostolia
A
Tsimberidou
Filip
F
Janku
Ralph
R
Zinner
Sarina
S
Piha-Paul
Chung-Yuan
CY
Hu
Karen
K
Lu
Razelle
R
Kurzrock
Siqing
S
Fu
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use; D058534:Class I Phosphatidylinositol 3-Kinases; D017321:Clinical Trials, Phase I as Topic; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D009362:Neoplasm Metastasis; D019869:Phosphatidylinositol 3-Kinases / Q000235:genetics; D012189:Retrospective Studies; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality* / Q000473:pathology; D055815:Young Adult
D000970:Antineoplastic Agents; D019869:Phosphatidylinositol 3-Kinases; D058534:Class I Phosphatidylinositol 3-Kinases; C484760:PIK3CA protein, human
Cervical cancer; PIK3CA mutation; PTEN loss; outcome analysis; phase I trial