Predictors of Oncologic Outcome in Patients Receiving Phase I Investigational Therapy for Recurrent or Metastatic Cervical Cancer

Ji Son, Heather Y. Lin, Siqing Fu, Amadeo B. Biter, Ecaterina E. Dumbrava, Daniel D. Karp, Aung Naing, Shubham Pant, Sarina A. Piha-Paul, Jordi Rodon, Vivek Subbiah, Apostolia M. Tsimberidou, Timothy A. Yap, Michael M. Frumovitz, Amir A. Jazaeri, Pedro T. Ramirez, Shannon N. Westin, Ying Yuan, Funda Meric-Bernstam, David S. Hong

Research output: Contribution to journalArticlepeer-review


INTRODUCTION: We aimed to identify clinical, pathologic, and treatment factors that are predictive of response and survival in patients with cervical cancer referred to phase I clinical trials.

METHODS: Patients with cervical cancer who received at least one dose of a phase I investigational agent at our institution between 2014 and 2022 were included. The log-rank test was used to analyze differences in progression-free survival (PFS) and overall survival (OS), and multivariable regression analysis was performed.

RESULTS: We included 65 patients with a median age of 41 years (range, 20-74), 3 prior therapies (range, 1-7), and 67.7% squamous carcinoma. The rate of distant metastasis at trial entry was 84.6%. The most common molecular alterations included PIK3CA (46.5%), PD-L1+ (46.2%), EPH (30.0%), and CREBBP (23.1%); 23.1% had received a prior checkpoint inhibitor. Phase I trials were for immunotherapy (58.5%) or targeted therapy (41.5%). The rate of biomarker matching was 21.5%. For all patients, median PFS was 3.6 months (95% CI, 2.0-5.2) and OS was 9.3 months (95% CI, 7.0-10.6). Factors at study entry associated with worse survival were presence of bone metastasis (PFS 1.6 vs 4.4 months: hazard ratio [HR], 2.8; p = 0.001; OS 3.8 vs 10.0 months: HR, 3.9; p < 0.0001) and absolute lymphocyte count below 1000/μL (PFS 1.8 vs 5.2 months: HR, 2.9; p = 0.0004; OS 7.0 vs 10.6 months: HR, 3.2; p = 0.0009). Factors associated only with worse OS were absolute neutrophil count above 4700/μL, hemoglobin below 10.5 g/dL, and smoking status. Grade 3+ treatment-related adverse events were seen in 16.9% of cases.

CONCLUSION: Bone metastasis and absolute lymphocyte count below normal range at phase I study entry portend poor survival in patients with recurrent or metastatic cervical cancer.

Original languageEnglish (US)
Pages (from-to)10-18
Number of pages9
JournalJournal of Immunotherapy and Precision Oncology
Issue number1
StatePublished - Feb 2023


  • lymphopenia
  • metastatic cervical cancer
  • phase I trial prognosis
  • recurrent cervical cancer

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Oncology
  • Cancer Research


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