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Cervical cancer
2022-RA-262-ESGO Predictors of oncologic outcome in recurrent cervical cancer patients receiving phase 1 cancer therapy
  1. Ji Son1,
  2. Heather Y Lin2,
  3. Siqing Fu3,
  4. Ecaterina E Dumbrava3,
  5. Daniel D Karp3,
  6. Aung Naing3,
  7. Shubham Pant3,
  8. Sarina A Piha-Paul3,
  9. Jordi Rodon3,
  10. Vivek Subbiah3,
  11. Apostolia M Tsimberidou3,
  12. Timothy A Yap3,
  13. Michael M Frumovitz1,
  14. Amir A Jazaeri1,
  15. Pedro T Ramirez1,
  16. Shannon N Westin1,
  17. Ying Yuan2,
  18. Funda Meric-Bernstam3 and
  19. David S Hong3
  1. 1Gynecologic Oncology and Reproductive Medicine, MD Anderson Cancer Center, Houston, TX
  2. 2Department of Biostatistics, MD Anderson Cancer Center, Houston, TX
  3. 3Department of Investigational Cancer Therapeutics, MD Anderson Cancer Center, Houston, TX

Abstract

Introduction/Background Few treatment options exist in recurrent cervical cancer, which makes phase 1 clinical trials a compelling option. In order to identify candidates for referral, we analyzed factors predictive of response and survival in cervical cancer patients referred to phase 1 trials.

Methodology Cervical cancer patients who received at least 1 cycle of a phase 1 agent between 2014–2022 were retrospectively reviewed. Clinical and pathologic data were abstracted, Log-rank test was used to test the difference in progression-free survival (PFS) and overall survival (OS). Multivariable regression analysis was performed for predictors of response and survival.

Results 65 patients met eligibility. At trial entry, patient characteristics included the following median (range) values: age 41 years (20,74), 3 prior therapies (1,7), and 5-month progression-free interval before trial (1,32). 67.7% had squamous carcinoma, 27.7% adenocarcinoma, 4.5% other. The rate of distant metastasis was 84.6%. The most common alterations included PIK3CA (46.5%), PDL1+ (46.2%), EPH (30.0%), and CREBBP (23.1%). 23.1% received a prior check point inhibitor. The phase 1 trials were immunotherapy (58.5%) and targeted therapy (41.5%). In all, objective response rate was 10.8%, median PFS 3.6 months, and OS 9.3 months. On multivariable analysis of significant covariates, factors at study entry that were associated with worse survival were the presence of bone metastasis (PFS 1.6 vs 4.4 months, HR 2.8; OS 3.8 vs 10.0 months, HR 3.9; both p<0.001), and absolute lymphocyte count (ALC) <1k/μl (PFS 1.8 vs 5.2 months, HR 2.9; OS 7.0 vs 10.6 months, HR 3.2; both p<0.0009). Other factors associated only with negative OS were Hb<11g/dl, absolute neutrophil count>4.7k/μl, and current or former smoking status. The rate of grade 3+ treatment-related adverse events was 16.9%.

Abstract 2022-RA-262-ESGO Figure 1
Abstract 2022-RA-262-ESGO Figure 1

Conclusion The presence of bone metastasis and ALC below normal range at phase 1 study entry portend poor survival in recurrent cervical cancer patients.

https://doi.org/10.1136/ijgc-2022-ESGO.16

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