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Quantitation of Intra-peritoneal Ovarian Cancer Metastasis
Published on: July 18, 2016
A systematic review of phase I trials in patients with ovarian cancer
Giuliana Pavone1, Federica Martorana1, Vincenza Ricco2
1Department of Clinical and Experimental Medicine, University of Catania, Italy; University Oncology Unit, Humanitas Istituto Clinico Catanese, Misterbianco, Catania, Italy.
Background:
Ovarian cancer (OC) is the leading cause of death among gynecological malignancies, with limited treatment options for advanced and platinum-resistant disease. This systematic review analyzes phase I trials to assess recent therapeutic advancements.
Methods:
We performed a systematic review of phase I trials in OC, published between 2012 and 2023, retrieving data on trial characteristics and outcomes. Studies were classified according to the tested treatment strategies into chemotherapy-only (CO), chemotherapy + non-chemotherapy agents (CNC) and chemotherapy-free (CF).
Results:
78 trials were included, with more than 50 % of them published in the last four years. Overall, chemotherapy and immunotherapy were the most investigated agents. Fourteen trials (17.9 %) evaluated a CO strategy, 42 (53.8 %) a CNC combination and 22 (28.2 %) a CF therapy. Dose-limiting toxicities and toxic deaths were observed in 71 % and 100 % of CO studies, in 45.2 % and 21 % of CNC trials and in 37.4 % and 13.6 % of CF trials, respectively. CNC regimens outperformed the other treatment types in terms of efficacy outcomes, including overall response rate (11.5 % CO; 32.2 % CNC; 25.5 % CF), clinical benefit rate (40 % CO; 62 % CNC; 52 % CF) and median progression free survival (mPFS 5.9 months CO; 6.45 months CNC; 4.85 months CF). Trials enrolling platinum resistant or agnostic patients displayed worse clinical outcomes.
Conclusions:
In the last years, there has been an increasing number of phase 1 trials assessing new agents and new combinations in patients with OC. Chemotherapy-free strategies display a more favorable safety profile, while regimens combining CNC agents seem to be more effective compared to CO approaches.
Insights
New ovarian cancer treatments are emerging, with chemotherapy + non-chemotherapy combinations showing the best efficacy. Chemotherapy-free options offer better safety, guiding future ovarian cancer therapy development.
Area of Science:
- Oncology
- Clinical Trials
- Gynecologic Malignancies
Background:
- Ovarian cancer (OC) is a leading cause of gynecologic cancer death.
- Limited treatment options exist for advanced and platinum-resistant OC.
- Phase I trials are crucial for assessing novel therapeutic advancements.
Purpose of the Study:
- To systematically review phase I trials in ovarian cancer.
- To analyze recent therapeutic advancements and treatment strategies.
- To evaluate the efficacy and safety of different treatment regimens.
Main Methods:
- Systematic review of phase I trials in ovarian cancer (2012-2023).
- Classified studies into chemotherapy-only (CO), chemotherapy + non-chemotherapy (CNC), and chemotherapy-free (CF) strategies.
- Extracted data on trial characteristics, outcomes, toxicities, and efficacy.
Main Results:
- 78 trials were included, with a recent increase in publications.
- Chemotherapy and immunotherapy were the most investigated agents.
- CNC regimens demonstrated superior efficacy (ORR 32.2%, CBR 62%, mPFS 6.45 months) compared to CO and CF.
- CF strategies showed a more favorable safety profile with lower toxicity rates.
Conclusions:
- Phase I trials for ovarian cancer are increasingly evaluating novel agents and combinations.
- Chemotherapy-free strategies offer improved safety.
- Combining chemotherapy with non-chemotherapy agents (CNC) appears more effective than chemotherapy-only approaches for ovarian cancer.
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