Dataset Information

Time to progression ratio in cancer patients enrolled in early phase clinical trials: time for new guidelines?

ABSTRACT:

Background

Reliable evaluation of treatment benefit in early phase clinical trials is necessary. The time to progression ratio (TTPr), which compares successive TTP in a single patient, is a powerful criteria for determining targeted or immune therapies efficacy.

Methods

We evaluated 205 TTPr in a large cohort of 177 advanced cancer patients enrolled in at least two Phase 1/1b trials (out of 2827 phase 1/1b-treated patients) at Gustave Roussy.

Results

This first wide description of TTPr showed that, under the hypothesis of overall absence of treatment line effect, the median TTPr was 0.7 and that 25% of patients presented a TTPr above the conventional efficacy threshold of 1.3.

Conclusions

A higher median TTPr and a larger proportion of patients above the 1.3 threshold should therefore be achieved to conclude to drug efficacy. New guidelines for TTPr interpretation and calibration are proposed, which warrant independent prospective validation.

SUBMITTER: Watson S

PROVIDER: S-EPMC6203755 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Publications

Time to progression ratio in cancer patients enrolled in early phase clinical trials: time for new guidelines?

Watson Sarah S Menis Jessica J Baldini Capucine C Martin-Romano Patricia P Michot Jean-Marie JM Hollebecque Antoine A Armand Jean-Pierre JP Massard Christophe C Soria Jean-Charles JC Postel-Vinay Sophie S Paoletti Xavier X

British journal of cancer 20181017 8

<h4>Background</h4>Reliable evaluation of treatment benefit in early phase clinical trials is necessary. The time to progression ratio (TTPr), which compares successive TTP in a single patient, is a powerful criteria for determining targeted or immune therapies efficacy.<h4>Methods</h4>We evaluated 205 TTPr in a large cohort of 177 advanced cancer patients enrolled in at least two Phase 1/1b trials (out of 2827 phase 1/1b-treated patients) at Gustave Roussy.<h4>Results</h4>This first wide descri ...[more]

PMID: 30327567

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Project description:BackgroundInterstitial lung disease (ILD) encompasses a heterogeneous group of disorders sharing pathophysiological inflammatory mechanisms, leading to parenchymal distortions. The prevalence of ILD with new cancer drugs is underreported: the identification of potential determinants is priority.Materials and methodsILDE is a retrospective study aimed at describing the clinical course and potential determinants of ILD in patients receiving experimental treatments.ResultsWe identified 226 eligible patients, of whom 5.3% (n = 12) had ILD. In five patients, the diagnosis was radiological, while seven patients had initial cough, dyspnea, fatigue or fever. ILD was graded as grade 1 (G1) in four, G2 in five and G3 in three patients. The first occurrence of ILD resolved completely in 50% of patients (n = 6/12). No patient had fatal ILD. Eight patients (66.7%) resumed the treatment after the first episode of ILD, while four patients (33.3%) had to discontinue the therapy. Five out of six patients had resolved the first ILD episode and then resumed treatment, experiencing a second ILD episode (n = 5/6; 83.3%). The second ILD event was G1 in three patients and G2 in two patients, resulting in three patients who eventually discontinued the treatment (n = 3/5; 60%). Correlation analysis showed a higher risk of ILD in older patients (P = 0.051), those who had received previous chest radiation therapy (P = 0.047) or those receiving antibody-drug conjugates (P = 0.006). In a survival analysis adjusted for immortal time bias, ILD was not independently prognostic (hazard ratio 0.50, 95% confidence interval 0.23-1.09, P = 0.082).ConclusionsIn ILDE, patients experiencing ILD had generally good outcomes, and many could resume the cancer treatments. Implementing best practices to prompt diagnosis and management of ILD is critical to treat a potentially severe adverse effect of new drugs, while not affecting patients' outcomes. Research efforts to identify risk factors is warranted, to implement risk-based monitoring schedules and develop ad hoc strategies to improve the cure rates of ILD.

Dataset Information

Time to progression ratio in cancer patients enrolled in early phase clinical trials: time for new guidelines?

Background

Methods

Results

Conclusions

Publications

Time to progression ratio in cancer patients enrolled in early phase clinical trials: time for new guidelines?

Similar Datasets

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