Abstract
Aims and methods
This multicenter retrospective study aims to evaluate the correlations between Body Weight Loss (BWL), Body Mass Index (BMI) and clinical outcomes (ORR, PFS, and OS) of advanced gastric cancer (aGC) patients treated with second-line ramucirumab-based therapy in a “real-life” setting.
Results
From December 2014 to October 2018, 101 consecutive aGC patients progressed to a first-line chemotherapy were treated with ramucirumab alone (10.9%) or in combination with paclitaxel (89.1%). Median BMI was 21.2 kg/m2 and mBWL since first-line treatment commencement was 4.5%. Among 53 patients who underwent primary tumor resection (PTR), 73.6% experienced BWL, while 26.4% did not experience BWL (p = 0.0429). Patients who underwent PTR had a significantly higher probability of experiencing BWL (yes vs no) [OR = 2.35 (95% CI 1.02–5.42), p = 0.0439]. Among the 89 evaluable patients, ORR was 26.9% (95% CI 17.2–40.1). At a median follow-up of 17.3 months, mPFS was 5.4 months (95% CI 3.6–6.8) and mOS was 8.7 months (95% CI 7.3–11.9). In the multivariate analysis, only ECOG-PS and BMI were confirmed independent predictors for shorter PFS [HR = 1.69 (95% CI 1.01–2.82), p = 0.04] [HR = 1.97 (95% CI 1.12–3.46), p = 0.01] and OS [HR = 1.69 (95% CI 1.01–2.83), p = 0.04] [HR = 2.08 (95% CI 1.17–3.70), p = 0.01].
Conclusion
Efficacy of ramucirumab is confirmed in this “real-life” analysis. BWL seems not to have correlations with clinical outcomes in these patients, while BMI and ECOG-PS remain major prognostic factors. A possible explanation for the lack of prognostic effect of BWL might be the proportion of patients subjected to PTR in this series (52.5%).
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Availability of data and materials
The data sets used during the present study are available from the corresponding author upon reasonable request.
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This work was supported by the Consorzio Interuniversitario Nazionale per la Bio-Oncologia (CINBO).
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Dr Alessio Cortellini received grants as speaker by MSD, Astra-Zeneca and Boehringer Ingelheim, gran consultancies by BMS, Roche, Novartis, Istituto Gentili and Ipsen.
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All patients provided informed consent to participate in this observational non-interventional study.
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The procedures followed were in accordance with the precepts of Good Clinical Practice and the Declaration of Helsinki. The study was conducted following the rules of the local bioethical committee competent on human experimentation (Comitato etico per le province di L’Aquila e Teramo).
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Parisi, A., Cortellini, A., Roberto, M. et al. Weight loss and body mass index in advanced gastric cancer patients treated with second-line ramucirumab: a real-life multicentre study. J Cancer Res Clin Oncol 145, 2365–2373 (2019). https://doi.org/10.1007/s00432-019-02971-7
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DOI: https://doi.org/10.1007/s00432-019-02971-7