Law Offices of Thomas J. Lamb

  • Free Case Evaluation
  • Mesothelioma & Asbestos Diseases
  • Legal Compensation
  • Asbestos Overview
  • Common Questions
  • About Our Firm

Gemcitabine with or without ramucirumab as second-line treatment for malignant pleural mesothelioma (RAMES): a randomised, double-blind, placebo-controlled, phase 2 trial

October 21, 2021 By Thomas Lamb

Background:  There is a preclinical rationale for inhibiting angiogenesis in mesothelioma. We aimed to assess the efficacy and safety of the anti-VEGFR-2 antibody ramucirumab combined with gemcitabine in patients with pretreated malignant pleural mesothelioma [ as a second-line treatment ].

Methods:  RAMES was a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial done at 26 hospitals in Italy. Eligible patients were aged 18 years or older, had Eastern Cooperative Oncology Group performance status 0–2, and histologically proven malignant pleural mesothelioma progressing during or after first-line treatment with pemetrexed plus platinum. Patients were randomly assigned (1:1) to receive intravenous gemcitabine 1000 mg/m2 on days 1 and 8 every 3 weeks plus either intravenous placebo (gemcitabine plus placebo group) or ramucirumab 10 mg/kg (gemcitabine plus ramucirumab group) on day 1 every 3 weeks, until tumour progression or unacceptable toxicity. Central randomisation was done according to a minimisation algorithm method, associated with a random element using the following stratification factors: ECOG performance status, age, histology, and first-line time-to-progression. The primary endpoint was overall survival, measured from the date of randomisation to the date of death from any cause [ with this second-line treatment ]. Efficacy analyses were assessed in all patients who had been correctly randomised and received their allocated treatment, and safety analyses were assessed in all patients who received at least one dose of their assigned treatment. This trial is registered with ClinicalTrials.gov, NCT03560973, and with EudraCT, 2016-001132-36.

Findings:  Between Dec 22, 2016, and July 30, 2018, of 165 patients enrolled 161 were correctly assigned and received either gemcitabine plus placebo (n=81) or gemcitabine plus ramucirumab (n=80). At database lock (March 8, 2020), with a median follow-up of 21·9 months (IQR 17·7–28·5), overall survival was longer in the ramucirumab group (HR 0·71, 70% CI 0·59–0·85; p=0·028). Median overall survival was 13·8 months (70% CI 12·7–14·4) in the gemcitabine plus ramucirumab group and 7·5 months (6·9–8·9) in the gemcitabine plus placebo group. Grade 3–4 treatment-related adverse events were reported in 35 (44%) of 80 patients in the gemcitabine plus ramucirumab group and 24 (30%) of 81 in the gemcitabine plus placebo group. The most common treatment-related grade 3–4 adverse events were neutropenia (16 [20%] for gemcitabine plus ramucirumab vs ten [12%] for gemcitabine plus placebo) and hypertension (five [6%] vs none). Treatment-related serious adverse events were reported in five (6%) in the gemcitabine plus ramucirumab group and in four (5%) patients in the gemcitabine plus placebo group; the most common was thromboembolism (three [4%] for gemcitabine plus ramucirumab vs two [2%] for gemcitabine plus placebo). There were no treatment-related deaths.

Interpretation:  Ramucirumab plus gemcitabine significantly improved overall survival after first-line standard chemotherapy, with a favourable safety profile. This combination could be a new option [ as a second-line treatment ] in this setting.

[View article at original source]


 Asbestos & Mesothelioma Information

  Asbestos-Mesothelioma Case Evaluation
Free.  Confidential.  No Obligation.

Filed Under: Medicine, Mesothelioma Tagged With: malignant pleural mesothelioma (MPM), mesothelioma, mesothelioma treatments

Do I Have A Possible Case?

If you have a possible asbestos disease or mesothelioma lawsuit, you can get a free, confidential, and no obligation case review from asbestos lawyer Tom Lamb.

Main Navigation Menu

  • Who Was Exposed to Asbestos
  • NC Asbestos Exposure Sites
  • Asbestos-Contaminated Talc
  • Asbestos Diseases
  • Legal Compensation
  • Free Case Evaluation
  • Frequently Asked Questions
  • About Our Law Firm
  • Attorney Tom Lamb
  • Collection of Articles
  • Sitemap

Attorney Tom Lamb

TJL@LambLawOffice.com

Phone: 800-426-9535

Lumina Station, Suite 225
1908 Eastwood Road
Wilmington, North Carolina

Please know that you can use our Quick Contact Form to tell us about your case.

Lamb Law Office Newsletter

Lamb Law Office Newsletter provides periodic updates about some of the cases that we are working on for clients, as well as an information resource you might find helpful.

Subscribe using Form below.

Subscription Form

* indicates required

Our Other Website

Lamb Law Office

Contact Information

Law Offices of Thomas J. Lamb, P.A.
1908 Eastwood Road, Suite 225
Wilmington, North Carolina 28403
910-256-2971 | 800-426-9535
TJL@LambLawOffice.com

  • Home
  • Disclaimer and Copyright Notices
  • Sitemap

Copyright © 2023 · Law Offices of Thomas J. Lamb, P.A.