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Prof. Dr. Mustafa Özdoğan · Medical Oncologist

Attention Patients with Stage 4 (Metastatic) Stomach Cancer!

Attention Patients with Stage 4 (Metastatic) Stomach Cancer!
In this article

Ramucirumab (Cyramza), a new option after progression following treatment, is available in our country through compassionate early access.

Stomach canceris often diagnosed late in developed countries and ours. Across all stages, only %30 survive 5 years or longer. In advanced (4.), metastatic stomach cancer, treatment aims to improve life quality and survival. Adding taxanes to Cisplatin and 5 Fluorouracil (5FU) has extended survival. Among targeted treatments, Trastuzumab, known in breast cancer, benefits only %20 of gastric patients.

Aggressive biology and low success make stomach cancer especially in need of new treatments

Recently, drugs disrupting tumor-feeding vessels have received FDA approval and entered international use. In stomach cancer, two studies published in 2014 first found the tumor-vessel-disrupting drug Ramucirumab effective. Both involved previously treated patients with progression, using it alone or with Paclitaxel chemotherapy. In the first, RAINBOW, after initial chemotherapy (Cisplatin+5FU), 665 advanced gastric cancer patients with progression were divided into two groups: Ramucirumab-Paclitaxel combination or Paclitaxel alone. Disease control and survival were significantly longer with Ramucirumab.

A survival difference around 2 months may seem short but was considered meaningful in this difficult cancer, leading to FDA approval in America in 2014.

In the second study, REGARD, 355 patients whose disease progressed with treatment were divided into two groups. Ramucirumab alone was compared with placebo, an inactive treatment, producing significantly longer disease control and survival.

These successful studies showed a new drug would enter routine gastric cancer practice

Our country began compassionate early access for Ramurcirumab. Eligible patients can obtain it following Ministry of Health application. Those progressing after advanced gastric treatment and fit for further therapy can discuss it with their oncologists.

What Is a Compassionate Early Drug Access Program?

It allows company-supplied free medicines approved abroad but not locally for life-threatening illness after failure of locally approved treatments and no trial access. Ministry of Health approval is required.

Further information is available in the Ministry of Health General Directorate of Pharmaceuticals and Pharmacy’s Compassionate Early Access Guideline.

Sources

FDA Approval for Ramucirumab.
https://www.cancer.gov/about-cancer/treatment/drugs/fda-ramucirumab#anchor-combo
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