Fatima Of The Kingdom
AstraZeneca announced this Thursday at a press conference the availability of two new treatment options for patients with Liver cancer (hepatocarcinoma and bile duct cancer). Specifically, it is durvalumab (Imfinzi) + gem-cis followed by durmalumab in manotherapy for the first-line treatment of adults with unresectable or metastatic bile duct canceras well as the new Stride regime Single Tremelimumab Regular Interval Durvalumab), which consists of a single dose of tremelimumab (Imjudo) + durvalumab, followed by durvalumab monotherapy for the first-line treatment of adults with advanced or unresectable hepatocellular carcinoma that improves the rate of overall survival with 1 in 4 patients alive at 4 years.
Dr. Sangro: “Liver cancer is the third cause of death from cancer and the sixth most diagnosed tumor in the world”
In this way, this therapeutic option shows 4-year survival data in the treatment of hepatocellular carcinoma. In the case of bile duct cancer, there are currently few therapeutic options, and few improvements in survival have been achieved in recent decades.
Both drugs available since May and financed by the Ministry of Health, are human monoclonal antibodies: durvalumab binds to the PD-L1 protein and blocks the interaction of PD-L1 with PD-1 and CD80 proteins, counteracting tumor immune evasion tactics and releasing the inhibition of immune responses. For its part, tremelimumab is a human monoclonal antibody of the immunoglobulin G2 type (IgG2a) against cytotoxic T lymphocyte antigen 4 (CTLA-4).
Dr. Sangro: “In Spain, every year about 7,000 new cases of liver cancer are diagnosed”
According to him Dr. Bruno Sangrodirector of the Hepatology Unit of the Clínica Universidad de Navarra and principal investigator in the Ciber of Liver and Digestive Diseases, “Liver cancer is the third cause of cancer death and the sixth most diagnosed tumor worldwide. In Spain, around 7,000 new cases are diagnosed every year.“Sangro added.
For his part, the Dr. Andrés Muñozassistant physician of the Medical Oncology Service of the Gregorio Marañón General University Hospital, Digestive unit and Phase I unit, has detailed that bile duct cancer (CVB) is a group of rare and aggressive gastrointestinal cancers that form in the bile duct cells inside or outside the liver (cholangiocarcinoma) or in the gallbladder that requires new effective treatment alternatives.
Dr. Andrés Muñoz: “It represents 1% of all cancers, because we are talking about a rare tumor”
“It represents 1% of all cancers, because we are talking about a rare tumor. Therefore, the number of cases in Spain is not known.“Muñoz has indicated. In this context, the expert has highlighted that, with the aim of better understanding the disease, a national registration which currently has about 2,000 patients.
Early-stage CVB often presents without clear symptoms, so most new cases of CVB are diagnosed in an advanced stage, when treatment options are limited and the prognosis is poor. Approximately 5 to 15% of patients with CVB survive five years; For patients with metastatic disease, the five-year survival rate drops to less than 5%.
“CVB is a pathology with few therapeutic options and few improvements in survival in recent decades, which requires new effective treatment alternatives. Therefore, this new therapeutic option represents an advance for these patients whose prognosis, unfortunately, remains very adverse. Hence the importance of continuing research and ensuring that innovation reaches patients as soon as possible.“Muñoz pointed out.
Dr. Muñoz: “This new therapeutic option represents an advance for these patients whose prognosis, unfortunately, remains very adverse”
Updated exploratory results from the Phase III Topaz-1 trial showed that this drug, combined with standard chemotherapy treatment, demonstrated a clinically significant benefit in three-year long-term overall survival (OS) in patients with CVB, and They constitute the longest survival follow-up recorded to date in a global randomized phase III trial in this context.
After more than three years (median follow-up of 41.3 months), the results showed that the treatment, added to chemotherapy, reduced the relative risk of death by 26% compared to chemotherapy alone. The median OS was 12.9 months for this treatment plus chemotherapy versus 11.3 months for chemotherapy alone. More than twice as many patients treated with immunotherapy-based treatment were still alive at three years compared to those treated with chemotherapy alone (14.6% vs. 6.9%).
More than twice as many patients treated with immunotherapy-based treatment were still alive at three years compared to those treated with chemotherapy alone
Additionally, the Topaz-1 trial met its primary OS endpoint in October 2021 in a planned interim analysis, showing that the combination reduced the risk of death by 20% versus monotherapy chemotherapy.
Survival rate in hepatocellular carcinoma
About 75% of all primary liver cancers in adults are hepatocellular carcinoma (HCC). More than half of patients are diagnosed in advanced stages of the disease, often when the first symptoms appear. The prognosis of advanced-stage HCC is poor, with a 5-year survival rate of only 3.3%.
Liver diseases that cause chronic inflammation are the most common cause of HCC. The updated 4-year analysis of the Phase III Himalaya trial presents the longest follow-up to date of a Phase III study in unresectable hepatocellular carcinoma. After an additional 17 months of follow-up from the primary analysis, the Stride regimen demonstrated a sustained OS benefit compared with sorafenib.
About 75% of all primary liver cancers in adults are hepatocellular carcinoma
“25.2% of participants were alive 4 years after initiation of treatment with the Stride regimen versus 15.1% with sorafenib. Until now, in the treatment of hepatocellular carcinoma, no therapeutic option had demonstrated this 4-year survival benefit, so having this new resource represents a great advance for patients and a new tool for professionals.“Sangro added.
For Javier Letellez, hospital pharmacist in the oncology area of the Fuenlabrada University Hospital, these two new therapeutic options for patients with liver cancer “represent a great advance. From the Hospital Pharmacy Service, we are happy to be able to offer new therapeutic alternatives, as well as to provide all the information that oncologists and patients need to better understand the available therapeutic arsenal and achieve greater adherence among all. We try to manage the information directed to these patients and the accessibility they have to pharmacists and we are aware that, with oncology patients, the relationship with their needs must be highly personalized,” Letellez concluded.