The most common gastrointestinal tumors in the world are esophageal cancers. A recent article in DovePress reports that the malignancy is also the eighth most common worldwide. In China alone, 324,000 new cases were reported and alarmingly, there were 301,000 deaths from esophageal cancer.
The study was conducted at the Radiation Oncology Department, Zhengzhou University Hospital, Henan China.
The study investigated the safety and feasibility of anlotinib monotherapy to treat metastatic esophageal squamous cell carcinoma (ESCC). It can be described as a real-world study.
Real-world data come from a variety of sources rather than the standard clinical trials. Sources may include databases of insurance claims, medical billings, or patient registries. The databases play a critical role in healthcare decisions.
About the Study
Eighty-three patients who had advanced ESCC and who received the anlotinib monotherapy were enrolled in the study.
The hospital’s electronic records system documented patients’ demographic characteristics, treatment efficacy, and any adverse reactions. All patients had regular monthly follow-ups.
Progression-free survival was the primary endpoint. The secondary endpoints were the objective response rate (response to treatment), overall survival, disease control rate, and as aforementioned, safety and analysis of Progression-free survival associated with adverse reactions.
- Stable disease was observed in fifty-one patients
- Seven patients had a partial response
- Progressive disease occurred in twenty-five patients
The most common adverse events were fatigue, hypertension, weight loss, diarrhea, and hand-foot syndrome.
The researchers concluded that the study found that anlotinib monotherapy showed tolerable toxicity and promising efficacy.
The team suggested the potential for hypertension to be used as a biomarker as it can predict the progression-free survival of ESCC patients.
An East/West Discrepancy
The researchers acknowledged the difference between esophageal adenocarcinoma which is the most common esophageal disease in the West. Esophageal squamous cell carcinoma (ESCC) constitutes ninety-five percent of China’s esophageal cancers.
Therefore, the highest and best use strategies for ESCC would not be used for esophageal adenocarcinoma.
Then and Now
Most ESCC patients are initially diagnosed with either metastatic (spreading) or advanced disease.
For the past several decades, ESCC patients were primarily treated with chemotherapy. Currently, a first-line combination of cisplatin (chemotherapy) plus fluorouracil (5-FU administered topically) for ESCC patients brought about overall survival of ten months.
Cisplatin may be combined with paclitaxel for overall survival of about twelve months.
Docetaxel, irinotecan, or paclitaxel had been available for the past several decades as second-line chemotherapy yielded an overall survival of over seven months.
About Immune Checkpoint Inhibitors
When certain proteins bind together, they send out an “off” signal to T cells. This prevents the T cells from killing cancer.
Immune checkpoint inhibitors block the proteins from sending out the “off” signal thus giving T cells free rein to kill the cancer.
Pembrolizumab is an effective immune checkpoint inhibitor that blocks the programmed death receptor-1 (PD-1). Improvement was seen with the introduction of the PD-1 blockade plus chemotherapy.
However, therapeutic options remain limited, causing an urgent need for effective regimens.
Anlotinib is a tyrosine kinase inhibitor (TKI) that attacks cancer cells while minimizing damage to normal cells.
According to the results of Phase II ALTER1102 clinical trial, anlotinib shows promising efficacy for ESCC patients.
The current study investigated progression-free survival as well as the safety and feasibility of anlotinib for ESCC patients. The study analyzed anlotinib-induced hypertension.
Anlotinib had been approved three years ago in China. Therefore, since many patients had already received anlotinib monotherapy, it seemed feasible to include these patients in the clinical trial. The primary endpoint of the trial was progression-free survival.
Anlotinib was given orally with an initial dosage of either 10mg or 12mg daily for two weeks. The treatment was halted for one week, thus completing a three-week therapeutic cycle.
The cycle continued until the disease progressed or the patient experienced adverse reactions that became intolerable. Also, dose adjustments were made in accordance with the patient’s tolerance.
Patients were contacted by telephone through a monthly follow-up system.
- Partial response was observed in seven patients
- Stable disease was found in fifty-one patients
- Progressive disease was observed in twenty-five patients
With respect to PFS data, sixty-five deaths and disease progression events occurred. However, a few patients did benefit from the anlotinib administration, as their lesions showed significant shrinkage.