Treatment of Colorectal and Stomach Cancer with Lonsurf (Trifluridine and Tipiracil)

Which cancers is Lonsurf used for, and how does it work?

Lonsurf (active ingredients trifluridine and tipiracil) received approvals for colorectal cancer in 2015, and stomach and gastroesophageal junction cancer in 2019 from the US Food and Drug Administration (FDA). However, it has not yet been licensed by the Ministry of Health in Turkey. If its use is desired, an off-label approval application must first be made to the Ministry of Health. If approval is granted, it must be obtained from abroad through the Turkish Pharmacists' Association, with the cost covered by the patient.

Mechanism of action

Trifluridine is designed to kill cancer cells or slow their growth. Tipiracil slows the body's ability to break down trifluridine, allowing it to stay in the body longer and affect more colon cancer cells.

The goal of treatment with Lonsurf

Lonsurf (trifluridine and tipiracil) is given to shrink colorectal, stomach and gastroesophageal tumors or reduce symptoms caused by these cancers. It is not given with the aim of a cure (complete recovery) and is used only in advanced colorectal, stomach and gastroesophageal cancers that have previously received multiple lines of treatment.

Lonsurf administration, dose and schedule

Lonsurf (trifluridine and tipiracil) is taken in the morning and evening only on days 1, 2, 3, 4, 5 and 8, 9, 10, 11, 12 of a 28-day treatment period; no medication is taken on the remaining days.

Take each dose one hour after a meal (breakfast and dinner).

Lonsurf (trifluridine and tipiracil) is repeated every 28 days. Treatment continues until it no longer works or unacceptable side effects occur.

Note: Your doctor will calculate your morning and evening medication dose based on your height and weight.

Lonsurf side effects

In clinical trials, the most frequently reported side effects of Lonsurf (trifluridine and tipiracil) were as follows:

Decreased red blood cell count [anemia] (77%)

Decreased white blood cell count [neutropenia] (67%)

Nausea (48%); decreased platelet count (blood platelets that enable clotting) [thrombocytopenia] (42%)

Decreased appetite (39%)

Increased blood bilirubin levels [a sign of liver damage] (36%)

Fatigue (35%)

Diarrhea (32%)

Increased liver enzymes in the blood [a sign of liver damage] (24-30%)

Vomiting (28%)

Abdominal pain (21%)

Fever (19%)

Weakness (18%)

Increased blood creatinine levels [a sign of kidney damage] (13%)

Mouth sores (8%)

Neutropenic fever (4%)

Redness, blisters and peeling skin on the palms and soles (2%)

Note: On average, 4% of patients discontinue Lonsurf (trifluridine and tipiracil) treatment because of unacceptable side effects.

Follow-up

How often is follow-up needed?

Blood tests should be checked every 28 days before starting a new treatment cycle. The blood tests needed are a complete blood count (hemogram) and a comprehensive metabolic panel (biochemistry). Other blood tests may be added as recommended by the doctor. A CA19-9 (a tumor marker) blood test may usually be checked at the start of treatment and then every eight weeks to determine whether the chemotherapy drugs are working.

How often is radiological imaging needed?

Imaging is performed before treatment, at certain intervals during treatment and at the end of treatment. Magnetic resonance imaging (MRI), computed tomography (CT) and positron emission tomography (PET/CT) are among the imaging methods used.

How do blood test or imaging results affect treatment?

Depending on the results, your doctor may continue Lonsurf (trifluridine and tipiracil) as planned, change its dose or change the treatment.

Points to consider

Your medication dose is calculated based on your height and weight. You may need to take tablets of two different strengths to obtain your total dose of Lonsurf (trifluridine and tipiracil). Read the label carefully to make sure you take the correct number of Lonsurf (trifluridine and tipiracil) tablets of each strength.

Patients aged 65 and older may experience decreased red blood cell, white blood cell and platelet counts more frequently than patients younger than 65.

Your oncology pharmacist should ALWAYS review your medication list to ensure that drug interactions are appropriately prevented or managed.

Individual medication label information

Lonsurf is an oral tablet sold in two different strengths: 15 mg trifluridine / 6.14 mg tipiracil and 20 mg trifluridine / 8.19 mg tipiracil

Take it at the same times each day with a large glass of water, 1 hour after eating.

If you forget to take a dose, skip it and take the next dose at the scheduled time. Do not make up the missed dose.

Store your medication at room temperature.

Dose adjustment may be needed because of low blood counts.

It may cause fetal harm if taken during pregnancy. Use an effective method of birth control during treatment and for at least 3 months afterward. Do not breastfeed during treatment or for at least one day after the last dose.