Combination of Two Medicines Helps Ease Chemotherapy-Induced Nausea Better Than Standard Treatments

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Nausea – a sick feeling in your stomach that makes you feel like you have to vomit – is a common and very distressing side effect of chemotherapy to treat breast cancer. Doctors call vomiting and/or retching “emesis.”

While there are medicines available to help ease chemotherapy-induced nausea, researchers are always looking for treatments that are more effective than what we have right now.

Three studies have found that a new combination of two medicines, netupitant and Aloxi (chemical name: palonosetron), works better to control chemotherapy-induced nausea and vomiting better than standard anti-nausea treatments.

The studies were published in the July 2014 issue of Annals of Oncology. Read:

The combination of Aloxi (0.50 mg) and netupitant (300 mg) is called NEPA. It comes as a pill taken by mouth.

Aloxi is a standard treatment for nausea and vomiting. It is a type of medicine that blocks the action of serotonin, a chemical made by the body that may cause nausea and vomiting.

Netupitant is an experimental medicine that blocks the action of another chemical, called Substance P, made by the body that also may cause nausea and vomiting.

For these three studies, the researchers wanted to know if NEPA would control nausea and vomiting caused by chemotherapy better than Aloxi alone, as well as the most effective dose of netupitant in NEPA.

The first study listed above was the largest of the three studies. It involved 1,455 people diagnosed with cancer who had never been treated with chemotherapy before. More than 97% of the people in the study had been diagnosed with breast cancer. All the people were then treated with a chemotherapy combination of Cytoxan (chemical name: cyclophosphamide) and an anthracycline. Anthracycline chemotherapy medicines are:

  • Adriamycin (chemical name: doxorubicin)
  • Ellence (chemical name: epirubicin)
  • Doxil (chemical name: doxorubicin)
  • daunorubicin (brand names: Cerubidine, DaunoXome)
  • mitoxantrone (brand name: Novantrone)

The researchers randomly assigned the people to receive one of two anti-nausea treatments:

  • a single dose of NEPA plus a 12 mg dose of dexamethasone
  • a single dose of 0.50 mg of Aloxi plus a 20 mg dose of dexamethasone

Dexamethasone is a steroid that relieves inflammation and is also used to treat intestinal disorders.

The goal was for people to have no nausea or vomiting at all (called complete response) for three time points:

  • the first 24 hours after the first cycle of chemotherapy (acute phase)
  • 25 to 120 hours after the first cycle of chemotherapy (delayed phase)
  • 0-120 hours after the first cycle of chemotherapy (overall)

The acute phase results showed:

  • 88.4% of the people treated with NEPA had no nausea or vomiting
  • 85% of the people treated with Aloxi had no nausea or vomiting

The delayed phase results showed:

  • 76.9% of the people treated with NEPA had no nausea or vomiting
  • 69.5% of the people treated with Aloxi had no nausea or vomiting

Overall:

  • 74.3% of the people treated with NEPA had no nausea or vomiting
  • 66.6% of the people treated with Aloxi had no nausea or vomiting

Both groups had about the same amount and severity of side effects. The most common side effects were headache and constipation.

Researchers in the second study listed above wanted to know if NEPA was better than a combination of Aloxi and Emend (chemical name: aprepitant) over multiple chemotherapy cycles.

In this study, 413 people diagnosed with cancer who have never been treated with chemotherapy before were randomly assigned in a 3:1 ratio to get either:

  • a single dose of NEPA plus dexamethasone on the first day of chemotherapy
  • Aloxi and Emend plus dexamethasone for the first three days of chemotherapy

As in the first study, the goal was no nausea or vomiting.

The people in the study completed 1,961 cycles of chemotherapy:

  • 75% of cycles involved chemotherapy medicines that were moderately likely to cause nausea and vomiting
  • 25% of the cycles involved chemotherapy medicines that were highly likely to cause nausea and vomiting

From 0 to 120 hours after the first cycle of chemotherapy:

  • 81% of the people treated with NEPA had no nausea or vomiting
  • 76% of the people treated with Aloxi and Emend had no nausea or vomiting

As more chemotherapy cycles were completed, the people treated with NEPA continued to have less nausea and vomiting compared to people treated with Aloxi and Emend.

As in the first study, both groups had about the same amount and severity of side effects. The most common side effects also were headache and constipation.

In the third study listed above, the researchers wanted to know if a particular dose of netupitant in NEPA was more effective than another.

The researchers randomly assigned 694 people diagnosed with cancer who had never been treated with chemotherapy before to one of five treatments:

  • NEPA with 100 mg of netupitant on the first day of chemotherapy
  • NEPA with 200 mg of netupitant on the first day of chemotherapy
  • NEPA with 300 mg of netupitant on the first day of chemotherapy
  • 0.50 mg of Aloxi on the first day of chemotherapy
  • Emend plus intravenous Zofran (chemical name: ondansetron) for 3 days

All the people also received dexamethasone on the first 4 days of the chemotherapy cycle. The chemotherapy medicines the people were receiving were considered highly likely to cause nausea and vomiting. As with the other two studies, the goal was no nausea or vomiting.

From 0 to 120 hours after the first chemotherapy cycle:

  • 89.6% of the people treated with NEPA with 300 mg of netupitant had no nausea or vomiting
  • 87.6% of the people treated with NEPA with 200 mg of netupitant had no nausea or vomiting
  • 87.4% of the people treated with NEPA with 100 mg of netupitant had no nausea or vomiting
  • 76.5% of the people treated with Aloxi had no nausea or vomiting
  • 86.6% of the people treated with Emend plus Zofran had no nausea or vomiting

As in the other two studies, all five groups had about the same amount and severity of side effects. The most common side effects were headache and hiccups.

While all the doses of NEPA were better than Aloxi alone, NEPA with 300 mg of netupitant offered the most benefits.

NEPA is made by the Helsinn Group and Eisai Inc. The U.S. Food and Drug Administration has accepted the companies’ new drug application for NEPA for review but it hasn’t been approved yet. Because the results of these three studies are so encouraging, the companies are hoping that NEPA will be approved soon.

If you’re experiencing nausea and vomiting from chemotherapy, talk to your doctor. While NEPA isn’t available yet, there are other medicines that can ease your nausea. You also can try these tips to help manage nausea:

  • Eat small amounts of food all day long, so you don’t feel full too quickly.
  • Eat dry foods that are less likely to upset your stomach, such as crackers, toast, and cereal.
  • Stay away from greasy foods that might disagree with your stomach.
  • Sit up after eating -- lying down after meals may disrupt digestion.
  • Rinse your mouth before and after meals to get rid of any bad tastes that may make you nauseated.
  • Ask someone to cook for you or order take-out so you can avoid strong smells that may be unpleasant for you.
  • Consider complementary and holistic techniques such as acupuncture, relaxation, and visualization to reduce nausea.

Visit the Breastcancer.org pages on Nausea and Vomiting for more tips on how to manage these side effects.


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