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Treatment Name: Cisplatin + Vinorelbine (Navelbine®)

Cisplatin + Vinorelbine (Navelbine®) is a Chemotherapy Regimen for Lung Cancer, Non-Small Cell Lung Cancer (NSCLC)

How does cisplatin + vinorelbine work?
Cisplatin and vinorelbine are chemotherapy drugs designed to kill lung cancer cells and prevent the lung cancer cells from dividing into new cells.

Goals of therapy:
Cisplatin + vinorelbine chemotherapy is given to shrink tumors and improve symptoms of lung cancer. It is typically given to patients as first-line adjuvant or neoadjuvant therapy with the goal of cure.

Schedule

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  • Cisplatin intravenous (I.V.) infusion over 60 minutes on Days 1 and 8
  • Vinorelbine I.V. infusion over 5 to 10 minutes on Days 1, 8, 15, and 22

OR

  • Cisplatin I.V. infusion over 60 minutes on Day 1
  • Vinorelbine I.V. infusion over 5 to 10 minutes on Days 1, 8, 15, and 22

Estimated total infusion time for this treatment:

  • Up to 2 hours for days when both cisplatin and vinorelbine are gieven; as short as 1 hour when only vinorelbine is given
  • Infusion times are based on clinical studies, but may vary depending on doctor preference or patient tolerability. Pre-medications and intravenous (I.V.) fluids, such as hydration, may add more time

Cisplatin + vinorelbine chemo is usually given in an outpatient infusion center, allowing the person to go home afterwards. On occasion, it may be given in the hospital if someone is too sick for outpatient treatment.

Cisplatin + vinorelbine is repeated every 28 days. This is known as one Cycle. Each cycle may be repeated up to 4 times, depending upon the stage of the disease. Duration of therapy may last up to four months, depending upon response, tolerability, and number of cycles prescribed.

Click here for the common cisplatin + vinorelbine starting doses.

Side Effects

In a multi-drug regimen, each medication has unique side effects. When these medicines are given together, drug-related side effects reported in clinical studies give the best estimate of what to expect. In clinical studies, the most commonly reported cisplatin + vinorelbine side effects are shown here. Side effects sometimes have percentage ranges [example: 55-71%] because they differed between clinical studies:

  • Low red blood cells [Anemia] (78-93%)
  • Low white blood cells [Neutropenia] (88-92%)
  • Weakness (82%)
  • Fatigue (81%)
  • Nausea (80%)
  • Weight loss (55-71%)
  • Hair loss (32-57%)
  • Vomiting (48%)
  • Pain, numbmess, or tingling in finger or toes (48%)
  • Constipation (45-47%)
  • Infection (22-32%)
  • Low platelets [Thrombocytopenia] (14-32%)
  • Weakness or trouble with movement of arms and legs (15-28%)
  • Diarrhea (16-23%)
  • Hearing loss (21%)
  • Shortness of breath (18%)
  • Elevation in liver blood tests (18%)
  • Elevation in kidney blood tests (16%)
  • Neutropenic fever (7-9%)

On average, 16% of patients discontinue treatment due to unacceptable side effects.

Side effect videos Side Effect Videos
Fatigue Fatigue Nausea and VomitingNausea and VomitingAnemiaAnemiaPainPainConstipationConstipationHair LossHair LossDiarrheaDiarrheaNeutropenic FeverNeutropenic Fever

Monitoring

How often is monitoring needed?
Labs (blood tests) may be checked before each chemotherapy treatment. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), blood magnesium levels, plus any others your doctor may order.

How often is imaging needed?
Imaging may be checked before chemo treatment, during treatment if there are concerns for disease progression or chemo side effects, or at the end of treatment to determine response to treatment. Imaging may include: X-rays, magnetic resonance imaging (MRI), computerized tomography (CT) scans, or positron emission tomography (PET) scans.

How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to continue cisplatin + vinorelbine as planned, reduce the dose of future treatments, delay the next dose until the side effect goes away, or switch to an alternative therapy.

ChemoExperts Tips

  • Cisplatin chemotherapy can possibly damage the kidneys. Any damage is usually reversible. Your doctor will monitor your blood for signs of any kidney damage and may give intravenous fluid to help protect your kidneys before or after cisplatin therapy. If you feel dehydrated, tell your doctor
  • Vinorelbine chemotherapy may cause significant constipation, which could lead to a blockage in the intestines. If you are experiencing constipation, taking daily medications such as senna + docusate and MiraLAX® can help avoid constipation
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
  • Clinical trials may exist for NSCLC. Ask your doctor if any studies are currently enrolling in your area. If not, go to clinicaltrials.gov to search for other centers offering study medications

Patient Assistance & Co-payment Coverage

Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for Cisplatin + Vinorelbine (Navelbine®), we have provided links that may help.

Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for Cisplatin + Vinorelbine (Navelbine®). Depending upon your income, they may be able to help cover the cost of:

  • Cisplatin
  • Vinorelbine

For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.

  • If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.

Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as Cisplatin + Vinorelbine (Navelbine®) and are the best source to help you understand drug cost.

  • Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.

Emotional Wellness

What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.

Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.

Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.

Learn more about pursuing emotional wellness while receiving treatment with Cisplatin + Vinorelbine (Navelbine®)

Individual Drug Label Information

Cisplatin (Platinol®)

  • Cisplatin is an intravenous (I.V.) infusion that is typically given over one to two hours
  • Cumulative toxicity to kidneys from cisplatin can be severe 
  • Other toxicities from multiple doses are:  low blood counts, nausea, vomiting, and hearing loss
  • Dosage adjustments may be required for poor kidney function or bone marrow toxicity (low blood counts) 
  • Cisplatin is hazardous to a human fetus; women should avoid pregnancy while on this drug 
  • Women should not breast-feed while on cisplatin; it has been reported to be in human milk 
  • Patients on anticonvulsant drugs may have decreased levels while on cisplatin 
General Cisplatin (Platinol) Side Effects 
  • Kidney problems (nephrotoxicity), especially in elderly patients. 
  • Nausea and vomiting, both acute (within first 24 hours) and delayed (two to five days after infusion) 
  • Diarrhea 
  • Low blood cell counts (myelotoxicity, acute leukemia)
  • Hearing problems- ringing ears.  All patients should have a baseline hearing test done.  All children should have hearing test done before each dose and for several years after therapy is complete 
  • Low blood electrolytes:  magnesium, potassium, calcium, sodium, and phosphate
  • Nerve pain 
  • Vision problems; improvement and/or complete recovery usually occurs after stopping therapy 
  • Liver toxicity; recovery usually occurs after stopping therapy 
  • Click on the cisplatin (Platinol) package insert below for reported side effects and possible drug interactions

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaFatigue Fatigue PainPainAnemiaAnemiaNeutropenic FeverNeutropenic Fever

See DailyMed package insert.

Vinorelbine (Navelbine®)

  • ​Is an intravenous infusion
  • Has a FDA Black Box Warning for very low red blood cells, white blood cells, and platelets
  • Vinorelbine MUST only be given by intravenous infusion. May NOT be administered any other way
  • Dosage adjustments may be required for poor liver function or low blood cell counts during treatment
  • May interact with certain antifungal and seizure medications
  • May interact with grapefruit and grapefruit juice causing increased blood levels of vinorelbine. This could increase your risk of experiencing side effects. Avoid eating grapefruit and drinking anything containing grapefruit juice during treatment 
  • Avoid therapy with St. Johns Wort as it will decrease blood levels of vinorelbine and could decrease its effectiveness
  • Can cause fetal harm if given while pregnant. Females should use effective contraception while receiving vinorelbine. Males should use effective contraception while receiving vinorelbine and for at least 3 months after the last dose
  • Talk to your doctor about the risks of breastfeeding while receiving vinorelbine

General side effects from vinorelbine (Navelbine®)
  • Livery injury
  • Constipation
  • Tingling and numbness in fingers or toes
  • Lung injury
  • Nausea and vomiting
  • Weakness
  • Leakage into skin or surrounding muscle may cause severe irritation (extravasation)
  • Click on the vinorelbine (Navelbine®) package insert below for reported side effects, possible drug interactions, and other vinorelbine prescribing information

Side Effect Videos
Nausea and VomitingNausea and VomitingConstipationConstipationPainPainAnemiaAnemia

See DailyMed package insert.

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References

1) Winton T, Livingston R, Johnson D, et al. Vinorelbine plus cisplatin vs. observation in resected non-small-lung cancer. N Engl J Med. 2005;352:2589-2597.

2) Arriagada R, Bergman B, Dunant A, et al. The International Adjuvant Lung Cancer Trial Collaborative Group. Cisplatin-based adjuvant chemotherapy in patients with c completely resected non-small cell lung cancer. N Engl J Med. 2004;350:351-360.

3) Douillard JY, Rosell R, De Lena M, et al. Adjuvant vinorelbine plus cisplatin versus observation in patients with completely resected stage IB-IIIA non-small-cell lung d cancer (Adjuvant Navelbine International Trialist Association [ANITA]): a randomised controlled trial. Lancet Oncol. 2006;7:719-727.

Created: March 12, 2019 Updated: June 26, 2019

What is Lung Cancer, Non-Small Cell Lung Cancer (NSCLC)?

What is Non-Small Cell Lung Cancer?
A disease of the tissue found in the lung.  Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. Known causes include smoking and exposure to environmental toxins.  The stage of NSCLC can vary at diagnosis and throughout treatment.  Stages include stage I, II, III, and IV.  The effectiveness of the treatment may depend upon the stage at diagnosis.

NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose which therapy is appropriate for you.

What is Adjuvant Chemotherapy?

Adjuvant chemotherapy is given after surgical removal of the primary cancer tumor. The goal of adjuvant chemotherapy is to target microscopic cancer cells that may remain after surgical removal of the primary tumor to help prevent recurrence of the disease.

What is Neoadjuvant Chemotherapy?

Neoadjuvant chemotherapy is given before surgery or radiation with the goal of shrinking the primary cancer tumor to make either surgical removal of the tumor or radiation of the tumor easier.

What does Cure mean?

The word “cure” means there are no cancer cells left in the body and cancer will never come back. Depending on the cancer type and stage, this may be the true goal of therapy. However, it is very difficult to prove all cancer cells are gone. Even though images, like X-rays and MRI’s, and blood tests may not show any signs of cancer, there can be a small amount of cancer cells still left in the body. Because of this, the word “remission” is used more often. This means there are no signs or symptoms of cancer. Patients in remission are followed closely for any signs of cancer returning. Sometimes, more chemotherapy may be given while in remission to prevent the cancer from coming back.

Doctors usually do not consider a patient “cured” until the chance of cancer returning is extremely low. If cancer does return, it usually happens within 5 years of having a remission. Because of this, doctors do not consider a patient cured unless the cancer has not come back within 5 years of remission. The five-year cutoff does not apply to all cancers.

Common Cisplatin + Vinorelbine starting doses

  • Cisplatin 50 mg/m2 intravenous (I.V.) infusion over 60 minutes on Days 1 and 8
  • Vinorelbine 25 mg/m2 I.V. infusion over 5 to 10 minutes on Days 1, 8, 15, and 22
                                                    OR
  • Cisplatin 100 mg/m2 I.V. infusion over 60 minutes on Day 1
  • Vinorelbine 30 mg/m2 I.V. infusion over 5 to 10 minutes on Days 1, 8, 15, and 22

Note: Individual doses may vary based upon your Doctor's recommendation, or drug availability.

Clinical Studies

1) Winton T, Livingston R, Johnson D, et al. Vinorelbine plus cisplatin vs. observation in resected non-small-lung cancer. N Engl J Med. 2005;352:2589-2597.

2) Arriagada R, Bergman B, Dunant A, et al. The International Adjuvant Lung Cancer Trial Collaborative Group. Cisplatin-based adjuvant chemotherapy in patients with c completely resected non-small cell lung cancer. N Engl J Med. 2004;350:351-360.

3) Douillard JY, Rosell R, De Lena M, et al. Adjuvant vinorelbine plus cisplatin versus observation in patients with completely resected stage IB-IIIA non-small-cell lung d cancer (Adjuvant Navelbine International Trialist Association [ANITA]): a randomised controlled trial. Lancet Oncol. 2006;7:719-727.

What is a CBC?

A Complete Blood Count (CBC) is a frequently ordered blood test that tells clinicians the status of your: 1) White blood cell count, 2) Hemoglobin, and 3) Platelet count at the time the test was taken.

Common uses:
1) White blood cell count (WBC): is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.

2) Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.

3) Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.

What is a CMP?

A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.

Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

Calcium:
14) Serum calcium