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Treatment Name: Gemcitabine (Gemzar®) + Cisplatin

Gemcitabine (Gemzar®) + Cisplatin is a Chemotherapy Regimen for Bladder Cancer

How does gemcitabine + cisplatin work?
Each of the medications in the gemcitabine and cisplatin (also known as gem/cis) regimen are designed to kill or slow growth of bladder cancer cells.

Goals of therapy:
Cisplatin plus gemcitabine is given to shrink tumors and decrease symptoms from bladder cancer. It can be given either after surgery to eliminate microscopic cells, or it can be given before surgery to shrink the size of the tumor and minimize the size of the surgery.

If there is no metastatic disease (cancer is limited to bladder only and not other parts of the body), cisplatin plus gemcitabine are commonly given with the goal of cure.

If metastatic disease is present (cancer has spread beyond the bladder to other areas of the body), cisplatin and gemcitabine are not commonly given with the goal of cure, but rather to shrink tumors, decrease symptoms from bladder cancer, and prolong life.

Schedule

Every 28-Day Regimen Schedule

  • Gemcitabine intravenous (I.V.) infusion over 30 minutes on Days 1, 8, and 15
  • Cisplatin I.V. infusion over 1 hour on Day 2 (or Day 1, if recommended by your Doctor)

Every 21-Day Regimen Schedule

  • Gemcitabine I.V. infusion over 30 minutes on Days 1 and 8
  • Cisplatin I.V. infusion over 1 hour on Day 2 (or Day 1, if recommended by your Doctor)

Estimated total infusion time for this treatment:

  • Up to two hours for Day 1 of each cycle; as short as one hour for Days 8, and 15 of each cycle
  • Typically, I.V. hydration is given both before and after cisplatin and can add up to two hours on Day 1
  • 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

Gemcitabine (Gemzar) and cisplatin are usually given in an outpatient infusion center, allowing the person to go home afterwards. On occasion, they may be given in the hospital if someone is too sick.

Gemcitabine + cisplatin is repeated every 21 or 28 days. This is known as one cycle. Each cycle may be repeated up to four times if the disease is not metastatic. If the disease is metastatic, then each cycle may be repeated up to 6 times. Duration of therapy depends upon response, tolerability, and number of cycles prescribed.

Click here for the common gemcitabine and cisplatin 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 gemcitabine plus cisplatin side effects are shown here:

On average, 13% of patients discontinue gem/cis treatment due to unacceptable side effects.

Side effect videos Side Effect Videos
Nausea and VomitingNausea and VomitingBleedingBleedingAnemiaAnemiaDiarrheaDiarrheaPainPain

Monitoring

How often is monitoring needed?
Labs (blood tests) may be checked before each treatment and periodically in-between treatments. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), magnesium, alkaline phosphatase, plus any others your doctor may order.

How often is imaging needed?
Imaging may be checked before treatment, at the completion of treatment, or as often as every 2 cycles during treatment at your doctor’s discretion. 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 gemcitabine + cisplatin as planned, reduce the doses, delay or switch therapy. Gemcitabine doses may be reduced or treatment may be delayed for a low platelet count or a low neutrophil count. Cisplatin doses may be reduced or treatment may be delayed nerve pain, hearing loss, or kidney problems.

ChemoExperts Tips

  • Cisplatin can possibly damage the kidneys. Be sure to maintain good hydration to lessen the risk of experiencing kidney damage
  • Depending on the results of blood tests (labs) you may need extra I.V. infusions of magnesium or potassium. This can make your total infusion time for the day increase by 2 hours or more. It is best to start this regimen early in the day if extra infusions are common for you
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
  • Clinical trials may exist for bladder cancer. 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 Gemcitabine (Gemzar®) + Cisplatin, 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 Gemcitabine (Gemzar®) + Cisplatin. Depending upon your income, they may be able to help cover the cost of:

  • Gemcit­abine
  • Cisplatin

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 Gemcitabine (Gemzar®) + Cisplatin 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 Gemcitabine (Gemzar®) + Cisplatin

Individual Drug Label Information

Gemcit­abine (Gemzar®)

  • Gemcitabine is an intravenous infusion
  • Toxicity is increased with infusion time greater than one hour or dosing more than once per week
  • Liver and kidney function should be monitored regularly to minimize toxicity
  • Dosage adjustments may be required for low white blood cells, low platelets, or liver dysfunction
  • Known to cause fetal harm; this drug should be avoided during pregnancy 
General gemcitabine (Gemzar) side effects
  • Low red and white blood cells
  • Low blood platelets
  • Fever
  • Nausea & vomiting
  • Increased liver enzymes and toxicity
  • Diarrhea
  • Bleeding
  • Skin rash
  • Pins and needles tingling & pain in hands and feet
  • Hair loss
  • Kidney problems and fluid retention
  • Although rare, can cause serious lung injury or shortness of breath
  • Click on the gemcitabine (Gemzar) package insert below for reported side effects and possible drug interactions

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaHair LossHair LossBleedingBleedingPainPainAnemiaAnemiaNeutropenic FeverNeutropenic Fever

See DailyMed package insert.

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.

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References

1) Dogliotti L, Cartenì G, Siena S, et al. Gemcitabine plus cisplatin versus gemcitabine plus carboplatin as first-line chemotherapy in advanced transitional cell carcinoma of the urothelium: results of a randomized phase 2 trial. Eur Urol. 2007;52:134-141.

2) von der Maase H, Sengelov L, Roberts JT, et al. Long-term survival results of a randomized trial comparing gemcitabine plus cisplatin, with methotrexate, vinblastine, doxorubicin, plus cisplatin in patients with bladder cancer. J Clin Oncol. 2005;23:4602-4608.

Created: March 27, 2017 Updated: March 27, 2017

What is Bladder Cancer?

A disease of the cells that line the inside of the bladder. Bladder cancer is a rare disease that is most commonly seen in older adults. It is known to cause blood in the urine in up to 90% of patients at diagnosis. Causes of bladder cancer include smoking, exposure to certain chemicals (arylamines), and chronic bladder infections.

Treatment includes surgery (full or partial removal of the bladder), chemotherapy, immunotherapy (giving certain vaccines into the bladder), or thermotherapy (heating the lining of the bladder combined with chemotherapy). The stage of bladder cancer can vary at diagnosis and throughout treatment. Bladder cancer is staged using the Tumor, Node, Metastasis (TNM) system, as well as Stage Grouping 0, I, II, III, or IV. Staging systems describe the extent of cancer throughout the body and help doctors determine which treatments to offer. 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 Chemotherapy given AFTER surgery called?

Chemotherapy given after surgery is also known as “adjuvant” therapy.

What is Chemotherapy given BEFORE surgery called?

Chemotherapy given before surgery is known as “neoadjuvant” therapy.

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, doctors use 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 gemcitabine and cisplatin starting doses

Every 28-Day Regimen Schedule

  • Gemcitabine 1000 mg/m2 intravenous (I.V.) infusion over 30 minutes on Days 1, 8, and 15
  • Cisplatin 70 mg/m2 I.V. over one hour on Day 2

Every 21-Day Regimen Schedule

  • Gemcitabine 1250 mg/m2 I.V. over 30 minutes on Days 1 and 8
  • Cisplatin 70 mg/m2 I.V. over one hour on Day 2

NOTE: the gemcitabine doses differ between the 28-Day and 21-Day regimens. In addition, some physicians may recommend cisplatin to be given on Day 1 instead of Day 2.

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

Clinical Studies

If you are interested in reading the clinical trials results, please click on reference below:

1) Dogliotti L, Cartenì G, Siena S, et al. Gemcitabine plus cisplatin versus gemcitabine plus carboplatin as first-line chemotherapy in advanced transitional cell carcinoma of the urothelium: results of a randomized phase 2 trial. Eur Urol. 2007;52:134-141.

2) von der Maase H, Sengelov L, Roberts JT, et al. Long-term survival results of a randomized trial comparing gemcitabine plus cisplatin, with methotrexate, vinblastine, doxorubicin, plus cisplatin in patients with bladder cancer. J Clin Oncol. 2005;23:4602-4608.

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