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Chemotherapy means the treatment of a disease with the use of chemical agents. In the context of cancer, chemotherapy involves the administration of drugs that are designed to destroy cancer cells by stopping them from growing or multiplying. Healthy cells can also be harmed, especially those that divide quickly. Harm to healthy cells is what causes side effects.
Nearly every chemotherapy drug used in the treatment of children’s cancers is toxic. In addition, some are also known carcinogens. Incredibly, very few of these drugs have been FDA approved for children. Nonetheless, they are routinely used to treat pediatric cancer. Below are some examples. The sources of this information include: the FDA, Physicians Desk Reference (2002), U.S. Department of Health and Human Services National Toxicology Program Report on Carcinogens, and the International Agency for Research on Cancer (IARC) Toxic? Yes. “Cumulative renal toxicity associated with [Cisplatin] is severe…Ototoxicity which may be more pronounced in children, and is manifested by tinnitus, and/or loss of high frequency hearing and occasionally deafness, is significant.” Carcinogenic?
Yes. Cisplatin was listed as “Reasonably Anticipated to
be a Human Carcinogen” in the Eighth Report on Carcinogens published
by the U.S. Department of Health and Human Services. FDA approved
only for metastatic testicular cancer, metastatic ovarian cancer and transitional
cell bladder cancer. Carboplatin Toxic? Yes. “Loss of vision…has been reported…” Carcinogenic? Unknown. “The carcinogenic potential of carboplatin has not been studied… Carboplatin has been shown to be mutagenic both invitro and invivo.” FDA Approved for Children? No. Not FDA approved for children. According to the manufacturer, “Safety and effectiveness in pediatric patients have not been established.” FDA approved only for ovarian cancer.
Toxic? Yes. “[Cyclophosphamide] may cause sterility in both sexes…Serious, sometimes fatal, infections may develop in severely immunosuppressed patients.” Carcinogenic? Yes. Cyclophosphamide was listed as a “Known Human Carcinogen” by the First Annual Report on Carcinogens published by the U.S. Department of Health and Human Services in 1980. FDA Approved for Children? FDA approved for malignant lymphomas, leukemias, retinoblastoma and adenocarcimoma.
Toxic? Yes. “Myelosuppression resulting in death has been reported.” Carcinogenic? Yes. “[Etoposide] should be considered a potential carcinogen in humans.” FDA Approved for Children? No. Not FDA approved for children. According to the manufacturer, “Safety and effectiveness in pediatric patients have not been established.” FDA approved only for small cell lung cancer and testicular tumors.
Toxic? Yes. “Dosages within and minimally above the recommended therapeutic doses have been associated with potentially life-threatening hematopoietic toxicity.” Carcinogenic?
Yes. “Thiotepa is known to be a human carcinogen based on studies
in humans which indicate a causal relationship between exposure to thiotepa
and human cancer (reviewed in International Agency for Research on Cancer FDA Approved for Children? No. Not FDA approved for children. According to the manufacturer, “Safety and effectiveness in pediatric patients have not been established.” FDA approved only for treating breast cancer.
Toxic? Yes. In pre-marketing tests, 26 out of 112 adults had fever/grade 4 neutropenia and 2 out of 112 died from sepsis (i.e. infection). “Labels Required: Poison… Death from septicemia and hemorrhage has occurred as a direct result of hematopoietic depression …Exposure to this compound may also result in the development of acute nonlymphocytic leukemia.” Carcinogenic? Unknown. “Carcinogenicity testing of topotecan has not been performed. Topotecan, however, is known to be genotoxic to mammalian cells and is a probable carcinogen.” FDA Approved for Children? No. Not FDA approved for children. According to the manufacturer, “Safety and effectiveness in pediatric patients have not been established.” FDA approved only for treating metastatic ovarian cancer and small cell lung cancer.
Toxic? Yes. “Several instances of convulsions followed by coma have been reported in pediatric patients. Transient cortical blindness and optic atrophy with blindness have been reported.” “Labels Required: Poison…This compound is highly toxic and may be fatal if inhaled, swallowed or absorbed through the skin.” Carcinogenic? Unknown. “Neither invivo nor invitro laboratory tests have conclusively demonstrated the mutagenicity of this product.” FDA Approved
for Children? FDA approved only for treating Wilm’s tumor and
leukemias.
Besides being toxic, carcinogenic and not approved for children, some chemotherapy drugs and drug combinations have proven to be ineffective in the treatment of some pediatric cancers. Despite this knowledge, some oncologists continue to use the same drugs in the treatment of the same cancers. Below is one example: Topotecan Effective? Below are two studies that demonstrate that the chemotherapy drug called “Topotecan” is “inactive” or has “insufficient activity” in pediatric central nervous system tumors: “Topotecan administered as a 24-hour infusion every 21 days is inactive in high grade gliomas, medulloblastomas, and brain stem tumors.” (emphasis added)
“It was concluded that topotecan as given according to this schedule showed insufficient activity to promote it to frontline protocol usage.” (emphasis added)
Despite the fact that “Topotecan” has been called “inactive” or has “insufficient activity” in pediatric central nervous system tumors, it is still being used in children with the same cancers. St. Jude Children’s Research Hospital has labeled Topotecan as “new,” “promising,” and “active” despite the fact that this hospital has participated in the studies that called it “inactive” and showing “insufficient activity.”
And a national study involving many pediatric hospitals is currently recruiting children with brain tumors in order to administer topotecan directly into their spines.
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