Testimony of the National Coalition for Cancer Research
House Committee on Energy and Commerce Health Subcommittee Hearing:
 "Examining the Increase in Drug Shortages."

September 23, 2011

 


Another residual impact of drug shortages is the delay in obtaining the data necessary to bring new cancer therapeutics to patients. With more than 400 cancer agents in various stages of development, it is imperative that cancer clinical trials continue uninterrupted in order to obtain the necessary data to seek approval of new anti-cancer drugs as soon as possible.






  • According to the Coalition of Cancer Cooperative Groups, approximately half of all active cooperative group cancer clinical trials have at least one drug on the shortages list.

  • Cooperative Group research sites report they are unable to enroll patients in certain clinical trials, even though the patients meet protocol eligibility requirements, due to the lack of an existing cancer drug being used in the clinical trial.

  • Due to a shortage of the drug doxorubicin, two important clinical trials have been delayed. These clinical trials were designed to test this drug in combination with novel agents in patients with Advanced Recurrent Epithelial Ovarian Cancer and those with Hepatocellular Carcinoma of the liver, which is one of the most common tumors in the world and is a leading cause of cancer deaths.

  • A shortage of the drug paclitaxel has resulted in delaying the enrollment of eligible lung cancer patients into clinical trials. Furthermore, the shortage of paclitaxel may result in current clinical trial participants being removed from the study.

  • Daunorubicin is a chemotherapy treatment for children and adults with Acute Lymphoblastic Leukemia and Acute Myelogenous Leukemia. In one adult trial, a comprehensive cancer center in Alabama reported that, although a patient was eligible to participate in a study, they had no daunorubicin at the center. Drug substitutions are not allowed for this study, so they were unable to enroll the patient into the study.

  • The Children's Oncology Group reports difficulties in obtaining daunorubcin for its pediatric Acute Lymphoblastic Leukemia studies. In one trial, a substitution is allowed by the National Cancer Institute when no drug is available; however, the substitution is more toxic, resulting in increased risk for patient harm and side effects.

  • According to the American Cancer Society, the 5-year relative survival rate for all cancers diagnosed between 1999 and 2006 is 68%, up from 50% in 1975-1977.

  • The National Cancer Institute estimates that approximately 11.7 million Americans with a history of cancer were alive in January 2007.

  • The 5-year relative survival rate for female breast cancer patients has improved from 63% in the early 1960s to 90% today. The survival rate for women diagnosed with localized breast cancer (cancer that has not spread to lymph nodes or other locations outside the breast) is 98%.

  • For all childhood cancers combined, the 5-year relative survival rate has improved markedly over the past 30 years, from less than 50% before the 1970s to 80% today.

 




Addendum to testimony of the National Coalition for Cancer Research House Committee on Energy and Commerce Health Subcommittee Hearing:
"Examining the Increase in Drug Shortages."

September 23, 2011

  • One large phase III trial compares outcomes for lung cancer patients given an accepted standard treatment (either carboplatin and paclitaxel or carboplatin, paclitaxel, and bevacizumab) and patients given the same treatment plus an additional drug - cetuximab. A research site in Lexington, KY reports not being able to offer participation in this clinical trial because the center cannot guarantee availability of paclitaxel to these patients.

  • No daunorubicin in supply at a research site in Birmingham, Alabama led to physicians being unable to enroll a patient with Acute Myeloid Leukemia in a cooperative group protocol, and there was no substitution allowed.

  • Standard initial treatment for children with Acute Myeloid Leukemia, which has a survival rate of between 50-60%, involves the drug daunorubicin, which is in short supply.

  • A cancer center in Boston, MA almost missed an opportunity for one of its patients to participate on the trial due to the shortage of daunorubicin. Fortunately, the patient was randomized to the clofarabine arm of the trial. If the patient had been randomized to the daunorubicin arm, the center may not have been able to keep the patient on study due to the daunorubicin shortage. Until the drug shortage is resolved, the center may not be able to continue to accrue patients onto this trial.

  • The same center reports that lack of availability of paclitaxel, one of the drugs used in a clinical trial, has been affected by this drug shortage and substitution for paclitaxel is not allowed for this study. If the paclitaxel supply is expected within three weeks from the planned date of treatment, treatment can be delayed for those three weeks by the participating clinical trial sites. After a three-week delay, participating clinical trial sites are asked to remove patients from the study. Until the shortage of paclitaxel is resolved, the center may not be able to accrue patients to this trial because of uncertainty over drug supply.

  • Shortage of drug daunorubicin for a cooperative group are impacting a study testing a new therapy for patients (ages 18-60) with newly diagnosed Acute Myeloid Leukemia, as reported by a research site in Pittsburgh, PA, where drug has not been available since June I, 2011.

  • A cancer center in St. Louis, MO reports that a clinical trial for breast cancer that has had scientific approval for over two months, but has not begun because the clinical trial involves a study drug in combination with doxorubicin. Due to the shortage of doxorubicin, the investigator is rewriting the trial protocol to change the doxorubicin to another drug. This will delay final approval and activation of the study, which delays this treatment option for its patients.

  • Due to the national shortage and allocation of doxorubicin, a cancer center in Tampa, FL has had to limit accmal to a study involving patients with Advanced Recurrent Epithelial Ovarian Cancer. It has also been extremely difficult to obtain sufficient supplies of doxorubicin for patients that were previously enrolled in the trial prior to the shortage. One of its active patients is currently on the "waiting list" to receive an allocation of the drug.

  • The Albuquerque, NM, cancer center recently lost 21 breast cancer patients to accrual to a cooperative group trial due to the lack of doxorubicin. The trial is exploring improved treatment methods for women with breast cancer who have a high risk of recurrence. This same research site was unable to enroll an additional 19 patients to other trials for breast, melanoma or ovarian cancer primarily due to the doxorubicin and doxorubicin shortages.

  • A research site in Lombard, IL reported shortages of 5FU and Taxol. The site had three patients with stage 3 colon cancer eligible for a cooperative group study, who were not able to go on protocol due to the shortage of 5FU. In another study involving 5FU a center in St. Louis, MO reported a 5FU shortage that impacted one of its active colon trials. The investigator is working on adding language allowing capecitabine to be substituted for 5FU.

  • Shortages of Taxol reported by a research site in Wheeling, WV, had led to loss of patient accrual to a cooperative group study for patients with inoperable non-small cell lung cancer, stage III. The site seeks to ensure that supply will be available prior to placing patients on study, and the pharmacy at the site is advising that it cannot guarantee supply.

  • The same location in Wheeling, WV reported shortage of Taxol had led to loss of patient accrual in a cooperative group study testing a second line treatment for patients with metastatic esophageal or GE (gastro-esophageal) junction cancer. Adenocarcinoma of the esophagus and the gastro-esophageal junction is reportedly one of the fastest rising malignancies.

  • Without Taxol, 5FU, or Leucovorin, many patients have been unable to participate in trials at a research site in Columbus, OH. Access to drug varies with hospitals in this community network, but priority in the shortage is given to the adjuvant patient population. The site is now getting Taxol in but it is not promised to study patients at this time nor can the site assure its physicians that if they start a patient that there will be enough of the drug for the entire treatment plan.

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