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Needleless Chemotherapy: Safety and Efficacy of Aerosolized Chemotherapy Being Studied in Young Patients with Cancerby Ann SuttonNo one enjoys getting a shot, and intravenous therapy can be even more traumatic for children, who may not fully understand why they must be stuck, sometimes repeatedly, with a needle. The development of the first corticosteroid inhaler in 1972 was a welcome change for patients with asthma, mostly children, who had previously been treated with oral epinephrine and intravenous aminophylline. Patients with cancer in the lung may soon experience a similar change in treatment—needleless chemotherapy that is almost as easy as breathing. Researchers in the Division of Pediatrics at The University of Texas M. D. Anderson Cancer Center are investigating the safety and efficacy of delivering chemotherapy drugs via aerosol inhalation in pediatric patients. “Clearly, once we’ve improved the technology, giving aerosol is going to be a lot easier on children than us constantly having to stick something in their arms,” said Eugenie S. Kleinerman, M.D., division head and professor of pediatrics. Eventually, she said, “aerosol therapy could even be given at home, just like we treat asthma.” Benefits of aerosolized therapy If aerosol delivery is determined to be as safe and effective as intravenous delivery, treating disease at home would be one of its main advantages. In addition to eliminating the pain of needles, home-based aerosol therapy would allow the patient to avoid frequent trips to the hospital or clinic. “That’s what patients would like to not have to do. It interferes with their lives,” said Cynthia E. Herzog, M.D., an associate professor in the Division of Pediatrics. Another benefit would be that aerosol delivery allows more of the drug to be absorbed than oral or intravenous delivery does because of the lung’s large surface area (an adult lung has the same surface area as a tennis court). Drugs are sometimes absorbed faster when administered by inhalation than by subcutaneous injection. The most obvious benefit will be in treating patients with any kind of cancer in the lungs. “I think anything that goes to the lung can be treated, whether it’s lung cancer, melanoma that goes to the lung, sarcoma, or Wilms’ tumor—anything that’s in the lung,” said Dr. Kleinerman. Researchers have found that patients receiving aerosolized chemotherapy experience fewer side effects because more of the drug stays in the lungs at the tumor site and less is distributed systemically. “By giving the therapy by aerosol, we can get higher concentrations [of the drug] in the lung, where the tumor is, and we can get less of a spillover effect in the blood,” said Dr. Kleinerman. Current research Dr. Herzog is principal investigator on a phase I/II trial investigating the effectiveness of aerosolized rubitecan (9-nitrocamptothecin) in the treatment of patients 10 to 25 years of age with any kind of cancer that has spread to the lungs. Rubitecan is an oral semisynthetic topoisomerase I inhibitor that has been studied in the treatment of pancreatic cancer. The drug is not water soluble, so it must be encapsulated in liposomes to allow it to travel through the bloodstream. Liposomal formulations of various insoluble drugs have been found to have potent antitumor effects in nude mice when administered intravenously, with no serious side effects. The rubitecan will be administered from a nebulizer through a face mask while the patient sits under a scavenging tent to contain the drug. Scavenging tents are similar to oxygen tents; air is drawn up from the bottom and filtered to remove any drug particles that escape the nebulizer or face mask. Patients breathe in the therapy for 30 minutes, after which they take a break before continuing for another 30 minutes. This schedule is repeated five days a week for four weeks, after which the patients are given a week’s rest. In a previous phase I study conducted at M. D. Anderson, 25 patients (ages 33 to 84 years) with primary lung cancer and other kinds of cancer that had spread to the lungs underwent aerosol therapy with rubitecan. Researchers determined that the drug could be administered safely at a dosage of 13.3 µg/kg/day, five days a week for eight of every 10 weeks. A few of the most common adverse effects were cough, nausea, and fatigue. The dose-limiting toxicities were chemical pharyngeal mucositis and fatigue. If toxic effects no worse than grade 2 were found, the patient was allowed to continue the treatment at home with a portable air compressor. Future applications Theoretically, any agent could be delivered via aerosol. Dr. Kleinerman is currently researching the delivery of gemcitabine via aerosol in her laboratory. Researchers at M. D. Anderson are also investigating aerosol delivery of paclitaxel and polyethyleneimine with the p53 gene, which is mutated or altered in many human cancers. Some researchers believe that gene therapy will be able to significantly increase the long-term survival of patients with lung cancer—something that surgery, radiation therapy, and chemotherapy have not been able to do for years—but developing aerosolized gene therapy—like any gene therapy—is challenging, requiring extra caution to prevent spillover into the environment. “That’s not ready for prime time,” said Dr. Kleinerman. “I’d say probably the chemotherapy, the aerosolized gemcitabine, is closer to being tested in the clinic than any of the gene therapy investigations.” Aerosolized therapy is not new, but its use in treating cancer is cutting edge. “We’re at the end of the diving board, and we’re jumping off,” said Dr. Kleinerman. “Whether there will be water in the pool is the question.” “I think there’s water in the pool; it’s a question of how deep,” suggested Dr. Herzog. For more information on this topic or for questions about M. D. Anderson’s treatments, programs, or services, call askMDAnderson at (877) MDA-6789. Other articles in OncoLog, September 2004 issue:
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