Colorectal cancer is the second leading cause of malignancy-related death in the U.S. It accounts for more than 10% to 15% of all cancer deaths. Every year about 150,000 new cases in the U.S. and about one million cases worldwide are diagnosed.
After a 46-day priority review, the Food and Drug Administration (FDA) approved oxaliplatin (Eloxatin, Sanofi-Synthelabo) as an injection to treat patients with col-orectal cancer that has recurred or progressed following six months of completion of first-line therapy with bolus infusional 5-fluorouracil (5-FU) and leu-covorin (LV) plus irinotecan (Camptosar, Pharmacia). Oxaliplatin will be administered in combination with 5-FU/LV. Approval was based on response rate and interim analysis showing improved time to radiographic progression.
At this time, no results have demonstrated a clinical benefit, such as improvement of disease-related symptoms or increased survival.
A new breast cancer treatment uses an unusual method of administering chemotherapy— patients soak their breasts in hot water, which forces the chemotherapy drugs that are encapsulated in liposomes to release most of their contents into the breast tissue. The liposomal packaging melts above the usual body temperature (in this study, 104° F).
The encapsulation allows delivery of 30 times more of the drug to the breast tissue, without poisoning the rest of the body, according to researchers who reported on their study at the annual meeting of the American Society of Clinical Oncology. The 12-week, phase I trial of doxorubicin encased in liposomes (Myocet, The Liposome Company Inc.) and paclitaxel (Taxol, Bristol-Myers Squibb Company) is the only clinical trial of its kind in the U.S.
Of the 21 patients with newly diagnosed, large invasive breast tumors, 33% had complete remission; 17% were able to have lumpec-tomy instead of mastectomy, and 11% had complete pathologic responses. Tumor growth was arrested in all women in the study and half of the women had at least partial tumor shrinkage, even though many of the tumors were initially inoperable. Moreover, the researchers observed that nausea, fatigue, and cardiac tox-icity were lower than with traditional chemotherapy.
The study reversed the usual order of surgery, followed by chemotherapy and radiation. After a traditional infusion of chemotherapy, patients underwent hyperthermia drug treatments every three weeks for four cycles, followed by the least invasive surgery needed to remove the tumor. Additional chemotherapy and radiation might be needed postoperatively, the researchers say.
A new study gives Americans over age 50 one more reason not to put off having a colonoscopy to check for colon cancer and its forerunners. The screening technique not only is excellent at detecting problems but also appears to be far more cost-effective for most people than new cancer-preventing drugs will probably ever be.
Researchers at the University of California, San Francisco, and the University of Michigan Health System used a computer model to compare the cost-effectiveness of colonoscopy and other screening procedures for colon cancer with that of COX-2 inhibitors, a class of drugs used to treat arthritis but also considered promising in preventing colon cancer.
The data suggest that the drugs are unlikely to be as effective—dollar for dollar—as colonoscopy in cutting cancer death risk for those with average colon cancer risk. Screening plus drugs was most effective but was even more costly.
Two other studies reportedly found that even aspirin had only a modest effect on preventing colon polyps and predicted that aspirin’s effectiveness in reducing colorectal cancer risk would never be superior to the life-saving effect of colon-oscopy.
For an average-risk person, it would cost $20,200 to save one life-year through colonoscopy screening but $233,300 to save the same life-year through COX-2 inhibitors. Even for a person with a higher risk of colon cancer, a colon-oscopy once every five years would still cost less and save more years of life than a daily drug. But the difference was smaller: $3,900 per life-year saved through screening every 10 years or $6,200 for screening every five years, versus $80,300 for drug therapy.
The Food and Drug Administration (FDA) has announced the accelerated approval of gefitinib (IressaTM, Astra-Zeneca) tablets as a single-agent treatment for patients with advanced non-small cell lung cancer (NSCLC), the most common form of lung cancer in the U.S. Cancer of the lung and bronchus is the leading cause of cancer death in men and women in the U.S. NSCLC accounts for almost 80% of lung cancers.
The drug is intended for patients whose cancer has continued to progress despite chemotherapy with platinum and docetaxel (Taxotere®, Aventis), the two drugs that are currently the standard of care for this disease.
The drug was developed to block growth stimulatory signals in cancer cells. These signals are mediated, in part, by enzymes called tyrosine kinases. The drug blocks several of these tyrosine kin-ases, including one associated with epidermal growth factor receptor (EGFR).
In theory, clinicians who treat patients with advanced colorectal cancer can extend treatment indefinitely because of the low cumulative toxicity associated with therapy. However, researchers from the Medical Research Council Colorectal Cancer Group advise that it is safe to stop chemotherapy and then restart the treatment. In fact, doing so can enhance quality of life without compromising survival. In a study of 354 patients with chemo-sensitive, advanced colorectal cancer , chemotherapy was safely stopped after 12 weeks …
The U.S. Food and Drug Administration (FDA) has approved bevacizumab (Avastin™, Genentech) as a first-line treatment for patients with metastatic colorectal cancer. A monoclonal antibody, it is the first FDA-approved product that prevents the formation of new blood vessels, a process known as angiogene-sis. Avastin™ extended patients’ lives by about five months when it was given intravenously as a combination treatment with standard chemotherapy drugs for colon cancer in a regimen consisting of ironotecan, 5-fluorouracil …
Oxaliplatin for injection (Eloxatin™, Sanofi-Synthelabo/Debiopharm SA), in combination with 5-fluorouracil/leuco-vorin (5-FU/LV), has been approved by the FDA for the first-line treatment of advanced colorectal cancer. Eloxatin™ was approved in 2002 for the second-line treatment of patients with metastatic carcinoma of the colon or rectum.
In a study sponsored by the National Cancer Institute and coordinated by the North Central Cancer Treatment Group (NCCTG), patients treated first with Eloxatin™, combined with infusional 5-FU/LV (the FOLFOX regimen), experienced an overall median survival time of 19.4 months after starting therapy. Patients taking a standard combination of irinotecan (Camptosar®, Pharmacia & Upjohn) plus 5-FU/LV (the IFL regimen) had a median survival time of 14.6 months; therefore, the median survival advantage for the FOLFOX patients was 4.8 months (a 35% improvement). The FOLFOX group reported less severe, more manageable, and more reversible side effects than the IFL group did.)