10 notable developments and events in cancer research and care
1. ESAs and the national coverage decision: The Centers for Medicare and Medicaid Services national coverage decision limiting reimbursement of erythropoiesis-stimulating agents (ESAs) in cancer patients to low-dose levels continues to be hotly debated. In March, US Food and Drug Administration (FDA)-revised product labeling strongly advised physicians to use the lowest possible ESA dose to increase hemoglobin level to the point that a blood transfusion may be avoided. In October, the American Society of Clinical Oncology (ASCO) and the American Society of Hematology announced updated ESA guidelines consistent with drug labeling.
2. Sorafenib (Nexavar) and hepatocellular carcinoma (HCC): FDA approved sorafenib for treatment of patients with HCC in November (see page 1745), based on the pivotal international phase III SHARP study, which showed that sorafenib improved overall survival in patients with previously untreated advanced HCC by 44% (HR = 0.69, P = .0006), compared with placebo (median overall survival = 10.7 vs 7.9 months).
3. Advances in kidney cancer treatment: In May, FDA approved a third agent, temsirolimus (Torisel), for the treatment of renal cell carcinoma (RCC), based on data from a 626-patient randomized trial. Temsirolimus alone resulted in a significant improvement in overall survival (10.9 vs 7.3 months) and progression-free survival (5.5 vs 3.1 months) compared to interferon alone. Approval of temsirolimus followed approval of sorafenib (Nexavar, 2005) and sunitinib (Sutent, 2006) for treatment of RCC, together dramatically improving prognosis for patients with this disease.
4. Magnetic resonance imaging (MRI) scans and breast cancer: Dr. Christiane K. Kuhl, of the University of Bonn, Germany, investigated the sensitivity of MRI in more than 5,000 women, 167 of whom had confirmed ductal carcinoma in situ. MRI was positive for 153 (92%) of the 167 women, whereas mammography was positive for only 93 (65%). The American Cancer Society recommended that women with a 20% or higher risk of developing breast cancer add MRI to their annual breast cancer screening protocol.
5. Cetuximab (Erbitux) and colorectal cancer: For the first time, a single-agent monoclonal antibody produced a survival benefit in advanced colorectal cancer. Third-line cetuximab improved survival by 23% compared with best supportive care in the NCIC CO.17 trial reported at ASCO 2007 and published in The New England Journal of Medicine (see page 1748). In second-line treatment (the EPIC trial), patients receiving cetuximab/irinotecan (Camptosar) vs irinotecan alone had a 31% reduction in disease progression. In October, FDA approved cetuximab as a single agent for advanced colorectal cancer after failure of irinotecan and platinum-based chemotherapy.
6. Decline in breast cancer incidence linked to decline in use of postmenopausal hormonal therapy: As reported in the Journal of the National Cancer Institute, Dr. Karla Kerlikowske, of the University of California, San Francisco, and colleagues collected data on more than 600,000 mammograms performed on women ages 50 to 69. Use of hormone therapy declined by 7% between 2000 and 2002 and then by 34% between 2002 and 2003. Over the same period, breast cancer rates declined annually by 5%.
7. Decline in deaths due to cancer: Cancer death rates decreased on average 2.1% per year from 2002 through 2004, nearly twice the annual decrease of 1.1% per year from 1993 through 2002, as reported online in October and in the November 15 issue of Cancer. Death rates decreased for the majority of the top 15 cancers in both men and women.
8. HPV vaccine in head and neck cancer: Infection with the human papillomavirus (HPV) appears to be a significant factor in head and neck cancer, according to recent reports in Cancer and at ASCO 2007. At an ASCO symposium, Dr. Marshall Posner, of the Dana-Farber Cancer Institute, reported that HPV-related cancers are seen in 25% of community patients and that almost 50% of oropharynx cancers at Dana-Farber are HPV-positive.
9. Prophylactic cranial irradiation, brain metastases, and small-cell lung cancer: A randomized trial reported in The New England Journal of Medicine definitively found that preventive radiation therapy to the head reduced the incidence of symptomatic brain metastases and prolonged the disease-free and overall survival of patients with extensive small-cell lung cancer (SCLC) who had responded to chemotherapy. Irradiation was associated with a significant increase in disease-free (P = .0218) and overall survival (P = .0033). The incidence of brain metastases was 14.6% among irradiated patients vs 40.4% in the control group, and the 1-year survival rate was 27.1% for irradiated patients compared to 13.3% for controls.
10. Other new drug approvals/indications: October: topotecan (Hycamtin) for SCLC; ixabepilone (Ixempra) for breast cancer; nilotinib (Tasigna) for chronic myelogenous leukemia; docetaxel (Taxotere) combined with cisplatin/fluorouracil for induction therapy of locally advanced squamous cell carcinoma of the head and neck; September: raloxifene (Evista) to reduce breast cancer risk in postmenopausal women; alemtuzumab (Campath) for single-agent treatment of B-cell chronic lymphocytic leukemia; dexrazoxane (Totect) for extravasation symptoms from intravenous anthracycline chemotherapy; May: doxorubicin (Doxil) plus bortezomib (Velcade) in multiple myeloma patients given at least one prior therapy; dalteparin (Fragmin) to reduce recurrence of symptomatic venous thromboembolism in cancer patients; March: lapatinib (Tykerb) for breast cancer.