Addition of Taxotere® to Initial Therapy Improves Survival in Head and Neck Cancer

According to results presented at the 42nd annual meeting of the American Society of Clinical Oncology (ASCO), the addition of Taxotere® (docetaxel) to cisplatin (Platinol®) and fluorouracil (5-FU) as initial therapy significantly improves survival in patients with advanced head and neck cancer.

Approximately 40,000 people in the U.S. are diagnosed with head and neck cancer every year. Cancers of the head and neck include several types of cancers affecting the nasal cavity and sinuses, oral cavity, nasopharynx (upper part of throat, behind ear), oropharynx (middle part of throat, including soft palate, base of tongue, and tonsils), and other sites throughout the head and neck. In 2005 the American Cancer Society estimated that 11,000 people would die from head and neck cancer.

Advanced head and neck cancer refers to cancer that spreads from its site of origin to other sites in the body. Standard treatment for advanced head and neck cancer often includes the use of several chemotherapy agents, the targeted agent Erbitux® (cetuximab), and/or radiation therapy. Some patients are able to undergo the surgical removal of their cancer following treatment. Since long-term survival for advanced head and neck cancer remains suboptimal, researchers continue to evaluate new therapeutic and chemotherapy combinations to determine optimal treatment strategies for patients with head and neck cancer.

Researchers from Harvard Medical School reported results from a phase III trial (phase of trials prior to FDA review) comparing Taxotere/cisplatin/fluorouracil to cisplatin/fluoruracil only in patients with advanced head and neck cancer.

This trial included 538 patients with squamous cell advanced head and neck cancer. Approximately half of the patients were treated with Taxotere/cisplatin/fluorouracil and the other half received cisplatin/fluorouracil (control group). All patients were then treated with the chemotherapy agent carboplatin (Paraplatin®), radiation therapy, and in some cases, surgery.

Overall, patients were followed for a median of 42 months.
Patients initially treated with the addition of Taxotere had significantly improved survival.
At three years, 62% of patients treated with Taxotere/cisplatin/fluorouracil were alive, compared with only 48% of patients in the control group.
The side effects were comparable between the two treatment groups.
The most common side effects related to chemotherapy include mouth sores, nausea, vomiting, and low blood cell levels.
The researchers concluded that the addition of Taxotere to the standard cisplatin/fluorouracil as initial therapy in advanced head and neck cancer significantly improves survival when patients undergo subsequent chemotherapy and radiation therapy. The authors stated that the addition of Taxotere as initial therapy should now be considered the standard of care in advanced head and neck cancer. However, it is important for patients to discuss their individual risks and benefits of treatment including Taxotere with their physician.

Reference: Posner MR, Herchock D, Le Lann L, Devlin PM, Haddad RI. TAX 324: a phase III trial of TPF vs PF induction chemotherapy followed by chemoradiotherapy in locally advanced SCCHN: preliminary results of GORTEC 2000-1. Proceedings from the 42nd Annual Meeting of the American Society of Clinical Oncology; June 2-6, 2006; Atlanta, Georgia. Special session.

Related News: Erbitux® plus Induction Chemotherapy

Erbitux® plus Induction Chemotherapy Results in 100% Response Rate for Head and Neck Cancer

According to results presented at the 42nd annual meeting of the American Society of Clinical Oncology (ASCO), initial therapy for head and neck cancer that includes standard chemotherapy plus Erbitux® (cetuximab) provides anticancer responses in 100% of patients.

Approximately 40,000 people in the U.S. are diagnosed with head and neck cancer every year. Cancers of the head and neck include several types of cancers affecting the nasal cavity and sinuses, oral cavity, nasopharynx (upper part of throat, behind ear), oropharynx (middle part of throat, including soft palate, base of tongue, and tonsils), and other sites throughout the head and neck. In 2005 the American Cancer Society estimated that 11,000 people would die from head and neck cancer.

The epidermal growth factor receptor (EGFR) pathway is a biologic pathway that plays a role in cellular replication and is often over-expressed in cancer. Erbitux, a monoclonal antibody (or protein), is designed to bind to the EGFR and inhibit the receptor’s effects on cellular replication. This ultimately reduces or prevents growth and spread of cancer cells in some cancers.

Recently, Erbitux was approved by the FDA for use combination with radiation therapy for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (cancer that has spread from its site of origin but not to distant sites in the body), or as a single agent in recurrent or metastatic squamous cell carcinoma of the head and neck (cancer that has spread to distant sites in the body) that has progressed following prior platinum-based chemotherapy (chemotherapy agents including Platinol® [cisplatin] and Paraplatin® [carboplatin]). Erbitux continues to be evaluated in combination with different treatment regimens for various types of cancer.

Researchers recently conducted a clinical trial to evaluate the effectiveness of Erbitux in combination with chemotherapy including Taxol® (paclitaxel) and Paraplatin as initial therapy in patients with head and neck cancers. This trial included patients who did not have metastatic cancer; some patients also received treatment with surgery and/or radiation therapy, depending on the aggressiveness and/or extent of spread of their cancer.

100% of patients achieved anticancer responses.
83% of patients achieved a complete disappearance of cancer (complete response).
17% of patients achieved a partial disappearance of cancer (partial response).
Nearly one-quarter of patients were considered to be cancer-free following chemotherapy/Erbitux.
Currently, three patients have experienced a recurrence of their cancer.
Erbitux did not increase notable side effects; however, approximately half of patients treated with Erbitux experienced severe skin rash.
Longer follow-up will provide progression-free and overall survival data for these patients.
The researchers concluded that the addition of Erbitux to standard chemotherapy appears highly active in the treatment of head and neck cancer. Longer follow-up will provide additional data regarding this treatment option.

Reference: Kies M, Garden A, Holsinger C, et al. Induction Chemotherapy (CT) with Weekly Paclitaxel, Carboplatin, and Cetuximab for Squamous Cell carcinoma of the Head and Neck (HN). Proceedings from the 42nd annual meeting of the American Society of Clinical Oncology. June 2006. Atlanta, GA. Abstract 5520.

Smoking Marijuana Does Not Increase Risk of Lung or Head and Neck Cancers

According to results recently presented at the 2006 American Thoracic Society Annual Meeting, smoking marijuana, even in large quantities, does not increase the risk of lung or head and neck cancers.

Lung cancer remains the leading cause of cancer-related deaths in the U.S. Smoking tobacco cigarettes is the most well-known cause of lung cancer.

The incidence of head and neck cancer is also known to be increased among tobacco smokers. Since lung cancer and head and neck cancers have suboptimal long-term survival rates, researchers continue to evaluate ways to reduce the risks of developing these cancers or prevent their development altogether.

Smoking marijuana or “joints” has worried researchers about the potential of increasing risks of developing lung and/or head and neck cancers since it leaves four-times the amount of tar in the lungs as tobacco cigarettes. Furthermore, marijuana smokers tend to inhale large quantities of smoke into their lungs.

Researchers from the University of California in Los Angeles and the University of Michigan in Ann Arbor recently conducted a study to evaluate the potential relationship between marijuana use and the development of cancer.

This study included 611 individuals with lung cancer, 601 individuals with head and neck cancer, and 1,040 individuals who did not have cancer. People in the study were aged between 18 and 59 years, and several variables were evaluated between all groups of patients.

Individuals with a history of smoking marijuana did not have an increased risk of lung or head and neck cancers.
Even individuals who smoked marijuana from several years to several decades, including those who have smoked more than 22,000 joints with in their lifetime, did not have an increased risk of lung or head and neck cancers compared to individuals who did not smoke marijuana.
There were no differences in cancer rates among individuals who smoked fewer or larger amounts of marijuana.
The researchers concluded that smoking marijuana, even large amounts over extended periods of time, does not increase the risk of head and neck or lung cancers. However, the researchers stated that "it's never a good idea to take anything into your lungs, including marijuana smoke."

Reference: Tashkin D, et al. Marijuana Use and Lung Cancer: Results of a Case-Control Study. Proceedings from the 2006 annual meeting of the American Thoracic Society. Presented May 23, 2006.

Low-Dose Isotretinoin Does Not Reduce Subsequent Tumors in Head and Neck Cancers

According to an article recently published in the Journal of the National Cancer Institute, therapy with low-dose isotretinoin (13-cis-retinoic acid) does not reduce the rate of developing subsequent cancers in patients with head and neck cancer.

Approximately 40,000 people in the U.S. are diagnosed with head and neck cancer every year.

Cancers of the head and neck comprise several types of cancers affecting the nasal cavity and sinuses, oral cavity, nasopharynx (upper part of throat, behind ear), oropharynx (middle part of throat, including soft palate, base of tongue, and tonsils), and other sites throughout the head and neck. In 2005 the American Cancer Society estimated that 11,000 people would die from head and neck cancer.

Patients with early head and neck cancer, or cancer that has not spread far from its site of origin, may be susceptible to developing another cancer (second primary tumor) in the head and neck area or in another area in the body. Research continues in an effort to reduce these patients’ risk of developing a second primary tumor.

Isotretinoin is a derivative of vitamin A. Results from studies evaluating high doses of isotretinoin have produced some encouraging results. These results prompted researchers from several medical institutions in the U.S. and Canada to conduct a trial to evaluate low doses of isotretinoin in patients with early head and neck cancer.

This trial included 1,190 patients with early head and neck cancer who had been treated with surgery and/or radiation therapy. Patients were then treated with low-dose isotretinoin for 3 years or placebo (inactive substitute) for 3 years.

Patients treated with isotretinoin did not have better outcomes than those treated with placebo:

There was no significant difference between the rate of developing second primary tumors in either group of patients.
There was no significant difference in survival between the two groups of patients.
Patients who were current or former smokers had a higher rate of second primary tumors than patients who had not smoked; the lung and oral cavity were the most common sites.
Patients who were current smokers had a higher rate of death than former smokers and never-smokers.
The researchers concluded that low-dose isotretinoin does not reduce the risk of developing second primary tumors or improve survival in patients with early head and neck cancer.

Reference: Khuri F, Lee J, Lippman S, et al. Randomized Phase III Trial of Low-dose Isotretinoin for Prevention of Second Primary Tumors in Stage I and II Head and Neck Cancer Patients. Journal of the National Cancer Institute. 2006; 98: 441-450.

Levels of ET-1 Help Predict Outcomes of Nasopharyngeal Cancer

According to an article recently published in the journal Cancer, high levels of endothelin-1 (ET-1) prior to therapy are associated with a worse prognosis in patients with nasopharyngeal cancer.

The nasopharynx is the area above the soft palate (roof of the mouth) and behind the nose. Nasopharyngeal cancer (NPC) is considered a type of head and neck cancer. Approximately 40,000 people in the US are diagnosed with head and neck cancer every year.

Cancers of the head and neck comprise several types of cancer affecting the nasal cavity, sinuses, oral cavity, nasopharynx, oropharynx, and other sites throughout the head and neck. In 2005 the American Cancer Society estimated that 11,000 people would die from head and neck cancer that year.

Advanced nasopharyngeal cancer refers to cancer that has spread from its site of origin to different sites in the body. Patients with advanced nasopharyngeal cancer have different prognoses following standard therapies.

Researchers are evaluating different patient and disease variables, or “markers”, to help determine which patients are at a higher risk for developing cancer progression following standard therapies. Those at a higher risk for cancer spread or progression may benefit from more extensive or aggressive therapy.

Researchers from China recently conducted a study to evaluate a possible association between levels of ER-1, a molecule associated with the development and spread of cancer, and outcomes of patients with advanced nasopharyngeal cancer. Levels of ER-1 in a blood sample were measured in 62 patients with advanced nasopharyngeal prior to treatment; these levels were compared with 19 healthy patients (control group).

Patients with nasopharyngeal cancer had significantly higher levels of ER-1 than the control group.
At 2 years, patients with nasopharyngeal cancer who had lower levels of ER-1 had a survival rate with no cancer spread to distant sites of 81.1%, compared with 56.7% for those with higher levels of ER-1.
The researchers concluded that higher levels of ER-1 prior to treatment may indicate which patients with advanced nasopharyngeal cancer are at an increased risk of developing distant cancer spread following standard therapy. Future clinical trials will establish variables or markers that indicate which patients are at a higher risk of cancer spread and/or a worse prognosis than others. Patients with a poorer prognosis may benefit from more aggressive therapy or the participation in a clinical trial evaluating novel therapeutic strategies.

Patients diagnosed with nasopharyngeal cancer may wish to speak with their physician regarding their individual risks and benefits of participating in a clinical trial. Two sources of information regarding ongoing clinical trials include the National Cancer Institute (cancer.gov) and www.cancerconsultants.com.

Reference: Mai H-Q, Zeng Z-Y, Zhang C-Q, et al. Elevated Plasma Big ET-1 is Associated with Distant Failure in patients with Advanced-Stage Nasopharyngeal Carcinoma. Cancer. 2006; 206: 1548-1553.