Head and neck cancers are unusual, comprising roughly 6 to 7 percent of all cancers, and they are difficult to treat successfully, with a four-year survival rate following surgery and radiation of only 38 percent (excluding laryngeal cancers). That figure goes up slightly when chemotherapy is added, but overall survival rates have not changed significantly over the past 60 years.
Treating cancer can be a delicate balancing act, with physicians often juggling the timing and intensity of a variety of treatments, including surgery, radiation and chemotherapy over many months. Ironically, in some cases, less can be more. For example, physicians often counsel patients with prostate cancer to "watch and wait," essentially to do nothing until the cancer presents itself more aggressively.
Not so with head and neck cancer.
"We want to go after it as decisively and as quickly as possible," says Dr. David E. Schuller, director of the Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, "and that's what 'intensification therapy' allows us to do."
Schuller, who is also deputy director of The Ohio State University Comprehensive Cancer Center (OSUCCC), says the therapy was developed by an interdisciplinary team of clinician-scientists at The James, tracing its roots to work in the early '90s with Drs. John Grecula, Reinhard Gahbauer, Christopher Rhoades and others in the OSUCCC. Over the past decade, the research team has fine-tuned the approach with three clinical trials to try to maximize the resources to fight the cancer and minimize patient non-compliance.
The most recent version of the regimen began in 1999 and involves 43 patients with advanced head and neck cancers that could be treated surgically. All enrolled in a 2 and one-half month treatment plan consisting of chemotherapy (cisplatin) along with twice-daily radiation for the three days immediately prior to surgery, then more radiation intra-operatively, followed by weekly chemotherapy (cisplatin and paclitaxel) beginning just one week post-operatively. Further radiotherapy was added one month post-operatively for an additional 4 to 5 weeks.
"We are going after these advanced cancers very aggressively over a very short time span," says Schuller, "and thus we call it 'intensification therapy.' Patients in this regimen require a lot of support from everyone around them, including physicians, nurses, dietitians, social workers, and most importantly, from their family."
Patients with head and neck cancer sometimes have difficulty complying with treatment because it frequently involves facial reconstruction and the use of plastic or other man-made materials that can sometimes slow healing or complicate daily routines, like eating. That's one of the reasons why patient non-compliance in head and neck cancer trials is typically higher than in other kinds of cancer studies. In the most recent version of the "intensification therapy" trial, 21 percent of the patients chose not to follow through with treatment. "Given the demanding nature of the regimen, that number is understandable," says Schuller, noting it is lower than non-compliance rates in all studies previously reported in the literature for patients with similar stage malignancies.
Following treatment, 100 percent of patients had no disease at the original site or in the lymph nodes in the neck with a median follow-up at 14.6 months. Nine percent of the patients developed spread of their cancer to other parts of the body.
"We suspect micrometastases were already present at those sites before the 'intensification therapy' was given," says Schuller.
The results of the study are published in the June 15 issue of Cancer.
Schuller says long-term survival rates for patients who elect "intensification therapy" are promising, although longer follow-up is required for more complete data. The five-year survival rate among the first group of the patients in the study - those who began in 1993 - is 60 percent. The five-year survival rate of the second group, which began in 1996, is projected to be 76 percent. Further studies are planned to continue to evaluate this new regimen.