Oncology Times:
doi: 10.1097/01.COT.0000294351.92772.61
Clinical Notes

CLINICAL NOTES

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▪ Thyroid Cancer Recurrence Predicted by Serum Thyroglobulin

Blood thyroglobulin measurements taken after thyroid stimulation can predict recurrent or persistent disease, indicating the need for periodic thyroglobulin testing in certain groups of patients, according to a study scheduled for publication in the Journal of Clinical Endocrinology & Metabolism and now available online.

“Historically thyroid cancer recurrences have happened over many decades,” lead author Richard T. Kloos, MD, Associate Professor of Internal Medicine and Radiology at Ohio State University Comprehensive Cancer Center—Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, said in an interview.

“Typically patients seem to have entered into a period where they are thought to be free of disease, and it is then a surprise when the cancer comes back. Recurrences may appear 30 or even 40 years after the initial diagnosis. “This is cancer that has been undetected for all these years, and it has flown under the doctor's radar.”

The positive predictive level of stimulated serum thyroglobulin levels has been low, Dr. Kloos and his coauthor Ernest L. Mazzaferri, MD, wrote, spurring them to conduct a prospective follow-up study to determine the accuracy of a single stimulated thyroglobulin measurement over time.

The study included 107 patients, average age 36, with papillary, follicular, or Hürthle cell carcinoma who had surgery and radioactive iodine treatment. Between January 1999 and March 2001, the participants, 88 of whom were women and 19 of whom were men, were injected with thyrotropin alfa (Thyrogen) and tested for thyroglobulin level.

The patients were split into three groups, depending on their initial thyroglobulin level—Group 1 had a level less than 0.5 ng/mL (68 patients); Group 2 had a level of 0.6 to 2.0 ng/mL (19 patients); and Group 3 had a level greater than 2 ng/mL (20 patients).

Figure. Richard T. K...
Figure. Richard T. K...
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A single thyroglobulin level greater than 2 ng/mL predicted persistent tumor, while no value could indicate for certain that a patient would not have disease recurrence, the study found.

The positive predictive value of an initial thyroglobulin measurement greater than 2 ng/mL was 80%, and the negative predictive value of that measurement was 98%.

Tumor was identified in one patient in each of Groups 1 (1.6%) and 2 (5.5%) and 16 patients in Group 3 (80%). The thyroglobulin level, after being stimulated by thyroglobulin-stimulating hormone (TSH), spontaneously dropped to less than 0.5 ng/mL in 50% of Group 2 patients and 5% of Group 3 patients over 1.7 to 5.0 years.

Following re-treatment, 100% of Group 1, 74% of Group 2, and 55% of Group 3 patients had no evidence of tumor.

The authors recommended TSH-stimulated studies for patients at risk of recurrence, particularly those with a stimulated thyroglobulin level greater than 1 ng/mL.

“I think that patients with differentiated thyroid cancer who are thought to be free of disease need to undergo stimulation testing—it's the most important thing they can have done,” Dr. Kloos said.

An undetectable single TSH-stimulated thyroglobulin level—one less than 0.5 ng/mL—in patients without serum anti-thyroglobulin antibodies, has a 98% likelihood of identifying patients who are completely tumor-free.

The authors suggested that TSH suppression to low levels seems unnecessary in these patients, but an annual thyroglobulin measurement during TSH suppression is recommended.

“Now we've moved comparatively to a much more sensitive level of being able to figure out a restaging,” Dr. Kloos said.

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▪ NCI Report: High Rates of Cervical Cancer Indicate Broader Problems in Access to Care

A report from the National Cancer Institute found that high rates of cervical cancer are indicators of larger problems in access to health care. The report also found that cervical cancer mortality, which is higher in certain geographic areas and populations, is a marker for other health disparities.

The authors, from the NCI's Center to Reduce Cancer Health Disparities (CRCHD), concluded that the nation's public health system must improve its delivery of cervical cancer education, screening, and treatment and related health care to women at risk.

Despite a consistent decline in cervical cancer deaths in the United States overall, patterns of high cervical cancer mortality have existed for decades in specific geographic areas and populations, a news release noted.

Figure. Harold P. Fr...
Figure. Harold P. Fr...
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Those groups with the highest mortality rates include African American women in the South, Hispanic women along the Texas-Mexico border, white women in Appalachia, American Indians of the Northern Plains, Vietnamese American women, and Alaska Natives.

The authors hypothesize that cervical cancer is an indicator of larger health system concerns, including medical care access, cultural issues, and health communication and education issues.

To examine the underlying causes of this ongoing disparity, CRCHD embarked on a two-phase project, the Cervical Cancer Mortality Project. In the first phase, researchers reviewed the literature and analyzed both historical and current data on cervical cancer incidence, screening, treatment, and mortality in the US.

An analysis of the literature showed that women suffering from high cervical cancer mortality share several life conditions: They tend not to have a usual source of health care; they have lower rates of preventative health services, including cancer screening; they have low income and educational levels; and they live in regions with high rates of screenable and treatable diseases, such as breast cancer, colorectal cancer, cerebrovascular disease, and infant mortality.

The Center's Director, Harold P. Freeman, MD, emphasized the importance of efforts to find a solution to this problem: “Effectively addressing cervical cancer mortality can provide a model for action and an opportunity to address not only the health problems facing women who are dying from cervical cancer, but also the full set of human circumstances that lead to health disparities.”

The authors of the report outline specific actions and targeted interventions to eliminate cervical cancer mortality disparities. These actions fall into four key strategy areas: “access” (services, outreach, and navigation); “information and communication”; “collaborations, partnerships, and advocacy”; and “research.”

The authors recommend that health care workers intensify outreach to women who have rarely or never been screened for cervical, breast, or colon cancers and other screenable diseases.

To achieve this outreach, the report suggests that it is very important for women at risk for cervical cancer and other cancers to have a “medical home”—a usual source of medical care where they can receive screening and counseling, experience continuity of care, and build relationships with the medical caregivers.

The authors also recommend pairing all women with patient navigators at local hospitals or primary health centers, who can help at-risk women through the health system once an abnormality has been detected. Increased patient navigator programs would help improve communication between primary care, screening services, and follow-up/treatment at hospitals.

The report also suggests strategies to remove cultural and economic barriers to care. When only male physicians are available to conduct examinations, distrust and cultural taboos may cause at-risk women to avoid screening. Increasing the number of female providers, particularly those of the patient's race/ethnicity, is thus an important step in breaking down resistance to screening.

The report also calls for improved coverage and reimbursement for cancer-related services—specifically, that any uninsured woman with cervical or other cancer should be considered eligible for Medicaid or Medicare for the duration of her treatment and follow-up care.

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▪ Time under Anesthesia Influences Outcome after Head & Neck Surgery

The amount of time under general anesthesia and a patient's comorbidity, but not age, were linked to complications after head and neck surgery, according to a study published in the July issue of Archives of Otolaryngology—Head & Neck Surgery.

“There is a myth that the older the person is the less their physical reserve is, just based on their age,” said lead author Marina Boruk, MD, of State University of New York Downstate Medical Center. “We wanted to ask whether that's true or not.”

While she and her colleagues set out to investigate the effect of age on postsurgical outcome, they did not initially intend to investigate the effect of time under general anesthesia on outcome.

The rise in the number of elderly patients in the United States has resulted in more elderly patients requiring head and neck surgery, Dr. Boruk and her colleagues wrote.

There is controversy about the notion of age as linked to postsurgical outcome, they noted. There is growing concern that physicians will deny older patients curative treatment with radical surgical procedures in favor of more “‘conservative’” or palliative therapies.

The researchers reviewed medical records between January 1999 and January 2004. Included were 157 patients who had undergone ablative, reconstructive, and other major surgical procedures of the head and neck, including neck dissection, laryngectomy, maxillectomy, thyroidectomy with lymphadenectomy, and composite resection of the oral cavity with reconstruction, for both malignant and benign disease.

Of these patients, 20% were age 70 or older, with a range of 9 to 95. In the study, 59% of the participants were men. The time under general anesthesia ranged from 75 to 1,160 minutes, and the length of stay ranged from zero days (i.e., less than a 24-hour admission for observation) to 56 days.

“Time under general anesthesia was the only factor consistently linked to complications in multiple logistic regression and to hospital length of stay in multiple regression analysis,” the researchers said.

“Comorbidity was related to outcome in some analyses, but the effect size was smaller than for general anesthesia and the relationship was inconsistent. However, age of 70 years or older was not related to complications or hospital length of stay in any of the multivariate analyses.”

The odds of having a complication increased by 0.6% with every minute of anesthesia, which translated to a 36% increase in the odds of having a major complication for every 60 minutes under general anesthesia.

“Even patients who are older than 70 should be offered surgical procedures and surgical interventions,” Dr. Boruk said.

When asked the implications of the study for members of the cancer care team, she said, “It's just to be aware of the bias that one may have toward a patient who is over age 70.”

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▪ Laparoscopic Colorectal Surgery Shows Less Immune Disruption than Open Surgery

Laparoscopic colorectal surgery resulted in less of an inflammatory response and less suppression of the nonspecific immune response compared with open colorectal surgery, according to an article published in the July issue of Archives of Surgery.

The researchers, led by Matthias W. Wichmann, MD, of the Department of Surgery at Ludwig-Maximilians-Universität München in Munich, Germany, found that surgery's effects on the cell-mediated immune response, however, were comparable in both groups of patients.

These results are significant, because this study is the first to report a divergent effect on specific and nonspecific immunity of laparoscopic surgery for colorectal disease, he and his colleagues wrote.

Evidence has shown that laparoscopic surgery is feasible in most patients with benign disease and does not raise perioperative morbidity and mortality rates.

The Clinical Outcomes of Surgical Therapy Study Group recently reported that laparoscopic-assisted colectomy and open colectomy for colon cancer resulted in similar long-term outcomes in a multi-institutional setting, and a single-center study showed that laparoscopic surgery surpassed open surgery for colon cancer therapy when comparing morbidity, hospital stay, tumor recurrence, and cancer-related survival, Dr. Wichman and his coauthors wrote.

Only limited information is available regarding the perioperative immunological effects of laparoscopic surgery when compared with open bowel surgery—an issue of major clinical interest because the reduced surgical trauma should result in less immune dysfunction following surgery and, by extension, clinical and oncological advantages, according to the researchers.

They analyzed blood samples from 70 prospectively enrolled patients with colorectal diseases undergoing laparoscopic or open surgery, with 35 patients in each group. Samples were taken on the day before surgery and on the first, third, and fifth days after surgery.

In the study group, the mean age was 64, and in the control group, 62. In both groups most patients were men (71% in the study group, 57% in the control group) and had surgery for colorectal cancer (76% in the study group, 77% in the control group).

Patients in both groups had a significant surge in circulating C-reactive protein levels following surgery, but the increase was significantly higher in patients who had conventional surgery.

Serum IL-6 levels showed a similar significant rise in both groups on Day 5 after surgery, but patients in the open surgery group had significantly higher levels during the early postoperative period.

The levels of B and T lymphocytes and of helper and cytotoxic T-cells did not show significant differences between groups.

“Laparoscopic surgery is as safe as open colorectal surgery, and laparoscopic colorectal cancer surgery is feasible but should be performed within clinical studies and in surgical centers that have sufficient experience with laparoscopic colorectal surgery for benign diseases,” the researchers concluded.

“In addition to the ongoing discussion about the oncologic safety of the approach, it is still not completely clear whether the laparoscopic approach offers significant immunological advantages over the conventional open approach.”

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▪ Needle-free Injector Could Help More HIV Patients Use Salvage Therapy

A needle-free, gas-powered injection system can simplify use of enfuvirtide, the only antiretroviral used in combating HIV that has to be injected under the skin—and might allow more patients who have few remaining medical options to use the potentially life-saving product.

In an oral presentation at the 3rd International AIDS Society Conference on HIV Pathogenesis and Treatment, Marianne Harris, MD, Clinical Research Adviser at the British Columbia Centre for Excellence in HIV/AIDS, noted that the Biojector B2000 provides bioavailability that is similar to that of injection and that it has the potential to eliminate a number of the drawbacks of the use of enfuvirtide.

“The T-20 trough levels in patients receiving the drug through the Biojector appear to be exactly the same as with needle injection,” she said.

The device will make it easier for the drug to be delivered to patients twice a day, she noted, citing the following other advantages:

* The lack of needles will allow its use by former injecting drug users who are reluctant to use needles for fear of triggering a return to illicit use, as well as people who have “needle phobia” in general.

* Because the drug is dispersed under the skin when fired from the Biojector, it may reduce the number of injection site reactions and lesions caused with the bolus of drug deposited with a needle. Julio Montaner, MD, a co-researcher on the project, who is Professor of Medicine and Chair in AIDS Research at the University of British Columbia, said, “Many patients start to have bumps of hard tissue around their body after months of injecting themselves. The Biojector should relieve that problem.”

* The Biojector can be used with one hand, making for much easier injection.

In addition to those reasons, Celso Ramos, MD, Professor of Medicine at the Federal University of Rio de Janeiro, who was not involved in the research, said the Biojector also eliminates the need to dispose of used syringes.

“While there is little chance that these safe syringes could transmit disease, they, nevertheless, represent a health risk that has to be considered as well as these other factors,” Dr. Ramos said. “I think the Biojector will make a great difference in getting people to use T-20.” (Enfuvirtide's trade name is Fuzeon, also known as T-20.)

In the study, Dr. Harris recruited 33 HIV-infected individuals to use the device, teaching them how to use both the gas-powered instruments and needles. Eventually 23 of the patients switched to the Biojector.

Patients were asked to rate their injection site reactions on a scale of 0 to 31. The needle users scored 11; the Biojector users scored 5.5, indicating few if any reactions.

Dr. Harris said there were a few cases in which use of the Bioject close to joints appeared to cause nerve pain that in some cases radiated through a limb and caused numbness that lasted for weeks or months before resolving. However, only two individuals stopped use of the device due to those reactions.

Bioject, the company that makes the Biojector, filed for FDA approval in August for use of the device for delivering Fuzeon.

The study was funded by Bioject, and Trimeris and Roche, the pharmaceutical companies that developed the drug. A spokesperson for Roche said that patients or physicians interested in receiving information on expanded access for the Biojector should contact the specialty pharmacy house, BioScrip, www.bioscrip.com

© 2005 Lippincott Williams & Wilkins, Inc.

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