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Format: 04/20/2014
Format: 04/20/2014

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AGH Cancer Specialists Join Major NIH Study to Determine If Less Invasive Lung Surgery Benefits Patients

Thursday, December 3rd, 2009

PITTSBURGH – Researchers at Allegheny General Hospital are now investigating whether certain early-stage lung cancer patients are best treated by the standard surgical method of removing a large portion of the lung, or whether a less invasive surgery is just as effective in promoting disease-free survival.

Study Co-Chair Robert Keenan, MD, Chief of the Division of Thoracic Surgery for West Penn Allegheny Health System and Director of the Allegheny Center for Thoracic Surgery, said this important clinical trial could dramatically change how some early-stage lung cancer patients are treated. 

The study is being conducted by Cancer and Leukemia Group B and involves 117 leading medical centers across the country, including AGH. Other AGH/West Penn Allegheny Health System doctors involved in the clinical trial include Mathew Van Deusen, MD, Richard Maley, MD and Jason Lamb, MD.

Dr. Keenan, who serves as study co-chair, compared it to the 1970s clinical trials that established the efficacy of lumpectomy as an alternative to mastectomy in the treatment of many women with breast cancer. Studies by the now AGH-based National Adjuvant Breast and Bowel Project demonstrated that the less invasive removal of just the cancerous breast tumor (lumpectomy), combined with lymph node excision and radiation was as effective as the conventional mastectomy technique in which both breasts are removed.

“A lobectomy, in which 1/3 to ½ of the lung is removed, is now considered the standard of care for any size lung tumor,” Dr. Keenan said. “Do we need to remove so much lung? The time is right to revisit this question in a randomized, prospective way.”

The current trial compares a lobectomy to wedge resection or segmentectomy, in which only the tumor and a portion of the lobe is removed. The trial will measure disease-free survival of patients with small stage 1A lung cancers, tumors that do not appear to have spread.

Removal of a greater portion of the lung has health consequences for the patient both immediately and in the years following the surgery, Dr. Keenan said. Patients undergoing lobectomies lose about 20 percent of their total lung function, compared to 5 to 10 percent for those undergoing the less invasive options.

The best previous trial, by the Lung Cancer Study Group, found a significantly lower rate of regional cancer recurrence for patients who underwent lobectomies, but no significant difference overall in terms of disease-free survival. The investigators concluded lobectomies should remain the standard of care, but the study was criticized for its small sample size and inclusion of patients with tumors up to 3 centimeters in diameter.

The current trial focuses on tumors less than two centimeters in diameter; a size associated with a better survival rate compared with larger tumors. Retrospective studies have indicated this size tumor can be effectively treated with a lobectomy or limited resection (segmentectomy or wedge resection.)

Under Dr. Keenan’s direction, the “Phase III Randomized trial of lobectomy versus sublobar resection for small (<2 cm) peripheral non-small cell lung cancer” trial has begun enrolling patients at AGH. Researchers nationwide seek to enroll 1,297 patients with April 2012 as a final data collection date. Subjects will be randomly assigned to a particular surgical approach once it has been confirmed in the operating room that the tumor is 2 centimeters or less and that it has not spread.

Disease-free survival will be the primary outcome measured; secondary outcome includes overall survival, rate of regional or systemic recurrence, and pulmonary function six months following the surgery.

Lung cancer is the leading cause of cancer deaths in the United States for both men and woman, with about 200,000 cases diagnosed each year. It takes the lives of more than 160,000 people each year; a figure that is greater than colon, prostate, lymph and breast cancer combined. About six out of 10 people with lung cancer die within a year of diagnosis. Most cases, about 8 to 9 out of 10, are non-small cell lung cancer.

 

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