AMSTERDAM – Initial endosonographic assessment of mediastinal lymph node metastases in patients with resectable non–small cell lung cancer surpassed initial surgical staging not just in clinical outcomes but also with lower cost and better quality of life in a controlled, head-to-head comparison of the two staging approaches.
"Given that assessment of lymph nodes by the endoscopic approach was more effective [and] better tolerated by patients, and seems cheaper than the surgical approach, we recommend that endoscopic tests be used, reserving surgical tests as a backup if endoscopy does not show evidence of cancer," Dr. Robert C. Rintoul said in presenting the results of a follow-up analysis at the World Conference on Lung Cancer.
"We think this is the way forward, and that this will change practice globally," said Dr. Rintoul, lead physician for thoracic oncology at Papworth Hospital in Cambridge, England.
He reported new data and addressed implications of the totality of evidence now available from ASTER (Assessment of Surgical Staging vs. Endoscopic Ultrasound in Lung Cancer: A Randomized Clinical Trial) that was conducted in patients with potentially resectable NSCLC.
Although the overall weight of evidence now in from ASTER uniformly favors endosonography first, perhaps the most noteworthy findings from the study were those included in a report in JAMA last November: Endosonography first cut the rate of unnecessary thoracotomies to 7% compared with an 18% rate in patients assessed by mediastinoscopy first (P = .02). In addition, 45% of patients evaluated by endosonography first had positive lymph nodes and so avoided mediastinoscopy (JAMA 2010;304:2245-52).
"A few years ago, people said all these patients need mediastinoscopy. What we’ve learned [from ASTER] is that about half never need mediastinoscopy. That is practice changing," commented Dr. Richard Gralla, chief of hematology oncology at North Shore–Long Island Jewish Health System in New Hyde Park, N.Y. "As a rule, patients find EBUS [endobronchial ultrasound–guided transbronchial needle aspiration] and EUS [transesophageal ultrasound-guided fine-needle aspiration] much simpler procedures," compared with mediastinoscopy, he noted at the meeting, which was sponsored by the International Association for the Study of Lung Cancer.
The ASTER results that were published last year proved so compelling that many surgeons and thoracic oncologists have already switched to endosonography first, noted Dr. Jouke T. Annema, a thoracic surgeon at Leiden (the Netherlands) University and lead ASTER investigator.
"EBUS is the new standard," he said in an interview, noting that earlier this year the Dutch agency responsible for setting medical policy adopted endosonography as the preferred initial method for lymph node assessment in patients with resectable NSCLC. The National Institute for Health and Clinical Excellence (NICE), which sets U.K. health policies, did not name endosonography as the preferred initial staging method for lung cancer in its revised guidelines last April because the cost-effectiveness findings reported at the meeting had not yet been published, Dr. Rintoul said.
ASTER randomized 118 patients to initial mediastinoscopy staging and 123 to initial endosonographic staging at four medical centers in the United Kingdom, the Netherlands, and Belgium. The initial results reported last November also showed that initial endosonography followed by surgical staging in patients who were initially found to be node negative produced 94% sensitivity for finding positive lymph nodes, which was significantly better than the 79% sensitivity rate using mediastinoscopy first (P = .02).
Dr. Robert Rintoul
The additional analyses reported by Dr. Rintoul used patient quality of life assessment by the EQ-5D (EuroQol five-domain) instrument at baseline, immediately after staging, and again at 2 and 6 months after staging. Researchers ran EQ-5D assessments on 144 of the study’s 241 patients at baseline, and on 124 patients after 6 months. The results showed similar, average EQ-5D levels at baseline and after 2 and 6 months in the two arms of the trial; however, immediately after staging, the endosonography-first patients had a statistically significant edge in average quality of life of 0.117 EQ-5D units, compared with patients who were staged by mediastinoscopy first (P = .003).
Average medical costs rung up by patients over the 6 months of treatment after baseline were about £746 (about $1,200) less per patient using endosonography first, a difference that was not statistically significant but suggested that initial endosonographic staging produced better cost-effectiveness, Dr. Rintoul said. He also reported that initial endosonography led to an average gain per patient of 0.015 quality-adjusted life-years, an advantage over initial surgical staging that just missed statistical significance (P = .052).
ASTER received no commercial support, and Dr. Rintoul said that he had no disclosures. He said that Papworth Hospital has received unrestricted educational grants and equipment loans from Olympus. Dr. Gralla and Dr. Annema had no disclosures.