ENDOSCOPY FOR NSCLC BEFORE SURGERY SAVES PATIENTS FROM SURGERY

July 14, 2011 (Amsterdam, the Netherlands) — New data support the use of endoscopic approaches in the initial staging process for nonsmall-cell lung cancer (NSCLC), using surgery as a backup.
Two presentations here at the 14th World Conference on Lung Cancer (WCLC) suggest that 40% to 45% of patients can be spared having to undergosurgery.
"Before performing lung cancer surgery, it's important to determine whether the cancer has spread to the lymph glands in the middle of the chest, or mediastinum," Robert Rintoul, MD, from Papworth Hospital, Cambridge, United Kingdom, explained at a press briefing held during the meeting.
"It's an important clinical issue," he noted. If the cancer has already spread to the mediastinum, a surgical operation to attempt to remove the tumor might not be appropriate, he said, adding that those patients would be treated with chemoradiation instead.

Historically, this determination has been made in an exploratory operation, such as a mediastinoscopy. "Not so many years ago, everyone would undergo this procedure," said Richard Gralla, MD, chief of hematology-oncology and vice president of cancer services at North Shore University Hospital and the Long Island Jewish Medical Center in New York, who moderated the press conference. Over the past 10 years or so, there has been a move toward using nonsurgical techniques for this determination, such as endobronchial ultrasound (EBUS) and endoesophageal ultrasound (EUS), he explained. These approaches involve an outpatient visit instead of an overnight stay for surgery. "You can see how this is practice-changing," he noted.
The new data discussed at the meeting, from 2 separate studies, suggest that these endoscopic techniques work in about half of patients, Dr. Gralla said. In the other patients, in whom the endoscopic findings are negative, exploratory surgery is still required.
Endoscopy More Effective
Dr. Rintoul presented new data from the recently published ASTER study (JAMA. 2010;304:2245-2252), in which he was an investigator. This was a randomized trial comparing surgical staging (mediastinoscopy) with combined EBUS/EUS in 241 patients with resectable (suspected) NSCLC, and was conducted in Belgium and the United Kingdom.
Among the 123 patients randomized to endoscopy, nodal metastases were found in 56 (46%). If the endoscopy was negative, patients went on to have a mediastinoscopy; together, these procedures found nodal metastases in 62 patients (50%).
Among the 118 patients randomized to surgical staging, nodal metastases were found in 41 (35%),
This corresponds to sensitivities of 85% for endoscopy alone, 94% for endoscopy followed by surgery, and 79% for surgery alone.
These findings show that the endoscopic approach, with mediastinoscopy as a backup if endoscopy did not show any evidence of cancer, was more effective than using mediastinoscopy alone, Dr. Rintoul told those attending the briefing.
The new data reported at the WCLC also showed that patients who underwent endoscopy had better a quality of life, and that the endoscopic approach resulted in a cost saving of approximately £746 (US$1210) per patient. For patients who underwent only an endoscopy and did not go on to surgical staging, the cost saving was even higher, around £2124 (US$3450) per patient.
Dr. Rintoul suggested that these results should change clinical practice.
"Given that assessment of lymph glands using the endoscopic approach was more effective, better tolerated by patients, and no more expensive than surgical approaches, we recommend that investigation should commence with the endoscopic tests, reserving the surgical tests as a backup if the endoscopic approaches do not show any evidence of cancer," Dr. Rintoul concluded.
"Surgery Not Dead Yet"
However, another presentation at the meeting, which was highlighted in the same press briefing, suggested that surgery is more effective than endoscopy at finding metastases. "Surgery is not dead yet," declared lead investigator Marcin Zielinski, MD, from the Pulmonary Hospital in Zakopane, Poland.
Dr. Zielinski reported the largest study to date comparing surgery with endoscopy, involving more than 1000 patients. In this study, 617 patients underwent endoscopy (400 patients had EBUS, 55 had EUS, and 241 had combined EBUS/EUS) and 375 underwent surgery.
However, the surgery conducted in this study was a new technique, developed by Dr. Zielinski himself. Transcervical extended mediastinal lymphadenectomy (TEMLA) removes all the mediastinal nodal stations except 1, as well as surrounding fatty tissue, and is "extraordinarily complete," he explained.
Dr. Zielinski also suggested that "TEMLA should probably be regarded as a gold standard of primary staging and restaging of NSCLC, instead of mediastinoscopy."
The study results "show that TEMLA had a significantly higher diagnostic yield than endoscopic staging," Dr. Zielinski said.
"The sensitivity of TEMLA in discovering cancer in the primary staging was 98.6%, compared with 88.9% for EBUS/EUS," he reported. TEMLA had 100% specificity and 100% positive predictive value, compared with 98.7% and 99.1%, respectively, for EBUS/EUS. The negative predictive value was 99.7% for TEMLA, compared with 84.1% for EBUS/EUS.
Commenting on this study to Medscape Medical News, Dr. Gralla noted that the TEMLA surgery carried out here is more extensive than a standard mediastinoscopy, and would involve 2 days in hospital rather than an overnight stay.
Benefit of Initial Endoscopy
Despite the declarations of Dr. Zielinski about the superior surgical approach of TEMLA, Dr. Gralla emphasized the benefit of having an initial endoscopic procedure. In the Polish study, among the patients who underwent endoscopy initially, 60% went on to have surgical staging anyway because their endoscopy findings were negative, he pointed out
This means that 40% of patients did not undergo surgery at all because the endoscopy found cancer in the mediastinum; those patients went on to treatment with chemoradiation, Dr. Gralla explained.
This is similar to the the ASTER study, in which 55% of patients who underwent endoscopy went on to have surgical staging, he said. Again, this meant that 45% of patients did not undergo any surgery, he noted.
"This is the logical direction to go," Dr. Gralla said. Endoscopy is easier and simpler, and it should be used as the first step, "but of course we should combine" this approach with surgery, he added. There is still "a fair amount of argument and debate," and the noninvasive staging approaches are being improved, such as with the addition of positron emission tomography scanning to the ultrasound endoscopy.
The debate is set to continue, he noted. But the data presented from these 2 studies suggest that initial endoscopy can find metastases in nearly half of patients, and spares those patients from undergoing surgery. "That alone is practice-changing," he told Medscape Medical News.
The authors have disclosed no relevant financial relationships.
14th World Conference on Lung Cancer (WCLC): Abstract 840 (Rintoul), presented July 6, 2011; abstract 2593 (Zielinski), presented July 4, 2011.