麻豆传媒

CHICAGO -- The complication rate following lung biopsies performed to obtain enough genetic material to allow treatment with targeted biologic agents appears to be safe with a low level of adverse events, researchers reported here.

In the so-called MOSCATO trial, Clara Prud'homme, MD, chief assistant in radiology at Gustave Roussy Cancer Campus Grand Paris in Villejuif, France, reported that 10.2% of the biopsies obtained for molecular analysis resulted in some complications – with 51 of the 89 complications being pneumothorax, and less than 10% of the complications considered Grade 3 events.

There were no deaths attributable to the biopsy procedure in the entire series of 877 biopsies performed on 817 patients, she said at the here.

The researchers reported that 21 cases of hemorrhage occurred in connection with the procedure, and three of those cases required embolization. Most of the hemorrhages – 14 of them – were described as Grade 1 intra-alveolar bleeds.

Eight patients reported pain from the biopsy procedure that was greater than level 3 on a visual analog scale, Prud'homme said in her oral report.

Her team defined minor complications as those that could be resolved within the same procedural session without additional therapy or post-procedure sequelae, or if they needed a prolonged observational course such as an overnight hospital stay and no post-procedural sequelae.

A hospital stay of longer than 48 hours to resolve a complication was considered a Grade 3 event. Grade 4 events were those causing a permanent mild sequelae that did not greatly affect quality of life. Grade 5 events were those in which the patient required assisted living conditions. Grade 6 was death resulting from the procedure.

There were no grade 4, 5 or 6 complications from the procedure in the study, Prud'homme said.

In order to take advantage of new treatments in lung cancer, it sometimes involves additional procedures that can bring greater risk to patients, said Hyun Kim, MD, chief of interventional radiology at the Yale.

"The complication rate found in this study appears to be acceptable," Kim told 麻豆传媒. "If you can get a biopsy from an area other than the lung, the complication rate is almost zero. And even if you have a pneumothorax, most of those complications can be treated conservatively, without further intervention or admission to the hospital."

"Even though these biopsies to obtain molecular material is minimally invasive, it is still an invasive procedure. However, at the present time, if you want to do genomics and you want to do an immuno-profile, the only way currently that you can get the data from the tumor that you are treating is from a biopsy. You get more accurate data and you can act on it. Therefore the biopsy is a necessary step," he added.

"In the future, this step might be replaced by analyzing circulating serum tumor cells," Kim said. "But we don't know yet if this will work. We need to biopsy the recurrent tumor because the genetics of the metastatic lesions can be different from the [original] tumor."

To be eligible for the study, patients had to be considered incurable by the institutional tumor board, and the patients had to have at least one tumor of at least 2 cm. The patients had to be in good performance status defined as ECOG 0-1.

About 45% of the metastatic lesions that were biopsied were located in the liver; about 26% were taken from the lungs, Prud'homme said. However, the complications arose mainly in biopsies taken from the lung. In fact, the risk of a complication for a biopsy of the lung was 15-fold greater than that of a biopsy taken from the the liver (P<0.01), she said.

There was also an increased risk of complications if doctors took multiple tumor samples (P=0.01), and there was a 63% increased risk of a complication if doctors had to penetrate deep into the organ to obtain a sample rather that getting genetic material from a tumor on the periphery (P=0.04).

Comment