SYDNEY — One of the few randomized phase 3 trials ever conducted in mesothelioma has found that keyhole surgery did not improve survival when compared with the standard treatment of talc pleurodesis. Patients in both groups of the trial lived for around 12 months.
However, there was a significant improvement in secondary end points. The surgery, video-assisted thoracoscopic surgery (VATS) partial pleurectomy, significantly improved control of recurrent build-up of fluid in the lungs in the first 6 months after the procedure, and improved quality of life for 12 months.
The findings come from the from the MesoVATS trial, conducted in 196 patients over a period of 10 years, and presented here as a "Top Abstract" at the presidential session at the 15th World Conference on Lung Cancer.
These results raise the question of whether mesothelioma patients should be offered the surgical procedure, said principal investigator Robert Rintoul, MD, from Papworth Hospital, Cambridge, United Kingdom.
Mesothelioma, which is caused by asbestos dust and affects the lining of the lungs in the pleural cavity, is "a nasty aggressive type of cancer," he explained at a press conference. As the cancer grows in the lining, the cavity fills with fluid, the lungs collapse, and the patient becomes more and more breathless. There is no known cure, and the average survival is about 9 to 12 months.
"We have to look at this quality-of-life issue more carefully, and the medical community will have to assess whether it is worth offering surgery to these patients.... Although there was no increase in survival, these patients live for 12 to 13 months, and if you can improve their quality of life with a procedure that is fairly well tolerated, it's potentially worth it," he commented to Medscape Medical News. However, there is also a financial consideration, as the surgery is more expensive than standard talc pleurodesis, he added.
Appropriate Palliative Option
"VAT pleural pleurectomy is an appropriate palliative option, especially in better-risk patients," commented Valerie Rusch, MD, chief of the thoracic service at the Memorial Sloan-Kettering Cancer Center in New York City, who acted as discussant for the study.
Many patients are not candidates for treatment with curative intent, so determining the best algorithm for palliative care is very important," she said.
Compared with standard talc pleurodesis, this surgery offered better early control of effusion and better quality of life, but with slightly more adverse events and slightly higher cost (mostly in the high-risk patients), she commented. "So it gives better control of symptoms, but at some price, both financial and otherwise," she said.
However, there is a question of how the procedure compares for controlling effusion with other approaches, such as the PleurX catheter drainage, she said.
Dr. Rusch congratulated Dr. Rintoul and colleagues on a "very well-designed and very well-performed trial," which has now "set the standard for trial design in mesothelioma." She also congratulated the researchers for their perseverance over the 10 years that it took to complete the study.
Compared With Traditional Approach
Historically, mesothelioma has been treated with talc pleurodesis, which involves inserting a tube into the lining cavity, removing the accumulated fluid, allowing the lung to reinflate, and then inserting talc, which encourages the lining to stick together.
With the VATS partial pleurectomy procedure, the surgeon removes as much as possible of the tumor growing in the lining and the outside of the lungs, Dr. Rintoul explained. "It's not always possible to get all of the tumor," he commented, but previous nonrandomized studies suggested it can improve survival when compared with historical data on talc pleurodesis.
However, the randomized MesoVATS did not show any survival advantage. The 1-year survival rate was 57% for the talc group and 52% in the pleurectomy group (hazard ratio, 1.03; P =.83).
These patients had very advanced disease, and they were well matched between the 2 groups, Dr. Rintoul noted. The average age was 69 years, and 85% of patients were male.
Among the secondary end point measures, pleural effusion was controlled in 37% of talc and 59% pleurectomy patients at 1 month (P = .008) and in 57% of talc and 76% pleurectomy patients at 6 months (P = .04), although by 9 and 12 months this difference between the groups had disappeared. Quality of life (measured on EQ5D) was significantly better in the pleurectomy group at both 6 and 12 months.
However, the median hospital stay was longer in pleurectomy patients (8 days [range, 1 - 31] vs 6 days [range, 1 - 15]; P < .001), and this group had significantly more complications, predominantly prolonged air leak (26% vs 8%; P = .009). But there was no difference in serious adverse events, Dr. Rintoul added.
He summarized the take-home message as follows: "Although there is no difference in survival, we feel that the improvement in symptom control and quality of life now raises the question of whether patients with mesothelioma should be offered this type of key hole surgery."
The trial was funded by BUPA Foundation UK. Dr. Rintoul reports serving on the advisory board of Lilly. Dr. Rusch has disclosed no relevant financial relationships.
15th World Conference on Lung Cancer (WCLC): Abstract PLO3. Presented October 29, 2013.
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Cite this: MesoVATS: Improved Symptoms, Not Survival, in Mesothelioma - Medscape - Oct 29, 2013.